SAMDaily.us | AWARD | 65 | DaTscan (I-123 loflupane)

SAMDAILY.US - ISSUE OF MAY 04, 2023 SAM #7828
AWARD

65 -- DaTscan (I-123 loflupane)

Notice Date: 5/2/2023 12:04:11 PM
Notice Type: Award Notice
NAICS: 325412 — Pharmaceutical Preparation Manufacturing
Contracting Office: 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
ZIP Code: 76006
Solicitation Number: 36C257-23-AP-1915
Archive Date: 05/17/2023
Point of Contact: Robert M Clark Jr, Phone: 5122281088
E-Mail Address: robert.clark15@va.gov
(robert.clark15@va.gov)
Award Number: 36C25723P0349
Award Date: 05/02/2023
Awardee: Medi-Physics, Inc. MA 01752-7220 USA
Award Amount: 133739.10
Description: Qualifications of Bidders: Bids will only be considered from those who are regularly involved in the business called for, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory service. 1. Contractor must be licensed by the US Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals must be shipped from the Licensee directly to VANTHCS. Nonmanufacturing waiver is not applicable to this solicitation. Please note that the Offeror must provide copies of all relevant licenses, certifications, and/or partnering agreement(s), along with their proposal to the Contracting Officer. 2. Contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals. 3. Contractor/licensee must be able to provide I-123 Ioflupane (DaTscan) radiopharmaceuticals to the following VANTHCS facilities: DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 5 of 35 a. VA North Texas HCS (Dallas VA Medical Center) b. Any other future additional leased or owned VANTHCS locations. 4. Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System with proof of contingency supply chain to prevent disruption of clinical care. 5. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. Contractor must supply each VANTHCS facility with a bar code reader or comparable VA approved device that is compatible with the VANTHCS Nuclear Medicine Information System (NMIS) or provide approved infrastructure/Nuclear Medicine Information System with inter-facility connectivity to meet this requirement. Contractor will support any necessary steps to ensure approval for use of new infrastructure (Example: Information Security) upon award, and prior to start of contract. For infrastructure change that may delay contract start, contractor must specify in detail alternative procedures and necessary contingency, which must be in compliance with listed requirements and be mutually acceptable. 6. If the Contractor's/licensee�s system varies from the VANTHCS facility NMIS, the Contractor shall provide means for compatibility or an alternative system with any needed data migration, technical support, and training for staff on its use at no additional cost to the Government. Any additional tracking system(s) provided must comply with all VA and associated IT, as well as information security, requirements [see above]. Any provided system must adequately, and securely, link different sites of Nuclear Medicine Service operations. 7. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. 8. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words ""CAUTION, RADIOACTIVE MATERIAL"" or ""DANGER, RADIOACTIVE MATERIAL"" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. 9. Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VANTHCS upon request. 10. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only: (a) By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 6 of 35 Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State. (b) Reagent kit that has been manufactured, labeled, packed, and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. 11. Contractor will utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care or IRB approved research. 12. Contractor/licensee will deliver radioisotope in an amount greater than or equal to the activity ordered with calibration for the specified appointment time so that patient administered quantity is within regulatory limits of the prescribed dose. All routine radiopharmaceutical dose deliveries must occur >30 minutes prior to the calibration time. Failure to meet this requirement will result in VANTHCS Nuclear Medicine Service to receive dose compensation that is separate from any returned dose quantities. Greater than 10 such instances within a year duration of the contract may result in penalties and/or contract termination. 13. Pricing and Radiopharmaceutical Returns for Credit: Pricing will be based on the Federal Supply Schedule which may be subject to change from time to time. VANTHCS Nuclear Medicine Service shall be allowed a maximum of 5 radioisotope return for all contracted radiopharmaceuticals due to patient cancellation, no show, and/or rescheduling at no cost. In addition, the Contractor shall accept returns for full credit toward future orders under the following conditions: a. Product(s) damaged in shipment b. Concealed shipping damages c. Recalled product(s) d. Outdated products in unopened, original container. 14. Invoicing: Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity, and amount, as well as the correct purchase order number. Unit dose (UD) based invoicing is preferred. A mutually agreed upon method to track unused reimbursable doses must be established prior to contract initiation. Offeror that provides a volume driven tiered approach that results in discounting with increased quantity purchased, is preferred. If volume-based tiered pricing is quoted, quantity thresholds may be set at monthly or quarterly increments. DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 7 of 35 15. Normal/ Routine Ordering: Routine I-123 DaTscan orders will be placed at least 48 hours in advance by authorized VA personnel during normal business hours throughout the workday (8:00am � 4:30pm). Completed background clearance checks must be submitted for review to VANTHCS Nuclear Medicine Service/Radiation Safety Office for all delivery personnel following award and prior to start of contract. Notification is required for any changes to these records, which should be made available for audit when requested. Orders shall only be placed by authorized VANTHCS NMS personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication process such as confirmation e-mails is preferred. 16. Normal/ Routine Deliveries: Depending upon changing Medical Center/Facility patient care requirements, the Contractor/licensee may be required to provide routine delivery and pick-up, multiple times (>2 times) throughout the day. Delivery orders, or the electronic ordering system, shall include the following information: � Contract item(s) and quantity � Time(s) of delivery � Applicable VA purchase order number Offeror with secure online ordering portal, or that utilizes a VA approved Information Security system that allows ordering which includes Protected Health Information (PHI) to better protect patient safety is preferred. Upon award, contractor will take necessary steps to ensure any needed infrastructure is in place prior to start of the contract. As noted above, Contractor/licensee agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. A maximum of 5- unit doses radiopharmaceutical return rate for all diagnostic tracers is considered requisite, and a broader return policy is preferred. Contractor is responsible for on time delivery of radiopharmaceutical and will have backup facilities/production options available to maintain greater than 99% on time delivery (per invoice cycle). All cancelled I-123 DaTscans due to contractor delayed delivery will be the responsibility of the contractor. It is incumbent upon the contractor to ensure delivery personnel are adequately familiar with each specific delivery location. Delivery personnel will park at the nearest secure location and proceed directly to the Nuclear Medicine Service site where they will be escorted to the radiopharmacy by VANTHCS staff. DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 8 of 35 17. Contractor will provide VANTHCS NMS personnel access to relevant online and/or live Initial, as well as Continuing, Education at no cost to VANTHCS to ensure staff are trained and remain current in safe receipt and handling of radioactive materials/radiopharmaceuticals, correct use of infrastructure applications such as an online ordering portal/NMIS, as well as any related regulatory requirements (Example: DOT). 18. Normal/ Routine Deliveries: Depending upon changing Medical Center/Facility patient care requirements, the Contractor/licensee may be required to provide routine delivery. Delivery orders, or the electronic ordering system, shall include the following information: � Contract item(s) and quantity � Time(s) of delivery � Applicable VA purchase order number Offeror with secure online ordering portal, or that utilizes a VA approved Information Security system that allows ordering which includes Protected Health Information (PHI) to better protect patient safety is preferred. Upon award, contractor will take necessary steps to ensure any needed infrastructure is in place prior to start of the contract. It is incumbent upon the contractor to ensure delivery personnel are adequately familiar with each specific delivery location. Delivery personnel will park at the nearest secure location and proceed directly to the Nuclear Medicine Service site where they will be escorted to the radiopharmacy (Hot Lab) by VANTHCS staff. Nuclear Medicine Service normal business hours are considered Monday through Friday: 7:00 am � 4:30 pm, except Federal Holidays, and Saturdays from 7:00 am � 11:00 am. The following are Federal Holidays: The following are Federal Holidays: New Year�s Day Birthday of Martin Luther King, Jr. (day of observance) Washington�s Birthday Memorial Day Juneteenth Day Independence Day Labor Day DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 9 of 35 Columbus Day Veteran�s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.) 19. Ordering Contact Information: Contractor/licensee shall provide contact information for the placement of orders for items listed in the �Schedule of Supplies and Services� Section. POC Name: Address: City/State/Zip Code: Ordering Phone Number: Ordering Fax Number: Ordering E-Mail Address: 20. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone/electronic order(s) shall become mandatory upon the Contractor's/licensee�s acceptance to commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by the Ordering Personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The contractor/licensee shall not be charged with damages when the delay in delivery arises out of causes beyond their control and without the fault or negligence of the contractor/licensee. DELIVERY LOCATION: Deliveries will be made to: VA North Texas HCS (Dallas) Attn: Nuclear Medicine Service (115) 3rd Floor, Room 3B-623 General Hot Lab 4500 S. Lancaster Road DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 10 of 35 Dallas, TX 75216 Delivery location will be defined for each shipment by VANTHCS authorized personnel. If needed, access to a VANTHCS main radiopharmacy, during non-business hours, shall be obtained by contacting designated on-call Nuclear Medicine personnel. VA Police Service may be called to assist with escort in certain circumstances; however, the primary point of contact will be Nuclear Medicine staff. Delivery personnel must be escorted at all times within facility �Controlled areas�/Nuclear Medicine Service, as per TJC and NRC/regulatory requirements. Contractor/licensee will provide updated lists of delivery personnel who will sign in/sign out with VANTHCS/Nuclear Medicine Service staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at VANTHCS facilities/Nuclear Medicine Service. Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is requisite. Upon request by VANTHCS/Radiation Safety Officer, the Contractor shall provide a copy/reports of contractor�s/licensee�s RSO Safety Audits of Federal Compliance. SCHEDULE OF SUPPLIES AND SERVICES The Department of Veterans Affairs North Texas Health Care System, Nuclear Medicine Service requires the contractor/licensee to provide radiopharmaceuticals. Items will be unit dose on an as needed basis, in accordance with patient requirements for the period of one year. Note: All annual quantities are estimates, contractor will only be paid for items and quantities actually ordered and delivered. The following line items are mandatory for this requirement: Item # Description/Part Number 12 Month Qty Est 1 I-123 Ioflupane Unit Dose up to 5 mCi per dose 90 Information Technology Security requirements section As prescribed in 839.201, the contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. 1. GENERAL DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 11 of 35 Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. 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 U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor�s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 12 of 35 a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor�s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA�s information is returned to the VA or destroyed in accordance with VA�s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 13 of 35 restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor�s firewall and Web services security controls, if applicable, shall meet or exceed VA�s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA�s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 14 of 35 GENERAL RULES OF BEHAVIOR a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job. b. The following rules apply to all VA contractors. I agree to: (1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract. (2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions. (3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE. (4) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract. (5) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee. (6) Contractors� use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply. (7) Grant access to systems and information only to those who have an official need to know. (8) Protect passwords from access by other individuals. (9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question. DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 15 of 35 (10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. (11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders. (12) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs. (13) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR. (14) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR. (15) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA. (16) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR. (17) Understand that restoration of service of any VA system is a concern of all users of the system. (18) Complete required information security and privacy training, and complete required training for the particular systems to which I require access. Records Management DocuSign Envelope ID: AB88ADCC-2484-4B34-B696-8A6D47F92A61 36C25723P0349 Page 16 of 35 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legalcontrol of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are est...
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65 -- DaTscan (I-123 loflupane)