Statement of Work.pdf

STATEMENT OF WORK

Radiopharmaceuticals

George E. Wahlen VA Salt Lake City Health Care System

500 Foothill Drive Salt Lake City, UT 84148

Description/Specifications

1. Contractor agrees to provide all needed radiopharmaceuticals, radioactive sources, and supplies as identified in Appendix A listed at the end of this document 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 5-mile radius of the VA Salt Lake City Health Care System (VASLCHCS) need to respond.

2. The contractor shall provide quality assurance/quality control radioactive sources at the discretion of the VASLCHCS.

3. 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, but not limited to: DOT, DOE, NRC, and ICC regulations and standards.

4. Supplier shall hold a current unrevoked NRC 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, Salt Lake City VA Medical Center (500 Foothill Drive, Salt Lake City, Utah 84148) upon commencement of this contract. Supplier shall immediately notify Nuclear Medicine Service at the Salt Lake City VA Medical Center, upon any action by the NRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and by a certified nuclear medicine pharmacist.

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

a. Product(s) shipped in error

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by the manufacturer)

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

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

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

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

f. 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.

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

8. Current package inserts 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 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.

9. Contractor shall make quality control records available to the Salt Lake City VA Medical Center upon written request from the Contracting Officer.

10. 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.

11. 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 ±10%.

12. 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 two (2) hours.

b. FDG: Not shorter than two (2) hours.

c. Axumin: Not shorter than two (2) hours.

d. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

e. 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.

13. If a quality control or material defect is 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:

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.

14. Contractor shall be responsible for all costs for any radiopharmaceuticals and nonradioactive items contracted for if the VASLCHCS must find an alternate supplier for contracted items.

15. Contractor shall produce radiopharmaceuticals as described in Appendix A below.

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

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

a. A licensee may use for medical use only:

i. 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.

ii. 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.

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 multiple deliveries per day during regular operating hours to Nuclear Medicine

Service at the Salt Lake City VA.

b. Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT

84148, room 1E27-1 daily quantity of radiopharmaceuticals by 7:30 am, as requested from the previous day.

c. Deliver directly to the Nuclear Medicine Service at 500 Foothill Dr. Salt Lake City, UT 84148, room 1E27-1 any quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

d. Other delivery times may be outlined by the contractor under this contract.

2. Shipments “called when needed” may be requested during regular work hours, or after, as “emergency”, including weekends, holidays, and nights, dependent on Contractor hours and availability of radiopharmaceutical doses.

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

a. Emergent requests placed during regular work hours will be delivered within two (2) hours, or as specified.

b. Emergency/Additional shipments are to be delivered to Nuclear Medicine Service at the Salt Lake City VA Medical Center 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 Nuclear Medicine Service at the Salt Lake City VA Medical Center under this contract, will be strictly adhered to.

4. All shipments will have a Packing Slip enclosed, giving information about the product and its 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.) The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes.

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, 7:00a.m. to 4:30 p.m.

(2) Normal Next Day Delivery: 7:30a.m.

(3) National Holidays: The eleven 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.

(4) State Holidays: Pioneer Day as observed by the state of Utah.

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

(1) Submit capability statement showing how they intend to meet requirements of contract for

VASLCHCS.

(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.)

(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)

(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.

(5) Documentation as USP 797/825 Compliant Pharmacy.

(6) Contractor shall be able to provide unit doses within 60 minutes or less add-on FDG doses to VASLCHCS hot lab door (1E27-1).

(7) Ability to provide by product material or cyclotron produced materials manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State.

(8) Ability to have adequate supply of contract products to meet the requirements of System at said distribution point and ability to label all supplies as to amount of radiopharmaceutical/ pharmaceutical, preparation time, date, etc. and provide a bar labeled insert to allow scanning data into a Nuclear medicine information system.

(9) 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.

Appendix A

Item # Description

0001 C-14 Urea 0002 Cu-64 DetectNet 0003 Ga-67 0004 I-123 Caps

0005 I-123 MIBG

0006 I-131 Caps 0007 I-131 Liquid 0008 I-131 Therapeutic Sol.

0009 In-111 DTPA 0010 In-111 WBC 0011 In-111 Octreoscan 0012 Tc99m Sestamibi 0013 Tc99m Mebrofenin 0014 Tc99m DTPA 0015 Tc99m DMSA 0016 Tc99m ECD (Neurolite) 0017 Tc99m HMPAO Leuk.

0018 Tc99m MAA 0019 Tc99m MAG3 0020 Tc99m MDP 0021 Tc99m PYP 0022 Tc99m Sulfur Colloid 0023 Tc99m Tc04 0024 Tl-201 0025 Xe-133 0026 Co-57 15mCi Sheet

Source 0027 Ultra Tag Kit 0028 Trip Fee 0029 Stat Fee