Inactive

VHAPM Part 813.106 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 Page 1 of 2 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase T... VHAPM Part 813.106 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 Page 1 of 2 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C242-21-AP-0212 Contracting Activity: Department of Veterans Affairs, VISN 02, James J Peters VA Medical Center, 130 W. Kingsbridge Rd., Bronx, NY 10468 seeks to purchase pharmacy compounding chemotherapy drugs through on a non-competitive acquisition. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The request is to procure as a firm-fixed price, sole source, 5-year BPA agreement to a large business, compounded chemotherapy drugs delivered in the final form ready for administration to Veterans with oncology appointments. This includes patient specific orders, closed chemotherapy system (Equa-shield) pieces directly attached to the preparation, as well as appropriate IV lines and in-line filters. Currently, the campus drug hood and preparation room are out of service and this needs to be in place to cover on a case by case basis. The procurement will provide James J. Peters pharmacy department daily chemotherapy compounded drugs, pursuant to a valid order, signed by VA Oncologist for disease state treatment. The medication must be delivered on the day of scheduled treatment with enough beyond-use-dating to allow infusion of the chemotherapy during the day shift at infusion suite. The chemotherapy must be shipped in appropriate containers with enough ice packs or dry ice (or equivalent) as needed for refrigeration or freezing based on medication manufacturers guidelines. The final product must use Equa-shield closed system transfer devices and tubing required to allow for proper infusion. Period of Performance: Base Year: 11/20/2020-11/19/2021- Option Year 1: 11/20/2021-11/19/2022- Option Year 2: 11/20/2022-11/19/2023- Option Year 3: 11/20/2023-11/19/2024- Option Year 4: 11/20/2024-11/19/2025- Total Contract Value: Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: is the only suitable 503A facility that has a few capabilities unique to them. Primarily they are capable of compounding personalized hazardous medications based off provider prescription with a wide formulary of agents. Additionally, they provide these medications connected to CSTDs (closed system transfer devices) that VA use within the facility and they maintain competency with and have receiving pieces to infuse patients. They have the capability to send these rapidly via FedEx with appropriate safety and cold chain storage requirements. Optum is capable of supporting VA patient load. They also fulfill all requirements for testing and quality assurance reporting. The 503A pharmacy completing this type of service must be USP< 797> and USP< 800> compliant, be a certified 503A pharmacy, maintain hood and room certification, and provide VA copies of all certifications, viable for particle testing, and competencies upon demand. The company is compliant in accordance with VHA Directive 1108.12. The high-quality pharmaceutical outsourcing (503A) can supply the following along with service required for the agency s needs: All products arrive Ready to Administer (admixed, spiked tubing, CSTD, labeled); all pharmacy have to do is administer the medication. One day turnaround time on all prescriptions. 15-point check system-done by pharmacists on each prescription. Unit cost, Inventory and supply savings-All drugs provided on a patient specific regimen. Eliminates drug-waste-No drug is wasted as a result of patient specific nature of compounding. Staff-Time-Elimination of non-reimbursable staff mixing time. USP<800>-all products mixed in USP<800>compliant environments. Description of market research conducted and results or statement why it was not conducted: Market research was conducted, which included consulting with a representative of the Original Pharmaceutical Manufacturer (OPM) trying to find potential suppliers of chemotherapy compound drugs, searching Veterans Information Pages (VIP), posting an intent to sole source on contract opportunities on 10/28/2020, searching Small Business Dynamics (SBA), searching VA NAC online pharmaceutical catalog, as well as communicating with peers throughout the VA network. This resulted in CO finding that even though there is a potential for one SDVOSB on VIP that could maybe supply the service, an Intent to Sole source was posted on Contract Opportunities and yielded no responses. A search in GSA, SBA and VA NAC pharmaceutical yielded that there are some vendors that supply the drugs individually, but they do not have the capacity to mix the drugs as needed for the requirement. CO ordered this type of requirement and know from own personal knowledge that there are no other vendors that could supply this type of Compound Chemotherapy service. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.