6640--NTX CAP Survey

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT Last Updated: 02/01/22 Page 1 of 1 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: 36C257-24-AP-0131 JOFOC Tracker Number: FY24 - NCO 17 - 340 Contracting Activity: Department of Veterans Affairs, NCO 17, VA North Texas Health Care System, (VANTHCS), 2237 number 549-24-1-190-0033 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: NCO 17 intends to award an open market sole source contract for proficiency testing surveys and calibration verification/linearity for the VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service. VANTHCS is in need of proficiency testing surveys and linearity materials that are not provided through P&LMS VA Central Office (VACO) but are still required by the guidelines set forth in VA Handbook 1106.01 7.2, 42 CFR 493 Subpart H and K, and many CAP standards. The estimated amount is $15,564.32 for one year. This requirement is being procured for one year only. Per the using service, most of their proficiency testing is provided on a National Contract executed by VA Central Office (VACO) with CAP. What is provided and how it is provided change year to year on the National Contract. For the upcoming year, VACO has added quite a few programs to the National Contract changing what VANTHCS has to fund locally. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The College of American Pathologists (CAP) is the only Centers for Medicare and Medicaid Services (CMS) approved agency for Proficiency Testing (PT) program that meets the Clinical Laboratory Improvement Act of 1988 (CLIA 88) and its amendments, and also provides linearity materials for validation of the Analytical Measurement Range (AMR) for certain analytes in Chemistry, Immunology, and Microbiology. CAP s linearity material is both matrix specific and spans the range of AMR for the required analytes through a single vendor. This requirement is addressed in 42 CFR 493.1255(b) and the CAP standard CHM.13600. Additional information provided by the using service states that VACO National Enforcement Office (NEO) is interfaced with CAP, so all VA laboratories proficiency testing is uploaded in the VACO NEO database for national review and compliance. CAP is the only proficiency testing provider that can handle the required high volume. VACO NEO instructs the facilities to use CAP when they provide the proficiency testing program. Description of market research conducted and results or statement why it was not conducted: This requirement is for the procurement of proficiency the procurement of proficiency and linearity materials that are not provided through the P&LMS VA Central Office (VACO) but are still required by the guidelines set forth in VA Handbook 1106.01 7.2, 42 CFR 493 Subpart H and K, and many CAP standards. This is a requirement of for all VA laboratories. A Notice of Intent to Sole Source was published from October 27, 2023, through November 3, 2023. There were no responses. A search of the Ability One site using the keyword linearity yielded no results. A conducted in GSA eLibrary using the keyword linearity yielded no results. As stated in Section 3 above, additional information provided by the using service states that VACO NEO is interfaced with CAP, so all VA laboratories proficiency testing is uploaded in the VACO NEO database for national review and compliance. CAP is the only proficiency testing provider that can handle the required high volume. VACO NEO instructs the facilities to use CAP when they provide the proficiency testing program. 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. ____________________________ ________________________ Robyn J. Nussbaum Date Contracting Officer