6505--Radiopharmaceutical Isotopes (Cardiology)

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular Deviations FEB 2025 CAAC Letters 2025-01/02 (eff.02/18/2025).

This solicitation is full and open competition.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The small business size standard of 1,300 employees. The FSC/PSC is 6505, Drugs and Biologicals.

The Department of Veterans Affairs, Network Contracting Office 12 (NCO 12), Veterans Integrated Services Network 12 (VISN 12), William S. Middleton Memorial Veterans Hospital, 2500 Overlook Terrace, Madison, WI 53705-2286 has a requirement for radiopharmaceutical isotopes. The radiopharmaceutical isotopes will be used for diagnostic testing and quality assurance.

All interested companies shall provide quotations for the following:

Schedule of Supplies

Base Year 04/01/2025 03/31/2026

Line Item

Description

Qty

Unit of Measure

Unit Price

0001

99mTc-Tetrofosmin (Myoview)

2200

EA

0002

99mTc-Pertechnatate (NaTcO4)

3000

UN

0003

99mTc-methyldiphosphonate (MDP, Medronate)

20

EA

0004

Ultratag RBC Labelling Kit

5

UN

0005

67Ga-Gallium Citrate

1

UN

0006

131I-Sodium Iodide

20

UN

Option Year One 04/01/2026 03/31/2027

Line Item

Description

Qty

Unit of Measure

Unit Price

1001

99mTc-Tetrofosmin (Myoview)

2200

EA

1002

99mTc-Pertechnatate (NaTcO4)

3000

UN

1003

99mTc-methyldiphosphonate (MDP, Medronate)

20

EA

1004

Ultratag RBC Labelling Kit

5

UN

1005

67Ga-Gallium Citrate

1

UN

1006

131I-Sodium Iodide

20

UN

Option Year Two 04/01/2027 03/31/2028

Line Item

Description

Qty

Unit of Measure

Unit Price

2001

99mTc-Tetrofosmin (Myoview)

2200

EA

2002

99mTc-Pertechnatate (NaTcO4)

3000

UN

2003

99mTc-methyldiphosphonate (MDP, Medronate)

20

EA

2004

Ultratag RBC Labelling Kit

5

UN

2005

67Ga-Gallium Citrate

1

UN

2006

131I-Sodium Iodide

20

UN

Option Year Three 04/01/2028 03/31/2029

Line Item

Description

Qty

Unit of Measure

Unit Price

3001

99mTc-Tetrofosmin (Myoview)

2200

EA

3002

99mTc-Pertechnatate (NaTcO4)

3000

UN

3003

99mTc-methyldiphosphonate (MDP, Medronate)

20

EA

3004

Ultratag RBC Labelling Kit

5

UN

3005

67Ga-Gallium Citrate

1

UN

3006

131I-Sodium Iodide

20

UN

Option Year Four 04/01/2029 03/31/2030

Line Item

Description

Qty

Unit of Measure

Unit Price

4001

99mTc-Tetrofosmin (Myoview)

2200

EA

4002

99mTc-Pertechnatate (NaTcO4)

3000

UN

4003

99mTc-methyldiphosphonate (MDP, Medronate)

20

EA

4004

Ultratag RBC Labelling Kit

5

UN

4005

67Ga-Gallium Citrate

1

UN

4006

131I-Sodium Iodide

20

UN

Pricing Overview Total Cost for each Period of Performance

Base Period

$

Option Year One

$

Option Year Two

$

Option Year Three

$

Option Year Four

$

Total

$

Statement of Work/Description/Specifications

1. Contract Title. Radiopharmaceuticals for Nuclear Cardiology Procedures

2. Background. The Nuclear Cardiology lab at the William S. Middleton Memorial VAH, in Madison WI performs nuclear medicine procedures on the heart. We do not have appropriate space or staffing to mix and dispense radiopharmaceuticals in our lab and require outside services to provide us with this.

3. Scope. The contract will cover mixing and dispensing required radiopharmaceuticals doses to the Nuclear Cardiology department. Schedule of Supplies includes doses for diagnostic testing of patients and quality assurance of equipment. Preference will be given to contractors who obtain their Tc99m generators from sources who use Low Enriched Uranium to make their generators.

4. Specific Tasks.

a. The Contractor shall provide Radionuclides to the Nuclear Cardiology Department at the Veterans Affairs Hospital (VA) in Madison, Wisconsin.

b. The vendor is preferred to have a secure way of ordering for next day orders and provide telephone response for same day ordering. All services rendered will be itemized by date of service, radiopharmaceutical provided, and unit cost.

c. Time of delivery specified or mutually agreed to at the time of receipt of order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

d. The Nuclear Cardiology staff will provide the vendor with patient s first and last names when ordering doses. Contractor will be responsible for maintaining patient information in the strictest confidence in accordance with the Privacy Act.

e. Provision of the products listed in the schedule of items shall include all services, equipment and materials necessary in the generation of those products in a form ready to be administered directly to the patient or used for equipment maintenance. This includes:

1) Generation and compounding of the radionuclides.

2) Quality Control and Purity testing of the radionuclides.

3) Dispensing of individual patient doses into syringes using a minimum volume of 2cc.

4) Labeling of individual doses with the patient s name, radionuclide, dose/time requested, the lot number of the kit used for manufacturing the radiopharmaceutical, dose activity at the time of drawing up and calculated activity at the specified time of administration, product purity, and the name of pharmacist/ tech responsible for the dose preparation.

f. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, UNNRC, and ICC regulations and standards.

g. The Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service upon commencement of this contract. Supplier shall immediately notify Nuclear Medicine Service, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts.

h. Products shall be provided Monday through Friday, 7:00 am to 2:00 pm, excluding Federal holidays. Federal Holidays observed by the VA are as follows:

New Year s Day

January 1st

Martin Luther King s Birthday

Third Monday in January

President s Day

Third Monday in February

Memorial Day

Last Monday in May

Juneteenth

June 19th

Independence Day

July 4th

Labor Day

First Monday in September

Columbus Day

Second Monday in October

Veterans Day

November 11th

Thanksgiving Day

4th Thursday in November

Christmas Day

December 25th

i. A copy of the Quality Control testing results of radiopharmaceuticals will be provided to the designated Nuclear Medicine Service point of contact upon request.

j. The contractor will provide a monthly listing of each individual product (including date, patient name, and specific product), for which the VA will be billed, to the designated Nuclear Medicine Service point of contact.

k. The VA Nuclear Cardiology technical staff will provide the contractor a minimum of 16 hours notice, if a non-Tc99m radiopharmaceutical will be required. The Nuclear Cardiology technical staff at the VA will notify the contractor, via phone call, if an order for a non-Tc99m radiopharmaceutical will be cancelled.

l. The VA Nuclear Cardiology technical staff will provide at least 60 minutes notice to the contractor if Tc99m products need to be provided or recalibrated and relabeled. The VA Nuclear Cardiology technical staff will notify the contractor, via phone call, at least 30 minutes in advance if a Tc99m product will not be required.

m. The VA Nuclear Cardiology staff will notify the contractor via telephone of additional Tc99m products will be required for same day delivery. The contractor will be required to deliver these additional doses with 60 min of the notification. This is necessary so medical decisions can be made regarding patient treatment, admission, or discharge can be made in a timely matter without incurring unnecessary hospital costs.

n. The work performed under this contract will be done at the contractor s facilities and the final products will be transported to the VAH, according to the Department of Transportation regulations.

5. Performance Monitoring. The Program Manager will certify that the work that is being billed for is the work that was performed, by comparing the invoices to the delivery packing lists and daily worklists.

6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). The government will not provide any equipment for the execution of this contract.

7. Other Pertinent Information or Special Considerations.

a. Packaging, Packing and Shipping Instructions. All packaging must adhere to DOT standards, be labelled according to DOT regulations, and contain an itemized packing list. All individual doses should be safety sealed to ensure the doses have not been tampered with.

b. Inspection and Acceptance Criteria. All packages received will undergo inspection in compliance with DOT. regulations and for order accuracy prior to being accepted.

c. Risk Control

1) The contractor must have measures in place to ensure sterility of their product.

2) The contractor must conduction industry standard quality control testing.

3) The contractor must have cybersecurity in place to prevent the loss of patient information.

4) Contractor personnel will undergo a vetting process prior to gaining access to the hospital facilities.

Period of Performance

Base Year: 04/01/2025 to 03/31/2026

Option Year 1: 4/1/2026 to 3/31/2027

Option Year 2: 4/1/2027 to 3/31/2028

Option Year 3: 4/1/2028 to 3/31/2029

Option Year 4: 4/1/2029 to 3/31/2030

Place of Performance/Place of Delivery

Address: William S. Middleton Memorial Veterans Hospital

2500 Overlook Terrace

Madison, WI

Postal Code: 53705-2286

Country: UNITED STATES

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.201-1, Acquisition 360: Voluntary Survey (SEPT 2023)

2. FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP 2023)

Refer to Attachment 2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

3. FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998)

4. FAR 52.204-7, System for Award Management (NOV 2024)

5. FAR 52.204-16, Commercial and Government Entity Code Reporting (AUG 2020)

6. FAR 52.204-20, Predecessor of Offeror (AUG 2020)

7. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

8. FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders-Representation and Disclosures (DEC 2023)

9. FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018)

10. FAR 52.214-21, Descriptive Literature (APR 2002), Alternate I (JAN 2017)

11. FAR 52.225-18, Place of Manufacture (AUG 2018)

12. FAR 52.233-2, Service of Protest (SEPT 2006)

13. VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018)

14. VAAR 852.233-71, Alternate Protest Procedure (OCT 2018)

15. VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

End of Addendum to 52.212-1

16. FAR 52.212-2, Evaluation-Commercial Items (NOV 2021)

17. FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (MAY 2024)(DEVIATION FEB 2025)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required.

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

The following contract clauses apply to this acquisition:

1. FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV 2023)

Addendum to FAR 52.212-4

2. FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998)

3. FAR 52.203-16, Preventing Personal Conflicts of Interest (JUN 2020)

4. FAR 52.204-13, System for Award Management Maintenance (OCT 2018)

5. FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020)

6. FAR 52.216-18, Ordering (AUG 2020)

7. FAR 52.216-22, Indefinite Quantity (OCT 1995)

8. FAR 52.217-7, Option for Increased Quantity-Separately Priced Line Item (MAR 1989)

9. FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000)

10. FAR 52.224-1, Privacy Act Notification (APR 1984)

11. FAR 52.224-2, Privacy Act (APR 1984)

12. VAAR 852.203-70, Commercial Advertising (MAY 2018)

13. VAAR 852.208-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors Orders or BPAs (JAN 2023) (DEVIATION)

14. VAAR 852.208-71, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factor Commitments Orders and BPAs (JAN 2023) (DEVIATION)

15. VAAR 852.211-72, Technical Industry Standards (NOV 2018)

16. VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JAN 2023) (DEVIATION)

17. VAAR 852.215-71, Evaluation Factor Commitments (OCT 2019)

18. VAAR 852.223-71, Safety and Health (SEP 2019)

19. VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018)

20. VAAR 852.242-71, Administrative Contracting Officer (OCT 2020)

21. VAAR 852.246-71, Rejected Goods (OCT 2018)

22. VAAR 852.247-71, Delivery Location (OCT 2018)

23. VAAR 852.247-72, Marking Deliverables (OCT 2018)

End of Addendum to 52.212-4

24. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (JAN 2025)

Invoicing

The Contractor will submit each invoice online, including all back-up data, to VA s Electronic Invoice Presentment and Payment System. The Financial Services Center (FSC) uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. Additional information can be found at http://www.fsc.va.gov/einvoice.asp.

All quoters shall submit the following: Refer to ATTACHMENT 1: Tailored FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

All quotes shall be sent to the Contracting Officer at Stacy.Massey@va.gov.

Evaluation

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on price and other factors resulting in a Contracting Officer s decision for the quote that is most favorable to the Government. Refer to ATTACHMENT 2: TAILORED 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES.

The following are the decision factors:

Technical Features

Price

The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than 5:00pm on March 20, 2025. Responses should be sent to the Contracting Officer, Stacy Massey at Stacy.Massey@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact

Stacy Massey

Contracting Officer

Network Contracting Office 12

Stacy.Massey@va.gov