S02 36C25722Q0463.pdf

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Attached to: Radiopharmaceuticals Federal contract opportunity
Solicitation number: 36C25722Q0463
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C25722Q0463 04-11-2022

Melanie Williams 210-694-6378 04-15-2022 1:00pm CDT

36C257 Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

325412

1250 Employees

N/A

West Texas VA Health Care System Building 1, Room 264 Hot Closet 300 Veterans Blvd

Big Spring TX 79720

36C257

Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

The West Texas VA Health Care System located in Big Spring, TX requires the manufacture and delivery of medical radioisotopes from non-High Enriched Uranium (LEU) sources as outlined within the Statement of Work (SOW).

The Government intends to award a Firm Fixed-Price, single award IDIQ to a responsible vendor that is capable of providing the required supplies at a fair and reasonable price.

See Section B for SOW and Price/Cost Schedule

*NOTE: All questions must be submitted in writing to the Contract Specialist Melanie Williams at melanie.williams5@va.gov by close of business (COB) on 4/13/22

Please see Page 4 for Instructions to Offerors and the Provision at 52.212-2 on Page 68.

See CONTINUATION Page

X 1

Robyn Nussbaum Contracting Officer

36C25722Q0463

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INSTRUCTIONS TO OFFERORS

B.2 CONTRACT ADMINISTRATION DATA

B.3 STATEMENT OF WORK

B.4 VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors as shown below is hereby incorporated into the scope of work for the subject contract B.5 Performance Monitoring-Quality Assurance Surveillance Plan (QASP)

B.6 PRICE/COST SCHEDULE

B.7 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES AND

REMEDIES (JAN 2020) (JUL 2020) (DEVIATION)

C.7 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 46

C.12 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.13 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INSTRUCTIONS TO OFFERORS

Evaluation Factors for Award

This solicitation is issued as a Small Business set-aside. The vendor must be registered for NAICS 325412 in SAM to be eligible for award.

Quotations due on 4/15/2022 at 1:00 p.m. Central Time

Point of Contact:

Melanie Williams Contract Specialist Network Contracting Office 17 (NCO 17) 5441 Babcock Road, Suite 302 San Antonio, TX 78240 Phone: 210-694-6378 Melanie.Williams5@va.gov

Late quotes or documentation may not be accepted. All questions, comments, or inquiries are to be submitted in writing to the Point of Contact, referenced above, prior to the closing of the solicitation.

I. Basis of Award The Government intends to award a Firm Fixed-Price, single award IDIQ resulting from this solicitation to the responsible offeror whose quote conforming to the solicitation meets or exceeds the requirement. The quotes will be evaluated based on the evaluation factors listed below as Lowest Price Technically Acceptable. The technical capability will be evaluated on an "acceptable" or "unacceptable" basis.

The following areas will be evaluated:

Technical Capability Price

Factor 1: Technical Capability – The contractor shall provide a written statement addressing the following item. The written statement must describe each point and must provide enough detail to determine minimum qualifications.

Relevant license issued by the US Nuclear Regulatory Commission (USNRC) Current copy of the Radioactive Material License

Factor 2: Price – Contractor shall complete B.2 Price/Cost Schedule. The schedule may be altered, or an alternate schedule used where appropriate in order to express quote detail.

B.2 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: __________________________

ADDRESS: __________________________

Contractor Point of Contact (POC) for Contract: _______________________ Title: _______________________ Phone: _______________________ Email: _______________________

DUNS: ____________________ BUSINESS SIZE: ____________________

b. GOVERNMENT: Contracting Officer, 36C257 Robyn Nussbaum Robyn.nussbaum@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road, Suite 302 San Antonio, TX 78240

Contract Specialist Melanie Williams Melanie.Williams5@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road, Suite 302 San Antonio, TX 78240

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Monthly mailto:Melanie.Williams5@va.gov

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK

B.3 STATEMENT OF WORK

STATEMENT OF WORK:

GENERAL RADIOPHARMACEUTICAL CONTRACT

Requirement: Contractor/licensee must be able to provide general Nuclear Medicine radiopharmaceuticals to West Texas VA Health Care System:

In accordance with the VA Memorandum dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium-235 (LEU) sources.

Contractor shall ensure that all Tc-99m provided under this contract has been produced by the low enriched uranium method when available. Presidential/White House request for preferential procurement made to the Veterans Health Administration (VHA), >90% of Technetium-99m unit doses will be derived from Non-High Enriched Uranium-235 (Non-HEU) sources, also known as Low Enriched Uranium-235 (LEU) sources.

Pricing should include cost for both LEU and non-LEU derived Technetium-99m to account for instances where product availability becomes limited.

Items will be unit dose and on as needed basis, in accordance with scheduling requirements for the during each of the Periods of Performance.

Delivery Location:

West Texas VA Health Care System (Big Spring) Building 1, Room 264 Hot Closet 300 Veterans Blvd Big Spring, TX 79720

Same-Day Delivery/STAT Orders: Delivery times for ASAP/Urgent and add-on deliveries shall be during routine business hours. Deliveries should not exceed 180 minutes (3 hours) from time the order is placed and at no additional cost.

Routine business hours are considered Monday through Friday: 7:30 am – 3:30 pm, except Federal Holidays.

The following days are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr. (day of observance) Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.)

Ordering Information:

Contractor/licensee shall provide contact information for the placement of orders for items listed in the Price/Cost Schedule.

Orders shall be placed each day (Monday thru Friday by 4:00pm) for delivery the next business day (Monday thru Friday). Additional orders may be placed daily for same day delivery at no additional delivery charge.

Ordering Periods:

Ordering Period 1 12 Months 8/12/2022 – 8/11/2023 Ordering Period 2 12 Months 8/12/2023 – 8/11/2024 Ordering Period 3 12 Months 8/12/2024 – 8/11/2025 Ordering Period 4 12 Months 8/12/2025 – 8/11/2026 Ordering Period 5 12 Months 8/12/2026 – 8/11/2027

Qualifications of Offerors: Contractor shall maintain a current license issued by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of licenses and certifications along with quote to the Contracting Officer.

Radioactive Material License: The Contractor shall provide current copy of their Radioactive Material License no later than 30 days after each radioactive materials license renewal. Upon request by Contracting Officer Representative (COR), the Contractor shall provide a report of contractor’s/licensee’s RSO Safety Audits of Federal Compliance.

A contractor may subcontract with a Licensee to provide Radiopharmaceuticals to the West Texas Health Care System (WTVAHCS). The Radiopharmaceuticals must be shipped from the Licensee directly to WTVAHCS. 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.

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.

Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, and date. Compliant with Nuclear Medicine information system.

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" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173.

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 WTVAHCS upon request.

Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only:

By-product material shall be labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State.

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.

In order to comply with the Nuclear Regulatory Commission’s requirement that shippers and recipients of the radioactive material clearly delineate roles and responsibilities relating to shipper functions, the contractor will be responsible for the following while transporting radioactive materials to and from the medical center.

Transporting radioactive material only in DOT and NC Department of Radiation Protection Section approved transport containers.

Properly placarding the containers where appropriate with radioactive White I, Yellow II or Yellow III Radioactive Labels, following the current standard DOT guidelines.

Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the WTVAHCS with proof of contingency supply chain to prevent disruption of clinical care. Contractor will utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care. Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or surcharges. A tiered pricing structure with lower cost per increased quantity used is preferred.

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. The quantity of radioactivity will not deviate more than 10% or less than 5%, at the time of calibration, from the quantity ordered.

Radiopharmaceutical Returns for Credit: WTVAHCS facilities are each allowed a minimum 10% radioisotope returns for all contracted radiopharmaceuticals due to patient cancellation, no show, and/or rescheduling at no cost to the facility. In addition, the Contractor shall accept returns for full credit toward future orders under the following conditions:

Product(s) ordered or shipped in error.

Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container.

Invoicing: Contractor will provide monthly invoices with complete itemized list of all procedures performed during the month, listed by prescription number, dose amount. patient name, procedure, date with time and individual cost per item listed. The invoice will show period covered and the correct purchase order number. Invoicing shall be submitted within 7 days after the last day of each month (period covered).

Normal/ Routine Ordering: Routine orders shall be placed by authorized VA Nuclear Medicine Service (NMS) personnel during normal business hours throughout the workday. The Contractor/licensee will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract and will provide appropriate personnel and contact information for staff receiving orders, able to offer technical or administrative support, as well as staff involved in radiopharmaceutical delivery in accordance with VA Radiation Safety Office requirements.

Orders shall only be placed by authorized WTVAHCS personnel via secure online ordering system. For electronic ordering systems, a closed-loop communication process such as confirmation e-mails is preferred. Secure VA approved email may also be used when online services are down.

Normal/ Routine Deliveries: Radiopharmaceutical delivery will be required based upon clinical schedule. Depending on the schedule the Contractor/licensee may be required to provide daily routine delivery and pick-up. Delivery orders, or the electronic ordering system, shall include the following information:

Contract line item(s) and quantity Time(s) of delivery Applicable VA purchase order number Offeror with VA approved Information Security systems that allow ordering that includes Protected Health Information (PHI) to better protect patient safety.

As noted above, Contractor/licensee agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. A minimum 10% 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 back-up facilities/production options available to maintain greater than 99% on time delivery (per invoice cycle) or risk penalty that includes no charge doses that, at a minimum, equal the number of missed doses and 10% discount for that invoice.

Radiopharmaceutical may be ordered up to 2:00 pm the day before the delivery is required.

Contractor will provide WTVAHCS NMS personnel access to relevant online and/or live Continuing Education opportunities at no cost to WTVAHCS to ensure staff remain current in safe receipt and handling of radioactive materials/radiopharmaceuticals, as well as related regulatory requirements.

Delivery Commitment:

Time of delivery specified or mutually agreed to at the time of receipt of 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.

When the Contractor offers an earlier or later delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contractor offers no other delivery schedule, the delivery requested shall apply.

Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. Delivery date and time specified may be adjusted by the VA Ordering Activity. The Contractor will be notified of this change at least one

(1) day prior to the original or adjusted delivery date.

Delivery personnel must check in with VA Police Service personnel located on the ground floor, main facility prior to delivery to room 264. Contractors are required to abide by all facility requirements in regard to screening and masking requirements.

Privacy Officer:

Vendor will not have access to information deemed to be “VA sensitive information”. The certification and accreditation (C&A) do not apply.

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.

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 VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

Records Manager:

Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format

[paper, electronic, etc.] or mode of transmission [email, fac, etc.] or state of completions [draft, final, etc.]

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation of unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S. C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the Agency records schedules.

Contractor is required to obtain the contracting officer’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive ad proprietary information.

Contractor’s Requirement During Contract Period:

Contractor/licensee will provide updated lists of delivery personnel who will sign in/sign out with WTVAHCS/Nuclear Medicine Service staff upon each delivery of radiotracer and follow all relevant policies and procedures in place at WTVAHCS facilities/Nuclear Medicine Service.

Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is requisite.

Waste Removal: Contractor shall be responsible for proper disposal/removal of radioactive waste materials from doses that originated by the Contractor.

Consultation: A licensed Radio pharmacist shall be provided by the Contractor and will be available for consultation inquiries, via telephone, during normal duty hours, Monday through Friday, 7:00 am to 4:30 pm at no additional charge

Quality Control (QC)/Quality Assurance (QA): Contractor shall ensure that all radiopharmaceuticals supplied by the Vendor shall meet Food and Drug Administration (FDA) and Nuclear Regulatory Commission (NRC) standards for sterility, freedom from pyrogens and contaminants, and radiochemical integrity. In the event a quality control or material defect is suspect and/or detected by a VA Nuclear Medicine Technologist, the Contractor shall provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

Provide technical expertise in calibration; and Provide professional examination of product, submit recommendation to Contacting Officer; and Make expedient replacement of any product suspected of being deficient.

Offerors will also be required to perform all quality control procedures as required by Federal and State regulatory agencies and Joint Commission as they pertain to Radio Pharmaceuticals.

Integrated Tool Dose Management: The contractor shall provide an Integrated Tool Dose Management software for reporting purposes; example: manage inventory, daily doses, waste receipts, area wipe, surveys, linearity tests, etc. Offeror must provide all computer system requirements for the software, along with their proposal to the Contracting Officer.

Performance Factor Rating: Evaluations factors shall be rated for technical performance, strengths, weaknesses, fair pricing and overall past performance. Based on the areas, the contractor shall be rated on a scale from 1 to 5; 1 being unsatisfactory and 5 being exceptional.

The Evaluation Memo shall be forwarded to the contracting officer as a part of the records folder and consideration for renewal of option years.

1=Unsatisfactory, 2=Marginal, 3=Satisfactory, 4=Very Good, 5=Exceptional

Technical Performance 1 2 3 4 5 Strengths 1 2 3 4 5 Weaknesses 1 2 3 4 5 Fair Pricing 1 2 3 4 5

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

Contractor employees who work in or travel to VHA locations must comply with the following:

Documentation requirements:

If fully vaccinated, shall show proof of vaccination.

NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

All other terms and conditions remain unchanged.

https://www.va.gov/covid19screen/ https://www.va.gov/covid19screen/

B.5 Performance Monitoring-Quality Assurance Surveillance Plan (QASP)

The Government will periodically evaluate the Contractor’s performance to ensure performance objectives are being met. The Government may inspect each delivery as deemed appropriate to ensure quality, standards and safe products are received. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The COTR will validate any complaints and report to the Government Contracting Officer who will then take necessary action to enforce Contract compliance.

Measure Acceptable Quality Level

Surveillance Method

Standard Disincentive/Deduct

Maintain/Provide Current Copy of Radioactive Material License

Contractor will provide current/updated copy of license

Direct Observation 100% Unfavorable contractor performance evaluation.

Removal from contract until such time the contract physician