Solicitation for PET Radiopharmaceuticals for Prostate Cancer Imaging

This requirement must be contracted due to the local production requirements of the radioisotope being provided. PET pharmaceuticals have a short shelf life ( ) guidelines. Maintain Illinois Emergency Management Agency (IEMA) license and provide copies prior to award. Perform Quality Control testing per USP at no cost to VA; provide test details upon request.

Assign a sales representative for coordination between the hospital and the contractor s pharmacy. Replace damaged or incorrect products at contractor s expense. Apply unused dose fee policy: If a dose is unused due to patient no-show or cancellation, VA may request an unused dose fee of $450 instead of full price if requested by 8:00 PM ET next business day. Item Description Description Normal Dose Unit Est.

Annual Qty F-18 PSMA Imaging Radiopharmaceutical 9 mCi Unit Dose 205 4. Performance Monitoring Nuclear Medicine inspects every package for compliance and contamination. Invoices compared to packing slips; discrepancies reported to vendor. Delivery timeliness monitored; vendor notified of issues. 5. Security Requirements None identified. 6. Government-Furnished Equipment/Information Not Applicable. 7.

Packaging, Packing, and Shipping All packaging must meet federal and state regulations and be clearly labeled RADIOACTIVE on the outside of the carton. 8. Inspection and Acceptance Every package is inspected upon receipt; testing is performed to ensure compliance. Nuclear Medicine will compare invoices to orders and notify vendor of discrepancies within 24 hours. 9.

Risk Control The contractor must comply with all applicable regulations for safe transport and delivery of radioactive materials, including NRC, DOT, IEMA, and VA National Health Physics Program requirements. 10. Delivery Schedule PET Prostate doses delivered daily as needed based on patient demand; no routine weekend deliveries.

(End Performance Work Statement) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer.

In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identified and provide the appropriate information with its quotation or offer.

The full text of FAR and VAAR provisions or clauses may be accessed electronically at: https://www.acquisition.gov/far-overhaul https://www.acquisition.gov/vaar The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (FEB 1998) FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025) FAR 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (SEP 2024) FAR 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (JAN 2017) FAR 52.204-7, System for Award Management (NOV 2024)(DEVIATION NOV 2025) FAR 52.209-7, Information Regarding Responsibility Matters (OCT 2018) (DEVIATION NOV 2025) FAR 52.219-1, Small Business Program Representations (FEB 2024) (DEVIATION NOV 2025) FAR 52.225-6, Trade Agreements Certificate (FEB 2021) FAR 52.225-18, Place of Manufacture (AUG 2018) FAR 52.233-2, Service of Protest (SEP 2006) (DEVIATION NOV 2025) FAR 52.252-5, Authorized Deviations in Provisions (NOV 2020) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (OCT 2018) VAAR 852.233-71, Alternate Protest Procedure (OCT 2018) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) The Offeror shall have an active Federal Government contracts registration in the System for Award Management (SAM) when submitting an offer or quotation in response to this solicitation and at the time of award.

To register in SAM, go to https://www.sam.gov. Allow for processing time when registering in SAM. If the Offeror is not registered in SAM, it should register immediately after receiving this solicitation.

The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV 2023)(DEVIATION OCT 2025) FAR 52.252-2, Clauses Incorporated by Reference (FEB 1998) FAR 52.203-6, Restrictions on Subcontractor Sales to the Government ALT 1(NOV 2021) FAR 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) FAR 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) FAR 52.204-13, System for Award Management Maintenance (OCT 2018)(DEVIATION NOV 2025) FAR 52.204-18, Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (JAN 2025) (DEVIATION NOV 2025) FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (DEVIATION NOV 2025) FAR 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015) (DEVIATION NOV 2025) FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (DEVIATION NOV 2025) FAR 52.219-8, Utilization of Small Business Concerns (JAN 2025) (DEVIATION NOV 2025) FAR 52.222-3, Convict Labor (JUN 2003) (DEVIATION NOV 2025) FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2025) (DEVIATION NOV 2025) FAR 52.222-35, Equal Opportunity for Veterans (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-37, Employment Reports on Veterans (JUN 2020) (DEVIATION NOV 2025) FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)(DEVIATION NOV 2025) FAR 52.222-50, Combating Trafficking in Persons (NOV 2021) (DEVIATION NOV 2025) FAR 52.223-23, Sustainable Products (MAY 2024) (DEVIATION NOV 2025) FAR 52.224-1, Privacy Act Notification (APR 1984) FAR52.224-2, Privacy Act (APR 1984) FAR 52.225-5, Trade Agreements (NOV 2023) FAR 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) FAR 52.229-3, Federal, State, and Local Taxes (FEB 2013) (DEVIATION SEP 2025) FAR 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) FAR 52.233-3, Protest After Award (AUG 1996) (DEVIATION NOV 2025) FAR 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (DEVIATION NOV 2025) FAR 52.244-6, Subcontracts for Commercial Products and Commercial Services (JAN 2025)(DEVIATION OCT 2025) FAR 52.252-6, Authorized Deviations in Clauses (NOV 2020) VAAR 852.203-70, Commercial Advertising (MAY 2018) VAAR 852.208-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors Orders or BPAs (JAN 2023) (DEVIATION) VAAR 852.208-71, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factor Commitments Orders and BPAs (JAN 2023) (DEVIATION) VAAR 852.222-71, Compliance with Executive Order 13899 (DEVIATION)(APR 2025) VAAR 852.223-71, Safety and Health (SEP 2019) VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2018) VAAR 852.237-74, Nondiscrimination in Service Delivery (OCT 2019) VAAR 852.242-71, Administrative Contracting Officer (OCT 2020) VAAR 852.246-71, Rejected Goods (OCT 2018) VAAR 852.247-71, Delivery Location (OCT 2018) VAAR 852.247-72, Marking Deliverables (OCT 2018) (End of clause) Protests Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from the Contracting Officer, Stacy Massey at Stacy.Massey@va.gov.

The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. 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.

When preparing offers/quotes in response to this solicitation offerors shall refer to FAR 52.212-1 (Instructions to Offerors-Commercial Products and Commercial Services), and FAR 52.212-2 (Evaluation-Commercial Products and Commercial Services). These sections contain specific instructions, guidance, format, and exact requirements for what constitutes a complete and responsive offer/quote.

As specified in these sections an incomplete and/or non-responsive offer/quote shall not be considered for a contract award by the contracting officer. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: 52.212-1Â Instructions to Offerors Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025) (a) Submission of offers.

Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation.

As a minimum, offers shall include (NOTE: The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.) The solicitation number; The name, address, and telephone number of the Offeror; The Offeror s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator; The offeror must demonstrate compliance with all mandatory requirements in the PWS.

The offeror must demonstrate the ability to meet delivery requirements Relevant experience with similar contracts Completed Attachment 1: Price Cost Schedule Template and any discount terms; "Remit to" address, if different than mailing address; Authorized distributor/reseller letter signed by the manufacturer, if applicable; A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

(b) Period for acceptance of Quotes. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation. (c) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is late and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition.

However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(4) Offerors may withdraw their offers by written notice to the Government received at any time before award. (d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror s initial offer should contain the Offeror s best terms.

However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received. (e) Debriefings.

If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable: (1) The agency s evaluation of the significant weak or deficient factors in the debriefed Offeror s offer. (2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror. (End of provision) Evaluation The award will be based upon a comparative evaluation of quotes in accordance with the evaluation process of FAR 12.201-1.

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. The award will be made to the contractor whose response is most advantageous to the Government. Responses should contain your best terms and conditions.

The government reserves the right to select a response that provides benefit to the government that exceeds the minimum. The government is not required to select a response that exceeds the minimum. Responses may exceed requirements. Each response must at a minimum meet the solicitation requirement.

While price is important, the Government reserves the right to award to a higher-priced offeror if the technical solution and delivery reliability provide greater value and lower risk to patient care. The following provision is incorporated into 52.212-2 as an addendum to this solicitation: 52.212-2 Evaluation Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025) Evaluation factors.

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

The following factors will be used to evaluate offers: The following factors will be used to evaluate quotations: Technical Acceptability: The offeror must demonstrate compliance with all mandatory requirements in the Performance Work Statement (PWS). Technical proposals will be evaluated on a Pass/Fail basis.

To receive a Pass, the offeror must provide evidence of: FDA Approval for PET-CT F-18 PSMA prostate imaging radiopharmaceuticals. Regulatory Compliance with NRC, DOT, FDA, USP 825, and state licensing requirements (including Illinois Emergency Management Agency license). Delivery Capability to provide daily unit doses within required timeframes and proximity (preferably within 30 miles of Jesse Brown VA Hospital).

Quality Assurance including proper labeling, packaging, and documentation (calibrated activity, expiration date/time, SDS). Performance Support with a dedicated representative and procedures for cancellations, replacements, and quality control testing. Failure to meet any mandatory requirement will result in a Fail rating and elimination from further consideration.

Delivery Reliability: The Government will evaluate the offeror s ability to meet delivery requirements, including: Proximity to Jesse Brown VA Hospital (preferably within 30 miles). Ability to accommodate urgent schedule changes. On-time delivery performance history.

Contingency plans for emergencies or supply disruptions Past performance: The Government will assess the offeror s past performance on similar contracts for PET radiopharmaceuticals or related nuclear medicine services. Evaluation will consider: Quality of product and service. Timeliness of delivery. Responsiveness and customer support. Compliance with regulatory requirements.

Offerors should provide at least three references for contracts performed within the last three years. Price: Price will be evaluated for fairness and reasonableness in accordance with FAR 12.204(a). Pricing for unused dose fee and ancillary charges (if applicable) Offerors must submit a complete price schedule for all items. (b) Options (if applicable).

The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s). (c) Notice of award.

A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) Submission of your response shall be received not later than 5:00pm on January 26, 2025.

Responses should be sent to the Contracting Officer, Stacy Massey at Stacy.Massey@va.gov. 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