SOW AMYVID.pdf
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- Solicitation number
- FA860124Q0039
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This document includes a statement of work and federal contract opportunity notice for a five-year blanket purchase agreement for Amyvid (Florbetapir F18) radioactive tracer. The 88th Medical Treatment Facility at Wright-Patterson Air Force Base requires the tracer to perform positron emission tomography scans to estimate beta-amyloid plaque density in the brain as an indicator for Alzheimer's disease. The statement of work outlines delivery, safety, regulatory, and quality requirements for the tracer, which must be FDA-approved. The federal contract opportunity is a combined synopsis and solicitation to establish a blanket purchase agreement solely with PETNET Solutions, Inc., as they are the only supplier licensed to produce and provide the tracer in the specified region. Interested parties may submit a capability statement or exception by February 21, 2024, but the government intends to award solely to PETNET Solutions due to regulatory restrictions.
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Attachment 1 – Statement of Work
STATEMENT OF WORK
Florbetapir F18 (Amyvid) Radioactive Tracer for PET/CT Imaging
1 February 2024
1. Introduction:
o The 88TH Medical Treatment Facility (MTF) located at Wright–Patterson AFB, OH requires a five (5) year Blanket Purchase Agreement (BPA) for Amyvid (Florbetapir F18) The primary objective of this effort is to allow for the rapid procurement of these solutions to perform necessary examinations.
2. Background:
o Florbetapir F18, commonly known as Amyvid, is a radioactive tracer in Positron
Emission Tomography (PET) imaging. The primary objective is to utilize Amyvid to estimate the density of beta-amyloid plaque in the brain, which is an indicator of Alzheimer's disease.
3. Minimum Requirements:
o Item description:
o Amyvid (Florbetapir F18) injection o Performance Requirements:
o Vendors shall obtain base pass access to deliver doses of Amyvid to the Nuclear Medicine clinic in the Wright-Patterson Medical Center. Vendor shall coordinate with 88th Medical Treatment Facility, Nuclear Medicine Clinic Point of Contact to obtain base passes via certified AF Form 1440.
o This product shall be supplied in a syringe that will have a milliCurie activity level matching each individual order specification.
o Vendor shall only invoice the customer for doses arriving in usable form, resulting in successful patient scan.
o Delivery driver shall pick up old tracer package(s) when dropping off a new tracer package(s). Upon completion of the Blanket Purchase Agreement Period of Performance or Maximum Dollar Limit being exhausted, the package from the final dose shall be picked up from 88th MTF Nuclear Medicine Clinic upon notification of completion.
o Standards, guidelines, or approvals – Must be FDA approved.
4. Regulatory Compliance:
o All activities related to the use of Amyvid shall comply with applicable regulatory requirements, including but not limited to local, state, and federal laws governing the handling of radioactive materials, radiopharmaceuticals, and patient safety.
Attachment 1 – Statement of Work
5. Safety:
o Safety protocols for radiopharmaceutical handling, patient exposure, and radiation safety shall be strictly followed.
o Personnel involved in the administration and imaging process shall be appropriately trained and certified in handling radioactive materials.
6. Review and Continuous Improvement:
o Regular review of procedures and protocols will be conducted to ensure best practices and continuous improvement in the use of Amyvid for PET imaging.
7. Conclusion:
o This Statement of Work outlines the procedures and responsibilities for the utilization of Florbetapir F18 (Amyvid) as a radioactive tracer in PET imaging.
The aim is to ensure the accurate, safe, and effective utilization of Amyvid for the detection of beta-amyloid plaques in the brain, contributing to the diagnosis, research, and management of Alzheimer's disease and related conditions.
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