Attachment 1 - SOW.docx

STATEMENT OF WORK

Radiopharmaceuticals George E. Wahlen VA Salt Lake City Health Care System 500 Foothill Drive Salt Lake City, UT 84148

1. General Information

1.1. Scope of Work: The VA Salt Lake City Health Care System (VASLCHCS) requires a Contractor to provide unit dose radiopharmaceuticals, radioactive sources, and supplies for diagnostic imaging exams and/or quality assurance procedures. The Contractor shall provide routine weekday (Monday thru Friday) deliveries, excluding holidays, during normal working hours (7:00AM – 16:30PM MST) to the Nuclear Medicine Department at the VASLCHCS no later than 8:00AM; barring any production complications. The Contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work, except as may otherwise be specified.

1.2. Background: Radiopharmaceuticals, or medicinal radio-compounds, are a group of pharmaceutical drugs containing radioactive isotopes. Radiopharmaceuticals can be used as diagnostic and therapeutic agents to diagnose specific pathologies, such as cancer, osteomyelitis, cardiac ischemia, and infection; to name a few.

2. General Requirements

2.1. Contractor shall provide unit dose syringes of F-18 Piflufolastat (Pylarify), or equivalent, for positron emitting tomography (PET) imaging as ordered by the Nuclear Medicine Section.

2.2. Contractor will provide radiation safety equipment, such as syringe shields and shielded syringe box/carriers when transporting radiopharmaceuticals, ensuring staff are protected from radiation exposure.

2.3. Contractor shall have an adequate supply of contract products to meet the requirements of the VASLCHCS with proof of contingency supply chain (where such contingency supply chain exists) to prevent disruption of clinical care.

2.4. Contractor shall provide, as needed, the radiopharmaceutical as soon as possible but within a two (2) hour time frame during normal working hours.

2.5. Contractor shall provide F-18, or equivalent, quality assurance/quality control radioactive sources as needed and during normal working hours.

2.6. Contractor must follow all U.S. Pharmacopeia (USP) 797 and 825 guidelines and provide verification of compliance upon Contracting Officer request.

2.7. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state regulations relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include, but not limited to: Department of Transportation (DOT), Department of Energy, U.S. Nuclear Regulatory Commission (NRC), and Interstate Commerce Commission (ICC).

2.8. Contractor must be licensed by the State of Utah and hold a current, unrevoked NRC and/or Federal Drug Administration (FDA) license to produce and distribute radiopharmaceuticals for human administration, to include receiving, and disposing of radioactive waste. Contractor shall provide a copy of their radioactive material license to the Nuclear Medicine Service, Salt Lake City VA Medical Center (500 Foothill Drive, Salt Lake City, Utah 84148) upon request. Contractor shall promptly notify Nuclear Medicine Service at the Salt Lake City VA Medical Center, upon any action by the NRC, state, and/or FDA to suspend or revoke any license required by Contractor to perform under this Statement of Work. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and by a certified nuclear medicine pharmacist.

2.9. Contractor shall accept returns for credit under the following conditions:

2.9.1. Product(s) shipped due to Contractor error.

2.9.2. Product(s) damaged in shipment

2.9.3. Concealed shipping damages

2.9.4. Recalled product(s)

2.9.5. Products that have expired prior to receipt by the VASLCHCS due to no fault of VASLCHCS

2.10. Contractor shall establish a fair and competitive return for credit policy for unused radiopharmaceuticals.

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

2.11.1. Contractor’s regular work hours

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

2.11.3. Email address and/or web portal for placing orders, if applicable.

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

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

2.11.6. 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 United States Pharmacopeia (USP).

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

2.12. Current package inserts and material safety data sheets (SDS) of all radiopharmaceuticals supplied under this contract will be shipped and/or a digital copy supplied to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts/SDS are made available, these will be sent to the Nuclear Medicine Service at the Salt Lake City VA Medical Center. 500 Foothill Drive, 114N, Salt Lake City, Utah 84148.

2.13. Contractor must perform all quality control procedures as required by Federal and State regulatory agencies and shall make quality control records available to the Salt Lake City VA Medical Center upon written request from the Contracting Officer. This testing shall be performed at no cost to the VA.

2.14. Contractor must provide current safety data sheets (SDSs) in a binder and update as necessary for all products delivered to this medical center, or the contractor must provide their website link where SDS and package inserts for all radiopharmaceuticals can be read and printed.

2.15. Contractor must provide patient orientation education videos and/or other appropriate material as deemed necessary by the medical center.

2.16. Contractor may provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in the handling of radioactive materials.

2.17. 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.

2.18. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided at the calibration time. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±10%.

2.19. The expiration date and time shall be indicated and affixed to each product as noted below; Contractor will use commercially reasonable efforts to achieve the following expiration times:

2.20. If a quality control or material defect is reasonably suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

2.20.1. Provide technical expertise in calibration.

2.20.2. Provide a credit for any product confirmed to be deficient.

2.20.3. Provide professional examination of product; submit results and recommendations to the Contracting Officer. In the event product is found to be compliant after examination under this subsection, VASLCHCS shall be responsible for costs associated with the examination.

2.21. Contractor, in accordance with its production schedule, shall produce radiopharmaceuticals as described in the Price Schedule.

2.22. Payment shall be made for only those orders specifically requested by the VASLCHCS.

2.23. Must be in compliance with all applicable NRC, USP, state, local requirements. Contractor shall abide by Title 10 Code of Federal Regulation (CFR), which states:

2.23.1. A licensee may use for medical use only:

2.23.2. Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State.

2.23.3. Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with the approval by the Commission pursuant to SS32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

2.24. Contractor must submit a monthly invoice to the Nuclear Medicine Service, showing period covered, billing date, name of preparation, quantity, amount, and purchase order number.

2.25. The C&A requirements do not apply, and that a Security Accreditation Package is not required.

3. Deliverables and Acceptance Criteria

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

3.1.1. Provide one delivery per day during regular operating hours to Nuclear Medicine Service at the Salt Lake City VA. Deliveries in excess of one per day will be made in the discretion of Contractor and charged to VASLCHCS at Contractor’s then-current rate.

3.1.2. Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT 84148, room 1E27-1 daily quantity of radiopharmaceuticals no later than 8:00AM MST, as requested from the previous day.

3.1.3. Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT 84148, room 1E27-1 any mutually agreed upon quantity of radiopharmaceutical requested at an agreed upon time or as soon as is reasonably practicable.

3.1.4. Other delivery times may be outlined by the Contractor under this contract.

3.2. Shipments “called when needed” may be requested during regular work hours, as “emergency”, dependent on Contractor hours and availability of radiopharmaceutical doses.

3.3. All shipments will have a Packing Slip enclosed, giving information about the product and its identification. The VA Medical Center’s Purchase Order Number issued for the current fiscal quarter or month, and the Contractor’s invoice number will be provided via monthly notice. (Incorrect P.O. numbers may cause a substantial delay in payments.) The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes.

4. Work Hours

4.1. The delivery of products provided by this contract shall be furnished by Contractor as available and according to Contractor’s production schedule. Contractor shall not be required to furnish such products on a national holiday or during Contractor’s non-working hours or non-production days

5. Qualifications

5.1. Personnel assigned by 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 by the VA Facility Director.

6. Contractor Staff, Roles and Responsibilities

6.1. Contractor shall meet requirements of contract for VASLCHCS.

6.2. Documentation the Contractor has a courier to deliver to the VASLCHCS hot lab (specially designed and secured room to keep all radioactive unit doses and sources until time of use.)

6.3. Documentation the Contractor is local (within 60 minutes of the medical facility to deliver stat low energy unit doses for same day patient orders)

6.4. Documentation that shows Contractor has a cyclotron (special equipment that generates the radioactive material) located within 2 hours of the VASLCHCS facility. The Contractor can provide for add-on patient studies with each line item delivered as a unit dose.

6.5. Documentation to support compliance with USP 797/825.

6.6. Upon request, Contractor shall provide proof of Dose Management System (ie: Syntrac, Biodose NMIS Ec2 or Nuctrac) for Health Physics, unit doses tracking and Radiation Safety purposes.

Contractor Performance Assessments

Assessments. The Government may 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.