S02 - Combined Synopsis Solicitation - PET Radiopharmaceutical.docx

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 2025-03.

This solicitation is not set-aside and allows for Full and Open competition.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 - Pharmaceutical Preparation Manufacturing, with a small business size standard of 1,300 employees.

The FSC/PSC is 6505 – Drugs and Biologicals.

The Network Contracting Office 02, 130 W. Kingsbridge Road, building 16, Bronx, NY 10468 is seeking to purchase Positron Emission Tomography (PET) Radiopharmaceuticals for the Nuclear Medicine Department at the Buffalo VA Medical Center (VAMC).

Prices quoted should be all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc. All shipping is FOB Destination.

This is an annual estimate of the radiopharmaceuticals needed. These are not required minimum purchases. The Government is not obligated to purchase any specific quantity of any specific item under the awarded IDIQ. The Guaranteed Minimum dollar amount to be executed between the date of contract award and 9/30/2025 is $100,000.00.

All interested companies shall provide quotations for the following:

April 15, 2025 through April 14, 2026 – Base Period

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

April 15, 2026 through April 14, 2027 – Option Period 1

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

April 15, 2027 through April 14, 2028 – Option Period 2

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

Statement of Work Radiopharmaceuticals

1.0 Scope

The Department of Veterans Affairs Western New York Healthcare System located at 3495 Bailey Avenue, Buffalo, NY 14215 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The VA Western NY Healthcare System at Buffalo intends to award a three-year, firm fixed price, Indefinite Delivery, Indefinite Requirements (IDIQ) Contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of April 15, 2025 through April 14, 2028. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State, and Local Regulations. The Contractor must be licensed by the Nuclear Regulatory Commission or an Agreement State and be regularly established to have been in the business of providing radiopharmaceuticals for at least three (3) years. The Contractor shall be able to provide all items listed in the Schedule of Radiopharmaceuticals with deliveries as required. Multiple awards will not be made and Subcontracting is not authorized.

2.0 Statement Of Work

1. The Contractor agrees to provide all radiopharmaceuticals as identified in the Schedule of Radiopharmaceuticals to the VA Western NY Healthcare System at Buffalo on a daily and or as needed basis in accordance with this Statement of Work and the respective awarded contract. The Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides New York and be regularly established in the business of providing radionuclides. The Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their quote submission.

2. 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 the FDA, USDOT, DOE, USNRC, and ICC regulations and standards. Documentation of USDOT package integrity testing shall also be provided.

3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled radioactive on the outside of the carton in which it is shipped.

4. The Contractor shall label all products delivered as to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, calibration time, expiration time, and date.

5. The Contractor shall hold a current unrevoked NRC or an agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. The Contractor shall provide a copy of their radioactive material license with their quote. The Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify their radioactive materials license. The Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and applicable FDA requirements. The Contractor shall perform all quality control procedures as required by Federal and State Regulatory Agencies.

6. The Contractor shall provide with their quote, the following information:

a. The Contractor’s regular work hours.

b. The Contractor’s telephone number for call-in orders during regular work hours.

c. The Contractor’s telephone number for expert advice concerning awarded products.

d. The Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and or with the United States Pharmacopeia.

e. Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide those updated changes in writing to the CO and COR.

7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR at the VA Western NY Healthcare System at Buffalo Nuclear Medicine Service.

8. The Contractor shall make quality control records available to the COR upon written request from the CO or COR.

9. The Contractor shall test all products for quality control periodically as required by the USFDA. This testing shall be performed at no cost to the Government. The Contractor shall provide a detailed description of the test upon request.

10. The Contractor shall replace any items delivered damaged or in error at no cost to the Government. The COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with patient needs.

11. If a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following:

a. Provide technical expertise in calibration;

b. Provide professional examination of product; submit results and recommendations to the COR;

c. Make expedient replacement of any product suspected of being deficient.

12. The Contractor shall pick up packaged Radiopharmaceuticals (used and unused) for proper disposal at no cost to the Government.

13. The Contractor shall produce radiopharmaceuticals as described in the Schedule of Radiopharmaceuticals.

3.0 Deliverables and Acceptance Criteria

1. The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:

a. Provide Radiopharmaceutical Isotopes to the Nuclear Medicine/PET Department for PET oncology, cardiac, and research studies.

b. All radiopharmaceuticals shall be provided on a unit dose basis, or otherwise specified, predrawn into a syringe, calibrated and delivered to the PET/CT Department. This includes new, enhanced, upgraded or other radiopharmaceuticals

c. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo daily quantity of radiopharmaceuticals by 8:00 AM, or by calibration time Monday through Friday as requested from the previous day. Due to the demands of the Medical Center patient care requirements, there shall be no restrictions on the number of orders which may be placed by the VA. All Deliveries shall be FOB Destination.

d. Orders can be placed orally by telephone or fax transmission by Ordering Officers provided by the Contracting Officer Representative.

e. All orders placed will be delivered free of charge with the exception of any add-on order for the same day. Any delivery fees shall be included in the pricing provided Schedule of Radiopharmaceuticals.

f. Deliveries shall be made to the following location: VA Western NY Healthcare System, Attention: PET Department Hot Lab, Room 143, 3495 Bailey Avenue, Buffalo, NY 14215

g. Other delivery times may be outlined by the VA Western NY Healthcare System at Buffalo in this Statement of Work.

2. If Monday is a Federal Holiday, no deliveries will be expected. Holidays are listed herein.

3. Shipments called when needed may be requested during regular work hours.

4. All shipments will have packing slips enclosed providing information about the product and its identification, plus for billing purposes the VA Western NY Healthcare System at Buffalo Purchase Order Number issued for the current fiscal year, and the Contractor’s invoice number. Incorrect Purchase Order Numbers as well as invoicing discrepancies will cause a delay in payments.

5. In the event of a shutdown or production issue of contractors radiopharmacy, contractor must have a contingency plan in place in order to fill the radiopharmaceutical orders.

4.0 VA Operating Hours

The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor shall not be required to furnish such products on a national holiday or during non-working hours as described below except for normal next day delivery.

The following terms have the following meanings:

Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 AM to 4:30 PM Eastern Standard Time Deliveries shall be accomplished by 8:00 AM or by dose calibration time and on an as needed basis during normal operating hours.

The Contractor to include up to one (1) delivery per normal working day during normal working hours as needed at no additional charge.

National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

5.0 Contract Award

Upon contract award, within five (5) business days, the awarded Contractor shall provide:

1. A copy of their Laboratory’s current quality control manual to the COR.

2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Medical Center and the Contractor’s Laboratory Pharmacy.

3. Material safety data sheets and updates on all delivered products as per contract award and any additions throughout the period of performance of the awarded contract.

4. Patient orientation education video presentations and other appropriate material at no additional cost to the Government.

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

6.0 Quality Requirements

The Contractor shall guarantee the quality of their radiopharmaceuticals. Quality Control shall include, but is not limited to, pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of Quality Control results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer or COR.

7.0 Personnel Policy

1. The Contractor is responsible for all costs, including personnel costs, associated with the respective awarded contract unless otherwise specified.

2. Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

8.0 Special Contract Requirements: HHS/OIG

To ensure that the individuals providing services under this respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and or abuse of the Medicare and Medicaid programs. During the performance of this respective awarded contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their quote, the Contractor certifies that all persons or entities listed in the Contractor’s quote have been compared against the OIG list and are NOT listed as of the date their quote was signed.

9.0 Contactor Staff Roles And Responsibilities

The Contractor must be in compliance with all Nuclear Regulatory Commission, United States Pharmacopeia, United States Food and Drug Administration, State, Local, and Joint Commission guidelines, as well as United States Pharmacopeia 797 guidelines.

10.0 Contractor Performance Assessments

Assessments: The Government will complete assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to said assessments.

Record: The Government will keep completed assessments to serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future requirements.

11.0 Designation Of Contract Officer Representation

The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance and advice regarding the work being performed under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

12.0 Contractor Recall And Safety Plan And Process Notification To The Facility

The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and maintain a record system to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.

13.0 HIPAA Compliance

The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs.

14.0 Availability Of Funds During A Continuing Resolution

At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for the respective awarded contract are provided under a CR, funds will only be available for performance under this respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of the respective awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.

15.0 Required Registration With Contractor Performance Assessment System (CPARS)

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials through the Contractor Performance Assessment Reporting System (CPARS). The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement, the Department of Veterans Affairs uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is available to all Federal Agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the Contracting Officer contact information for the Contractor’s representative with their response to the solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor’s representative during the respective awarded contract period of performance. The Contractor’s representative contact information consists of their name, telephone number, and email address.

The Government will register the respective awarded contract within thirty (30) days after contract award. For contracts exceeding one (1) year, the Contracting Officer will evaluate the Contractor’s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the Contractor’s designated representative for comment. The Contractor’s representative will have thirty (30) days to submit any comments and return the report to the Contracting Officer. Failure by the Contractor to respond within those thirty (30) days will result in the Government’s evaluation being placed on file in PPIRS without any Contractor comments.

16.0 Prohibition On Working Outside Of The United States

The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any Department of Veterans Affairs data or information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any Department of Veterans Affairs data or information to locations outside the above-stated borders.

17.0 Term of Contract

This will be a single award, firm fixed price three (3) year IDIQ Contract. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer, the awarded IDIQ Contract may be canceled with thirty (30) days written notice to the Contractor by the Contracting Officer.The awarded IDIQ Contract shall be reviewed annually.

18.0 Schedule of Required Radiopharmaceuticals

Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc. All shipping is FOB Destination.

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

April 15, 2025 through April 14, 2026 – Base Year

April 15, 2026 through April 14, 2027 – Option Year 1

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

April 15, 2027 through April 14, 2028 – Option Year 2

(DetectNet)

(Pylarify)

(Neuraceq) β-amyloid imaging

The Indefinite Delivery/Indefinite Quantity contract period of performance will be from April 15, 2025 – April 14, 2028, to include a base requirement period of performance of April 15, 2025 – April 14, 2026, and two (2) twelve (12) month Option periods.

Delivery shall be FOB Destination.

Place of Performance/Place of Delivery

3495 Bailey Avenue, Buffalo, NY

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 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services” ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have 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 version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provision is incorporated into 52.212-1 as an addendum to this solicitation:

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits an quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified in this solicitation. Quotes may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotes must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Quotation Amendments;

(10) Past performance information will not be considered in simplified acquisition procurements.

(11) Quotes should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations, or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of Quotes. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotes. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during preaward testing.

(e) Alternate Quotes. The Government is not requesting alternate quotations, however, quoters may present alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Any exceptions taken by the quoter must clearly be identified in writing.

(f) Late submissions, modifications, revisions, and withdrawals of quotes.

(1) Quoters are responsible for submitting quotes, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotes or revisions are due.

(2) Any quote received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quote would not unduly delay the acquisition.

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotes cannot be received at the Government office designated for receipt of quotes by the exact time specified in the Request for Quote, 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 quotes 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.

(g) Issuance of Contract. The Government may issue a contract to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter’s initial quote should contain the best terms from a price and technical standpoint. However, the Government may reject any or all quotes if such action is in the public’s best interest. In addition, the Contracting Officer (CO) may issue a contract to other than the quoter with the lowest quoted price.

(h) Multiple awards. The Government may accept issue a contract for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the quotation, offers may not be submitted for quantities less than those specified in the RFQ. The Government reserves the right to issue a contract for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quote.

(i) Availability of requirements documents cited in the solicitation.

(1)

(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101–29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by—

(i) Using the ASSIST feedback module ( https://assist.dla.mil/feedback); or

(ii) Contacting the Defense Standardization Program Office by telephone at 571–767–6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier.(Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the Request for Quote (RFQ) requires the Contractor to be registered in the System for Award Management (SAM).) The quoter shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Quoter's name and address. The Quoter also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Quoter does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Quoter should indicate that it is an planning to submit a quote for a Government Request for Quote (RFQ) when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) [Reserved]

(l) Notification. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ).

(m) Licensure. The quoter must include a copy of their Nuclear Pharmacy License with their submission.

(n) Emergency Plan. The quoter must provide an emergency plan procedure for deliveries in inclement weather with their submission.

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR)

52.204-7 SYSTEM FOR AWARD MANAGEMENT (NOV 2024)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (AUG 2020)

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS – NOTICE AND REPR

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

52.233-2 SERVICE OF PROTEST (SEP 2006)

VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (SEP 2018)

VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023) (End of provision)

2. FAR 52.212-2, “Evaluation-Commercial Products and Commercial Services”

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(a) Basis for Award. The Government will issue a contract to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate quotations:

(1) Technical Capability

(2) Past Performance

(3) Price Evaluation Approach. The Government may evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting alternate quotations; however, the offeror may present alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Any exceptions taken by the offeror must clearly identified in writing. The evaluation will consider the following:

(1) Technical Capability: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

(2) Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis. If applicable, quoter’s should provide a list of current contracts or contracts awarded within the past three years of similar size, scope, or complexity. Contracts may have been awarded by Federal, State, and Local Government, as well as private customers. List should include:

i. Name and Address of Contracting Activity or Company

ii. Name and email address or phone number of a Point of Contact (Contracting Officer, Lab Contracting Officer Representative, Lab Manager, etc.) who would have firsthand knowledge of the contract performance.

iii. Contract Number and Period of Performance.

(3) Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Total Evaluated Price will be that sum. Prices quoted should be all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc.

(b) Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by adding six months of the quoter's price for the last potential period of performance under this contract to the quoter's total price. For example, if the contract includes option periods that are exercisable under FAR 52.217-9, the quoter's total price for the purpose of evaluation will include the base period, all option periods, and an additional six months of the last option period. Quoters must price only the base and option periods specified in the contract line item numbers (CLINs), and shall not submit a price for the potential six-month extension of services under FAR 52.217-8. The Government reserves the right to exercise the option under FAR 52.217-8 before the end of any of the contractor's performance periods and will be exercised at the price and/or rates in effect at the time the clause is exercised. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise 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)

3. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services”

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.

Note: www.sam.gov registration is required to be complete at the time of submission of response.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services” (NOV 2023)

Addendum to 52.212-4 – Contract Terms and Conditions – Commercial Products and Commercial Services (NOV 2023)

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020)

52.216-18 ORDERING (AUG 2020)

(a) Such orders may be issued from April 15, 2025 through April 14, 2028.

52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) In an amount of less than $20,000.00

(b) (1) In excess of $700,000.00

(b) (2) In excess of $700,000.00

(b) (3) seven days

(d) seven days

52.216-22 INDEFINITE QUANTITY (OCT 1995)

(d) December 31, 2028

52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989)

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of exercising the option.

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

52.225-5 TRADE AGREEMENTS (NOV 2023)

52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

52.247-34 F.O.B. DESTINATION (NOV 1991)

VAAR 852.201-70 CONTRACTING OFFICER’S REPRESENTATIVE (DEC 2022)

VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

VAAR 852.246-71 REJECTED GOODS (OCT 2018)

VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS OR BPAS (NOV 2022)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Buffalo VA Medical Center 3495 Bailey Avenue Buffalo, NY 14215

VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

(b) All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled radioactive on the outside of the carton in which it is shipped. The Contractor shall label all products delivered as to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, calibration time, expiration time, and date.

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

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services” (FEB 2025)

The following subparagraphs of FAR 52.212-5 are applicable:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E. Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kapersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78) (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[X ] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

[X ] (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

[X ] (5) 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

[ X ] (9) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub L. 117-328).

[X ] (11) (i) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

[X ] (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded (JAN 2025) (31 U.S.C. 6101 note).

[ X ] (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

[ X ] (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[ X ] (20) 52.219-8, Utilization of Small Business Concerns (JAN 2025) (15 U.S.C. 637(d)(2) and (3)).

[ X ] (26) (i) 52.219-28, PostAward Small Business Program Rerepresentation (JAN 2025) (15 U.S.C. 632(a)(2)).

[X ] (30) 52.219-33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 637(a)(17)).

[ X ] (31) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[X ] (32) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2025)(E.O.13126).

[ X ] (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X ] (34)(i) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

[ X ] (35)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[ X ] (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[X ] (37) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X ] (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[ X ] (39)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

[ X ] (46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

[X ] (50) 52.225-5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X ] (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O’.s, proclamations and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[ X ] (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513)

[ X ] (56) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021)

[X ] (59) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) (31 U.S.C. 3332).

[ X ] (63) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (NOV 2024) (Sections 1821-1826, Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records - Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form.