36C25525Q0010.docx

36C25525Q0010

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

589-25-1-1126-0001 36C25525Q0010 12-03-2024 Espinosa, Maria/maria.espinosa@va.gov 913-946-9922 12-20-2024 10:00 am

CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth, KS 66048

X 325180 1000 Employees Net 30 days N/A X Kansas City VA Medical Center Nuclear Medicine Service 4801 Linwood Boulevard Kansas City MO 64128-2226 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page This is a request for quotes for Radiopharmaceuticals for Kansas City VAMC, Missouri, in accordance with the Statement of Work.

The resulting contract will be firm-fixed price with a base, plus four (4) options, to be exercised at the discretion of the Government.

This solicitation is set as full and open competition.

Please put solicitation number 36C25525Q0010 in the subject line of all correspondence and emails to ensure proper tracking and accountability.

All questions are due no later than December 13, 2024, at 10:00 AM CST and shall be emailed to maria.espinosa@va.gov.

Responses are due no later than December 20, 2024, at 10AM CST and shall be emailed to maria.espinosa@va.gov.

$0.00 See CONTINUATION Page 57-3640160-2105-829800-2119 0100K0289 X X Janie Juszczak 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: Contracting Officer 36C255 Janie Juszczak/janie.juszczak@va.gov Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth, KS 66048

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.

Financial Services Center http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Sodium Pertechnetate (UP TO 30 mCi) Contract Period: Base POP Begin: 02-01-2025 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Tc-99m Mebrofenin

POP Begin: 02-01-2025 POP End: 01-31-2026

Sources (TcO4)

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m DTPA

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m MAA

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m HDP

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m MAG 3

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m Sulfur Colloid

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m Sestamibi (up to 35mCi)

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m Tetrofosmin (Myoview)

POP Begin: 02-01-2025 POP End: 01-31-2026

Tc-99m Medronate

POP Begin: 02-01-2025 POP End: 01-31-2026

Thallium-201 (per mCi)

POP Begin: 02-01-2025 POP End: 01-31-2026

Gallium-67

POP Begin: 02-01-2025 POP End: 01-31-2026

Iodine-123 100 uCi

POP Begin: 02-01-2025 POP End: 01-31-2026

Iodine-123 200 uCi

POP Begin: 02-01-2025 POP End: 01-31-2026

Iodine-131 DX

POP Begin: 02-01-2025 POP End: 01-31-2026

Iodine-131 TX Cap (20 mCi)

POP Begin: 02-01-2025 POP End: 01-31-2026

Iodine-131 TX Cap (100 mCi)

POP Begin: 02-01-2025 POP End: 01-31-2026

In-111 Chloride

POP Begin: 02-01-2025 POP End: 01-31-2026

In-111 Leukocytes (500 uCi dose)

POP Begin: 02-01-2025 POP End: 01-31-2026

In-111 OctreoScan

POP Begin: 02-01-2025 POP End: 01-31-2026

In-111 Prostascint

POP Begin: 02-01-2025 POP End: 01-31-2026

Xe-133 (20mCi vial)

POP Begin: 02-01-2025 POP End: 01-31-2026

Delivery (4 Deliveries during hours)

POP Begin: 02-01-2025 POP End: 01-31-2026

Delivery over 4 per day

POP Begin: 02-01-2025 POP End: 01-31-2026

Emergency Delivery (after hours)

POP Begin: 02-01-2025 POP End: 01-31-2026

Pharmacist Call-Out

POP Begin: 02-01-2025 POP End: 01-31-2026

STAT Delivery

POP Begin: 02-01-2025 POP End: 01-31-2026

Sodium Pertechnetate (UP TO 30 mCi) Contract Period: Option 1 POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m Mebrofenin

POP Begin: 02-01-2026 POP End: 01-31-2027

Sources (TcO4)

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m DTPA

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m MAA

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m HDP

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m MAG 3

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m Sulfur Colloid

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m Sestamibi (up to 35mCi)

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m Tetrofosmin (Myoview)

POP Begin: 02-01-2026 POP End: 01-31-2027

Tc-99m Medronate

POP Begin: 02-01-2026 POP End: 01-31-2027

Thallium-201 (per mCi)

POP Begin: 02-01-2026 POP End: 01-31-2027

Gallium-67

POP Begin: 02-01-2026 POP End: 01-31-2027

Iodine-123 100 uCi

POP Begin: 02-01-2026 POP End: 01-31-2027

Iodine-123 200 uCi

POP Begin: 02-01-2026 POP End: 01-31-2027

Iodine-131 DX

POP Begin: 02-01-2026 POP End: 01-31-2027

Iodine-131 TX Cap (20 mCi)

POP Begin: 02-01-2026 POP End: 01-31-2027

Iodine-131 TX Cap (100 mCi)

POP Begin: 02-01-2026 POP End: 01-31-2027

In-111 Chloride

POP Begin: 02-01-2026 POP End: 01-31-2027

In-111 Leukocytes (500 uCi dose)

POP Begin: 02-01-2026 POP End: 01-31-2027

In-111 OctreoScan

POP Begin: 02-01-2026 POP End: 01-31-2027

In-111 Prostascint

POP Begin: 02-01-2026 POP End: 01-31-2027

Xe-133 (20mCi vial)

POP Begin: 02-01-2026 POP End: 01-31-2027

Delivery (4 Deliveries during hours)

POP Begin: 02-01-2026 POP End: 01-31-2027

Delivery over 4 per day

POP Begin: 02-01-2026 POP End: 01-31-2027

Emergency Delivery (after hours)

POP Begin: 02-01-2026 POP End: 01-31-2027

Pharmacist Call-Out

POP Begin: 02-01-2026 POP End: 01-31-2027

STAT Delivery

POP Begin: 02-01-2026 POP End: 01-31-2027

Sodium Pertechnetate (UP TO 30 mCi) Contract Period: Option 2 POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m Mebrofenin

POP Begin: 02-01-2027 POP End: 01-31-2028

Sources (TcO4)

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m DTPA

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m MAA

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m HDP

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m MAG 3

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m Sulfur Colloid

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m Sestamibi (up to 35mCi)

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m Tetrofosmin (Myoview)

POP Begin: 02-01-2027 POP End: 01-31-2028

Tc-99m Medronate

POP Begin: 02-01-2027 POP End: 01-31-2028

Thallium-201 (per mCi)

POP Begin: 02-01-2027 POP End: 01-31-2028

Gallium-67

POP Begin: 02-01-2027 POP End: 01-31-2028

Iodine-123 100 uCi

POP Begin: 02-01-2027 POP End: 01-31-2028

Iodine-123 200 uCi

POP Begin: 02-01-2027 POP End: 01-31-2028

Iodine-131 DX

POP Begin: 02-01-2027 POP End: 01-31-2028

Iodine-131 TX Cap (20 mCi)

POP Begin: 02-01-2027 POP End: 01-31-2028

Iodine-131 TX Cap (100 mCi)

POP Begin: 02-01-2027 POP End: 01-31-2028

In-111 Chloride

POP Begin: 02-01-2027 POP End: 01-31-2028

In-111 Leukocytes (500 uCi dose)

POP Begin: 02-01-2027 POP End: 01-31-2028

In-111 OctreoScan

POP Begin: 02-01-2027 POP End: 01-31-2028

In-111 Prostascint

POP Begin: 02-01-2027 POP End: 01-31-2028

Xe-133 (20mCi vial)

POP Begin: 02-01-2027 POP End: 01-31-2028

Delivery (4 Deliveries during hours)

POP Begin: 02-01-2027 POP End: 01-31-2028

Delivery over 4 per day

POP Begin: 02-01-2027 POP End: 01-31-2028

Emergency Delivery (after hours)

POP Begin: 02-01-2027 POP End: 01-31-2028

Pharmacist Call-Out

POP Begin: 02-01-2027 POP End: 01-31-2028

STAT Delivery

POP Begin: 02-01-2027 POP End: 01-31-2028

Sodium Pertechnetate (UP TO 30 mCi) Contract Period: Option 3 POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m Mebrofenin

POP Begin: 02-01-2028 POP End: 01-31-2029

Sources (TcO4)

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m DTPA

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m MAA

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m HDP

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m MAG 3

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m Sulfur Colloid

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m Sestamibi (up to 35mCi)

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m Tetrofosmin (Myoview)

POP Begin: 02-01-2028 POP End: 01-31-2029

Tc-99m Medronate

POP Begin: 02-01-2028 POP End: 01-31-2029

Thallium-201 (per mCi)

POP Begin: 02-01-2028 POP End: 01-31-2029

Gallium-67

POP Begin: 02-01-2028 POP End: 01-31-2029

Iodine-123 100 uCi

POP Begin: 02-01-2028 POP End: 01-31-2029

Iodine-123 200 uCi

POP Begin: 02-01-2028 POP End: 01-31-2029

Iodine-131 DX

POP Begin: 02-01-2028 POP End: 01-31-2029

Iodine-131 TX Cap (20 mCi)

POP Begin: 02-01-2028 POP End: 01-31-2029

Iodine-131 TX Cap (100 mCi)

POP Begin: 02-01-2028 POP End: 01-31-2029

In-111 Chloride

POP Begin: 02-01-2028 POP End: 01-31-2029

In-111 Leukocytes (500 uCi dose)

POP Begin: 02-01-2028 POP End: 01-31-2029

In-111 OctreoScan

POP Begin: 02-01-2028 POP End: 01-31-2029

In-111 Prostascint

POP Begin: 02-01-2028 POP End: 01-31-2029

Xe-133 (20mCi vial)

POP Begin: 02-01-2028 POP End: 01-31-2029

Delivery (4 Deliveries during hours)

POP Begin: 02-01-2028 POP End: 01-31-2029

Delivery over 4 per day

POP Begin: 02-01-2028 POP End: 01-31-2029

Emergency Delivery (after hours)

POP Begin: 02-01-2028 POP End: 01-31-2029

Pharmacist Call-Out

POP Begin: 02-01-2028 POP End: 01-31-2029

STAT Delivery

POP Begin: 02-01-2028 POP End: 01-31-2029

Sodium Pertechnetate (UP TO 30 mCi) Contract Period: Option 4 POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m Mebrofenin

POP Begin: 02-01-2029 POP End: 01-31-2030

Sources (TcO4)

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m DTPA

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m MAA

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m HDP

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m MAG 3

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m Sulfur Colloid

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m Sestamibi (up to 35mCi)

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m Tetrofosmin (Myoview)

POP Begin: 02-01-2029 POP End: 01-31-2030

Tc-99m Medronate

POP Begin: 02-01-2029 POP End: 01-31-2030

Thallium-201 (per mCi)

POP Begin: 02-01-2029 POP End: 01-31-2030

Gallium-67

POP Begin: 02-01-2029 POP End: 01-31-2030

Iodine-123 100 uCi

POP Begin: 02-01-2029 POP End: 01-31-2030

Iodine-123 200 uCi

POP Begin: 02-01-2029 POP End: 01-31-2030

Iodine-131 DX

POP Begin: 02-01-2029 POP End: 01-31-2030

Iodine-131 TX Cap (20 mCi)

POP Begin: 02-01-2029 POP End: 01-31-2030

Iodine-131 TX Cap (100 mCi)

POP Begin: 02-01-2029 POP End: 01-31-2030

In-111 Chloride

POP Begin: 02-01-2029 POP End: 01-31-2030

In-111 Leukocytes (500 uCi dose)

POP Begin: 02-01-2029 POP End: 01-31-2030

In-111 OctreoScan

POP Begin: 02-01-2029 POP End: 01-31-2030

In-111 Prostascint

POP Begin: 02-01-2029 POP End: 01-31-2030

Xe-133 (20mCi vial)

POP Begin: 02-01-2029 POP End: 01-31-2030

Delivery (4 Deliveries during hours)

POP Begin: 02-01-2029 POP End: 01-31-2030

Delivery over 4 per day

POP Begin: 02-01-2029 POP End: 01-31-2030

Emergency Delivery (after hours)

POP Begin: 02-01-2029 POP End: 01-31-2030

Pharmacist Call-Out

POP Begin: 02-01-2029 POP End: 01-31-2030

STAT Delivery

POP Begin: 02-01-2029 POP End: 01-31-2030

B.3 DELIVERY SCHEDULE

DELIVERY DATE

Kansas City VA Medical Center 4801 East Linwood Boulevard Kansas City, MO 64128 2226

USA

TBD

(816) 861-4700 ext. 55416;

Darin.Compton@va.gov

B.4 Statement of Work

STATEMENT OF WORK

Radiopharmaceuticals Kansas City, MO

Description/Specifications

1. Contractor agrees to provide all needed LEU (Low Enriched Uranium) radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Kansas City VA Medical Center, Kansas City, MO located at 4801 E. Linwood Blvd, Kansas City, MO 64128 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Kansas City, MO.

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 DOT, DOE, UNNRC, and ICC regulations and standards.

3. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at Kansas City VA Medical Center (KCVA) upon commencement of this contract. Supplier shall immediately notify KCVA, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts.

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

5. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center:

a. Contractor’s regular work hours

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

c. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends.

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

e. 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 (TJC) and/or with the United States Pharmacopeia.

f. Should any changes occur in above information during contract performance period, contractor will provide updates in writing.

6. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Kansas City VA Medical Center.

7. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

8. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

9. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

10. 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.

11. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration.

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

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

12. PROCEDURE for labeling of patient's white blood cells (WBC) with Indium IN-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 3:00 PM 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 will be at 8:00 AM or later, if so, specified by the COR.

c. The return by the Contractor, of the patient's Indium labeled white blood cells will 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.

13. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule.

Deliverables and Acceptance Criteria

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

a. Provide up to four deliveries per day during regular operating hours to KCVA.

b. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day.

c. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

d. Deliveries occurring outside of working hours are directed to KCVA Police. Contractor will not have access Nuclear Medicine outside of working hours.

e. Other delivery times may be outlined by the KCVA under this contract.

2. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular workday. Holidays are listed herein.

3. Shipments “called when needed” may be requested during regular work hours, or after, as “emergency”, including weekends, holidays, and nights.

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

a. Requests placed after regular work hours (weekend, holiday, and night) will be delivered within three (3) hours, or as specified.

b. Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for.

c. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.

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

e. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by KCVA under this contract, will be strictly adhered to.

5. All shipments will have a Packing Slip enclosed, giving information about the product and it’s identification, plus (for billing purposes) the VA Medical Center’s Purchase Order Number issued for the current fiscal quarter or month, and the Contractor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

Work Hours The delivery of products provided by this contract shall be furnished by the contractor. 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 as described in (1) above and (2) below.

The following terms have the following meanings:

(1) Normal Operating hours of Nuclear Medicine: Monday through Friday, 6:30a.m. to 4:30 p.m.

(2) Normal Next Day Delivery: 7:15a.m.

(3) 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, Juneteenth, 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 Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract.

Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and TJC guidelines.

Contractor Performance Assessments Assessments. The Government shall do assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to assessments.

Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts.

VA RECORDS POLICY: All records (administrative and specific) creating, maintaining, safeguarding, and disposing during the period of the contract belong to Kansas City VAMC and must be returned to Kansas City VAMC at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1.

RECORDS MANAGEMENT STATEMENT:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Kansas City VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Kansas City VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Kansas City VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Kansas City VAMC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Kansas City VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public Kansas City VAMC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The Kansas City VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Kansas City VAMC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Kansas City VAMC-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] Flow down of requirements to subcontractors

12. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

Radiopharmaceutical list for the Kansas City Nuclear Medicine Section.

*These are estimated requirements only, amounts may differ*

Pharmacist Call-Out Charge

Per Use

B.5 CONTRACT ADMINISTRATION DATA

a. All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

ACROYYMS AND DEFINITIONS

CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance.

CLIN: Contract Line Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item.

CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

POC: An individual, authorized by the contracting officer to perform specific technical or administrative functions related to the contract.

QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements.

QASP: Quality Assurance Surveillance Plan. A written document specifying the method used for surveillance of contractor performance.

PWS: Performance Work Statement.

HOURS OF OPERATION

(1) Business hours for the VAMC follow:

(A) Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

(B) National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Juneteeth;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

(C) Off-Duty hours: Monday through Sunday 4:30 pm – 8:00 am.

36C25525Q0010

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES 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:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of Contract Award through Contract Expiration.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than one dose, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 90% of the total estimated quantity;

(2) Any order for a combination of items in excess of 90% of the total estimated quantity; or

(3) A series of orders from the same ordering office within one (1) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within one (1) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the end of period of performance..

(End of Clause)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause) C.6 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 1 day. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days.; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.9 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

(a) The Contractor shall conform to the standards established by: as to .

(b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(c) Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title and number of the publication to:

(d) The offeror shall contact the Contracting Officer if response is not received within two weeks of the request.

(End of Clause) C.10 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA…