6640 - SHORT TERM CEPHEID COVID/FLU 22,053 KITS

This Justification and Approval is for the award of a sole source firm-fixed purchase order to Cepheid for the acquisition of Cepheid GeneXpert Xpress test kits(SARS?CoV?2/Flu/RSV Plus test kits, SARS-CO-2 test kits and M-100 Swab kits), to resolve urgent supply needs. The procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. - 1903. The GeneXpert Xpress serve as a critical testing capability in the diagnosis of the disease. The use of GeneXpert Xpress test kits must be increased as soon as possible to support diagnostic patient testing. It will take time for the newly vaccinated to get protection from the virus. The COVID-19 Delta variant is the predominant variant of the virus in the United States. The Delta variant is highly contagious and more than twice as contagious as previous variants. There can be breakthrough infections for vaccinated people and can cause more severe illness than previous variants for unvaccinated people.[1] In addition to the Delta variant, new variants such as Omicron continue to appear with the potential to be as infectious, or even more so.[2] As we continue to combat COVID-19, testing is a key tool to identify infected individuals and prevent the spread to others. On September 10, 2021, President Biden announced the - Department of Labor is developing an emergency rule to require all employers with 100 or more employees, that together employee over 80 million workers, to ensure their workforces are fully vaccinated or show a negative test at least once a week.[3] Although this mandate is currently challenged in a Federal District Court, this declaration has caused additional constraint on an already burdened supply chain, which has led to the difficulty of obtaining these highly sought-after items. Veteran Affairs Medical Centers (VAMCs) shall be prepared to continue ongoing and weekly testing. Testing shall also be available to those that were potentially exposed to the virus to limit the spread. After communications between Veterans Health Administration (VHA) and SAC in December 2021, the decision was made to award a new, short-term national contract for test kits and supplies in order to obtain an adequate number of test kits to allow time for a long-term solution to be executed. The consensus was also reached to assign the SAC the task of awarding and administering the contract for test kits and supplies on behalf of VHA as the procurement is aligned with SAC's existing medical supplies contract portfolio. As of December 9, 2021, VA is currently using approximately 3,080 Cepheid GeneXpert Xpress kits on a weekly basis across the enterprise. Executing an award in the amount of $14,999,715.00 will enable VA to acquire approximately 5-7 weeks worth of COVID test kits. 3. Description of Supplies or Services: The proposed action is to procure the Cepheid GeneXpert Xpress test kits (SARS?CoV?2/Flu/RSV Plus test kits, SARS-CO-2 test kits and M-100 Swab kits) to support VA meeting the diagnostic needs of in excess of 1,200 VA healthcare facilities which includes 170 medical centers and over 1,000 outpatient sites within all 18 VISN throughout the U.S. and its territories. The GeneXpert Xpress platform provides detection and differentiation of SARS?CoV?2, Flu A, Flu B, and RSV, which all present with similar symptoms allowing accurate diagnoses and identifying potential cases of co?infections during respiratory season. The POP for the contract issued under the authority of this justification is expected to be January 1, 2022 through March 1, 2022, to ensure availability of the test kits until a long-term procurement can be facilitated. This contract will be awarded on a firm-fixed-price basis with a total dollar value not to exceed $14,999,715.00, in accordance with the Independent Government Cost Estimate, as developed from using previous historical SAC contract 36C10X21D0015 and verified via quote from Contractor. Reference the below schedule: CLIN Item OEM Part # Price 0001 Xpert Xpress SARS-CoV-2/Flu/RSV Plus Kit* XP3COV2/ FLU/RSV-10 [REDACTED] 0002 M-100 Swab Kit SWAB/M-100 [REDACTED] TOTAL $14,999,715.00 * Each test kit contains sufficient reagents to process 10 specimens or quality control samples. 4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. - 1903 Special Emergency Procurement Authority as implemented by Federal Acquisition Regulation (FAR) 13.106-1(b) entitled, - Soliciting from a single source, using procedures in accordance with FAR Subpart 13.500(c), specifically 41 U.S.C. - 1903(a)(4). On February 24, 2021, President Biden declared a continuation of a national emergency in response to the COVID-19 pandemic. The Contracting Officer has determined that it is in the best interest of the government to solicit from a single source due to the urgent need of these items, to allow time for a long-term solution to be executed. 5. Rationale Supporting Use of Authority Cited Above: Due to continued consequences of the COVID-19 pandemic, the Secretary of Health and Human Services renewed the Public Health Emergency Declaration on October 15, 2021.[4] As of December 9, 2021, VA is currently using approximately 3,080 Cepheid GeneXpert Xpress kits on a weekly basis across the enterprise. Based on current usage, VA will exhaust all supply of COVID test kits by January 15, 2021, therefore it is in the best interest of the government to pursue a sole source contract in order to ensure VA maintains an adequate supply of test kits. Ninety-two percent (92%) of the VA clinical laboratories (157 out of 171) have acquired the Cepheid GeneXpert equipment and implemented and validated the SARS-CoV-2 testing as a key part of their COVID-19 response and in compliance with the VA's Moving Forward Plan. This equipment represents a total investment of $ 27,781,370.00. Due to historical knowledge paired with the number of VA clinical laboratories that have this equipment, VA is confident that the test kits received in performance of this contract will meet VA's needs until a long-term national contract is established. Approval of this individual justification enables VA to avoid delays in providing vital Cepheid GeneXpert Xpress test kits and the catastrophic negative impact to the Department's ability to provide world-class patient care to our nation's veterans. This justification will allow VA to be more agile in its acquisition of critical medical items in the currently everchanging and quickly evolving marketplace. 6. Efforts to Obtain Competition: A competitive contract is normally in the best interest of the government; however, due to the urgency to ensure all facilities have valid test kits to comply with the EO 14043 that was signed on September 9, 2021 by President Biden, and to meet the mission of providing care to the nation's veterans, it is in the best interest of the government to execute this contract to fulfill the immediate need and to avoid any lapse in availability of test kits. As increased global demand on the worldwide supply chain continues to result in acute global shortages, VA is exercising due diligence in continuing to validate the source of supply; obtaining medical-field subject matter expertise to determine if the offered equipment will meet the needs of the Government; validating the need for the offered test kits; ensuring the price is reasonable; and, is making appropriate contractor responsibility determinations prior to issuing a contract award. 7. Contracting Officer determination that the anticipated cost to the Government will be Fair and Reasonable: The Contracting Officer has determined the cost to the Government to be fair and reasonable. In accordance with FAR 13.106-3(a)(2), this determination is based on a comparison of proposed pricing to historical contract prices, comparison with competitive published price lists from the Medical Product Data Bank (MedPDB) and the U.S. General Services Administration Advantage website for similar products, in addition to other information made available utilizing price analysis for the Cepheid SARS?CoV?2/Flu/RSV test kits, SARS?CoV-2 test kits, nasopharyngeal swabs kits, GeneXpert XVI module configurations, and associated accessories.Cepheid's proposal is in line with recent past offers. Previous SAC contract 36C10X21D0015 priced all items for the SARS?CoV?2/Flu/RSV test kits, SARS CoV-2 test kits, nasopharyngeal swabs kits, as reflected in the table in paragraph 3 Description of Supplies or Services, of this J&A. On the Medical Product Data Bank (MedPDB) website, the average price of SARS?CoV?2/Flu/RSV test kits, nasopharyngeal swabs kits, and SARS-CO-2 test kits are [REDACTED], [REDACTED] and [REDACTED] respectively. Therefore, Cepheid's pricing is determined to be fair and reasonable as proposed and described herein. A search of the System for Award Management database concluded there were no restrictions in place that would limit the Government from contracting with Cepheid. 8. Description of Market Research Conducted: A Request for Information was issued on October 15, 2021 and seven responses were received. Five responses were substitute items that were determined incompatible with existing equipment, and two were brand name requested items. One of the brand name items was from the manufacturer and the other was from an unauthorized distributor. The Cepheid SARS?CoV?2/Flu/RSV Plus test kits and SARS?CoV-2 test kits are for use with the proprietary GeneXpert Xpress platform, and Cepheid has no authorized distributors, no other vendors can satisfy this procurement. 9. Other Facts: VA supports FEMA and U.S. Department of Health & Human Services with the delivery of medical supplies and coordination of support missions in response-to and recovery-from nationally declared emergencies and disasters. Given that VA Medical Centers and other select federal facilities are designated FEMA facilities with significant contingency and emergency response roles, the failure to rapidly acquire COVID-19 test kits would not only negatively impact healthcare delivery to our nation's Veterans and their dependents, but also potentially have a direct negative impact on the greater public. 10. A listing of the sourcs, if any, that expressed an interest in the acquisition: The contracting office has determined that Cepheid is a responsible domestic source for producing the required health and medical resources, specifically Cepheid SARS?CoV?2/Flu/RSV Plus test kits and SARS?CoV-2 test kits suitable to provide the needed response to the spread of COVID-19. The following companies expressed interest in this procurement: All Hands On Deck Company Skippack Medical Lab L Mac Solutions LLC Vetguard Medical Supply Keystone Solutions Group Journey Events LLC Cepheid 11 Series Energy 11. Statement of Actions the Agency may take to overcome barriers to competition in the future: As the actions under the authority of this justification and is from a single source in response to a declared national emergency, there are currently no actions being taken to overcome barriers to competition for the purchase of Cepheid GeneXpert Xpress test kits(SARS?CoV?2/Flu/RSV Plus test kits, SARS-CO-2 test kits and M-100 Swab kits), for this immediate requirement. In accordance with FAR 6.305(a) as prescribed by FAR 13.501(a)(1)(iii), the sole source justification will be made publicly available within 30 days after the purchase order has been awarded. Parties interested in future business opportunities, should they occur, for the same or similar listed equipment are encouraged to respond to the Point of Contact identified in the sole source justification posting. 12. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief. [SIGNATURE REDACTED] _____________________________________________________ _________________________________ Song Gotiangco Date Director, Medical Supply Program Office VHA Procurement and Logistics Office (10NA2) Contracting Officer Certification: Pursuant to (FAR 13.501(a)(2)), I certify that this justification is accurate and complete to the best of my knowledge and belief. [SIGNATURE REDACTED] Nathan Bradley Date Contracting Officer Strategic Acquisition Center Approval In my role as Competition Advocate for the procuring activity, based on the forgoing justification, I hereby approve the Justification and Approval, on an other-than full and open competition basis pursuant to the statutory authority cited in paragraph 4 above, subject to availability of funds, and provided that the items herein described have otherwise been authorized for acquisition. [SIGNATURE REDACTED] __________________________ ___________ Adam Spacht Date Strategic Acquisition Center Procuring Activity Competition Advocate [1] Delta Variant: What We Know About the Science | CDC [2] Omicron Variant: What You Need to Know | CDC [3] Biden announces COVID-19 vaccine mandates that will affect 100 million Americans (cbsnews.com) [4] https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-19July2021.aspx