RFQ - 36C24220Q0809 - Radiopharmaceuticals for Albany VAMC.docx

36C24220Q0808

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24220Q0809 07-27-2020

DEMUZIO, SAM

585-393-7735 08-12-2020

4 PM

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

X

325412 1000 Employees

N/A

Albany VA Medical Center

113 Holland Avenue Albany NY 12208

Network Contracting Activity 400 Fort Hill Ave.

Canandaigua NY 14424

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

See CONTINUATION Page

Radiopharmaceuticals Albany Nuclear Medicine

See CONTINUATION Page

Sam DeMuzio

CONTRACTING OFFICER

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT:

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Statement of Work Radiopharmaceuticals

1.0 SCOPE

The Department of Veterans Affairs Stratton VA Medical Center (VAMC) located at 113 Holland Avenue, Albany, NY 12208 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 Albany VAMC intends to award a base year plus two option years, firm fixed price, Requirements Contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of October 1, 2020 through September 30, 2023. 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 shall be able to provide all of the items listed in the Schedule of Radiopharmaceuticals with deliveries when required. Multiple awards will not be made.

1.1 BACKGROUND

The Stratton VAMC is responsible for providing high quality and timely commodities and services for our Veterans. One area to serve our Veterans is to ensure that the best possible medical supplies are both timely and in accordance with proper regulations with Contractors that are licensed and monitored according to Federal, State, and Local Regulations. Under the Atomic Energy Act, the US NRC is responsible for regulating uses of radioactive material, including radio pharmaceuticals. The US NRC requires all nuclear medicine facilities to be licensed. The license 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 the safe use of radioactive materials. The US NRC has transferred regulatory authority over the use of this material to 35 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. 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.

2.0 STATEMENT OF WORK

1. The Contractor agrees to provide all listed radiopharmaceuticals as identified in the Schedule of Radiopharmaceuticals to the Stratton VAMC on a daily or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only Contractors that can deliver within two hours to the Stratton VAMC need to respond to this solicitation. Time is of the essence for all deliveries. These delivery timeframes are absolutely critical to ensure proper patient care and safety. The two-hour timeframe shall include the following: order processing, compounding order, travel, locating parking at the Medical Center, and delivery of radiopharmaceuticals to Radiology. The Contractor shall be licensed by the State of New York or another agreement state approved by the Nuclear Regulatory Commission and shall be regularly established in the business of providing radionuclides in accordance with New York State regulations. The Contractor shall provide evidence of delivery in less than 2 hours with their proposal. The Contractor shall identify the location of the point of shipment to the address listed in the first paragraph of this solicitation. Verification will be completed via www.mapquest.com.

2. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal, State, and Local standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This will include the FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided with each delivery.

3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal, State, and Local 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 Stratton VAMC with the radiopharmaceutical, activity, time of preparation, and 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, as well as 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. The Contractor shall immediately notify the Contracting Officer (CO) and the Contracting Officer Representative (COR), upon any action by the NRC or 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 State Regulatory Agencies.

6. The Contractor will provide with their proposal all of the following information for paragraphs a through d:

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 and instructions for placing Emergency orders after the Contractor’s regular work hours to include weekends.

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

e. 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 with the United States Pharmacopeia.

f. Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide all applicable updates 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 Stratton VAMC Nuclear Medicine Department.

8. The Contractor shall make quality control records available 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 results when requested.

10. The calibration time for each requested radiopharmaceutical shall be provided in the Schedule of Radiopharmaceuticals as part of the Contractor’s proposal pricing.

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

12. Technetium product radiopharmaceuticals not used will be returned for credit the next workday (including the bulk doses), using the DOT regulations. Credit will 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 needs.

14. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

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 will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.

15. In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be requested 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.

16. Approximately five (5) times per year, the below procedures are to be followed for labeling of patient's white blood cells (WBC) with Indium-111 Oxine or Tc-Ceretec, for re-injecting to the same patient:

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

b. The Contractor shall be at the Nuclear Medicine Department no later than 8:30 AM to pick up the patient's blood specimen for labeling.

c. The return by the Contractor, of the patient's Indium or Tc-Ceretec labeled white blood cells will take place no more than 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, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:

a. Provide up to two deliveries per day during regular operating hours to the Stratton Nuclear Medicine Service at no additional charge. The delivery charge for emergency orders to be included on the Schedule of Radiopharmaceuticals. The Delivery charge for STAT orders is to be included on the Schedule of Radiopharmaceuticals. STAT deliveries will average, three (3) times a week.

b. Deliver directly to the Stratton Nuclear Medicine Service daily quantity of radiopharmaceuticals by 7:00 AM, as requested from the previous workday by 4:00 PM, unless otherwise noted as an emergency, requiring a two-hour turnaround time.

c. Second daily delivery, if necessary, must be delivered no later than 11:00 AM.

d. Orders can be placed orally by telephone by Ordering Officers provided by the COR.

e. Deliver directly to the Nuclear Medicine Service at the Stratton VAMC, the quantity of radiopharmaceutical requested on an emergency basis to arrive in less than two (2) hours after notification.

f. Radioactive dose boxes that are delivered outside of working hours will be delivered to Nuclear Medicine. The Contractor shall not leave a radioactive materials package at the Stratton VAMC unless they have verbally communicated with a Nuclear Medicine staff member.

g. Other delivery times may be outlined by the Stratton VA Medical Center in this Statement of Work.

2. On Federal Holidays, no normal deliveries will be expected. If Monday is a Federal Holiday, no deliveries will be expected. Holidays are listed under 4.0 VA Operating Hours.

3. Emergency deliveries may be requested at any time outside normal delivery times, including weekends, holidays, and nights.

4. Shipments requested as an Emergency will be delivered as follows:

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

b. Emergency, weekend, and holiday deliveries are to be delivered to location(s) specified by the Stratton VA Nuclear Medical Department, unless otherwise specified when called for.

c. Emergency deliveries will be required within two (2) hours after the order is placed.

d. All shipments will be labeled as “RADIOACTIVE MATERIAL” in compliance with all pertinent regulations.

e. All Radiopharmaceuticals, Radioassay Kits, and Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Federal, State, and Local Laws.

f. Delivery dates, times, frequency of deliveries, specific dosages, and all other specific requirements by the Stratton VAMC in this Statement of Work will be strictly adhered to.

5. All shipments must have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the Stratton VAMC Purchase Order Number issued for the current fiscal year, and the Contractor’s invoice number. Providing incorrect Purchase Order numbers on invoices will cause a substantial delay in payments to the Contractor.

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, except in case of an emergency, to furnish such products on a national holiday or during non-working 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 4:00 PM Eastern Standard Time Normal deliveries shall be accomplished at 7:00 AM and 11:00 AM. The Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no additional charge.

National Holidays: The ten (10) 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, and 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 Stratton VA Medical Center and the Contractor’s Laboratory Pharmacy.

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

4. Patient orientation education video presentations and other appropriate material at no additonal 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 (QC) shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC 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, 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

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

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 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 respective 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 period of 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 CONTRACTOR PERFORMANCE ASSESSMENTS (CPARS)

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 that will serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future contracts.

11.0 DESIGNATION OF CONTRACT OFFICER REPRESENTATIVE (COR)

The 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 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 are necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment or items can be made in an 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 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.

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 (VA).

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 this contract are provided under a CR, funds will only be available for performance under the 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 the 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 (VA) 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 Past Performance Information Retrieval System (PPIRS). 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 VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which 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 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 VA 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 contractor’s comments.

16.0 PROHIBITION (WORKING OUTSIDE OF US)

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 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 CONTRACT TERM

The respective awarded IDIQ contract shall be for one (1) base year and two (2) option years. The base year period of performance is from October 1, 2020 through September 30, 2021. Option year one (1) period of performance is from October 1, 2021 through September 30, 2022. Option year two (2) period of performance is from October 1, 2022 through September 30, 2023.

18.0 Schedule of Radiopharmaceuticals

Please Note: Your proposal must provide pricing on ALL items in the Schedule of Radiopharmaceuticals Required and all four columns must be filled in with your proposal.

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.

Option Year Two (October 1, 2022 through September 30, 2023)

After hour/Emergency charges – Stratton VA Medical Center Deliveries during normal work hours (Monday - Friday) at no charge. Offeror (s) may 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 Stratton 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.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of…