CMS Issues Proposed Rule on Fire Safety Requirements for Health Care Facilities
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A Proposed Rule by the
Publication Date:
Agencies:
Dates: To be assured consideration, comments must be received at one of
Entry Type: Proposed Rule
Action: Proposed rule.
Document Citation: 79 FR 21551
Page: 21551 -21576 (26 pages)
CFR:
42 CFR 403
42 CFR 416
42 CFR 418
42 CFR 460
42 CFR 482
42 CFR 483
42 CFR 485
Agency/Docket Number: CMS-3277-P
RIN: 0938-AR72
Document Number: 2014-08602
Shorter URL: https://federalregister.gov/a/2014-08602
Action
Proposed Rule.
Summary
This proposed rule would amend the fire safety standards for
Unified Agenda
Fire Safety Requirements for Certain Health Care Facilities (CMS-3277-P)
DATES:
To be assured consideration, comments must be received at one of the addresses provided below, no later than
ADDRESSES:
In commenting, please refer to file code CMS-3277-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
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Please allow sufficient time for mailed comments to be received before the close of the comment period.
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a. For delivery in
(Because access to the interior of the
b. For delivery in
If you intend to deliver your comments to the
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the
I. Background
A. Overview of the Life Safety Code and the Health Care Facilities Code
The Life Safety Code (LSC) is a compilation of fire safety requirements for new and existing buildings, and is updated and published every 3 years by the
In our regulations, issued pursuant to the Act, we have stated that we believe CMS has the authority to grant waivers of some provisions of the LSC when necessary; for instance, to hospitals under section 1861(e)(9) of the Act, and to LTC facilities at sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Act. Currently, the Secretary may waive specific provisions of the LSC for any type of facility, if application of the rule would result in unreasonable hardship for the facility, and if the health and safety of its patients would not be compromised.
We do not consider it always necessary for a facility to be cited for a deficiency before it can apply for or receive a waiver. This is particularly the case when we have evaluated specific provisions of the LSC, determined that a waiver would arguably apply to all similarly-situated facilities with respect to the LSC requirement in question, and issued a public communication describing the specifics of such a categorical waiver, including any particular requirements that must be met in order for the waiver to apply to a facility. Waiver approval in these instances would be subject to a review of documentation maintained by the facility, verification of the applicability of the waiver, and confirmation that the terms and requirements of the waiver have been implemented by the facility. In most cases such verification occurs when an onsite survey of the facility is conducted. We plan to continue this approach, but would like to clarify that in those cases where we have issued a prior public communication providing for a categorical waiver, an advance recommendation from a state survey agency or accrediting organization (as applicable), is not required in order for a waiver to be granted. We have issued categorical waivers of LSC requirements when newer editions of the LSC provided equally effective means of ensuring life safety compared to requirements of earlier LSC editions. When CMS has evaluated the alternative (such as examining the new fire safety research and technology), and concluded that the specific alternative would improve or maintain the safety of the residents or patients of the facility, CMS may defer to newer editions of the LSC. CMS requires that providers comply with applicable provisions of the version of the LSC referenced in the categorical waiver.
In addition, the Secretary may accept a state's fire and safety code instead of the LSC if CMS determines that the protections of the state's fire and safety code are equivalent to the protections offered by the LSC. Further, the
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B. 2012 Edition of the Life Safety Code
The 2012 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible. The term "Patient(s)" will be globally used throughout this document, and refers to patient, clients, residents and all other terms used to describe the type of individuals cared for in each provider type. The use of earlier editions of the code can become problematic due to advances in safety and technology, and changes made to each edition of the code. Newer buildings are typically built to comply with the newer versions of the LSC because state and local jurisdictions, as well as non-CMS-approved accreditation programs, often adopt and enforce newer versions of the code as they become available. Therefore, a health care facility that is constructed or renovated in 2013 would likely be required by its state and local authorities to comply with a more recent edition of the LSC, while also being required to comply with the 2000 edition of the LSC to meet the
The 2012 edition of the LSC contains several significant changes from the 2000 edition. First, the format of the LSC has been altered. The LSC has eliminated the use of "exceptions" throughout the entire code to provide more consistency and easier reading. There was also a change in measurement systems, from centimeters to millimeters. Using a smaller unit of measurement allows for more precision and consistency throughout the LSC.
The 2000 LSC requires minor renovation projects to meet the same stringent requirements as those applied to completely new construction. However, the 2012 edition of the LSC contains a new chapter entitled, "Chapter 43--Building Rehabilitation." This new chapter replaces the requirements that all modernizations/renovations meet the requirements for new construction. The degree to which requirements for new construction must be met now varies with the rehabilitation work category. This chapter sets out different types of building rehabilitation work (that is, repair, renovation, modification, reconstruction, change of use, change of occupancy and addition) to which different standards apply. We believe that this clarification will assist health care facilities by reducing costs for minor construction projects.
Buildings that have not received all pre-construction governmental approvals required by the jurisdiction(s) in which the building is to be built before the rule's effective date, or those buildings that begin construction after the effective date of this regulation, would be required to meet the New Occupancy chapters of the 2012 edition of the LSC. Buildings constructed before the effective date of this regulation would be required to meet the Existing Occupancy chapters of the 2012 edition of the LSC. Changes made to buildings would be required to comply with Chapter 43--Building Rehabilitation, which could require compliance with the New Occupancy chapters, depending on the changes being made. In instances where mandatory LSC references do not include existing chapters, existing occupancies must ensure buildings and equipment are in compliance with provisions previously adopted by CMS at the time they were constructed or installed.
Health Care Occupancies
The following are provisions that appear in the 2012 edition of the LSC, but that did not exist in the 2000 edition of the LSC, for Chapter 18, "New Health Care Occupancies," and Chapter 19, "Existing Health Care Occupancies." We are providing the LSC citation, a description of the 2012 requirement, and an explanation of its benefits for health care facilities, patients, staff, and visitors over the 2000 version.
Both the 2000 and 2012 editions of the LSC classify a "Health Care Occupancy" as a facility having 4 or more patients on an inpatient basis. However, CMS does not apply this LSC standard with respect to patient census numbers. Unless specifically noted, the requirements, conditions of participation, and conditions for coverage for all
Sections 18.2.3.4 (2) and 19.2.3.4(2)--Corridor Projections
This provision requires noncontinuous projections to be no more than 6 inches from the corridor wall. In addition to following the requirements of the LSC, health care facilities are also required to follow the requirements of the Americans with Disabilities Act (ADA). Section 307 of the "ADA Accessibility Guidelines for Buildings and Facilities" (http://www.ada.gov/regs2010/2010ADAStandards/2010ADAstandards.htm#c4) requires that projections be no more than 4 inches from the corridor wall. Therefore, while the LSC allows facilities to have 6 inch projections, so long as the
Sections 18.2.5.7 and 19.2.5.7--Suites
This new provision has enlarged the size of permissible sleeping suites for patients to potentially allow `more comfort and space for patients' if the facilities choose to use the larger size patient rooms. The provision requires that new construction sleeping suites cannot exceed 7500 square feet. Previously sleeping suites could not exceed 5000 square feet. Sleeping suites greater than 7500 square feet, and not exceeding 10,000 square feet, may be permitted where there is direct visual supervision and a complete smoke detection system. This change allows health care facilities to have more patients in a single area, reducing the number of staff that are necessary to visually monitor patients and allowing facilities to accommodate additional pieces of medical equipment or visitor space. This could improve facility staffing flexibility and reduce costs by allowing this increase in size thereby reducing the number of suites to treat the same number of patients.
Sections 18.7.5.7.2 and 19.7.5.7.2--Recycling
This new provision requires that containers used solely for recycling clean waste be limited to a maximum capacity of 96 gallons. If the recycling containers are located in a protected hazardous area, container size will not be limited. In the 2000 edition of the LSC, the container size was limited to 32 gallons. The larger containers allowed in the 2012 edition of the LSC require less frequent emptying, which could reduce housekeeping costs.
Sections 18.3.6.3.9.1 and 19.3.6.3.5--Roller Latches
A roller latch is a type of door latching mechanism to keep a door closed. The 2012 edition of the LSC requires corridor doors to be provided with a means for keeping the door closed that is acceptable to the authority having jurisdiction. The LSC permits roller latches capable of keeping the door fully closed if a force of 5 pounds is applied at the latch edge or roller latches in fully sprinklered buildings. However, we would not adopt these standards from the 2012 LSC. Through fire investigations, roller latches have proven to be an unreliable door latching mechanism requiring extensive maintenance to operate properly. Many roller latches in fire situations failed to provide adequate protection to residents in their rooms during an emergency. Therefore, roller latches would be prohibited in existing and new Health Care Occupancies, and corridor doors would be required to have positive latching devices.
Sections 18.4.2 and 19.4.2--Sprinklers in High-Rise Buildings
This is a new provision for existing health care occupancies. This provision requires buildings over 75' (generally greater than 7 or 8 stories) in height to have automatic sprinkler systems installed throughout the building. The 2012 LSC allows 12-years from when the authority having jurisdiction (which in this case is CMS) officially adopts the 2012 edition of the LSC for existing facilities to comply with the sprinkler system installation requirement. Therefore, those facilities that are not already required to do so would have 12 years following publication of the final rule adopting the 2012 LSC to install sprinklers. We propose to adopt this new provision because high-rise buildings require more time to evacuate, and sprinklers would very likely allow additional time to safely evacuate a facility.
We believe that this provision would mainly affect hospitals. However, we are specifically soliciting public comment to determine if other provider types are, or may be, located in a high-rise building. We would also like to solicit public comments regarding the phase-in period of 12 years, including if 12-years is enough time for the installation of sprinklers in high-rise buildings.
Sections 18.2.2.2.5.2 and 19.2.2.2.5.2--
This new provision requires that, where the special needs of patients require specialized protective measures for their safety, door-locking arrangements are permitted. This provision allows interior doors to be locked to reduce the risk of infant abductions and individuals who may wander, subject to the following requirements: (1) All staff must have keys; (2) smoke detection systems must be in place; and (3) the facility must be fully sprinklered; (4) the locks are electrical locks that will release upon loss of power to the device and (5) the locks release by independent activation of the smoke detection system and the water flow in the automatic sprinkler system. This provision would improve the security of health care facilities with specialized needs and improve patient safety.
Sections 18.3.2.6 and 19.3.2.6--Alcohol Based Hand Rubs (ABHRs)
This provision now explicitly allows aerosol dispensers, in addition to gel hand rub dispensers. The aerosol dispensers are subject to limitations on size, quantity, and location, just as gel dispensers are limited. Automatic dispensers are also now permitted in health care facilities, provided that the following requirements are met: (1) They do not release contents unless they are activated; (2) the activation occurs only when an object is within 4 inches of the sensing device; (3) any object placed in the activation zone and left in place must not cause more than one activation; (4) the dispenser must not dispense more than the amount required for hand hygiene consistent with the label instructions; (5) the dispenser is designed, constructed and operated in a way to minimize accidental or malicious dispensing; and (6) all dispensers are tested in accordance with the manufacturer's care and use instructions each time a new refill is installed. The provision further defines prior language regarding "above or adjacent to an ignition source" as being "within 1 inch" of the ignition source. These new provisions would allow for more hand hygiene dispenser options for all facilities.
Sections 18.3.5 and 19.3.5--Extinguishment Requirements
This provision is related to sprinkler system requirements and cross references section 9.7 of the LSC, "Automatic sprinklers and other extinguishing equipment." Section 9.7 further cross references the 2011 edition of
Section 18.3.2.3 and 19.3.2.3--Anesthetizing Locations
This provision requires that anesthetizing locations be protected in accordance with the 2012 edition of
Sections 18.2.3.4 and 19.2.3.4--Corridors
This new provision allows for storage of medical equipment in the corridors. Any equipment that is in use, including medical emergency equipment, and patient lift and transportation equipment is permitted to be stored in the corridors for more timely patient care. This provision also allows facilities to place fixed furniture in the corridors. This creates resting points in the corridors for patients and families in facilities and makes for a more home-like setting.
Sections 18.3.2.5.3 and 19.3.2.5.3--Cooking Facilities
This provision is a new section, which further supports a more home-like setting in health care facilities. Cooking facilities are allowed in a smoke compartment where food is prepared for 30 individuals or fewer (by bed count). The cooking facility is permitted to be open to the corridor, provided that the following conditions are met:
* The area being served is limited to 30 beds or less;
* The area is separated from other portions of the facility by a smoke barrier;
* The range hood and stovetop meet certain standards--
++ A switch must be located in the area that is used to deactivate the cook top or range whenever the kitchen is not under staff supervision
++ The switch also has a timer, not exceeding 120-minute capacity that automatically shuts off after time runs out
* Two smoke detectors must be located no closer than 20 feet and not further than 25 feet from the cooktop or range.
Sections 18.7.5.1 and 19.7.5.1--Furnishings & Decorations
This provision has been revised to allow combustible decor in any health care occupancy as long as they are flame-retardant or treated with approved fire-retardant coating that is listed and labeled, and meet fire test standards. The decor (such as photographs, paintings and other art) may be attached directly to the walls, ceilings, and non fire-rated doors as long as it does not interfere with the operation of the doors. Additionally, decor may not exceed--(1) 20 percent of the wall, ceiling and doors, in any room that is not protected by an approved automatic sprinkler system; (2) 30 percent of the wall, ceiling and doors, in any room that is not protected by an approved, supervised automatic sprinkler system; and (3) 50 percent of the wall, ceiling and doors, in any room with a capacity of 4 people (the actual number of occupants in the room may be less than its capacity) that is not protected by an approved, supervised automatic sprinkler system. These changes would allow individuals to bring in their own furnishings and decor, which helps to provide a more home-like setting.
Sections 18.5.2.3 and 19.5.2.3--Fireplaces
This provision has been revised to allow direct-vent gas fireplaces in smoke compartments without the 1 hour fire wall rating. Fireplaces must not be located inside of any patient sleeping room. Solid fuel-burning fireplaces are permitted and can be used only in areas other than patient sleeping rooms, and must be separated from sleeping rooms by construction of no less than a 1 hour fire resistance wall rating. This provision allows for more options for the location of fireplaces in health care facilities, which makes the facilities feel more home-like.
Outside Window or Door Requirements
The 2000 edition of the LSC required that every health care occupancy patient sleeping room shall have an outside window or outside door, with new health care occupancies having an allowable sill height not to exceed 36 inches above the floor with certain exceptions. This requirement no longer exists in the 2012 edition of the LSC; however, as outside windows and doors may be used for smoke control, building entry, patient and resident evacuation, and other emergency forces operations during an emergency situation, we propose to retain this requirement. We propose the following exceptions to the outside window or door requirement, as included in the 2000 edition of the LSC:
* Newborn nurseries and rooms intended for occupancy for less than 24 hours have no sill height requirements.
* Windows in atrium walls shall be considered outside windows for the purposes of this requirement.
* The window sill height in special nursing care areas shall not exceed 60 inches above the floor.
Ambulatory Health Care Occupancies
The following are new provisions in the 2012 edition of the LSC from Chapter 20, "New Ambulatory Health Care Occupancies" and Chapter 21, "Existing Ambulatory Health Care Occupancies." We are providing the LSC citation, a description of the requirement, and an explanation of its benefits for health care facilities, patients, staff, and visitors.
Both the 2000 and 2012 edition of the LSC define an "Ambulatory Health Care Occupancy" as a facility capable of treating 4 or more patients simultaneously on an outpatient basis. CMS regulations at 42 CFR section 416.44 require that all ASCs meet the provisions applicable to Ambulatory Health Care Occupancy, regardless of the number of patients served. We believe that hospital outpatient surgical departments are comparable to ASCs and thus should also be required to meet the provisions applicable to Ambulatory Health Care Occupancy Chapters, regardless of the number of patients served.
Sections 20.1.6.4 and 21.1.6.5--Interior Nonbearing Walls
This new provision allows all interior nonbearing walls that are required to have a minimum 2 hour fire resistance rating to be constructed of fire-retardant treated wood enclosed within noncombustible or limited combustible materials, provided that these walls are not used as shaft enclosures. The use of fire-retardant treated wood allows for more flexibility during construction and could reduce the cost of construction.
Sections 20.3.2.1 and 21.3.2.1--Doors
This new provision requires all doors to hazardous areas to be self-closing or close automatically. This provision was added to provide an extra level of protection for all patients. Adding this provision aligns the requirements for both ASCs and Health care occupancies to assure the same basic level of protection for all patients.
Sections 20.3.2.6 and 21.3.2.6--ABHRs
This provision now explicitly allows aerosol dispensers, in addition to gel hand rub dispensers. The aerosol dispensers are subject to limitations on size, quantity, and location, just as gel dispensers are. Automatic dispensers are also now permitted in health care facilities, provided, among other things, that--(1) they do not release contents unless they are activated; (2) the activation occurs only when an object is within 4 inches of the sensing device; (3) any object placed in the activation zone and left in place must not cause more than one activation; (4) the dispenser must not dispense more than the amount required for hand hygiene consistent with the label instructions; (5) the dispenser is designed, constructed and operated in a way to minimize accidental or malicious dispensing; (6) all dispensers are tested in accordance with the manufacturer's care and use instructions each time a new refill is installed. The provision further defines prior language regarding "above or adjacent to an ignition source" as being "within 1 inch" of the ignition source. These new provisions allow for more hand hygiene dispenser options for all facilities.
Sections 20.3.5 and 21.3.5--Extinguishment Requirements
This provision is related to sprinkler system requirements and cross references section 9.7 of the LSC, "Automatic sprinklers and other extinguishing equipment." Section 9.7 also cross references the 2011 edition of
Section 20.3.2.3 and 21.3.2.3--Anesthetizing Locations
This provision requires that anesthetizing locations be protected in accordance with the 2012 edition of
Residential Board and Care Occupancies
The LSC requirements for residential care facilities are differentiated based on the evacuation capability of the facility in question. The term "evacuation capability" refers to the ability of occupants, residents, and staff as a group either to evacuate a building, or to relocate from one point of occupancy to a point of safety. An "impractical evacuation capability" means that a group is unable to reliably move to a point of safety in a timely manner. A "prompt evacuation capability" means that a group is able to move reliably to a point of safety in a timely manner that is equivalent to the capacity of a household in the general population. A "slow evacuation capability" means that a group is able to move reliably to a point of safety in a timely manner, but not as rapidly as members of a household in the general population. The LSC requirements for a facility that has a prompt evacuation capability may be different from those for a facility that has an impractical evacuation capability. Those differences are reflected in the following provisions.
Both the 2000 and 2012 editions of the LSC classify "board and care" as a facility "used for lodging or boarding of 4 or more patients not related by blood or marriage to the owners or operators, for the purpose of providing personal care services." However, for CMS regulatory purposes, unless specifically noted, the conditions of participation and conditions for coverage for all affected health care providers and suppliers apply to all patients in a facility, regardless of the number of patients served. These basic requirements are established to assure a core level of safety and quality for all patients, regardless of where they receive health care services. We continue to believe that patients in very small facilities should be assured the same level of fire safety as those residing in very large facilities. Therefore, the LSC "4 or more" criteria would not apply to any
The following are provisions that appear in the 2012 edition of the LSC, but that did not exist in the 2000 edition of the LSC, for Chapter 32, "New Residential Board and Care Occupancies" and Chapter 33, "Existing Residential Board and Care Occupancies." We are providing the LSC citation, a description of the requirement, and an explanation of its benefits for health care facilities, patients, staff, and visitors.
Section 32.2.3.5.3.2--Sprinklers
This revised provision has been expanded to require that sprinkler systems be installed in all habitable areas, closets, roofed porches, balconies and decks of new facilities. Although this section of the LSC does not apply to existing facilities, we strongly encourage all existing facilities be sprinklered in all habitable areas in the same manner that newly constructed facilities are required to be sprinklered.
Sections 32.2.3.5.7 and 33.2.3.5.7--Attics
This new provision requires attics of new and existing facilities to be sprinklered. The attics of new board and care facilities are required to be protected in accordance with sections 32.2.3.5.7.1 or 32.2.3.5.7.2 of the LSC. The attics of existing board and care facilities are required to be protected in accordance with sections 33.2.3.5.7.1 or 33.2.3.5.7.2 of the LSC. For both new and existing board and care facilities, if the attic is used for living purposes, storage, or housing of fuel fired equipment, it must be protected with an automatic approved sprinkler system. If the attic is used for other purposes or is not used, then it must meet one of the following requirements: (1) Have a heat detection system that activates the building fire alarm system; (2) have automatic sprinklers; (3) be of noncombustible or limited-combustible construction; or (4) be constructed of fire-retardant-treated-wood. We are requesting public comment on the length of time needed to install sprinklers in attics. This provision was added after fire investigations demonstrated that fires in attics pose a high hazard in this type of occupancy. For example, one well-known case would be the fire in a board and care facility in
Sections 32.2.2 and 33.2.2--Means of Escape
This new provision requires designated means of escape to be continuously maintained free of all obstructions or impediments to full instant use in the case of a fire or emergency. This provision was added because there were no provisions within the occupancy chapter to prohibit an obstructed means of escape, and to emphasize that all means of escape are required to be free of obstructions to allow use without delay.
Section 32.3.3.4.7--Smoke Alarms
This new provision would only affect newly constructed facilities. Approved smoke alarms are required to be installed in accordance with 9.6.2.10 of the LSC inside every sleeping room, outside every sleeping area, in the immediate vicinity of the bedrooms, and on all levels within a resident unit. This requirement is located in Chapter 32, which only applies to newly constructed facilities. We are soliciting public comments about whether or not CMS should also require existing facilities to have smoke alarms that meet the requirements of this section.
Sections 32.7.6 and 33.7.6--Staff
This new provision for both newly constructed and existing facilities requires staff to be on duty and in the facility at all times when residents requiring evacuation assistance are present. This provision was added because staff assistance during evacuation is a necessity in this occupancy. This would increase safety for patients that are unable to independently exit the building in an emergency situation.
Sections 32.3.2.2.2 and 33.3.2.2.2--Access-Controlled Egress Doors
New and existing facilities must be permitted to have access-controlled egress doors that are in accordance with 7.2.1.6.2 of the LSC. When using the term "egress," we are describing, for example, hallways or corridors, interior and exterior stairways, entrance ways or lobbies, and escalators. Section 7.2.1.6.2 of the LSC permits means of egress to be equipped with electrical lock hardware to prevent egress. This provision was added to improve safety while allowing for more flexibility.
Section 33.3.3.2.3--Hazardous Areas
This new provision is for existing facilities with impractical evacuation capabilities. All hazardous areas must be separated from other parts of the building by smoke partitions, and also in accordance with section 8.4 of the LSC. Section 8.4 of the LSC addresses the continuity of smoke partitions and requires that they be placed appropriately. We are requesting public comment on the length of time needed to install smoke partitions in hazardous areas. This new provision provides a higher level of safety for facilities with impractical evacuation capabilities, and allows more time for individuals using facilities with slower evacuation capabilities to exit the building.
Section 33.3.3.4.6.2--Emergency Forces Notification
This new provision is only for existing facilities. Where a new fire alarm system is installed, or the existing fire alarm system is replaced, notification of emergency forces must be handled in accordance with section 9.6.4 of the LSC, which states that, where required by another section of this code, notification of emergency forces should alert the municipal fire department and fire brigade (if provided) of fire or other emergency. This new provision would increase safety for residents and staff by assuring that the appropriate emergency force is quickly notified of an emergency situation, enabling the emergency force to arrive in the fastest time possible to aid residents and staff.
Waiver Authority
We are proposing to retain our existing authority to waive provisions of the LSC under certain circumstances, further reducing the exposure to additional cost and burden for facilities with unique situations. A waiver may be granted for a specific LSC requirement if we determine that--(1) The waiver would not adversely affect patient/staff health and safety; and (2) it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. We do not consider it always necessary for a facility to be cited for a deficiency before it can apply for or receive a waiver, and we have periodically issued communications regarding specific provisions of the LSC that we evaluated and for which we have determined that a waiver would generally apply, subject to documentation maintained by the facility and verification of the applicability of the waiver when a survey of the facility is conducted. We plan to continue this approach.
In cases where a provider or supplier has been cited for a LSC deficiency, the provider or supplier may request a waiver from its
The LSC recognizes alternative systems, methods, or devices approved as equivalent by the authority having jurisdiction as being in compliance with the LSC. CMS, as the authority having jurisdiction for certification, will determine equivalency through the waiver approval process.
State Fire Codes
In addition to the proposed waiver option, a state may request that its state fire safety requirements, imposed by state law, be used in lieu of the 2012 edition of the LSC, which we are proposing to adopt in this rule. The state must submit the request to the appropriate CMS Regional Office, and the Regional Office would forward the request to CMS central office for final determination. We would retain our authority to apply the Fire Safety Evaluation System (FSES) as an alternative approach to meeting the requirements of the LSC.
C. 2012 Edition of the Health Care Facilities Code
The 2012 edition of the
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Chapter 4--Fundamentals
Chapter 4 is new to the 2012 edition and provides guidance on how to apply
There are four categories utilized in the risk assessment methodology, depending on the types of treatment and services being provided to patients or residents. Section 4.1.1 of
Section 4.2 would require that each facility that is a health care or ambulatory occupancy define its risk assessment methodology, implement the methodology and document the results. We do not propose to require the use of any particular risk assessment procedure. Section A.4.2 provides examples of appropriate risk assessment procedures, such as ISO/IEC31010, Risk management--Risk Assessment, or
Chapter 5--Gas and Vacuum Systems
The hazards addressed in Chapter 5 include the ability of oxygen and nitrous oxide to exacerbate fires, safety concerns from the storage and use of pressurized gas, and the reliance upon medical gas and vacuum systems for patient care. Adopting Chapter 5 would ensure a minimal level of the performance, maintenance, installation, and testing of piped medical gas and vacuum systems in all patient and resident care areas (for example, operating rooms, intensive care units, critical care units, procedure rooms, and sleeping rooms). Chapter 5 would not mandate the installation of any systems; rather, if they are installed or are required to be installed, the systems would be required to comply with
Chapter 5 covers the performance, maintenance, installation, and testing of the following:
* Nonflammable medical gas systems with operating pressure below a gauge pressure of 300 psi;
* Vacuum systems in health care facilities;
* Waste anesthetic gas disposal systems (WAGD); and
* Manufactured assemblies that are intended for connection to the medical gas, vacuum, or WAGD systems.
The
Section 3.3.108--Medical Gas Systems
Medical gas systems are an assembly of equipment and piping for the distribution of nonflammable medical gases such as oxygen, nitrous oxide, compressed air, carbon dioxide, and helium.
Section 3.3.110--Medical-surgical Vacuum
Medical-surgical vacuum systems are used to provide a source of drainage, aspiration, and suction in order to remove body fluids from patients.
Section 3.3.183--Waste Anesthetic Gas Disposal Systems (WAGD)
A WAGD system is the process of capturing and carrying gases vented from the patient breathing circuit during the normal operation of gas anesthesia or analgesia equipment.
Section 3.3.111--Medical-Surgical Vacuum System
A medical-surgical vacuum system is an assembly of central vacuum-producing equipment and a network of piping for patient suction in medical, surgical, and WAGD applications.
Section 3.3.102--
A manufactured assembly is a factory-assembled product that contains medical gas or vacuum outlets, piping, or other devices related to medical gas.
Chapter 5 is organized by category as described in Chapter 4.
Section 5.1.3--Category 1 Sources
This section includes information on the management of the sources for the medical gas, vacuum, WAGD, and instrument supply systems. It requires facilities to identify and label storage containers and other system components. It also contains requirements related to areas used to store gas and equipment, and how to handle gas cylinders and containers. Facilities would be required to design and construct systems and storage locations in accordance with the requirements for this section. This section also regulates the requirements for construction materials and placement of system components, and requirements for emergency power and quality assurance.
Section 5.1.9--Category 1 Warning Systems
This section includes information on the requirements for warning systems that monitor piped gas and vacuum systems. Warning systems monitor and alert the facility if a condition exists that could have a negative effect on the health and safety of patients, staff, and visitors. This section regulates the functions, capabilities, placement, labeling, emergency power, wiring, computer systems, initiating devices, and monitoring requirements for master, area, and local alarm systems.
Section 5.1.10--Category 1 Distribution
This section includes information on the requirements for the piping system for medical gas, vacuum, and WAGD systems. It regulates piping system installation, location, assembly, cleaning, and materials of construction, inspection, and installer qualifications.
Section 5.1.14--Category 1 Operation and Management
This section includes information on the operation and maintenance of medical gas, vacuum, WAGD and support gas systems. Issues addressed in this section include system limitations, maintenance programs, inspection and testing, management of flexible connections, piping and valve labeling, and recordkeeping. This section allows facilities flexibility in meeting the maintenance program requirements by focusing on the basic goals, timing, and qualifications for performing the work.
Section 5.2 Category--
Category 2 requirements apply to facilities treating patients who might require the gases occasionally, but ordinarily would not require them. When the use of gas is required for patient care, the need is short term. The provisions for Category 2 are virtually the same as for Category 1, except some equipment is permitted to be simplex rather than duplex. Category 3 applies to office-based care, where gases are used in such a manner that the life of the patient is never at issue in the event of failure of gas. Many requirements in the Category 3 section are similar to the requirements in Category 1 and Category 2.
Chapter 6--Electrical Systems
The hazards addressed in Chapter 6 are related to the electrical power distribution systems in health care facilities, and address issues such as electrical shock, power continuity, fire, electrocution, and explosions that might be caused by faults in the electrical system. Although these threats are present in any facility, the vulnerabilities of patients or residents in health care facilities, coupled with the complexity of the systems involved, create a need for distinct considerations.
Chapter 6 covers the performance, maintenance, and testing of both the normal and essential electrical systems (EES) in health care facilities. The normal electrical system is comprised of a normal power supply, typically provided by a public utility, connected to the facility electrical distribution system and ancillary equipment. The normal electrical system supplies power to the health care facility under normal operating conditions. An EES is comprised of an alternate source of power, typically a generator, connected to the facility's separate essential electric distribution systems and ancillary equipment. An EES is designed to ensure continuity of electrical power to designated areas and functions of a health care facility during a disruption of the normal power sources, and also to minimize disruptions with the internal wiring system (3.3.48).
Certain provisions in Chapter 6 related to the normal power system are defined by category as described in Chapter 4; however, all EES provisions are organized by "Type." Category 1 systems are the most reliable and complex, because patients being served by these systems are the most dependent on this system to function properly and will be at the greatest risk if the system fails. Category 2 systems are a step down from Category 1 systems, and Category 3 systems are another step down. Critical care rooms (Category 1) would be required to be served by a Type 1 EES, general care rooms would be required to be served by a Type 1 or Type 2 EES, and basic care rooms and non-patient care rooms are not required to be served by any EES.
Chapter 6 includes several sections, which are significant to managing the hazards associated with the normal electrical system. Subject areas include:
Section 6.3.1--Sources
This section requires each line-powered electrical appliance in a health care facility to be supported by sources and distribution systems that provide power adequate for each service.
Section 6.3.2--Distribution
This section includes information on the electrical distribution systems within a health care facility. Some of the issues addressed include:
* Electrical system installation;
* Specific requirements for patient care rooms (circuits, overcurrent protection, receptacles, wet locations);
* Ground-fault protection; and
* Isolated power systems.
Section 6.3.3--Performance Criteria and Testing
This section includes information on electrical system performance criteria. Electrical systems that support patient rooms would be required to be tested in order to ensure that they are safe and reliable. Some of the issues addressed include:
* Grounding system testing;
* Voltage measurements;
* Impedance measurements;
* Testing equipment;
* Receptacle testing;
* Isolated power systems testing; and
* Ground-fault protection testing.
Section 6.3.4--
This section includes information on the frequency of electrical system component testing and record keeping requirements. Where hospital-grade receptacles are required at patient bed locations and in locations where deep sedation or general anesthesia is administered, testing must be performed after initial installation, replacement, or servicing of the device. Receptacles not listed as hospital-grade must be tested in intervals not exceeding 12 months. The minimum acceptable documentation would identify what was tested, when it was tested, and whether it performed successfully.
Chapter 6 also includes several sections related to managing the hazards associated with the EES, including but not limited to:
See rest of the document here: https://www.federalregister.gov/articles/2014/04/16/2014-08602/medicare-and-medicaid-programs-fire-safety-requirements-for-certain-health-care-facilities
[*Federal RegisterMT 2014-04-16]
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