6550--Siemens EPOC-POCT Blood Gas Analyzer

OFOC SOP Revision 10 Original Date: 03/22/11 Revision 10 Date: 09/10/2020 Page of 4 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C242-20-AP-3156 Contracting Activity: Department of Veterans Affairs, VISN 02, James J. Peters VA Medical Center 130 West Kingsbridge Road, Bronx, NY 10468. Organizational Activity; New York Harbor Healthcare System Brooklyn and Manhattan Campuses 800 Poly Place Brooklyn, NY 11209 and 423 East 23rd Street New York, NY 10010 Nature and/or Description of the Action Being Processed: The proposed action is a COVID 19 related standard priority, sole source, firm fixed priced (FFP) 5-year Requirements Contract to , a large business vendor. The analyzer is required on-site as soon as possible to provide lifesaving, in-house diagnostics and expedited testing turn-around-time. Description of Supplies/Services Required to Meet the Agency s Needs: New York Harbor Healthcare System Brooklyn and Manhattan campuses require Siemen Epoc readers, reagent kits and software license service on equipment used in point-of care Testing (POCT) blood gas analyzers. This request is for an essential, diagnostic medical device as part of the medical center s efforts to combat current COVID 19 pandemic anticipated second wave to coincide with upcoming flu season. The Epoc POCT is the only FDA-approved handheld, wireless solution capable of comprehensive blood analysis testing at the patient s side on a single room temperature card, with results in less than a minute. The requirement is based on instruments, consumables and software license support to be placed on an as needed basis to be used for panel of tests to include pH, carbon dioxide, oxygen, sodium potassium, ionized calcium, lactate, glucose, hematocrit, creatinine, chloride, blood urea nitrogen, hemoglobin, actual bicarbonate, total carbon dioxide, estimated glomerular filtration rate and oxygen saturation for new admission/transfer, and rapid testing for patient diagnosis. This requirement will provide middleware licensing support for covered Epoc blood analyzer and accessories. The vendor has proprietary rights to the equipment and reagent kits needed for this award. The following will satisfy the agency s needs; Epoc Eurotrol Gas-ISE-Ctrl-BG-CON-Lvl 1. Epoc Eurotrol Gas-ISE-Ctrl-BG-CON-Lvl 2. Epoc-Eurotrol Gas-ISE-Ctrl-BG-CON-Lvl 3. Epoc Eurotrol Gas-ISE-Ctrl-BG-CON-Lvl 6. Epoc Eurotrol Gas-ISE/BUN cal/verif-CON-Lvl 1-5. Epoc Eurotrol Hematocrit Ctrl-BG-CON-Lvl A. Epoc Eurotrol Hematocrit-Ctrl-BG-CON-Lvl B. Epoc Eurotrol Hematocrit-Ctrl-BG-CON-Lvl C. Epoc Eurotrol Hematocrit Cal/verif-BG-CON-Lvl 1-5. POCcelerator SE Core License (SO). Epoc readers for Manhattan and Brooklyn campuses. Helix-New Install Enterprise 5+ sites The estimated value of the proposed action is $ Period of Performance: Year 1- Award 09/30/2021-$ (Covered by COVID Funds) Year 2-10/01/2021-09/30/2022-$ Year 3-10/01/2022-09/30/2023-$ Year 4-10/01/2023-09/30/2024-$ Year5-10/01/2024-09/30/2025-$ **Note-Only Year one Period of Performance is Funded by COVID funds. Statutory Authority Permitting Other than Full and Open Competition: (x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; () (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; () (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; () (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 () (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; () (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; () (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Epoc® is only one of two handheld POCT blood gas instruments on the market capable of fulfilling NYHHS Pathology and Laboratory service (PLMS) requirements. Technical reviewers identified one other POCT analyzer from , but according to Food and Drug Administration (FDA) imposed sanctions, does not have the necessary timeliness and menu capacity presented in the analyzer. epoc analyzer will effectively identify, in one minute, COVID 19 patients and patients with other causes of acute respiratory distress or arrest. All 13 direct-measured assays (items to be tested) are contained in one test card and only require 92 microliters of sample. These are a list of advantage features unique to analyzer: A single test card with 13 different direct-measured assays (items to be tested) contained on one card vs. a single card needed for each different assay. No refrigeration of reagent or test cards for stability promoting less waste and/or funds for supplies vs. a refrigeration requirement by most suppliers. A sample size of 92( l) microliters vs. variation per assay. Food and Drug administration approval of Siemens Epoc® for blood gas analysis vs. Food and Drug (FDA) imposed sanctions and non-approval of the device for blood gas analysis. The blood analysis equipment and license middleware are needed and unique to the needs of the agency. It is necessary for the Original Equipment Manufacturer (OEM) to provide reagent kits and middleware license agreement for the above-mentioned reasons. Any other brand will not work. Accordingly, is the only firm capable of providing the supplies and support described in line 3 above without the Veteran s Health Administration experiencing substantial duplication of costs, that could not be expected to be recovered through competition, and unacceptable delays in fulfilling its requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted by reviewing Siemens Healthcare literature, searching the GSA/FSS Library to find other potential suppliers, and consulting with the original equipment manufacturer by technical experts at VA. This identified one other POCT analyzer, , but according to Food and Drug Administration (FDA) imposed sanctions, does not have as referred to in section 3 and 5 above as analyzer and the device is not approved for VA. Additionally, searches were conducted through Veterans Information Page (VIP) using NAICS 325413 and Keyword Blood Gas Analyzer, Dynamic Small Business Search (DSBS), NAC Medsurg Catalog and GSA Ebuy, seeking as many potential suppliers for POCT blood gas analyzers. An intent to sole source was also posted on Contract Opportunities on 9/18/2020. Results identified three (3) distributors; . All would be considered pass throughs, and pricing is not anticipated to be fair and reasonable. Additionally, the distributors would not be able to support the middleware software licensing which is a mandatory element of the purchase and must be made through directly. Siemen is the sole supplier for all Epoc readers, reagents and middleware licenses needed to meet the agency s needs. Currently, there are no other POCT blood analyzers that meet NYHHS PLMS performance standard that are FDA approved. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Obtained a vendor report on feddatacheck to identify comparable prices. Open market pricing quoted by OEM for Epoc®POCT blood gas system is consistent with previous pricing. This is not subject to competition, but in determining the price for the Epoc® readers, reagents kits and software license service support, online pricing and researching recent award in 2018 show price to be unchanged, deeming it fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted as described in section 6 above and in accordance with FAR Part 10. The synopsis of the proposed acquisition advising industry of the pending acquisition yielded no responses other than distributor who is unable to provide middleware software license support. Any Other Facts Supporting the Use of Other than Full and Open Competition: Original equipment manufacturer supplied VA with a letter confirming they are the sole manufacturer of the Epoc reader and accessories required. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Market conditions will be monitored in the future for entrants with FDA approval. No other source can currently provide an FDA approved solution that meets the Government s needs. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. Date Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Date One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. Date