65– Radiophamaceuticals
Notice Type: Sources Sought Notice
Posted Date:
Office Address:
Subject: 65-- Radiophamaceuticals
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: 36C24918Q0184
Contact: Lori L Ellis615-225-6338 [email protected] mailto:[email protected]
Setaside: N/AN/A
Place of Performance (address): VA Tennessee Valley Healthcare System Medical Cent;Nashville Campus;l3l0
Place of Performance (zipcode): 37212-2637
Place of Performance Country:
Description:
Nashville VAMC
The Government is particularly interested in identifying Service Disabled Veteran Owned Small Business (SDVOSB)/Veteran Owned-Small Business (VOSB) and their capability. The Government is seeking potential sources to provide Radiopharmaceuticals for the
CCR: Interested parties should register in the SAM as prescribed in FAR Clause 52.232-33. The SAM can be obtained by accessing the internet at www.sam.gov.
STATEMENT OF WORK
RADIOPHARMACEUTICAL (ISOTOPES) SUPPLIES & SERVICES
I. STATEMENT OF OBJECTIVES
The Contractor will be required to provide radiopharmaceutical supplies and services to the
A. DELIVERY: Authorized employees of TVHS will place orders on an as needed basis. Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of TVHS. Two free daily deliveries during routine business hours defined as Monday-Friday 0800-04:00 pm (excluding holidays). Contractor will supply two (2) phone numbers for ordering after working hours. Orders shall be placed the afternoon before the required delivery date for exact quantities of each unit dose or quantity for bulk (vial) orders. In addition to the two free daily deliveries, emergency orders can be placed at any time with expected delivery within one (1) hour of the order. Deliveries during normal business hours will be to: Nuclear Medicine, Room A-25,
The contractor will provide, prepare and QC Myoview or Sestamibi kits for Myocardial Perfusion Imaging. Technetium will be provided by the contractor.
As needed, the contractor will provide unit dose radiopharmaceuticals on weekends and holidays for emergency procedures. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. Deliveries outside of normal business hours will be to: Nuclear Medicine, Room A-25,
QUALITY: Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control
(QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided twenty-four hours per day, seven days per week, upon request and at no charge.
WASTE REMOVAL: Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials) without cost. Safe transport of the waste is the responsibility of the contractor. The Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor must adhere to
INVOICES:
Invoices shall be paid to the contractor monthly, in arrears, upon submission of a properly prepared invoice for services/ supplies during the period. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges. Invoices shall be sent to
COMPUTER SYSTEM: The Contractor shall provide computer hardware and software for the management and disposal of inventory, patient dose records. The Contractor will provide updates on computer systems as needed.
HARDWARE: The Contractor will provide equipment as needed and deliver the equipment to
The Nuclear Medicine, Room A-25,
The contractor shall keep the equipment in good working order, and shall furnish all parts, mechanisms, and devices to keep the equipment in good mechanical working order. Should the equipment fail to operate at no fault to the VAMC, the contractor will repair and/or replace by close of business the next business day. In the event
SOFTWARE: The contractor grants the
Upon termination, for any reason,
II. TERM OF CONTRACT
This contract is effective for the period
III. DEFINITIONS
Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the definitions and other sections of this contract, the language in this section shall govern.
A. Contracting Officer (CO) - The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.
B. Contracting Officer s Representative (COR) - A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.
C.
D. Veterans Integrated Services Network (VISN) - The regional oversight for the VA Medical Centers in
IV. QUALITY REQUIREMENTS
Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge.
On an annual basis, the Contractor will provide documentation demonstrating compliance with NRC requirements to the Radiation Safety Officer.
V. CREDENTIAL REVIEWS/PRIVILEGING
Not Applicable
VI. KEY PERSONNEL
A. The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract to the
B. The contractor must identify key personnel proposed to provide the required services and their qualifications upon award of contract and on an annual basis thereafter. The contractor cannot change key personnel without VAMC approval.
VII. PATIENT RIGHTS AND SAFETY
A.
B. The Contractor will have evidence of implementation of the Joint Commission National Patient Safety Goals as applicable.
VIII.
Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of the
IX. QUALITY ASSURANCE SURVEILLANCE PLAN
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. The performance standards are as follows:
Task
ID
Indicator
Standard
Acceptable Quality Level
Method of Surveillance
Incentive
Patient Safety and Quality Control
1
Pharmaceutical dose accuracy
Contractor will guarantee that all radiopharmaceutical doses are delivered according to specific request.
100%
All doses are verified by Nuclear Technicians. Contractor will be immediately notified of discrepancies. Nuclear Techs will document all incorrect doses on log and report to Cardiology Manager.
Replacement dose will be provided within one hour of call, and there will be no charge for dose or delivery.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
Quality Control
2
Availability and responsiveness of radiopharmaceutical consultation services
Consultation services will be immediately available by telephone, 24hrs/day, 7 days per week.
100%
Nuclear Techs will document instances of failure.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
Quality Control
3
Evidence of compliance with NRC Requirements
On an annual basis, the Contractor will provide a copy of current NRC license. License will be received at VAMC before previous license expires.
100%
Radiation Safety Officer will monitor and report receipt of license to COR.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
X. ENVIRONMENT OF CARE
Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials). Safe transport of the waste is the responsibility of the contractor. Contractor must adhere to
XI. INFORMATION MANAGEMENT SECURITY
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as
2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
A. A contractor/subcontractor shall request logical (technical) or physical access to
C. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared
D. Custom software development and outsourced operations must be located in the
E. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a
3. VA INFORMATION CUSTODIAL LANGUAGE
A. Information made available to the contractor or subcontractor by
D. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of
E. The contractor/subcontractor shall not make copies of
F. If
H. The contractor/subcontractor must store, transport, or transmit
I. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed
J. Except for uses and disclosures of
K. Notwithstanding the provision above, the contractor/subcontractor shall not release
L. For service that involves the storage, generating, transmitting, or exchanging of
4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT
A. Information systems that are designed or developed for or on behalf of
B. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the
C. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the
D. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.
E. The security controls must be designed, developed, approved by
F. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579,
G. The contractor/subcontractor agrees to:
1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:
a) The Systems of Records (SOR); and
b) The design, development, or operation work that the contractor/subcontractor is to perform;
2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and
3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.
H. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.
1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.
2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.
3) System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.
I. The contractor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hot-fixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the contractor anywhere in the Systems, including Operating Systems and firmware. The contractor shall ensure that Security Fixes shall not negatively impact the Systems.
J. The contractor shall notify
K. When the Security Fixes involve installing third party patches (such as
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
A. For information systems that are hosted, operated, maintained, or used on behalf of
B. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by
C. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to
D. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the
E. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.
H. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with
1) Contractor must accept the system without the drive;
2)
3)
4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the
a) The equipment contractor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using
c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
A. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to
B. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to
D. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with
7. LIQUIDATED DAMAGES FOR DATA BREACH
A. Consistent with the requirements of 38 U.S.C. --5725, a contract may require access to sensitive personal information. If so, the contractor is liable to
B. The contractor/subcontractor shall provide notice to
C. Each risk analysis shall address all relevant information concerning the data breach, including the following:
1) Nature of the event (loss, theft, unauthorized access);
2) Description of the event, including:
a) Date of occurrence;
b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
3) Number of individuals affected or potentially affected;
4) Names of individuals or groups affected or potentially affected;
5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
6) Amount of time the data has been out of
7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
8) Known misuses of data containing sensitive personal information, if any;
9) Assessment of the potential harm to the affected individuals;
10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
D. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the
1) Notification;
2) One year of credit monitoring services consisting of automatic daily monitoring of at least three relevant credit bureau reports;
3) Data breach analysis;
4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
5) One year of identity theft insurance with
6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis,
XII. HIPPA AND OTHER REGULATORY COMPLIANCE
1. Contractor shall adhere to provisions of Public Law 104-191, Health Insurance Portability and
Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).
2. Contractor shall provide health care to patients seeking such are from or though
XIII. ON CALL REQUIREMENTS AND HOW THEY WILL BE BILLED
Emergency orders can be placed at any time with delivery within one (1) hour of the order. Deliveries during normal business hours will be to: Nuclear Medicine, Room A-25,
CLIN
EST QTY
UNIT COST
TOTAL COST
0001
Technetium
455
*-
*-
0002
Technetium
87
*-
*-
0003
Technetium
267
*-
*-
0004
Technetium
108
*-
*-
0005
Technetium LEU-99mTc Sulfur Colloid patient dose, 5-12 mCi
72
*-
*-
0006
Technetium LEU- 99m Mebrofenin patient dose, 4 to 6 mCi
112
*-
*-
0007
Technetium
4
*-
*-
0008
Technetium
61
*-
*-
0009
WBC Label (indium 111 OXINE)
1
*-
*-
0010
WBC label (LEU ) 99mTc - HMPAO
0
*-
*-
0011
Technetium
7975
*-
*-
0012
Technetium
16
*-
*-
0013
Technetium
78
*-
*-
0014
Technetium LEU 99mTc- Sestamibi, patient dose, 8 to 30 mCi
60
*-
*-
0015
Thallium-201 per mCi
168
*-
*-
0016
Gallium-67 patient dose, per mCi
0
*-
*-
0017
15
*-
*-
0018
I-131 Capsule patient dose 1-6mCi
10
*-
*-
0019
I-131 Therapy capsule, per mCi, ea addn mCi above 6 mCi,
10
*-
*-
0020
111-Indium DTPA 1.5mCi vial
2
*-
*-
0021
In111 Octreoscan
10
*-
*-
0022
I-123 Whole Body Scan 4 mCi
1
*-
*-
0023
153
*-
*-
0024
I-123 Dx capsule 200 uCi
152
*-
*-
0025
I-123 MIBG per dose 10 mCi
2
*-
*-
0026
Biodose dose management system, (York) Annual maintenance
1
*-
*-
0027
Biodose dose management system, (
1
*-
*-
0028
Leuckocyte prep kit
1
*-
*-
0029
Emergency Call Out (after hours)
7
*-
*-
Submission of Information: Companies having capabilities necessary to meet or exceed the stated requirements are invited to provide information to contribute to this market survey/sources sought notice including commercial market information and company information. Companies may respond to this Sources Sought Notice via e-mail to [email protected] no later than
1.
2. Point of contact and Phone Number.
3. Business Size applicable to the NAICS Code: a. HuBZone Small Business; b. Service-Disabled Veteran Owned Small Business (SDVOSB); c. Veteran Owned Small Business (VOSB); d Small Business; e. Large Business
4. Documentation Verifying Small Business Certification:
a. If claiming HuBZone status, provide a copy of your HuBZone Certificate from SBA.
b. If claiming SDVOSB/VOSB status, provide documentation that shows the business is VetBiz certified.
d. If claiming Small Business status, provide documentation to show the business is small under NAICS code 325412.
Link/URL: https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/36C24918Q0184/listing.html
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