SOW FY 27 Kent Low Energy RP Cleveland and Kent - Draft.pdf

STATEMENT OF WORK (SOW)

as of 10/19/2026

Contract Number: (completed by the CO at time of award) Task Order Number: (completed by the CO at time of award if a TO) IFCAP Tracking Number:

1. Contracting Officer’s Representative (COR).

Name: TBD Section: TBD Address: TBD Phone Number: TBD E-Mail Address: TBD

2. Contract Title.

Low energy radiopharmaceuticals (non-fluorodeoxyglucose F 18 agents), unit doses for patient care at VA Northeast Ohio Healthcare System and VA Kent Imaging and Infusion Center. A base contract plus 4 option years is recommended due to the constant need of radiopharmaceuticals for diagnostic imaging.

3. Background.

The VA Northeast Ohio Healthcare system, Kent, Ohio has a requirement for Radiopharmaceutical Isotopes (non-fluorodeoxyglucose F 18 agents), for patient care.

The Contractor is to provide Unit Dose Radiopharmaceutical products as listed herein, as requested by authorized VA staff, in accordance with Public Law 104-262 and 38 USC 8153 to support the VA.

4. Scope.

Contractor will provide products for routine (non-emergent) and emergent orders (aka Emergencies). Emergencies are requested during and outside of regular work hours (Monday through Friday 06:30am to 4:30pm) requiring delivery within 120 minutes after receipt of phoned, faxed, or electronic orders from VA. VA requires prompt processing of Tc-99m tagged WBC Orders, White Blood Cell Count (aka WBC’s).

Quantities are expressed as estimates and may vary based on patient demand. The Contractor is to follow generally accepted standard practices for the industry and regulation for the preparation, transportation, and delivery of Radiopharmaceuticals.

These may include but are not limited to the Society of Nuclear Medicine and Molecular

Imaging (SNMMI), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Center for Disease Control (CDC), Untied States Pharmacopeia (USO), and Joint Commission (JC).

The Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc. and provide a bar code label to facilitate scanning data into a nuclear medicine information system (NMIS). Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug, RX number and calibration time. Each vial shield and syringe shield must also be correctly labeled.

The Contractor will be furnished the names of the individuals authorized to purchase against the Contract. The VA will provide its own Contracting Officer’s Representative (COR). Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of radiopharmaceuticals may vary based on patient demand.

All radiopharmaceuticals and pharmaceuticals or 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.

The Contractor is to follow generally accepted standard practices for the industry and regulation for the preparation, transportation, and delivery of Radiopharmaceuticals.

These may include but are not limited to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Center for Disease Control (CDC), United States Pharmacopeia (USP), and Joint Commission (JC).

5. Specific Tasks.

1. The government requires delivery to be made according to the schedule for quantities as ordered.

2. Contractor shall provide deliveries as determined by the government.

3. Contractor shall replace any items delivered in error at no cost to the medical center.

4. Contractor shall label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date; and to comply with the specific facility requirements.

5. The Contractor shall ensure that all doses are provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist and all doses will be compounded within required guidelines of the Board of Pharmacy, specifically USP <797> and USP <825> as appropriate.

6. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation and F.D.A., and all other agency rules and regulations (Federal and State). Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

7. Items shall be adequately packaged to prevent damage during handling and storage.

8. All packaging of radioactive material SHALL BE clearly labeled RADIOACTIVE on the outside of the carton it is shipped in.

9. Contractor shall invoice at least once a month to the Nuclear Medicine Service, no later than 15 days after the end of the month being billed showing the period covered, billing date, name of preparation, blanket purchase order number, quantity, and amount. All doses shall be listed as a separate line item on the invoice.

10. Contractor shall provide a copy of their laboratory’s current quality control manual and shall be willing to discuss discrepancies in lab results, which do not fit the clinical picture.

11. Contractor shall test the product for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

12. All Technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated.

13. If the ordered radiopharmaceutical cannot be delivered to the VA when needed due to a supply, production, or other issues, the Contractor will notify the VA as soon as possible to minimize the impact on patient care. The Contractor will obtain the needed doses(s) from another source, including another Radiopharmacy, to be delivered as near as possible to the scheduled delivery time, with concurrence of the VA.

14. Contractor shall assign to this medical center an individual sales representative to aid in facilitation in the smooth coordination between the medical center and nuclear pharmacy.

15. Contractor shall provide a credit of 100% of the purchase price for unused doses for the following reasons: patient death, blood work results out of range, scheduling delays due to weather, traffic or transportation difficulty, any doses deemed below standard by the facility including missing appropriate labels, wet or damaged product, product not containing the ordered dose (not within 10% variance based on guidelines outlined in 10CFR Part 35), or other considerations at the outside of the generally and widely accepted norms of the industry.

16. Credits shall be provided by credit memo.

17. Contractor shall provide current material safety data sheets in a binder and updates as necessary on all delivered products for the medical center.

18. Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor.

Replacements shall be received within 72 hours of notification by the VA.

19. Contractor shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radionuclides. Contractor shall provide copies of licenses and certifications along with a proposal to the Contracting Officer.

5.1 Task 1 - Enterprise Management Controls.

5.1.1 Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this SOW. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation, and related functions.

5.1.2 Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources, and management controls to be employed to meet the cost, performance, and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract.

Contractor shall test all products for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

Each radiopharmaceutical will be inspected and measured in a dose calibrator to ensure that the correct dosage is in a properly labeled syringe/vial. Any unlabeled or mislabeled syringes/vials will be subject to immediate action by the facility’s nuclear medicine staff. Replacement doses will be sent at no cost to the VAMC.

The parties’ representatives will meet periodically as agreed to review the radiopharmaceuticals and to address any requests or issues as may have arisen in the period prior to review. Meetings can be held over the telephone or face to face.

Either party may call a meeting upon not less than three (3) days’ notice if that party reasonably considers that there are issues which need to be discussed and/or resolved relating to the therapeutic doses. Both parties will make reasonable efforts to attend meetings called on shorter notice when required. Any meeting may be carried out by teleconference or videoconference.

Deliverables:

Item number Description Quantity 1 99mTc Sulfur Colloid 320 2 99mTc MDP 850 3 99mTc Mebrofenin 110 4 99mTc MAG-3 80 5 99mTc Tetrofosmin 10 6 99mTc MAA 75 7 111IN Pentreotide 2 8 99mTc04- 90 9 99mTc Sestamibi 5000 10 99mTc White Blood Cell Labeling 90 11 111IN Whilte Blood Cell Labeling 2 12 99mTc DTPA 30-40 mCi 60 13 99mTc DTPA 0.4 – 0.7mCi 5 14 I 123 Iodine Capsules 200 microcuries 90 15 I 123 Iodine Capsules 2-5 millicuries 12 16 Ultratag Kit 22 17 99mTc Filtered Sulfur Colloid: 0.5 – 1 millicurie 6 18 123I MIBG dose 2 19 Cold PYP vials 50 20 99mTc PYP 100 21 99mTc DMSA 2 22 67 Gallium Citrate 2

23 111IN DTPA 2

24 99mTc HMPAO 2 25 131I Diagnostic capsule 10 26 131I Therapeutic capsule 1-3 mCi 12 27 131I Therapeutic capsule each additional mCi 1500 28 99mTc HDP 55 29 99mTc WBC Blood Kit (Heparin) 90

Radiopharmaceutical Isotopes (non-fluorodeoxyglucose F 18 agents) listed below are for patient care. The Contractor is to provide Unit Dose Radiopharmaceutical products as listed herein, as requested by authorized VA staff, in accordance with Public Law 104- 262 and 38

6. Performance Monitoring

We expect a 100% arrival time for all Radiopharmaceutical Isotopes (non-fluorodeoxyglucose F 18 agents) along with 98% efficiency rate of pharmaceutical on delivery time. All Radiopharmaceutical Isotopes (non-fluorodeoxyglucose F 18 agents) shall be calibrated and labeled with concentration, calibration time, total volume, total activity, expiration date and expiration time.

7. Security Requirements

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

The Contractor Service Personnel and/or representative must report to the appropriate department Supervisor or designated point of contact (POC) to sign in with department staff before work begins. Additionally, one must submit any mobile media devices that would be used on the system for a virus scan. Upon completion of work, the Contractor Service Personnel and/or representative must report to the appropriate department Supervisor to brief that Supervisor or related department staff point of contact (POC) if Supervisor is unavailable concerning completion of service, and then to sign out. At the end of each briefing, Contractor Service Personnel and/or representative will and must sign out.

Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

c. Vendor is only delivering products. No Government-Furnished Equipment or Government Furnished Information will be provided to the vendor.

9. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work: N/A

b. Identification of Potential Conflicts of Interest (COI): N/A

c. Identification of Non-Disclosure Requirements: N/A

d. Packaging, Packing and Shipping Instructions:

All radiopharmaceuticals are to be packaged and monitored following all nuclear regulatory guidelines.

e. Inspection and Acceptance Criteria:

All radiopharmaceuticals are monitored and inspected by the VA nuclear medicine staff and is tracked via Nuclear Medicine Information System (NMIS), an electronic dose tracking system, that is also monitored by Radiation Safety’s medical health physicist.

10. Risk Control

All radiopharmaceuticals are monitored by nuclear medicine staff and are tracked via NMIS our electronic dose tracking system, that is also monitored by Radiation Safety’s medical health physicist.

11. Place of Performance.

Hot Lab Room B-C432 at 10701 East Boulevard, Cleveland, OH 44106 Hot lab Room B109 at 3838 Cascades Boulevard, Kent, OH. 44240

12. Period of Performance.

Dates of performance: Base: 1/01/2027 – 12/31/2027 Option year 1: 1/01/2028 – 12/31/2028 Option Year 2: 1/01/2029 – 12/31/2029 Option Year 3: 1/01/2030 – 12/31/2030 Option Year 4: 1/01/2031 – 12/31/2031

13. Delivery Schedule.

Vendor is ready to start delivery of products as soon as contract is approved.