Radiopharmaceuticals Unusual and Compelling Justification.pdf

Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2.

Revision: 01 Effective Date: 11/01/2024 Page 1 of 2 Acquisition ID#: 36C24425AP2374

DEPARTMENT OF VETERANS AFFAIRS

Justification for Unusual and Compelling Urgency IAW FAR 6.302-2 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C24425AP2374

1. Contracting Activity: Department of Veterans Affairs, VISN 04, 693 Philadelphia VA Medical Center, 3900 Woodland Ave. Philadelphia PA 19104 2237: 642-25-2-029-0044.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Philadelphia VAMC urgently requires radiopharmaceuticals, specifically Fludeoxyglucose F-18 (FDG) and Sodium Fluoride (NaF). These substances are used alongside Positron Emission Tomography (PET) scans to diagnose and assess various medical conditions, primarily cancer, but also heart disease and epilepsy. They work by illustrating how effectively different parts of the body are utilizing glucose, which serves as a marker for metabolic activity. These radiopharmaceuticals are essential for determining the stage of cancer, a critical step in developing an effective treatment plan. Additionally, they provide valuable feedback on how well a patient is responding to cancer treatment. Philadelphia VAMC is currently unable to provide care to any of their cancer patients due to not having the radiopharmaceuticals.

Estimated Value: $121,000.00

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The half-life of these radiopharmaceuticals is 110 minutes, meaning that they begin to decay after this time period. Cardinal Health is capable of meeting the timeline required for delivering these radiopharmaceuticals. A solicitation was issued for the provision of these products; however, all the small businesses and Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) indicated that they were unable to supply the radiopharmaceuticals due to the constraints posed by the half-life of the drugs.

4. Description of market research conducted and results or statement why it was not conducted:

Market research revealed that several small businesses have been awarded contracts for radiopharmaceuticals. Currently, PetNet a large business, is in the process of establishing a facility in Philadelphia to supply the required F18 and NaF. However, this facility will not be set up and approved by the FDA for an additional 4 to 6 months. No other options currently exist but to Sole-source to Cardinal Health with has the stock and means to circumvent an interruption of Veteran care for cancer procedures.

Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2.

Revision: 01 Effective Date: 11/01/2024 Page 2 of 2 Acquisition ID#: 36C24425AP2374

5. Contracting Officer's Certification: The Purchase is approved in accordance with FAR 6.302-2 and FAR 13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Keri Hester Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466