36C24220Q0295-000.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Radiopharmaceuticals for Buffalo Nuclear Medicine 12208-3410 36C24220Q0295 03-20-2020 N 325412 Department of Veterans Affairs Samuel S . Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410 Michael.Spatuzzi@va.gov

The Buffalo VA Medical Center has a procurement request for radiopharmaceuticals. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this solicitation. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued. Interested Contractors that respond to this Combined Synopsis Solicitation must provide evidence that they are able to meet all of the requirements identified herein. This requirement is being solicited unrestricted.

The proposed contract action is for supplies for which the Government intends to solicit competitive offers to award a firm fixed price contract. Interested Contractors may submit offers, and all eligible offers received prior to the date listed in Beta Sam shall be considered by the Government. The NAICS code for this requirement is 325412 and the size standard is 1250 Employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-95. Only emailed proposals received directly from the offeror shall be considered.

Statement of Work

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 shall award a three year firm fixed price contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies in New York State with a period of performance of July 1, 2020 through June 30, 2023. The Contractor agrees in accordance with the terms and conditions listed in this statement of work (SOW) to furnish radiopharmaceuticals in accordance with Local, New York State, and Federal Regulations. The Contractor shall be able to provide all items listed in the Schedule of Required Radiopharmaceuticals with deliveries as needed. Multiple awards shall not be made and subcontracting is not authorized.

1.1 BACKGROUND

Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. Licensing assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to thirty-four (34) NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. The FDA’s Center for Drug Evaluation and Research regulates the radio pharmaceuticals ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. Although a non-regulatory federal agency, NIST develops the standards for correct patient dosage of radiopharmaceuticals.

2.0

1. The Contractor shall provide all radiopharmaceuticals identified in the Schedule of Required Radiopharmaceuticals to the VA Western NY Healthcare System at Buffalo on a daily and or as needed basis in accordance with this SOW. Due to the critical need for these supplies in a timely manner, only Contractors that are able to complete deliveries within two (2) hours to the VA Western NY Healthcare System at Buffalo need respond to the solicitation. The Contractor shall be licensed by the State of New York. Additionally, 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 proposal. The Contractor shall provide evidence of being able to make deliveries within two (2) hours with their proposal. As part of their proposal package, the Contractor shall identify the location of the point of shipment to the address identified under section 1.0 of this SOW. Verification shall be completed utilizing MapQuest, via www.mapquest.com.

2. Deliveries shall incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal or State standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and New York State regulations. This shall include the FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT 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 New York 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 to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, 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 proposal documents. The Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR) upon any action by the NRC, an agreement state, or the 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 New York State Regulatory Agencies.

6. The Contractor shall provide with their proposal the below information from letters a through f.

a. The Contractor’s normal work hours.

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

c. The Contractor’s telephone number and instructions for placing emergency orders after the Contractor’s normal work hours to include weekends.

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

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

f. If 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 Contracting Officer (CO) and Contracting Officer Representative (COR).

7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract shall be shipped to the Nuclear Medicine Service. If any new or updated additions to the package inserts are made available, these shall 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. 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 calibration time for each requested radiopharmaceutical is listed in the Schedule of Radiopharmaceuticals. If a calibration time is not indicated, then it shall be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

11. If an ordered dosage of radioactive material is given to the Contractor and it falls within a specified range, then the quantity of radioactivity must be within the dose range provided. If the dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals must not deviate more than ±20%.

12. Technetium product radiopharmaceuticals not used shall be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit shall be reflected in the current month’s invoice.

13. 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 care needs.

14. The expiration date and time shall be indicated and affixed to each product as noted in a through d below.

a. Ready-to-use doses not shorter than six (6) hours.

b. Tc-99m Pertechnetate not shorter than twelve (12) hours.

c. Kits intended for reconstitution by user not shorter than three (3) months from date of delivery.

d. Unused kits having expiration time not less than two (2) weeks shall be exchanged by the Contractor at no additional charge for a comparable kit having a three (3) months life span.

15. If a quality control or material defect is suspected or detected by the COR, the Contractor shall 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 and submit results and recommendations to the COR.

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

16. The procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc-Ceretec for reinjecting to the same patient:

a. Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM Eastern Standard Time for the next workday procedure.

b. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor shall be at 7:30 AM Eastern Standard Time or later, if specified by the COR.

c. The return by the Contractor of the patient's Indium labeled White Blood Cells shall take place not later than within 5 (five) hours from the time of specimen pick up time.

d. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

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

18. 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 in accordance with this Statement of Work, as set forth below:

a. Provide up to two deliveries per day during regular operating hours to the VA Western NY Healthcare System at Buffalo at no additional charge. Delivery charges for STAT orders shall be included on the Schedule of Radiopharmaceuticals. STAT deliveries shall average approximately three times a week.

b. Regular daily radiopharmaceutical doses ordered the previous day shall be delivered in one morning delivery by 7:00 AM Eastern Standard Time and not split into two separate deliveries with one delivered later in the day.

c. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo daily quantity of radiopharmaceuticals by 7:00 AM Eastern Standard Time, as requested from the previous day. In addition to the morning delivery, one more delivery (During Normal Operating Hours) shall be allowed daily at no cost per additional order or emergency.

d. Orders may be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative.

e. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than two (2) hours after notification.

f. Radioactive dose boxes that are delivered outside of working hours shall be placed in the locked box on floor 4C. The Contractor shall have a key to the locked box for this purpose and shall not leave a radioactive materials package at the VA Western NY Healthcare System at Buffalo unless they have verbally communicated this with a Nuclear Medicine staff member.

2. On federal holidays, no deliveries shall be accepted. Federal holidays are listed in this SOW.

3. Shipments called when needed may be requested during regular work hours, or after hours as an emergency to include weekends, holidays, and nights.

4. Shipments requested as an emergency shall be delivered as follows:

a. Requests placed after regular work hours (weekends, holidays, and nights) shall be delivered within two (2) hours, or as otherwise specified.

b. Emergency, weekend, and holiday shipments shall be delivered to the location specified by the VA Western NY Healthcare System at Buffalo, unless otherwise specified when called for.

c. All shipments shall be labeled as RADIOACTIVE MATERIAL in compliance with all Federal, New York State, and Local Laws.

d. All Radiopharmaceuticals, Radioassay Kits, or Analytic Kits shall to be furnished by the Contractor in strict accordance with the terms and conditions of this Statement of Work and all applicable Federal, New York State, and Local Laws.

e. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by the VA Western NY Healthcare System at Buffalo identified within this Statement of Work shall be strictly adhered to.

5. All shipments must have packing slips enclosed providing information about the product and its identification. All invoices shall be submitted electronically through the Tungsten Network and all invoices shall include the purchase order number, product ordered, national drug code, quantity ordered, and the unit price.

6. The Contractor must provide a radiopharmaceutical invoice with each delivery with each dose bar coded using the Pinestar system. If the Buffalo VA Medical Center’s Pinestar system is not compatible with the bar coding that is provided, then the Contractor must provide whatever software or hardware is necessary to make Buffalo’s system compatible with the Contractor’s barcoding technology.

4.0 VA OPERATING HOURS

The delivery of products under 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 except in the case of an emergency to furnish products on a national holiday or during nonworking hours as described below with the exception of 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 7:00 AM Eastern Standard Time and on an as needed basis during normal operating hours.

The Contractor shall include up to two (2) deliveries per normal working day during normal working hours as needed at no additional charge.

Federal Holidays: The ten holidays observed by the Federal Government are as follows:

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 federal holiday.

5.0 CONTRACT AWARD

Within five (5) business days of the contract award the awarded Contractor shall provide the following:

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 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 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 shall 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, shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with the applicable agreement state or NRC license requirements to the 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 radiopharmaceuticals listed in 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 individuals providing services under the 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 the awarded contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the performance of the 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 proposal, the Contractor certifies that all persons or entities listed in the Contractor’s proposal have been compared against the OIG list and are not listed as of the date their proposal was signed.

9.0 CONTRACTOR 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 DESIGNATION OF CONTRACTING OFFICER REPRESENTATIVE (COR)

The COR shall be designated in writing. The COR shall furnish 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 the sole responsibility of the Contracting Officer.

11.0 CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO 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 in order 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 also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.

12.0 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.

13.0 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. 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). 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 contract period of performance. The Contractor’s representative contact information consists of their name, telephone number, and email address.

The Government shall 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 shall be filed each year until the last year of the contract, when the final report shall 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 shall result in the Government’s evaluation being placed on file in CPARS without any Contractor comments.

14.0 CONTRACT TERM

The respective awarded contract shall be for three years and the period of performance shall run from July 1, 2020 through June 30, 2023.

Schedule of Required Radiopharmaceuticals Please Note: Offerors must provide pricing on all items in the Schedule of Required Radiopharmaceuticals. Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses etc., excluding emergency delivery, Pharmacist After-Hour Emergency Call-Back, and Weekend White Blood Cell labeling charge.

Year 1: July 1, 2020 through June 30, 2021

(ESTIMATED 156 DELIVERIES ANNUALLY)

Order

N/A

Year Two: July 1, 2021 through June 30, 2022

N/A

Order

Year Three: July 1, 2022 through June 30, 2023

N/A

Order

After hour and emergency charges for the VA Western NY Healthcare System at Buffalo .Deliveries during normal work hours Monday through Friday are at no charge. Offeror must list any additional charges below:

Emergency Delivery: Charge for delivering unscheduled emergency orders during normal business hours within two (2) hours of receiving the order by phone from the Buffalo VA Medical Center Nuclear Medicine Department.

Pharmacist (Emergency after hours): The charge for having a Pharmacist called back to the Pharmacy after hours, prepare the ordered dose and have it delivered to the VA within two hours. (Emergency orders only).

Weekend WBC labeling charge: The charge for the Pharmacy to attach a radionuclide to the patient’s white blood cells on a weekend.

Year One Total Price is _______________________ Year Two Total Price is _______________________ Year Three Total Price is _______________________ Total Price for all three years is _______________________ 52.212-2 EVALUATION—COMMERCIAL ITEMS (October 2014) 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 shall be used to evaluate offers: Technical Approach and Capability, Past Performance, and Price.

Factor I: Technical Approach and Capability Subfactor 1: The offeror must include a copy of their Nuclear Pharmacy License.

Subfactor 2: The offeror must demonstrate their ability to deliver products Monday through Friday by 7:00 AM Eastern Standard Time. The offeror must provide a MapQuest illustration demonstrating their ability to make deliveries.

Subfactor 3: The offeror must provide an emergency plan procedure for deliveries in inclement weather.

Factor II: Past Performance The Offeror shall provide a minimum of three (3) references of current contracts within the past three (3) years of similar size, scope, and or complexity. References may include Federal, State, and Local Government as well as private customers and shall include the following information:

Name and address of the Contracting Activity (Medical Center or Company).

Names, email addresses, and telephone numbers of two points of contact (Contracting Officer and Customer) that would have firsthand knowledge on the performance of the contract.

Contract type, scope of work, and contract total dollar value.

Contract number to include the beginning date and ending date of the contract period of performance.

The past performance evaluation factor will assess the relevance and breadth of the offeror’s experience and the quality of the offeror’s past performance. The Government is seeking to determine whether the offeror has experience that will enhance its technical capability to perform and whether the offeror consistently delivers quality services in a timely and cost effective manner. In evaluating past performance, the Government will only take into consideration the relevant experience from the offeror’s customers.

Information obtained from the offerors and any other sources deemed appropriate shall be used by the Government in conducting past performance evaluations. The Government shall analyze the historical facts of the offerors past performance made by its customers, and make qualitative judgements about the facts and observations. Offeror’s may provide information on problems encountered on identified contracts and the offeror’s corrective action. The Government shall determine the relevance of similar past performance information.

In accordance with FAR 15.305(a)(2)(iv) offeror’s with no relevant performance history shall not be evaluated favorably or unfavorably on past performance.

Factor III: Price

In accordance with FAR 17.206 price shall be evaluated for the entire three year contract period. Price evaluation shall be undertaken in accordance with FAR 12.209.

All evaluation factors except price shall be evaluated as either acceptable or unacceptable. Your proposal must meet all the requirements identified in the SOW. If your proposal does not meet all of the SOW requirements it will be evaluated as unacceptable and will receive no further consideration for award. If your proposal does not provide pricing for all of the Schedule of Radiopharmaceuticals it shall be evaluated as unacceptable and will receive no further consideration for award. Price is the most important evaluation factor, followed by technical approach and capability, and then past performance.

At a minimum, proposals must include the following:

1. Offerors must return provision 52.212-3 with their quote. Offerors may either (1) complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at sam.gov.

2. Company name, phone number, and fax number.

3. Company point of contact name, email address, and phone number.

4. Company Mailing address and Remit to address, if different than mailing address.

5. Acknowledgment of Solicitation Amendment(s) if applicable.

6. Offeror's Federal Tax ID Number.

7. Offeror's DUNS number.

8. Offeror’s Business Size.

9. Offeror must provide copies of all required licenses and certifications as identified in the SOW.

10. A detailed statement regarding the offeror’s emergency plan for providing deliveries during periods of inclement weather.

11. MapQuest illustration demonstrating that the offeror can complete all deliveries within two (2) hours.

This is a combined synopsis solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and the Government shall award a contract for the delivery of radiopharmaceuticals to the Buffalo Nuclear Medicine Department. The solicitation number is VA242-20-Q-0295 and the solicitation is issued as a request for quotation (RFQ). This combined synopsis solicitation shall result in the award of a three year firm fixed price contract. The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) may be accessed on the Internet at https://www.acquisition.gov/content/regulations. The North American Industry Classification System (NAICS) code is 325412 with a size standard of 1250 employees applies to this solicitation. This requirement consists of supplying radiopharmaceuticals with a period of performance of July 1, 2020 through June 30, 2023. Delivery of radiopharmaceuticals shall be to the Buffalo VA Medical Center Nuclear Medicine Department, 3495 Bailey Avenue, Buffalo, NY 14215. The following solicitation provisions and contract clauses apply:

FAR 52.202-1, Definitions (November 2013) FAR 52.203-3, Gratuities (April 1984) FAR 52.203-6, Alt I- Restrictions on Subcontractor Sales to the Government (September 2006) FAR 52.203-11, Certification & Disclosure Regarding Payments to Influence Certain Federal Transactions (September 2007) FAR 52.203-12, Limitation on Payments to Influence Certain Federal Transactions (October 2010) FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (April 2014) FAR 52.204-7, System for Award Management (October 2018) FAR 52.209-2, Prohibition on Contracting with inverted Domestic Corporations – Representation (November 2015) FAR 52.209-5, Certification Regarding Responsibility Matters (Oct 2015) FAR 52.212-1, Instructions to Offerors - Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (Dec 2019). Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at 52.212-1 Instructions to Offerors—Commercial Items.

FAR 52-212-4, Contract Terms and Conditions - Commercial Items (Oct 2018).

FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2020). For the purposes of this clauses, items (b), 1, 4, 6, 7 14, 26, 27, 28, 29, 30,31, 32, 33, and 48 are considered checked and apply.

FAR 52.216-21, Requirements (Oct 1995) FAR 52.216-22, Indefinite Quantity (Oct 1995) FAR 52.217-6 Option for Increased Quantity (March 1989) FAR 52.217-8, Option to Extend Services (November 1999) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-19, Child Labor – Cooperation with Authorities and Remedies (October Jan 2020) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (July 2014) FAR 52.222-50, Combating Trafficking in Persons (January 2019) FAR 52.223-3, Hazardous Material Identification and Material Safety Data (January 1997) FAR 52.225-1, Buy American – Supplies (May 2014) FAR 52.232-18, Availability of Funds (April 1984) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (April 1984) FAR 52.232-33, Payment by Electronic Funds Transfer (Oct 2018) FAR 52.232-38, Submission of Electronic Funds Transfer Information with Offer (July 2013) FAR 52.233-3, Protest After Award (August 1996) FAR 52.233-4, Applicable Law for Breach of Contract Claim (October 2004) FAR 52.246-2, Inspection of Supplies – Fixed Price (August 1996) FAR 52.247-34 F.o.b. Destination (November 1991) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in’s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively.

FAR 52.252-2, Clauses Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in’s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively.

VAAR 852.203-70, Commercial Advertising (May 2018) VAAR 852.232-72, Electronic Submission of Payment Requests (November 2018) VAAR 852.246-71, Reject Goods (October 2018) VAAR 852.270-1, Representatives of Contracting Officers (Jan 2008) VAAR 852.273-74, Award Without Exchanges (January 2003) Proposals are due no later than Friday March 20, 2020, 4:00 PM Eastern Standard Time. Use electronic mail to submit proposals to Michael.Spatuzzi@va.gov and ensure that your proposal is signed and dated. Telephone inquiries shall not be accepted. Please submit any questions regarding this solicitation via email to Michael.Spatuzzi@va.gov by no later than Wednesday February 26, 2020, 4:00 PM Eastern Standard Time. If necessary, the Contracting Officer shall publish an amendment to Beta Sam to answer all questions received during the time period for questions.

Attachment A: Delivery Information and Invoicing Information Individual Orders: Delivery orders and purchase orders shall be issued by a Contracting Officer. No other methodology for ordering is acceptable. Only warranted Contracting Officers have the authority to issue delivery orders and purchase orders.

Delivery: All deliveries shall be made to the following address:

VA Western NY Health Care System Attention: Nuclear Medicine 3495 Bailey Avenue Buffalo, NY 14215 Shipping: All orders placed against the awarded IDIQ Contract are to be shipped FOB Destination without any exceptions.

Invoicing: The obligation of funds shall occur at the delivery order level. Each delivery order number shall have a corresponding purchase order number. To receive payment, the Contractor must invoice against the purchase order number associated with the corresponding delivery order number. Invoices must be submitted electronically through the Tungsten Network against the correct purchase order number. Invoices must include the following: the purchase order number, the order date, the order number or the invoice number, and an itemized bill that clearly identifies the radiopharmaceuticals that are being invoiced against along with the correct unit prices for each radiopharmaceutical.

Ordering Period: July 1, 2020 through June 30, 2023

Note: The Government is not obligated to purchase any specific quantity of any specific item under the awarded IDIQ Contract.