36C25225Q0339_1 - FINAL 03 19 2025.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

National Contracting Office 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

POINT OF CONTACT*

Contracting Officer Tiffany Pevey Tiffany.Pevey@va.gov

PLACE OF PERFORMANCE

Captain James A. Lovell FHCC

3001 North Green Bay Ave

North Chicago, IL 60064

USA

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Combined Synopsis-Solicitation for Commercial Products and Commercial Services

Description 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 unrestricted.

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), Captain James A. Lovell FHCC has a requirement for Radiopharmaceutical. The Radiopharmaceutical Isotopes will be used for diagnostic testing and quality assurance.

All interested companies shall provide quotations for the following:

Schedule of Supplies(min:)

Base Year 04/01/2025 – 03/31/2026

*est. at 200 total mCi*

*NOTE: Co-57 dose calibrator Vial is 10mCi model #BM06E-157, Co-57 sheet source 15mCi model #BM01L-15*

Statement of Work/Description/Specifications:

1. Offeror shall be able to provide all Radiopharmaceutical unit doses and other supplies listed in supplies and services of this solicitation, Multiple awards WILL NOT be made.

2. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/

a. A Licensee may use for medical use only:

3. By product material manufactured, labeled, packaged, and distributed in accordance with a License issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State

4. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Nuclear Regulatory Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of Radiopharmaceuticals for medical use

5. Contractor shall be licensed by the Nuclear Regulatory Commission and/or licensed by an Agreement State and be regularly established in the business of providing radionuclides. Offeror must provide copies of these licenses prior to award

6. Contractor shall be in compliance with USP 797 guidelines

7. Contractor shall provide routine delivery and pick-up:

· Routine Weekday (M-F) delivery times: 4A to 6A (first daily delivery) and 10A (2nd daily delivery) and 1PM (3rd daily delivery)

· There are no scheduled weekend deliveries. However, FHCC may require STAT orders within two hours of receiving the order by phone or otherwise from FHCC. FHCC has averaged approximately four STAT orders per month. Delivery and pick up shall be to the Nuclear Medicine Department, Room 2D110 at the Captain James A. Lovell FHCC, 3001 Green Bay Road, North Chicago, IL 60064.

8. Contractor shall upon request replace the wrong delivered item or replace damaged item at no cost to the FHCC medical center

9. Contractor shall label all supplies as to the amount of Radiopharmaceutical, preparation time, expiration time, date, etc

10. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation. Federal Department of Agriculture and all other agency rules and regulations (Federal and State).

11. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

12. Contractor must provide a copy of their laboratory’s current quality control manual and must be willing to discuss any discrepancies in lab results which do not fit the clinical picture.

13. Contractor shall provide upon request a detailed description of the test to be performed, as provided by the manufacturer

14. Contractor shall provide at no charge, periodic quality control testing upon VA’s request. Contractor shall provide at no charge the results of the contractor’s testing

15. Contractor shall assign to this medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy

16. Contractor shall pick up and return scheduled items (9 and 15) within six hours

17. Contractor shall provide material safety data sheet binders and update on all delivered products

18. Contractor shall provide patient orientation education video presentations and other appropriate material as deemed necessary by the hospital

19. Contractor shall provide appropriate signs and posters alerting patients, employees and the public of safety precautions in handling of radioactive materials

20. Contractor shall provide educational materials as necessary

21. Contractor shall include packing list with barcodes of all doses to be entered into Nuclear Medicine Information System (NMIS) Inventory System

22. Contractor shall include barcode label on each individual dose pig to be scanned into NMIS prior to injection

23. Contractor shall provide Low Enriched Uranium Technetium when at all possible, as mandated by VA Central Office

24. Contractor delivery personnel would need to comply with the visitor requirements for access to FHCC

1) The Federal Holidays observed by the VA are as follows:

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:

3001 North Green Bay Road North Chicago, IL 60064 USA

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) 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: FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES All quotes shall be sent to the Contracting Officer at via email to Tiffany.Pevey@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. 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES.

The following are the decision factors:

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 21, 2025. Responses should be sent to the Contracting Officer, Tiffany Pevey at Tiffany.Pevey@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 before the solicitation closes:

Point of Contact:

Tiffany Pevey Contracting Officer Network Contracting Office 12 Tiffany.Pevey@va.gov

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