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The Department of veterans Affairs is looking to obtain a courtesy quote as well as vendors that can provide this service. If so, also provide the place of manufacture, and your business size under NAICS Code.

68Ga-DOTATATE, is a radioactive PET/CT diagnostic drug shown to detect neuroendocrine tumors.

The drug is administered in a single injection of 5.4 mCi (millicuries) followed by a 45-90 minute uptake period and PET/CT scan (skull vertex to mid thighs or skull base to mid thighs).

A 2237 request will be generated for bulk funded purchase for the performance period of 1/16/2023 to 12/15/2023. Estimated usage is 20 patients for the period of performance. Each dose costs $ requesting curtesy quote for a total cost of requesting curtesy quote.

The Nuclear Medicine clinic will make the appointment for the patient to receive the injection. There will only be three time slots for the production of NETSPOT per day in Seattle, WA. The Nuclear Medicine technologist will reserve a time slot in advance and place an order with awarded vendor Nuclear Pharmacy for the radiopharmaceutical. A radioactive calibration date and time needs to be established. The radioactive drug is very short lived and good only for the date of calibration. Therefore, Nuclear Medicine requests that a PO be generated and communicated to Nuclear Medicine for the injection and to have the liberty to place the order. PO will be provided to awarded vendor Nuclear Pharmacy at the time of order.

awarded vendor Nuclear Pharmacy is exclusive local distributor of NETSPOT, or 68Ga-DOTATATE. Deliveries will be made directly to the Nuclear Medicine clinic. Payment will be made directly to awarded vendor Nuclear Pharmacy and the associated PO will reflect on the invoices. C series Purchase Order will be needed.

Ordering: NETSPOT® (Gallium-68 dotatate) ( Product ) must be ordered through the pharmacy via Web Ordering, NuctracTM, phone or fax.


STATEMENT OF WORK (SOW)
as of 24 December, 2022


Contract Number:

Task Order Number:

IFCAP Tracking Number:

Follow-on to Contract and Task Order Number:
Not Applicable

1. Contracting Officer s Representative (COR).

Name:
Mario Ramos
Section:
DIS-Nuclear Medicine
Address:
1660 So. Columbian Way, S114NUC, Seattle, WA 98108
Phone Number:
(206) 764 2535
Fax Number:
(206) 764-2535
E-Mail Address:
Mario.Ramos1@va.gov

2. Contract Title.

Procurement of NETSPOT (68Ga-DOTATATE) for diagnosis of neuroendocrine tumor. This is not a request for contract services. This is for the purchase of goods a diagnostic radioactive drug which will be ordered on a case by case basis.
3. Background.
Neuroendocrine cancer is a considered an orphan disease or disease that affects less than 200,000 people per year. The current gold standard for imaging patients with neuroendocrine tumor is Octreoscan with/without SPECT/CT using 111In-DTPA Octreotide. However, 68Ga-DOTATATE PET/CT is more superior than Octreoscan with/without SPECT/CT in detecting cancer, performed in less time and more comfortable for the patient, and has less cost and associated radiation. By saving time and money, the nuclear medicine section can perform more scans and improve patient comfort and safety. There have been numerous publications regarding the differences between the two types of scans and the superiority of 68Ga-DOTATATE PET/CT to Octreoscan with/without SPECT/CT.

We currently perform approximately 10 Octreoscans with SPECT/CT per year at the VAPSHCS and plan to perform 68Ga-DOTATATE PET/CT instead of Octreoscan with SPECT/CT for patients with neuroendocrine tumor in the future. In addition, the VAPSHCS will be the only VA in the VISN20 with access to this radiopharmaceutical, which will increase the number of PET/CT scans in our section. We anticipate performing approximately 20 68Ga-DOTATATE PET/CT scans per fiscal year accounting for the additional patients sent from other VA hospitals in the region and along the west coast.
NETSPOT is a radioactive pharmaceutical used for the detection of neuroendocrine tumor. It is supplied as a unit dose intravenous injection. NETSPOT is administered as a one-time only injection. The drug will be purchased with a single purchase order.
4. Scope.

NETSPOT is a sole source product produced by Advanced Accelerator Applications and distributed exclusively through the awarded vendor Nuclear Pharmacy. Once a patient is identified, funding is secured, and a PO is issued, Nuclear Medicine will place the order to awarded vendor Nuclear Pharmacy and direct delivery to the Nuclear Medicine clinic will be arranged by awarded vendor for a unit dose.

5. Specific Tasks.

Advanced Accelerator Applications will place a 68Ge-68Ga generator in Seattle, WA and partner with awarded vendor Nuclear Pharmacy to distribute the unit radiopharmaceutical dose. The generator must be placed not too far from the hospital so the radiopharmaceutical does not substantially decay before delivery and injection. Advanced Accelerator Application will ensure this criterion is met.

Special Delivery Instructions

Delivery Request Notification to Vendor Once a patient is identified then the Netspot order will be communicated to the vendor. Nuclear Medicine will place the order to the vendor and direct delivery to the Nuclear Medicine clinic will be arranged by the vendor in coordination with the VA.
Delivery Timeline The amount of the drug administered is set at 5.4 mCi for each patient. The vendor of Netspot will supply and deliver the drug by Nuclear Medicine s requested calibration date and time to ensure enough of the radiopharmaceutical is delivered. Specifically, the VA PET/CT technologist will review the on-line supply calendar and reserve an available dose. The vendor will be called and given information for the order. The Vendor will place the order with their contracted supplier for compounding and to deliver the patient-ready dose directly to the Nuclear Medicine Clinic. The vendor will make accommodations to supply a replacement dose at no charge due to inclement weather delaying delivery making the original dose below calibration levels.

Deliveries will be made directly to the Seattle VA PSHCS, 1660 So. Columbian
Way, Seattle WA, 98108, Building 100, Room 2D196b. Courier should report to the police office to gain entrance to 2D196b (hot lab) if delivery is being made outside of clinic hours.


6. Performance Monitoring
All doses will be correctly dated and calibrated with on-time delivery.
Any doses deemed below standard by the facility (i.e. visually unacceptable, incorrectly calibrated, etc.) shall be credited toward the account.
It is the offeror s responsibility to provide the VAPSHCS with recall notices on any product that has been delivered to the VAPSHCS that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method.
Vendor shall provide complete documentation of quality control results upon request. Results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided at no additional charge on request.
Offeror will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass Quality Control may be sent to the VAPSHCS Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VAPSHCS Nuclear Medicine Service.
All products purchased are subject to acceptance by the VAPSHCS, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VAPSHCS will not be financially liable for unacceptable materials.
7. Security Requirement
Vendor will not require access to patient information. Courier will be escorted directly to the hot lab for deliveries and will not be unattended or have access to patient information.
.

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

None

9. Other Pertinent Information or Special Considerations.

None
a. Identification of Possible Follow-on Work.

None

b. Identification of Potential Conflicts of Interest (COI).

No potential for COI identified.

c. Identification of Non-Disclosure Requirements.

There is no sensitive or proprietary information identified to which the vendor will have access to during contract performance.

d. Packaging, Packing and Shipping Instructions.

Packaging of the Product: Product shall be delivered in unit dose syringes, one per container, in D.O.T. approved radioactive material shipping containers labeled in accordance with NRC regulations.

e. Inspection and Acceptance Criteria.

Radioactive shipments are received, inspected and documented in a dedicated Nuclear Medicine database per NRC regulations. Acceptance criteria are performance based with particular attention to on-time delivery and accuracy of prescriptions.
10. Risk Control
None. This is for the procurement and delivery of radioactive treatment doses. Radioactive shipments are regulated and monitored by the Radiation Safety Office.

11. Place of Performance.

Deliveries will be made directly to the Seattle VAPSHCS, 1660 South Columbian Way, Seattle WA, 98108, Building 100, Room 2D196b. Courier should report to the police officer to gain entrance to 2D196b (hot lab) if delivery is being made outside of clinic hours.

12. Period of Performance.
N/A not a contract request. This is a request for goods.

13. Delivery Schedule.

Delivery dates of doses will be coordinated between the Nuclear Medicine clinic and vendor.

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