Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
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Proposed rule.
CFR Part: "42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 491, and 494"
RIN Number: "RIN 0938-AO91"
Citation: "78 FR 79082"
Document Number: "CMS-3178-P"
"Proposed Rules"
SUMMARY: This proposed rule would establish national emergency preparedness requirements for
We are proposing emergency preparedness requirements that 17 provider and supplier types must meet to participate in the
   EFFECTIVE DATE: To be assured consideration, comments must be received at one of the addresses provided below, no later than
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Acronyms
AAR/IP After Action Report/Improvement Plan
ACHE
AHA
ASC Ambulatory Surgical Center
ARCAH Accreditation Requirements for Critical Access Hospitals
ASPR Assistant Secretary for Preparedness and Response
BTCDP Bioterrorism Training and Curriculum Development Program
CAMCAH Comprehensive Accreditation Manual for Critical Access Hospitals
CAMH Comprehensive Accreditation Manual for Hospitals
CASPER Certification and the Survey Provider Enhanced Reporting
CFC Conditions for Coverage
CHAP Community Health Accreditation Program
COI Collection of Information
COP Conditions of Participation
CORF Comprehensive Outpatient Rehabilitation Facilities
CRI Cities Readiness Initiative
DPU Distinct Part Units
DSA Donation Service Area
EOP Emergency Operations Plans
EC Environment of Care
EMP Emergency Management Plan
EP Emergency Preparedness
ESF Emergency Support Function
ESRD End-Stage Renal Disease
FEMA
GAO
HFAP Healthcare Facilities Accreditation Program
HHA Home Health Agencies
HPP Hospital Preparedness Program
HSEEP Homeland Security Exercise and Evaluation Program
HSPD Homeland Security Presidential Directive
HVA Hazard Vulnerability Analysis
ICFs/IID Intermediate Care Facilities for Individuals with Intellectual Disabilities
ICR Information Collection Requirements
JPATS Joint Patient Assessment and Tracking System
LD Leadership
LPHA Local Public Health Agencies
LSC Life Safety Code
LTC Long Term Care
MMRS Metropolitan Medical Response System
MS Medical Staff
NDMS National Disaster Medical System
NF Nursing Facilities
NIMS National Incident Management System
NLTN National Laboratory Training Network
NRP National Response Plan
NRF National Response Framework
NSS National Security Staff
OBRA Omnibus Budget Reconciliation Act
OPT Outpatient Physical Therapy
OPTN Organ Procurement and Transplantation Network
PACE Program for the All-Inclusive Care for the Elderly
PAHPA Pandemic and All-Hazards Preparedness Act
PHEP Public Health Emergency Preparedness
PIN Policy Information Notice
PPD Presidential Policy Directive
PRTF Psychiatric Residential Treatment Facilities
QAPI Quality Assessment and Performance Improvement
QIES Quality Improvement and Evaluation System
RFA Regulatory Flexibility Act
RNHCI Religious Nonmedical Health Care Institutions
SLP Speech Language Pathology
SNF Skilled Nursing Facility
SNS Strategic National Stockpile
TEFRA Tax Equity and Fiscal Responsibility Act
TJC
TTX Tabletop Exercise
UMRA Unfunded Mandates Reform Act
UPMC
WHO
Table of Contents
I. Overview
   A. Executive Summary
   1. Purpose
   2. Summary of the Major Provisions
   B. Current State of Emergency Preparedness
   1. Federal Emergency Preparedness
   2. State and Local Emergency Preparedness
   3. Hospital Preparedness
   4. GAO and OIG Reports
   C. Statutory and Regulatory Background
II. Provisions of the Proposed Regulation
   A. Emergency Preparedness Regulations for Hospitals (
   1. Emergency Plan
   a. Emergency Planning Resources
   b. Risk Assessment
   c. Patient Population and Available Services
   d. Succession Planning and Cooperative Efforts
   2. Policies and Procedures
   3. Communication Plan
   4. Training and Testing
   B. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions (RNHCIs) (
   C. Emergency Preparedness Regulations for Ambulatory Surgical Centers (ASCs) (
   D. Emergency Preparedness Regulations for Hospice (
   E. Emergency Preparedness Regulations for Inpatient Psychiatric Residential Treatment Facilities (PRTFs) (
   F. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly (PACE) (
   G. Emergency Preparedness Regulations for Transplant Centers (
   H. Emergency Preparedness Regulations for
   I. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) (
   J. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (
   K. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation Facilities (CORFs) (
   L. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (
   M. Emergency Preparedness Regulations for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (
   N. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (
   O. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) (
   P. Emergency Preparedness Regulations for
   Q. Emergency Preparedness Regulations for End-Stage Renal Disease (ESRD) Facilities (
III. Collection of Information
   A. Factors Influencing ICR Burden Estimates
   B. Sources of Data Used in Estimates of Burden Hours and Cost Estimates
   C. ICRs Regarding Condition of Participation: Emergency Preparedness (
   D. ICRs Regarding Condition for Coverage: Emergency Preparedness (
   E. ICRs Regarding Condition of Participation: Emergency Preparedness (
   F. ICRs Regarding Emergency Preparedness (
   G. ICRs Regarding Emergency Preparedness (
   H. ICRs Regarding Condition of Participation: Emergency Preparedness (
   I. ICRs Regarding Condition of Participation: Emergency Preparedness for Transplant Centers (
   J. ICRs Regarding Emergency Preparedness (
   K. ICRs Regarding Condition of Participation: Emergency Preparedness (
   L. ICRs Regarding Condition of Participation: Emergency Preparedness (
   M. ICRs Regarding Condition of Participation: Emergency Preparedness (
   N. ICRs Regarding Condition of Participation: Emergency Preparedness (
   O. ICRs Regarding Condition of Participation: Emergency Preparedness (
   P. ICRs Regarding Condition of Participation: Emergency Preparedness (
   Q. ICRs Regarding Condition of Participation: Emergency Preparedness (
   R. ICRs Regarding Condition of Participation: Emergency Preparedness (
   S. ICRs Regarding Condition of Participation: Emergency Preparedness (
   T. Summary of Information Collection Burden
IV. Regulatory Impact Analysis (RIA)
   A. Statement of Need
   B. Overall Impact
   C. Anticipated Effects on Providers and Suppliers: General Provisions
   D. Condition of Participation: Emergency Preparedness for Religious Nonmedical Health Care Institutions (RNHCIs)
   E. Condition for Coverage: Emergency Preparedness for Ambulatory Surgical Centers (ASCs)--Testing (
   F. Condition of Participation: Emergency Preparedness for Hospices--Testing (
   G. Emergency Preparedness for Psychiatric Residential Treatment Facilities (PRTFs) Training and Testing (
   H. Emergency Preparedness for Program for the All-Inclusive Care for the Elderly (PACE) Organizations--Training and Testing (
   I. Condition of Participation: Emergency Preparedness for Hospitals
   J. Condition of Participation: Emergency Preparedness for Transplant Centers
   K. Emergency Preparedness for
   L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs/IID)
   M. Condition of Participation: Emergency Preparedness for Home Health Agencies (HHAs)
   N. Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities (CORFs)-- (
   O. Condition of Participation: Emergency Preparedness for Critical Access Hospitals (CAHs)--Testing (
   P. Condition of Participation: Emergency Preparedness for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology ("Organizations")--Testing (
   Q. Condition of Participation: Emergency Preparedness for Community Mental Health Centers (CMHCs)--Training and Testing (
   R. Conditions of Participation: Emergency Preparedness for Organ Procurement Organizations (OPOs)--Training and Testing (
   S. Emergency Preparedness: Conditions for Certification for
   T. Condition of Participation: Emergency Preparedness for End-Stage Renal Disease Facilities (Dialysis Facilities)--Testing (
   U. Summary of the Total Costs
   V. Benefits of the Proposed Rule
   W. Alternatives Considered
   X. Accounting Statement
Appendix--Emergency Preparedness Resource Documents and Sites
I. Overview
A. Executive Summary
1. Purpose
   Over the past several years,
   In preparing this proposed rule, we reviewed the guidance, developed by the
   We also reviewed existing
   Based on our analysis of the written reports, articles, and studies, as well as on our ongoing dialogue with representatives from the federal, state, and local levels and with various stakeholders, we believe that, currently, in the event of a disaster, health care providers and suppliers across the nation would not have the necessary emergency planning and preparation in place to adequately protect the health and safety of their patients. Underlying this problem is the pressing need for a more consistent regulatory approach that would ensure that providers and suppliers nationwide are required to plan for and respond to emergencies and disasters that directly impact patients, residents, clients, participants, and their communities. As we have learned from past events and disasters, the current regulatory patchwork of federal, state, and local laws and guidelines, combined with the various accrediting organization emergency preparedness standards, falls far short of what is needed to require that health care providers and suppliers be adequately prepared for a disaster. Thus, we are proposing these emergency preparedness requirements to establish a comprehensive, consistent, flexible, and dynamic regulatory approach to emergency preparedness and response that incorporates the lessons learned from the past, combined with the proven best practices of the present. We recognize that central to this approach is to develop and guide emergency preparedness and response within the framework of our national health care system. To this end, these proposed regulations would also encourage providers and suppliers to coordinate their preparedness efforts within their own communities and states as well as across state lines, as necessary to achieve their goals. We are soliciting comments on whether certain requirements should be implemented on a staggered basis.
2. Summary of the Major Provisions
   We are proposing emergency preparedness requirements that will be consistent and enforceable for all affected
   Based on our research and consultation with stakeholders, we have identified four core elements that are central to an effective and comprehensive framework of emergency preparedness requirements for the various
    * Risk assessment and planning: This proposed rule would propose that prior to establishing an emergency plan, a risk assessment would be performed based on utilizing an "all-hazards" approach. An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters. This approach is specific to the location of the provider and supplier considering the particular types of hazards which may most likely occur in their area.
    * Policies and procedures: We are proposing that facilities be required to develop and implement policies and procedures based on the emergency plan and risk assessment.
    * Communication plan: This proposed rule would require a facility to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. Patient care must be well-coordinated within the facility, across health care providers, and with state and local public health departments and emergency systems to protect patient health and safety in the event of a disaster.
    * Training and testing: We are proposing that a facility develop and maintain an emergency preparedness training and testing program. A well-organized, effective training program must include providing initial training in emergency preparedness policies and procedures. We propose that the facility ensure that staff can demonstrate knowledge of emergency procedures and provide this training at least annually. We would require that facilities conduct drills and exercises to test the emergency plan.
   We are seeking public comments on when these CoPs should be implemented.
1. Federal Emergency Preparedness
   In response to the
a. Presidential Directives
   Three Presidential Directives HSPD-5, HSPD-21 and PPD-8, require agencies to coordinate their emergency preparedness activities with each other and across federal, state, local, tribal, and territorial governments. Although these directives do not specifically require
b. Assistant Secretary for Preparedness and Response
   In
   ASPR also administers the Hospital Preparedness Program (HPP), which provides leadership and funding through grants and cooperative agreements to states, territories, and eligible municipalities to improve surge capacity and enhance community and hospital preparedness for public health emergencies. Through the work of its state partners, HPP has advanced the preparedness of hospitals and communities in numerous ways, including building healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the availability of beds and other resources using electronic systems, and developing communication systems that are interoperable with other response partners.
   The first response in a disaster is always local, and comprised of local government emergency services supplemented by state and volunteer organizations. This aspect of the "disaster response" is specifically coordinated by state and local authorities. When an incident overwhelms or is anticipated to overwhelm state resources, the Governor of a state or chief executive of a tribe may request federal assistance. In such cases, the affected local jurisdiction, tribe, state, and the federal government will collaborate to provide that necessary assistance. When it is clear that state capabilities will be exceeded, the Governor or the tribal executive can request federal assistance, including assistance under the Robert Stafford Disaster Relief and Emergency Assistance Act (Stafford Act). The Stafford Act authorizes the President to provide financial and other assistance to state and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts following Presidential emergency or major disaster declarations.
   The National Response Framework (NRF), a guide to how the nation should conduct all hazards responses, includes 15 Emergency Support Functions (ESFs), which are groupings of governmental and certain private sector capabilities into an organizational structure. The purpose of the ESFs is to provide support, resources, program implementation, and services that are most likely needed to save lives, protect property and the environment, restore essential services and critical infrastructure, and help victims and communities return to normal following domestic incidents. HHS is the primary agency responsible for ESF 8--Public Health and
   The Secretary of HHS leads all federal public health and medical response to public health and medical emergencies and incidents that are covered by the Stafford Act, via NRF, or the Public Health Service Act. Under the NRF, ESF 8 is coordinated by the Secretary of HHS principally through the Assistant Secretary for Preparedness and Response (ASPR). ESF 8--Public Health and
c.
   
   The Cities Readiness Initiative (CRI), led by CDC, is a federally funded pilot program to help cities increase their capacity to deliver medicines and medical supplies within 48 hours after recognition of a large-scale public health emergency such as a bioterrorism attack or a nuclear accident. More information on this effort can be found at: http://www.bt.cdc.gov/cri/. An evaluative report of this program since its inception, requested by the CDC, performed by the
   Given the heightened concern regarding the impact of various influenza outbreaks in recent years, the federal government has created a Web site with "one-step access to U.S. Government H1N1, Avian, and Pandemic Flu Information" at www.flu.gov. The Web site provides links to influenza guidance and information from federal agencies, such as the CDC, as well as checklists for pandemic preparedness. The information and links are found at http://www.flu.gov/professional/index.html. This Web site includes information for hospitals, long term care facilities, outpatient facilities, home health agencies, other health care providers, and clinicians. For example, the "Hospital Pandemic Influenza Planning Checklist" provides guidance on structure for planning and decision making; development of a written pandemic influenza plan; and elements of an influenza pandemic plan. The checklist is comprehensive and lists everything a hospital should do to prepare for a pandemic, from planning for coordination with local and regional planning and response groups to infection control.
2. State and Local Preparedness
   A review of studies and articles regarding readiness of state and local jurisdictions reveals that there is inconsistency in the level of emergency preparedness amongst states and need for improvement in certain areas. In a report by the
   An article entitled, "Public Health Response to Urgent Case Reports," published in Health Affairs (
   During a 4-month period of time, each LPHA was contacted several times and asked questions regarding triage procedures, what questions would be asked in the event of an urgent case being filed, next steps taken after receiving such a report, and who would be contacted. Although the LPHAs had a substantial role in community public health through prevention and treatment efforts, the authors found significant variation in performance and the systems in place to respond to such reports.
   We also reviewed an article published in
   Throughout the jurisdictions investigated, there were similarities noted in the shortage of nurses, the number of essential workers nearing retirement age, and the lack of epidemiologists, lab personnel, and public health nurses to meet potential needs. Such gaps in personnel infrastructure were found in many jurisdictions. In some jurisdictions, there was incomplete information regarding the demographics of persons who could be considered potentially vulnerable or part of an underserved population.
   In one situation, there was also great variability in the length of time it took to bring three suspicious cases to public health officers' attention and for these officers to realize that these cases were related. There was great variation in the public health officers' ability to rapidly alert the physician and hospital community of an outbreak. There was a lack of consensus regarding when to report a potential outbreak to the public. There also was wide variation in knowledge of public health legal authority, specifically, in regard to quarantine and its enforcement. We believe these findings to be typical of most states.
3. Hospital Preparedness
   Hospitals are the focal points for health care in their respective communities; thus, it is essential that hospitals have the capacity to respond in a timely and appropriate manner in the event of a natural or man-made disaster. Additionally, since
   In 2007, ASPR contracted with the
   The authors stated that major disasters can severely challenge the ability of healthcare systems to adequately care for large numbers of patients (surge capacity) or victims with unusual or highly specialized medical needs (surge capability) such as occurred with Hurricane Katrina. The authors further stated that addressing medical surge and medical system resilience requires implementing systems that can effectively manage medical and health responses, as well as developing and maintaining preparedness programs. There were numerous findings and conclusions in the 2007 report. The researchers found that since the start of the HPP in 2002, individual hospitals' disaster preparedness has improved significantly. The report found that hospital senior leadership is actively supporting and participating in preparedness activities, and disaster coordinators within hospitals have given sustained attention to preparedness and response planning efforts. Hospital emergency operations plans (EOPs) have become more comprehensive and, in many locations, are coordinated with community emergency plans and local hazards. Disaster training has become more rigorous and standardized; hospitals have stockpiled emergency supplies and medicines; situational awareness and communications are improving; and exercises are more frequent and of higher quality. The researchers also found improved collaboration and networking among and between hospitals, public health departments, and emergency management and response agencies. These coalitions are believed to represent the beginning of a coordinated community-wide approach to medical disaster response.
   However, ASPR Healthcare Preparedness Capabilities: National Guidance for Healthcare System Preparedness (2012) and CDC Public Health Preparedness Capabilities: National Standards for State and Local Planning (
4.
   Since Katrina, several studies regarding the preparedness of health care providers have been published. In general, these reports and studies point to a need for improved requirements to ensure that providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations.
   In response to a request from the
   The OIG also found that some facility administrators deviated, many significantly, from their emergency plans or worked beyond the plans, either because the plans were not updated or plans did not include instructions for certain circumstances. The report goes on to note that many of the nursing home emergency preparedness plans did not consider the following factors: the need to evacuate residents to alternate sites as evidenced by a formal agreement with a host facility; criteria to determine whether to evacuate residents or shelter them in place; a means by which an individual resident's care needs would be identified and met; and re-entry into the facility following an evacuation.
   Although some local communities were directly involved in the evacuation of their nursing home residents, other nursing homes received assistance with evacuation from resident and staff family members, parent corporations, and "sister facilities," according to the
   Based on this study, the
   We also reviewed several
   The GAO found that "hospital and nursing home administrators are often responsible for deciding whether to evacuate patients from their facilities due to disasters, including hurricanes or other natural disasters. State and local governments can order evacuations of the population or segments of the population during emergencies, but health care facilities may be exempt from these orders." The GAO found that hospitals and nursing home administrators evacuate only as a last resort and that these facilities' emergency plans are designed primarily to shelter in place. The GAO also found that administrators considered the availability of adequate resources to shelter in place, the risks to patients in deciding when to evacuate, the availability of transportation to move patients, the availability of receiving facilities to accept patients, and the destruction of the facility's or community's infrastructure.
   The GAO noted that nursing home administrators also must consider the fact that nursing home residents cannot care for themselves and generally have no home and no place to live other than the nursing home. Therefore, in the event of an evacuation, nursing homes also need to consider the necessity of locating facilities that can accommodate their residents for a long period of time.
   A second report from the GAO about the hurricanes' impact entitled, "Disaster Preparedness: Limitations in Federal Evacuation Assistance for Health Facilities Should be Addressed," (GAO-06-826) July, 2006, www.gao.gov/cgi-bin/getrpt?GAO-06-826), supports the findings noted in the first GAO report on the disasters. In addition, the GAO noted that the evacuation issues that facilities faced during and after the hurricanes occurred due to their inability to secure transportation when needed. Despite previously established contracts with transportation companies, demand for this assistance overwhelmed the supply of vehicles in the community.
   A third report, an after-event analysis entitled, "Hurricane Katrina: Status of Hospital Inpatient and Emergency Departments in the
   While this study focused specifically on patient care issues in the
   In another report from the GAO, an after-event analysis entitled, "Disaster Recovery: Past Experiences Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters," (GAO-09-437T
   In a report from the GAO, entitled, "Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to be Addressed," (GAO-09-909T
   In
C. Statutory and Regulatory Background
   Various sections of the Social Security Act (the Act) define the terms
   The following are the statutory and regulatory citations for the providers and suppliers for which we intend to propose emergency preparedness regulations:
    * Religious Nonmedical Health Care Institutions (RNHCIs)--section 1821 of the Act and 42 CFR 403.700 through 403.756.
    * Ambulatory Surgical Centers (ASCs)--section 1832(a)(2)(F)(i) of the Act and 42 CFR 416.40 through 416.49.
    * Hospices--section 1861(dd)(1) of the Act and 42 CFR 418.52 through 418.116.
    * Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs (PRTFs)--sections 1905(a) and 1905(h) of the Act and 42 CFR 441.150 through 441.182 and 42 CFR 483.350 through 483.376.
    * Programs of All-Inclusive Care for the Elderly (PACE)--sections 1894, 1905(a), and 1934 of the Act and 42 CFR 460.2 through 460.210.
    * Hospitals--section 1861(e)(9) of the Act and 42 CFR 482.1 through 482.66.
    * Transplant Centers--sections 1861(e)(9) and 1881(b)(1) of the Act and 42 CFR 482.68 through 482.104.
    *
    * Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID)--section 1905(d) of the Act and 42 CFR 483.400 through 483.480.
    * Home Health Agencies (HHAs)--sections 1861(o), 1891 of the Act and 42 CFR 484.1 through 484.55.
    * Comprehensive Outpatient Rehabilitation Facilities (CORFs)--section 1861(cc)(2) of the Act and 42 CFR 485.50 through 485.74.
    * Critical Access Hospitals (CAHs)--sections 1820 and 1861(mm) of the Act and 42 CFR 485.601 through 485.647.
    * Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services--section 1861(p) of the Act and 42 CFR 485.701 through 485.729.
    * Community Mental Health Centers (CMHCs)--section 1861(ff)(3)(B)(i)(ii) of the Act, section 1913(c)(1) of the PHS Act, and 42 CFR 410.110.
    * Organ Procurement Organizations (OPOs)--section 1138 of the Act and section 371 of the PHS Act and 42 CFR 486.301 through 486.348.
    *
    * End-Stage Renal Disease (ESRD) Facilities--sections 1881(b), 1881(c), 1881(f)(7) of the Act and 42 CFR 494.1 through 494.180.
   We considered proposing these regulations for each provider and supplier type individually, as we updated their CoPs or CfCs over time. However, for the reasons we have already discussed, we believe the most prudent course of action is to publish emergency preparedness requirements for
II. Provisions of the Proposed Regulations
   This proposed rule responds to concerns from the
   We are proposing requirements for facilities to ensure the continued provision of necessary care at the facility or, if needed, the evacuation and transfer of patients to a location that can supply necessary care. Regulations that address these functions too specifically may become outdated over time as technology and the nature of threats change. However, as our analysis of existing regulations, and the
   We have identified four core elements that we believe are central to an effective emergency preparedness system and must be addressed to offer a more comprehensive framework of emergency preparedness requirements for the various
   We believe many of the proposed elements of an emergency preparedness plan need to be conducted at the level of an individual facility. However, other elements may be addressed as effectively, and more efficiently, at a broader organizational level, for example, a system for preserving medical documentation. Our regulatory requirements for each provider and supplier type are based on the comprehensive emergency preparedness requirements that we are proposing for hospitals. Since we are aware that the application of the proposed regulatory language for hospitals may be inappropriate or overly burdensome for some providers and suppliers, we have used the proposed hospital requirements as a template for our proposed emergency preparedness regulations for other providers and suppliers but have specific proposed requirements tailored to each providers' and suppliers' unique needs. Any contracted services furnished to patients must be in compliance with all the facilities' CoPs and standards of this rule, and all services must be provided in a safe and effective manner.
   All providers and suppliers would be required to establish an emergency preparedness plan that addressed the four core elements noted previously. The proposed requirements vary based on the type of provider. We discuss the hospital requirements in detail at the beginning of this section. The subsequent discussion of the proposed requirements for all remaining providers and suppliers focuses on how the requirements differ from those proposed for hospitals and why.
   For example, because they are inpatient facilities, religious nonmedical health care institutions (RNHCIs), psychiatric residential treatment facilities (PRTFs), skilled nursing facilities and nursing homes (referred to in this document as long term care (LTC) facilities), intermediate care facilities individuals with intellectual disabilities (ICFs/IID), and critical access hospitals (CAHs) may have greater responsibility than outpatient facilities during an emergency for ensuring the health and safety of persons for whom they provide care, their employees, and volunteers. Thus, proposed requirements for RNHCIs, PRTFs, ICFs/IID, LTC facilities, and CAHs are similar to those proposed for hospitals.
   In the event of a natural or man-made disaster, providers and suppliers of outpatient services, such as ambulatory surgical centers (ASCs), programs of all-inclusive care for the elderly (PACE) organizations, home health agencies (HHAs), comprehensive outpatient rehabilitation facilities (CORFs), rural health clinics (RHCs), federally qualified health centers (FQHCs), and end stage renal disease (ESRD) facilities, may not open their facilities or may close them, sending patients and staff home or to a place where they can safely shelter in place. However, we recognize that outpatient facilities may find it necessary to shelter their patients until they can be evacuated or may be called upon to provide some level of care for community residents in the event of an emergency. For example, a CORF that is housed in a large building may open its doors to persons in the community who would otherwise have no place to go. The CORF may provide only shelter from the elements or may provide water, food, and basic self-care items, if available.
   Finally, given that some hospice facilities provide both inpatient and home based services, and that transplant centers and OPOs are unique in their provision of health care, our proposed requirements are tailored even more specifically to address the circumstances of these entities. We believe lessons learned following the 2005 hurricanes and subsequent disasters, such as the flooding in the Midwest in 2008, and the tornadoes and flooding in 2011 and 2012, have provided us with an opportunity to work collaboratively with the health care community to ensure best practices in emergency preparedness across providers and suppliers.
   It is important to point out that we expect that implementation of certain requirements that we propose for providers and suppliers would be different, based on the category of the provider or supplier. For example, we propose that nearly all providers and suppliers would be required to have policies and procedures to provide subsistence needs to staff and patients during an emergency. However, a small RHC's implementation of this requirement would be quite different from a large metropolitan hospital's implementation. Specifically, with respect the proposed requirement that hospitals, CAHs, inpatient hospice facilities, PRTFs, LTC facilities, ICFs/IID, and RNHCIs would be required to maintain various subsistence needs, we are requesting public comment regarding whether this should be a requirement and in what quantities and for what time period these subsistence needs would be maintained. Nevertheless, we expect that each facility would determine how to implement a requirement considering similar variables such as whether the provider might have the option of notifying staff and patients not to come to the facility due to an emergency; the number of staff and patients likely to be in the facility at the time of an emergency; whether the provider would have the capability of providing shelter, provisions, and health care to members of the community; and the amount of space within the facility available for storing provisions. Although various providers and suppliers utilize different nomenclature to describe the individuals for whom they provide care (patient, resident, client, or participant), unless otherwise indicated, we will use the term "patients" to refer to the individuals for whom the provider or supplier under discussion provides care.
   Data regarding the number of providers cited in this proposed rule were obtained from a variety of different CMS databases. The number of providers and suppliers deemed by accrediting organizations to meet the
   Data for CAHs that report having psychiatric and rehabilitation Distinct Part Units (DPUs) are from the Medicare Quality Improvement and Evaluation System (QIES)/Certification and the Survey Provider Enhanced Reporting (CASPER) system as of
   Note that the CMS OSCAR data system is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited facilities shown may not equal the total number of facilities.
   Discussion of the proposed regulatory provisions for each type of provider and supplier follows the discussion in this section of the hospital requirements in the order in which they would appear in the Code of Federal Regulations (CFR). However, our discussion of the hospital requirements includes a general discussion of the differences between our proposed requirements, based on whether providers and suppliers provide outpatient services or inpatient services or both. Thus, we encourage all providers to read the discussion of the proposed hospital emergency preparedness requirements in section II.A. of this proposed rule.
   This section also provides detailed discussion of each proposed hospital requirement, offers resources that providers and suppliers can use to meet these proposed requirements, offers a means to establish and maintain emergency preparedness for their facilities, and provides links to guidance materials and toolkits that can be used to help meet these requirements.
A. Emergency Preparedness Regulations for Hospitals (
   Section 1861(e) of the Act defines the term "hospital" and subsections (1) through (8) list requirements that a hospital must meet to be eligible for
   Section 1905(a) of the Act provides that
   As of
   Services provided by hospitals encompass inpatient and outpatient care for persons with various acute or chronic medical or psychiatric conditions, including patient care services provided in the emergency department. Hospitals are the focal points for health care in their respective communities; thus, it is essential that hospitals have the capacity to respond in a timely and appropriate manner in the event of a natural or man-made disaster. Additionally, since
   We are proposing a new requirement under 42 CFR 482.15 that would require that hospitals have both an emergency preparedness program and an emergency preparedness plan. Conceptually, an emergency preparedness program encompasses an approach to emergency preparedness that allows for continuous building of a comprehensive system of health care response to a natural or man-made emergency. We are also proposing that a hospital, and all other providers and suppliers, utilize an "all-hazards" approach in the preparation and delivery of emergency preparedness services in order to meet the health and safety needs of its patient population. The definition of "all hazards" is discussed later in this section under "Emergency Plan."
   We would expect that during an emergency, injured and ill individuals would seek health care services at a hospital or CAH, rather than from another provider or supplier. For example, during a pandemic, individuals with influenza-like symptoms are more likely to visit a hospital or CAH emergency department than an ASC. Typically, in the event of a chemical spill, affected individuals would not expect to receive emergency health care services at an LTC facility but would seek health care services at the hospital or CAH in their community. However, we believe it is imperative that each provider think in broader terms than their own facility, and plan for how they would serve similar and other healthcare facilities, as well as the whole community during and surrounding an emergency event. We believe the first step in emergency management is to develop an emergency plan. An emergency plan sets forth the actions for emergency response based on a risk assessment that addresses an "all-hazards approach" to medical and non-medical emergency events. In keeping with the emergency management industry and with strong recommendation from the Department's Assistant Secretary for Preparedness and Response (ASPR), we are proposing that all providers utilize an all-hazards approach to emergency response. We do not specify the quantity or the expected level of detail in which each hazard would be addressed by each provider; however, we do believe it would encourage the adoption of a well thought out, cohesive system of response both within and across provider types.
   Analysis of anticipated outcomes to the facility-based and community-based risk assessments would drive revision to the emergency preparedness program, the plan for response, or both. A facility-based risk assessment is contained within the actual facility and carried out by the facility. A community based risk assessment is carried out outside the organization within their defined community.
1. Emergency Plan
a. Emergency Planning Resources
   To stimulate and foster improved emergency preparedness continuity of operations, the federal interagency community has developed fifteen all-hazards planning scenarios, entitled the "National Planning Scenarios" for use in federal, state, and local homeland security preparedness activities. These scenarios serve as planning tools for response to the range of man-made and natural disasters the nation could face. The scenarios are: nuclear detonation-improvised nuclear device; biological attack--aerosol anthrax; biological disease outbreak--pandemic influenza; biological attack--plague; chemical attack--blister agent; chemical attack--toxic industrial chemicals; chemical attack--nerve agent; chemical attack--chlorine tank explosion; natural disaster--major earthquake; and natural disaster--major hurricane; radiological attack--radiological dispersal devices; explosive attack--bombing using improvised explosive device; biological attack--food contamination; biological attack--foreign animal disease (foot and mouth disease); and cyber attack. Additional scenarios include volcano preparedness and severe winter weather (snow/ice). Additional information regarding the National Planning Scenarios and how they align to the National Preparedness Goal can be found at: http://www.fema.gov/preparedness-1/learn-about-presidential-policy-directive-8#MajorElements.
   These planning tools along with other emergency management and business continuity information can be found on HRSA's Web site at: http://www.hrsa.gov/emergency/ and also in HRSA's, Policy Information Notice entitled, "Health Center Emergency Management Program Expectations," (No. 2007-15), dated
   
   Also of concern when developing an emergency plan is the issue of the allocation of scarce resources during a potentially devastating event. Disasters can create situations where such resources must be distributed in a manner that is different from usual circumstances, but still appropriate to the situation. As discussed in "Providing Mass Medical Care with Scarce Resources: A Community Planning Guide, Publication No. 07-0001,
   Another resource that would be useful in helping planners address the issues associated with preparing for and responding to an MCE in the context of broader emergency planning processes is the document entitled, "Standing Together: An Emergency Planning Guide for America's Communities" (published by
   Rural communities face challenges in the delivery of health care that are often very different from those faced by urban and suburban communities. While rural communities depend on public health departments, hospitals, and emergency medical services (EMS) providers just as urban and suburban communities do, rural communities tend to have fewer health care resources overall. A report entitled, "Rural Communities and Emergency Preparedness," (published by the
   The authors report that there are many factors that limit the ability of rural providers and suppliers to deliver optimal health care services in the event of a natural or man-made disaster. The authors found that geographic isolation is a significant barrier to providing a coordinated emergency response. Rural areas are also more affected by variations in weather conditions and by seasonal variations in populations (for instance, tourism). As reported by the authors, these areas have fewer human and technical resources (that is, health care professionals, medical equipment, and communication systems).
   For example, the study found that in 2002, only 20 percent of the 3,000 local public health departments in
b. Risk Assessment
   To ensure that all hospitals operate as part of a coordinated emergency preparedness system, as outlined in the PPD-8, NIMS, NRF, HSPD-21, and PAHPA/PAHPRA, we are proposing at
   In keeping with the focus of the emergency management field, we propose that prior to establishing an emergency preparedness plan, the hospital and all other providers would first perform a risk assessment based on utilizing an "all-hazards" approach. An all-hazards approach is an integrated approach to emergency preparedness planning. In the abstract of a
   It is imperative that hospitals perform all-hazards risk assessment consistent with the concepts outlined in the National Preparedness Guidelines, the "Guidelines" published by the
   Additionally, AHRQ published two additional guides to help hospital planners and administrators make important decisions about how to protect patients and health care workers and assess the physical components of a hospital when a natural or manmade disaster, terrorist attack, or other catastrophic event threatens the soundness of a facility. The guides examine how hospital personnel have coped under emergency situations in the past to better understand what factors should be considered when making evacuation, shelter-in-place, and reoccupation decisions.
   The guides entitled, "Hospital Evacuation Decision Guide" and "Hospital Assessment and Recovery Guide" are intended to supplement hospital emergency plans, augment guidance on determining how long a decision to evacuate may be safely deferred, and provide guidance on how to organize an initial assessment of a hospital to determine when it is safe to return after an evacuation.
   The evacuation guide distinguishes between "pre-event evacuations" which are undertaken in advance of an impending disaster, such as a storm, when the hospital structure and surrounding environment are not yet significantly compromised and "post-event evacuations," which are carried out after a disaster has damaged a hospital or the surrounding community. It draws upon past events including: the
   The assessment and recovery guide helps hospitals determine when to get back into a hospital after an evacuation. Comprised primarily of a 45-page checklist, the guide covers 11 separate areas of hospital infrastructure that should be evaluated before determining that it is safe to reoccupy a facility, such as security and fire safety, information technology and communication and biomedical engineering.
   The "Hospital Evacuation Decision Guide" can be found at: http://archive.ahrq.gov/prep/hospevacguide/) (AHRQ Publication No. 10-0009), and the " Hospital Assessment and Recovery Guide" can be found at (http://archive.ahrq.gov/prep/hosprecovery/) (AHRQ Publication No. 10-0081).
   Based on the guidance and information in these resources, we would expect a hospital's risk assessment, which we would require at
   We propose at
c. Patient Population and Available Services
   At SEC 482.15(a)(3), we propose that a hospital's emergency plan address its patient population, including, but not limited to, persons at-risk. As defined by the PAHPA, members of at-risk populations may have additional needs in one or more of the following functional areas: maintaining independence, communication, transportation, supervision, and medical care. In addition to those individuals specifically recognized as at-risk in the statute (children, senior citizens, and pregnant women), we are proposing to define "at-risk populations" as individuals who may need additional response assistance including those who have disabilities, live in institutionalized settings, are from diverse cultures, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. Also, as discussed in "Providing Mass Medical Care with Scarce Resources: A Community Planning Guide," (http://archive.ahrq.gov/research/mce/), at-risk populations would include, but are not limited to, the elderly, persons in hospitals and nursing homes, people with physical and mental disabilities, and infants, and children. Hospitals may find this resource helpful in establishing emergency plans that address the needs of such patients.
   We also propose at
d. Succession Planning and Cooperative Efforts
   In regard to emergency preparedness planning, we are also proposing at
   Finally, at
   While we are aware that the responsibility for ensuring a coordinated disaster preparedness response lies upon the state and local emergency planning authorities, the hospital would need to document its efforts to contact these officials and inform them of the hospital's participation in the coordinated emergency response. Although we propose to require the same efforts for all providers and suppliers as we propose for hospitals, we realize that federal, state, and local officials may not elect to collaborate with some providers and suppliers due to their size and role in the community. For example, a RNHCI, by the limited nature of its service within the community, may not be called upon to participate in such collaborative and cooperative planning efforts. In this instance, we are proposing that such a provider or supplier would only need to provide documentation of its efforts to contact such officials and, when applicable, its participation.
   Through the work of its state partners, the ASPR Hospital Preparedness Program (HPP) has advanced the preparedness of hospitals and communities in numerous ways, including building healthcare coalitions, planning for all hazards, increasing surge capacity, tracking the availability of beds and other resources using electronic systems, and developing communication systems that are interoperable with other response partners. Many more community healthcare facilities have equipment to protect healthcare workers and decontaminate patients in chemical, biological, radiological, or nuclear emergencies.
   While the HPP program continues to encourage preparedness at the hospital level, evidence and real-world events have illustrated that hospitals cannot be successful in response without robust community healthcare coalition preparedness--engaging critical partners. Critical partners include emergency management, public health, mental/behavioral health providers, as well as community and faith-based partners. Together these partners make up a community's
   We are aware that, among some emergency management leaders, healthcare coalitions are viewed as a valued and essential component of a coordinated system of response and that many providers now participate in such coalitions. While we are not requiring that providers participate in coalitions, we do recognize and support their value in the well-coordinated emergency response system and encourage providers of all types and sizes to engage in such collaborations, where possible, to ensure better coordination in planning, including the assessment of risk, surrounding an emergency event. The primary goal of health care coalitions is to foster collaboration amongst provider types in order to strengthen the overall health system by leveraging expertise, sharing resources, and increasing capacity to respond; thus reducing potential administrative burden for emergency preparedness, while similarly enabling easier emergency response integration and coordination during an emergency. Healthcare coalition activities provide, at a minimum, an optimal forum for: Leveraging leadership and operational expertise (health, public health, emergency management, public works, public safety, etc.) within a community; conducting mutual hazard vulnerability/risk assessments to identify community health gaps and develop plans and strategies to address them; developing standardized tools, emergency plans, processes and protocols, training and exercises to support the community and support ease of integration; and facilitating timely and/or shared resource management and coordination of communications and information during an emergency
2. Policies and Procedures
   We are proposing at
   We propose at
   Based on our experience with hospitals, most hospitals do maintain subsistence supplies in the event of an emergency. Thus, we believe it would be overly prescriptive to require hospitals to maintain a defined quantity of subsistence needs for a defined period of time. We believe hospitals and other inpatient providers should have the flexibility to determine what is adequate based on the location and individual characteristics of the facility. Although we propose requiring only that each hospital addresses subsistence needs for staff and patients, we recommend that hospitals keep in mind that volunteers, visitors, and individuals from the community may arrive at the hospital to offer assistance or seek shelter and consider whether the hospital needs to maintain a store of extra provisions. We are soliciting public comment on this proposed requirement.
   As stated earlier, we also have learned from attendance in the Hurricane Katrina Sharing Information During Emergencies (SIDE) conference held in July of 2006, and from on-going participation in the
   We are proposing at
   Use of the JPATS is referenced in Health Preparedness Capabilities: National Guidance for Health System Preparedness (2012). This document provides guidance for healthcare systems, healthcare coalitions and healthcare organizations emergency preparedness efforts that is intended to serve as a planning resource. Broad guidance as to the requirement for bed and patient tracking is included.
   Given the lessons learned, this requirement is being proposed for providers and suppliers who provide ongoing care to inpatients or outpatients. Such providers and suppliers would include RNHCIs, hospices, PRTFs, PACE organizations, LTC facilities, ICFs/IID, HHAs, CAHs, and ESRD facilities. Despite providing services on an outpatient basis, we would require hospices, HHAs, and ESRD facilities to assume this responsibility. These providers and suppliers maintain current patient census information and would be required to provide continuing patient care during the emergency. In addition, we would require ASCs to maintain responsibility for their staff and patients if patients were in the facility. Other outpatient providers, such as CORFs, FQHCs and clinics maintain patient information but they have the flexibility of cancelling appointments during an emergency thereby not needing to assume responsibility of the patients.
   This requirement is not being proposed for transplant centers; CORFs; OPOs; clinics, rehabilitation agencies as providers of outpatient physical therapy and speech-language pathology services; and RHCs/FQHCs. Transplant centers' patients and OPOs' potential donors would be in hospitals, and, thus, would be the hospital's responsibility. We believe it is likely that outpatient providers and suppliers would close their facilities prior to or immediately after an emergency, sending staff and patients home.
   We are not proposing a requirement for a specific type of tracking system. A hospital would have the flexibility to determine how best to track patients and staff, whether it used an electronic database, hard copy documentation, or some other method. However, it is important that the information be readily available, accurate, and shareable among officials within and across the emergency response system as needed in the interest of the patient. A number of states already have such tracking systems in place or under development and the systems are available for use by health care providers and suppliers. Lessons learned from the hurricanes in the Gulf States revealed that some facilities, despite having patient-related information backed up to computer databases within or outside of the state in which the disaster occurred, could not access the information in a timely manner. Therefore, we would recommend that a hospital using an electronic database consider backing up its computer system with a secondary source.
   Although we believe that it is important that a hospital, and other providers of critical care, be able to track a patient's whereabouts to ensure adequate sharing of patient information with other providers and to inform a patient's relatives of the patient's location after a disaster, we are specifically soliciting comments on the feasibility of this requirement for any outpatient facilities.
   We propose at
   We propose at
   During the
   We propose at
   Such policies and procedures would have to be in compliance with Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulations at 45 CFR parts 160 and 164, which protect the privacy and security of individual's personal health information. Information on how HIPAA requirements can be met for purposes of emergency preparedness and response can be found at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/index.html. The tornadoes that occurred in
   We propose at
   Facilities may find it helpful to utilize assistance from the
   Hospitals could use the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), found in section 107 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188), to verify the credentials of volunteer health care workers. The ESAR-VHP is a federal program to establish and implement guidelines and standards for the registration, credentialing, and deployment of medical professionals in the event of a large-scale national emergency. The program is administered by ASPR within the Department. All states must participate in ESAR-VHP.
   The purpose of the program is to facilitate the use of volunteers at all tiers of response (local, regional, state, interstate, and federal). The ESAR-VHP program has been working to establish a national network of state-based programs that manage the information needed to effectively use health professional volunteers in an emergency. These state-based systems will provide up-to-date information regarding the volunteer's identity and credentials to hospitals and other health care facilities in need of the volunteer's services. Each state's ESAR-VHP system is built to standards that will allow quick and easy exchange of health professionals with other states. We propose at
   We believe this requirement should apply only to providers and suppliers that provide continuous care and services for individual patients. Thus, we are not proposing this requirement for transplant centers; CORFs; OPOs; clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services; and RHCs/FQHCs.
   We also propose at
   In determining whether to invoke an 1135 waiver (once the conditions precedent to the authority's exercise have been met), the ASPR with input from relevant HHS operating divisions (OPDIVs) determines the need and scope for such modifications, considers information such as requests from Governor's offices, feedback from individual healthcare providers and associations, and requests from regional or field offices for assistance. Additional information regarding the 1135 waiver process is provided in the
   Providers must resume compliance with normal rules and regulations as soon as they are able to do so. Waivers or modifications permitted under an 1135 waiver are no longer available after the termination of the emergency period. Generally, federally certified or approved providers must operate under normal rules and regulations, unless they have sought and have been granted modifications under the waiver authority from specific requirements.
   When a waiver has been issued under section 1135(b)(3) of the Act, EMTALA sanctions do not apply to a hospital with a dedicated emergency department, providing the conditions at
   Once an 1135 waiver is authorized, health care providers and suppliers can submit requests to operate under that authority to the CMS Regional Office, with a copy to the
   This proposed requirement would be consistent with the ASPR's expectation that hospital grant awardees will continue to develop and improve their (ACS) plans and concept of operations for providing supplemental surge capacity within the health care system in their state. Further discussion of ASPR's expectation for ACSs can be found in the annual grant guidance on the web at: http://www.phe.gov/Preparedness/planning/hpp/Pages/funding.aspx.
   With respect to states, ASPR stresses that effective planning and implementation would depend on close collaboration among state and local health departments (for example, state public health agencies, state
   While our discussion is geared toward the state level response, we expect that hospitals would operationalize these efforts by working closely with the federal, state, tribal, regional, and local communities. According to AHRQ's "Providing Mass Medical Care with Scarce Resources: A Community Planning Guide," the impact of an MCE of any significant magnitude will likely overwhelm hospitals and other traditional venues for health care services. AHRQ believes an MCE may render such venues inoperable, necessitating the establishment of ACSs for the provision of care that normally would be provided in an inpatient facility. According to AHRQ, advance planning is critical to the establishment and operation of ACSs; this planning must be coordinated with existing health care facilities, as well as home care entities. Planners must delineate the specific medical functions and treatment objectives of the ACS. Finally, AHRQ asserts that the principle of managing patients under relatively austere conditions, with limited supplies, equipment, and access to pharmaceuticals and a minimal staffing arrangement, is the starting point for ACS planning.
   Further discussion of the issues and challenges of establishing and operating ACSs during an MCE, as well as specific case study examples of ACSs in operation during the response to Hurricane Katrina, can be found in Chapter VI of the AHRQ publication. The chapter discusses issues surrounding non-federal, non-hospital-based ACSs. It describes different types of ACSs, including critical issues and decisions that will need to be made regarding these sites during an MCE; addresses potential barriers; and includes examples of case studies.
   Subsequently, on
3. Communication Plan
   For a hospital to operate effectively in an emergency situation, we propose at
   As part of its communication plan, the hospital would be required at
   We propose to require at
   We recognize that some hospitals, especially in remote areas, have difficulty using some current communication systems, such as cellular phones, even in non-emergency situations. We would expect these hospitals to address such challenges when establishing and maintaining a well-designed communication system that will function during an emergency.
   The National Communication System (NCS) offers a wide range of National Security and Emergency Preparedness (NS-EP) communications services that support qualifying federal, state, local, and tribal governments, industry, and non-profit organizations in the performance of their missions during emergencies. Hospitals may seek further information on the NCS' programs for Government Emergency Telecommunications Services (GETS), Telecommunications Service Priority (TSP) Program, Wireless Priority Service (WPS), and Shared Resources (SHARES) High Frequency Radio Program at: www.ncs.gov. (Click on "services").
   Under this proposed rule, we would also require at
   We would expect hospitals to have a system of communication that would ensure that comprehensive patient care information would be disseminated across providers and suppliers in a timely manner, as needed. Such a system would ensure that information was sent with an evacuated patient to the next care provider or supplier, information would be readily available for patients being sheltered in place, and electronic information would be backed up both within and outside the geographic area where the hospital was located.
   Health care providers, who were in attendance during the Emergency Preparedness Summit in
   We propose at
   This proposed requirement would not be applied to transplant centers; CORFs; OPOs; clinics rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services; or RHCs/FQHCs. We believe this requirement would best be applied only to providers and suppliers who provide continuous care to patients, as well as to those providers and suppliers that have responsibilities and oversight for care of patients who are homebound or receiving services at home.
   We propose at
   We propose at
4. Training and Testing
   We propose at
   We believe a well organized, effective training program must include providing initial training in emergency preparedness policies and procedures. Therefore, we propose at
   While some large hospitals may have staff that could provide such training, smaller and rural hospitals may need to find resources outside of the hospital to provide such training. Many state and local governments can provide emergency preparedness training upon request. Thus, small hospitals and rural hospitals may find it helpful to utilize the resources of their state and local governments in meeting this requirement. Again, we support hospitals and other providers participating in coalitions in their area for assistance in effectively meeting this requirement. Conducting exercises at the healthcare coalition level could help to reduce the administrative burden on individual healthcare facilities and demonstrate the value of connecting into the broader medical response community during disaster planning and response. Conducting integrated planning with state and local entities could identify potential gaps in state and local capabilities. Regional planning coalitions (multistate coalitions) meet and provide exercises on a regular basis to test protocols for state-to-state mutual aid. The members of the coalitions are often able to test command and control procedures and processes for sharing of assets that promote medical surge capacity.
   Regarding testing, at
   We propose at
   Comprehensive emergency preparedness includes anticipating and adequately addressing the various natural and man-made disasters that could impact a given facility. We expect that hospitals would conduct both mock disaster drills and tabletop exercises, using various emergency scenarios, based on their risk analyses.
   Generally, in a mock disaster drill, a hospital must consider how it will move persons within and outside of the building to designated "safe zones" to ensure the safety of both ambulatory patients and those who are wheelchair users, have mobility impairments or have other special needs. Moving patients or mock patients to "safe zones" in and outside of buildings during fire drills and other mock disaster drills is common industry practice. However, if it is not feasible to evacuate patients, hospitals could meet this requirement by moving its special needs patients to "safe zones" such as a foyer or other areas as designated by the hospital. To assist hospitals, other providers, and suppliers in conducting table-top exercises, we sought additional resources to further define the actions involved in a paper-based, tabletop exercise. One hospital system representative described a tabletop exercise as one where the staff conducts, on paper, a simulated public health emergency that would impact the hospital and surrounding health care facilities. For this hospital, the tabletop exercise is a half-day event for representatives of every critical response area in the hospital. It is designed to test the effectiveness of the response plan in guiding the leadership team's efforts to coordinate the response to an emergency event.
   The hospital representative further explained that the exercise consists of a group discussion led by a facilitator, using a narrated, clinically-relevant scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. Exercise facilitators introduce the scenario, keep the exercise on schedule, and inject timed challenges to stress specific disaster response systems. Following the tabletop exercise, a debriefing for hospital staff is held, and then the hospital staff provides written feedback and planning improvement suggestions to the hospital administration.
   Some hospitals may be well-versed in performing mock drills and tabletop exercises. Other providers and suppliers, especially those that are small or remote, may not have any knowledge or hands-on experience in conducting such exercises. To this end, the
   There are also other training resources that may prove useful for hospitals and other providers and suppliers to comply with as they attempt to meet this proposed emergency preparedness requirement. In 2005, the
   The report was intended as a resource to train public health workers to detect and respond to bioterrorism events and to assess local public health agencies' (LPHAs) levels of preparedness over time. The exercises were beta tested and refined in 13 LPHAs across
   RAND also developed a 2006 technical report entitled, "Tabletop Exercise for Pandemic Influenza Preparedness in Local Public Health Agencies," by Dausey, D.J., Aledort, J. E., and
   Finally, the
   The "Health Care Provider After Action Report/Improvement Plan" template also meets requirements for hospitals or other health care providers wishing to ensure their compliance with the Hospital Preparedness Program (HPP).
   This AAR/IP template is based on the
   There are seven types of exercises defined within HSEEP, each of which is either discussions-based or operations-based.
   Discussions-based exercises familiarize participants with current plans, policies, agreements and procedures, or may be used to develop new plans, policies, agreements, and procedures.
   Types of discussion-based exercises include the following:
    * Seminar: A seminar is an informal discussion, designed to orient participants to new or updated plans, policies, or procedures (for example, a seminar to review a new Evacuation Standard Operating Procedure).
    * Workshop: A workshop resembles a seminar, but is employed to build specific products, such as a draft plan or policy (for example, a
    * Tabletop Exercise (TTX): A tabletop exercise involves key personnel discussing simulated scenarios in an informal setting. TTXs can be used to assess plans, policies, and procedures.
    * Games: A game is a simulation of operations that often involves two or more teams, usually in a competitive environment, using rules, data, and procedure designed to depict an actual or assumed real-life situation.
   Operations-based exercises validate plans, policies, agreements and procedures, clarify roles and responsibilities, and identify resource gaps in an operational environment. Types of operations-based exercises include the following:
    * Drill: A drill is a coordinated, supervised activity usually employed to test a single, specific operation or function within a single entity (for example, a nursing home conducts an evacuation drill).
    * Functional exercise (FE): A functional exercise examines or validates the coordination, command, and control between various multi-agency coordination centers (for example, emergency operation center, joint field office, etc.). A functional exercise does not involve any "boots on the ground" (that is, first responders or emergency officials responding to an incident in real time).
    * Full-Scale Exercise (FSE): A full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise involving functional (for example, joint field office, emergency operation centers, etc.) and "boots on the ground" response (for example, firefighters decontaminating mock victims). We expect hospitals to engage in such tabletop exercises to the extent possible in their communities. For example, we would expect a large hospital in a major metropolitan area to perform a comprehensive exercise with coordination, if possible, across the public health system and local geographic area.
   We propose at
   Finally, we propose at
   In addition to the emergency power system inspection and testing requirements found in
   We have also proposed the same emergency and standby power requirements for CAHs and LTC facilities. As such, we request information on this proposal and in particular on how we might better estimate costs in light of the existing LSC and other state and federal requirements.
   We have included a table of requirements based on the 5 standards in the regulation text for each of the 17 providers and suppliers. The table includes both additional requirements and exemptions. This table can be used to provide guidance to the facilities in planning their emergency preparedness program and disaster planning.
Table 1--Emergency Preparedness Requirements by Provider Type Provider type Emergency plan Policies and Communication plan procedures Inpatient Providers Hospital *Develop a plan *Develop and *Develop and based on a risk implement policies maintain an assessment using and procedures emergency an "all hazards" based on the preparedness approach, which is emergency plan and communication plan an integrated risk assessment, that complies with approach focusing which must be both federal and on capacities and reviewed and state law. Patient capabilities updated at least care must be well- critical to annually coordinated within preparedness for a the facility, full spectrum of across health care emergencies and providers and with disasters. The state and local plan must be public health updated annually departments and emergency systems Critical Access * * * Hospital Long Term Care Must account for * Share with Facility missing residents resident/family/re (existing presentative requirement) appropriate information from emergency plan (additional requirement) PRTF * * * ICF/IID Must account for * Share with missing clients client/family/repr (existing esentative requirement) appropriate information from emergency plan (additional requirement) RNHCI * * * Transplant Center * * * Outpatient Providers--Outpatient providers are not required to provide subsistence needs for staff and patients. Hospice * In home services-- In home services-- inform officials will not need to of patients in provide occupancy need of evacuation information (additional requirement) Ambulatory * * Will not need to Surgical Center provide occupancy information PACE * Inform officials Will not need to of patients in provide occupancy need of evacuation information (additional requirement) Home Health Agency * Will not require Will not need to shelter in place, provide occupancy provision of care information at alternate care sites Inform officials of patients in need of evacuation (additional requirement) CORF Must develop Will not need to Will not need to emergency plan provide provide occupancy with assistance transportation to information from fire, safety evacuation experts (existing locations, or have requirement) arrangements with other CORFs to receive patients CMHC * * * OPO Address type of Needs to have Does not need to hospitals OPO has system to track provide occupancy agreement staff during & info, method of (additional after emergency sharing pt. info, requirement) and maintain providing info on medical general condition documentation & location of (additional patients requirement) Clinics, Must develop * Does not need to Rehabilitation, emergency plan provide occupancy and Therapy with assistance information from fire, safety experts. Address location, use of alarm systems and signals & methods of containing fire (existing requirements) RHC/FQHC * Appropriate Does not need to placement of exit provide occupancy signs (existing information requirement) Does not have to track patients, or have arrangements with other RHCs to receive patients or have alternate care sites ESRD Must contact local Policies and Does not need to emergency procedures must provide occupancy preparedness include information agency annually to emergencies ensure dialysis regarding fire facility's needs equipment, power in an emergency failures, care (existing related requirement) emergencies, water supply interruption & natural disasters (existing requirement)
Table 1--Emergency Preparedness Requirements by Provider Type Provider type Training and Additional testing requirements Inpatient Providers Hospital *Develop and Generators-- maintain training Develop policies and testing and procedures programs, that address the including initial provision of training in alternate sources policies and of energy to procedures and maintain: (1) demonstrate temperatures to knowledge of protect patient emergency health and safety procedures and and for the safe provide training and sanitary at least annually. storage of Conduct drills and provisions; (2) exercises to test emergency the emergency plan lighting; (3) fire detection, extinguishing, and alarm systems. Critical Access * Generators. Hospital Long Term Care * Generators. Facility PRTF * ICF/IID * RNHCI No drills. Transplant Center * Maintain agreement with transplant center & OPO. Outpatient Providers--Outpatient providers are not required to provide subsistence needs for staff and patients. Hospice * Ambulatory * Surgical Center PACE *Home Health Agency * CORF Assign specific emergency preparedness tasks to new personnel. Provide instruction in location, use of alarm systems, signals & firefighting equip (existing requirements) CMHC * OPO Only tabletop Must maintain exercise agreement with other OPOs & hospitals. Clinics, * Rehabilitation, and Therapy RHC/FQHC * ESRD Ensure staff demonstrate knowledge of emergency procedures, informing patients what to do, where to go, whom to contact if emergency occurs while patient is not in facility (alternate emergency phone number), how to disconnect themselves from dialysis machine. Staff maintain current CPR certification, nursing staff trained in use of emergency equipment & emergency drugs, patient orientation (existing requirements) * Indicates that the requirements are the same as those proposed for hospitals.
B. Emergency Preparedness Regulations for Religious Nonmedical Health Care Institutions (RNHCIs) (
   Section 1861(ss)(1) of the Act defines the term "
   We have implemented these provisions in 42 CFR part 403, Subpart G, "Religious Nonmedical Health Care Institutions' Benefits, Conditions of Participation, and Payment." As of
   A RNHCI is a facility that is operated under all applicable federal, state, and local laws and regulations, which furnishes only non-medical items and services on a 24-hour basis to beneficiaries who choose to rely solely upon a religious method of healing and for whom the acceptance of medical services would be inconsistent with their religious beliefs. The religious non-medical care or religious method of healing means care provided under the established religious tenets that prohibit conventional or unconventional medical care for the treatment of the patient and exclusive reliance on the religious activity to fulfill a patient's total health care needs.
   Thus,
   The RNHCI does not furnish medical items and services (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs or biologicals) to its patients. RNHCIs must not be owned by or under common ownership or affiliated with a provider of medical treatment or services.
   This proposed rule would expand the current emergency preparedness requirements for RNHCIs, which are located within
   Our "Physical environment" CoP at
   Proposed SEC 403.748(a)(1) would require RNHCIs to consider loss of power, water, sewage and waste disposal in their risk analysis. The proposed policies and procedures at
   The proposed hospital requirement at
   At proposed
   The proposed hospital requirements at
   The proposed hospital requirements at
   The proposed hospital requirement at
   Finally, unlike proposed regulations for hospitals at
   At SEC 482.15(d)(2), "Testing," we propose that hospitals would conduct drills and exercises to test the emergency plan. Because RNHCIs have such a specific role and provide such a specific service in the community, we believe RNHCIs would not participate in performing such drills. We propose the RNHCI would be required to only conduct a tabletop exercise annually. Likewise, unlike that which we have proposed for hospitals at
   At SEC 482.15(d)(2)(iv), we propose to require hospitals to maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed. Again, at
   Currently, at existing
C. Emergency Preparedness Requirements for Ambulatory Surgical Centers (ASCs) (
   Section 416.2 defines an ambulatory surgical center (ASC) as any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which the expected duration of services would not exceed 24 hours following an admission.
   Section 1833(i)(1)(A) of the Act authorizes the Secretary to specify those surgical procedures that can be performed safely in an ASC. The surgical services performed in ASCs generally are scheduled, elective, non-life-threatening procedures that can be safely performed in either a hospital setting (inpatient or outpatient) or in a
   Patients are examined immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. Patients also are evaluated just prior to discharge from the ASC to ensure proper anesthesia recovery.
   Currently, there are 5,354
   This proposed regulation would require the ASC to meet most of the same proposed emergency preparedness requirements as those we propose for hospitals, with two exceptions. At
   While a large ASC in a metropolitan area may find it relatively easy to perform a risk analysis and develop an emergency plan, policies and procedures, a communications plan, and train staff, we understand a small or rural ASC may find it more challenging to meet our proposed requirements. However, we believe these requirements are important and small or rural ASCs would be able to develop an appropriate emergency preparedness plan and meet our proposed requirements with the assistance of resources in their state and local community guidance.
D. Emergency Preparedness Regulations for Hospices (
   Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Public Law 97-248, added section 1861(dd) to the Act to provide coverage for hospice care to terminally ill
   Hospice care provides palliative care rather than traditional medical care and curative treatment to terminally ill patients. Palliative care improves the quality of life of patients and their families facing the problems associated with terminal illness through the prevention and relief of suffering by means of early identification, assessment, and treatment of pain and other issues. Hospice care allows the patient to remain at home as long as possible by providing support to the patient and family and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. Hospices use an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of caregivers.
   Hospices are unique health care providers because they serve patients and their families in a wide variety of settings. Hospice patients may be served in their place of residence, whether that residence is a private home, a nursing home, an assisted living facility, or even a recreational vehicle, as long as such locations are determined to be the patient's place of residence. Hospice patients may also be served in inpatient facilities operated by the hospice.
   As of
   We believe that all hospices, even those without inpatient facilities, should have an emergency plan. Also, we believe that, given the diverse nature of hospice patients and the variety of locations where they receive hospice services, simply having a written plan that is "periodically" rehearsed with staff does not provide sufficient protection for hospice patients and hospice employees.
   For hospices, we propose to retain existing regulations at
   Otherwise, the proposed emergency preparedness requirements for hospice providers are very similar to those for hospitals. However, the average hospice (freestanding, not-for-profit, with far fewer annual admissions, and employees) is very different from an average hospital. Typically, hospice inpatient facilities are small buildings or a single unit in a larger medical complex, such as a hospital or long term care facility. Furthermore, hospice patients, given their terminally ill status, may be equally or more vulnerable in an emergency situation than their hospital counterparts. This may be due to the inherent severity of the hospice patient's illness or to the probability that the hospice patient's caregiver may not have the level of professional expertise, supplies, or equipment as that of the hospital-based clinician surrounding a natural or man-made emergency.
   Despite these core differences, we believe the hospital emergency preparedness requirement, with some reorganization and revision, is appropriate for hospice providers. Thus, our discussion will focus on the requirements as they differ from the requirements for hospitals within the context of the hospice setting. Since hospices serve patients in both the community and within various types of facilities, we propose to re-organize the requirements for the hospice provider's policies and procedures differently from the proposed policies and procedures for hospitals. Specifically, we propose to group requirements that apply to all hospice providers at
   Unlike our proposed hospital policies and procedures, we would require all hospices, regardless of whether or not they operate their own inpatient facilities, to have policies and procedures to inform state and local officials about hospice patients in need of evacuation from their respective residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. Such policies and procedures must be in accord with the HIPAA Privacy Rule, as appropriate. This proposed requirement recognizes that many of the frail hospice patients may be unable to evacuate from their homes without assistance during an emergency. This additional proposed requirement recognizes the responsibility of the hospice to support the safety of its patients that reside in the community.
   We expect that hospices would be able to identify patients most in need of evacuation assistance (for example, patients residing alone and patients using certain types of durable medical equipment), safe and appropriate evacuation methods, and the appropriate state or local authorities to assist in such evacuations. We believe this requirement is necessary to ensure the safety of vulnerable hospice patients, who are likely not capable of evacuating without assistance.
   We note that the proposed requirements for communication at
E. Emergency Preparedness Regulation for Inpatient Psychiatric Residential Treatment Facilities (PRTFs) (
   Sections 1905(a)(16) and (h) of the Act define the term "Psychiatric Residential Treatment Facility" (PRTF) and list the requirements that a PRTF must meet to be eligible for
   A PRTF provides inpatient psychiatric services for patients under age 21; services must be provided under the direction of a physician. Inpatient psychiatric services must involve active treatment which means implementation of a professionally developed and supervised individual plan of care. The patient's plan of care includes an integrated program of therapies, activities, and experiences designed to meet individual treatment objectives that have been developed by a team of professionals along with the patient, his or her parents, legal guardians, or others into whose care the patient will be released after discharge. The plan must also include post-discharge plans and coordination with community resources to ensure continued services for the patient, his or her family, school, and community.
   The current PRTF requirements do not include any requirements for emergency preparedness. We propose requiring that PRTF facilities meet the same requirements we are proposing for hospitals. Because these facilities vary widely in size, we expect their risk analyses, emergency plans, emergency policies and procedures, emergency communication plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe each of these providers/suppliers has the capability to comply fully with the requirements so that the health and safety of its patients are protected in the event of an emergency situation or disaster.
F. Emergency Preparedness Regulations for Programs of All-Inclusive Care for the Elderly (PACE) (
   The Balanced Budget Act (BBA) of 1997 established the Program of All-Inclusive Care for the Elderly (PACE) as a permanent
   Generally, a
   Regulations for
   Existing SEC 460.72(c)(1), Emergency and disaster preparedness procedures, states that the
   We propose incorporating the language from
   Existing SEC 460.72(c)(3), which states that "a
   We are proposing that
   The first difference between the proposed hospital emergency preparedness requirements and the proposed
   Finally, the third difference between the proposed requirements for hospitals and the proposed requirements for
G. Emergency Preparedness Regulations for Transplant Centers (
   Transplant centers are located within hospitals that meet the requirements for Conditions of Participation (CoPs) in
   Transplant centers are responsible for providing organ transplantation services from the time of the potential transplant candidate's initial evaluation through the recipient's post-transplant follow-up care. In addition, if a center performs living donor transplants, the center is responsible for the care of the living donor from the time of the initial evaluation through post-surgical follow-up care.
   Organs are viable for transplantation for a limited time after organ recovery. Although kidneys may remain viable for transplantation for more than 24 hours, other organs remain viable for only a few hours. Thus, according to the Organ Procurement and Transplantation Network (OPTN) longstanding policy, if a transplant center must turn down an organ for one of its patients, the organ may go to the next patient on the waiting list at another transplant center (Organ Distribution: Organ Procurement, Distribution and Allocation, http://optn.transplant.hrsa.gov/PoliciesandBylaws2/policies/pdfs/policy_6.pdf) . In such a situation, the patient on the waiting list of the transplant center experiencing an emergency may die before an organ becomes available again. In fact, according to the OPTN, about 18 patients die every day waiting for an organ transplant. (http://optn.transplant.hrsa.gov/)
   There are 770
   Our regulations at
   We believe a transplant center entering into an agreement for the provision of services during an emergency would be in the best position to judge whether post-transplant care could be competently provided during an emergency by a
   We also propose at
   Currently, under the transplant center CoP at
   We are not proposing to require transplant centers to provide basic subsistence needs for staff and patients, as we are proposing for hospitals at
H. Emergency Preparedness Requirements for
   Section 1819(a) of the Act defines a skilled nursing facility (SNF) for
   To participate in the
   LTC facilities provide a substantial amount of care to
   The current requirements for LTC facilities contain specific requirements for emergency preparedness set out at 42 CFR 483.75(m)(1) and (2). Section 483.75(m)(1) states that a "facility must have detailed written plans and procedures to meet all potential emergencies and disasters, such as fire, severe weather, and missing residents." We are proposing that this language be incorporated into proposed
   These requirements are not sufficient to ensure that facilities are prepared for more widespread disasters that may affect most or all of the other health care facilities in their area and that may tax the ability of local, state, and federal emergency management officials to provide assistance. For example, current LTC facility requirements do not require facilities to conduct a risk assessment or to have a plan, policies, or procedures to ensure continuity of facility operations during emergencies. We believe the additional requirements in this proposed rule would ensure facilities would be prepared for the emergencies they may face now and in the future. Thus, our proposed emergency preparedness requirements for LTC facilities are identical to those we are proposing for hospitals at
   In addition, long term care facilities are unlike many of the inpatient care providers. Many of the residents can be expected to have long term or extended stays in these facilities. Due to the long term nature of their stays, these facilities essentially become the residents' residences or homes. We believe this changes the nature of the relationship and duty to the residents and their families or representatives. Section
   Also, as discussed in section II.A.4 of the preamble we are proposing at
   In addition to the emergency energy requirements discussed earlier, we also believe that LTC facilities should consider their individual residents' power needs. For example, some residents could have motorized wheelchairs that they need for mobility or require a continuous positive airway pressure or CPAP machine due to sleep apnea. In
I. Emergency Preparedness Regulations for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs/IID) (
   Section 1905(d) of the Act created the ICF/IID benefit to fund "institutions" with four or more beds to serve people with [intellectual disability] or other related conditions. To qualify for
   Some ICFs/IID are small and serve only a few patients. However, we do not believe small ICFs/IID or ICFs/IID in general would have difficulty meeting the proposed requirements. In fact, small facilities might find it easier than large facilities to develop an emergency preparedness plan and emergency preparedness policies and procedures. As an example, an ICF/IID with only four patients is likely to have a sufficient number of its own vehicles available during an emergency to evacuate patients and staff, eliminating the need to contract with an outside entity to provide transportation during an emergency situation or disaster.
   Because ICFs/IID vary widely in size and the services they provide, we expect that the risk analyses, emergency plans, emergency policies and procedures, emergency communication plans, and emergency preparedness training will vary widely as well. Nevertheless, we believe each of them has the capability to comply fully with the requirements so that the health and safety of its patients are protected in the event of an emergency situation or disaster.
   Thus, we propose requiring that ICFs/IID meet the same requirements we are proposing for hospitals, with two exceptions. At
   In addressing the special needs of its client population, we believe that ICFs/IID should consider their individual residents' power needs. For example, some residents could have motorized wheelchairs that they need for mobility or require a continuous positive airway pressure or CPAP machine due to sleep apnea. We believe that the currently proposed requirements at
   As we stated earlier, the purpose of this proposed rule is to establish requirements to ensure that
   The current regulations for ICFs/IID include requirements for emergency preparedness. Specifically,
   Current SEC 483.470, Physical environment, includes a standard for emergency plan and procedures at
   Currently SEC 483.470(h)(2) states, with regard to a facility's emergency plan, that the facility must communicate, periodically review the plan, make the plan available, and provide training to the staff. These requirements are covered in proposed
   ICFs/IID are unlike many of the inpatient care providers. Many of the clients can be expected to have long term or extended stays in these facilities. Due to the long term nature of their stays, these facilities essentially become the clients' residences or homes. We believe this changes the nature of the relationship and duty to the clients and their families or representatives. Section 483.475(c) requires these facilities to develop an emergency preparedness communication plan, which includes, among other things, a means of providing information about the general condition and location of clients under the facility's care. We also believe that the clients and their families or representatives require more information about the facility's emergency plan. Specifically, ICFs/IID should be required to determine what information in their emergency plan is appropriate to share with its clients and their families or representatives and that facilities have a means by which that information is disseminated to those individuals. The facility should also determine the appropriate time for that information to be disseminated. We are not indicating what information from the emergency plan should be shared or the timing or manner in which it should be disseminated. We believe that each facility should have the flexibility to determine the information that is most appropriate to be shared with its clients and their families or representatives and the most efficient manner in which to share that information. Therefore, we propose to add an additional requirement at
   The standard for disaster drills set forth at existing
J. Emergency Preparedness Regulations for Home Health Agencies (HHAs) (
   Under the authority of sections 1861(m), 1861(o), and 1891 of the Act, the Secretary has established in regulations the requirements that a home health agency (HHA) must meet to participate in the
   As of
   With so many patients depending on the services of HHAs nationwide, it is imperative that HHAs have processes in place to address the safety of patients and staff and the continued provision of services in the event of a disaster or emergency. However, there are no existing emergency preparedness requirements contained under the HHA Medicare regulations at part 484, Subparts B and C.
   Thus, we propose to add emergency preparedness requirements at
   First, because HHAs provide health care in patients' homes, we propose at
   Second, because we learned from the experience of Hurricane Katrina that many medically compromised people were unable to escape their homes to seek safe shelter, at
   We are not proposing to require that HHAs meet all of the same requirements that we are proposing for hospitals. Since HHAs provide health care services only in patients' homes, we are not including proposed requirements for policies and procedures for the provision of subsistence needs (
   In developing its policies and procedures, we would expect an HHA to consider whether it would accept new referrals during a disaster or emergency situation, and how it would care for new patients. We also would urge HHAs to include a method for providing information to all new patients and their families about the role the HHA would play in the event of an emergency.
   Overall, our expectation for HHAs is that they would work closely with other HHAs and with the hospitals in their referral areas to plan for disasters and emergency situations.
K. Emergency Preparedness Regulations for Comprehensive Outpatient Rehabilitation Facilities (CORFs) (
   Section 1861(cc) of the Act defines the term "comprehensive outpatient rehabilitation facility" (CORF) and lists the requirements that a CORF must meet to be eligible for
   Section 1861(cc)(2)(J) of the Act also states that the CORF must meet other requirements that the Secretary finds necessary in the interest of the health and safety of a CORF's patients. Under this authority, the Secretary has established in regulations, at part 485, Subpart B, requirements that a CORF must meet to participate in the
   Currently SEC 485.64 "Conditions of Participation: Disaster procedures" includes emergency preparedness requirements CORFs must meet. The regulations state that the CORF must have written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters. The regulation requires that all personnel be knowledgeable with respect to these procedures, be trained in their application, and be assigned specific responsibilities.
   Currently SEC 485.64(a) requires a CORF to have a written disaster plan that is developed and maintained with the assistance of qualified fire, safety, and other appropriate experts. The other elements under
   Currently SEC 485.64(b) requires each CORF to: (1) provide ongoing training and drills for all personnel associated with the CORF in all aspects of disaster preparedness; and (2) orient and assign specific responsibilities regarding the facility's disaster plan to all new personnel within 2 weeks of their first workday.
   Although these requirements are important, they do not address the coordination across providers and suppliers and across the various federal, state, and local emergency response systems necessary to ensure the health and safety of CORF patients during an emergency.
   Despite CORFs being non-residential treatment facilities, we believe they should comply with the same requirements that would be required for hospitals, with appropriate exceptions.
   At SEC 485.68(a)(5), we propose that CORFs develop and maintain the emergency preparedness plan with assistance from fire, safety, and other appropriate experts. We do not propose to require CORFs to provide basic subsistence needs for staff and patients as we are proposing for hospitals at
   At SEC 482.15(b)(3), we propose that hospitals have policies and procedures for safe evacuation from the hospital, which would include consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. We do not believe all of these requirements are appropriate for CORFs, which serve only outpatients. Therefore, at
   Because CORFs are outpatient facilities that provide specific, limited services to patients, we are not proposing that CORFS have arrangements with other CORFs or other providers to receive patients in the event of limitations or cessation of operations. Finally, we do not propose to require CORFs to comply with the proposed hospital requirement at
   With respect to communication, we would not require CORFs to comply with the proposed requirement for hospitals at
   We propose including in the CORF emergency preparedness provisions a requirement for CORFs to have a method for sharing information and medical documentation for patients under the CORF's care with other health care providers, as necessary, to ensure continuity of care (see proposed
   Our goal is to ensure that we incorporate existing CORF disaster preparedness requirements into our proposed emergency preparedness rule. Although we believe the current CORF disaster preparedness requirements are largely reflected in the language we propose for other providers and suppliers, there are specific instances in which the existing CORF requirements are more stringent, such as the requirement to assign specific disaster preparedness tasks to new personnel within two weeks of their first work day. This existing requirement at
   Currently SEC 485.64 requires a CORF to develop and maintain its disaster plan with assistance from fire, safety, and other appropriate experts. We have incorporated this requirement at proposed
L. Emergency Preparedness Regulations for Critical Access Hospitals (CAHs) (
   Sections 1820 and 1861(mm) of the Act provide that critical access hospitals participating in
   CAHs are small, generally rural, limited-service facilities with low patient volume. The intent of designating facilities as "critical access hospitals" is to preserve access to primary care and emergency services that meet community needs.
   A CAH is not required to be staffed if there are no inpatients in the facility. However, in the event of an emergency, existing requirements state there must be a doctor of medicine or osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist, with training or experience in emergency care, on call and immediately available by telephone or radio contact and available onsite within 30 minutes on a 24-hour basis or, under certain circumstances, within 60 minutes. CAHs currently are required to coordinate with emergency response systems in the area to provide 24-hour emergency coverage. We believe the existing requirements provide only a limited framework for protecting the health and safety of CAH patients in the event of a major disaster. They do not include the requirements we propose that we believe will ensure a well-coordinated emergency preparedness system of care.
   CAHs are required at existing
   We propose to remove the current standard at
   We propose to relocate current
   Also, as discussed in section II.A.4 of the preamble we are proposing at
M. Emergency Preparedness Regulation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (
   Under the authority of section 1861(p) of the Act, the Secretary has established CoPs that clinics, rehabilitation agencies, and public health agencies must meet when they provide outpatient physical therapy (OPT) and speech-language pathology (SLP) services. Under section 1861(p) of the Act, the Secretary is responsible for ensuring that the CoPs and their enforcement are adequate to protect the health and safety of individuals receiving OPT and SLP services from these entities. The CoPs are set forth at part 485, Subpart H.
   Section 1861(p) of the Act describes "outpatient physical therapy services" to mean physical therapy services furnished by a provider of services, a clinic, rehabilitation agency, or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient. The patient must be under the care of a physician.
   The term "outpatient physical therapy services" also includes physical therapy services furnished to an individual by a physical therapist (in the physical therapist's office or the patient's home) who meets licensing and other standards prescribed by the Secretary in regulations, other than under arrangement with and under the supervision of a provider of services, clinic, rehabilitation agency, or public health agency, if the furnishing of such services meets such conditions relating to health and safety as the Secretary may find necessary. The term also includes SLP services furnished by a provider of services, a clinic, rehabilitation agency, or by a public health agency, or by others under an arrangement.
   As of
   At SEC 485.727(b)(1), we are proposing to require that organizations have policies and procedures for evacuation from the organization, including staff responsibilities and needs of the patients.
   We believe these organizations comply with a provision similar to our proposed requirement for hospitals at
   The current regulations at
   However, existing
   Existing requirements at
   Currently SEC 485.727(b) specifies requirements for staff training and drills. This requirement states that all employees must be trained, as part of their employment orientation, in all aspects of preparedness for any disaster. This disaster program must include orientation and ongoing training and drills for all personnel in all procedures so that each employee promptly and correctly carries out his or her assigned role in case of a disaster. Because these requirements are addressed in proposed
N. Emergency Preparedness Regulations for Community Mental Health Centers (CMHCs) (
   A Community Mental Health Center (CMHC) as defined in section 1861(ff)(3)(B) of the Act, is an entity that meets applicable licensing or certification requirements in the state in which it is located and provides the set of services specified in section 1913(c)(1) of the Public Health Service Act. Section 4162 of Public Law 101-508 (OBRA 1990), which amended section 1861(ff)(3)(A) and 1832(a)(2)(J) of the Act, includes CMHCs as entities that are authorized to provide partial hospitalization services under Part B of the
   Pursuant to 42 CFR 410.2 and 410.110, a CMHC may receive
    * Outpatient services, including specialized outpatient services for children, the elderly, individuals who are chronically mentally ill, and residents of the CMHC's service area who have been discharged from inpatient treatment at a mental health facility.
    * 24 hour-a-day emergency care services.
    * Day treatment, or other partial hospitalization services, or psychosocial rehabilitation services.
    * Screening for clients being considered for admission to state mental health facilities to determine the appropriateness of such admission. However, effective
    * Meets applicable licensing or certification requirements for CMHCs in the state in which it is located.
    * Provides at least 40 percent of its services to individuals who are not eligible for benefits under Title XVIII of the Act.
   To qualify for
   Since CMHCs are outpatient facilities, we would expect that in an emergency, the CMHC would instruct clients and staff not to report to the facility. In the event that clients and staff were in the facility when a disaster or emergency situation occurred, we would expect the CMHC to encourage clients and staff to leave the facility to seek safe shelter in the community. We would expect most clients and staff to return to their homes.
   Additionally, at
   Some CMHCs are small facilities with just a few clients and may be located in rural areas. These CMHCs could find it challenging to develop a well-coordinated emergency preparedness plan. However, we believe even small CMHCs would be able to develop an appropriate emergency preparedness plan with the assistance of federal, state, and local community resources.
O. Emergency Preparedness Regulations for Organ Procurement Organizations (OPOs) (
   Section 1138(b) of the Act and 42 CFR part 486, subpart G establish that OPOs must be certified by the Secretary as meeting the requirements to be an OPO and designated by the Secretary for a specific Donation Service Area (DSA). The current OPO CfCs do not contain any emergency preparedness requirements.
   There are currently 58
   Our proposed requirements for OPOs to develop and maintain an emergency preparedness plan, are similar to those proposed for hospitals, with some exceptions.
   Since potential donors generally are located within hospitals, at proposed
   Because the services provided by OPOs are so different from the services provided by a hospital and because potential donors generally are located within hospitals, we propose only two requirements for OPOs at
   Since OPOs' potential donors generally are located within hospitals and since OPOs do not have physical structures in which to house patients, OPOs would not be expected to have policies and procedures to address the provision of subsistence needs for staff and patients. Instead, we believe these responsibilities would rest upon the hospital.
   In addition, at
   Unlike the requirement we have proposed for hospitals at
   Finally, at
P. Emergency Preparedness Regulations for
   Section 1861(aa) sets forth the
   Conditions for Certification for RHCs and Conditions of Coverage for FQHCs are found at 42 CFR part 491, Subpart A. Current emergency preparedness requirements are found at
   Currently, an RHC is staffed with personnel that are required to provide medical emergency procedures as a first response to common life threatening injuries and acute illnesses and to have available the drugs and biologicals commonly used in life-saving procedures. The definition of a "first response" is a service that is commonly provided in a physician's office. FQHCs are required to provide emergency care either on site or through clearly defined arrangements for access to health care for medical emergencies during and after the FQHC's regularly scheduled hours. Therefore, FQHCs must provide for access to emergency care at all times. Clinics and centers have varying hours and days of operation based on staff and anticipated patient load.
   We are aware of the difficulties that rural communities have attracting and retaining a variety of professionals, including health care professionals. However, there is a present and growing need for all providers and suppliers to develop plans to care for their staff and patients during a disaster. We propose that the RHCs' and FQHCs' emergency preparedness plans must address the type of services the facility has the capacity to provide in an emergency. We expect that they would evaluate their ability to provide services based on, but not limited to, the facility's size, available human and material resources, geographic location, and ability to coordinate with community resources. Thus, while
   We believe many RHCs and FQHCs would be able to develop a comprehensive emergency plan that addresses "all-hazards" policies and procedures, a communication plan, and training and testing by drawing upon a variety of resources that can provide technical assistance. For example,
   Although RHCs and FQHCs currently do not have specific requirements for emergency preparedness, they have requirements for "Emergency Procedures" found at
   We are proposing emergency preparedness requirements based on the requirements that we are proposing for hospitals, modified to address the specific characteristics of RHCs and FQHCs. We do not propose to require RHC/FQHCs to provide basic subsistence needs for staff and patients. Also, unlike that proposed for hospitals at
   At SEC 482.15(b)(3), we propose that hospitals have policies and procedures for safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. We do not believe all of these requirements are appropriate for RHCs/FQHCs, which serve only outpatients. Therefore, at
   Unlike the requirement that is being proposed for hospitals at
   In addition, we would not require RHCs/FQHCs to comply with the proposed requirement for hospitals found at
Q. Emergency Preparedness Regulation for End-Stage Renal Disease (ESRD) Facilities (
   Sections 1881(b), 1881(c), and 1881(f)(7) of the Act establish requirements for End-Stage Renal Disease (ESRD) facilities. ESRD is a kidney impairment that is irreversible and permanent and requires either a regular course of dialysis or kidney transplantation to maintain life. Dialysis is the process of cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. There are 5,923
   We addressed emergency preparedness requirements for ESRD facilities in the
   Current regulations include the requirement that dialysis facilities be organized into ESRD Network areas. Our regulations describe these networks at
   At SEC 494.62(b), we propose to require facilities to address in their policies and procedures, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters in the facility's geographic area.
   At SEC 482.15(b)(3), we propose that hospitals have policies and procedures for the safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. We do not believe all of these requirements are appropriate for ESRD facilities, which serve only outpatients. Therefore, at
   At SEC 494.62(b)(6), we are proposing to require ESRD facilities to develop arrangements with other dialysis facilities or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to dialysis facility patients. Experience has shown that ESRD facilities tend to use hospitals as back-up when hospital space and personnel need to be used to care for the sickest patients in the community during such emergencies. Thus, we want to emphasize that an organized system of patient care among ESRD facilities during and surrounding emergency events encompasses having a robust system for back-up care available at the various dialysis centers.
   At SEC 494.62(c)(7), dialysis facilities would be required to comply with the proposed requirement for hospitals at
   At SEC 494.62(d)(1)(i), we propose to require ESRD facilities to ensure that staff can demonstrate knowledge of various emergency procedures, including: informing patients of what to do; where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and how to disconnect themselves from the dialysis machine if an emergency occurs.
   We would relocate existing requirements for patient training from
   Current SEC 494.60(d) would be redesignated. Current requirements for emergency plans at
III. Collection of Information Requirements
   Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
    * The need for the information collection and its usefulness in carrying out the proper functions of our agency.
    * The accuracy of our estimate of the information collection burden.
    * The quality, utility, and clarity of the information to be collected.
    * Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
   We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).
A. Factors Influencing ICR Burden Estimates
   Please note that under this proposed rule, a hospital's ICRs would differ from the ICRs of other
   Further, some accrediting organizations (AOs) that have deeming authority for
   In addition, many facilities already have begun preparing for emergencies. According to a study by Niska and Burt, virtually all hospitals already have plans to respond to natural disasters (Niska, R.W. and Burt, C.W. "Bioterrorism and Mass Casualty Preparedness in Hospitals:
   Hospitals, as well as other health care providers, also receive grant funding for disaster or emergency preparedness from the federal and state governments, as well as other private and non-profit entities. However, we were unable to determine the amount of funding that has been granted to hospitals, the number of hospitals that received funding, or whether that funding would continue in a predictable manner. We also do not know how the hospitals spent this funding. Therefore, in determining the burden for this proposed rule, we did not take into account any funding a hospital or other health care provider might have received from sources other than
B. Sources of Data Used in Estimates of Burden Hours and Cost Estimates
   We obtained the data used in this discussion on the number of the various
   Unless otherwise indicated, we obtained all salary information for the different positions identified in the following assessments from the
   Based on our experience, certain providers and suppliers typically pay less than the median salary, in which case, we used a salary from a lower percentile. Salary may also be affected by the rural versus urban locations. For example, based on our experience with CAHs, they usually pay their administrators less than the mean hourly wage for Health Service Managers in general medical and surgical hospitals. Thus, we considered the impact of the rural nature of CAHs to estimate the hourly wage for CAH administrators and calculated total compensation by adding in an amount for fringe benefits. According to the
Health Resources and Services Administration--Emergency Preparedness and Continuity of Operations
* http://www.hrsa.gov/emergency/
Centers for Disease Control and Prevention--
* http://www.fda.gov/EmergencyPreparedness/default.htm
* http://www.samhsa.gov/Disaster/
* www.cdc.gov/niosh/topics/emres/business.html
* www.osha.gov/SLTC/emergencypreparedness
* http://www.fema.gov/about/contact/statedr.shtm
* http://www.fema.gov/plan-prepare-mitigate
* http://www.dhs.gov/training-technical-assistance
   We will discuss the burden for each provider and supplier type included in this proposed rule in the order in which they appear in the CFR.
C. ICRs Regarding Condition of Participation: Emergency Preparedness (
   Proposed SEC 403.748(a) would require Religious Nonmedical Health Care Institutions (RNHCIs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We propose that the plan must meet the requirements specified at
   The current RNHCI CoPs already require RNHCIs to have a written disaster plan that addresses "loss of power, water, sewage, and other emergencies" (42 CFR 403.742(a)(4)). In addition, the CoPs also require RNHCIs' to include measures to evaluate facility safety issues, including physical environment, in their quality assessment and performance improvement (QAPI) program (42 CFR 403.732(a)(1)(vi)). We expect that all RNHCIs have considered some of the risks likely to happen in their facility. However, we expect that all RNHCIs would need to review any existing risk assessment and perform the tasks necessary to ensure their assessment is documented and utilize a facility-based and community based all-hazards approach.
   We have not designated any specific process or format for RNHCIs to use in conducting their risk assessment because we believe they need the flexibility to determine how best to accomplish this task. However, we expect that they would obtain input from all of their major departments in the process of developing their risk assessments.
   Based on our experience with RNHCIs, we expect that complying with this requirement would require the involvement of an administrator, the director of nursing, and the head of maintenance. It is important to note that RNHCIs do not provide medical care to their patients. Depending upon the state in which they are located, RNHCIs may not be licensed and may not have licensed or certified staff. RNHCIs generally do not compensate their staff at the same level we have used to determine the burden for other health care providers and suppliers. Therefore, for the purpose of estimating the burden, we have used lower hourly wages for the RNHCI staff than for other providers and suppliers whose staff must comply with licensing and certification standards.
   We expect that to perform a risk assessment, the RNHCI's administrator, the director of nursing, and the head of maintenance would attend an initial meeting; review relevant sections of the current risk assessment; prepare comments; attend a follow-up meeting; perform a final review, and approve the risk assessment. We expect that the director of nursing would coordinate the meetings, review and critique the current risk assessment, coordinate comments, develop the new risk assessment, and ensure that it is approved.
   We estimate that it would require 9 burden hours for each RNHCI to complete the risk assessment at a cost of
   After conducting a risk assessment, RNHCIs would need to review, revise, and, if necessary, develop new sections for their emergency plans. The current RNHCI CoPs require RNHCIs to have a written disaster plan for emergencies (42 CFR SEC 403.742(a)(4)). However, based on our experience with RNHCIs, their plans likely would address only evacuation from their facilities. We expect that all RNHCIs would need to review, revise, and develop new sections for their plans.
   We expect that the same individuals who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect that it would require substantially more time to complete the plan than to complete the risk assessment. We estimate that complying with this requirement would require 12 burden hours for each RNHCI at a cost of
   Under this proposed rule, RNHCIs would be required to review and update their emergency preparedness plans at least annually. For the purpose of determining the burden associated with this requirement, we would expect that RNHCIs already review their plans annually. Based on our experience with
   Proposed SEC 403.748(b) would require RNHCIs to develop and implement emergency preparedness policies and procedures in accordance with their emergency plan based on the emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. These policies and procedures would have to be reviewed and updated at least annually. At a minimum, we propose that the policies and procedures be required to address the requirements specified in
   The current RNHCI CoPs require them to have written policies concerning their services (42 CFR SEC 403.738). Thus, some RNHCIs may have some emergency preparedness policies and procedures. However, based on our experience with RNHCIs, most of their emergency preparedness policies address only evacuation from the facility.
   We expect that these tasks would involve the administrator, the director of nursing, and the head of maintenance. All three would need to review and comment on the RNHCI's current policies and procedures. The director of nursing would revise or develop new policies and procedures, as needed, ensure that they are approved, and compile and disseminate them to the appropriate parties. We estimate that it would require 6 burden hours for each RNHCI to comply with this requirement at a cost of
   Proposed SEC 403.748(c) would require RNHCIs to develop and maintain an emergency preparedness communication plan that complies with both federal and state law and must be reviewed and updated at least annually. We propose that the communication plan include the information specified at
   We propose that RNHCIs would also have to review and update their emergency preparedness communication plan at least annually. We believe that RNHCIs already review their emergency preparedness communication plans periodically. Thus, complying with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Therefore, we have not assigned a burden.
   Proposed SEC 403.748(d) would require RNHCIs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We are proposing that a RNHCI meet the requirements specified at
   We expect that complying with these requirements would require the involvement of the RNHCI administrator and the director of nursing. We estimate that it would require 7 burden hours for each RNHCI to develop an emergency training program at a cost of
   We are proposing that RNHCIs also review and update their emergency preparedness training and testing programs at least annually. Based on our experience with
   Proposed SEC 403.748(d)(2) would require RNHCIs to conduct a paper-based, tabletop exercise at least annually. The RNHCI must also analyze its response to and maintain documentation of all tabletop exercises and emergency events, and revise its emergency plan, as needed.
   The burden associated with complying with this requirement would be the resources RNHCIs would need to develop the scenarios for the exercises and the necessary documentation. Based on our experience with RNHCIs, RNHCIs already conduct some type of exercise periodically to test their emergency preparedness plans. However, we expect that RNHCIs would not be fully compliant with our proposed requirements. We expect that the director of nursing would develop the scenarios and required documentation. We estimate that these tasks would require 3 burden hours at a cost of
Table 2--Burden Hours and Cost Estimates for All 16 RNHCIS To Comply With the ICRs Contained in S. 403.748 Condition: Emergency Preparedness Regulation OMB Control Number of Number of Burden per Total section(s) No. respondents responses response annual (hours) burden (hours) S. 403.748(a)(1) 0938--New 16 16 9 144 S. 0938--New 16 16 12 192 403.748(a)(1)-- (4) S. 403.748(b) 0938--New 16 16 6 96 S. 403.748(c) 0938--New 16 16 4 64 S. 403.748(d)(1) 0938--New 16 16 7 112 S. 403.748(d)(2) 0938--New 16 16 3 48 Totals 16 108 41 656
Table 2--Burden Hours and Cost Estimates for All 16 RNHCIS To Comply With the ICRs Contained in S. 403.748 Condition: Emergency Preparedness Regulation Hourly Total labor Total Total cost section(s) labor cost cost of capital/mai ( ] of reporting ntenance reporting ( ] costs ( ] ( ] S. 403.748(a)(1) * * 4,240 0 4,240 S. * * 5,568 0 5,568 403.748(a)(1)-- (4) S. 403.748(b) * * 2,624 0 2,624 S. 403.748(c) * * 1,856 0 1,856 S. 403.748(d)(1) * * 3,488 0 3,488 S. 403.748(d)(2) * * 1,152 0 1,152 Totals 18,928 * * The hourly labor cost is blended between the wages for multiple staffing levels.
D. ICRs Regarding Condition for Coverage: Emergency Preparedness (
   Proposed SEC 416.54(a) would require Ambulatory Surgical Centers (ASCs) to develop and maintain an emergency preparedness plan and review and update that plan at least annually. We propose that the plan must meet the requirements contained in
   We will discuss the burden for these activities individually below beginning with the risk assessment requirement in
   The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. There are 5,354 ASCs. The current regulations covering ASCs include some emergency preparedness requirements; however, those requirements primarily are related to internal emergencies, such as a fire.
   A significant factor in determining the burden is the accreditation status of an ASC. Of the 5,354 ASCs, 3,786 are non-accredited and 1,568 are accredited. Of the 1,568 accredited ASCs, we estimate that 350 are accredited by
   TJC and AAAHC's accreditation standards contain more extensive emergency preparedness requirements than the accreditation standards of either AOA or AAAASF. For example, TJC standards contain requirements for risk assessments and an emergency management plan. AAAHC's standards include requirements for both internal and external emergencies and drills for the facility's internal emergency plan. Therefore, in discussing the individual burden requirements in this proposed rule, we will discuss the burden for the estimated 1,226 accredited ASCs by either the
   For the purpose of determining the burden for the TJC-accredited ASCs, we used TJC's Comprehensive Accreditation Manual for Ambulatory Care: The Official Handbook 2008 (CAMAC). Concerning the requirement for a risk assessment in proposed
   For the purpose of determining the burden for the 876 AAAHC-accredited ASCs, we used the Accreditation Handbook for Ambulatory Health Care 2008 (AHAHC). The AAAHC standards do not contain a specific requirement for the ASC to perform a risk assessment. However, in discussing the requirement for drills, the AAAHC notes that such drills should be appropriate to the facility's activities and environment (AHAHC,
   We expect that all ASCs have already performed at least some of the work needed for a risk assessment. However, many probably have not performed a thorough risk assessment. Therefore, we expect that all non TJC-accredited ASCs would perform thorough reviews of their current risk assessments, if they have them, and revise them to ensure they have updated the assessments and that they have included all of the requirements in proposed
   We have not designated any specific process or format for ASCs to use in conducting their risk assessments because we believe that ASCs, as well as other health care providers and suppliers, need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect health care facilities to, at a minimum, include input from all of their major departments in the process of developing their risk assessments. Based on our experience working with ASCs, we expect that conducting the risk assessment would require the involvement of an administrator and a quality improvement nurse. We expect that to comply with the requirements of this subsection, both of these individuals would need to attend an initial meeting, review the current assessment, prepare their comments, attend a follow-up meeting, perform a final review, and approve the risk assessment. In addition, we expect that the quality improvement nurse would coordinate the meetings; perform an initial review of the current risk assessment; provide suggestions or a critique of the risk assessment; coordinate comments; revise the original risk assessment; develop any necessary sections for the risk assessment; and ensure that the appropriate parties approve the new risk assessment. We estimate that complying with this risk assessment requirement would require 8 burden hours for each ASC at a cost of
   After conducting the risk assessment, ASCs would be required to develop and maintain emergency preparedness plans in accordance with
   AAAHC-accredited ASCs are required to have a "comprehensive emergency plan to address internal and external emergencies" (AHAC, Chapter 8. Facilities and Environment, Element D, p. 37). However, we do not believe that this requirement ensures compliance with all of the requirements for an emergency plan. We will include the 876 AAAAHC-accredited ASCs in the burden analysis for this requirement.
   We expect that the 5,004 non TJC-accredited ASCs have developed some type of emergency preparedness plan. However, under this proposed rule, all of these ASCs would have to review their current plans and compare them to the risk assessments they performed in accordance with proposed
   The burden associated with this requirement would be the time and effort necessary to develop an emergency preparedness plan that complies with all of the requirements in proposed
   All of the ASCs would also be required to review and update their emergency preparedness plans at least annually. For the purpose of determining the burden for this requirement, we would expect that ASCs would review their plans annually. All ASCs have a professional staff person, generally a quality improvement nurse, whose responsibility entails ensuring that the ASC is delivering quality patient care and that the ASC is complying with regulations concerning patient care. We expect that the quality improvement nurse would be primarily responsible for the annual review of the ASC's emergency preparedness plan. We expect that complying with this requirement would constitute a usual and customary business practice for ASCs in accordance with 5 CFR 1320.3(b)(2). Therefore, we will not include this activity in the burden analysis.
   Section 416.54(b) proposes that each ASC be required to develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan set forth in paragraphs (c) of this section. We would require ASCs to review and update these policies and procedures at least annually. These policies and procedures would be required to include, at a minimum, the requirements listed at
   The TJC accreditation standards already require many of the specific elements that are required in this subsection. For example, in the chapter entitled "Leadership" (LD), TJC-accredited ASCs are required to "develop policies and procedures that guide and support patient care, treatment, and services" (
   AAAHC standards require ASCs to have "the necessary personnel, equipment and procedures to handle medical and other emergencies that may arise in connection with services sought or provided" (AHAHC, Chapter 8. Facilities and Environment, Element B, p. 37). Although, we expect that AAAHC-accredited ASCs probably already have policies and procedures that address at least some of the requirements, we expect that they will sustain a considerable burden in satisfying all of the requirements. We will include the AAAHC-accredited ASCs with the non-accredited ASCs in determining the burden for the requirements in proposed
   We expect that all of the 5,004 non TJC-accredited ASCs have some emergency preparedness policies and procedures. However, we expect that all of these ASCs would need to review their policies and procedures and revise their policies and procedures to ensure that they address all of the proposed requirements. We expect that the quality improvement nurse would initially review the ASC's emergency preparedness policies and procedures. The quality improvement nurse would send any recommendations for changes or additional policies or procedures to the ASC's administrator. The administrator and quality improvement nurse would need to make the necessary revisions and draft any necessary policies and procedures. We estimate that for each non TJC-accredited ASC to comply with this proposed requirement would require 9 burden hours at a cost of
   Proposed SEC 416.54(c) would require each ASC to develop and maintain an emergency preparedness communication plan that complies with both federal and state law. We also propose that ASCs would have to review and update these plans at least annually. These communication plans would have to include the information listed in
   The TJC-accredited ASCs are required to have a plan that "identifies backup internal and external communication systems in the event of failure during emergencies" (
   The AAAHC standards do not have a specific requirement for a communication plan for emergencies. However, AAAHC-accredited ASCs are required to have the "necessary personnel, equipment and procedures to handle medical and other emergencies that may arise in connection with services sought or provided (AAAHC, 8. Facilities and Environment, Element B, p. 37) and "a comprehensive emergency plan to address internal and external emergencies" (AAAHC, 8. Facilities and Environment, Element D, p. 37). Since communication is vital to any ASC's operations, we expect that communications would be included in the AAAHC-accredited ASC's plans and procedures. However, we do not believe that these requirements ensure that the AAAHC-accredited ASCs are already fully satisfying all of the requirements. Therefore, we will include the AAAHC-accredited ASCs in with the non-accredited ASCs in determining the burden for these requirements for a total of 5,004 non TJC-accredited ASCs (5,354 total ASCs--350 TJC accredited ASCs).
   We expect that all non TJC-accredited ASCs currently have some type of emergency preparedness communication plan. It is standard practice in the health care industry to have and maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility, such as cell phones; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. We expect that all ASCs already satisfy the requirements in proposed
   We also propose that ASCs must review and update their emergency preparedness communication plans at least annually. We believe that ASCs already review their emergency preparedness communication plans periodically. Therefore, complying with this requirement would constitute a usual and customary business practice for ASCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 416.54(d) would require ASCs to develop and maintain emergency preparedness training and testing programs that ASCs must review and update at least annually. Specifically, ASCs must meet the requirements listed at proposed
   The burden associated with complying with these requirements would be the time and effort necessary for an ASC to review, update, and, in some cases, develop new sections for its emergency preparedness training program. We expect that all ASCs already provide training on their emergency preparedness policies and procedures. However, all ASCs would need to review their current training and testing programs and compare their contents to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans.
   Proposed SEC 416.54(d)(1) would require ASCs to provide initial training in their emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. ASCs would have to ensure that their staff can demonstrate knowledge of emergency procedures. Thereafter, ASCs would have to provide the training at least annually. TJC-accredited ASCs must provide an initial orientation to their staff and independent practitioners (
   The AAAHC-accredited ASCs are already required to ensure that "all health care professionals have the necessary and appropriate training and skills to deliver the services provided by the organization" (AAAHC, Chapter 4. Quality of Care Provided, Element A, p. 28). Since these ASCs are required to have an emergency plan that addresses internal and external emergencies, we expect that all of the AAAHC-accredited ASCs already are providing some training on their emergency preparedness policies and procedures. However, this requirement does not include any requirement for annual training or for any training for staff that are not health care professionals. This AAAHC-accredited requirement does not ensure that these ASCs are already complying with the proposed requirements. Therefore, we will include these AAAHC-accredited ASCs in determining the information collection burden for these requirements.
   Based upon our experience with ASCs, we expect that all 5,354 ASCs have some type of emergency preparedness training program. We also expect that these ASCs would need to review their training programs and compare them to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. The ASCs would then need to make any necessary revisions to their training programs to ensure they comply with these requirements. We expect that complying with this requirement would require the involvement of an administrator and a quality improvement nurse. We estimate that for each ASC to develop a comprehensive emergency training program would require 6 burden hours at a cost of
   We propose that ASCs would also have to review and update their emergency preparedness training programs at least annually. For the purpose of determining the burden for this requirement, we would expect that ASCs would review their emergency preparedness training program annually. We expect that all ASCs have a quality improvement nurse responsible for ensuring that the ASC is delivering quality patient care and that the ASC is complying with patient care regulations. We expect that the quality improvement nurse would be primarily responsible for the annual review of the ASC's emergency preparedness training program. Thus, complying with this requirement would constitute a usual and customary business practice for ASCs in accordance with 5 CFR 1320.3(b)(2). Thus, we will not include this activity in this burden analysis.
   Proposed SEC 416.54(d)(2) would require ASCs to participate in a community mock disaster drill and, if one was not available, conduct an individual, facility-based mock disaster drill, at least annually. ASCs would also have to conduct a paper-based, tabletop exercise at least annually. If the ASC experiences an actual natural or man-made emergency that requires activation of their emergency plan, the ASC would be exempt from the requirement for a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. ASCs would also be required to analyze their response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, ASCs would need to develop a scenario for each drill and exercise. ASCs would also need to develop the documentation necessary for recording what happened during drills, exercises, and emergency events and analyze their responses to these events.
   TJC-accredited ASCs are required to regularly test their emergency management plans at least twice a year, critique each exercise, and modify their emergency management plans in response to those critiques (
   The AAAHC-accredited ASCs already are required to perform at least four drills annually of their internal emergency plans (AAAHC, Chapter 8. Facilities and Environment, Element E, p. 37). However, there is no requirement for a paper-based, tabletop exercise; for a community-based drill; or for the ASCs to maintain documentation of their drills, exercises, or emergency events. This AAAHC accreditation requirement does not ensure that AAAHC-accredited ASCs are already complying with these requirements. Therefore, the AAAHC-accredited ASCs will be included in the burden estimate.
   Based on our experience with ASCs, we expect that all of the 5,354 ASCs would be required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the documentation necessary to record and analyze these events, as well as any emergency events. Although we believe many ASCs may have developed scenarios and documentation for whatever type of drills or exercises they had previously performed, we expect all ASCs would need to ensure that the testing of their emergency preparedness plans comply with these requirements. Based upon our experience with ASCs, we expect that complying with this requirement would require the involvement of an administrator and a quality improvement nurse. We estimate that for each ASC to comply would require 5 burden hours at a cost of
Table 3--Burden Hours and Cost Estimates for All 5,354 ASCs To Comply With the ICRs Contained in S. 416.54 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 416.54(a)(1) 0938--New 5,004 5,004 8 40,032 S. 416.54(a)(1)- 0938--New 5,004 5,004 11 55,044 (4) S. 416.54(b) 0938--New 5,004 5,004 9 45,036 S. 416.54(c) 0938--New 5,004 5,004 4 20,016 S. 416.54(d)(1) 0938--New 5,354 5,354 6 32,124 S. 416.54(d)(2) 0938--New 5,354 5,354 5 26,770 Totals 5,354 30,724 219,022
Table 3--Burden Hours and Cost Estimates for All 5,354 ASCs To Comply With the ICRs Contained in S. 416.54 Condition: Emergency Preparedness Regulation Hourly Total labor Total Total cost section(s) labor cost cost of capital/ ( ] of reporting maintenance reporting ( ] costs ( ] ( ] S. 416.54(a)(1) * * 2,386,908 0 2,386,908 S. 416.54(a)(1)- * * 3,267,612 0 3,267,612 (4) S. 416.54(b) * * 2,527,020 0 2,527,020 S. 416.54(c) * * 1,135,908 0 1,135,908 S. 416.54(d)(1) * * 1,758,176 0 1,758,176 S. 416.54(d)(2) * * 1,488,412 0 1,488,412 Totals 12,564,036 * * The hourly labor cost is blended between the wages for multiple staffing levels.
E. ICRs Regarding Condition of Participation: Emergency Preparedness (
   Proposed SEC 418.113(a) would require hospices to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We propose that the plan meet the criteria listed in proposed
   Although proposed
   Proposed SEC 113(a)(1) would require all hospices to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. We expect that in performing a risk assessment, a hospice would need to consider its physical location, the geographic area in which it is located, and its patient population.
   The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. There are 3,773 hospices. There are 2,584 hospices that provide care only to patients in their homes and 1,189 hospices that offer inpatient care directly (inpatient hospices). When we use the term "inpatient hospice," we are referring to a hospice that operates its own inpatient care facility; that is, the hospice provides the inpatient care itself. By "outpatient hospices", we are referring to hospices that only provide in-home care, and contract with other facilities to provide inpatient care. The current requirements for hospices contain emergency preparedness requirements for inpatient hospices only (42 CFR 418.110). Inpatient hospices must have "a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care," as stated in 42 CFR 418.110(c)(1)(ii). Thus, we expect inpatient hospices already have performed some type of risk assessment during the process of developing their disaster preparedness plan. However, these risk assessments may not be documented or may not address all of the requirements under proposed
   We have not designated any specific process or format for hospices to use in conducting their risk assessments because we believe hospices need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we believe that in the process of developing a risk assessment, health care institutions should include representatives from or obtain input from all of their major departments. Based on our experience with hospices, we expect that conducting the risk assessment would require the involvement of the hospice's administrator and an interdisciplinary group (IDG). The current Hospice CoPs require every hospice to have an IDG that includes a physician, registered nurse, social worker, and pastoral or other counselor. The responsibilities of one of a hospice's IDGs, if they have more than one, include the establishment of "policies governing the day-to-day provision of hospice care and services" (42 CFR 418.56(a)(2)). Thus, we believe the IDG would be involved in performing the risk assessment.
   We expect that members of the IDG would attend an initial meeting; review any existing risk assessment; develop comments and recommendations for changes to the assessment; attend a follow-up meeting; perform a final review; and approve the risk assessment. We expect that the administrator would coordinate the meetings, perform an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary staff approves the new risk assessment. We believe it is likely that the administrator would spend more time reviewing and working on the risk assessment than the other individuals in the IDG. We estimate it would require 10 burden hours to review and update the risk assessment at a cost of
   There are no emergency preparedness requirements in the current hospice CoPs for hospices that provide care to patients in their homes. However, it is standard practice for health care facilities to plan and prepare for common emergencies, such as fires, power outages, and storms. Although we expect that these hospices have considered at least some of the risks they might experience, we anticipate that these facilities would require more time than an inpatient hospice to perform a risk assessment. We estimate that each hospice that provides care to patients in their homes would require 12 burden hours to develop its risk assessment at a cost of
   After conducting the risk assessments, hospices would have to develop and maintain emergency preparedness plans that they would have to review and update at least annually. We expect all hospices to compare their current emergency plans, if they have them, to the risk assessments they performed in accordance with proposed
   The current hospice CoPs require inpatient hospices to have "a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care" (42 CFR 418.110(c)(1)(ii)). We believe that all inpatient hospices already have some type of emergency preparedness or disaster plan. However, their plans may not address all likely medical and non-medical emergency events identified by the risk assessment. Further, their plans may not include strategies for addressing likely emergency events or address their patient population; the type of services they have the ability to provide in an emergency; or continuity of operations, including delegations of authority and succession plans. We expect that an inpatient hospice would have to review its current plan and compare it to its risk assessment, as well as to the other requirements we propose. We expect that most inpatient hospices would need to update and revise their existing emergency plans, and, in some cases, develop new sections to comply with our proposed requirements.
   The burden associated with this proposed requirement would be the time and effort necessary to develop an emergency preparedness plan or to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with inpatient hospices, we expect that these activities would require the involvement of the hospice's administrator and an IDG, that is, a physician, registered nurse, social worker, and counselor. We believe that developing the plan would require more time to complete than the risk assessment.
   We expect that these individuals would have to attend an initial meeting, review relevant sections of the facility's current emergency preparedness or disaster plan(s), develop comments and recommendations for changes to the facility's plan, attend a follow-up meeting, perform a final review, and approve the emergency plan. We expect that the administrator would probably coordinate the meetings, perform an initial review of the current emergency plan, provide a critique of the emergency plan, offer suggested revisions, coordinate comments, develop the new emergency plan, and ensure that the necessary parties approve the new emergency plan. We expect the administrator would probably spend more time reviewing and working on the emergency plan than the other individuals. We estimate that it would require 14 burden hours for each inpatient hospice to develop its emergency preparedness plan at a cost of
   As discussed earlier, we have no current regulatory requirement for hospices that provide care to patients in their homes to have emergency preparedness plans. However, it is standard practice for health care providers to plan for common emergencies, such as fires, power outages, and storms. Although we expect that these hospices already have some type of emergency or disaster plan, each hospice would need to review its emergency plan to ensure that it addressed the risks identified in its risk assessment and complied with the proposed requirements. We expect that an administrator and the individuals from the hospice's IDG would be involved in reviewing, revising, and developing a facility's emergency plan. However, since there are no current requirements for hospices that provide care to patients in their homes have emergency plans, we believe it would require more time for each of these hospices than for inpatient hospices to complete an emergency plan. We estimate that for each hospice that provides care to patients in their homes to comply with this proposed requirement would require 20 burden hours at an estimated cost of
   Hospices would also be required to review and update their emergency preparedness plans at least annually. The current hospice CoPs require inpatient hospices to periodically review and rehearse their disaster preparedness plan with their staff, including non-employee staff (42 CFR 418.110(c)(1)(ii)). For purposes of this burden estimate, we would expect that under this proposed rule, inpatient hospices would review their emergency plans prior to reviewing them with all of their employees and that this review would occur annually.
   We expect that all hospices, both inpatient and those that provide care to patients in their homes, have an administrator who is responsible for the day-to-day operation of the hospice. Day-to-day operations would include ensuring that all of the hospice's plans are up-to-date and in compliance with relevant federal, state, and local laws, regulations, and ordinances. In addition, it is standard practice in health care organizations to have a professional employee, generally an administrator, who periodically reviews their plans and procedures. We expect that complying with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Thus, we will not include this activity in the burden analysis.
   Proposed SEC 418.113(b) would require each hospice to develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. It would also require hospices to review and update these policies and procedures at least annually. At a minimum, the hospice's policies and procedures would be required to address the requirements listed at
   We expect that all hospices have some emergency preparedness policies and procedures because the current hospice CoPs for inpatient hospices already require them to have "a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care" (42 CFR 418.110(c)(1)(ii)). In addition, the responsibilities for at least one of a hospice's IDGs, if they have more than one, include the establishment of "policies governing the day-to-day provision of hospice care and services" (42 CFR 418.56(a)(2)). However, we also expect that all inpatient hospices would need to review their current policies and procedures, assess whether they contain everything required by their facilities' emergency preparedness plans, and revise and update them as necessary.
   The burden associated with reviewing, revising, and updating a hospice's emergency policies and procedures would be the resources needed to ensure they comply with these requirements. Since at least one of a hospice's IDGs would be responsible for developing policies that govern the daily care and services for hospice patients (42 CFR 418.56(a)(2)), we expect that an IDG would be involved with reviewing and revising a hospice's existing policies and procedures and developing any necessary new policies and procedures. We estimate that an inpatient hospice's compliance with this requirement would require 8 burden hours at a cost of
   Although there are no existing regulatory requirements for hospices that provide care to patients in their homes to have emergency preparedness policies and procedures, it is standard practice for health care organizations to prepare for common emergencies, such as fires, power outages, and storms. We expect that these hospices already have some emergency preparedness policies and procedures. However, under this proposed rule, the IDG for these hospices would need to accomplish the same tasks as described earlier for inpatient hospices to ensure that these policies and procedures comply with the proposed requirements.
   We estimate that each hospice's compliance with this requirement would require 9 burden hours at a cost of
   Thus, we estimate that development of emergency preparedness policies and procedures for all 3,773 hospices would require 32,768 burden hours at a cost of
   Proposed SEC 418.113(c) would require a hospice to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Hospices would also have to review and update their plans at least annually. The communication plan would have to include the requirements listed at
   We believe that all hospices already have some type of emergency preparedness communication plan. Although only inpatient hospices have a current requirement for disaster preparedness (42 CFR 418.110(c)), it is standard practice for health care organizations to maintain contact information for their staff and for outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the organization (for example, cell phones); and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many hospices, both inpatient hospices and hospices that provide care to patients in their homes, may not have formal, written emergency preparedness communication plans. We expect that all hospices would need to review, update, and in some cases, develop new sections for their plans to ensure that those plans include all of the elements we propose requiring for hospice communication plans.
   The burden associated with complying with this requirement would be the resources required to ensure that the hospice's emergency communication plan complied with these requirements. Based upon our experience with hospices, we anticipate that satisfying these requirements would require only the involvement of the hospice's administrator. Thus, for each hospice, we estimate that complying with this requirement would require 3 burden hours at a cost of
   We are proposing that a hospice review and update its emergency preparedness communication plan at least annually. We believe that all hospices already review their emergency preparedness communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for hospices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 418.113(d) would require each hospice to develop and maintain an emergency preparedness training and testing program that would be reviewed and updated at least annually. Proposed SEC 418.113(d)(1) would require hospices to provide initial training in emergency preparedness policies and procedures to all hospice employees, consistent with their expected roles, and maintain documentation of the training. The hospice would also have to ensure that their employees could demonstrate knowledge of their emergency procedures. Thereafter, the hospice would have to provide emergency preparedness training at least annually. Hospices would also be required to periodically review and rehearse their emergency preparedness plans with their employees, with special emphasis placed on carrying out the procedures necessary to protect patients and others.
   Under current regulations, all hospices are required to provide an initial orientation and in-service training and educational programs, as necessary, to each employee ( SEC 418.100(g)(2) and (3)). They must also provide employee orientation and training consistent with hospice industry standards (42 CFR 418.78(a)). In addition, inpatient hospices must periodically review and rehearse their disaster preparedness plans with their staff, including non-employee staff (42 CFR 418.110(c)(1)(ii)). We expect that all hospices already provide training to their employees on the facility's existing disaster plans, policies, and procedures. However, under this proposed rule, all hospices would need to review their current training programs and compare their contents to their updated emergency preparedness plans, policies and procedures, and communications plans. Hospices would then need to review, revise, and in some cases, develop new material for their training programs so that they complied with these requirements.
   The burden associated with the aforementioned requirements would be the time and effort necessary for a hospice to bring itself into compliance with the requirements in this section. We expect that compliance with this requirement would require the involvement of a registered nurse. We expect that the registered nurse would compare the hospice's current training program with the facility's emergency preparedness plan, policies and procedures, and communication plan, and then make any necessary revisions, including the development of new training material, as needed. We estimate that these tasks would require 6 burden hours at a cost of
   We are proposing that hospices also be required to review and update their emergency preparedness training programs at least annually. We believe that hospices already review their emergency preparedness training programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for hospices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 418.113(d)(2) would require hospices to participate in a community mock disaster drill, and if one were not available, conduct an individual, facility-based mock disaster drill, and a paper-based, tabletop exercise at least annually. Hospices would also be required to analyze their responses to and maintain documentation of all their drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, a hospice would need to develop scenarios for their drills and exercises. A hospice also would have to develop the required documentation.
   Hospices would also have to periodically review and rehearse their emergency preparedness plans with their staff (including nonemployee staff), with special emphasis on carrying out the procedures necessary to protect patients and others ( SEC 418.110(c)(1)(ii)). However, this periodic rehearsal requirement does not ensure that hospices are performing any type of drill or exercise annually or that they are documenting their responses. In addition, there is no requirement in the current CoPs for outpatient hospices to have an emergency plan or for these hospices to test any emergency procedures they may currently have. We believe that developing the scenarios for these drills and exercises and the documentation necessary to record the events during drills, exercises, and emergency events would be new requirements for all hospices.
   The associated burden would be the time and effort necessary for a hospice to comply with these requirements. We expect that complying with these requirements would require the involvement of a registered nurse. We expect that the registered nurse would develop the necessary documentation and the scenarios for the drills and exercises. We estimate that these tasks would require 4 burden hours at an estimated cost of
   Thus, for all 3,773 hospices to comply with all of the requirements in SEC 418.113, it would require an estimated 193,041 burden hours at a cost of
Table 4--Burden Hours and Cost Estimates for All 3, 773 Hospices To Comply With the ICRs In S. 418.113 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden Total section(s) No. per annual response burden (hours) (hours) S. 418.113(a)(1) 0938--New 1,189 1,189 10 11,890 (inpatient) S. 418.113(a)(1) 0938--New 2,584 2,584 12 31,008 (outpatient) S. 0938--New 1,189 1,189 14 16,646 418.113(a)(1)-(4) (inpatient) S. 0938--New 2,584 2,584 20 51,680 418.113(a)(1)-(4) (outpatient) S. 418.113(b) 0938--New 1,189 1,189 8 9,512 (inpatient) S. 418.113(b) 0938--New 2,584 2,584 9 23,256 (outpatient) S. 418.113(c) 0938--New 3,773 3,773 3 11,319 S. 418.113(d)(1) 0938--New 3,773 3,773 6 22,638 S. 418.113(d)(2) 0938--New 3,773 3,773 4 15,092 Totals 3,773 22,638 193,041
Table 4--Burden Hours and Cost Estimates for All 3,773 Hospices To Comply With the ICRs In S. 418.113 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor capital/ ( ] cost of cost of maintenance reporting reporting costs ( ] ( ] ( ] S. 418.113(a)(1) 589,744 589,744 (inpatient) S. 418.113(a)(1) 1,532,312 1,532,312 (outpatient) S. 882,238 882,238 418.113(a)(1)-(4) (inpatient) S. 2,702,864 2,702,864 418.113(a)(1)-(4) (outpatient) S. 418.113(b) 474,411 474,411 (inpatient) S. 418.113(b) 1,173,136 1,173,136 (outpatient) S. 418.113(c) 622,545 622,545 S. 418.113(d)(1) 950,796 950,796 S. 418.113(d)(2) 633,864 633,864 Totals 10,444,148 * *The hourly labor cost is blended between the wages for multiple staffing levels.
F. ICRs Regarding Emergency Preparedness ( SEC 441.184)
   Proposed SEC 441.184(a) would require Psychiatric Residential Treatment Facilities (PRTFs) to develop and maintain emergency preparedness plans and review and update those plans at least annually. We propose that these plans meet the requirements listed at SEC 441.184(a)(1) through (4).
   Section SEC 441.184(a)(1) would require each PRTF to develop a documented, facility-based and community-based risk assessment that would utilize an all-hazards approach. We expect that all PRTFs have already performed some of the work needed for a risk assessment because it is standard practice for health care facilities to prepare for common hazards, such as fires and power outages, and disasters or emergencies common in their geographic area, such as snowstorms or hurricanes. However, many PRTFs may not have documented their risk assessments or performed one that would comply with all of our proposed requirements. Therefore, we expect that all PRTFs would have to review and revise their current risk assessments.
   We have not designated any specific process or format for PRTFs to use in conducting their risk assessments because we believe that PRTFs need maximum flexibility to determine the best way to accomplish this task. However, we expect that PRTFs would include representation from or seek input from all of their major departments. Based on our experience with PRTFs, we expect that conducting the risk assessment would require the involvement of the PRTF's administrator, a psychiatric registered nurse, and a clinical social worker. We expect that all of these individuals would attend an initial meeting, review their current assessment, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the psychiatric registered nurse would coordinate the meetings, perform an initial review, offer suggested revisions, coordinate comments, develop a new risk assessment, and ensure that the necessary parties approve the new risk assessment. We also expect that the psychiatric registered nurse would spend more time reviewing and working on the risk assessment than the other individuals. We estimate that in order for each PRTF to comply, it would require 8 burden hours at a cost of
   After conducting the risk assessment, SEC 441.184(a)(1) through (4) would require PRTFs to develop and maintain an emergency preparedness plan. Although it is standard practice for health care facilities to have some type of emergency preparedness plan, all PRTFs would need to review their current plans and compare them to their risk assessments. Each PRTF would need to update, revise, and, in some cases, develop new sections to complete its emergency preparedness plan.
   Based upon our experience with PRTFs, we expect that the administrator and psychiatric registered nurse who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect it would require substantially more time to complete the plan than the risk assessment. We expect that the psychiatric nurse would be the most heavily involved in reviewing and developing the PRTF's emergency preparedness plan. We also expect that a clinical social worker would review the drafts of the plan and provide comments on it to the psychiatric registered nurse. We estimate that for each PRTF to comply with this requirement would require 12 burden hours at a cost of
   PRTFs also would be required to review and update their emergency preparedness plans at least annually. We believe that PRTFs are already reviewing their emergency preparedness plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 441.184(b) would require each PRTF to develop and implement emergency preparedness policies and procedures, based on their emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. We also propose requiring PRTFs to review and update these policies and procedures at least annually. At a minimum, we would require that the PRTF's policies and procedures address the requirements listed at SEC 441.184(b)(1) through (8).
   Since we expect that all PRTFs already have some type of emergency plan, we also expect that all PRTFs have some emergency preparedness policies and procedures. However, we expect that all PRTFs would need to review their policies and procedures; compare them to their risk assessments, emergency preparedness plans, and communication plans they developed in accordance with SEC 441.183(a)(1), (a) and (c), respectively; and then revise their policies and procedures accordingly.
   We expect that the administrator and a psychiatric registered nurse would be involved in reviewing and revising the policies and procedures and, if needed, developing new policies and procedures. We estimate that it would require 9 burden hours at a cost of
   We are also proposing that PRTFs review and update their emergency preparedness policies and procedures at least annually. We believe that PRTFs are already reviewing their emergency preparedness policies and procedures periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 441.184(c) would require each PRTF to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. PRTFs also would have to review and update these plans at least annually. The communication plan would have to include the information set out in SEC 441.184(c)(1) through (7).
   We expect that all PRTFs have some type of emergency preparedness communication plan. It is standard practice for health care facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their residents. However, most PRTFs may not have formal, written emergency preparedness communication plans. Therefore, we expect that all PRTFs would need to review and, if needed, revise their plans.
   Based on our experience with PRTFs, we anticipate that satisfying these requirements would require the involvement of the PRTF's administrator and a psychiatric registered nurse to review, revise, and if needed, develop new sections for the PRTF's emergency preparedness communication plan. We estimate that for each PRTF to comply would require 5 burden hours at a cost of
   PRTFs must also review and update their emergency preparedness communication plans at least annually. We believe that PRTFs are already reviewing their emergency preparedness communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 441.184(d) would require PRTFs to develop and maintain emergency preparedness training programs and review and update those programs at least annually. Proposed SEC 441.184(d)(1) would require PRTFs to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The PRTF would also have to ensure that their staff could demonstrate knowledge of the emergency procedures. Thereafter, the PRTF would have to provide emergency preparedness training at least annually.
   Based on our experience with PRTFs, we expect that all PRTFs have some type of emergency preparedness training program. However, PRTFs would need to review their current training programs and compare them to their risk assessments and emergency preparedness plans, policies and procedures, and communication plans and update and, in some cases, develop new sections for their training programs.
   We expect that complying with this requirement would require the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse would review the PRTF's current training program; determine what tasks would need to be performed and what materials would need to be developed; and develop the necessary materials. We estimate that for each PRTF to comply with the requirements in this section would require 10 burden hours at a cost of
   PRTFs would also be required to review and update their emergency preparedness training program at least annually. We believe that PRTFs are already reviewing their emergency preparedness training programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for PRTFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 441.184(d)(2) would require PRTFs to participate in a community mock disaster drill, and if one were not available, conduct an individual, facility-based mock disaster drill, and a paper-based, tabletop exercise at least annually. PRTFs would also have to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. However, if a PRTF experienced an actual natural or man-made emergency that required activation of its emergency plan, that PRTF would be exempt from engaging in a community or an individual, facility-based mock disaster drill for 1 year following the onset of the actual emergency event. To comply with this requirement, PRTFs would need to develop scenarios for each drill and exercise and the documentation necessary to record and analyze drills, exercises, and actual emergency events.
   Based on our experience with PRTFs, we expect that all PRTFs have some type of emergency preparedness testing program and most, if not all, PRTFs already conduct some type of drill or exercise to test their emergency preparedness plans. We also expect that they have already developed some type of documentation for drills, exercises, and emergency events. However, we do not expect that all PRTFs are conducting both a drill and a paper-based, tabletop exercise annually or have developed the appropriate documentation. Thus, we will analyze the burden of these requirements for all PRTFs.
   Based on our experience with PRTFs, we expect that the same individual who developed the emergency preparedness training program would develop the scenarios for the drill and the exercise and the accompanying documentation. We estimate that for each PRTF to comply with the requirements in this section would require 3 burden hours at a cost of
   Based on the previous analysis, for all 387 PRTFs to comply with the ICRs in this proposed rule would require 18,189 burden hours at a cost of
Table 5--Burden Hours and Cost Estimates for All 387 PRTFs To Comply With the *ICRs Contained in S. 441.184 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden Total section(s) No. per annual response burden (hours) (hours) S. 441.184(a)(1) 0938--New 387 387 8 3,096 S. 0938--New 387 387 12 4,644 441.184(a)(1)-(4) S. 441.184(b) 0938--New 387 387 9 3,483 S. 441.184(c) 0938--New 387 387 5 1,935 S. 441.184(d)(1) 0938--New 387 387 10 3,870 S. 441.184(d)(2) 0938--New 387 387 3 1,161 Totals 387 2,322 18,189
Table 5--Burden Hours and Cost Estimates for All 387 PRTFs To Comply With the *ICRs Contained in S. 441.184 Condition: Emergency Preparedness Regulation Hourly Total Total Total section(s) labor labor capital/ cost cost of cost of maintenance ( ] reporting reporting costs ( ] ( ] ( ] S. 441.184(a)(1) * * 152,478 0 152,478 S. * * 245,358 0 245,358 441.184(a)(1)-(4) S. 441.184(b) * * 192,726 0 192,726 S. 441.184(c) * * 110,682 0 110,682 S. 441.184(d)(1) * * 178,020 0 178,020 S. 441.184(d)(2) * * 53,406 0 53,406 Totals 932,670
G. ICRs Regarding Emergency Preparedness ( SEC 460.84)
   Proposed SEC 460.84(a) would require the Program for the All-Inclusive Care for the Elderly (PACE) organizations to develop and maintain emergency preparedness plans and review and update those plans at least annually. We propose that each plan must meet the requirements listed at SEC 460.84(a)(1) through (4).
   Section SEC 460.84(a)(1) would require PACE organizations to develop documented, facility-based and community-based risk assessments utilizing an all-hazards approach. We believe that the performance of a risk assessment is a standard practice, and that all of the PACE organizations have already conducted some sort of risk assessment based on common emergencies the organization might encounter, such as fires, loss of power, loss of communications, etc. Therefore, we believe that each PACE organization should have already performed some sort of risk assessment.
   Under the current regulations, PACE organizations are required to establish, implement, and maintain procedures for managing medical and non-medical emergencies and disasters that are likely to threaten the health or safety of the participants, staff, or the public ( SEC 460.72(c)(1)). The definition of "emergencies" includes natural disasters that are likely to occur in the PACE organization's area ( SEC 460.72(c)(2)). PACE organizations are required to plan for emergencies involving participants who are in their center(s) at the time of an emergency, as well as participants receiving services in their homes.
   For the purpose of determining the burden, we will assume that a PACE organization's risk assessment, emergency plan, policies and procedures, communication plan, and training and testing program would apply to all of a PACE organization's centers. Based on the existing PACE regulations, we expect that they already assess their physical structure(s), the areas in which they are located, and the location(s) of their participants. However, these risk assessments may not be documented or address all of our proposed requirements. Therefore, we expect that all 91 PACE organizations would have to review, revise, and update their current risk assessments.
   We have not designated any specific process or format for PACE organizations to use in conducting their risk assessments because we believe that they would be able to determine the best way for their facilities to accomplish this task. However, we expect that they would include representation or input from all of their major departments. Based on our experience with PACE organizations, we expect that conducting the risk assessment would require the involvement of the PACE organization's program director, medical director, home care coordinator, quality improvement nurse, social worker, and a driver. We expect that these individuals would either attend an initial meeting or be asked to individually review relevant sections of the current risk assessment and prepare and forward their comments to the quality assurance nurse. After initial comments are received, some would attend a follow-up meeting, perform a final review, and ensure the new risk assessment was approved by the appropriate individuals. We expect that the quality improvement nurse would coordinate the meetings, review the current risk assessment, suggest revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the quality improvement nurse and the home care coordinator would spend more time reviewing and developing the risk assessment than the other individuals.
   We estimate that complying with the requirement to conduct a risk assessment would require 14 burden hours at a cost of
   After conducting a risk assessment, PACE organizations would have to develop and maintain emergency preparedness plans that satisfied all of the requirements in SEC 460.84(a)(1) through (4). In addition to the requirement to establish, implement, and maintain procedures for managing emergencies and disasters, current regulations require PACE organizations to have a governing body or designated person responsible for developing policies on participant health and safety, including a comprehensive, systemic operational plan to ensure the health and safety of the PACE organization's participants ( SEC 460.62(a)(6)). We expect that an emergency preparedness plan would be an essential component of such a comprehensive, systemic operational plan. However, this regulatory requirement does not guarantee that all PACE organizations have developed a plan that complies with our proposed requirements.
   Thus, we expect that all PACE organizations would need to review their current plans and compare them to their risk assessments. PACE organizations would need to update, revise, and, in some cases, develop new sections to complete their emergency preparedness plans.
   Based upon our experience with PACE organizations, we expect that the same individuals who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect that it would require more time to complete the plan. We expect that the quality improvement nurse would have primary responsibility for reviewing and developing the PACE organization's emergency preparedness plan. We expect that the program director, home care coordinator, and social worker would review the current plan, provide comments, and assist the quality improvement nurse in developing the final plan. Other staff members would work only on the sections of the plan that would be relevant to their areas of responsibility.
   We estimate that for each PACE organization to comply with the requirement for an emergency preparedness plan would require 23 burden hours at a cost of
   Proposed SEC 460.84(b) would require each PACE organization to develop and implement emergency preparedness policies and procedures based on the emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at (c) of this section. It would also require PACE organizations to review and update these policies and procedures at least annually. At a minimum, we would require that a PACE organization's policies and procedures address the requirements listed at SEC 460.84(b)(1) through (9).
   Current regulations already require that PACE organizations establish, implement, and maintain procedures for managing emergencies and disasters ( SEC 460.72(c)). The definition of "emergencies" includes medical and nonmedical emergencies, such as natural disasters likely to occur in a PACE organization's area (42 CFR 460.72(c)(2)). In addition, all PACE organizations must have a governing body or a designated person who functions as the governing body responsible for developing policies on participant health and safety ( SEC 460.62(a)(6)). Thus, we expect that all PACE organizations have some emergency preparedness policies and procedures. However, these requirements do not ensure that all PACE organizations have policies and procedures that would comply with our proposed requirements.
   The burden associated with the proposed requirements would be the resources needed to review, revise, and, if needed, develop new emergency preparedness policies and procedures. We expect that the program director, home care coordinator, and quality improvement nurse would be primarily responsible for reviewing, revising, and if needed, developing any new policies and procedures needed to comply with our proposed requirements. We estimate that for each PACE organization to comply with our proposed requirements would require 12 burden hours at a cost of
   We propose that each PACE organization must also review and update its emergency preparedness policies and procedures at least annually. We believe that PACE organizations are already reviewing their emergency preparedness policies and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 460.84(c) would require each PACE organization to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. Each PACE organization would also have to review and update this plan at least annually. The communication plan must include the information set out at SEC 460.84(c)(1) through (7).
   All PACE organizations must have a governing body (or a designated person who functions as the governing body) that is responsible for developing policies on participant health and safety, including a comprehensive, systemic operational plan to ensure the health and safety of the PACE organization's participants ( SEC 460.62(a)(6)). We expect that the PACE organizations' comprehensive, systemic operational plans would include at least some of our proposed requirements. In addition, it is standard practice in the health care industry to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for patients. Thus, we expect that all PACE organizations have some type of emergency preparedness communication plan. However, each PACE organization would need to review its current plan and revise or, in some cases, develop new sections to comply with our proposed requirements.
   Based on our experience with PACE organizations, we expect that the home care coordinator and the quality assurance nurse would be primarily responsible for reviewing, and if needed, revising, and developing new sections for the communication plan. We estimate that for each PACE organization to comply with the proposed requirements would require 7 burden hours at a cost of
   Each PACE organization must also review and update its emergency preparedness communication plan at least annually. We believe that PACE organizations are already reviewing and updating their emergency preparedness communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for PACE organizations and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 460.84(d) would require PACE organizations to develop and maintain emergency preparedness training and testing programs and review and update those programs at least annually. We propose that each PACE organization would have to meet the requirements listed at SEC 460.84(d)(1) and (2).
   Proposed SEC 460.84(d)(1) would require PACE organizations to provide initial training on their emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles and maintain documentation of this training. PACE organizations would also have to ensure that their staff could demonstrate knowledge of the emergency procedures. Thereafter, PACE organizations would be required to provide this training annually.
   Current regulations require PACE organizations to provide periodic orientation and appropriate training to their staffs and participants in emergency procedures ( SEC 460.72(c)(3)). However, these requirements do not ensure that all PACE organizations would be in compliance with our proposed requirements. Thus, each PACE organization would need to review its current training program and compare the training program to its risk assessment, emergency preparedness plan, policies and procedures, and communication plan. The PACE organization would also need to revise and, in some cases, develop new sections to ensure that its emergency preparedness training program complied with our proposed requirements. We expect that the quality assurance nurse would review all elements of the PACE organization's training program and determine what tasks would need to be performed and what materials would need to be developed to comply with our proposed requirements. We expect that the home care coordinator would work with the quality assurance nurse to develop the revised and updated training program. We estimate that for each PACE organization to comply with the proposed requirements would require 12 burden hours at a cost of
   PACE organizations would also be required to review and update their emergency preparedness training program at least annually. We believe that PACE organizations are already reviewing and updating their emergency preparedness training programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for PACE organizations and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 460.84(d)(2) would require PACE organizations to participate in a community mock disaster drill at least annually. If a community mock disaster drill was not available, the PACE organization would have to conduct an individual, facility-based mock disaster drill. They would also be required to conduct a paper-based, tabletop exercise at least annually. PACE organizations would also be required to analyze their responses to, and maintain documentation of, all drills, exercises, and any emergency events they experienced. If a PACE organization experienced an actual natural or man-made emergency that required activation of its emergency plan, it would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. To comply with these requirements, PACE organizations would need to develop a specific scenario for each drill and exercise. The PACE organizations would also have to develop the documentation necessary for recording and analyzing their response to all drills, exercises, and emergency events.
   Current regulations require each PACE organization to conduct a test of its emergency and disaster plan at least annually (42 CFR 460.72(c)(5)). They also must evaluate and document the effectiveness of their emergency and disaster plans. Thus, PACE organizations already conduct at least one test annually of their plans. We expect that as part of testing their emergency plans annually, PACE organizations would develop a scenario for and document the testing. However, this does not ensure that all PACE organizations would be in compliance with all of our proposed requirements, especially the proposed requirement for conducting a paper-based, tabletop exercise; performing a community-based mock disaster drill; and using different scenarios for the drill and the exercise.
   The 91 PACE organizations would be required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the documentation necessary to record and analyze their response to all drills, exercises, and any emergency events. Based on our experience with PACE organizations, we expect that the same individuals who developed their emergency preparedness training programs would develop the required documentation. We expect the quality improvement nurse would spend more time on these activities than the health care coordinator. We estimate that this activity would require 5 burden hours for each PACE organization at a cost of
Table 6--Burden Hours and Cost Estimates for All 91 PACE Organizations to Comply With the ICRs Contained in S. 460.84 Emergency Preparedness Regulation OMB Respondents Responses Burden per Total section(s) Control No. response annual (hours) burden (hours) S. 460.84(a)(1) 0938--New 91 91 14 1,274 S. 460.84(a)(1)- 0938--New 91 91 23 2,093 (4) S. 460.84(b) 0938--New 91 91 12 1,092 S. 460.84(c) 0938--New 91 91 7 637 S. 460.84(d)(1) 0938--New 91 91 12 1,092 S. 460.84(d)(2) 0938--New 91 91 5 455 Totals 91 546 6,643
Table 6--Burden Hours and Cost Estimates for All 91 PACE Organizations to Comply With the ICRs Contained in S. 460.84 Emergency Preparedness Regulation Hourly Total labor Total Total cost section(s) labor cost cost of capital/ ( ] of eporting maintenance reporting ( ] costs ( ] ( ] S. 460.84(a)(1) * * 69,251 0 69,251 S. 460.84(a)(1)- * * 112,749 0 112,749 (4) S. 460.84(b) * * 54,418 0 54,418 S. 460.84(c) * * 28,665 0 28,665 S. 460.84(d)(1) * * 49,140 0 49,140 S. 460.84(d)(2) * * 20,475 0 20,475 Totals 334,698 * * The hourly labor cost is blended between the wages for multiple staffing levels.
H. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 482.15)
   Proposed SEC 482.15(a) would require hospitals to develop and maintain emergency preparedness plans. We propose that hospitals be required to review and update their emergency preparedness plans at least annually and meet the requirements set out at SEC 482.15(a)(1) through (4).
   Note that we obtain data on the number of hospitals, both accredited and non-accredited, from the CMS CASPER data system, which are updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited hospitals shown may not equal the number of hospitals at the time of this proposed rule's publication. In addition, some hospitals may have chosen to be accredited by more than one accrediting organization.
   There are approximately 4,928 Medicare-certified hospitals. This includes 107 critical access hospitals (CAHs) that have rehabilitation or psychiatric distinct part units (DPUs) as of
   Accreditation can substantially affect the burden a hospital would sustain under this proposed rule.
   The other two accrediting organizations, AOA and DNVHC, accredit 185 and 176 hospitals, respectively. The AOA hospital accreditation requirements do not emphasize emergency preparedness. In addition, these hospitals account for less than 5 percent of all of the hospitals. Thus, for purposes of determining the burden, we have included the 185 AOA-accredited hospitals and the 176 DNVHC-accredited hospitals in with the hospitals that are not accredited. Therefore, unless indicated otherwise, we have analyzed the burden for the 3,410 TJC-accredited hospitals separately from the remaining 1,518 non TJC-accredited hospitals (4,928 hospitals--3,410 TJC-accredited hospitals = 1,518 non TJC-accredited hospitals).
   We have used TJC's "Comprehensive Accreditation Manual for Hospitals: The Official Handbook 2008 (CAMH)" to determine the burden for TJC-accredited hospitals. In the chapter entitled, "Management of the Environment of Care" (EC), hospitals are required to plan for managing the consequences of emergencies (CAMH, Standard EC.4.11, CAMH Refreshed Core,
   Proposed SEC 482.15(a)(1) would require that hospitals perform a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. We expect that most non TJC-accredited hospitals have already performed at least some of the work needed for a risk assessment. The Niska and Burt article indicated that most hospitals already have plans for natural disasters. However, many may not have thoroughly documented this activity or performed as thorough a risk assessment as needed to comply with our proposed requirements.
   We have not designated any specific process or format for hospitals to use in conducting a risk assessment because we believe that hospitals need the flexibility to determine how best to accomplish this task. However, we expect that hospitals would obtain input from all of their major departments when performing a risk assessment. Based on our experience, we expect that conducting a risk assessment would require the involvement of at least a hospital administrator, the risk management director, the chief medical officer, the chief of surgery, the director of nursing, the pharmacy director, the facilities director, the health information services director, the safety director, the security manager, the community relations manager, the food services director, and administrative support staff. We expect that most of these individuals would attend an initial meeting, review relevant sections of their current risk assessment, prepare and send their comments to the risk management director, attend a follow-up meeting, perform a final review, and approve the new risk assessment.
   We expect that the risk management director would coordinate the meetings, review and comment on the current risk assessment, suggest revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the hospital administrator would spend more time reviewing the risk assessment than most of the other individuals.
   We estimate that the risk assessment would require 36 burden hours to complete at a cost of
   Proposed SEC 482.15(a)(1) through (4) would require hospitals to develop and maintain emergency preparedness plans. We expect that all hospitals would compare their risk assessments to their emergency plans and revise and, if necessary, develop new sections for their plans. TJC-accredited hospitals must develop and maintain written Emergency Operations Plans (EOPs) (CAMH, Standard EC.4.12, EP 1, CAMH Refreshed Care,
   We expect that most, if not all, non TJC-accredited hospitals already have some type of emergency preparedness plan. The Niska and Burt article noted that the majority of hospitals have plans for natural disasters; incendiary incidents; and biological, chemical, and radiological terrorism. In addition, all hospitals must already meet the requirements set out at 42 CFR 482.41, including emergency power, lighting, gas and water supply requirements as well as specified Life Safety Code provisions. However, those existing plans may not be fully compliant with our proposed requirements. Thus, it would be necessary for non TJC-accredited hospitals to review their current plans and compare them to their risk assessments and revise, update, or, in some cases, develop new sections for their emergency plans.
   Based on our experience with hospitals, we expect that the same individuals who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we estimate that it would require substantially more time to complete an emergency preparedness plan. We estimate that complying with this requirement would require 62 burden hours at a cost of
   Under this proposed rule, a hospital also would be required to review and update its emergency preparedness plan at least annually. We believe that hospitals already review their emergency preparedness plans periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for hospitals and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Under proposed SEC 482.15(b), we would require each hospital to develop and implement emergency preparedness policies and procedures based on its emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. We would also require hospitals to review and update these policies and procedures at least annually. At a minimum, we would require that the policies and procedures address the requirements at SEC 482.15(b)(1) through (8).
   We would expect all hospitals to review their emergency preparedness policies and procedures and compare them to their emergency plans, risk assessments, and communication plans. We expect that hospitals would then review, revise, and, if necessary, develop new policies and procedures that comply with our proposed requirements.
   The CAMH's chapter entitled, "Leadership" (LD), requires TJC-accredited hospital leaders to "develop policies and procedures that guide and support patient care, treatment, and services" (CAMH, Standard LC.3.90, EP 1, CAMH Refreshed Core,
   Proposed SEC 482.15(b)(1) would require hospitals to have policies and procedures for the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited hospitals are required to make plans for obtaining and replenishing medical and non-medical supplies, including food, water, and fuel for generators and transportation vehicles (CAMH, Standard EC.4.14, EPs 1-8 and 10-11, p. EC-13d). In addition, hospitals must identify alternative means of providing electricity, water, fuel, and other essential utility needs in cases when their usual supply is disrupted or compromised (CAMH, Standard EC.4.17, EPs 1-5, p. EC-13f). Thus, we expect that TJC-accredited hospitals would be in compliance with our proposed provision of subsistence requirements in proposed SEC 482.15(b)(1).
   Proposed SEC 482.15(b)(2) would require hospitals to have policies and procedures to track the location of staff and patients in the hospital's care both during and after an emergency. TJC-accredited hospitals must plan for communicating with patients and their families at the beginning of and during an emergency (CAMH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-13c). We expect that TJC-accredited hospitals would be in compliance with proposed SEC 482.15(b)(2).
   Proposed SEC 482.15(b)(3) would require hospitals to have policies and procedures for a plan for the safe evacuation from the hospital. TJC-accredited hospitals are required to make plans to evacuate patients as part of managing their clinical activities (CAMH, Standard EC.4.18, EP 1, p. EC-13g). They also must plan for the evacuation and transport of patients, as well as their information, medications, supplies, and equipment, to alternative care sites (ACSs) when the hospital cannot provide care, treatment, and services in their facility (CAMH, Standard EC.4.14, EPs 9-11, p. EC-13d). Proposed SEC 482.15(b)(3) also would require hospitals to have "primary and alternate means of communication with external sources of assistance." TJC-accredited hospitals must plan for communicating with external authorities once the hospital initiates its emergency response measures (CAMH, Standard EC.4.13, EP 4, p. EC-13c). Thus, TJC-accredited hospitals would be in compliance with most of the requirements in proposed SEC 482.15(b)(3). However, we do not believe these requirements would ensure compliance with the proposed requirement that the hospital establish policies and procedures for staff responsibilities.
   Proposed SEC 482.15(b)(4) would require hospitals to have policies and procedures that address a means to shelter in place for patients, staff, and volunteers who remain at the facility. The rationale for CAMH Standard EC.4.18 states, "a catastrophic emergency may result in the decision to keep all patients on the premises in the interest of safety" (CAMH, Standard EC.4.18, p. EC-13f). We expect that TJC-accredited hospitals would be in compliance with our proposed shelter in place requirement in SEC 482.15(b)(4).
   Proposed SEC 482.15(b)(5) would require hospitals to have policies and procedures that address a system of medical documentation that preserves patient information, protects the confidentiality of patient information, and ensures that records are secure and readily available. The CAMH chapter entitled "Management of Information" requires TJC-accredited hospitals to have storage and retrieval systems for their clinical/service and hospital-specific information (CAMH, Standard IM.3.10, EP 5, CAMH Refreshed Core,
   Proposed SEC 482.15(b)(6) would require hospitals to have policies and procedures that address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state and federally-designated health care professionals to address surge needs during an emergency. TJC-accredited hospitals must already define staff roles and responsibilities in their EOPs and ensure that they train their staffs for their assigned roles (CAMH, Standard EC.4.16, EPs 1 and 2, p. EC-13e). The rationale for Standard EC.4.15 indicates that the "hospital determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated." In addition, in the chapter entitled "Medical Staff" (MS), hospitals "may grant disaster privileges to volunteers that are eligible to be licensed independent practitioners" (CAMH, Standard MS.4.110, CAMH Refreshed Care,
   Proposed SEC 482.15(b)(7) would require hospitals to have policies and procedures that would address the development of arrangements with other hospitals or other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hospital patients. TJC-accredited hospitals must plan for the sharing of resources and assets with other health care organizations (CAMH, Standard EC.4.14, EPs 7 and 8, p. EC-13d). However, we would not expect TJC-accredited hospitals to be substantially in compliance with the requirements we propose in SEC 482.15(b)(7) based on compliance with TJC accreditation standards alone.
   Proposed SEC 482.15(b)(8) would require hospitals to have policies and procedures that address the hospital's role under an "1135 waiver" (that is, a waiver of some federal rules pursuant to SEC 1135 of the Social Security Act) in the provision of care and treatment at an ACS identified by emergency management officials. TJC-accredited hospitals must already have plans for transporting patients, as well as their associated information, medications, equipment, and staff to ACSs when the hospital cannot support their care, treatment, and services on site (CAMH, Standard EC.4.14, EPs 10 and 11, p. EC-13d). We expect that TJC-accredited hospitals would be in compliance with the requirements we propose in SEC 482.15(b)(8).
   In summary, we expect that TJC-accredited hospitals have developed and are maintaining policies and procedures that would comply with the requirements in proposed SEC 482.15(b), except for proposed SUBSEC 482.15(b)(3), (6), and (7). Later we will discuss the burden on TJC-accredited hospitals with respect to these provisions. We expect that any modifications that TJC-accredited hospitals would need to make to comply with the remaining proposed requirements would not impose a burden above that incurred as part of usual and customary business practices. Thus, with the exception of the proposed requirements set out at SEC 482.15(b)(3), (b)(6), and (b)(7), the proposed requirements would constitute usual and customary business practices and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   The burden associated with proposed SEC 482.15(b)(3), (b)(6), and (b)(7) would be the resources required to develop written policies and procedures that comply with the proposed requirements. We expect that the risk management director would review the hospital's policies and procedures initially and make recommendations for revisions and development of additional policies or procedures. We expect that representatives from the hospital's major departments would make revisions or draft new policies and procedures based on the administrator's recommendation. The appropriate parties would then need to compile and disseminate these new policies and procedures.
   We estimate that complying with these requirements would require 17 burden hours for each TJC-accredited hospital at a cost of
   The 1,518 non TJC-accredited hospitals would need to review their policies and procedures, ensure that their policies and procedures accurately reflect their risk assessments, emergency preparedness plans, and communication plans, and incorporate any of our proposed requirements into their policies and procedures. We expect that the risk management director would coordinate the meetings, review and comment on the current policies and procedures, suggest revisions, coordinate comments, develop the policies and procedures, and ensure that the necessary parties approve it. We expect that the hospital administrator would spend more time reviewing the policies and procedures than most of the other individuals.
   We estimate that complying with this requirement would require 33 burden hours for each non TJC-accredited hospital at an estimated cost of
   In addition, we expect that there would be a burden as a result of proposed SEC 482.15(b)(7). Proposed SEC 482.15(b)(7) would require hospitals to develop and maintain policies and procedures that address a hospital's development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure continuity of services to hospital patients. We expect that hospitals would base those arrangements on written agreements between the hospital and other hospitals and other providers. Thus, in addition to the burden related to developing the policies and procedures, hospitals would also sustain a burden related to developing the written agreements related to those arrangements.
   All 4,928 hospitals would need to identify other hospitals and other providers with which they could have agreements, negotiate and draft the agreements, and obtain all necessary authorizations for the agreements. For the purpose of determining the burden, we will assume that hospitals would have written agreements with two other hospitals and other providers. Based on our experience with hospitals, we expect that complying with this requirement would primarily require the involvement of the hospital's administrator and risk management director. We also expect that a hospital attorney would assist with drafting the agreements and reviewing those documents for any legal implications. We estimate that complying with this requirement would require 8 burden hours for each hospital at an estimated cost of
   Based upon the previous estimates, for all hospitals to be in compliance with all of the requirements in SEC 482.15(b) it would require 147,488 burden hours at a cost of
   Proposed SEC 482.15(b) would also require hospitals to review and update their emergency preparedness policies and procedures at least annually. We believe hospitals are already reviewing and updating their emergency preparedness policies and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for both TJC-accredited and non TJC-accredited hospitals and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 482.15(c) would require each hospital to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The plan would have to be reviewed and updated at least annually. The communication plan would have to include the information listed at SEC 482.15(c)(1) through (7).
   We expect that all hospitals currently have some type of emergency preparedness communication plan. We expect that under this proposed rule, hospitals would review their current communication plans, compare them to their emergency preparedness plans and emergency policies and procedures, and revise their communication plans, as necessary.
   It is standard practice for health care facilities to maintain contact information for staff and outside sources of assistance; have alternate means of communication in case there is an interruption in phone service to the facility; and have a method for sharing information and medical documentation with other health care providers to ensure continuity of care for patients. However, under this proposed rule, all hospitals would need to review and update their plans to ensure compliance with our proposed requirements.
   The TJC-accredited hospitals are required to establish emergency communication strategies (CAMH, Standard EC.4.13, p. EC-13b). In addition, TJC-accredited hospitals are specifically required to ensure communication with staff, external authorities, patients, and their families (CAMH, Standard EC.4.13, EPs 1-5, p. EC-13c). TJC-accredited hospitals also are required to establish "back-up communications systems and technologies" for such activities (CAMH, Standard EC.4.13, EP 14, p. EC-13c). Moreover, TJC-accredited hospitals are required specifically to define "the circumstances and plans for communicating information about patients to third parties (such as other health care organizations) . . . " (CAMH, Standard EC.4.13, EP 12, p. EC-13c). Thus, we expect that that TJC-accredited hospitals would be in compliance with proposed SEC 482.15(c)(1) through (c)(4). In addition, the rationale for EC.4.13 states, "the hospital maintains reliable surveillance and communications capability to detect emergencies and communicate response efforts to hospital response personnel, patient and their families, and external agencies (CAMH, Standard EC.4.13, pp. EC-13b--13c). We expect that most, if not all, TJC-accredited hospitals would be in compliance with proposed SEC 482.15(c)(5) through (c)(7). Therefore, we expect that TJC-accredited hospitals already have developed and are currently maintaining emergency communication plans that would satisfy the requirements contained in proposed SEC 482.15(c). Therefore, compliance with this requirement would constitute a usual and customary business practice and would not be subject to PRA in accordance with 5 CFR 1320.3(b)(2).
   Most, if not all, non TJC-accredited hospitals would be substantially in compliance with proposed SEC 482.15(c)(1) through (c)(4). Nevertheless, non TJC-accredited hospitals would need to review, update, and in some cases, develop new sections for their emergency communication plans to ensure they are in compliance with all of the proposed requirements in this subsection. We expect that this activity would require the involvement of the hospital's administrator, the risk management director, the facilities director, the health information services director, the security manager, and administrative support staff. We estimate that complying with this requirement would require 10 burden hours at a cost of
   Proposed SEC 482.15(c) also would require hospitals to review and update their emergency preparedness communication plans at least annually. We believe that hospitals are already reviewing and updating their emergency preparedness communication plans periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 482.15(d) would require hospitals to develop and maintain emergency preparedness training and testing programs and review and update those plans at least annually. The hospital would be required to meet the requirements in SEC 482.15(d)(1) and (2).
   Proposed SEC 482.15(d)(1) would require hospitals to provide initial and thereafter annual training on their emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. Hospitals must also maintain documentation of all of this training.
   The burden for proposed SEC 482.15(d)(1) would be the time and effort necessary to develop a training program and the materials needed for the required initial and annual training. We expect that all hospitals would review their current training programs and compare them to their risk assessments, emergency plans, policies and procedures, and communication plans as set forth in SEC 482.15(a)(1), (a), (b), and (c), respectively. Hospitals would need to revise and, if necessary, develop new sections or material to ensure that their training programs comply with our proposed requirements.
   The TJC-accredited hospitals are required to define staff roles and responsibilities in their EOP and train their staff for their assigned roles during emergencies (CAMH, EC.4.16, EPs 1-2, p. EC-13e). In addition, the TJC-accredited hospitals are required to provide an initial orientation, which includes information that the hospital has determined are key elements the staff need before they provide care, treatment, or services to patients (CAMH, Standard HR.2.10, EPs 1-2, CAMH Refreshed Core,
   Although TJC requirements do not specifically address training for individuals providing services under arrangement or training for volunteers consistent with their expected roles, it is standard practice for health care facilities to provide some type of training to all personnel, including those providing services under contract or arrangement and volunteers. If a hospital does not already provide such training, we would expect the additional burden to be negligible. Thus, for the TJC-accredited hospitals, the proposed requirements would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Based on our experience with non TJC-accredited hospitals, we expect that the non TJC-accredited hospitals have some type of emergency preparedness training program and provide training to their staff regarding their duties and responsibilities under their emergency plans. However, under this proposed rule, non TJC-accredited hospitals would need to compare their existing training programs with their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. They also would need to revise, update, and, if necessary, develop new sections and new material for their training programs.
   To develop their training programs, hospitals could draw upon the resources of federal, state, and local emergency preparedness agencies, as well as state and national health care associations and organizations. In addition, hospitals could develop partnerships with other hospitals and health care facilities to develop the necessary training. Some hospitals might also choose to purchase off-the-shelf emergency training programs or hire consultants to develop the programs for them. However, for purposes of estimating a burden for these requirements, we will assume that hospitals would use their own staff.
   Based on our experience with hospitals, we expect that complying with this requirement would require the involvement of the hospital administrator, the risk management director, a health care trainer, and administrative support staff. We estimate that it would require 40 burden hours for each hospital to develop an emergency preparedness training program at a cost of
   Proposed SEC 482.15(d) would also require hospitals to review and update their emergency preparedness training program at least annually. We believe that hospitals are already reviewing and updating their emergency preparedness training programs periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Hospitals also would be required to maintain documentation of their training. Based on our experience, we believe it is standard practice for hospitals to document the training they provide to their staff, individuals providing services under arrangement, and volunteers. Therefore, compliance with this requirement would constitute a usual and customary business practice for the hospitals and not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 482.15(d)(2) would also require hospitals to participate in a community mock disaster drill and a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, hospitals would have to conduct an individual, facility-based mock disaster drill. Hospitals also would be required to analyze their responses to, and maintain documentation of, all drills, exercises, and emergency events. If a hospital experienced an actual emergency which required activation of its emergency plan, it would be exempt from the requirement for a community or individual, facility-based disaster drill for 1 year following the onset of the emergency (proposed SEC 482.15(d)(2)(ii)). Thus, to satisfy the burden for these requirements, hospitals would need to develop a scenario for each drill and exercise, as well as the documentation necessary for recording what happened. If a hospital participated in a community mock disaster drill, it probably would not need to develop a scenario for that drill. However, for the purpose of determining the burden, we will assume that hospitals would need to develop at least two scenarios annually, one for a drill and one for an exercise.
   The TJC-accredited hospitals are required to test their EOP twice a year (CAMH, Standard EC.4.20, EP 1, p. EC-14a). In addition, TJC-accredited hospitals must analyze all drills and exercises, identify deficiencies and areas for improvement, and modify their EOPs in response to the analysis of those tests (CAMH, Standard EC.4.20, EPs 15-17, p. EC-14b). Therefore, we expect that TJC-accredited hospitals have already developed scenarios for drills and have the documentation needed for the analysis of their responses. Since tabletop exercises generally do not require as much preparation as drills and do not require different documentation than drills, we expect that any change a hospital needed to make to conduct a tabletop exercise would be minimal.
   We expect that it would be a usual and customary business practice for the TJC-accredited hospitals to comply with the proposed requirement to prepare scenarios for emergency preparedness drills and exercises and to develop the necessary documentation. Thus, compliance with this requirement would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Based on our experience with non TJC-accredited hospitals, we expect that the remaining non TJC-accredited hospitals have some type of emergency preparedness training program and that most, if not all, of them already conduct some type of drill or exercise to test their emergency preparedness plans. In addition, many hospitals participate in mock drills and exercises held by their communities, counties, and states. We also expect that many of these hospitals have already developed the required documentation for recording the events, and analyzing their responses to, their drills, exercises, and emergency events. However, we do not believe that all non-TJC accredited hospitals would be in compliance with our proposed requirements. Thus, we will analyze the burden for non TJC-accredited hospitals.
   The non TJC-accredited hospitals would be required to develop scenarios for a drill and an exercise and the documentation necessary to record and analyze their responses to drills, exercises, and emergency events. Based on our experience with hospitals, we expect that the same individuals who developed the emergency preparedness training program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the health care trainer would spend more time developing the scenarios and documentation. Thus, for each of the 1,518 non TJC-accredited hospitals to comply with these requirements, we estimate that it would require 9 burden hours at a cost of
Table 7--Burden Hours and Cost Estimates for All 4,928 Hospitals To Comply With the ICRs Contained in S. 482.15 Condition: Emergency Preparedness 1800141075 OMB Control Respondents Responses Burden per Total No. response annual (hours) burden (hours) S. 482.15(a)(1) 0938--New 1,518 1,518 36 54,648 S. 482.15(a)(1)- 0938--New 1,518 1,518 62 94,116 (4) S. 482.15(b) 0938--New 3,410 3,410 17 57,970 (TJC-accredited) S. 482.15(b) 0938--New 1,518 1,518 33 50,094 (Non TJC- accredited) S. 482.15(b)(7) 0938--New 4,928 4,928 8 39,424 S. 482.15(c) 0938--New 1,518 1,518 10 15,180 S. 482.15(d)(1) 0938--New 1,518 1,518 40 60,720 S. 482.15(d)(2) 0938--New 1,518 1,518 9 13,662 Totals 4,928 17,446 385,814
Table 7--Burden Hours and Cost Estimates for All 4,928 Hospitals To Comply With the ICRs Contained in S. 482.15 Condition: Emergency Preparedness 1800141075 Hourly Total labor Total Total cost labor cost cost of capital/ ( ] of reporting maintenance reporting ( ] costs ( ] ( ] S. 482.15(a)(1) * * 4,437,114 0 4,437,114 S. 482.15(a)(1)- * * 7,719,030 0 7,719,030 (4) S. 482.15(b) * * 4,852,430 0 4,852,430 (TJC-accredited) S. 482.15(b) * * 3,981,714 0 3,981,714 (Non TJC- accredited) S. 482.15(b)(7) * * 3,543,232 0 3,543,232 S. 482.15(c) * * 1,449,126 0 1,449,126 S. 482.15(d)(1) * * 3,178,692 0 3,178,692 S. 482.15(d)(2) * * 793,914 0 793,914 Totals 29,655,252 * * The hourly labor cost is blended between the wages for multiple staffing levels.
I. ICRs Regarding Condition of Participation: Emergency Preparedness for Transplant Centers ( SEC 482.78)
   Proposed SEC 482.78 would require transplant centers to have policies and procedures that address emergency preparedness. Proposed SEC 482.78(a) would require transplant centers or the hospitals in which they operate to have an agreement with at least one other Medicare-approved transplant center to provide transplantation services and related care for its patients during an emergency. We propose that the agreements must address, at a minimum, the circumstances under which the agreement would be activated and the types of services that would be provided during an emergency.
   "Transplantation services and related care" would include all of a center's transplant-related activities, ranging from the evaluation of potential transplant recipients and living donors through post-operative care of transplant recipients and living donors. If the agreement does not include all services normally provided by the receiving transplant center, the agreement should state precisely what services the receiving transplant center would provide during an emergency.
   We would also expect each transplant center to ensure that its agreement with another transplant center is sufficient to provide its patients with the care they would need during any period in which the transplant center could not provide its services due to an emergency. If not, we would expect the transplant center to make additional agreements, when possible, to ensure all services are available for its patients during an emergency.
   For the purpose of determining a burden for this requirement, we expect that each transplant center would develop an agreement with one other transplant center to provide transplantation services and related care to its patients and living donors in an emergency.
   Based on our experience with transplant centers, we expect that developing this agreement would require the involvement of an administrator, the transplant center medical director, the clinical transplant coordinator, and a hospital attorney. We believe the clinical transplant coordinator would be primarily responsible for initially identifying what types of services the center's patients would need to have provided by another transplant center during an emergency, as well as which transplant center(s) could provide such services. We expect that all of the individuals we have identified would have to attend an initial meeting to approve the list of services needed by the center's patients and the transplant center(s) to contact. The hospital attorney would be primarily responsible for drafting an agreement with input from the transplant center medical director. We estimate that it would require 15 burden hours for each transplant center to develop an agreement with another transplant center to provide services for its patients and living donors during an emergency, if applicable, at a cost of
   According to
   Proposed SEC 482.78(b) would require a transplant center to ensure that the written agreement between the hospital in which it is located and the hospital's designated OPO as required under SEC 482.100 addresses the duties and responsibilities of the hospital and the OPO during an emergency. We expect that transplant centers would propose language; review any language proposed by the hospital, the OPO, or both; and approve the final agreement.
   The burden associated with ensuring that the duties and responsibilities of the hospital and OPO during an emergency are addressed in the agreement would be the resources needed to draft, review, revise, and approve the language. Based on our experience with transplant centers, we expect that accomplishing these tasks would require the involvement of an administrator, the transplant center medical director, the clinical transplant coordinator, and a hospital attorney. We expect that the medical director and the clinical transplant coordinator would be primarily responsible for drafting, reviewing, revising, and approving the language of the agreement. A hospital attorney would be primarily responsible for drafting and reviewing any proposed language before the agreement was approved. The attorney would also brief the administrator and the administrator would approve the language. Thus, we estimate that it would require 15 burden hours for each transplant center to comply with the requirement to ensure that the duties and responsibilities of the hospital and OPO are identified in these agreements at a cost of
Table 8--Burden Hours and Cost Estimates for All 770 Transplant Centers To Comply With the ICRs Contained in S. 482.78 Condition: Emergency Preparedness for Transplant Centers Regulation OMB Control Respondents Responses Burden Total section(s) No. per annual response burden (hours) (hours) S. 482.78(a) 770 770 15 11,550 S. 482.78(b) 238 238 15 3,570 Totals 770 1008 15,120
Table 8--Burden Hours and Cost Estimates for All 770 Transplant Centers To Comply With the ICRs Contained in S. 482.78 Condition: Emergency Preparedness for Transplant Centers Regulation Hourly Total Labor Total Total cost section(s) labor cost cost of capital/ ( ] of reporting maintenance reporting ( ] costs ( ] ( ] S. 482.78(a) * * 1,068,760 0 1,068,760 S. 482.78(b) * * 330,344 0 330,344 Totals 1,399,104 * * The hourly labor cost is blended between the wages for multiple staffing levels.
J. ICRs Regarding Emergency Preparedness ( SEC 483.73)
   Proposed SEC 483.73 sets forth the emergency preparedness requirements for long term care (LTC) facilities. LTC facilities would be required to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually ( SEC 483.73(a)). The emergency plan would have to include and be based upon a documented, facility-based and community based risk assessment that utilizes an all-hazards approach and must address missing residents ( SEC 483.73(a)(1)). LTC facilities would be required to develop and maintain emergency preparedness policies and procedures based on their emergency preparedness plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan that is required in paragraph (c) of this section ( SEC 483.73(b)). Proposed SEC 483.73(d) would require LTC facilities to develop and maintain emergency preparedness training and testing programs.
   We would usually be required to estimate the information collection requirements (ICRs) for these proposed requirements in accordance with chapter 35 of title 44, United States Code. However, sections 4204(b) and 4214(d), which cover skilled nursing facilities (SNFs) and nursing facilities (NFs), respectively, of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) provide for a waiver of Paperwork Reduction Act (PRA) requirements for the regulations that implement the OBRA '87 requirements. Section 1819(d), as implemented by section 4201 of OBRA '87, requires that SNFs "be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident (consistent with requirements established under subsection (f)(5))." Section 1819(f)(5)(C) of the Act, requires the Secretary to establish criteria for assessing a SNF's compliance with the requirement in subsection (d) with respect for disaster preparedness. Nursing facilities have the same requirement in sections 1919(d) and (f)(5)(C), as implemented by OBRA '87.
   All of the proposed requirements in this rule relate to disaster preparedness. We believe this waiver still applies to those revisions we have proposed to existing requirements in part 483 subpart B. Thus, the ICRs for the proposed requirements in SEC 483.73 are not subject to the PRA.
K. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 483.475)
   Proposed SEC 483.475(a) would require Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) to develop and maintain an emergency preparedness plan that would have to be reviewed and updated at least annually. We propose that the plan would include the elements set out at SEC 483.475(a)(1) through (4). We will discuss the burden for these activities individually beginning with the risk assessment.
   Proposed SEC 483.475(a)(1) would require each ICFs/IID to develop a documented, facility-based and community-based risk assessment utilizing an all-hazard approach, including missing clients. We expect an ICF/IID to identify the medical and non-medical emergency events it could experience in the facility and the community in which it is located and determine the likelihood of the facility experiencing an emergency due to the identified hazards. In performing the risk assessment, we expect that an ICF/IID would need to consider its physical location, the geographical area in which it is located, and its client population.
   The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. The current CoPs for ICFs/IID already require ICFs/IID to "develop and implement detailed written plans and procedures to meet all potential emergencies and disasters such as fires, severe weather, and missing clients" (42 CFR 483.470(h)(1)). During the process of developing these detailed written plans and procedures, we expect that all ICFs/IID have already performed some type of risk assessment. However, as discussed earlier in the preamble, the current requirement is primarily designed to ensure the health and safety of the ICF/IID clients during emergencies that are within the facility or in the facility's local area. We do not expect that this requirement would be sufficient to protect the health and safety of clients during more widespread local, state, or national emergencies. In addition, an ICF/IID current risk assessment may not address all of the elements required in proposed SEC 483.475(a). Therefore, all ICFs/IID would have to conduct a thorough review of their current risk assessments, if they have them, and then perform the necessary tasks to ensure that their risk assessments comply with the requirements of this section.
   We have not designated any specific process or format for ICFs/IID to use in conducting their risk assessments because we expect ICFs/IID would need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, an ICF/IID would include representatives from, or obtain input from, all of the major departments in their facilities. Based on our experience with ICFs/IID, we expect that conducting the risk assessment would require the involvement of the ICF/IID administrator and a professional staff person, such as a registered nurse. We expect that both individuals would attend an initial meeting, review relevant sections of the current assessment, develop comments and recommendations for changes to the assessment, attend a follow-up meeting, perform a final review, and approve the risk assessment. We expect that the administrator would coordinate the meetings, perform an initial review of the current risk assessment, critique the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approve the new risk assessment. We also expect that the administrator would spend more time reviewing and working on the risk assessment. Thus, we estimate that complying with this requirement would require 10 burden hours to complete at a cost of
   Under this proposed rule, ICFs/IID would be required to develop emergency preparedness plans that addressed the emergency events that could affect not only their facilities but also the communities in which they are located. An ICF/IID current disaster plan might not address all of the medical and non-medical emergency events identified by its risk assessment, include strategies for addressing those emergency events, or address its patient population. It may not specify the type of services the ICF/IID has the ability to provide in an emergency, or continuity of operations, including delegation of authority and succession plans. Thus, we expect that each ICFs/IID would have to review its current plans and compare them to its risk assessments. Each ICF/IID would then need to update, revise, and, in some cases, develop new sections to comply with our proposed requirements.
   The burden associated with this requirement would be the resources needed to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with ICFs/IID, we expect that the same individuals who were involved in the risk assessment would be involved in developing the facility's new emergency preparedness plan. We also expect that developing the plan would require more time to complete than the risk assessment. We estimate that it would require 9 burden hours at a cost of
   The ICF/IID also would be required to review and update its emergency preparedness plan at least annually. We believe that ICFs/IID already review their emergency preparedness plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 483.475(b) would require each ICF/IID to develop and implement emergency preparedness policies and procedures, based on its emergency plan set forth in paragraph (a) of this section, the risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. We would also require the ICF/IID to review and update these policies and procedures at least annually. At a minimum, the ICF/IID policies and procedures would be required to address the requirements listed at SEC 483.475(b)(1) through (8).
   We expect all ICFs/IID to compare their current emergency preparedness policies and procedures to their emergency preparedness plans, risk assessments, and communication plans. They would then need to revise and, if necessary, develop new policies and procedures to ensure they comply with the requirements in this section.
   We expect that all ICFs/II already have some emergency preparedness policies and procedures. As discussed earlier, the current CoPs for ICFs/IID require them to have "written . . . procedures to meet all potential emergencies and disasters" ( SEC 483.470(h)(1)). In addition, we expect that all ICFs/IID already have procedures that comply with some of the other proposed requirements in this section. For example, as will be discussed later, current regulations require ICFs/IID to perform drills, evaluate the effectiveness of those drills, and take corrective action for any problems they detect ( SEC 483.470(i)). We expect that all ICFs/IID have developed procedures for safe evacuation from and return to the ICF/IID ( SEC 483.475(b)(4)) and a process to document and analyze drills and revise their emergency plan when they detect problems.
   We expect that each ICF/IID would need to review its current disaster policies and procedures and assess whether they incorporate all of the elements we are proposing. Each ICF/IID also would need to revise, and, if needed, develop new policies and procedures.
   The burden incurred by reviewing, revising, updating and, if necessary, developing new emergency policies and procedures would be the resources needed to ensure that the ICF/IID policies and procedures complied with the proposed requirements of this subsection. We expect that these tasks would involve the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comply would require 9 burden hours at a cost of
   We expect ICFs/IID to review and update their emergency preparedness policies and procedures at least annually. We believe that ICFs/IID already review their policies and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 483.475(c) would require each ICF/IID to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The ICF/IID would also have to review and update the plan at least annually. The communication plan must include the information set out at SEC 483.475(c)(1) through (7).
   We expect all ICFs/IID to compare their current emergency preparedness communications plans, if they have them, to the requirements in this section. ICFs/IID also would need to perform any tasks necessary to ensure that they document their communication plans and that those plans comply with the proposed requirements of this subsection.
   We expect that all ICFs/IID have some type of emergency preparedness communication plan. The current CoPs require ICFs/IID to have written disaster plans and procedures for all potential emergencies ( SEC 483.470(h)(1)). We expect that an integral part of these plans and procedures would include communication. Further, it is standard practice for health care organizations to maintain contact information for both staff and outside sources of assistance; have alternate means of communication in case there is an interruption in phone service to the facility (for example, cell phones); and have a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their clients. However, many ICFs/IID may not have a formal, written emergency preparedness communication plan, or their plan may not comply with all the elements we are requiring.
   The burden associated with complying with this requirement would be the resources required to ensure that the ICF/IID emergency communication plan complied with the proposed requirements. Based upon our experience with ICFs/IID, we anticipate that meeting the requirements in this section would primarily require the involvement of the ICF/IID administrator and a registered nurse. We estimate that for each ICF/IID to comply with the proposed requirement would require 6 burden hours at a cost of
   ICFs/IID would also have to review and update their emergency preparedness communication plans at least annually. We believe that ICFs/IID already review their plans, policies, and procedures periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 483.475(d) would require ICFs/IID to develop and maintain emergency preparedness training and testing programs that would have to be reviewed and updated at least annually. Each ICF/IID would also have to meet the requirements for evacuation drills and training at SEC 483.470(i).
   To comply with the requirements at SEC 483.475(d)(1), an ICF/IID would have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the ICF/IID would have to provide emergency preparedness training at least annually.
   The ICFs/IID would need to compare their current emergency preparedness training programs' contents to their risk assessments and updated emergency preparedness plans, policies and procedures, and communication plans and then revise and, if necessary, develop new sections for their training programs to ensure they complied with the proposed requirements. The current ICFs/IID CoPs require ICFs/IID to periodically review and provide training to their staff on the facility's emergency plan ( SEC 483.470(h)(2)). In addition, staff on all shifts must be trained to perform the tasks to which they are assigned for evacuations ( SEC 483.470(i)(1)(i)). We expect that all ICFs/IID have emergency preparedness training programs for their staff. However, under this proposed rule, each ICF/IID would need to review its current training program and compare its contents to its updated emergency preparedness plan, policies and procedures, and communications plan. Each ICF/IID also would need to revise and, if necessary, develop new sections for their training program to ensure it complied with the proposed requirements.
   The burden would be the time and effort necessary to comply with the proposed requirements. We expect that a registered nurse would be primarily involved in reviewing the ICF/IID current training program and the ICF/IID updated emergency preparedness plan, policies and procedures, and communication plan; determining what tasks would need to be performed to comply with the proposed requirements of this subsection; accomplishing those tasks, and developing an updated training program. We expect the administrator would work with the registered nurse to update the training program. We estimate that it would require 7 burden hours for each ICF/IID to develop an emergency training program at a cost of
   ICFs/IID would have to review and update their emergency preparedness training program at least annually. We believe that ICFs/IID already review their emergency preparedness training programs periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 483.475(d)(2) would require ICFs/IID to participate in a community mock disaster drill and a paper-based, tabletop exercise at least annually. The ICFs/IID would also be required to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. If an ICF/IID experienced an actual natural or man-made emergency that required activation of its emergency plan, the ICF/IID would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. To comply with this requirement, an ICF/IID would need to develop scenarios for each drill and exercise. An ICF/IID also would have to develop the required documentation.
   The current ICF/IID CoPs require them to "hold evacuation drills at least quarterly for each shift and under varied conditions to . . . evaluate the effectiveness of emergency and disaster plans and procedures" ( SEC 483.470(i)(1)). In addition, ICFs/IID must "actually evacuate clients during at least one drill each year on each shift . . . file a report and evaluation on each evacuation drill . . . and investigate all problems with evacuation drills, including accidents, and take corrective action" (42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/IID already conduct quarterly drills. However, the current CoPs do not indicate the type of drills ICFs/IID must perform. In addition, although the CoPs require that a report and evaluation be filed, this requirement does not ensure that ICFs/IID have developed the type of paperwork we propose requiring or that scenarios are used for each drill or table top exercise. For the purpose of determining a burden for these requirements, all ICFs/IID would have to develop scenarios, one for the drill and one for the table top exercise, and all ICFs/IID would have to develop the necessary documentation.
   The burden associated with these requirements would be the resources the ICF/IID would need to comply with the proposed requirements. We expect that complying with these requirements would likely require the involvement of a registered nurse. We expect that the registered nurse would develop the required documentation. We also expect that the registered nurse would develop the scenarios for the drill and exercise. We estimate that these tasks would require 4 burden hours at a cost of
Table 9--Burden Hours and Cost Estimates for All 6,442 ICFs/IID To Comply With the ICRs Contained in S. 485.475 Condition: Emergency Preparedness Regulation OMB control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 483.475(a)(1) 6,442 6,442 8 51,536 S. 6,442 6,442 9 57,978 483.475(a)(1)-(4) S. 483.475(b) 6,442 6,442 9 57,978 S. 483.475(c) 6,442 6,442 6 38,652 S. 483.475(d)(1) 6,442 6,442 7 45,094 S. 483.475(d)(2) 6,442 6,442 4 25,768 Totals 6,442 38,652 277,006
Table 8--Burden Hours and Cost Estimates for All 770 Transplant Centers To Comply With the ICRs Contained in S. 482.78 Condition: Emergency Preparedness for Transplant Centers Regulation Hourly Total labor Total Total cost section(s) labor cost cost of capital/ ( ] of reporting maintenance reporting ( ] costs ( ] ( ] S. 483.475(a)(1) * * 2,969,762 0 2,969,762 S. * * 3,382,050 0 3,382,050 483.475(a)(1)-(4) S. 483.475(b) * * 3,382,050 0 3,382,050 S. 483.475(c) * * 2,254,700 0 2,254,700 S. 483.475(d)(1) * * 2,338,446 0 2,338,446 S. 483.475(d)(2) * * 1,211,096 0 1,211,096 Totals 15,538,104 * * The hourly labor cost is blended between the wages for multiple staffing levels.
L. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 484.22)
   Proposed SEC 484.22(a) would require home health agencies (HHAs) to develop and maintain emergency preparedness plans. Each HHA also would be required to review and update the plan at least annually. Specifically, we propose that the plan meet the requirements listed at SEC 484.22(a)(1) through (4). We will discuss the burden for these activities individually, beginning with the risk assessment.
   Accreditation may substantially affect the burden a HHA would experience under this proposed rule. HHAs are accredited by three different accrediting organizations (AOs):
   There are currently 12,349 HHAs. There are 1,734 TJC-accredited HHAs. A review of TJC deeming standards indicates that the 1,734 TJC-accredited HHAs already perform certain tasks or activities that would partially or completely satisfy our proposed requirements. Therefore, since TJC accreditation is a significant factor in determining the burden, we will analyze the burden for the 1,734 TJC-accredited HHAs separately from the 10,615 non TJC-accredited HHAs (12,349 HHAs--1,734 TJC-accredited HHAs = 10,615 non TJC-accredited HHAs), as appropriate. Note that we obtain data on the number of HHAs, both accredited and non-accredited, from the CMS CASPER data system, which is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited HHAs may not equal the total number of HHAs.
   Section 484.22(a)(1) would require that HHAs develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. To perform this risk assessment, an HHA would need to identify the medical and non-medical emergency events the HHA could experience and how the HHA's essential business functions and ability to provide services could be impacted by those emergency events based on the risks to the facility itself and the community in which it is located. We would expect HHAs to consider the extent of their service area, including the location of any branch offices. An HHA with an existing risk assessment would need to review, revise and update it to comply with our proposed requirements.
   For TJC accreditation standards, we used TJC's CAMHC Refreshed Core,
   It is standard practice for health care facilities to prepare for common internal and external medical and non-medical emergencies, based on their location, structure, and the services they provide. We believe that the 10,615 non TJC-accredited HHAs have conducted some type of risk assessment. However, those risk assessments are unlikely to satisfy all of our proposed requirements. Therefore, we will analyze the burden for the 10,615 non TJC-accredited HHAs to comply.
   We have not designated any specific process or format for HHAs to use in conducting their risk assessments because we believe that HHAs need the flexibility to determine the best way to accomplish this task. However, we expect that HHAs would include representatives from or input from all of their major departments. Based on our experience working with HHAs, we expect that conducting the risk assessment would require the involvement of an HHA administrator, the director of nursing, director of rehabilitation, and the office manager. We expect that these individuals would attend an initial meeting, review relevant sections of the current assessment, prepare and forward their comments to the administrator and the director of nursing, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the director of nursing would coordinate the meetings, review the current risk assessment, provide suggestions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We expect that the director of nursing would spend more time developing the facility's new risk assessment than the other individuals. We estimate that the risk assessment would require 11 burden hours for each non TJC-accredited HHA to complete at a cost of
   After conducting a risk assessment, HHAs would have to develop an emergency preparedness plan that complied with SEC 484.22(a)(1) through (4). As discussed earlier, TJC already has accreditation standards similar to the requirements we propose at SEC 484.22(a). Thus, we expect that TJC-accredited HHAs have an emergency preparedness plan that would satisfy most of our proposed requirements. Although the current HHA CoPs require that there be a qualified person who "is authorized in writing to act in the absence of the administrator" ( SEC 484.14(c)), the TJC standards do not specifically address delegations of authority or succession plans. Furthermore, TJC standards do not address persons-at-risk. Therefore, we expect that the 1,734 TJC-accredited HHAs would incur some burden due to reviewing, revising, and in some cases, developing new sections for their emergency preparedness plans. However, we will analyze the burden for TJC-accredited HHAs separately from the 10,615 non TJC-accredited HHAs because we expect the burden for TJC-accredited HHAs to be substantially less.
   We expect that the 10,615 non TJC-accredited HHAs already have some type of emergency preparedness plan, as well as delegations of authority and succession plans. However, we also expect that their plans do not comply with all of our proposed requirements. Thus, all non TJC-accredited HHAs would need to review their current plans and compare them to their risk assessments. They also would need to update, revise, and, in some cases, develop new sections for their emergency plans.
   Based on our experience with HHAs, we expect that the same individuals who were involved in the risk assessment would be involved in developing the emergency preparedness plan. We estimate that complying with this requirement would require 10 burden hours for each TJC-accredited HHA at a cost of
   We estimate that complying with this requirement would require 15 burden hours for each of the 10,615 non TJC-accredited HHAs at a cost of
   Based on these estimates, for all 12,349 HHAs to develop an emergency preparedness plan that complies with our proposed requirements would require 176,565 burden hours at a cost of
   We would also require HHAs to review and update their emergency preparedness plans at least annually. We believe that HHAs are already reviewing and updating their emergency preparedness plans periodically. Hence, compliance with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 484.22(b) would require each HHA to develop and implement emergency preparedness policies and procedures based on the emergency plan, risk assessment, communication plan as set forth in SEC 484.22(a), (a)(1), and (c), respectively. The HHA would also have to review and update its policies and procedures at least annually. We would require that, at a minimum, these policies and procedures address the requirements listed at SEC 484.22(b)(1) through (6).
   We expect that HHAs would review their emergency preparedness policies and procedures and compare them to their risk assessments, emergency preparedness plans, and emergency communication plans. HHAs would need to revise or, in some cases, develop new policies and procedures to ensure they complied with all of the proposed requirements.
   In the chapter entitled, "Leadership," TJC accreditation standards require that each HHA's "leaders develop policies and procedures that guide and support patient care, treatment, and services" (CAMHC, Standard LD.3.90, EP 1, p. LD-13). In addition, TJC accreditation standards and EPs specifically require each HHA to develop and maintain an emergency management plan that provides processes for managing activities related to care, treatment, and services, including scheduling, modifying, or discontinuing services (CAMHC, Standard EC.4.10, EP 10, EC-9); identify backup communication systems in the event of failure due to an emergency event (CAMHC, Standard EC.4.10, EP 18, EC-10); and develop processes for critiquing tests of its emergency preparedness plan and modifying the plan in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11).
   We expect that the 1,734 TJC-accredited HHAs already have emergency preparedness policies and procedures that address some of the proposed requirements at SEC 484.22(b). However, we do not believe that TJC accreditation requirements ensure that TJC-accredited HHAs' policies and procedures address all of our proposed requirements for emergency policies and procedures. Thus, we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC-accredited HHAs in our analysis of the burden for proposed SEC 484.22(b).
   Under proposed SEC 484.22(b)(1), the HHA's individual plans for patients during a natural or man-made disaster would be included as part of the comprehensive patient assessment, which would be conducted according to the provisions at SEC 484.55. We expect that HHAs already collect data during the comprehensive patient assessment that they would need to develop for each patient's emergency plan. At SEC 484.22(b)(2), we propose requiring each HHA to have procedures to inform state and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patients' medical and psychiatric condition and home environment.
   Existing HHA regulations already address some aspects of proposed SEC 484.22(b)(1) and (b)(2). For example, regulations at SEC 484.18 make it clear that HHAs are expected to accept patients only on the basis of a reasonable expectation that they can provide for the patients' medical, nursing, and social needs in the patients' home. Moreover, the plan of care for each patient must cover any safety measures necessary to protect the patient from injury SEC 484.18(a). Thus, the activities necessary to be in compliance with SEC 484.22(b)(1) and (2) would constitute usual and customary business practices for HHA and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   We expect that all 12,349 HHAs (1,734 TJC-accredited HHAs + 10,615 non TJC-accredited HHAs = 12,349 HHAs) have some emergency preparedness policies and procedures. However, we also expect that all HHAs would need to review their policies and procedures and revise and, if necessary, develop new policies and procedures that complied with our proposed requirements set out at SEC 484.22(3) through (6). We expect that a professional staff person, most likely the director of nursing, would review the HHA's policies and procedures and make recommendations for changes or development of additional policies and procedures. The administrator or director of nursing would brief representatives of most of the HHA's major departments and assign staff to make necessary revisions and draft any new policies and procedures. We estimate that complying with this requirement would require 18 burden hours for each HHA at a cost of
   We are also proposing that HHAs review and update their emergency preparedness policies and procedures at least annually. The current HHA CoPs already require that "a group of professional personnel . . . reviews the agency's policies governing scope of services offered" (42 CFR 484.16). Thus, we believe that complying with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   In proposed SEC 484.22(c), each HHA would be required to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. We propose that each HHA review and update its communication plan at least annually. We would require that the emergency communication plan include the information listed at SEC 484.22(c)(1) through (6).
   It is standard practice for health care facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method of sharing information and medical documentation with other health care providers to ensure continuity of care for patients.
   All TJC-accredited HHAs are required to identify backup communication systems for both internal and external communication in case of failure due to an emergency (CAMHC, Standard EC.4.10, EP 18, p. EC-10). They are required to have processes for notifying their staff when the HHA initiates its emergency plan (CAMHC, Standard EC.4.10, EP 7, p. EC-9); identifying and assigning staff to ensure that essential functions are covered during emergencies (CAMHC, Standard EC.4.10, EP 9, p. EC-9); and activities related to care, treatment, and services, such as controlling information about their patients (CAMHC, Standard EC.4.10, EP 10, p. EC-9). However, we do not believe these requirements ensure that all TJC-accredited HHAs are already in compliance with our proposed requirements. Thus, we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC-accredited HHAs in assessing the burden for this requirement.
   We expect that all 12,349 HHAs maintain some contact information, an alternate means of communication, and a method for sharing information with other health care facilities. However, this would not ensure that all HHAs would be in compliance with our proposed requirements for communication plans. Thus, we will analyze the burden for this requirement for all 12,349 HHAs.
   The burden associated with complying with this requirement would be the time and effort necessary for each HHA to review its existing communication plan, if any, and revise it; and, if necessary, to develop new sections for the emergency preparedness communication plan to ensure that it complied with our proposed requirements. Based on our experience with HHAs, we expect that these activities would require the involvement of the HHA's administrator, director of nursing, director of rehabilitation, and office manager. We estimate that complying with this requirement would require 10 burden hours for each HHA at a cost of
   We propose requiring HHAs to review and update their emergency preparedness communication plans at least annually. We believe that HHAs already review their emergency preparedness plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Section 484.22(d) would require each HHA to develop and maintain an emergency preparedness training and testing program. Each HHA would also have to review and update its training and testing program at least annually. We propose requiring that each HHA meet the requirements listed at SEC 484.22(d)(1) and (2).
   Proposed SEC 484.22(d)(1) states that each HHA would have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the HHA would have to provide emergency preparedness training at least annually. Each HHA would also have to ensure that their staff could demonstrate knowledge of their emergency procedures.
   Based on our experience with HHAs, we expect that all 12,349 HHAs have some type of emergency preparedness training program. The 1,734 TJC-accredited HHAs are already required to provide both an initial orientation to their staff before they can provide care, treatment, or services (CAMHC, Standard HR.2.10, EP 2, p. HR-6) and "ongoing in-services, training or other staff activities [that] emphasize job-related aspects of safety . . ." (CAMHC, Standard HR.2.30, EP 4, p. HR-8). Since emergency preparedness is a critical aspect of job-related safety, we expect that TJC-accredited HHAs would ensure that their orientations and ongoing staff training would include the facility's emergency preparedness policies and procedures.
   However, we expect that under proposed SEC 484.22(d), all HHAs would need to compare their training and testing programs with their risk assessments, emergency preparedness plans, emergency policies and procedures, and emergency communication plans. We expect that most HHAs would need to revise and, in some cases, develop new sections for their training programs to ensure that they complied with our proposed requirements. In addition, HHAs would need to provide an orientation and annual training in their facilities' emergency preparedness policies and procedures to individuals providing services under arrangement and volunteers, consistent with their expected roles. Hence, we will analyze the burden of these proposed requirements for all 12,349 HHAs.
   Based on our experience with HHAs, we expect that complying with this requirement would require the involvement of an administrator, the director of training, director of nursing, director of rehabilitation, and the office manager. We expect that the director of training would spend more time reviewing, revising or developing new sections for the training program than the other individuals. We estimate that it would require 16 burden hours for each HHA to develop an emergency preparedness training and testing program at a cost of
   We also propose requiring HHAs to review and update their emergency preparedness training programs at least annually. We believe that HHAs already review their training and testing programs periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for HHAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 484.22(d)(2) would require each HHA to conduct drills and exercises to test its emergency plan. Each HHA would have to participate in a community mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, each HHA would have to conduct an individual, facility-based mock disaster drill at least annually. If an HHA experienced an actual natural or man-made emergency that required activation of the emergency plan, it would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. Each HHA would also be required to analyze its responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise its emergency plan as needed. For the purposes of determining the burden for these requirements, we expect that all HHAs would have to comply with all of the proposed requirements.
   The burden associated with complying with this requirement would be the time and effort necessary to develop the scenarios for the drill and the exercise and the required documentation. All TJC-accredited HHAs are required to test their emergency management plan once a year; the test cannot be a tabletop exercise (CAMHC, Standard EC.4.20, EP 1 and Note 1, p. EC-11). The TJC also requires HHAs to critique the drills and modify their emergency management plans in response to those critiques (CAMHC, Standard EC.4.20, EPs 15-17, p. EC-11). Therefore, TJC-accredited HHAs already prepare scenarios for drills, develop documentation to record the events during drills, critique them, and modify their emergency preparedness plans in response. However, TJC standards do not describe what type of drill HHAs must conduct or require a tabletop exercise annually. Thus, TJC accreditation standards would not ensure that TJC-accredited HHAs would be in compliance with our proposed requirements. Therefore, we will include the 1,734 TJC-accredited HHAs with the 10,615 non TJC-accredited HHAs in our analysis of the burden for these requirements.
   Based on our experience with HHAs, we expect that the same individuals who are responsible for developing the HHA's training and testing program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the director of nursing would spend more time on these activities than would the other individuals. We estimate that it would require 8 burden hours for each HHA to comply with the proposed requirements at an estimated cost of
   Based upon the previous analysis, we estimate that it would require 909,855 burden hours for all HHAs to comply with the ICRs contained in this proposed rule at a cost of
Table 10--Burden Hours and Cost Estimates for All 12,349 HHAS To Comply With the ICRs Contained in S. 484.22 Condition: Emergency Preparedness Regulation OMB Number Number Burden Total section(s) Control of of per annual No. respondents responses response burden (hours) (hours) S. 484.22(a)(1) 0938--New 10,615 10,615 11 116,765 S. 484.22(a)(1)- 0938--New 1,734 1,734 10 17,340 (4) (TJC- accredited) S. 484.22(a)(1)- 0938--New 10,615 10,615 18 159,225 (4) (Non TJC- accredited) S. 484.22(b) 0938--New 12,349 12,349 18 222,282 S. 484.22(c) 0938--New 12,349 12,349 10 123,490 S. 484.22(d)(1) 0938--New 12,349 12,349 16 197,584 S. 484.22(d)(2) 0938--New 12,349 12,349 8 98,792 Total 935,478
Table 10--Burden Hours and Cost Estimates for All 12,349 HHAS To Comply With 484.22 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor capital/ ( ] cost of cost of maintenance reporting reporting costs ( ] ( ] ( ] S. 484.22(a)(1) * * 6,422,075 0 6,422,075 S. 484.22(a)(1)- * * 946,764 0 946,764 (4) (TJC- accredited) S. 484.22(a)(1)- * * 8,693,685 0 8,693,685 (4) (Non TJC- accredited) S. 484.22(b) * * 12,299,604 0 12,299,604 S. 484.22(c) * * 6,421,480 0 6,421,480 S. 484.22(d)(1) * * 9,335,844 0 9,335,844 S. 484.22(d)(2) * * 4,606,177 0 4,606,177 Total 48,725,629 * * The hourly labor cost is blended between the wages for multiple staffing levels.
M. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 485.68)
   Proposed SEC 485.68(a) would require all Comprehensive Outpatient Rehabilitation Facilities (CORFs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. We propose that the plan meet the requirements listed at SEC 485.68(a)(1) through (5).
   Proposed SEC 485.68(a)(1) would require a CORF to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. The CORFs would need to identify the medical and non-medical emergency events they could experience. The current CoPs for CORFs already require CORFs to have "written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters" ( SEC 485.64). We expect that all CORFs have performed some type of risk assessment during the process of developing their disaster policies and procedures. However, their risk assessments may not meet our proposed requirements. Therefore, we expect that all CORFs would need to review their existing risk assessments and perform the tasks necessary to ensure that those assessments meet our proposed requirements.
   We have not designated any specific process or format for CORFs to use in conducting their risk assessments because we believe they need the flexibility to determine how best to accomplish this task. However, we expect that CORFs would obtain input from all of their major departments.
   Based on our experience with CORFs, we expect that conducting the risk assessment would require the involvement of the CORF's administrator and a therapist. The type of therapists at each CORF varies, depending upon the services offered by the facility. For the purposes of determining the burden, we will assume that the therapist is a physical therapist. We expect that both the administrator and the therapist would attend an initial meeting, review relevant sections of the current assessment, develop comments and recommendations for changes, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrator would coordinate the meetings, review and critique the risk assessment, coordinate comments, develop the new risk assessment, and ensure that it was approved.
   We estimate that complying with this requirement would require 8 burden hours at a cost of
   After conducting the risk assessment, each CORF would need to review, revise, and, if necessary, develop new sections for its emergency plan so that it complied with our proposed requirements. The current CoPs for CORFs require them to have a written disaster plan ( SEC 485.64) that must be developed and maintained with the assistance of appropriate experts and address, among other things, procedures concerning the transfer of casualties and records, notification of outside emergency personnel, and evacuation routes ( SEC 485.64(a)). Thus, we expect that all CORFs have some type of emergency preparedness plan. However, we also expect that all CORFs would need to review, revise, and develop new sections for their plans to ensure that their plans complied with all of our proposed requirements.
   Based on our experience with CORFs, we expect that the administrator and physical therapist who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect that it would require more time to complete the emergency plan than to complete the risk assessment. We estimate that complying with this requirement would require 11 burden hours at a cost of
   The CORF also would be required to review and update its emergency preparedness plan at least annually. We believe that CORFs already review their plans periodically. Therefore, compliance with the requirement for an annual review of the emergency preparedness plan would constitute a usual and customary business practice for CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.68(b) would require CORFs to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in SEC 485.68(a), (a)(1), and (c), respectively. We would also require CORFs to review and update these policies and procedures at least annually. We would require that a CORF's policies and procedures address, at a minimum, the requirements listed at SEC 485.68(b)(1) through (4).
   We expect that all CORFs have some emergency preparedness policies and procedures. As discussed earlier, the current CoPs for CORFs already require CORFs to have "written policies and procedures that specifically define the handling of patients, personnel, records, and the public during disasters" (42 CFR 485.64). However, all CORFs would need to review their policies and procedures and compare them to their risk assessments, emergency preparedness plans, and communication plans. Most CORFs would need to revise their existing policies and procedures or develop new policies and procedures to ensure they complied with all of our proposed requirements.
   We expect that both the administrator and the therapist would attend an initial meeting, review relevant policies and procedures, make recommendations for changes, attend a follow-up meeting, perform a final review, and approve the policies and procedures. We expect that the administrator would coordinate the meetings, coordinate the comments, and ensure that they are approved.
   We estimate that it would take 9 burden hours for each CORF to comply with this requirement at a cost of
   Proposed SEC 485.68(b) also proposes that CORFs review and update their emergency preparedness policies and procedures at least annually. We believe that CORFs already review their policies and procedures periodically. Therefore, we believe that complying with this requirement would constitute a usual and customary business practice for CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.68(c) would require CORFs to develop and maintain emergency preparedness communication plans that complied with both federal and state law and that would be reviewed and updated at least annually. We propose that a CORF's communication plan include the information listed in SEC 485.68(c)(1) through (5). Current CoPs require CORFs to have a written disaster plan that must include, among other things, "procedures for notifying community emergency personnel" ( SEC 486.64(a)(2)). In addition, it is standard practice in the health care industry to maintain contact information for staff and outside sources of assistance; alternate means of communication in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many CORFs may not have formal, written emergency preparedness communication plans. Therefore, we expect that all CORFs would need to review, update, and in some cases, develop new sections for their plans to ensure they complied with all of our proposed requirements.
   Based on our experience with CORFs, we anticipate that satisfying the requirements in this section would primarily require the involvement of the CORF's administrator with the assistance of a physical therapist to review, revise, and, if needed, develop new sections for the CORF's emergency preparedness communication plan. We estimate that it would take 8 burden hours for each CORF to comply with this requirement at a cost of
   We propose that each CORF would also have to review and update its emergency preparedness communication plan at least annually. We believe that compliance with this requirement would constitute a usual and customary business practice for CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.68(d) would require CORFs to develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. We propose that each CORF would have to satisfy the requirements listed at SEC 485.68(d)(1) and (2).
   Proposed SEC 485.68(d)(1) would require that each CORF provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, each CORF would have to provide emergency preparedness training at least annually. Each CORF would also have to ensure that its staff could demonstrate knowledge of its emergency procedures. All new personnel would have to be oriented and assigned specific responsibilities regarding the CORF's emergency plan within two weeks of their first workday. In addition, the training program would have to include instruction in the location and use of alarm systems and signals and firefighting equipment.
   The current CORF CoPs at SEC 485.64 require CORFs to ensure that all personnel are knowledgeable, trained, and assigned specific responsibilities regarding the facility's disaster procedures. Section SEC 485.64(b)(1) specifies that CORFs must also "provide ongoing training . . . for all personnel associated with the facility in all aspects of disaster preparedness". In addition, SEC 485.64(b)(2) specifies that "all new personnel must be oriented and assigned specific responsibilities regarding the facility's disaster plan within 2 weeks of their first workday".
   In evaluating the requirement for proposed SEC 485.68(d)(1), we expect that all CORFs have an emergency preparedness training program for new employees, as well as ongoing training for all staff. However, under this proposed rule, all CORFs would need to compare their current training programs to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans. CORFs would then need to revise, and in some cases, develop new material for their training programs.
   We expect that these tasks would require the involvement of an administrator and a physical therapist. We expect that the administrator would review the CORF's current training program to identify necessary changes and additions to the program. We expect that the physical therapist would work with the administrator to develop the revised and updated training program. We estimate it would require 8 burden hours for each CORF to develop an emergency training program at a cost of
   We also propose that each CORF review and update its emergency preparedness training program at least annually. We believe that CORFs already review their training programs periodically. Thus, complying with the requirement for an annual review of the emergency preparedness training program would constitute a usual and customary business practice for CORFs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.68(d)(2) would require CORFs to participate in a community mock disaster drill and a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, the CORF would have to conduct an individual, facility-based mock disaster drill at least annually. If a CORF experienced an actual natural or man-made emergency that required activation of its emergency plan, it would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. CORFs would also be required to analyze their responses to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. To comply with this requirement, a CORF would need to develop scenarios for these drills and exercises. The current CoPs at SEC 485.64(b)(1) require CORFs to "provide ongoing . . . drills for all personnel associated with the facility in all aspects of disaster preparedness". However, the current CoPs do not specify the type of drill, how often the CORF must conduct drills, or that a CORF must use scenarios for their drills and tabletop exercises.
   Based on our experience with CORFs, we expect that the same individuals who develop the emergency preparedness training program would develop the scenarios for the drills and exercises, as well as the accompanying documentation. We expect that the administrator would spend more time on these tasks than the physical therapist. We estimate that for each CORF to comply with the proposed requirements would require 6 burden hours at a cost of
   Based on the previous analysis, for all 272 CORFs to comply with the ICRs contained in this proposed rule would require 13,600 total burden hours at a total cost of
Table 11--Burden Hours and Cost Estimates for All 272 CORFS To Comply With the ICRs Contained in S. 485.68 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 485.68(a)(1) 0938--New 272 272 8 2,176 S. 485.68(a)(2- 0938--New 272 272 11 2,992 (4) S. 485.68(b) 0938--New 272 272 9 2,448 S. 485.68(c) 0938--New 272 272 8 2,176 S. 485.68(d)(1) 0938--New 272 272 8 2,176 S. 485.68(d)(2) 0938--New 272 272 6 1,632 Totals 272 1,632 13,600
Table 11--Burden Hours and Cost Estimates for All 272 CORFS To Comply With the ICRs Contained in S. 485.68 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor cost capital/ ( ] cost of of maintenance reporting reporting costs ( ] ( ] ( ] S. 485.68(a)(1) * * 131,920 0 131,920 S. 485.68(a)(2- * * 184,144 0 184,144 (4) S. 485.68(b) * * 149,328 0 149,328 S. 485.68(c) * * 131,920 0 131,920 S. 485.68(d)(1) * * 131,920 0 131,920 S. 485.68(d)(2) * * 99,552 0 99,552 Totals 828,784 * * The hourly labor cost is blended between the wages for multiple staffing levels.
N. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 485.625)
   Proposed SEC 485.625(a) would require critical access hospitals (CAHs) to develop and maintain a comprehensive emergency preparedness program that utilizes an all-hazards approach and would have to be reviewed and updated at least annually. Each CAH's emergency plan would have to include the elements listed at SEC 485.625(a)(1) through (4).
   Proposed SEC 485.625(a)(1) would require each CAH to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. CAHs would need to review their existing risk assessments and perform any tasks necessary to ensure that it complied with our proposed requirements.
   There are approximately 1,322 CAHs. CAHs with distinct part units were included in the hospital burden analysis. Approximately 402 CAHs are accredited either by TJC (370) or by the AOA (32); the remainder are non-accredited CAHs. Many of the TJC and AOA accreditation standards for CAHs are similar to the requirements in this proposed rule. For purposes of determining the burden, we have analyzed the burden for the 370 TJC-accredited and 32 AOA-accredited CAHs separately from the non-accredited CAHs. Note that we obtain data on the number of CAHs, both accredited and non-accredited, from the CMS CASPER database, which is updated periodically by the individual states. Due to variations in the timeliness of the data submissions, all numbers are approximate, and the number of accredited and non-accredited CAHs may not equal the total number of CAHs.
   For purposes of determining the burden for TJC-accredited CAHs, we used TJC's Comprehensive Accreditation Manual for Critical Access Hospitals: The Official Handbook 2008 (CAMCAH). In the chapter entitled, "Management of the Environment of Care" (EC), Standard EC.4.11 requires CAHs to plan for managing the consequences of emergency events (CAMCAH, Standard EC.4.11, CAMCAH Refreshed Care,
   For purposes of determining the burden for AOA-accredited CAHs, we used the AOA's Healthcare Facilities Accreditation Program: Accreditation Requirements for Critical Access CAHs 2007 (ARCAH). In Chapter 11 entitled, "Physical Environment," CAHs are required to have disaster plans, external disaster plans that include triaging victims, and weapons of mass destruction response plans (ARCAH, Standards 11.07.01, 11.07.02, and 11.07.05-6, pp. 11-38 through 11-41, respectively). In addition, AOA-accredited CAHs must "coordinate with federal, state, and local emergency preparedness and health authorities to identify likely risks for their area . . . and to develop appropriate responses" (ARCAH, Standard 11.02.02, p. 11-5). Thus, we believe that to develop their plans, AOA-accredited CAHs already perform some type of risk assessment. However, the AOA standards do not require a documented facility-based and community-based risk assessment, as we propose. Therefore, we will include the 32 AOA-accredited CAHs with non- accredited CAHs in determining the burden for our proposed risk assessment requirement.
   The CAH CoPs currently require CAHs to assure the safety of their patients in non-medical emergencies ( SEC 485.623) and to take appropriate measures that are consistent with the particular conditions in the area in which the CAH is located (42 CFR 485.623(c)(4)). To satisfy this requirement in the CoPs, we expect that CAHs have already conducted some type of risk assessment. However, that requirement does not ensure that CAHs have conducted a documented, facility-based, and community-based risk assessment that would satisfy our proposed requirements.
   We believe that under this proposed rule, the 952 non TJC-accredited CAHs (1,322 CAHs - 370 TJC-accredited CAHs = 952 non TJC-accredited CAHs) would need to review, revise, and, in some cases, develop new sections for their current risk assessments to ensure compliance with all of our requirements.
   We have not designated any specific process or format for CAHs to use in conducting their risk assessments because we believe that CAHs need the flexibility to determine the best way to accomplish this task. However, we expect that CAHs would include representatives from or obtain input from all of their major departments in the process of developing their risk assessments.
   Based on our experience with CAHs, we expect that these activities would require the involvement of a CAH's administrator, medical director, director of nursing, facilities director, and food services director. We expect that these individuals would attend an initial meeting, review relevant sections of the current risk assessment, provide comments, attend a follow-up meeting, perform a final review, and approve the new or updated risk assessment. We expect the administrator would coordinate the meetings, perform an initial review of the current risk assessment, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approved it.
   We estimate that the risk assessment requirement would require 15 burden hours to complete at a cost of
   After conducting the risk assessment, CAHs would have to develop and maintain emergency preparedness plans that complied with proposed SEC 485.625(a)(1) through (4). We would expect all CAHs to compare their emergency plans to their risk assessments and then revise and, if necessary, develop new sections for their emergency plans to ensure that they complied with our proposed requirements.
   The TJC-accredited CAHs must develop and maintain an Emergency Operations Plan (EOP) (CAMCAH Standard EC.4.12, p. EC-10a). The EOP must cover the management of six critical areas during emergencies: communications, resources and assets, safety and security, staff roles and responsibilities, utilities, and patient clinical and support activities (CAMCAH, Standards EC.4.12 through 4.18, pp. EC-10a-EC-10g). In addition, as discussed earlier, TJC-accredited CAHs also are required to conduct an HVA (CAMCAH, Standard EC.4.11, EP 2, p. EC-10a). Therefore, we expect that the 370 TJC-accredited CAHs already have emergency preparedness plans that would satisfy our proposed requirements. If a CAH needed to complete additional tasks to comply with the proposed requirement, the burden would be negligible. Thus, for the 370 TJC-accredited CAHs, this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   The AOA-accredited CAHs must work with federal, state, and local emergency preparedness authorities to identify the likely risks for their location and geographical area and develop appropriate responses to assure the safety of their patients (ARCAH, Standard 11.02.02, p. 11-5). Among the elements that AOA-accredited CAHs must specifically consider are the special needs of their patient population, availability of medical and non-medical supplies, both internal and external communications, and the transfer of patients to home or other health care settings (ARCAH, Standard 11.02.02, p. 11-5). In addition, there are requirements for disaster and disaster response plans (ARCAH, Standards 11.07.01, 11.07.02, and 11.07.06, pp. 11-38 through 11-40). There also are specific requirements for plans for responses to weapons of mass destruction, including chemical, nuclear, and biological weapons; communicable diseases, and chemical exposures (ARCAH, Standards
   The CAH CoPs require all CAHs to ensure the safety of their patients during non-medical emergencies ( SEC 485.623). They are also required to provide, among other things, for evacuation of patients, cooperation with disaster authorities, emergency power and lighting in their emergency rooms and for flashlights and battery lamps in other areas, an emergency water and fuel supply, and any other appropriate measures that are consistent with their particular location ( SEC 485.623). Thus, we believe that all CAHs have developed some type of emergency preparedness plan. However, we also expect that the 920 non-accredited CAHs would have to review their current plans and compare them to their risk assessments and revise and, in some cases, develop new sections for their current plans to ensure that their plans would satisfy our proposed requirements.
   Based on our experience with CAHs, we expect that the same individuals who were involved in conducting the risk assessment would be involved in developing the emergency preparedness plan. We expect that these individuals would attend an initial meeting, review relevant sections of the current emergency preparedness plan(s), prepare and send their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the new plan. We expect that the administrator would coordinate the meetings, perform an initial review, coordinate comments, revise the plan, and ensure that the necessary parties approve the new plan. We estimate that complying with this requirement would require 26 burden hours at a cost of
   Under this proposed rule, CAHs also would be required to review and update their emergency preparedness plans at least annually. The CAH CoPs already require CAHs to perform a periodic evaluation of their total program at least once a year ( SEC 485.641(a)(1)). Hence, all CAHs should already have an individual or team responsible that is for the periodic review of their total program. Therefore, we believe that this requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Under proposed SEC 485.625(b), we would require CAHs to develop and maintain emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in SEC 485.625(a), (a)(1), and (c), respectively. We would also require CAHs to review and update these policies and procedures at least annually. These policies and procedures would have to address, at a minimum, the requirements listed at SEC 485.625(b)(1) through (8).
   We expect that all CAHs would review their policies and procedures and compare them to their risk assessments, emergency preparedness plans, and emergency communication plans. The CAHs would need to revise, and, in some cases, develop new policies and procedures to incorporate all of the provisions previously noted and address all of our proposed requirements.
   The CAMCAH chapter entitled, "Leadership" (LD), requires TJC-accredited CAH leaders to "develop policies and procedures that guide and support patient care, treatment, and services" (CAMCAH, Standard LC.3.90, EP 1, CAMCAH Refreshed Core,
   We propose at SEC 485.625(b)(1) that CAHs have policies and procedures that address the provision of subsistence needs for staff and patients, whether they evacuate or shelter in place. TJC-accredited CAHs must make plans for obtaining and replenishing medical and non-medical supplies, including food, water, and fuel for generators and transportation vehicles (CAMCAH, Standard EC.4.14, EPs 1-4, p. EC-10d). In addition, they must identify alternative means of providing electricity, water, fuel, and other essential utility needs in cases where their usual supply is disrupted or compromised (CAMCAH, Standard EC.4.17, EPs 1-5, p. EC-10f). We expect that TJC-accredited CAHs that comply with these requirements would be in compliance with our proposed requirement concerning subsistence needs at SEC 485.625(b)(1).
   We are proposing at SEC 485.625(b)(2) that CAHs have policies and procedures for a system to track the location of staff and patients in the CAH's care both during and after an emergency. TJC-accredited CAHs must plan for communicating with their staff, as well as patients and their families, at the beginning of and during an emergency (CAMCAH, Standard EC.4.13, EPs 1, 2, and 5, p. EC-10c). We expect that TJC-accredited CAHs that comply with these requirements would be in compliance with our proposed requirement.
   Proposed SEC 485.625(b)(3) would require CAHs to have a plan for the safe evacuation from the CAH. TJC-accredited CAHs are required to make plans to evacuate patients as part of managing their clinical activities (CAMCAH, Standard EC.4.18, EP 1, p. EC-10g). They also must plan for the evacuation and transport of patients, their information, medications, supplies, and equipment to alternative care sites (ACSs) when the CAH cannot provide care, treatment, and services in its facility (CAMCAH, Standard EC.4.14, EPs 9-11, p. EC-10d). We expect that TJC-accredited CAHs that comply with these requirements would be in compliance with our proposed requirement.
   We are proposing at SEC 485.625(b)(4) that CAHs have policies and procedures for a means to shelter in place for patients, staff, and volunteers who remain in the facility. The rationale for CAMCAH Standard EC.4.18 states, "[a] catastrophic emergency may result in the decision to keep all patients on the premises in the interest of safety" (CAMCAH, Standard EC.4.18, p. EC-10f). Therefore, we expect that TJC-accredited CAHs would be substantially in compliance with our proposed requirement.
   Proposed SEC 485.625(b)(5) would require CAHs to have policies and procedures that address a system of medical documentation that preserves patient information, protects the confidentiality of patient information, and ensures that records are secure and readily available. The CAMCAH chapter entitled "Management of Information" (IM), requires TJC-accredited CAHs to have storage and retrieval systems for their clinical/service and CAH-specific information (CAMCAH, Standard IM.3.10, EP 5, CAMCAH Refreshed Core,
   Proposed SEC 485.625(b)(6) would require CAHs to have policies and procedures that addressed the use of volunteers in an emergency or other emergency staffing strategies. TJC-accredited CAHs must define staff roles and responsibilities in their EOP and ensure that they train their staff for their assigned roles (CAMCAH, Standard EC.4.16, EPs 1 and 2, p. EC-10e). Also, the rationale for Standard EC.4.15 indicates that the CAH "determines the type of access and movement to be allowed by . . . emergency volunteers . . . when emergency measures are initiated" (CAMCAH, Standard EC.4.15, Rationale, p. EC-10d). In addition, in the chapter entitled "Medical Staff" (MS), CAHs "may grant disaster privileges to volunteers that are eligible to be licensed independent practitioners" (CAMCAH, Standard MS.4.110, CAMCAH Refreshed Care,
   Based upon the previous discussion, we expect that the activities required for compliance by TJC-accredited CAHs with SEC 485.625(b)(1) through (b)(5) constitutes usual and customary business practices for PRAs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   However, we do not believe TJC-accredited CAHs would be substantially in compliance with proposed SEC 485.625(b)(6) through (8). We will discuss the burden for TJC-accredited CAHs to comply with these requirements later in this section.
   The AOA accreditation standards also contain requirements for policies and procedures related to safety and disaster preparedness. The AOA-accredited CAHs are required to maintain plans and performance standards for disaster preparedness (ARCAH, Standard 11.00.02 Required Plans and Performance Standards, p. 11-2). They also must have "written procedures for possible situations to be followed by each department and service within the CAH and for each building used for patient treatment or housing" (ARCAH, Standard
   In regard to proposed SEC 485.625(b)(1), AOA-accredited CAHs are required to consider "pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations" and "provisions if gas, water, electricity supply is shut off to the community" when they are developing their emergency plans (ARCAH, Standard
   In regard to proposed SEC 485.625(b)(2), AOA-accredited CAHs are required to consider how they will communicate with their staff within the CAH when developing their emergency plans (ARCAH, Standard
   In regard to proposed SEC 485.625(b)(3), which requires policies and procedures regarding the safe evacuation from the facility, AOA-accredited CAHs are required to consider the "transfer or discharge of patients to home, other healthcare settings, or other CAHs" and the "transfer of patients with CAH equipment to another CAH or healthcare setting" (ARCAH, Standard
   In regard to proposed SEC 485.625(b)(4), AOA-accredited CAHs are required to consider the special needs of their patient population and the security of those patients and others that come to them for care when they develop their emergency plans (ARCAH, Standard
   Therefore, we believe that AOA-accredited CAHs have likely already incorporated many of the elements necessary to satisfy the requirements in proposed SEC 485.625(b); however, they would need to thoroughly review their current policies and procedures and perform whatever tasks are necessary to ensure that they complied with all of our proposed requirements for emergency policies and procedures. Because we expect that AOA-accredited CAHs already comply with many of our proposed requirements, we will include the AOA-accredited CAHs with the TJC-accredited CAHs in determining the burden.
   The burden for the 32 AOA-accredited CAHs and the 370 TJC-accredited CAHs to comply with all of the requirements in proposed SEC 485.625(b) would be the resources required to develop written policies and procedures that comply with all of our proposed requirements for emergency policies and procedures. Based on our experience working with CAHs, we expect that accomplishing these activities would require the involvement of an administrator, the medical director, director of nursing, facilities director, and food services director. We expect that the administrator would review the policies and procedures and make recommendations for necessary changes or additional policies or procedures. The CAH administrator would brief other staff and assign staff to make necessary revisions or draft new policies and procedures and disseminate them to the appropriate parties. We estimate that complying with this requirement would require 10 burden hours for each TJC and AOA-accredited CAH at a cost of
   We expect that the 920 non-accredited CAHs already have developed some emergency preparedness policies and procedures. The current CAH CoPs require CAHs to develop, maintain, and review policies to ensure quality care and a safe environment for their patients ( SEC 485.627(a), SEC 485.635(a), and SEC 485.641(a)(1)(iii)). In addition, certain activities associated with our proposed requirements are addressed in the current CAH CoPs. For example, all CAHs are required to have agreements or arrangements with one or more providers or suppliers, as appropriate, to provide services to their patients ( SEC 485.635(c)).
   The burden associated with the development of emergency policies and procedures would be the resources needed to review, revise, and if needed, develop emergency preparedness policies and procedures that include our proposed requirements. We believe the individuals and tasks would be the same as described earlier for the TJC and AOA-accredited CAHs. However, the non-accredited CAHs would require more time to accomplish these activities. We estimate that a non-accredited CAH's compliance would require 14 burden hours at a cost of
   Thus, for all 1,322 CAH to comply with the requirements in proposed SEC 485.625(b) would require 16,900 burden hours at a cost of
   Proposed SEC 485.625(b) would also require CAHs to review and update their emergency preparedness policies and procedures at least annually. As discussed earlier, TJC and AOA-accredited CAHs already periodically review their policies and procedures. In addition, the existing CAH CoPs require periodic reviews of the CAH's health care policies ( SEC 485.627(a), SEC 485.635(a), and SEC 485.641(a)(1)(iii)). Thus, compliance with this requirement would constitute a usual and customary business practice for all CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.625(c) would require CAHs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. We propose that CAHs review and update these plans at least annually. We propose that these communication plans include the information listed at SEC 485.625(c)(1) through (7).
   We expect that all CAHs would review their emergency preparedness communication plans and compare them to their risk assessments and emergency plans. We also expect that CAHs would revise and, if necessary, develop new sections that would comply with our proposed requirements. Based on our experience with CAHs, they generally have some type of emergency preparedness communication plan. Further, it is standard practice for health care facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. Thus, we believe that most, if not all, CAHs are already in compliance with proposed SEC 485.625(c)(1) through (3).
   However, all CAHs would need to review and, if needed, revise and update their plans to ensure compliance with proposed SEC 485.625(c)(4) through (7). The TJC-accredited CAHs are required to establish strategies or plans for emergency communications (CAMCAH, Standard 4.13, p. EC-10b-10c). These plans must cover both internal and external communications and include back-up technologies and communication systems (CAMCAH, Standard 4.13, and EPs 1-14, p. EC-10b-EC-10c). However, we do not believe that these standards would ensure compliance with proposed SEC 485.625(c)(4) through (7). Thus, we will include the 365 TJC-accredited CAHs in the burden below.
   The AOA-accredited CAHs must develop and implement communication plans to ensure the safety of their patients during emergencies (AOA Standard 11.02.02). These plans must specifically include both internal and external communications (AOA Standard 11.02.02, Elements 6, 7, and 10). Based on these standards, we do not believe they ensure compliance with proposed SEC 485.625(c)(4) through (7). Thus, we will include these 32 AOA-accredited CAHs in the burden below.
   The burden associated with complying with this requirement would be the resources required to develop a communication plan that complied with the requirements of this section. Based on our experience with CAHs, we expect that accomplishing these activities would require the involvement of an administrator, director of nursing, and the facilities director. We expect that the administrator would review the communication plan and make recommendations for necessary changes or additions. The director of nursing and the facilities director would meet with the administrator to discuss and revise or draft new sections for the CAH's existing emergency communication plan. We estimate that complying with this requirement would require 9 burden hours for each CAH at a cost of
   Proposed SEC 485.625(c) also would require CAHs to review and update their emergency preparedness communication plans at least annually. All CAHs are required to evaluate their entire program at least annually ( SEC 485.641(a)). Therefore, compliance with this requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.625(d) would require CAHs to develop and maintain emergency preparedness training and testing programs. We would also require CAHs to review and update their training and testing programs at least annually. We propose that a CAH comply with the requirements listed at SEC 485.625(d)(1) and (2).
   Regarding SEC 485.625(d)(1), CAHs would have to provide initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the CAH would have to provide emergency preparedness training at least annually.
   We expect that all CAHs would review their current training programs and compare them to their risk assessments and emergency preparedness plans, emergency policies and procedures, and emergency communication plans. The CAHs would need to revise and, if necessary, develop new sections or materials to ensure their training and testing programs complied with our proposed requirements.
   Current CoPs require CAHs to train their staffs on how to handle emergencies ( SEC 485.623(c)(1)). However, this training primarily addresses internal emergencies, such as a fire inside the facility. In addition, both TJC and AOA require CAHs to provide their staff with training. TJC-accredited CAHs are required to provide their staff with both an initial orientation and on-going training (CAMCAH, Standards HR.2.10 and 2.30, pp. HR-8 and HR-9, respectively). On-going training must also be documented (CAMCAH, Standard HR.2.30, EP 8, p. HR-10). The AOA-accredited CAHs are required to provide an education program for their staff and physicians for the CAH's emergency response preparedness (AOA Standard 11.07.01). Each CAH also must provide an education program specifically for the CAH's response plan for weapons of mass destruction (AOA Standard 11.07.07).
   Thus, we expect that all CAHs provide some emergency preparedness training for their staff. However, neither the current CoPs nor the TJC and AOA accreditation standards ensure compliance with all our proposed requirements. All CAHs would need to review their risk assessments, emergency preparedness plans, policies and procedures, and communication plans and then revise or, in some cases, develop new sections for their training programs to ensure compliance with our proposed requirements. They also would need to revise, update, or, in some cases, develop new materials for the initial and ongoing training.
   Based on our experience with CAHs, we expect that complying with our proposed requirement would require the involvement of an administrator, the director of nursing, and the facilities director. We expect that the director of nursing would perform the initial review of the training program, brief the administrator and the director of facilities, and revise or develop new sections for the training program, based on the group's decisions. We estimate that each CAH would require 14 burden hours to develop an emergency preparedness training program at a cost of
   Proposed SEC 485.625(d)(1) also would require CAHs to review and update their emergency preparedness training programs at least annually. Existing regulations require all CAHs to evaluate their entire program at least annually ( SEC 485.641(a)). Therefore, compliance with this proposed requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   The CAHs also would be required to maintain documentation of their training. Based on our experience with CAHs, it is standard practice for them to document the training they provide to staff and other individuals. If a CAH needed to make any changes to their normal business practices to comply with this requirement, the burden would be negligible. Thus, compliance with this requirement would constitute a usual and customary business practice for CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.625(d)(2) would require CAHs to participate in a community mock disaster drill and a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, the CAH would have to conduct an individual, facility-based mock disaster drill at least annually. CAHs also would be required to analyze the CAH's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CAH's emergency plan, as needed. If a CAH experienced an actual natural or man-made emergency that required activation of the emergency plan, it would be exempt from the proposed requirement for an annual community or individual, facility-based mock disaster drill for 1 year following the onset of the emergency (proposed SEC 485.625(d)(2)(ii)). Thus, to meet these requirements, CAHs would need to develop scenarios for each drill and exercise and develop the required documentation.
   If a CAH participated in a community mock disaster drill, it would likely not need to develop the scenario for that drill. However, for the purpose of determining the burden, we will assume that CAHs need to develop scenarios for both the drill and the exercise annually.
   The TJC-accredited CAHs are required to test their EOP twice a year, either as a planned exercise or in response to an emergency (CAMCAH, Standard EC.4.20, EP 1, p. EC-12). These tests must be monitored, documented, and analyzed (CAMCAH, Standard EC.4.20, EPs 8-19, pp. EC-12--EC-13). Thus, we believe that TJC-accredited CAHs already develop scenarios for these tests. We also expect that they also have developed the documentation necessary to record and analyze their tests and responses to actual emergency events. Therefore, compliance with this requirement would constitute a usual and customary business practice for TJC-accredited CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   The AOA-accredited CAHs are required to conduct two disaster drills annually (AOA Standard 11.07.03). In addition, AOA-accredited CAHs are required to participate in weapons of mass destruction drills, as appropriate (AOA Standard 11.07.09). We expect that since AOA-accredited CAHs already conduct disaster drills, they also develop scenarios for the drills. In addition, it is standard practice in the health care industry to document and analyze tests that a facility conducts. Thus, compliance with this requirement would constitute a usual and customary business practice for AOA-accredited CAHs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Based on our experience with CAHs, we expect that the 831 non-accredited CAHs already have some type of emergency preparedness training program and conduct some type of drills or exercises to test their emergency preparedness plans. However, this does not ensure that most CAHs already perform the activities needed to comply with our proposed requirements. Thus, we will analyze the burden for these requirements for the 920 non-accredited CAHs.
   The 920 non-accredited CAHs would be required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the documentation necessary to record and later analyze the events that occurred during these tests and actual emergency events. Based on our experience with CAHs, we believe that the same individuals who developed the emergency preparedness training program would develop the scenarios for the tests and the accompanying documentation. We expect that the director of nursing would spend more time than would the other individuals developing the scenarios and the accompanying documentation. We estimate that it would require 8 burden hours for the 920 non-accredited CAHs to comply with these proposed requirements at a cost of
Table 12--Burden Hours and Cost Estimates for ALL 1,322 CAHS to Comply With the ICRs Contained in S. 485.625 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 485.625(a)(1) 0938--New 952 952 15 14,280 S. 0938--New 952 952 26 24,752 485.625(a)(2)-(4) S. 485.625(b) 0938--New 402 402 10 4,020 (TJC and AOA- Accredited) S. 485.625(b) 0938--New 920 920 14 12,880 (Non-accredited) S. 485.625(c) 0938--New 1322 1322 9 11,898 S. 485.625(d)(1) 0938--New 1322 1322 14 18,508 S. 485.625(d)(2) 0938--New 920 920 8 7,360 Total 6,790 93,698
Table 12--Burden Hours and Cost Estimates for ALL 1,322 CAHS to Comply With 485.625 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor capital/mai ( ] cost of cost of ntenance reporting reporting costs ( ] ( ] ( ] S. 485.625(a)(1) * * 903,448 0 903,448 S. * * 1,542,240 0 1,542,240 485.625(a)(2)-(4) S. 485.625(b) * * 327,228 0 327,228 (TJC and AOA- Accredited) S. 485.625(b) * * 791,200 0 791,200 (Non-accredited) S. 485.625(c) * * 686,118 0 686,118 S. 485.625(d)(1) * * 1,102,548 0 1,102,548 S. 485.625(d)(2) * * 448,960 0 448,960 Total 5,801,742 * * The hourly labor cost is blended between the wages for multiple staffing levels.
O. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 485.727)
   Proposed SEC 485.727(a) would require clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (organizations) to develop and maintain emergency preparedness plans and review and update the plan at least annually. We are proposing that the plan comply with the requirements listed at SEC 485.727(a)(1) through (6).
   Proposed SEC 485.727(a)(1) would require organizations to develop documented, facility-based and community-based risk assessment utilizing an all-hazards approach. Organizations would need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area.
   The current CoPs for Organizations require these providers to have "a written plan in operation, with procedures to be followed in the event of fire, explosion, or other disaster" ( SEC 485.727(a)). To comply with this CoP, we expect that all of these providers have already performed some type of risk assessment during the process of developing their disaster plans and policies and procedures. However, these providers would need to review their current risk assessments and make any revisions to ensure they complied with our proposed requirements.
   We have not designated any specific process or format for these providers to use in conducting their risk assessments because we believe that they need the flexibility to determine the best way to accomplish this task. Providers of physical therapy and speech therapy services should include input from all of their major departments in the process of developing their risk assessments. Based on our experience with these providers, we expect that conducting the risk assessment would require the involvement of the organization's administrator and a therapist. The types of therapists at each Organization vary depending upon the services offered by the facility. For the purposes of determining the PRA burden, we will assume that the therapist is a physical therapist. We expect that both the administrator and the therapist would attend an initial meeting, review the current assessment, develop comments and recommendations for changes to the assessment, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrator would coordinate the meetings, review and critique the current risk assessment initially, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We also expect that the administrator would spend more time reviewing and working on the risk assessment than the physical therapist. We estimate that complying with this requirement would require 9 burden hours at a cost of
   After conducting the risk assessment, each organization would need to develop and maintain an emergency preparedness plan and review and update it at least annually. Current CoPs require these providers to have a written disaster plan with accompanying procedures for fires, explosions, and other disasters ( SEC 485.727(a)). The plan must include or address the transfer of casualties and records, the location and use of alarm systems and signals, methods of containing fire, notification of appropriate persons, and evacuation routes and procedures ( SEC 485.727(a)). Thus, we expect that all of these organizations have some type of emergency preparedness plan and that these plans address many of our proposed requirements. However, all organizations would need to review their current plans and compare them to their risk assessments. Each organization would need to revise, update, and, in some cases, develop new sections to complete a comprehensive emergency preparedness plan that complied with our proposed requirements.
   Based on our experience with these organizations, we expect that the administrator and physical therapist who were involved in developing the risk assessment would be involved in developing the emergency preparedness plan. However, we expect it would require more time to complete the plan and that the administrator would be the most heavily involved in reviewing and developing the organization's emergency preparedness plan. We estimate that for each organization to comply would require 12 burden hours at a cost of
   Each organization would also be required to review and update its emergency preparedness plan at least annually. We believe that these organizations already review their plans periodically. Thus, complying with this requirement would constitute a usual and customary business practice for organizations and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.727(b) would require organizations to develop and implement emergency preparedness policies and procedures based on their risk assessments, emergency plans, communication plans as set forth in SEC 485.727(a)(1), (a), and (c), respectively. It would also require organizations to review and update these policies and procedures at least annually. At a minimum, we would require that an organization's policies and procedures address the requirements listed at SEC 485.727(b)(1) through (4).
   We expect that all organizations have emergency preparedness policies and procedures. As discussed earlier, the current CoPs require organizations to have procedures within their written disaster plan to be followed for fires, explosions, or other disasters ( SEC 485.727(a)). In addition, we expect that those procedures already address some of the specific elements required in this section. For example, the current requirements at SEC 485.727(a)(1) through (4) are similar to our proposed requirements at SEC 485.727(a)(1) through (5). However, all organizations would need to review their policies and procedures, assess whether their policies and procedures incorporate all of the necessary elements of their emergency preparedness program, and, if necessary, take the appropriate steps to ensure that their policies and procedures are in compliance with our proposed requirements.
   We expect that the administrator and the physical therapist would be primarily involved with reviewing and revising the current policies and procedures and, if needed, developing new policies and procedures. We estimate that it would require 10 burden hours for each organization to comply at a cost of
   We would require organizations to review and update their emergency preparedness policies and procedures at least annually. We believe that these providers already review their emergency preparedness policies and procedures periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.727(c) would require organizations to develop and maintain emergency preparedness communication plans that complied with both federal and state law and would be reviewed and updated at least annually. The communication plan would have to include the information listed at SEC 485.727(c)(1) through (5).
   We expect that all organizations have some type of emergency preparedness communication plan. Current CoPs for these organizations already require them to have a written disaster plan with procedures that must include, among other things, "notification of appropriate persons" ( SEC 485.727(a)(4)). Thus, we expect that each organization has the contact information they would need to comply with this proposed requirement. In addition, it is standard practice for health care facilities to maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many organizations may not have formal, written emergency preparedness communication plans or their plans may not be fully compliant with our proposed requirements. Therefore, we expect that all organizations would need to review, update, and, in some cases, develop new sections for their plans.
   Based on our experience with these organizations, we anticipate that satisfying the requirements in this section would primarily require the involvement of the organization's administrator with the assistance of a physical therapist. We estimate that for each organization to comply would require 8 burden hours at a cost of
   We are proposing that organizations must review and update their emergency preparedness communication plans at least annually. We believe that these organizations already review their emergency communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.727(d) would require organizations to develop and maintain emergency preparedness training and testing programs and review and update these programs at least annually. Specifically, we are proposing that organizations comply with the requirements listed at SEC 485.727(d)(1) and (2).
   With respect to SEC 485.727(d)(1), organizations would have to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the CAH would have to provide emergency preparedness training at least annually.
   Current CoPs require organizations to ensure that "all employees are trained, as part of their employment orientation, in all aspects of preparedness for any disaster. The disaster program includes orientation and ongoing training and drills for all personnel in all procedures . . ."(42 CFR 485.727(b)). Thus, we expect that organizations already have an emergency preparedness training program for new employees, as well as ongoing training for all staff. However, organizations would need to review their current training programs and compare them to their risk assessments and emergency preparedness plans, policies and procedures, and communication plans. Organizations would need to review, revise, and, in some cases, develop new material for their training programs so that they comply with our proposed requirements.
   We expect that complying with this requirement would require the involvement of an administrator and a physical therapist. We expect that the administrator would primarily be involved in reviewing the organization's current training program and the current emergency preparedness program; determining what tasks would need to be performed and what materials would need to be developed to comply with our proposed requirements; and developing the materials for the training program. We expect that the physical therapist would work with the administrator to develop the revised and updated training program. We estimate that it would require 8 burden hours for each organization to develop a comprehensive emergency training program at a cost of
   In SEC 485.727(d)(1), we also propose requiring that an organization must review and update its emergency preparedness training program at least annually. We believe that these providers already review their emergency preparedness training programs periodically. Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 485.727(d)(2) would require organizations to participate in a community mock disaster drill and a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, the organization would have to conduct an individual, facility-based mock disaster drill at least annually. If an organization experienced an actual natural or man-made emergency that required activation of its emergency plan, it would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. Organizations also would be required to analyze their response to and maintain documentation of all the drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed. To comply with this requirement, an organization would need to develop scenarios for their drills and exercises. An organization also would have to develop the documentation necessary for recording and analyzing their responses to drills, exercises, and actual emergency events.
   The current CoPs require organizations to have a written disaster plan that is "periodically rehearsed" and have "ongoing . . . drills" ( SEC 485.727(a) and (b)). Thus, we expect that all 2,256 organizations currently conduct some type of drill or exercise of their disaster plan. However, the current organizations CoPs do not specify the type of drill, how they are to conduct the drills, or whether the drills should be community-based. In addition, there is no requirement for a paper-based, tabletop exercise. Thus, these requirements do not ensure that organizations would be in compliance with our proposed requirements. Therefore, we will analyze the burden from these requirements for all organizations.
   The 2,256 organizations would be required to develop scenarios for a mock disaster drill and a paper-based, tabletop exercise and the necessary documentation. Based on our experience with organizations, we expect that the same individuals who develop the emergency preparedness training program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator would spend more time than the physical therapist developing the scenarios and the documentation. We estimate that for each organization to comply would require 3 burden hours at a cost of
Table 13--Burden Hours and Cost Estimates for All 2,256 Organizations To Comply With the ICRs Contained in S. 485.727 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden Total section(s) No. per annual response burden (hours) (hours) S. 485.727(a)(1) 0938--New 2,256 2,256 9 20,304 S. 0938--New 2,256 2,256 12 27,072 485.727(a)(2)-(4) S. 485.727(b) 0938--New 2,256 2,256 10 22,560 S. 485.727(c) 0938--New 2,256 2,256 8 18,048 S. 485.727(d)(1) 0938--New 2,256 2,256 8 18,048 S. 485.727(d)(2) 0938--New 2,256 2,256 3 6,768 Totals 2,256 13,536 112,800
Table 13--Burden Hours and Cost Estimates for All 2,256 Organizations To Comply With the ICRs Contained in S. 485.727 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor capital/ ( ] cost of cost of maintenance reporting reporting costs ( ] ( ] ( ] S. 485.727(a)(1) * * 1,238,544 0 1,238,544 S. * * 1,671,696 0 1,671,696 485.727(a)(2)-(4) S. 485.727(b) * * 1,382,928 0 1,382,928 S. 485.727(c) * * 1,114,464 0 1,114,464 S. 485.727(d)(1) * * 1,114,464 0 1,114,464 S. 485.727(d)(2) * * 417,360 0 417,360 Totals 6,939,456 * * The hourly labor cost is blended between the wages for multiple staffing levels.
P. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 485.920)
   Proposed SEC 485.920(a) would require Community Mental Health Centers (CMHCs) to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. Specifically, we propose that the plan must meet the requirements listed at SEC 485.920(a)(1) through (4).
   We expect all CMHCs to identify the likely medical and non-medical emergency events they could experience within the facility and the community in which it is located and determine the likelihood of the facility experiencing an emergency due to the identified hazards. We expect that in performing the risk assessment, a CMHC would need to consider its physical location, the geographical area in which it is located and its patient population.
   The burden associated with this proposed requirement would be the time and effort necessary to perform a thorough risk assessment. We expect that most, if not all, CMHCs have already performed at least some of the work needed for a risk assessment because it is standard practice for health care organizations to prepare for common emergencies, such as fires, interruptions in communication and power, and storms. However, many CMHCs may not have performed a risk assessment that complies with the proposed requirements. Therefore, we expect that most, if not all, CMHCs would have to perform a thorough review of their current risk assessment and perform the tasks necessary to ensure that the facility's risk assessment complies with the proposed requirements.
   We do not propose designating any specific process or format for CMHCs to use in conducting their risk assessments because we believe CMHCs need maximum flexibility in determining the best way for their facilities to accomplish this task. However, we expect that in the process of developing a risk assessment, health care organizations would include representatives from or obtain input from all major departments. Based on our experience with CMHCs, we expect that conducting the risk assessment would require the involvement of the CMHC administrator, a psychiatric registered nurse, and a clinical social worker or mental health counselor. We expect that most of these individuals would attend an initial meeting, review relevant sections of the current assessment, prepare and forward their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the risk assessment. We expect that the administrator would coordinate the meetings, do an initial review of the current risk assessment, critique the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approve the new risk assessment. It is likely that the CMHC administrator would spend more time reviewing and working on the risk assessment than the other individuals. We estimate that complying with the proposed requirement to conduct a risk assessment would require 10 burden hours for a cost of
   After conducting the risk assessment, CMHCs would need to develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. CMHCs would need to compare their current emergency plan, if they have one, to their risk assessment. They would then need to revise and, if necessary, develop new sections of their plan to ensure it complies with the proposed requirements.
   It is standard practice for health care organizations to make plans for common disasters they may confront, such as fires, interruptions in communication and power, and storms. Thus, we expect that all CMHCs have some type of emergency preparedness plan. However, their plan may not address all likely medical and non-medical emergency events identified by the risk assessment. Further, their plans may not include strategies for addressing likely emergency events or address their patient population, the type of services they have the ability to provide in an emergency, or continuity of operation, including delegations of authority and succession plans. We expect that CMHCs would have to review their current plan and compare it to their risk assessment, as well as to the other requirements in proposed SEC 485.920(a). We expect that most CMHCs would need to update and revise their existing emergency plan and, in some cases, develop new sections to comply with our proposed requirements.
   The burden associated with this requirement would be due to the resources needed to develop an emergency preparedness plan or to review, revise, and develop new sections for an existing emergency plan. Based upon our experience with CMHCs, we expect that the same individuals who were involved in the risk assessment would be involved in developing the emergency preparedness plan. We also expect that developing the plan would require more time to complete than the risk assessment. We expect that the administrator and a psychiatric nurse would spend more time reviewing and developing the CMHC's emergency preparedness plan. We expect that the clinical social worker or mental health counselor would review the plan and provide comments on it to the administrator. We estimate that it would require 15 burden hours for a CMHC to develop its emergency plan at a cost of
   The CMHC would be required to review and update its emergency preparedness plan at least annually. For the purpose of determining the burden for this proposed requirement, we expect that the CMHCs will review and update their plans annually.
   We expect that all CMHCs have an administrator that is responsible for the day-to-day operation of the CMHC. This would include ensuring that all of the CMHC's plans are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. In addition, it is standard practice in the health care industry for facilities to have a professional staff person, generally an administrator, who periodically reviews their plans and procedures. We expect that complying with the requirement for an annual review of the emergency preparedness plan would constitute a usual and customary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities are not subject to the PRA.
   Proposed SEC 485.920(b) would require CMHCs to develop and maintain emergency preparedness policies and procedures based on the emergency plan, the communication plan, and the risk assessment. We also propose requiring CMHCs to review and update these policies and procedures at least annually. The CMHC's policies and procedures would be required to address, at a minimum, the requirements listed at SEC 485.920(b)(1) through (7).
   We expect that all CMHCs would compare their current emergency preparedness policies and procedures to their emergency preparedness plan, communication plan, and their training and testing program. They would need to review, revise and, if necessary, develop new policies and procedure to ensure they comply with the proposed requirements. The burden associated with reviewing, revising, and updating the CMHC's emergency policies and procedures would be due to the resources needed to ensure they comply with the proposed requirements. We expect that the administrator and the psychiatric registered nurse would be involved with reviewing, revising and, if needed, developing any new policies and procedures. We estimate that for a CMHC to comply with this proposed requirement would require 12 burden hours at a cost of
   The CMHCs would be required to review and update their emergency preparedness policies and procedures at least annually. For the purpose of determining the burden for this requirement, we expect that CMHCs would review their policies and procedures annually. We expect that all CMHCs have an administrator who is responsible for the day-to-day operation of the CMHC, which includes ensuring that all of the CMHC's policies and procedures are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. We also expect that the administrator is responsible for periodically reviewing the emergency preparedness policies and procedures as part of his or her responsibilities. We expect that complying with the requirement for an annual review of the emergency preparedness policies and procedures would constitute a usual and customary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities are not subject to the PRA.
   Proposed SEC 485.920(c) would require CMHCs to develop and maintain an emergency preparedness communications plan that complies with both federal and state law. The CMHC also would have to review and update this plan at least annually. The communication plan must include the information listed in SEC 485.920(c)(1) through (7).
   We expect that all CMHCs would compare their current emergency preparedness communications plan, if they have one, to the proposed requirements. CMHCs would need to perform any tasks necessary to ensure that their communication plans were documented and in compliance with the proposed requirements.
   We expect that all CMHCs have some type of emergency preparedness communications plan. However, their emergency communications plan may not be thoroughly documented or comply with all of the elements we are requiring. It is standard practice for health care organizations to maintain contact information for their staff and for outside sources of assistance; alternate means of communication in case there is a disruption in phone service to the facility (for example, cell phones); and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, we expect that all CMHCs would need to review, update, and in some cases, develop new sections for their plans to ensure that those plans include all of the elements we are requiring for CMHC communications plans.
   The burden associated with complying with this proposed requirement would be due to the resources required to ensure that the CMHC's emergency communication plan complies with the requirements. Based upon our experience with CMHCs, we expect the involvement of the CMHC's administrator and the psychiatric registered nurse. For each CMHC, we estimate that complying with this requirement would require 8 burden hours at a cost of
   We expect that CMHCs must also review and update their emergency preparedness communication plan at least annually. For the purpose of determining the burden for this proposed requirement, we expect that CMHCs would review their policies and procedures annually. We expect that all CMHCs have an administrator who is responsible for the day-to-day operation of the CMHC. This includes ensuring that all of the CMHC's policies and procedures are up-to-date and comply with the relevant federal, state, and local laws, regulations, and ordinances. We expect that the administrator is responsible for periodically reviewing the CMHC's plans, policies, and procedures as part of his or her responsibilities. In addition, we expect that an annual review of the communication plan would require only a negligible burden. Complying with the proposed requirement for an annual review of the emergency preparedness communications plan constitutes a usual and customary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities are not subject to the PRA.
   Proposed SEC 485.920(d) would require CMHCs to develop and maintain an emergency preparedness training program that must be reviewed and updated at least annually. We would require the CMHC to meet the requirements contained in SEC 485.920(d)(1) and (2).
   We expect that CMHCs would develop a comprehensive emergency preparedness training program. The CMHCs would need to compare their current emergency preparedness training program and compare its contents to the risk assessment and updated emergency preparedness plan, policies and procedures, and communications plan and review, revise, and, if necessary, develop new sections for their training program to ensure it complies with the proposed requirements.
   The burden would be due to the resources the CMHC would need to comply with the proposed requirements. We expect that complying with this requirement would include the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse would be primarily involved in reviewing the CMHC's current training program, determining what tasks need to be performed or what materials need to be developed, and developing the materials for the training program. We estimate that it would require 10 burden hours for each CMHC to develop a comprehensive emergency training program at a cost of
   Proposed SEC 485.920(d)(1) would also require the CMHCs to review and update their emergency preparedness training program at least annually. For the purpose of determining the burden for this proposed requirement, we will expect that CMHCs would review their emergency preparedness training program annually. We expect that all CMHCs have a professional staff person, probably a psychiatric registered nurse, who is responsible for periodically reviewing their training program to ensure that it is up-to-date and complies with the relevant federal, state, and local laws, regulations, and ordinances. In addition, we expect that an annual review of the CMHC's emergency preparedness training program would require only a negligible burden. Thus, we expect that complying with the proposed requirement for an annual review of the emergency preparedness training program constitutes a usual and customary business practice for CMHCs. As stated in 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the normal course of their activities are not subject to the PRA.
   Proposed SEC 485.920(d)(2) would require CMHCs to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually. CMHCs would be required to document the drills and the exercises. To comply with this proposed requirement, a CMHC would need to develop a specific scenario for each drill and exercise. A CMHC would have to develop the documentation necessary to record what happened during the drills and exercises.
   Based on our experience with CMHCs, we expect that all 207 CMHCs have some type of emergency preparedness training program and most, if not all, of these CMHCs already conduct some type of drill or exercise to test their emergency preparedness plans. However, we do not know what type of drills or exercises they typically conduct or how often they are performed. We also do not know how, or if, they are documenting and analyzing their responses to these drills and tests. For the purpose of determining a burden for these proposed requirements, we will expect that all CMHCs need to develop two scenarios, one for the drill and one for the exercise, and develop the documentation necessary to record the facility's responses.
   The associated burden would be the time and effort necessary to comply with the requirement. We expect that complying with this proposed requirement would likely require the involvement of a psychiatric registered nurse. We expect that the psychiatric registered nurse would develop the documentation necessary for both during the drill and the exercise and for the subsequent analysis of the CMHC's response. The psychiatric registered nurse would also develop the two scenarios for the drill and exercise. We estimate that these tasks would require 4 burden hours at a cost of
Table 14--Burden Hours and Cost Estimates for All 207 CMHCs To Comply With the ICRs Contained in S. 485.920 Emergency Preparedness Regulation OMB Control Respondents Responses Burden section(s) No. per response (hours) S. 0938--New 207 207 10 485.920(a)(1) S. 0938--New 207 207 15 485.920(a)(1)- (4) S. 485.920(b) 0938--New 207 207 12 S. 485.920(c) 0938--New 207 207 8 S. 0938--New 207 207 10 485.920(d)(1) S. 0938--New 207 207 4 485.920(d)(2) Totals 207 1,242
Table 14--Burden Hours and Cost Estimates for All 207 CMHCs To Comply With the ICRs Contained in S. 485.920 Emergency Preparedness Regulation Total Hourly Total Total cost section(s) annual labor labor ( ] burden cost of cost of (hours) reporting reporting ( ] ( ] S. 2,070 * * 97,290 97,290 485.920(a)(1) S. 3,105 * * 155,250 155,250 485.920(a)(1)- (4) S. 485.920(b) 2,484 * * 130,410 130,410 S. 485.920(c) 1,656 * * 85,905 85,905 S. 2,070 * * 85,698 85,698 485.920(d)(1) S. 828 * * 34,362 34,362 485.920(d)(2) Totals 12,213 588,915
Q. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 486.360)
   Proposed SEC 486.360(a) would require Organ Procurement Organizations (OPOs) to develop and maintain emergency preparedness plans that would have to be reviewed and updated at least annually. These plans would have to comply with the requirements listed in SEC 486.360(a)(1) through (4).
   The current OPO Conditions for Coverage (CfCs) are located at 42 CFR 486.301 through 486.348. These CfCs do not contain any specific emergency preparedness requirements. Thus, for the purpose of determining the burden, we have analyzed the burden for all 58 OPOs for all of the ICRs contained in this proposed rule.
   Proposed SEC 486.360(a)(1) would require OPOs to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. OPOs would need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area, including branch offices and hospitals in their donation services areas.
   The burden associated with this requirement would be the time and effort necessary to perform a thorough risk assessment. Based on our experience with OPOs, we believe that all 58 OPOs have already performed at least some of the work needed for their risk assessments. However, these risk assessments may not be documented or may not address all of the elements required under proposed SEC 486.360(a). Therefore, we expect that all 58 OPOs would have to perform a thorough review of their current risk assessments and perform the necessary tasks to ensure that their risk assessment complied with the requirements of this proposed rule. Based on our experience with OPOs, we believe that conducting a risk assessment would require the involvement of the OPO's director, medical director, quality assessment and performance improvement (QAPI) director, and an organ procurement coordinator (OPC). We expect that these individuals would attend an initial meeting; review relevant sections of the current assessment, prepare and send their comments to the QAPI director; attend a follow-up meeting; perform a final review; and approve the new risk assessment. We estimate that the QAPI Director probably would coordinate the meetings, review the current risk assessment, critique the risk assessment, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved it. We estimate that it would require 10 burden hours for each OPO to conduct a risk assessment at a cost of
   After conducting the risk assessment, OPOs would then have to develop emergency preparedness plans. The burden associated with this requirement would be the resources needed to develop an emergency preparedness plan that complied with the requirements in proposed SEC 486.360(a)(1) through (4). We expect that all OPOs have some type of emergency preparedness plan because it is standard practice in the health care industry to have a plan to address common emergencies, such as fires. In addition, based on our experience with OPOs (including the performance of the Louisiana OPO during the Katrina disaster), OPOs already have plans to ensure that services will continue to be provided in their donation service areas (DSAs) during an emergency. However, we do not expect that all OPOs would have emergency preparedness plans that would satisfy the requirements of this section. Therefore, we expect that all OPOs would need to review their current emergency preparedness plans and compare their plans to their risk assessments. Most OPOs would need to revise, and in some cases develop, new sections to ensure their plan satisfied the proposed requirements.
   We expect that the same individuals who were involved in the risk assessment would be involved in developing the emergency preparedness plan. We expect that these individuals would attend an initial meeting, review relevant sections of the OPO's current emergency preparedness plan, prepare and send their comments to the QAPI director, attend a follow-up meeting, perform a final review, and approve the new plan. We expect that the QAPI Director would coordinate the meetings, perform an initial review of the current emergency preparedness plan, critique the emergency preparedness plan, coordinate comments, ensure that the appropriate individuals revise the plan, and ensure that the necessary parties approve the new plan.
   Thus, we estimate that it would require 22 burden hours for each OPO to develop an emergency preparedness plan that complied with the requirements of this section at a cost of
   OPOs would also be required to review and update their emergency preparedness plans at least annually. We believe that all of the OPOs already review their emergency preparedness plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 486.360(b) would require OPOs to develop and maintain emergency preparedness policies and procedures based on their risk assessments, emergency preparedness plans, emergency communication plan as set forth in proposed SEC 486.360(a)(1), (a), and (c), respectively. It would also require OPOs to review and update these policies and procedures at least annually. The OPO's policies and procedures must address the requirements listed at SEC 486.360(b)(1) and (2).
   The OPO CfCs already require the OPOs' governing boards to "develop and oversee implementation of policies and procedures considered necessary for the effective administration of the OPO, including . . . the OPO's quality assessment and performance improvement (QAPI) program, and services furnished under contract or arrangement, including agreements for those services" ( SEC 486.324(e)). Thus, we expect that OPOs already have developed and implemented policies and procedures for their effective administration. However, since the current CfCs have no specific requirement that these policies and procedures address emergency preparedness, we do not believe that the OPOs have developed or implemented all of the policies and procedures that would be needed to comply with the requirements of this section.
   The burden associated with the development of the emergency preparedness policies and procedures would be the resources needed to develop emergency preparedness policies and procedures that would include, but would not be limited to, the specific elements identified in this requirement. We expect that all OPOs would need to review their current policies and procedures and compare them to their risk assessments, emergency preparedness plans, emergency communication plans, and agreements and protocols, they have developed as required by this proposed rule. Following their reviews, OPOs would need to develop and implement the policies and procedures necessary to ensure that they initiate and maintain their emergency preparedness plans, agreements, and protocols.
   Based on our experience with OPOs, we expect that accomplishing these activities would require the involvement of the OPO's director, medical director, QAPI director, and an Organ Procurement Coordinator (OPC). We expect that all of these individuals would review the OPO's current policies and procedures; compare them to the risk assessment, emergency preparedness plan, agreements and protocols they have established with hospitals, other OPOs, and transplant programs; provide an analysis or comments; and participate in developing the final version of the policies and procedures.
   We expect that the QAPI director would likely coordinate the meetings; coordinate and incorporate comments; draft the revised or new policies and procedures; and obtain the necessary signatures for final approval. We estimate that it would require 20 burden hours for each OPO to comply with the requirement to develop emergency preparedness policies and procedures at a cost of
   OPOs also would be required to review and update their emergency preparedness policies and procedures at least annually. We believe that OPOs already review their emergency preparedness policies and procedures periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 486.360(c) would require OPOs to develop and maintain emergency preparedness communication plans that complied with both federal and state law. The OPOs would have to review and update their plans at least annually. The communication plans would have to include the information listed in SEC 486.360(c)(1) through (3).
   OPOs must operate 24 hours a day, seven days a week. OPOs conduct much of their work away from their office(s) at various hospitals within their DSAs. To function effectively, OPOs must ensure that they and their staff at these multiple locations can communicate with the OPO's office(s), other OPO staff members, transplant and donor hospitals, transplant programs, the Organ Procurement and Transplantation Network (OPTN), other healthcare providers, other OPOs, and potential and actual donors' next-of-kin.
   Thus, we expect that the nature of their work would ensure that all OPOs have already addressed at least some of the elements that would be required by this section. For example, due to the necessity of communication with so many other entities, we expect that all OPOs would have compiled names and contact information for staff, other OPOs, and transplant programs.
   We also expect that all OPOs would have alternate means of communication for their staffs. However, we do not believe that all OPOs have developed formal plans that include all of the proposed elements contained in this requirement. The burden would be the resources needed to develop an emergency preparedness communications plan that would include, but not be limited to, the specific elements identified in this section. We expect that this would require the involvement of the OPO director, medical director, QAPI director, and OPC. We expect that all of these individuals would need to review the OPO's current plans, policies, and procedures related to communications and compare them to the OPO's risk assessment, emergency plan, and the agreements and protocols the OPO developed in accordance with proposed SEC 486.360(e), and the OPO's emergency preparedness policies and procedures. We expect that these individuals would review the materials described earlier, submit comments to the QAPI director, review revisions and additions, and give a final recommendation or approval for the new emergency preparedness communication plan. We also expect that the QAPI director would coordinate the meetings; compile comments; incorporate comments into a new communications plan, as appropriate; and ensure that the necessary individuals review and approve the new plan.
   We estimate that it would require 14 burden hours to develop an emergency preparedness communication plan at a cost of
   We propose that OPOs must review and update their emergency preparedness communication plans at least annually. We believe that all of the OPOs already review their emergency preparedness communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 486.360(d) would require OPOs to develop and maintain emergency preparedness training and testing programs. OPOs also would be required to review and update these programs at least annually. In addition, OPOs must meet the requirements listed in SEC 486.360(d)(1) and (2).
   In SEC 486.360(d)(1), we are proposing that OPOs be required to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of that training. OPOs must also ensure that their staff can demonstrate knowledge of their emergency procedures. Thereafter, OPOs would have to provide emergency preparedness training at least annually.
   Under existing regulations, OPOs are required to provide their staffs with the training and education necessary for them to furnish the services the OPO is required to provide, including applicable organizational policies and procedures and QAPI activities ( SEC 486.326(c)). However, since there are no specific emergency preparedness requirements in the current OPO CfCs, we do not believe that the content of their existing training would comply with the proposed requirements.
   We expect that OPOs would develop a comprehensive emergency preparedness training program for their staffs. Based upon our experience with OPOs, we expect that complying with this proposed requirement would require the OPO director, medical director, the QAPI director, an OPC, and the education coordinator. We expect that the QAPI director and the education coordinator would review the OPO's risk assessment, emergency preparedness plan, policies and procedures, and communication plan and make recommendations regarding revisions or new sections necessary to ensure that all appropriate information is included in the OPO's emergency preparedness training. We believe that the OPO director, medical director, and OPC would meet with the QAPI director and education coordinator and assist in the review, provide comments, and approve the new emergency preparedness training program.
   We estimate that it would require 40 burden hours for each OPO to develop an emergency preparedness training program that complied with these requirements at a cost of
   We propose that OPOs must review and update their emergency preparedness training programs at least annually. We believe that all of the OPOs already review their emergency preparedness training programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for OPOs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 486.360(d)(2) would require OPOs to conduct a paper-based, tabletop exercise at least annually. OPOs also would be required to analyze their responses to and maintain documentation of all tabletop exercises and actual emergency events, and revise their emergency plans, as needed. To comply with this requirement, OPOs would have to develop scenarios for each tabletop exercise and the necessary documentation.
   The OPO CfCs do not currently contain a requirement for OPOs to conduct a paper-based, tabletop exercise. However, OPOs are required to evaluate their staffs' performance and provide training to improve individual and overall staff performance and effectiveness (42 CFR 486.326(c)). Therefore, we expect that OPOs periodically conduct some type of exercise to test their plans, policies, and procedures, which would include developing a scenario for and documenting the exercise. Thus, compliance with these requirements would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   We expect that the QAPI director and the education coordinator would work together to develop the scenario for the exercise and the necessary documentation. We expect that the QAPI director would likely spend more time on these activities. We estimate that these tasks would require 5 burden hours for each OPO at a cost of
   Proposed SEC 486.360(e) would require each OPO to have an agreement(s) with one or more other OPOs to provide essential organ procurement services to all or a portion of the OPO's DSA in the event that the OPO cannot provide such services due to an emergency. This section would also require each OPO to include in the hospital agreements required under SEC 486.322(a), and in the protocols with transplant programs required under SEC 486.344(d), the duties and responsibilities of the hospital, transplant program, and the OPO in the event of an emergency.
   The burden associated with the development of an agreement with another OPO and with the hospitals in the OPO's DSA would be the resources needed to negotiate, draft, and approve the agreement. For the purpose of determining a burden for this requirement, we will assume that each OPO would need to develop an agreement with one other OPO.
   We expect that the OPO director, medical director, QAPI director, OPC, and an attorney would be involved in completing the tasks necessary to develop these agreements. We expect that all of these individuals would be involved in assessing the OPO's need for coverage of its DSA during emergencies and deciding with which OPO to negotiate an agreement. We also expect that the OPO director, QAPI director, and an attorney would be involved in negotiating the agreements and ensuring that the appropriate parties sign the agreements. The attorney would be responsible for drafting the agreement and making any necessary revisions.
   We estimate that it would require 22 burden hours for each OPO to develop an agreement with another OPO to provide essential organ procurement services to all or a portion of its DSA during an emergency at a cost of
   Proposed SEC 486.360(e) would also require OPOs to include in the agreements with hospitals required under SEC 486.322(a), and in the protocols with transplant programs required under SEC 486.344(d), the duties and responsibilities of the hospital, transplant center, and the OPO in the event of an emergency. The current OPO CfCs do not contain a requirement for emergency preparedness to be covered in these agreements and protocols. However, based on our experience with OPOs, hospitals, and transplant centers, we expect that most, if not all of these agreements and protocols already address roles and responsibilities during an emergency.
   Thus, for the purpose of determining an ICR burden for these requirements, we will assume that all 58 OPOs would need to draft a limited amount of new language for their agreements with hospitals and the protocols with transplant centers. We expect that an attorney would be primarily responsible for drafting the language for these agreements and protocols and making any necessary revisions required by the parties. The number of hospitals and transplant programs in each DSA would vary widely between the OPOs. However, we expect that the attorney would draft standard language for both types of documents. In addition, we expect that the OPO director, medical director, QAPI director, and OPC would work with the attorney in developing this standard language.
   We estimate that it would require 13 burden hours for each OPO to comply with these requirements at a cost of
   Based on the previous analysis, for all 58 OPOs to comply with all of the ICRs in proposed SEC 486.360 would require 8,468 burden hours at a cost of
Table 15--Burden Hours and Cost Estimates for All 58 OPOs To Comply With the ICRs Contained in S. 486.360 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 486.360(a)(1) 0938--New 58 58 10 580 S. 0938--New 58 58 22 1,276 486.360(a)(2)-(4) S. 486.360(b) 0938--New 58 58 20 1,160 S. 486.360(c) 0938--New 58 58 14 812 S. 486.360(d)(1) 0938--New 58 58 40 2,320 S. 486.360(d)(2) 0938--New 58 58 5 290 S. 486.360(e) 0938--New 58 58 35 2,030 Totals 58 406 146 8,468
Table 15--Burden Hours and Cost Estimates for All 58 OPOs To Comply With the ICRs Contained in S. 486.360 Condition: Emergency Preparedness Regulation Hourly Total Total Total section(s) labor labor Capital/ cost cost of cost of Maintenance ( ] reporting reporting Costs ( ] ( ] ( ] S. 486.360(a)(1) < * *> 47,676 0 47,676 S. < * *> 102,776 0 102,776 486.360(a)(2)-(4) S. 486.360(b) < * *> 85,956 0 85,956 S. 486.360(c) < * *> 62,524 0 62,524 S. 486.360(d)(1) < * *> 139,548 0 139,548 S. 486.360(d)(2) < * *> 16,124 0 16,124 S. 486.360(e) < * *> 152,366 0 152,366 Totals 606,970
R. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 491.12)
   Proposed SEC 491.12(a) would require
   Proposed SEC 491.12(a)(1) would require RHCs/FQHCs to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. RHCs/FQHCs would need to identify the medical and non-medical emergency events they could experience both at their facilities and in the surrounding area. RHCs/FQHCs would need to review any existing risk assessments and then update and revise those assessments or develop new sections for them so that those assessments complied with our proposed requirements.
   We obtained the total number of RHCs and FQHCs used in this burden analysis from the CMS CASPER data system, which the states update periodically. Due to variations in the timeliness of the data submission, all numbers in this analysis are approximate. There are currently 4,013 RHCs and 5,534 FQHCs. Thus, there are 9,547 RHC/FQHCs (4,013 RHCs + 5,534 FQHCs = 9,547 RHCs/FQHCs). Unlike RHCs, FQHCs are grantees under Section 330 of the Public Health Service Act. In 2007, the
   Based on our experience with RHCs, we expect that all 4,013 RHCs have already performed at least some of the work needed to conduct a risk assessment. It is standard practice for health care facilities to prepare for common emergencies, such as fires, power outages, and storms. In addition, the current Rural Health Clinic Conditions for Certification and the FQHC Conditions for Coverage (RHC/FQHC CfCs) already require each RHC and FQHC to assure "the safety of patients in case of non-medical emergencies by . . . taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic or center is located" ( SEC 491.6(c)(3)).
   Further, in accordance with the Emergency Management PIN, FQHCs should have initiated their "emergency management planning by conducting a risk assessment such as a Hazard Vulnerability Analysis" (HVA) (Emergency Management PIN, p. 5). The HVA should identify potential emergencies or risks and potential direct and indirect effects on the facility's operations and demands on their services and prioritize the risks based on the likelihood of each risk occurring and the impact or severity the facility would experience if the risk occurs (Emergency Management PIN, p. 5). FQHCs are also "encouraged to participate in community level risk assessments and integrate their own risk assessment with the local community" (Emergency Management PIN, p. 5).
   Despite these expectations and the existing Medicare regulations for RHCs/FQHCs, some RHC/FQHC risk assessments may not comply with all proposed requirements. For example, the expectations for FQHCs do not specifically address our proposed requirement to address likely medical and non-medical emergencies. In addition, participation in a community-based risk assessment is only encouraged, not required. We expect that all 4,013 RHCs and 5,534 FQHCs will need to compare their current risk assessments with our proposed requirements and accomplish the tasks necessary to ensure their risk assessments comply with our proposed requirements. However, we expect that FQHCs would not be subject to as many burden hours as RHCs.
   We have not designated any specific process or format for RHCs or FQHCs to use in conducting their risk assessments because we believe that RHCs and FQHCs need flexibility to determine the best way to accomplish this task. However, we expect that these health care facilities would include input from all of their major departments. Based on our experience with RHCs/FQHCs, we expect that conducting the risk assessment would require the involvement of the RHC/FQHC's administrator, a physician, a nurse practitioner or physician assistant, and a registered nurse. We expect that these individuals would attend an initial meeting, review the current risk assessment, prepare and forward their comments to the administrator, attend a follow-up meeting, perform a final review, and approve the new risk assessment. We expect that the administrator would coordinate the meetings, review the current risk assessment, provide an analysis of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and ensure that the necessary parties approve it. We also expect that the administrator would spend more time reviewing the risk assessment than the other individuals.
   We estimate that it would require 10 burden hours for each RHC to conduct a risk assessment that complied with the requirements in this section at a cost of
   We estimate that it would require 5 burden hours for each FQHC to conduct a risk assessment that complied with our proposed requirements at a cost of
   Based on those estimates, compliance with this proposed requirement for all RHCs and FQHCs would require 67,800 burden hours at a cost of
   After conducting the risk assessment, RHCs/FQHCs would have to develop and maintain emergency preparedness plans that complied with proposed SEC 491.12(a)(1) through (4) and review and update them annually. It is standard practice for healthcare facilities to plan for common emergencies, such as fires, hurricanes, and snowstorms. In addition, as discussed earlier, we require all RHCs/FQHCs to take appropriate measures to ensure the safety of their patients in non-medical emergencies, based on the particular conditions present in the area in which they are located ( SEC 491.6(c)(3)). Thus, we expect that all RHCs/FQHCs have developed some type of emergency preparedness plan. However, under this proposed rule, all RHCs/FQHCs would have to review their current plans and compare them to their risk assessments. The RHCs/FQHCs would need to update, revise, and, in some cases, develop new sections to complete their emergency preparedness plans that meet our proposed requirements.
   The Emergency Management PIN contains many expectations for an FQHC's emergency management plan (EMP). For example, it states that the FQHC's EMP "is necessary to ensure the continuity of patient care" during an emergency (Emergency Management PIN, p. 6) and should contain plans for "assuring access for special populations (Emergency Management PIN, p. 7). The FQHC's EMP also should address continuity of operations, as appropriate (Emergency Management PIN, p. 6). In addition, FQHCs should use an "all-hazards approach" so that these facilities can respond to all of the risks they identified in their risk assessment (Emergency Management PIN, p. 6). Based on the expectations in the Emergency Management PIN, we expect that FQHCs likely have developed emergency preparedness plans that comply with many, if not all, of the elements with which their plans would need to comply under this proposed rule. However, we expect that FQHCs would need to compare their current EMP to our proposed requirements and, if necessary, revise or develop new sections for their EMP to bring it into compliance. We expect that FQHCs would have less of a burden than RHCs.
   Based on our experience with RHCs/FQHCs, we expect that the same individuals who were involved in developing the risk assessments would be involved in developing the emergency preparedness plans. However, we expect that it would require more time to complete the plans than the risk assessments. We expect that the administrator would have primary responsibility for reviewing and developing the RHC/FQHC's EMP. We expect that the physician, nurse practitioner, and registered nurse would review the draft plan and provide comments to the administrator. We estimate that for each RHC to comply with this requirement would require 14 burden hours at a cost of
   We estimate that it would require 8 burden hours for each FQHC to comply with our proposed requirements at a cost of
   Based on the previous estimates, for all RHCs and FQHCs to develop an emergency preparedness plan that complies with our proposed requirements would require 100,454 burden hours at a cost of
   Each RHC/FQHC also would be required to review and update its emergency preparedness plan at least annually. We believe that RHCs and FQHCs already review their emergency preparedness plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for RHCs and FQHCs and would not subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 491.12(b) would require RHCs/FQHCs to develop and implement emergency preparedness policies and procedures based on their emergency plans, risk assessments, and communication plans as set forth in SEC 491.12(a), (a)(1), and (c), respectively. We would also require RHCs/FQHCs to review and update these policies and procedures at least annually. At a minimum, we would require that the RHC/FQHC's policies and procedures address the requirements listed at SEC 491.12(b)(1) through (4).
   We expect that all RHCs/FQHCs have some emergency preparedness policies and procedures. All RHCs and FQHCs are required to have emergency procedures related to the safety of their patients in non-medical emergencies ( SEC 491.6(c)). They also must set forth in writing their organization's policies ( SEC 491.7(a)(2)). In addition, current regulations require that a physician, in conjunction with a nurse practitioner or physician's assistant, develop the facility's written policies ( SEC 491.8(b)(ii) and (c)(i)). However, we expect that all RHCs/FQHCs would need to review their policies and procedures, assess whether their policies and procedures incorporate their risk assessments and emergency preparedness plans and make any changes necessary to comply with our proposed requirements.
   We expect that FQHCs already have policies and procedures that would comply with some of our proposed requirements. Several of the expectations of the Emergency Management PIN address specific elements in proposed SEC 491.12(b). For example, the PIN states that FQHCs should address, as appropriate, continuity of operations, staffing, surge patients, medical and non-medical supplies, evacuation, power supply, water and sanitation, communications, transportation, and the access to and security of medical records (Emergency Management PIN, p. 6). In addition, FQHCs should also continually evaluate their EMPs and make changes to their EMPs as necessary (Emergency Management PIN, p. 7). These expectations also indicate that FQHCs should be working with and integrating their planning with their state and local communities' plans, as well as other key organizations and other relationships (Emergency Management PIN, p. 8). Thus, we expect that burden for FQHCs from the requirement for emergency preparedness policies and procedures would be less than the burden for RHCs.
   The burden associated with our proposed requirements would be reviewing, revising, and, if needed, developing new emergency preparedness policies and procedures. We expect that a physician and a nurse practitioner would primarily be involved with these tasks and that an administrator would assist them. We estimate that for each RHC to comply with our proposed requirements would require 12 burden hours at a cost of
   As discussed earlier, we expect that FQHCs would have less of a burden from developing their emergency preparedness policies and procedures due to the expectations set out in the Emergency Management PIN. Thus, we estimate that for each FQHC to comply with the proposed requirements would require 8 burden hours at a cost of
   Based on the previous estimates, for all RHCs and FQHCs to develop emergency preparedness policies and procedures that comply with our proposed requirements would require 92,428 burden hours at a cost of
   We propose that RHCs/FQHCs review and update their emergency preparedness policies and procedures at least annually. We believe that RHCs and FQHCs already review their emergency preparedness policies and procedures periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 491.12(c) would require RHCs/FQHCs to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. RHCs/FQHCs would also have to review and update these plans at least annually. We propose that the communication plan must include the information listed in SEC 491.12(c)(1) through (5).
   We expect that all RHCs/FQHCs have some type of emergency preparedness communication plan. It is standard practice for health care facilities to maintain contact information for staff and outside sources of assistance; alternate means of communication in case there is an interruption in the facility's phone services; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for patients. As discussed earlier, RHCs and FQHCs are required to take appropriate measures to ensure the safety of their patients during non-medical emergencies ( SEC 491.6(c)). We expect that an emergency preparedness communication plan would be an essential element in any emergency preparedness preparations. However, some RHCs/FQHCs may not have a formal, written emergency preparedness communication plan or their plan may not include all the requirements we propose.
   The Emergency Management PIN contains specific expectations for communications and information sharing (Emergency Management PIN, pp. 8-9). "A well-defined communication plan is an important component of an effective EMP" (Emergency Management PIN, p. 8). In addition, FQHCs are expected to have policies and procedures for communicating with both internal stakeholders (such as patients and staff) and external stakeholders (such as federal, tribal, state, and local agencies), and for identifying who will do the communicating and what type of information will be communicated (Emergency Management PIN, p. 8). FQHCs should also identify alternate communications systems in the event that their standard communications systems become unavailable, and the FQHC should identify these alternate systems in their EMP (Emergency Management PIN, p. 9). Thus, we expect that all FQHCs would have a formal communication plan for emergencies and that those plans would contain some of our proposed requirements. However, we expect that all FQHCs would need to review, revise, and, if needed, develop new sections for their emergency preparedness communication plans to ensure that their plans are in compliance. We expect that these tasks will require less of a burden for FQHCs than for the RHCs.
   The burden associated with complying with this requirement would be the resources required to review, revise, and, if needed, develop new sections for the RHC/FQHC's emergency preparedness communication plan. Based on our experience with RHCs/FQHCs, as well as the requirements in current regulations for a physician to work in conjunction with a nurse practitioner or a physician assistant to develop policies, we anticipate that satisfying the requirements in this section would require the involvement of the RHC/FQHC's administrator, a physician, and a nurse practitioner or physician assistant. We expect that the administrator and the nurse practitioner or physician assistant would be primarily involved in reviewing, revising, and if needed, developing new sections for the RHC/FQHC's emergency preparedness communication plan.
   We estimate that for each RHC to comply with the proposed requirements would require 10 burden hours at a cost of
   We estimate that for a FQHC to comply with the proposed requirements would require 5 burden hours at a cost of
   We propose that RHCs/FQHCs also review and update their emergency preparedness communication plans at least annually. We believe that RHCs/FQHCs already review their emergency preparedness communication plans periodically. Thus, compliance with this requirement would constitute a usual and customary business practice for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 491.12(d) would require RHCs/FQHCs to develop and maintain emergency preparedness training and testing programs and review and update these programs at least annually. We propose that an RHC/FQHC would have to comply with the requirements listed in SEC 491.12(d)(1) and (2).
   Proposed SEC 491.12(d)(1) would require each RHC and FQHC to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of that training. Each RHC and FQHC would also have to ensure that its staff could demonstrate knowledge of those emergency procedures. Thereafter, each RHC and FQHC would be required to provide emergency preparedness training annually.
   Based on our experience with RHCs and FQHCs, we expect that all 9,045 RHC/FQHCs already have some type of emergency preparedness training program. The current RHC/FQHC regulations require RHCs and FQHCs to provide training to their staffs on handling emergencies ( SEC 491.6(c)(1)). In addition, FQHCs are expected to provide ongoing training in emergency management and their facilities' EMP to all of their employees (Emergency Management PIN, p. 7). However, neither the current regulations nor the PIN's expectations for FQHCs address initial training and ongoing training, frequency of training, or requirements that individuals providing services under arrangement and volunteers be included in the training. RHCs/FQHCs would need to review their current training programs; compare their contents to their risk assessments, emergency preparedness plans, policies and procedures, and communication plans and then take the necessary steps to ensure that their training programs comply with our proposed requirements.
   We expect that each RHC and FQHC has a professional staff person who is responsible for ensuring that the facility's training program is up-to-date and complies with all federal, state, and local laws and regulations. This individual would likely be an administrator. We expect that the administrator would be primarily involved in reviewing the RHC/FQHC's emergency preparedness program; determining what tasks need to be performed and what materials need to be developed to bring the training program into compliance with our proposed requirements; and making changes to current training materials and developing new training materials. We expect that the administrator would work with a registered nurse to develop the revised and updated training program. We estimate that it would require 10 burden hours for each RHC or FQHC to develop a comprehensive emergency training program at a cost of
   Proposed SEC 491.12(d) would also require that RHCs/FQHCs develop and maintain emergency preparedness training and testing programs that would be reviewed and updated at least annually. We believe that RHCs/FQHCs already review their emergency preparedness programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice for RHCs/FQHCs and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 491.12(d)(2) would require RHCs/FQHCs to participate in a community mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, RHCs/FQHCs would have to conduct an individual, facility-based mock disaster drill at least annually. RHCs/FQHCs would also be required to analyze their responses to and maintain documentation of drills, tabletop exercises, and emergency events, and revise their emergency plans, as needed. If an RHC or FQHC experienced an actual natural or man-made emergency that required activation of its emergency plan, it would be exempt from the requirement for a community or individual, facility-based mock drill for 1 year following the onset of the actual event. However, for purposes of determining the burden for these requirements, we will assume that all RHCs/FQHCs would have to comply with all of these proposed requirements.
   The burden associated with complying with these requirements would be the resources the RHC or FQHC would need to develop the scenarios for the drill and exercise and the documentation necessary for analyzing and documenting their drills, tabletop exercises, as well as any emergency events.
   Based on our experience with RHCs/FQHCs, we expect that most of the 9,547 RHCs/FQHCs already conduct some type of testing of their emergency preparedness plans and develop scenarios and documentation for their testing and emergency events. For example, FQHCs are expected to conduct some type of testing of their EMP at least annually (Emergency Management PIN, p. 7). However, we do not believe that all RHCs/FQHCs have the appropriate documentation for drills, exercises, and emergency events or that they conduct both a drill and a tabletop exercise annually. Thus, we will analyze the burden associated with these requirements for all 9,547 RHCs/FQHCs.
   Based on our experience with RHCs/FQHCs, we expect that the same individuals who are responsible for developing the RHC/FQHC's training and testing program would develop the scenarios for the drills and exercises and the accompanying documentation. We expect that the administrator and a registered nurse would be primarily involved in accomplishing these tasks. We estimate that for each RHC/FQHC to comply with the requirements in this section would require 5 burden hours at a cost of
Table 16--Burden Hours and Cost Estimates for All 9,547 RHC/FQHCS To Comply With the ICRs Contained in S. 491.12 Condition: Emergency Preparedness Regulation OMB Control Respondents Responses Burden per Total section(s) No. response annual (hours) burden (hours) S. 491.12(a)(1) 0938--New 4,013 4,013 10 40,130 (RHCs) S. 491.12(a)(1) 0938--New 5,534 5,534 5 27,670 (FQHCs) S. 491.12(a)(1)- 0938--New 4,013 4,013 14 56,182 (4) (RHCs) S. 491(a)(1)-(4) 0938--New 5,534 5,534 8 44,272 (FQHCs) S. 491.12(b) 0938--New 4,013 4,013 12 48,156 (RHCs) S. 491.12(b) 0938--New 5,534 5,534 8 44,272 (FQHCs) S. 491.12(c) 0938--New 4,013 4,013 10 40,130 (RHCs) S. 491.12(c) 0938--New 5,534 5,534 5 27,670 (FQHCs) S. 491.12(d)(1) 0938--New 9,547 9,547 10 95,470 S. 491.12(d)(2) 0938--New 9,547 9,547 5 47,735 Totals 57,282 471,687
Table 16--Burden Hours and Cost Estimates for All 9,547 RHC/FQHCS To Comply With the ICRs Contained in S. 491.12 Condition: Emergency Preparedness Regulation Hourly Total Total Total section(s) labor labor Capital/ cost cost of cost of Maintenance ( ] reporting reporting Costs ( ] ( ] ( ] S. 491.12(a)(1) < * *> 2,857,256 0 2,857,256 (RHCs) S. 491.12(a)(1) < * *> 1,970,104 0 1,970,104 (FQHCs) S. 491.12(a)(1)- < * *> 3,808,337 0 3,808,337 (4) (RHCs) S. 491(a)(1)-(4) < * *> 2,933,020 0 2,933,020 (FQHCs) S. 491.12(b) < * *> 3,884,584 0 3,884,584 (RHCs) S. 491.12(b) < * *> 3,364,672 0 3,364,672 (FQHCs) S. 491.12(c) < * *> 3,443,154 0 3,443,154 (RHCs) S. 491.12(c) < * *> 2,030,978 0 2,030,978 (FQHCs) S. 491.12(d)(1) < * *> 5,021,722 0 5,021,722 S. 491.12(d)(2) < * *> 2,634,972 0 2,634,972 Totals 31,948,799 * * The hourly labor cost is blended between the wages for multiple staffing levels.
S. ICRs Regarding Condition of Participation: Emergency Preparedness ( SEC 494.62)
   Proposed SEC 494.62(a) would require dialysis facilities to develop and maintain emergency preparedness plans that would have to reviewed and updated at least annually. Proposed SEC 494.62 would require that the plan include the elements set out at SEC 494.62(a)(1) through (4).
   Proposed SEC 494.62(a)(1) would require dialysis facilities to develop a documented, facility-based and community-based risk assessment utilizing an all-hazards approach. The risk assessment should address the medical and non-medical emergency events the facility could experience both within the facility and within the surrounding area. The dialysis facility would have to consider its location and geographical area; patient population, including, but not limited to, persons-at-risk; and the types of services the dialysis facility has the ability to provide in an emergency. The dialysis facility also would need to identify the measures it would need to take to ensure the continuity of its operations, including delegations of authority and succession plans.
   The burden associated with this requirement would be the resources needed to perform a thorough risk assessment. The current CfCs already require dialysis facilities to "implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failure, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area" ( SEC 494.60(d)). Thus, to be in compliance with this CfC, we believe that all dialysis facilities would have already performed some type of risk assessment during the process of developing their emergency preparedness processes and procedures. However, these risk assessments may not be as thorough or address all of the elements required in proposed SEC 494.62(a). For example, the current CfCs do not require dialysis facilities to plan for man-made disasters. Therefore, we believe that all dialysis facilities would have to conduct a thorough review of their current risk assessments and then perform the necessary tasks to ensure that their facilities' risk assessments complied with the requirements of this section.
   Based on our experience with dialysis facilities, we expect that conducting the risk assessment would require the involvement of the dialysis facility's chief executive officer or administrator, medical director, nurse manager, social worker, and a PCT. We believe that all of these individuals would attend an initial meeting, review relevant sections of the current assessment, develop comments and recommendations for changes to the assessment, attend a follow-up meeting, perform a final review and approve the risk assessment. We believe that the administrator would probably coordinate the meetings, do an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approve the new risk assessment. We also believe that the administrator would probably spend more time reviewing and working on the risk assessment than the other individuals involved in performing the risk assessment. Thus, we estimate that complying with this requirement to conduct and develop a risk assessment would require 12 burden hours at a cost of
   After conducting the risk assessment, each dialysis facility would then have to develop and maintain an emergency preparedness plan that the facility must evaluate and update at least annually. This emergency plan would have to comply with the requirements at proposed SEC 494.62(a)(1) through (4).
   Current CfCs already require dialysis facilities to "have a plan to obtain emergency medical system assistance when needed . . . " and "evaluate at least annually the effectiveness of emergency and disaster plans and update them as necessary" ( SEC 494.60(d)(4)). Thus, we expect that all dialysis facilities have some type of emergency preparedness or disaster plan. In addition, dialysis facilities must also "implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, the staff, or the public. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area" ( SEC 494.60(d)). We expect that the facility would incorporate many, if not all, of these processes and procedures into its emergency preparedness plan. We expect that each dialysis facility has some type of emergency preparedness plan and that plan should already address many of these requirements. However, all of the dialysis facilities would have to review their current plans and compare them to the risk assessment they performed pursuant to proposed SEC 494.62(a)(1). The dialysis facility would then need to update, revise, and, in some cases, develop new sections to complete an emergency preparedness plan that addressed the risks identified in their risk assessment and the specific requirements contained in this subsection. The plan would also address how the dialysis facility would continue providing its essential services, which are the services that the dialysis facility would continue to provide despite an emergency. The dialysis facility would also need to review, revise, and, in some cases, develop delegations of authority or succession plans that the dialysis facility determined were necessary for the appropriate initiation and management of their emergency preparedness plan.
   The burden associated with this requirement would be the time and effort necessary to develop the emergency preparedness plan. Based upon our experience with dialysis facilities, we expect that developing the emergency preparedness plan would require the involvement of the dialysis facility's chief executive officer or administrator, medical director, nurse manager, social worker, and a PCT. We believe that all of these individuals would probably have to attend an initial meeting, review relevant sections of the facility's current emergency preparedness or disaster plan(s), develop comments and recommendations for changes to the assessment, attend a follow-up meeting, and then perform a final review and approve the risk assessment. We believe that the administrator would probably coordinate the meetings, do an initial review of the current risk assessment, provide a critique of the risk assessment, offer suggested revisions, coordinate comments, develop the new risk assessment, and assure that the necessary parties approved the new risk assessment. We also believe that the administrator, medical director, and nurse manager would probably spend more time reviewing and working on the risk assessment than the other individuals involved in developing the plan. The social worker and PCT would likely just review the plan or relevant sections of it. In addition, since the medical director's responsibilities include participation in the development of patient care policies and procedures (42 CFR 494.150(c)), we expect that the medical director would be involved in the development of the emergency preparedness plan. We estimate that complying with this requirement would require 10 burden hours at a cost of
   Each dialysis facility would also be required to review and update its emergency preparedness plan at least annually. We believe that dialysis facilities already review their emergency preparedness plans periodically. The current CfCs already requires dialysis facilities to evaluate the effectiveness of their emergency and disaster plans and update them as necessary (42 CFR 494.60(d)(4)(ii)). Thus, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 494.62(b) would require dialysis facilities to develop and implement emergency preparedness policies and procedures based on the emergency plan, the risk assessment, and communication plan as set forth in SEC 494.62(a), (a)(1), and (c), respectively. These emergencies would include, but would not be limited to, fire, equipment or power failures, care-related emergencies, water supply interruptions, and natural and man-made disasters that are likely to occur in the facility's geographical area. Dialysis facilities would also have to review and update these policies and procedures at least annually. The policies and procedures would be required to address, at a minimum, the requirements listed at SEC 494.62(b)(1) through (9).
   We expect that all dialysis facilities have some emergency preparedness policies and procedures. The current CfCs at 42 CFR 494.60(d) already require dialysis facilities to have and "implement processes and procedures to manage medical and nonmedical emergencies . . . [that] include, but not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area". In addition, we expect that dialysis facilities already have procedures that would satisfy some of the requirements in this section. For example, each dialysis facility is already required at 42 CFR 494.60(d)(4)(iii) to "contact its local disaster management agency at least annually to ensure that such agency is aware of dialysis facility needs in the event of an emergency". However, all dialysis facilities would need to review their policies and procedures, assess whether their policies and procedures incorporated all of the necessary elements of their emergency preparedness program, and then, if necessary, take the appropriate steps to ensure that their policies and procedures encompassed these requirements.
   The burden associated with the development of these emergency policies and procedures would be the time and effort necessary to comply with these requirements. We expect the administrator, medical director, and the nurse manager would be primarily involved with reviewing, revising, and if needed, developing any new policies and procedures that were needed. The remaining individuals would likely review the sections of the policies and procedures that directly affect their areas of expertise. Therefore, we estimate that complying with this requirement would require 10 burden hours at a cost of
   The dialysis facility must also review and update its emergency preparedness policies and procedures at least annually. We believe that dialysis facilities already review their emergency preparedness policies and procedures periodically. In addition, the current CfCs already require (at 42 CFR 494.150(c)(1)) the medical director to participate in a periodic review of patient care policies and procedures. Thus, compliance with this requirement would constitute a usual and customary business practice for dialysis facilities and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 494.62(c) would require dialysis facilities to develop and maintain an emergency preparedness communication plan that complied with both federal and state law. The dialysis facility must also review and update this plan at least annually. The communication plan must include the information listed at SEC 494.62(c)(1) through (7).
   We expect that all dialysis facilities have some type of emergency preparedness communication plan. A communication plan would be an integral part of any emergency preparedness plan. Current CfCs already require dialysis facilities to have a written disaster plan (42 CFR 494.60(d)(4)). Thus, each dialysis facility should already have some of the contact information they would need to have in order to comply with this section. In addition, we expect that it is standard practice in the healthcare industry to have and maintain contact information for both staff and outside sources of assistance; alternate means of communications in case there is an interruption in phone service to the facility, such as cell phones or text-messaging devices; and a method for sharing information and medical documentation with other health care providers to ensure continuity of care for their patients. However, many dialysis facilities may not have formal, written emergency preparedness communication plans. Therefore, we expect that all dialysis facilities would need to review, update, and in some cases, develop new sections for their plans to ensure that those plans included all of the previously-described required elements in their emergency preparedness communication plan.
   The burden associated with complying with this requirement would be the resources required to review and revise the dialysis facility's emergency preparedness communication plan to ensure that it complied with these requirements. Based upon our experience with dialysis facilities, we anticipate that satisfying these requirements would primarily require the involvement of the dialysis facility's administrator, medical director, and nurse manager. For each dialysis facility, we estimate that complying with this requirement would require 4 burden hours at a cost of
   Each dialysis facility would also have to review and update its emergency preparedness communication plan at least annually. For the purpose of determining the burden for this requirement, we would expect that dialysis facilities would review their emergency preparedness communication plans annually. We believe that all dialysis facilities have an administrator that would be primarily responsible for the day-to-day operation of the dialysis facility. This would include ensuring that all of the dialysis facility's policies, procedures, and plans were up-to-date and complied with the relevant federal, state, and local laws, regulations, and ordinances. We expect that the administrator would be responsible for periodically reviewing the dialysis facility's plans, policies, and procedures as part of his or her work responsibilities. Therefore, we expect that complying with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 494.62(d) would require dialysis facilities to develop and maintain emergency preparedness training, testing and patient orientation programs that would have to be evaluated and updated at least annually. The dialysis facility would have to comply with the requirements located at SEC 494.62(d)(1) through (3).
   Proposed SEC 494.62(d)(1) would require that dialysis facilities provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Thereafter, the dialysis facility would have to provide emergency preparedness training at least annually.
   Current CfCs already require dialysis facilities to "provide training and orientation in emergency preparedness to the staff" (42 CFR 494.60(d)(1)) and "provide appropriate orientation and training to patients . . . " in emergency preparedness (42 CFR 494.60(d)(2)). In addition, the dialysis facility's patient instruction would have to include the same matters that are specified in the current CfCs (42 CFR 494.60(d)(2)). Thus, dialysis facilities should already have an emergency preparedness training program for new employees, as well as ongoing training for all their staff and patients. However, all dialysis facilities would need to review their current training programs and compare their contents to their updated emergency preparedness programs, that is, the risk assessment, emergency preparedness plan, policies and procedures, and communications plans that they developed pursuant to proposed SEC 494.62(a) through (c). Dialysis facilities would then need to review, revise, and in some cases, develop new material for their training programs so that they complied with these requirements.
   The burden associated with complying with this requirement would be the time and effort necessary to develop the required training program. We expect that complying with this requirement would require the involvement of the administrator, medical director, and the nurse manager. In fact, the medical director's responsibilities include, among other things, staff education and training (42 CFR 494.150(b)). We estimate that it would require 7 burden hours for each dialysis facility to develop an emergency training program at a cost of
   The dialysis facility must also review and update its emergency preparedness training program at least annually. We believe that dialysis facilities already review their emergency preparedness training programs periodically. Therefore, compliance with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 494.62(d)(2) requires dialysis facilities to participate in a mock disaster drill and conduct a paper-based, tabletop exercise at least annually. If a community mock disaster drill was not available, the dialysis facility would have to conduct an individual, facility-based mock disaster drill at least annually. If the dialysis facility experienced an actual natural or man-made emergency that required activation of their emergency plan, the dialysis facility would be exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event. Dialysis facilities would also be required to analyze their responses to and maintain document of all drills, tabletop exercises, and emergency events. To comply with this requirement, a dialysis facility would need to develop scenarios for each drill and exercise. A dialysis facility would also have to develop the documentation necessary for recording and analyzing the drills, tabletop exercises, and emergency events.
   The current CfCs already require dialysis facilities to evaluate their emergency preparedness plan at least annually (42 CFR 494.60(d)(4)(ii)). Thus, we expect that all dialysis facilities are already conducting some type of tests to evaluate their emergency plans. Although the current CfCs do not specify the type of drill or test, dialysis facilities should have already been developing scenarios for testing their plans. Thus, complying with this requirement would constitute a usual and customary business practice and would not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2).
   Proposed SEC 494.62(d)(3) would require dialysis facilities to provide appropriate orientation and training to patients, including the areas specified in proposed SEC 494.62(d)(1). Proposed SEC 494.62(d)(1) specifically would require that staff demonstrate knowledge of emergency procedures including the emergency information they must give to their patients. Thus, the burden associated with this section would already be included in the burden estimate for SEC 494.62(d)(1).
Table 17--Burden Hours and Cost Estimates for All 5,923 Dialysis Facilities to Comply With the ICRs Contained in S. 494.62 Condition: Emergency Preparedness Regulation OMB control Respondents Responses Burden per Total section(s) no. response annual (hours) burden (hours) S. 494.62(a)(1) 0938--New 5,923 5,923 12 71,076 S. 494.62(a)(2)- 0938--New 5,923 5,923 10 59,230 (4) S. 494.62(b) 0938--New 5,923 5,923 10 59,230 S. 494.62(c) 0938--New 5,923 5,923 4 23,692 S. 494.62(d) 0938--New 5,923 5,923 7 41,461 Totals 5,923 29,615 254,689 * * The hourly labor cost is blended between the wages for multiple staffing levels.
Table 17--Burden Hours and Cost Estimates for All 5,923 Dialysis Facilities to Comply With the ICRs Contained in S. 494.62 Condition: Emergency Preparedness Regulation Hourly Total Total Total cost section(s) labor labor capital/ ( ] cost of cost of mintenance reporting reporting costs ( ] ( ] ( ] S. 494.62(a)(1) * * 4,963,474 0 4,834,422 S. 494.62(a)(2)- * * 4,596,248 0 4,476,744 (4) S. 494.62(b) * * 4,596,248 0 4,476,744 S. 494.62(c) * * 2,114,511 0 2,059,533 S. 494.62(d) * * 3,310,957 0 3,224,871 Totals 19,581,438 * * The hourly labor cost is blended between the wages for multiple staffing levels.
T. Summary of Information Collection Burden
   Based on the previous analysis, the first year's burden for complying with all of the requirements in this proposed rule would be 3,018,124 burden hours at a cost of
   To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced earlier, access CMS' Web site at http://www.cms.gov/PaperworkReductionActof1995/PRAL/list.asp#TopOfPage or email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected], or call the Reports Clearance Office at 410-786-1326.
   If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:
IV. Regulatory Impact Analysis
A. Statement of Need
   Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).
   In response to past terrorist attacks, natural disasters, and the subsequent national need to refine the nation's strategy to handle emergency situations, there continues to be a coordinated effort across federal agencies to establish a foundation for development and expansion of emergency preparedness systems. There are two Presidential Directives, HSPD-5 and HSPD-21, instructing agencies to coordinate their emergency preparedness activities with each other. Although these directives do not specifically require Medicare providers and suppliers to adopt measures, they have set the stage for what we expect from our providers and suppliers in regard to their roles in a more unified emergency preparedness system.
   Homeland Security Presidential Directive (HSPD-5): Management of Domestic Incidents authorizes the
   Homeland Security Presidential Directive (HSPD-21) addresses public health and medical preparedness. The directive establishes a National Strategy for
B. Overall Impact
   We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (
   Executive Orders 12866 and 13563 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (
   Published reports after Hurricane Katrina reported that the Louisiana Attorney General investigated approximately 215 deaths that occurred in hospitals and nursing homes following Katrina. Since nearly all hospitals and nursing homes are certified to participate in the Medicare program, we estimate that at least a small percentage of these lives could be saved as a result of emergency preparedness measures in a single disaster of equal magnitude. Katrina is an extreme example of a natural disaster, so we also considered other more common disasters. The United States experiences numerous natural disasters annually, including, in particular, tornadoes and flooding. Based on data from the
   We believe that this proposed rule would be an economically significant regulatory action under section 3(f)(1) of Executive Order 12866, since it may lead to impacts of greater than
   This proposed rule would establish a regulatory framework with which Medicare- and Medicaid-participating providers and suppliers would have to comply to ensure that the varied providers and suppliers of healthcare are adequately prepared to respond to natural and man-made disasters.
   Several factors influenced our estimates of the economic impact to the providers and suppliers covered by this proposed rule. These factors are discussed under section III. of this proposed rule (Collection of Information Requirements). In addition, we have used the same data source for the RIA that we used to develop the PRA burden estimates, that is, the
   The Regulatory Flexibility Act (RFA) (5 U.S.C.
   The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than
   In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Since the cost associated with this proposed rule is less than
   Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule that includes a federal mandate that could result in expenditure in any 1 year by state, local or tribal governments, in the aggregate, or by the private sector, of
   Executive Order 13132 establishes certain requirements that an agency must meet when it develops a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This proposed rule will not impose substantial direct requirement costs on state or local governments, preempt state law, or otherwise implicate federalism.
   This proposed regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C.
C. Anticipated Effects on Providers and Suppliers: General Provisions
   This proposed rule would require each of the Medicare- and Medicaid-participating providers and suppliers discussed in previous sections to perform a risk analysis; establish an emergency preparedness plan, emergency preparedness policies and procedures, and an emergency preparedness communication plan; train staff in emergency preparedness, and test the emergency plan. The economic impact would differ between hospitals and the various other providers and suppliers, depending upon a variety of factors, including existing regulatory requirements and accreditation standards.
   We discuss the economic impact for each provider and supplier type included in this proposed rule in the order in which they appear in the CFR. Most of the economic impact of this proposed rule would be due to the cost for providers and suppliers to comply with the information collection requirements. Thus, we discuss most of the economic impact under the Collection of Information Requirements section of this proposed rule. We provide a chart at the end of the RIA section of the total regulatory impact for each provider/supplier.
   As stated in the ICR section, we obtained all salary information from the
1. Subsistence Requirement
   This proposed rule would require all inpatient providers to meet the subsistence needs of staff and patients, whether they evacuate or shelter in place, including, but not limited to, food, water, and supplies, alternate sources of energy to maintain temperatures to protect patient health and safety and for the safe and sanitary storage of such provisions.
   Based on our experience, we expect inpatient providers to currently have food, water, and supplies, alternate sources of energy to provide electrical power, and the maintenance of temperatures for the safe and sanitary storage of such provisions as a routine measure to ensure against weather related and non-disaster power failures. Thus, we believe that this requirement is a usual and customary business practice for inpatient providers and we have not assigned any impact for this requirement.
   Further, we expect that most providers have agreements with their vendors to receive supplies within 24 to 48 hours in the event of an emergency, as well as arrangements with back-up vendors in the event that the disaster affects the primary vendor. We considered proposing a requirement that providers must keep a larger quantity of food and water on hand in the event of a disaster. However, we believe that a provider should have the flexibility to determine what is adequate based on the location and individual characteristics of the facility. While some providers may have the storage capacity to stockpile supplies that would last for a longer duration, other may not. Thus, we believe that to require such stockpiling would create an unnecessary economic impact on some health care providers.
   We expect that when inpatient providers determine their supply needs, they would consider the possibility that volunteers, visitors, and individuals from the community may arrive at the facility to offer assistance or seek shelter.
   Based on the previous factors, we have not estimated a cost for a stockpile of food and water.
2. Generator Location and Testing
   This proposed rule would require hospitals, CAHs, and LTC facilities to test and maintain their emergency and standby power systems in such a way to ensure proper operation in the event they are needed. The 2000 edition of the Life Safety Code (LSC) of the
   In addition to the emergency power system inspection and testing requirements found in NFPA 99 and NFPA 110 and NFPA 101, we propose that hospitals test their emergency and stand-by-power systems for a minimum of 4 continuous hours every 12 months at 100 percent of the power load the hospital anticipates it will require during an emergency. As a result of lessons learned from hurricane Sandy, we believe that this annual 4 hour test will more closely reflect the actual conditions that would be experienced during a disaster of the magnitude of hurricane Sandy. Also, later editions of NFPA 110 require 4 hours of continuous generator testing every 36 months to provide reasonable assurance emergency power systems are capable of running under load during an emergency. In order to provide further assurance that generators will be capable of operating during an emergency, 4 hours of continuous generator testing will be required every 12 months. We have also proposed the same emergency and standby power requirements for CAHs and LTC facilities.
   We have estimated the cost in this section for these additional testing requirements. Based on information from the
    * Labor: 6 hours (1-hour preparation, 4 hour run-time, 1 hour restoration) x
    * Fuel: Diesel cost of
D. Condition of Participation: Emergency Preparedness for Religious Nonmedical Health Care Institutions (RNHCIs)
1. Training and Testing ( SEC 403.748(d))
   We discuss the majority of the economic impact for this requirement in the ICR section, which is estimated at
2. Testing ( SEC 403.748(d)(2))
   Proposed SEC 403.748(d)(2) would require RHNCIs to conduct a paper-based, tabletop exercise at least annually. RHNCIs must analyze their response and maintain documentation of all tabletop exercises, and emergency events, and revise their emergency plan as needed.
   We expect that the cost associated with this requirement would be limited to the staff time needed to participate in the tabletop exercises. We estimate that approximately 4 hours of staff time would be required of the administrator and director of nursing, and 2 hours of staff time for the head of maintenance to coordinate facility evacuations and protocols for transporting residents to alternate sites. We believe that other staff members would be required to spend a minimal amount of time during these exercises and such staff time would be considered a part of regular on-going training for RHNCI staff. We estimate that it would require 10 hours of staff time for each of the 16 RNHCIs to conduct exercises at a cost of
E. Condition for Coverage: Emergency Preparedness for Ambulatory Surgical Centers (ASCs)--Testing ( SEC 416.54(d)(2))
   Proposed SEC 416.54(d)(2) would require ASCs to participate in a community mock disaster drill at least annually. If a community mock disaster drill were not available, the ASC would be required to conduct a facility-based mock disaster drill at least annually and maintain documentation of all mock disaster drills. ASCs also would be required to conduct a paper-based, tabletop exercise at least annually. ASCs also would be required to maintain documentation of the exercise.
   State, Tribal, Territorial, and local public health and medical systems comprise a critical infrastructure that is integral to providing the early recognition and response necessary for minimizing the effects of catastrophic public health and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal Government. There are currently three programs at HHS addressing education and training in the area of public health emergency preparedness and response: the
   As discussed earlier in this preamble, ASCs can use these and other resources, such as tools offered by the
F. Condition of Participation: Emergency Preparedness for Hospices--Testing ( SEC 418.113(d)(2))
   Proposed SEC 418.113(d)(2)(i) through (iii) would require hospices to participate in mock drills and tabletop exercises at least annually. In addition, hospices are to conduct a paper-based, tabletop exercise at least annually. We believe that the administrator would be responsible for participating in community-wide disaster drills and would be the primary person to organize a facility-wide drill and tabletop exercise with the assistance of one member of the IDG. We believe that the registered nurse would most likely represent the IDG on the drills and exercises. While we expect that all staff would be involved in the drills and exercises, we would consider their involvement as part of their regular staff training. However, for the purpose of this analysis we assume that the administrator would spend approximately 3 hours annually to participate in a community or facility-wide drill and 1 hour to participate in a tabletop exercise above their regular and ongoing training. We also assume that the registered nurse would spend 3 hours to participate in an annual drill and 1 hour to participate in a tabletop exercise. Thus, we estimate that each hospice would spend
G. Emergency Preparedness for Psychiatric Residential Treatment Facilities (PRTFs)--Training and Testing ( SEC 441.184(d))
   Proposed SEC 441.184(d)(2)(i) through (iii) would require PRTFs to participate in a community or facility-based mock disaster drill and a tabletop exercise annually. We propose that if a community drill is not available, the PRTF would be required to conduct a facility-based mock disaster drill. We estimate that the cost associated with this requirement is the time that it would take key personnel to participate in the mock drill and tabletop exercise. We further estimate that the drill and exercise would involve the administrator and registered nurse to spend about 4 hours each on an annual basis to participate (3 hours to participate in a community or facility-wide drill and 1 hour to participate in a table-top drill). Thus, we anticipate that complying with this requirement would require 4 hours for the administrator and 4 hours for the registered nurse at a combined estimated cost of
H. Emergency Preparedness for Program for the All-Inclusive Care for the Elderly (PACE) Organizations--Training and Testing ( SEC 460.84(d))
   Proposed SEC 460.84(d)(2)(i) through (iii) would require PACE organizations to conduct a mock community or facility-wide drill and a paper-based, tabletop exercise annually. Since PACE organizations are currently required to conduct a facility-wide drill annually, we are only estimating economic impact for the annual tabletop drill. We expect that both the home-care coordinator and the quality-improvement nurse would each spend 1 hour to conduct the tabletop exercise. Thus, we estimate the economic impact hours to be 2 hours for each PACE organization (total impact hours = 182) at an estimated cost of
I. Condition of Participation: Emergency Preparedness for Hospitals
1.
   We propose that hospitals must maintain medical supplies.
   
   The SNS, and other federal agencies, http://emergency.cdc.gov/stockpile/index.asp, have plans to address the medical needs of an affected population in the event of a disaster. The SNS has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local supplies to run out. After federal and local authorities agree that the SNS is needed, medicines can be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. States have the discretion to decide where to distribute the supplies in the event of multiple events.
   However, prudent emergency planning requires that some supplies be maintained in-hospital for immediate needs. The Federal Metropolitan Medical Response System (MMRS) guidelines call for MMRS communities to be self-sufficient for 48 hours. We encourage hospitals to work with stakeholders (state boards of pharmacy, pharmacy organizations, and public health organizations) for guidance and assistance in identifying medications they may need. Based on our experience with hospitals, we believe that they would have on hand a 2 to 3 day supply of medical supplies at the onset of a disaster. After such time, supplies could be replenished from the SNS and other federal agencies. Therefore, based on the previous information, we are not assessing additional burden for medical supplies.
2. Training Program ( SEC 482.15(d)(1))
   Proposed SEC 482.15(d)(1) would require hospitals to develop and maintain an emergency preparedness training program and review and update it at least annually. Based on our experience with health care facilities, we expect that all health care facilities provide some type of training to all personnel, including those providing services under contract or arrangement and volunteers. Since such training is required for the TJC-accredited hospitals, the proposed requirements for developing an emergency preparedness-training program and the materials they plan to use in providing initial and on-going annual training would constitute a usual and customary business practice for TJC-accredited hospitals.
   However, under this proposed rule, non TJC-accredited hospitals would need to review their existing training program and appropriately revise, update, or develop new sections and new material for their training program. The economic impact associated with this requirement is the staff time required for non-TJC accredited hospitals to review, update or develop a training program. We discuss the economic impact for this requirement in the ICR section.
3. Testing ( SEC 482.15(d)(2)(i) through (iii))
   Proposed SEC 482.15(d)(2)(i) through (iii) would require hospitals to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually.
   State, tribal, territorial, and local public health and medical systems comprise a critical infrastructure that is integral in providing early recognition and response necessary for minimizing the effects of catastrophic public health and medical emergencies. Educating and training these clinical, laboratory, and public health professionals has been, and continues to be, a top priority for the federal government. There are currently four programs at HHS addressing education and training in the area of public health emergency preparedness and response. The programs are the
   Thus, we have estimated the economic impact for the 1,518 non-TJC accredited hospitals. We anticipate that complying with this requirement would require 48 hours for an estimate of
   Based on TJC's standards, the TJC-accredited hospitals are currently required to test their emergency operations plan twice a year. Therefore, for TJC-accredited hospitals to conduct disaster drills and tabletop exercises would constitute a usual and customary business practice and we will not include this activity in the economic impact analysis.
4. Generator Testing ( SEC 482.15(e))
   Section SEC 482.15(e) would require hospitals to test each emergency generator and any associated essential electric systems for a minimum of 4 continuous hours at least once every 12 months under a full electrical load anticipated to be required during an emergency. The intent of this requirement is to provide an increased assurance that a generator and associated essential electrical systems will function during an emergency and are capable of running under a full electrical load required during an emergency for an extended period of time. AO's, including TJC, DNV, and HFAP; currently require accredited hospitals to test their generators/emergency power supply system once for 4 continuous hours every 36 months. Therefore, the cost of the existing testing requirement was deducted from the cost calculation for accredited hospitals. However, under this proposed rule, non-accredited hospitals would be required to run their emergency generators an additional 4 hours, with an additional 1 hour for preparation, and an additional 1 hour for restoration.
   For non-accredited hospitals, we estimate labor cost to be
   For accredited hospitals, we estimate labor cost to be
   Therefore, the total economic impact of this rule on hospitals would be
J. Condition of Participation: Emergency Preparedness for Transplant Centers
   There is no additional economic impact to discuss in this section for transplant centers. All transplant centers are located within a hospital and, thus, would not have to stockpile supplies in an emergency or conduct a mock disaster drill or a tabletop exercise.
K. Emergency Preparedness Long Term Care (LTC) Facilities
1. Subsistence ( SEC 483.73(b)(1))
   Section SEC 483.73(b)(1) would require LTC facilities to provide subsistence needs for staff and residents, whether they evacuate or shelter in place, including, but not limited to, food, water, and medical supplies alternate sources of energy for the provision of electrical power, and maintenance of temperatures for the safe and sanitary storage of such provisions.
   As stated earlier in this section, each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible. The federal responsibility ceases at the delivery of the push-packs to state-designated airports. It is then the responsibility of the state to break down and transport the components of the push-pack to the affected community. It is also at the state's discretion where to deliver push-pack material in the event of multiple events.
   We expect that a 1- to 2-day supply would be sufficient because various national agencies with stockpiles of medicine, medical supplies, food and water can be mobilized within 12 hours and supplies can be replenished or provided within 48 hours. Thus, for the sake of this impact analysis, we assume that, at a minimum, a LTC facility would have a 2-day supply of food and potable water for the patients and staff at the onset of a disaster and will not assign a cost to this requirement.
   We encourage LTC facilities to work with stakeholders (State Boards of Pharmacy, pharmacy organizations, and public health organizations) for guidance and assistance in identifying medications that may be needed and plan to provide access to all healthcare partners during an event.
2. Training and Testing ( SEC 483.73(d))
   Section SEC 483.73(d)(2)(i) through (iii) would require LTC facilities to participate in or conduct a mock disaster drill and a tabletop exercise at least annually. The current requirements for LTC facilities already mandate that these facilities periodically review their procedures with existing staff, and carry out unannounced staff drills (42 CFR 483.75(m)(2)). Thus, we expect that complying with the requirement for an annual community or facility-wide mock disaster drill and tabletop would constitute a minimal economic impact, if any, after the first year.
3. Generator Testing ( SEC 483.73(e))
   Proposed SEC 483.73(e) would require LTC facilities to test each emergency generator for a minimum of 4 continuous hours at least once every 12 months. We estimate labor cost to be
L. Condition of Participation: Emergency Preparedness for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)
1. Testing ( SEC 483.475(d)(2))
   Proposed SEC 483.475(d)(2)(i) through (iii) would require ICFs/IID to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually. The current ICF/IID CoPs require them to conduct evacuation drills at least quarterly for each shift and under varied conditions to evaluate the effectiveness of emergency and disaster plans and procedures" (42 CFR 483.470(i) and (i)(iii)). In addition, ICFs/IID must evacuate clients during at least one drill each year on each shift, file a report and evaluation on each evacuation drill and investigate all problems with evacuation drills, including accidents, and take corrective action (42 CFR 483.470(i)(2)). Thus, all 6,450 ICFs/IID already conduct quarterly drills. We estimate that any additional economic impact for an ICF/IID to conduct both a drill and an exercise would be minimal, if any. Therefore, the cost of this proposed rule for all ICFs/IID would be limited to the ICR burden of
M. SEC 484.22 Condition of Participation: Emergency Preparedness for Home Health Agencies (HHAs)--Training and Testing ( SEC 484.22(d))
   We discuss the majority of the economic impact for this requirement in the COI section which is estimated to be
   Proposed SEC 484.22(d)(2)(i) through (iii) would require HHAs to participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, we would require the HHA to conduct an individual, facility-based mock disaster drill at least annually and maintain documentation of all mock disaster drills. We would also require the HHA to maintain documentation of the exercises.
   There are currently two programs at HHS addressing education and training in the area of public health emergency preparedness and response: the
   As discussed earlier in this preamble, HHAs can use these and other resources, such as tools offered by the
N. Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities (CORFs)--Testing ( SEC 485.68(d)(2)(i) through (iii))
   Proposed SEC 485.68(d)(2)(i) through (iii) would require CORFs to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually and document the drills and exercises. To comply with this requirement, a CORF would need to develop a specific scenario for each drill and exercise.
   The current CoPs require CORFs to provide ongoing drills for all personnel associated with the facility in all aspects of disaster preparedness (42 CFR 485.64(b)(1)). Thus, for the purpose of this analysis, we believe that CORFs would incur minimal or no additional cost to comply with this requirement. Thus, we estimate the cost for all 272 CORFs to comply with this requirement would be limited to the ICR burden of
O. Condition of Participation: Emergency Preparedness for Critical Access Hospitals (CAHs)
1. Testing ( SEC 485.625(d)(2))
   Proposed SEC 485.625(d)(2)(i) through (iii) would require CAHs to conduct annual community or facility-based drills and tabletop exercises. Accredited CAHs are currently required to conduct such drills and exercises. Although we believe that non-accredited CAHs are currently participating in such drills and exercises, we are not convinced that it is at the level that would be required under this proposed rule. Thus, we will analyze the economic impact for these requirements for the 920 non-accredited CAHs. As discussed earlier in this preamble, CAHs would have access to various training resources and emergency preparedness initiatives to use in complying with this requirement. Thus, we believe that the cost associated with this requirement would be limited to staff time to participate in the community-wide and facility-wide trainings, and tabletop exercises. We believe that appreciable staff time would be required of the administrator, facilities director, director of nursing and nursing education coordinator. We believe that other staff members would be required to spend a minimal amount of time during these exercises that would be considered as part of regular on-going training for hospital staff. We estimate that the administrator, facilities director, and the director of nursing would spend approximately a total of 20 hours on an annual basis to participate in the disaster drills. Thus, we anticipate that complying with this requirement would require 20 hours for an estimated cost of
2. Generator Testing ( SEC 485.625(e))
   Proposed SEC 485.625(e) would require CAHs to test each emergency generator for a minimum of 4 continuous hours at least once every 12 months. AO's, including TJC, DNV, and HFAP; currently require accredited CAHs to test their generators/emergency power supply system once for 4 continuous hours every 36 months. Therefore, the cost of the existing testing requirement was deducted from the cost calculation for accredited CAHs. However, under this proposed rule, non-accredited CAHs would be required to run their emergency generators an additional 4 hours, with an additional 1 hour for preparation, and an additional 1 hour for restoration.
   For non-accredited CAHs, we estimate labor cost to be
   For accredited CAHs, we estimate labor cost to be
   Therefore, the total economic impact of this rule on CAHs would be
P. Condition of Participation: Emergency Preparedness for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology ("Organizations")--Testing ( SEC 485.727(d)(2)(i) through (iii))
   Current CoPs require these organizations to ensure that employees are trained in all aspects of preparedness for any disaster. They are also required to have ongoing drills and exercises to test their disaster plan. Rehabilitation Agencies would need to review their current activities and make minor adjustment to ensure that they comply with the new requirement. Therefore, we expect that the economic impact to comply with this requirement would be minimal, if any. Therefore, the total economic impact of this rule on these organizations would be limited to the estimated ICR burden of
Q. Condition of Participation: Emergency Preparedness for Community Mental Health Centers (CMHCs)--Training and Testing ( SEC 485.920(d))
   Proposed SEC 485.920(d)(2) would require CMHCs to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually. We estimate that to comply with the requirement to participate in a community mock disaster drill or to conduct an individual facility-based mock drill and a tabletop exercise annually would primarily require the involvement of the administrator and a registered nurse. We estimate that the administrator would spend approximately 4 hours to participate in a community or facility-wide drill and 1 hour to participate in a tabletop drill. We also estimate that a nurse would spend about 3 hours on an annual basis to participate in the disaster drills (2 hours to participate in a community or facility-wide drill and 1 hour to participate in a tabletop drill). Thus, we anticipate that complying with this requirement would require 8 hours for each CMHC at an estimated cost of
R. Conditions of Participation: Emergency Preparedness for Organ Procurement Organizations (OPOs)--Training and Testing ( SEC 486.360(d)(2)(i) through (iii))
   The OPO CfCs do not currently contain a requirement for OPOs to conduct mock disaster drills or paper-based, tabletop exercises. We estimate that these tasks would require the quality assessment and performance improvement (QAPI) director and the education coordinator to each spend 1 hour to participate in the tabletop exercise. Thus, the total annual economic impact hours for each OPO would be 2 hours. The total cost would be
S. Emergency Preparedness: Conditions for Certification for
1. Training and Testing ( SEC 491.12(d))
   We expect RHCs and FQHCs to participate in their local and state emergency plans and training drills to identify local and regional disaster centers that could provide shelter during an emergency.
   We propose that an RHC/FQHC must review and update its emergency preparedness policies and procedures at least annually. For purposes of determining the economic impact for this requirement, we expect that RHCs/FQHCs would review their emergency preparedness policies and procedures annually. Based on our experience with Medicare providers and suppliers, health care facilities generally have a compliance officer or other staff member who reviews the facility's program periodically to ensure that it complies with all relevant federal, state, and local laws, regulations, and ordinances. We believe that complying with the requirement for an annual review of the emergency preparedness policies and procedures would constitute a minimal economic impact, if any.
2. Testing ( SEC 491.12(d)(2)(i) through (iii))
   Proposed SEC 491.12(d)(2)(i) through (iii) would require RHCs/FQHCs to participate in a community or facility-wide mock disaster drill and a tabletop exercise at least annually. We have stated previously that FQHCs are currently required to conduct annual drills. We believe that for FQHCs to comply with these requirements would constitute a minimal economic impact, if any. Thus, we are estimating the economic impact for RHCs to comply with these requirements to conduct mock drills and tabletop exercises. We estimate that a RHCs administrator would spend 4 hours annually to participate in the disaster drills. Also, we estimate that a nurse coordinator (registered nurse) would each spend 4 hours on an annual basis to participate in the disaster drills (3 hours to participate in a community or facility-wide drill and 1 hour to participate in a table-top drill). Thus, we anticipate that complying with this requirement would require 8 hours for each RHC for an estimated cost of
T. Condition of Participation: Emergency Preparedness for End-Stage Renal Disease Facilities (Dialysis Facilities)--Testing ( SEC 494.62(d)(2)(i) through (iv))
   Proposed SEC 494.62(d)(2) would require dialysis facilities to participate in or conduct a mock disaster drill and a paper-based, tabletop exercise at least annually. The current CfCs already require dialysis facilities to evaluate their emergency preparedness plan at least annually ( SEC 494.60(d)(4)(ii)). Thus, we expect that all dialysis facilities are already conducting some type of tests to evaluate their emergency plans. Although the current CfCs do not specify the type of drill or test, we believe that dialysis facilities are currently participating in community or facility-wide drills. Therefore, for the purpose of this impact analysis, we estimate that dialysis facilities would need to add the tabletop exercise to their emergency preparedness activities. We estimate that it would require 1 hour each for the administrator (hourly wage of
U. Summary of the Total Costs
   The following is a summary of the total providers and the annual cost estimates for all providers to comply with the requirements in this rule.
Table 18--Total Annual Cost To Participate in Disaster Drills and Test Generators Across the Providers Facility Number of Total cost participants (in ] RNHCI 16 5,280 ASC 5,354 2,677,000 Hospices 3,773 1,463,924 PRTFs 387 139,320 PACE 91 8,190 Hospital 4,928 9,769,771 LTC 15,157 19,128,134 HHAs 12,349 2,897,895 CAHs 1,322 2,541,639 CMHCs 207 85,905 OPOs 58 6,206 RHCs & FQHCs 9,547 1,813,876 ESRD 5,923 817,374 Total 83,802 41,354,514
   Based upon the ICR and RIA analyses, it would require all 83,802 providers and suppliers covered by this emergency preparedness proposed rule to comply with all of its requirements an estimated total first-year cost of
Table 19--Total Estimated Cost from ICR and RIA To Comply with the Requirements Contained in this Proposed Rule Facility Number of Total cost Total cost participants in year 1 in year 2 (in ] and thereafter (in ] RNHCI 16 24,208 5,280 ASC 5,354 15,241,036 2,677,000 Hospices 3,773 10,076,910 1,463,924 PRTFs 387 1,071,990 139,320 PACE 91 342,888 8,190 Hospital 4,928 39,265,594 9,769,771 Transplant Center 770 1,399,104 0 LTC 15,157 19,128,134 19,128,134 ICF/IID 6,442 15,538,104 0 HHAs 12,349 51,623,524 2,897,895 CORFs 272 828,784 0 CAHs 1,322 8,339,742 2,541,639 Organizations 2,256 6,939,456 0 CMHCs 207 674,820 85,905 OPOs 58 613,176 6,206 RHCs & FQHCs 9,547 33,762,675 1,813,876 ESRD Facilities 5,923 20,398,812 817,374 Total 68,852 225,268,957$41,354,514
   The previous summaries include only the upfront and routine costs associated with emergency risk assessment, development and updating of policies and procedures, development and maintenance of communication plans, disaster training and testing, and generator testing (as specified). If these preparations are effective, they will lead to increased amounts of life-saving and morbidity-reducing activities during emergency events. These activities impose cost on society; for example, if complying with this proposed rule's requirements allows an ESRD facility to remain open during and immediately after a natural disaster, there would be associated increases in provision of dialysis services, thus entailing labor, material and other costs. As discussed in the next section ("Benefits of the Proposed Rule"), it is difficult to predict how disaster responses would be different in the presence of this proposed rule than in its absence, so we have been unable to quantify the portion of costs that will be incurred during emergencies. We request comments and data regarding this issue.
  &#160;Moreover, we have not estimated any costs for generator backup, on the assumption that such backup is already required for virtually all inpatient and many outpatient facilities, either for TJC or other accreditation, or under state or local codes. We request information on this assumption and in particular on any situations or provider types for which this could turn out to be unnecessarily costly.
V. Benefits of the Proposed Rule
   
   This proposed rule is intended to help ensure the safety of individuals by requiring providers and suppliers to adequately plan for and respond to both natural and man-made disasters. The devastation of the
   In the event of such disasters, vulnerable populations are at greatest risk for negative consequences from healthcare disruptions. According to one study, children and adolescents with chronic conditions are at increased risk of adverse outcomes following a natural disaster (Rath, Barbara, et. al. "Adverse Health Outcomes after Hurricane Katrina among Children and Adolescents with Chronic Conditions"
   Hospital closures during Sandy resulted in up to a 25 percent increase in emergency department visits at numerous centers in New York and a 70-percent increase in ambulance traffic. A proportion of this increase was due to populations being unable to receive routine care. Not only do vulnerable populations experience disruptions in care, they may also incur increased costs for care, especially when those who require ongoing medical treatment during disasters are required to visit emergency departments for treatment and/or hospitalization. Emergency department visits incur a copay for most beneficiaries. Similar costs are also incurred by patients for hospitalizations. The literature shows that natural catastrophes disproportionately affect ill and socioeconomically disadvantaged populations that are most at risk (Abdel-Kader K, Unrah ML. Disaster and end-stage renal disease: targeting vulnerable patients for improved outcomes. Kidney Int. 2009;75:1131-1133; Zoraster R, Vanholder R, Sever MS. Disaster management of chronic dialysis patients. Am J Disaster Med. 2007;2(2):96-106; and Redlener I, Reilly M. Lessons from Sandy--Preparing Health Systems for Future Disasters. N ENGL J MED. 367;24:2269-2271).
   We know that advance planning improves disaster response. In 2007,
   Therefore, we believe that it is essential to require providers and suppliers to conduct a risk assessment, to develop an emergency preparedness plan based on the assessment, and to comply with the other requirements we propose to minimize the disruption of services for the community and ensure continuity of care in the event of a disaster. As noted previously, we have varied our requirements by provider type and understand that the degree of vulnerability of patients in a disaster will vary according to provider type. For example, patients with scheduled outpatient appointments such as someone coming in for speech therapy or routine clinic services is likely more self-reliant in a disaster than someone in a hospital ICU or someone who is homebound and receiving services from an HHA.
   Overall, we believe that rule would reduce the risk of mortality and morbidity associated with disasters. We believe it very likely that some kind of disaster will occur in coming decades in which substantial numbers of lives will be saved by current emergency preparedness as supplemented by the additional measures we propose here. In New Orleans it seems very likely that dozens of lives could have been saved by competent emergency planning and execution. While New Orleans has a unique location below sea level, everywhere in the United States is vulnerable to weather emergencies and other potential natural or manmade disasters. We have not prepared an estimate in either quantitative or dollar terms of the potential life-saving benefits of this proposed rule. There are several reasons for this, most notably the difficulty of estimating how many additional lives would be saved from emergency preparedness contingency planning and training. While we are unable to estimate the number of lives that could be saved by emergency planning and execution, Table 20 provides the number of Medicare FFS beneficiaries receiving services from some of the provider types affected by this proposed rule during the month of
Table 20--Number of Medicare FFS Patients Who Received Services inJuly 2013 Provider type Number of FFS patients Hospitals 6,910,496Community Mental Health Center 84,959 Comprehensive Outpatient Rehabilitation Facility 4,045Critical Access Hospital 655,757 HHA 1,033,909 Hospice 312,799 Hospital based chronic renal disease facility 10,239 Non hospital renal disease treatment center 274,638Religious Nonmedical Health Care Institution 44 Renal disease treatment center 8,261 Rural health clinic (free standing) 261,067 Rural health clinic (provider based) 291,180 Skilled Nursing Facility 538,189 Note: InJuly 2013 there were 8,949,161 distinct patients.
   Benefits from effective disaster planning would not only accrue to individuals requiring health care services. Health care facilities themselves may benefit from improved ability to maintain or resume delivering services. After Hurricane Katrina, 94 dialysis facilities closed for at least one week. Almost 2 years later, in June, 2007, 17 dialysis facilities remained closed (Kopp et al, 2007). Following hurricane Sandy,
   Finally, taxpayers and insurance companies may benefit from effective emergency preparedness. After Hurricane Ike, it was estimated that the cost to Medicare for ESRD patients presenting to the ED for dialysis instead of their usual facility was, on average,
   With the annualized costs of the rule's emergency preparedness requirements estimated to be approximately
W. Alternatives Considered
1. No Regulatory Action
   As previously discussed, the status quo is not a desirable alternative because the current regulatory requirements for Medicare and Medicaid providers and suppliers addressing emergency and disaster preparedness are insufficient to protect beneficiaries and other patients during a disaster.
2. Defer to Federal, State, and Local Laws
   Another alternative we considered would be to propose a regulation that would require Medicare providers and suppliers to comply with local, state and federal laws regarding emergency/disaster planning. Various federal, state and local entities (FEMA, the National Response Plan (NRP), CDC, the Assistant Secretary for Preparedness and Response (ASPR), et al) have disaster management plans that provide an integrated process that involves all local and regional emergency responders. We also considered allowing health care providers to voluntarily implement a comprehensive emergency preparedness program utilizing grant funding from the
3.
   A potential regulatory alternative would involve requiring a power backup of some kind for outpatient facilities such as FQHCs and ESRD clinics. Some state codes, for example, require power backup, not generator backup, in such facilities. There are a number of ramifications of such options including, for example, preservation of refrigerated drugs and biologics, and the potential costs of replacing such items if power is not maintained for the duration of the emergency. For example, the current backup power would normally be expected to last for hours, not days.
4. Outpatient Tracking Systems
   Under another regulatory alternative, we would require facilities to have systems in place to keep track of outpatients; the benefits of this alternative would depend on whether such systems would have any chance of success in any emergency that led to substantial numbers of refugees before, during, or after the event. As an illustrative example, most southern states have hurricane evacuation systems in place. It is not uncommon for a million people or more to evacuate before a major hurricane arrives. In this or other situations, would it even be possible, and if so using what methods, for a hospital outpatient facility, an ESRD clinic, a
5. Request for Comments on Alternative Approaches to Implementation
   We request information and comments on the following issues:
    * Targeted approaches to emergency preparedness--covering one or a subset of provider classes to learn from implementation prior to extending the rule to all groups.
    * A phase in approach--implementing the requirements over a longer time horizon, or differential time horizons for the respective provider classes. We are proposing to implement all of the requirements 1 year after the final rule is published.
    * Variations of the primary requirements--for example, we have proposed requiring two annual training exercises--it would be instructive to receive public feedback on whether both should be required annually, semiannually, or if training should be an annual or semiannual requirement.
    * Integration with current requirements--we are soliciting comment on how the proposed requirements will be integrated with/satisfied by existing policies and procedures which regulated entities may have already adopted.
6. Conclusion
   We currently have regulations for Medicare and Medicaid providers and suppliers to protect the health and safety of Medicare beneficiaries and others. We revise these regulations on an as-needed basis to address changes in clinical practice, patient needs, and public health issues. The responses to the various past disasters demonstrated that our current regulations are in need of improvement in order to protect patients, residents, and clients during an emergency and that emergency preparedness for health care providers and suppliers is an urgent public health issue.
   Therefore, we are promulgating emergency preparedness requirements that will be consistent and enforceable for all Medicare and Medicaid providers and suppliers. This proposed rule addresses the three key elements needed to ensure that health care is available during emergencies: safeguarding human resources, ensuring business continuity, and protecting physical resources. Current regulations for Medicare and Medicaid providers and suppliers do not adequately address these key elements.
X. Accounting Statement
   As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circular/a004/a-4.pdf), we have prepared an accounting statement. As previously explained, achieving the full scope of potential savings will depend on the number of lives affected or saved as a result of this regulation.
Table 21--Accounting Statement Units Category Estimates Year Discount Period dollar rate covered Benefits Qualitative Help ensure the safety of individuals by requiring providers and suppliers to adequately plan for and respond to both natural and man-made disasters. Costs * Annualized Monetized ( 86 2013 7% 2014-2018 $million/year) 83 2013 3% 2014-2018 Qualitative Costs of performing life-saving and morbidity-reducing activities during emergency events. * The cost estimation is adjusted from 2011 to 2013 year dollars using the CPI-W published byBureau of Labor Statistics inJune 2013 .
   In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the
List of Subjects
   42 CFR Part 403
   Grant programs--health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 416
   Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 418
   Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 441
   Aged, Family planning, Grant programs--health, Infants and children, Medicaid, Penalties, Reporting and recordkeeping requirements.
   42 CFR Part 460
   Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 482
   Grant programs--health, Hospitals, Medicaid, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 483
   Grant programs--health, Health facilities, Health professions, Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting and recordkeeping requirements, Safety.
   42 CFR Part 484
   Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 485
   Grant programs--health, Health facilities, Medicaid, Medicare, Reporting and recordkeeping requirements.
   42 CFR Part 486
   Grant programs--health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.
   42 CFR Part 491
   Grant programs--health, Health facilities, Medicaid, Medicare, Reporting and recordkeeping requirements, Rural areas.
   42 CFR Part 494
   Health facilities, Incorporation by reference, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
   For the reasons set forth in the preamble, the
PART 403--SPECIAL PROGRAMS AND PROJECTS
   1. The authority citation for part 403 continues to read as follows:
   Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
SEC 403.742 [Amended]
   2. Amend SEC 403.742 by:
   A. Removing paragraphs (a)(1), (4), and (5).
   B. Redesignating paragraphs (a)(2) and (3) as paragraphs (a)(1) and (2), respectively.
   C. Redesignating paragraphs (a)(6) through (8) as paragraphs (a)(3) through (5), respectively.
    SEC 403.748 to subpart G to read as follows:
SEC 403.748 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The RNHCI must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address patient population, including, but not limited to, persons at-risk; the type of services the RNHCI has the ability to provide in an emergency; and, continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the RNHCI's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The RNHCI must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
   (i) Food, water, and supplies.
   (ii) Alternate sources of energy to maintain the following:
   (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
   (B) Emergency lighting.
   (C) Fire detection, extinguishing, and alarm systems.
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and patients in the RNHCI's care both during and after the emergency.
   (3) Safe evacuation from the RNHCI, which includes the following:
   (i) Consideration of care needs of evacuees.
   (ii) Staff responsibilities.
   (iii) Transportation.
   (iv) Identification of evacuation location(s).
   (v) Primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (5) A system of care documentation that does the following:
   (i) Preserves patient information.
   (ii) Protects confidentiality of patient information.
   (iii) Ensures records are secure and readily available.
   (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency.
   (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of nonmedical services to RNHCI patients.
   (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternate care site identified by emergency management officials.
   (c) Communication plan. The RNHCI must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under agreement.
   (iii) Next of kin, guardian or custodian.
   (iv) Other RNHCIs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) RNHCI's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to ensure continuity of care, based on the written election statement made by the patient or his or her legal representative.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the RNHCI's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The RNHCI must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The RNHCI must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of all emergency preparedness training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
   (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
PART 416--AMBULATORY SURGICAL SERVICES
   4. The authority citation for part 416 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
SEC 416.41 [Amended]
   5. Amend SEC 416.41 by removing paragraph (c).
   6. Add SEC 416.54 to subpart C to read as follows:
SEC 416.54 Condition for coverage: Emergency preparedness.
   The Ambulatory Surgical Center (ASC) must comply with all applicable Federal and State emergency preparedness requirements. The ASC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The ASC must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address patient population, including, but not limited to, the type of services the ASC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the ASC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The ASC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of staff and patients in the ASC's care both during and after the emergency.
   (2) Safe evacuation from the ASC, which includes the following:
   (i) Consideration of care and treatment needs of evacuees.
   (ii) Staff responsibilities.
   (iii) Transportation.
   (iv) Identification of evacuation location(s).
   (v) Primary and alternate means of communication with external sources of assistance.
   (3) A means to shelter in place for patients, staff, and volunteers who remain in the ASC.
 &#160; (4) A system of medical documentation that does the following:
   (i) Preserves patient information.
   (ii) Protects confidentiality of patient information.
   (iii) Ensures records are secure and readily available.
   (5) The use of volunteers in an emergency and other staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (6) The development of arrangements with other ASCs and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to ASC patients.
   (7) The role of the ASC under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The ASC must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other ASCs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) ASC's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the ASC's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction the Incident Command Center, or designee.
   (d) Training and testing. The ASC must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The ASC must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of all emergency preparedness training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The ASC must conduct exercises to test the emergency plan. The ASC must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the ASC's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the ASC's emergency plan, as needed.
PART 418--HOSPICE CARE
   7. The authority citation for part 418 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh), unless otherwise noted.
SEC 418.110 [Amended]
   8. Amend SEC 418.110 by removing paragraph (c)(1)(ii) and by removing the paragraph designation (i) from paragraph (c)(1)(i).
   9. Add SEC 418.113 to subpart D to read as follows:
SEC 418.113 Condition of participation: Emergency preparedness.
   The hospice must comply with all applicable Federal and State emergency preparedness requirements. The hospice must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.
   (3) Address patient population, including, but not limited to, the type of services the hospice has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
  &#160;(4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the hospice's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The hospice must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of hospice employees and patients in the hospice's care both during and after the emergency.
   (2) Procedures to inform State and local officials about hospice patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.
   (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (5) The development of arrangements with other hospices and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to hospice patients.
   (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following:
   (i) A means to shelter in place for patients, hospice employees who remain in the hospice.
   (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s). and primary and alternate means of communication with external sources of assistance.
   (iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
   (A) Food, water, and medical supplies.
   (B) Alternate sources of energy to maintain the following:
   ( 1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
   ( 2) Emergency lighting.
   ( 3) Fire detection, extinguishing, and alarm systems.
   (C) Sewage and waste disposal.
   (iv) The role of the hospice under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The hospice must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Hospice employees.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other hospices.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) Hospice's employees.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the hospice's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The hospice must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The hospice must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles.
   (ii) Ensure that hospice employees can demonstrate knowledge of emergency procedures.
   (iii) Provide emergency preparedness training at least annually.
   (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others.
   (v) Maintain documentation of all emergency preparedness training.
   (2) Testing. The hospice must conduct exercises to test the emergency plan. The hospice must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospice's emergency plan, as needed.
PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES
   10. The authority citation for Part 441 continues to read as follows:
   Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
   11. Add SEC 441.184 to subpart D to read as follows:
SEC 441.184 Emergency preparedness.
   The Psychiatric Residential Treatment Facility (PRTF) must comply with all applicable Federal and State emergency preparedness requirements. The PRTF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The PRTF must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address resident population, including, but not limited to, persons at-risk; the type of services the PRTF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the PRTF's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The PRTF must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following:
   (i) Food, water, and medical supplies.
   (ii) Alternate sources of energy to maintain the following:
   (A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions.
   (B) Emergency lighting.
   (C) Fire detection, extinguishing, and alarm systems.
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and residents in the PRTF's care both during and after the emergency.
   (3) Safe evacuation from the PRTF, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for residents, staff, and volunteers who remain in the facility.
   (5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other PRTFs and other providers to receive residents in the event of limitations or cessation of operations to ensure the continuity of services to PRTF residents.
   (8) The role of the PRTF under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The PRTF must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Residents' physicians.
   (iv) Other PRTFs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the PRTF's staff, Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for residents under the PRTF's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release resident information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of residents under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the PRTF's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The PRTF must develop and maintain an emergency preparedness training program that must be reviewed and updated at least annually.
   (1) Training program. The PRTF must do all of the following:
   (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) After initial training, provide emergency preparedness training at least annually.
   (iii) Ensure that staff can demonstrate knowledge of emergency procedures.
   (iv) Maintain documentation of all emergency preparedness training.
   (2) Testing. The PRTF must conduct exercises to test the emergency plan. The PRTF must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the PRTF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PRTF is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv)(A) Analyze the PRTF's response to and maintain documentation of all drills, tabletop exercises, and emergency events.
   (B) Revise the PRTF's emergency plan, as needed.
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
   12. The authority citation for part 460 continues to read as follows:
   Authority: Secs: 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).
SEC 460.72 [Amended]
   13. Amend SEC 460.72 by removing paragraph (c).
   14. Add SEC 460.84 to subpart E to read as follows:
SEC 460.84 Emergency preparedness.
   The Program for the All-Inclusive Care for the Elderly (PACE) organization must comply with all applicable Federal and State emergency preparedness requirements. The PACE organization must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The PACE organization must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address participant population, including, but not limited to, the type of services the PACE organization has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the PACE's efforts to contact such officials and, when applicable, of its participation in organization's collaborative and cooperative planning efforts.
   (b) Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. Policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of staff and participants under the PACE center(s) care both during and after the emergency.
   (2) Safe evacuation from the PACE center, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (3) The procedures to inform State and local emergency preparedness officials about PACE participants in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric conditions and home environment.
   (4) A means to shelter in place for participants, staff, and volunteers who remain in the facility.
   (5) A system of medical documentation that preserves participant information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other PACE organizations, PACE centers, or other providers to receive participants in the event of limitations or cessation of operations to ensure the continuity of services to PACE participants.
   (8) The role of the PACE organization under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (9)(i) Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs.
   (ii) Staff who know how to use the equipment must be on the premises of every center at all times and be immediately available.
   (iii) A documented plan to obtain emergency medical assistance from outside sources when needed.
   (c) Communication plan. The PACE organization must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for staff; entities providing services under arrangement; participants' physicians; other PACE organizations; and volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) PACE organization's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for participants under the organization's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release participant information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of participants under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the PACE organization's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The PACE organization must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The PACE organization must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Ensure that staff demonstrate a knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.
   (iv) Maintain documentation of all training.
   (2) Testing. The PACE organization must conduct exercises to test the emergency plan. The PACE organization must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the PACE organization experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE organization is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
   15. The authority citation for part 482 continues to read as follows:
   Authority: Secs. 1102, 1871, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
   16. Add SEC 482.15 to subpart B to read as follows:
SEC 482.15 Condition of participation: Emergency preparedness.
   The hospital must comply with all applicable Federal and State emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The hospital must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address patient population, including, but not limited to, persons at-risk; the type of services the hospital has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the hospital's efforts to contact such officials and, when applicable, its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The hospital must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to the following:
   (i) Food, water, and medical supplies.
   (ii) Alternate sources of energy to maintain the following:
   (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions.
   (B) Emergency lighting.
   (C) Fire detection, extinguishing, and alarm systems.
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and patients in the hospital's care both during and after the emergency.
   (3) Safe evacuation from the hospital, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (5) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other hospitals and other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to hospital patients.
   (8) The role of the hospital under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The hospital must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other hospitals
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) Hospital's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the hospital's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the hospital's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The hospital must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The hospital must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The hospital must conduct drills and exercises to test the emergency plan. The hospital must do all of the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the hospital experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the hospital's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed.
   (e) Emergency and standby power systems. The hospital must implement emergency and standby power systems based on the emergency plan set forth in paragraph (a) of this section and in the policies and procedures plan set forth in paragraphs (b)(2)(i) and (ii) of this section.
   (1) Emergency generator location. (i) The generator must be located in accordance with the location requirements found in NFPA 99, NFPA 101, and NFPA 110.
   (2) Emergency generator inspection and testing. In addition to the emergency power system inspection and testing requirements found in NFPA 99--Health Care Facilities and NFPA 110--Standard for
   (i) At least once every 12 months, test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the hospital anticipates it will require during an emergency.
   (ii) Maintain a written record, which is available upon request, of generator inspections, tests, exercising, operation and repairs.
   (3) Emergency generator fuel. Hospitals that maintain an onsite fuel source to power emergency generators must maintain a quantity of fuel capable of sustaining emergency power for the duration of the emergency or until likely resupply.
   17. Add SEC 482.78 to subpart E to read as follows:
SEC 482.78 Condition of participation: Emergency preparedness for transplant centers.
   A transplant center must have policies and procedures that address emergency preparedness.
   (a) Standard: Agreement with at least one Medicare approved transplant center. A transplant center or the hospital in which it operates must have an agreement with at least one other Medicare-approved transplant center to provide transplantation services and related care for its patients during an emergency. The agreement must address the following, at a minimum:
   (1) Circumstances under which the agreement will be activated.
   (2) Types of services that will be provided during an emergency.
   (b) Standard: Agreement with the
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
   18. The authority citation for part 483 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
   19. Add SEC 483.73 to subpart B to read as follows:
SEC 483.73 Emergency preparedness.
   The LTC facility must comply with all applicable Federal and State emergency preparedness requirements. The LTC facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the LTC facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to:
   (i) Food, water, and medical supplies;
   (ii) Alternate sources of energy to maintain:
   (A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions;
   (B) Emergency lighting;
   (C) Fire detection, extinguishing, and alarm systems, and;
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and residents in the LTC facility's care both during and after the emergency.
   (3) Safe evacuation from the LTC facility, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for residents, staff, and volunteers who remain in the LTC facility.
   (5) A system of medical documentation that preserves resident information, protects confidentiality of resident information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other LTC facilities and other providers to receive residents in the event of limitations or cessation of operations to ensure the continuity of services to LTC residents.
   (8) The role of the LTC facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The LTC facility must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
 &#160; (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Residents' physicians.
   (iv) Other LTC facilities.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, or local emergency preparedness staff.
   (ii)
   (iii)
   (iv) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) LTC facility's staff.
   (ii) Federal, State, tribal, regional, or local emergency management agencies.
   (4) A method for sharing information and medical documentation for residents under the LTC facility's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release resident information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of residents under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the LTC facility's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (8) A method for sharing information from the emergency plan that the facility has determined is appropriate with residents and their families or representatives.
   (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The LTC facility must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The LTC facility must conduct drills and exercises to test the emergency plan, including unannounced staff drills using the emergency procedures. The LTC facility must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the LTC facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the LTC facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the LTC facility's emergency plan, as needed.
   (e) Emergency and standby power systems. The LTC facility must implement emergency and standby power systems based on the emergency plan set forth in paragraph (a) of this section.
   (1) Emergency generator location. (i) The generator must be located in accordance with the location requirements found in NFPA 99 and NFPA 100.
   (2) Emergency generator inspection and testing. In addition to the emergency power system inspection and testing requirements found in NFPA 99--Health Care Facilities and NFPA 110--Standard for
   (i) At least once every 12 months test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the LTC facility anticipates it will require during an emergency.
   (ii) Maintain a written record, which is available upon request, of generator inspections, tests, exercising, operation and repairs.
   (3) Emergency generator fuel. LTC facilities that maintain an onsite fuel source to power emergency generators must maintain a quantity of fuel capable of sustaining emergency power for the duration of the emergency or until likely resupply.
SEC 483.75 [Amended]
   20. Amend SEC 483.75 by removing and reserving paragraph (m).
SEC 483.470 [Amended]
   21. Amend SEC 483.470 by--
   A. Removing paragraph (h).
   B. Redesignating paragraphs (i) through (l) as paragraphs (h) through (k), respectively.
   C. Newly redesginated paragraph (h)(3) is amended by removing the reference "paragraphs (i)(1) and (2)" and adding in its place the reference "paragraphs (h)(1) and (2)".
   22. Add SEC 483.475 to subpart I to read as follows:
SEC 483.475 Condition of participation: Emergency preparedness.
   The Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) must comply with all applicable Federal and State emergency preparedness requirements. The ICF/IID must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address the special needs of its client population, including, but not limited to, persons at-risk; the type of services the ICF/IID has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the ICF/IID efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The ICF/IID must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and residents, whether they evacuate or shelter in place, include, but are not limited to the following:
   (i) Food, water, and medical supplies.
   (ii) Alternate sources of energy to maintain the following:
   (A) Temperatures to protect resident health and safety and for the safe and sanitary storage of provisions.
   (B) Emergency lighting.
   (C) Fire detection, extinguishing, and alarm systems.
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and residents in the ICF/IID's care both during and after the emergency.
   (3) Safe evacuation from the ICF/IID, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for clients, staff, and volunteers who remain in the facility.
   (5) A system of medical documentation that preserves client information, protects confidentiality of client information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other ICF/IIDs or other providers to receive clients in the event of limitations or cessation of operations to ensure the continuity of services to ICF/IID clients.
   (8) The role of the ICF/IID under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The ICF/IID must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Clients' physicians.
   (iv) Other ICF/IIDs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (iii)
   (iv)
   (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for clients under the ICF/IID's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release client information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of clients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the ICF/IID's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (8) A method for sharing information from the emergency plan that the facility has determined is appropriate with clients and their families or representatives.
   (d) Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually. The ICF/IID must meet the requirements for evacuation drills and training at SEC 483.470(h).
   (1) Training program. The ICF/IID must do all the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The ICF/IID must conduct exercises to test the emergency plan. The ICF/IID must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
PART 484--HOME HEALTH SERVICES
   23. The authority citation for part 484 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
   24. Add SEC 484.22 to subpart B to read as follows:
SEC 484.22 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The HHA must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the HHA's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at SEC 484.55.
   (2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.
   (3) A system to track the location of staff and patients in the HHA's care both during and after the emergency.
   (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (6) The development of arrangements with other HHAs or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to HHA patients.
   (c) Communication plan. The HHA must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other HHAs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, or local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the HHA's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (6) A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
   (d) Training and testing. The HHA must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The HHA must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (ii) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The HHA must conduct drills and exercises to test the emergency plan. The HHA must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
   25. The authority citation for part 485 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
SEC 485.64 [Removed]
   26. Remove SEC 485.64.
   27. Add SEC 485.68 to subpart B to read as follows:
SEC 485.68 Condition of participation: Emergency preparedness.
   The Comprehensive Outpatient Rehabilitation Facility (CORF) must comply with all applicable Federal and State emergency preparedness requirements. The CORF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The CORF must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address patient population, including, but not limited to, the type of services the CORF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the CORF's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts;
   (5) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
   (b) Policies and procedures. The CORF must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) Safe evacuation from the CORF, which includes staff responsibilities, and needs of the patients.
   (2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (4) The use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (c) Communication plan. The CORF must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other CORFs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the CORF's staff, Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the CORF's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means of providing information about the CORF's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training and testing. The CORF must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The CORF must do all of the following:
   (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) The CORF must ensure that staff can demonstrate knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within two weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and fire fighting equipment.
   (2) Testing. The CORF must conduct drills and exercises to test the emergency plan. The CORF must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the CORF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CORF is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the CORF's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CORF's emergency plan, as needed.
SEC 485.623 [Amended]
   28. Amend SEC 485.623 by removing paragraph (c) and redesignating paragraph (d) as paragraph (c).
   29. Add SEC 485.625 to subpart F to read as follows:
SEC 485.625 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The CAH must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address patient population, including, but not limited to, persons at-risk; the type of services the CAH has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the CAH's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The CAH must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to:
   (i) Food, water, and medical supplies;
   (ii) Alternate sources of energy to maintain:
   (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions;
   (B) Emergency lighting;
   (C) Fire detection, extinguishing, and alarm systems; and
   (D) Sewage and waste disposal.
   (2) A system to track the location of staff and patients in the CAH's care both during and after the emergency.
   (3) Safe evacuation from the CAH, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (4) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (5) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (6) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (7) The development of arrangements with other CAHs or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to CAH patients.
   (8) The role of the CAH under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The CAH must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
 &#160; (iii) Patients' physicians.
   (iv) Other CAHs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) CAH's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the CAH's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the CAH's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training and testing. The CAH must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The CAH must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with fire fighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The CAH must conduct exercises to test the emergency plan. The CAH must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the CAH experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CAH is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the CAH's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CAH's emergency plan, as needed.
   (e) Emergency and standby power systems. The CAH must implement emergency and standby power systems based on the emergency plan set forth in paragraph (a) of this section.
   (1) Emergency generator location. (i) The generator must be located in accordance with the location requirements found in NFPA 99 and NFPA 100.
   (2) Emergency generator inspection and testing. In addition to the emergency power system inspection and testing requirements found in NFPA 99--Health Care Facilities and NFPA 110--Standard for
   (i) At least once every 12 months test each emergency generator for a minimum of 4 continuous hours. The emergency generator test load must be 100 percent of the load the CAH anticipates it will require during an emergency.
   (ii) Maintain a written record, which is available upon request, of generator inspections, tests, exercising, operation, and repairs.
   (3) Emergency generator fuel. Hospitals that maintain an onsite fuel source to power emergency generators must maintain a quantity of fuel capable of sustaining emergency power for the duration of the emergency or until likely resupply.
   30. Revise SEC 485.727 to read as follows:
SEC 485.727 Condition of participation: Emergency preparedness.
   The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services ("Organizations") must comply with all applicable Federal and State emergency preparedness requirements. The Organizations must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The Organizations must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must do all of the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address patient population, including, but not limited to, the type of services the Organizations have the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Address the location and use of alarm systems and signals; and methods of containing fire.
   (5) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation.
   (6) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
   (b) Policies and procedures. The Organizations must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) Safe evacuation from the Organizations, which includes staff responsibilities, and needs of the patients.
   (2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (4) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (c) Communication plan. The Organizations must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other Organizations.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, state, tribal, regional and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) Organizations' staff.
   (ii) Federal, state, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the Organizations' care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means of providing information about the Organizations' needs, and their ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training and testing. The Organizations must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The Organizations must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) The Organizations must ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The Organizations must conduct drills and exercises to test the emergency plan. The Organizations must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the Organizations experience an actual natural or man-made emergency that requires activation of the emergency plan, they are exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the Organization's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed.
   31. Section 485.920 is added to subpart J (as added on
SEC 485.920 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The CMHC must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address client population, including, but not limited to, the type of services the CMHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the CMHC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The CMHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of staff and clients in the CMHC's care both during and after the emergency.
   (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
   (3) A means to shelter in place for clients, staff, and volunteers who remain in the facility.
   (4) A system of medical documentation that preserves client information, protects confidentiality of client information, and ensures records are secure and readily available.
   (5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of state or federally designated health care professionals to address surge needs during an emergency.
   (6) The development of arrangements with other CMHCs or other providers to receive clients in the event of limitations or cessation of operations to ensure the continuity of services to CMHC clients.
   (7) The role of the CMHC under a waiver declared by the Secretary of Health and Human Services, in accordance with section 1135 of the Social Security Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (c) Communication plan. The CMHC must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.</p>
   (ii) Entities providing services under arrangement.
   (iii) Clients' physicians.
   (iv) Other CMHCs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) CMHC's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A method for sharing information and medical documentation for clients under the CMHC's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release client information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of clients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the CMHC's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training and testing. The CMHC must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must ensure that staff can demonstrate knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least annually.
   (2) Testing. The CMHC must conduct drills and exercises to test the emergency plan. The CMHC must:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the CMHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CMHC is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the CMHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CMHC's emergency plan, as needed.
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS
   32. The authority citation for part 486 continues to read as follows:
   Authority: Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C 273).
   33. Add SEC 486.360 to subpart G to read as follows:
SEC 486.360 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The OPO must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must do all of the following:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
   (2) Include strategies for addressing emergency events identified by the risk assessment.
   (3) Address the type of hospitals with which the OPO has agreements; the type of services the OPO has the capacity to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the OPO's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The OPO must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and, the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of staff during and after an emergency.
   (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and ensures records are secure and readily available.
   (c) Communication plan. The OPO must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Volunteers.
   (iv) Other OPOs.
   (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA).
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) OPO's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (d) Training and testing. The OPO must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training. The OPO must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) The OPO must ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
   (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the OPO's emergency plan, as needed.
   (e) Agreements with other OPOs and hospitals. Each OPO must have an agreement(s) with one or more other OPOs to provide essential organ procurement services to all or a portion of the OPO's Donation Service Area in the event that the OPO cannot provide such services due to an emergency. Each OPO must include within the hospital agreements required under SEC 486.322(a) and in the protocols with transplant programs required under SEC 486.344(d), the duties and responsibilities of the hospital, transplant program, and the OPO in the event of an emergency.
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
   34. The authority citation for part 491 continues to read as follows:
   Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
SEC 491.6 [Amended]
   35. Amend SEC 491.6 by removing paragraph (c).
   36. Add SEC 491.12 to read as follows:
SEC 491.12 Condition of participation: Emergency preparedness.
   
   (a) Emergency plan. The RHC/FQHC must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address patient population, including, but not limited to, the type of services the RHC/FQHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the RHC/FQHC's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
   (b) Policies and procedures. The RHC/FQHC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:
   (1) Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients.
   (2) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (3) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (4) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.
   (c) Communication plan. The RHC/FQHC must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other RHCs/FQHCs.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional, and local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) RHC/FQHC's staff.
   (ii) Federal, State, tribal, regional, and local emergency management agencies.
   (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (5) A means of providing information about the RHC/FQHC's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training and testing. The RHC/FQHC must develop and maintain an emergency preparedness training and testing program that must be reviewed and updated at least annually.
   (1) Training program. The RHC/FQHC must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles,
   (ii) Provide emergency preparedness training at least annually.
   (iii) Maintain documentation of the training.
   (iv) Ensure that staff can demonstrate knowledge of emergency procedures.
   (2) Testing. The RHC/FQHC must conduct exercises to test the emergency plan. The RHC/FQHC must do the following:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the RHC/FQHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC/FQHC is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the RHC/FQHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC/FQHC's emergency plan, as needed.
PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE FACILITIES
   37. The authority citation for part 494 continues to read as follows:
   Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. l302 and l395hh).
SEC 494.60 [Amended]
   38. Amend SEC 494.60 by--
   A. Removing paragraph (d).
   B. Redesignating paragraph (e) is as paragraph (d).
   39. Add SEC 494.62 to subpart B to read as follows:
SEC 494.62 Condition of participation: Emergency preparedness.
   The dialysis facility must comply with all applicable Federal and State emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
   (a) Emergency plan. The dialysis facility must develop and maintain an emergency preparedness plan that must be evaluated and updated at least annually. The plan must:
   (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach;
   (2) Include strategies for addressing emergency events identified by the risk assessment;
   (3) Address patient population, including, but not limited to, the type of services the dialysis facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
   (4) Include a process for ensuring cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to ensure an integrated response during a disaster or emergency situation, including documentation of the dialysis facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. The dialysis facility must contact the local emergency preparedness agency at least annually to ensure that the agency is aware of the dialysis facility's needs in the event of an emergency.
   (b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. At a minimum, the policies and procedures must address the following:
   (1) A system to track the location of staff and patients in the dialysis facility's care both during and after the emergency.
   (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients.
   (3) A means to shelter in place for patients, staff, and volunteers who remain in the facility.
   (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and ensures records are secure and readily available.
   (5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
   (6) The development of arrangements with other dialysis facilities or other providers to receive patients in the event of limitations or cessation of operations to ensure the continuity of services to dialysis facility patients.
   (7) The role of the dialysis facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
   (8) A process to ensure that emergency medical system assistance can be obtained when needed.
   (9) A process ensuring that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.
   (c) Communication plan. The dialysis facility must develop and maintain an emergency preparedness communication plan that complies with both Federal and State law and must be reviewed and updated at least annually. The communication plan must include all of the following:
   (1) Names and contact information for the following:
   (i) Staff.
   (ii) Entities providing services under arrangement.
   (iii) Patients' physicians.
   (iv) Other dialysis facilities.
   (v) Volunteers.
   (2) Contact information for the following:
   (i) Federal, State, tribal, regional or local emergency preparedness staff.
   (ii) Other sources of assistance.
   (3) Primary and alternate means for communicating with the following:
   (i) Dialysis facility's staff.
   (ii) Federal, State, tribal, regional, or local emergency management agencies.
   (4) A method for sharing information and medical documentation for patients under the dialysis facility's care, as necessary, with other health care providers to ensure continuity of care.
   (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510.
   (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
   (7) A means of providing information about the dialysis facility's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
   (d) Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that must be evaluated and updated at least annually.
   (1) Training program. The dialysis facility must do all of the following:
   (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
   (ii) Provide emergency preparedness training at least annually. Staff training must:
   (A) Ensure that staff can demonstrate knowledge of emergency procedures, including informing patients of--
   ( 1) What to do;
   ( 2) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
   ( 3) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
   ( 4) How to disconnect themselves from the dialysis machine if an emergency occurs.
   (B) Ensure that, at a minimum, patient care staff maintain current CPR certification; and
   (C) Ensure that nursing staff are properly trained in the use of emergency equipment and emergency drugs.
   (D) Maintain documentation of the training.
   (2) Testing. The dialysis facility must conduct drills and exercises to test the emergency plan. The dialysis facility must:
   (i) Participate in a community mock disaster drill at least annually. If a community mock disaster drill is not available, conduct an individual, facility-based mock disaster drill at least annually.
   (ii) If the dialysis facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the dialysis facility is exempt from engaging in a community or individual, facility-based mock disaster drill for 1 year following the onset of the actual event.
   (iii) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
   (iv) Analyze the dialysis facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the dialysis facility's emergency plan, as needed.
   (3) Patient orientation. Emergency preparedness patient training. The facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
(Catalog of Federal Domestic Assistance Program No. 93.778,
   Dated:
Marilyn Tavenner,
Administrator,
   Dated:
Kathleen Sebelius,
Secretary,
Editorial Note: This document was received in the
   Note: The following appendix will not appear in the Code of Federal Regulations
Appendix--Emergency Preparedness Resource Documents and Sites
Presidential Directives
    . Homeland Security Presidential Directive (HSPD-5): "Management of Domestic Incidents" authorized the
    * The elements of NIMS can be found at http://www.fema.gov/emergency/nims/index.shtm.
    * The National Response Framework (NRF) is a guide to how the nation should conduct all-hazards responses. Further information can be found at http://www.fema.gov/NRF.
    * The National Strategy for Pandemic Influenza and Implementation Plan is a comprehensive approach to addressing the threat of pandemic influenza and can be found at http://www.flu.gov/professional/federal/pandemic-influenza.pdf.
    *
    * The National Strategy for Pandemic Influenza Implementation Plan was established to ensure that the Federal government's efforts and resources would occur in a coordinated manner, the Federal government's response, international efforts, transportation and borders, protecting human and animal health, law enforcement, public safety, and security, protection of personnel and insurance of continuity of operations. This document can be found at http://www.fao.org/docs/eims/upload/221561/national_plan_ai_usa_en.pdf.
    . Homeland Security Presidential Directive (HSPD-21) addresses public health and medical preparedness. It establishes a National Strategy for
    * "National Preparedness Guidelines" adopt an all-hazards and risk-based approach to preparedness. It provides a set of national planning scenarios that represent a range of threats that warrant national attention. For further information, this document can be found at http://www.dhs.gov/xlibrary/assets/National_Preparedness_Guidelines.pdf.
    . Presidential Directive (PPD-8): National Preparedness. It is aimed at facilitating an integrated, all-of-nation, flexible, capabilities-based approach to preparedness. It requires the development of a National Preparedness Goal, a national system description, a national planning system that features the 5 integrated national planning frameworks for prevention, protection, response, recovery and mitigation and federal interagency operational plans (FIOPS). This directive can be found at http://www.dhs.gov/presidential-policy-directive-8-national-preparedness and at http://www.phe.gov/Preparedness/legal/policies/Pages/ppd8.aspx.
    * OIG study entitled, "Nursing Home Emergency Preparedness and Responses During Recent Hurricanes" (OEI-06-06-00020) conducted in response to a request from the
    *
    * GAO report entitled, "Disaster Preparedness: Preliminary Observations on the Evacuation of Hospitals and Nursing Homes Due to Hurricanes" (GAO-06-443R) discusses the GAO's findings regarding (1) responsibility for the decision to evacuate hospitals and nursing homes; (2) issues administrators consider when deciding to evacuate hospitals and nursing homes; and (3) the federal response capabilities that support evacuation of hospitals and nursing homes. This can be found at http://www.gao.gov/new.items/d06443r.pdf.
    * GAO report entitled, "Disaster Preparedness: Limitations in Federal Evacuation Assistance for Health Facilities Should be Addressed" (GAO-06-826) supports the findings noted in the first GAO report. In addition, the GAO noted that the evacuation issues that facilities faced during and after the hurricanes occurred due to their inability to secure transportation when needed. This report can be found at www.gao.gov/cgi-bin/getrpt?GAO-06-826.
    * GAO report, an after-event analysis, entitled, "Hurricane Katrina: Status of Hospital Inpatient and Emergency Departments in the Greater New Orleans Area" (GAO-06-1003) revealed that: (1) Emergency departments were experiencing overcrowding and (2) the number of staffed inpatient beds per 1,000 population was greater than that of the national average and expected to increase further and the number of staffed inpatient beds was not available in psychiatric care settings. While this study focused specifically on patient care issues in the New Orleans area, the same issues are common to hospitals in any major metropolitan area. This report can be found at http://www.gao.gov/docdblite/details.php?rptno=GAO-06-1003.
    * GAO report, an after-event analysis entitled, "Disaster Recovery: Past Experiences Offer Recovery Lessons for Hurricane Ike and Gustav and Future Disasters" (GAO-09-437T) concluded that recovery from major disasters involves the combined efforts of federal, state and local governments. This report can be found at http://www.gao.gov/products/GAO-09-437T.
    * OIG study entitled, "Gaps Continue to Exist in Nursing Home Emergency Preparedness and Response During Disasters: 2007-2010, OEI-06-09-00270. The report noted 6 areas of concern that nursing homes did not include in their plans but could affect residents during an emergency which are: Staffing, resident care, resident identification, information and tracking, sheltering in place, evacuation and communication and collaboration.
GAO Recommendations for Response to Influenza Pandemics
    * GAO report entitled, "Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to be Addressed" (GAO-09-909T
    * GAO report entitled, "Influenza Pandemic: Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement" (GAO-10-73). The GAO assessed the progress of the responsible federal agencies in implementing the plans 342 action items set forth in the "National Strategy for Pandemic Influenza: Implementation Plan. These reports can be found at http://www.gao.gov/new.items/d1073.pdf and http://georgewbush-whitehouse.archives.gov/homeland/pandemic-influenza-implementation.htm. Resources for Healthcare Providers and Suppliers for Responding to Pandemic Influenza:
    * "One-step access to U. S. Government h1N1, Avian, and Pandemic Flu Information" Web site provides links to influenza guidance and information from federal agencies. This can be found at www.flu.gov More information can be found at http://www.flu.gov/professional/index.html that provides information for hospitals, long term care facilities, outpatient facilities, home health agencies, other health care providers and clinicians.
    * "HHS Pandemic Influenza Plan Supplement 3: Healthcare Planning" provides planning guidance for the provision of care in hospitals. This can be located at http://www.hhs.gov/pandemicflu/plan/sup3.html.
    * "Best Practices in Preparing for Pandemic Influenza: A Primer for Governors and Senior State Officials (2006) written by the
    * The Public Readiness and Preparedness Act of 2005 establishes liability protections for program planners and qualified persons who prescribe, administer, or dispense covered counter measures in the event of a credible risk of a future public health emergency. Additional information can be found at: https://www.phe.gov/preparedness/legal/prepact/pages/default.aspx.
Public Health Emergency Preparedness
    * HRSA Policy Information notice entitled, "Health Center Emergency Management Program Expectations" (Document No. 2007-15 dated
    * CDC report describes natural disasters and man-made disasters. To access this list, go to http://emergency.cdc.gov/disasters/ under "emergency preparedness and response" and click on "specific hazards".
    *
2105/AJPH.2007.114496
    *
    * The HHS, 2011 Hospital Preparedness Program (HPP) report, entitled "From Hospitals to Healthcare Coalitions: Transforming Health Preparedness and Response in Our Communities", describes how the HPP has become a critical component of community resilience and enhancing the healthcare system's response capabilities, preparedness measures, and best practices across the country. The report can be found at: http://www.phe.gov/Preparedness/planning/hpp/Documents/hpp-healthcare-coalitions.pdf.
    * A 2008 ASPR published document entitled, "Pandemic and All-Hazards Preparedness Act: Progress Report on the Implementation of Provisions Addressing At Risk Individuals," describes the activities undertaken since the passage of the PAPHA to address needs of at-risk populations and describes some of the activities planned to work toward preparedness for at-risk populations. The report can be found at: http://www.phe.gov/Preparedness/legal/pahpa/Documents/pahpa-at-risk-report0901.pdf.
    * An
    * A
Development of Plans and Responses
    * Distributed nationally in FY 2012, ASPR's publication (distributed nationally in FY 2012), "Healthcare Preparedness Capabilities: National Guidance for Healthcare System Preparedness", takes an innovative capability approach to assist state and territory grant awardee planning that focuses on a jurisdiction's capacity to take a course of action. Additional information can be found at: http://www.phe.gov/preparedness/responders/ndms/Pages/default.aspx.
   A different ASFR guidance provides information, guidance and resources to support planners in preparing for mass casualty incidents and medical surges. The document includes a total of (8) healthcare preparedness capabilities that are: (1) Healthcare system preparedness (for example. information regarding healthcare coalitions); (2) healthcare system recovery; (3) emergency operations coordination, (4) fatality management; (5) information sharing; (6) medical surge; (7) responder safety and health; and (8) volunteer management. This information can be found at: http://www.phe.gov/Preparedness/planning/hpp/reports/Documents/capabilities.pdf.</p>
    *
    *
    * CMS published two guidance documents dated
Emergency Preparedness Related to People With Disabilities
   
*
* The Impact of Hurricanes Katrina and Rita on People with Disabilities: A Look Back and Remaining Challenges (2006)
* Saving Lives: Including People with Disabilities in Emergency Planning (2005)
[FR Doc. 2013-30724 Filed 12-20-13;
BILLING CODE 4120-01-P
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