Inactive

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 10 Page 1 of 9 Original Date: 03/22/11 Revision 10 Da... VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 10 Page 1 of 9 Original Date: 03/22/11 Revision 10 Date: 09/10/2020 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C252-21-AP-0012 Contracting Activity: Department of Veterans Affairs, VISN 12, Edward Hines Jr. VA Medical Center Great Lakes Acquistion Center, 578-21-1-1905-0006 Nature and/or Description of the Action Being Processed: EMERGENCY COVID-19 Testing Reagents from Roche Diagnostic Corporation for an estimated six months of tests. Due to an ongoing national shortage, this was the maximum quantity available for purchase. The weekly spending estimate of $25,137.59 is based on a weekly rate of 16 runs per week, or 8 full COVID kits but these estimates may increase as the number of test and cases increase in WI and IL. The total estimated value of the award is $653,577.34. This is a firm fixed price, emergency acquisition for COVID-19 tests to be run on the Roche c6800. Only Roche reagents are compatible with the Roche Diagnostic cobas 6800 currently in use for this purpose. Award was made on 10/2/2020 as an emergency under contract: 36C25221C0007. Description of Supplies/Services Required to Meet the Agency s Needs: Hines PLMS has an emergent need for COVID-19 tests, reagents and all associated accessories and consumables in response to the ongoing COVID-19 pandemic. The quantity originally forecasted in contract number 36C25220D0035 will not be sufficient for the near future, and demand for these tests has skyrocketed in the last two months, so additional tests need to be purchased immediately. The Hines Lab currently uses the Roche Diagnostic Corporation s cobas 6800 instrument to conduct these tests. No other reagents tests are compatible with this system. Failure to timely provide an adequate number of tests could result in grave danger to the safety of patients and caregivers. Due to an ongoing national shortage, this was the maximum quantity available for purchase. The weekly spending estimate of $25,137.59 is based on a weekly rate of 16 runs per week, or 8 full COVID kits. The total estimated value of the award is $653,577.34. See Below Table: Covid-19 Specific tests Tests/Pkg cobas SARS-COV-2 Kit 192 cobas SARS-COV-2 Kit control kit 1536 cobas Buffer Negative Control Kit 1536  6800 Generic Products*** cobas omni Amplification Plate 3072 cobas omni Pipette Tips 768 cobas omni Processing Plate 1536 KIT COBAS 6800/8800 LYS REAGENT IVD 922 KIT COBAS 6800/8800 MGP IVD 480 KIT COBAS 6800/8800 SPEC DIL REAGENT IVD 922 KIT COBAS 6800/8800 WASH IVD 230 cobas omni Liquid Waste container 3.00 Solid Waste containers 4.00 cobas omni secondary tubes 3.00 Statutory Authority Permitting Other than Full and Open Competition: ( ) (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; (X) (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): Based on the unusual and compelling urgency of the COVID-19 Pandemic, the VA in VISN 12 expects to have a continuing urgent need for COVID-19 tests in order to maintain the health and safety of patients and staff. The Pandemic is surging across the country, resulting in extreme delays in availability of tests. Cases in Wisconsin and Ilinois are accelerating beyond previous estimates and aare well in excess of testing quantities previously purchased to manage the forcasted need. Hines VA currently uses multiple platforms from many manufacturers to test for COVID-19 and sends out tests to third parties in order to meet the current growing needs. This still is insufficient to meet demand. This is the largest quantity of these tests available for us purchase at this time in order to ensure we have available testing in the VISN through the upcoming CY. We cannot meet our rapidly increasing need for testing without immediate purchase of these additional tests to satisfy the need of this public health crisis. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: These tests and reagents listed above are only available from the manufacturer and not available through distribution. As the items are proprietary no other product could be used for the devices from another source. Based on the urgent need for these tests, and the proprietary nature of the reagents, no further market research was conducted. A Sources Sought was not posted due to the urgency and immediate need. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Similar tests are available on the contractor s GSA contract, V797P-5279B for like items. The products in this procurement are only available under Emergency Use Authorization, and not available under any existing contract. Similar items and tests were previously competed and awarded under 36C25220D0035 where the price was found fair and reasonable. Pricing for these items is at or below cost for the previously competitively awarded action. Based on these factors, the CO determines the price to be fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A VIP search for SDVOSB/VOSB contractors under NAICS Code 334516 with the keyword reagents yielded zero results. The search results are documented in the Contracting Officers Market Research file as the rule of two could not be satisfied in this emergent procurement. Based on the urgent and compelling need, additional market research was not conducted for other mandatory sources. Any Other Facts Supporting the Use of Other than Full and Open Competition: VA purchases COVID-19 testing supplies and tests from multiple manufacturers, purchases testing from third parties and all are limited in compacity due to the increasing demand in the midwest. With the rapidly increasing demand for COVID-19 testing in the VISN all sources of testing are being sought to meet the needs. Forecasts were not able to project the now third wave of incoming cases within the United States and the need for these additional quantities within the VISN. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A 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: VISN 12 anticipates a continuing growing need for COVID testing in the near future as cases continue to rise. Multiple manufacturers provide COVID-19 tests and VA purchases test kits from all of them. They are all limited in compatibility to their respective devices. Based on the proprietary nature of these reagents, items and tests, a future procurement is expect in early CY21. This action will be sole sourced as a brand name only and VISN 12 will provide a Notice of Intent to Sole Source and Brand Name Only justification in advance to provide the market sufficient time to respond to the projected increased need. 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. _____________________________________________________ Courtney Feldmann Date Business Manager, VISN 12 PLMS Edward Hines, Jr. VA Hospital 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. _____________________________________________________ Farrukh Daniel Date Contracting Officer 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. _____________________________________________________ David Picchi Date NCO12 Branch Chief