Statement of Work.pdf

STATEMENT OF WORK:

NUCLEAR MEDICINE SERVICE – GENERAL AND THERAPEUTIC RADIOPHARMACEUTICAL

CONTRACT

The Department of Veterans Affairs Medical Center, Muskogee – Nuclear Medicine Service requires the commodit of Radiopharmaceuticals and ancillary supplies necessary for the diagnosis and treatment of various diseases and disorders in Veterans.

1. Contractor shall meet all Nuclear Regulatory Commission, National Health Physics Program (NHPP), Department of Transportation, FDA, OSHA, and all other agency rules and regulations (Federal and State), as well as any applicable Joint Commission Requirements.

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

3. Contractor shall be able to provide service of all general & therapeutic Nuclear Medicine radiopharmaceuticals to Muskogee VAMC facility.

4. Technetium-99m unit doses shall be non-high (LEU) enriched Uranium-235 versus the standard high enriched Technetium being supplied routinely to Nuclear Medicine clinics. Pricing should include cost for the non-high (LEU) enriched Uranium-235 along with the high enriched Uranium-235 (HEU) in those instances were product availability for the LEU product is limited or unavailable.

5. Contractor shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc.

6. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

7. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173.

8. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Quality Control results shall be furnished upon request.

9. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only:

(a) 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.

(b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

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

11. Contractor shall deliver radioisotope in an amount greater than or equal to the activity needed (ordered) at specified calibration time.

12. Contractor shall deliver up to three (3) scheduled deliveries of radiopharmaceutical per day with no associated fee.

13. Radiopharmaceutical Returns for Credit: The Contractor shall accept returns for full credit toward future order under the following conditions:

a. Product(s) ordered or shipped in error.

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container.

f. Unused doses.

Note: Muskogee VAMC may return the radioisotopes for credit due to patient cancellation or no show at no cost to the facility.

Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount and correct purchase order number.

14. Normal/ Routine Ordering: Orders shall be placed by authorized VA personnel during the normal workday (6:30 am to 4:30 pm) , and first delivery shall be received no earlier than 6:30 am the following workday to the Nuclear Medicine Service. After award, the Contractor shall be furnished the name(s) of VA personnel that are authorized to place orders against the Contract. Orders shall only be placed by authorized personnel via telephone/ fax or web ordering.

15. Normal/ Routine Deliveries: The contractor shall provide routine delivery and pick-up, as many times as required by Nuclear Medicine Service. Only the first 3 are at no-charge as per section 12 – any additional deliveries may be subject to Additional Routine delivery charges in accordance with the Schedule of Supplies

Delivery orders shall include the following information:

• Contract item (s) and quantity,

• Time(s) of delivery,

• Applicable VA purchase order number.

Contractor is responsible for on time delivery of radiopharmaceutical and shall have back-up facilities/production options available to maintain greater than 95% on time delivery or risk penalty that includes no charge doses that, at a minimum, equal the amount of missed doses.

16. Same-Day Delivery

Contractor shall be available for Emergency/STAT orders. During normal business hours, delivery time shall be within 90 minutes, and constitutes usage of 1 of the 3 free daily deliveries. After normal business hours (weekends, nights and holidays,), delivery shall be within 2 hours, and will be subject to the associated delivery fees in accordance with the schedule of supplies.

Same-Day Delivery is required to be delivered and received at the Nuclear Medicine Service no later than 2 hours after order is placed during normal business hours. Nuclear Medicine normal business hours are considered Monday through Friday: 6:30 am – 4:30 pm, except Federal Holidays.

NOTE: Vendor must be within local area (50 miles) in order to meet time constraints

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.(day of observance) Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.)

17. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services” Section.

POC Name:

Address:

City/State/Zip Code:

Ordering Phone Number:

Ordering Fax Number:

Ordering E-Mail Address:

18. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor's acceptance to commitment.

Delivery of supplies by the scheduled time shall be complete except as otherwise authorized by the Ordering Personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule.

The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.

DELIVERY LOCATION:

Deliveries shall be made to:

Department of Veterans Affairs Medical Center Attn: Nuclear Medicine Service (115) 1011, Honor Heights Drive, Muskogee, OK 74401

Delivery personnel shall be escorted at all times within the Nuclear Medicine Service. Access to the hot lab during non-business hours shall be coordinated by the on-call tech who shall meet the contractor in the department to escort them in.

19. INVOICING:

All invoices are to be sent to via electronic invoicing. The company is Tungsten Corporation – www.tungsten-network.com .

Upon request by Muskogee Radiation Safety Officer, the Contractor shall provide a copy of reports of contractor’s RSO Safety Audits of Federal Compliance.

HIPPA Compliance Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPPA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected heath information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPPA, the Contractor shall be required to enter into a Business Associate Agreement (BAA) with the VA.

Contractor shall be required to take annual HIPPA and Privacy and Security Training on TMS.

http://www.tungsten-network.com/