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OFOC SOP Revision 12 Original Date: 03/22/11 Revision 12 Date: 01/10/2022 Page 1 of 5 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Ac... OFOC SOP Revision 12 Original Date: 03/22/11 Revision 12 Date: 01/10/2022 Page 1 of 5 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C259-22-AP-4186 J&A Tracking Number: 2022-12-28T09:19:36 Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Organizational Activity: Department of Veterans Affairs VA Salt Lake City Health Care System 2237# 660-23-1-071-0013 500 Foothill Drive Salt Lake City, UT 84148 Oklahoma City VA Health Care System 2237# Funding Memo 921 N.E. 13th Street Oklahoma City, OK, 73104 Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for a sole source contract to procure specialized laboratory reagents, antibodies, detection kits, and supplies for the lab-owned Leica Histocore Peloris analyzer and Leica BOND III Processing Module that is located at the above two (2) VISN 19 stations. The proposed action is to provide the VA Salt Lake City Health Care System and the Oklahoma City VA Health Care System with compatible reagents, antibodies, detection kits, and supplies for the continuation of testing capabilities for immunohistology testing and diagnosis of cancer, as well as set-up and training of VA lab technicians for tests on the analyzers. This will be an open market, sole source, single award Blanket Purchase Agreement (BPA). The award will be a firm-fixed price BPA funded by yearly task orders by each facility. These products are critical to the support of VA patient care. They support the mission of the VA to provide timely, accurate, and appropriate care to oncology patients. The period of Performance will be May 1, 2023 through April 30, 2024, followed by four (4) option years. The estimated value of the proposed action is $1,957,992.95 for five (5) years. The estimated value of the base year is $391,598.59. 3. Description of Supplies/Services ds: The procurement will provide specialized Leica Biosystems (doing business as Leica Microsystems, hereinafter Leica ), products to the Pathology and Laboratory Medicine Services. Leica is the sole manufacturer of these proprietary reagents, antibodies, detection kits, and supplies compatible for this system and will not void any warranty by their use. These products are critical to the support of VA patient care. They support the mission of the VA to provide timely, accurate, and appropriate care to oncology patients. 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 C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Leica is the sole manufacturer of these proprietary reagents, antibodies, detection kits, and supplies compatible for this system and will not void any warranty by their use. Leica supplied a sole source letter indicating that Leica is the manufacturer and sole source provider of the BOND III system including proprietary regents and consumables. This includes the required BOND detection kits used for immunohistochemistry (IHC) staining required in this procurement. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A search was conducted on VetBiz on 10/31/2022 (Analytical Laboratory Instrument Manufacturing) (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets). No SDVOSBs or VOSBs resulted from the search. A search was performed on GSA eLibrary on 10/31/2022 using Two (2) large business contractors resulted from the search. One was Leica Geosystems (GS-07F-0069U) which listed NAICS code 334511 (Search, Detection, Navigation, Guidance, Aeronautical and Nautical Systems and Instruments). A search of Leica Geosystems (large) schedule illustrated that they could not fulfill this requirement. The only other business concern, Leica (large) did not offer the immunohistochemistry (IHC) staining reagents and detection kits on FSS (Federal Supply Schedule) required for this procurement, however they do have these tests offered through open market. A search conducted on SBA on 11/2/2022 using small business concerns resulted. None can fulfill the requirement. Associated Microscope company Only sells microscopes Arrowhead Scientific Only sells investigative products for law enforcement Exact Metrology Sales and support of Portable 3D CMM and 3D scanning BitterFboNotice Services & Technology (SDVOSB) Can sell KayPentax Medical Leica Microsystem equipment, not IHC reagents W. Nuhsbaum Sales and service of Leica microscopes and imaging systems A Sources Sought (36C25923Q0012) was posted on Contract Opportunity on 10/25/2022. Two responses were received, Government Scientific Source (Small Business) and Agilent (Large). Government Scientific Source (GSS) submitted a letter indicating that they are an authorized distributor for Leica. Agilent does not offer Leica reagents or stains. On November 24,2022, clause 52.217-8 Option to Extend Services, was exercised on current Leica contract, 36C25922P0101, to allow six (6) additional months for readiness for the new 5-year contract. This allowed more time for pending official quotes from Leica and for the document approval process within contracting. The award on this contract is due in May, 2023. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: CO will determine the price to be fair and reasonable based on historical pricing compared to proposed pricing from Leica. A comparison of 59 common reagents showed that the proposed pricing from Leica to be 7% less expensive than the 2020 pricing in contract GS-07F-5934R VA259-17-A- 0071 with GSS. Market research was conducted by searching and viewing historical awards in FPDS which showed the Department of Veterans Affairs has comparable contracts awarded to Leica, from VISNs 07 (36C24719C0116) and 16 (36C25622P0041 & 36C25622P1626). Total cost was extrapolated to allow for an accurate comparison by patient volume. Salt Lake City serves 72,000 veterans and Oklahoma City serves 63,000 veterans for a total of 135,000 patients per year. The estimated cost for this contract is 37% less than contract 36C24719C0116 and within 10% of the average cost of all three (3) contracts found on FPDS, when adjusted for patient volume. For these reasons, the total cost of $1,957,992.95 is deemed fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Contracting Specialist (CS) performed a search on VetBiz, GSA eLibrary, SBA, as well as posted a Sources Sought on Contract Opportunities for five days. Results are below: A search was conducted on VetBiz on 10/31/2022 SDVOSBs or VOSBs resulted from the search. A search was performed on GSA eLibrary on 10/31/2022 using keywor Two (2) large business contractors resulted from the search. One was Leica Geosystems (GS-07F-0069U) which listed NAICS code 334511 (Search, Detection, Navigation, Guidance, Aeronautical and Nautical Systems and Instruments). A search of Leica Geosystems (large) schedule illustrated that they could not fulfill this requirement. The other business concern, Leica (large) did not offer the immunohistochemistry (IHC) staining reagents and detection kits required for this procurement. A search conducted on SBA on 11/2/2022 using small business concerns resulted. None can fulfill the requirement. Associated Microscope company Only sells microscopes Arrowhead Scientific Only sells investigative products for law enforcement Exact Metrology Sales and support of Portable 3D CMM and 3D scanning BitterFboNotice Services & Technology (SDVOSB) Can sell KayPentax Medical Leica equipment, not IHC reagents W. Nuhsbaum Sales and service of Leica microscopes and imaging systems A Sources Sought (36C25923Q0012) was posted on Contract Opportunity on 10/25/2022. Two responses were received, Government Scientific Source (Small Business) and Agilent (Large). Government Scientific Source (GSS) submitted a letter indicating that they are an authorized distributor for Leica. Agilent does not offer Leica reagents or stains. Leica is the incumbent for Salt Lake City VA Medical Center and provided a sole source letter on 11/2/2022 and a quote on 10/19/2022 in writing, in advance of the 6-month extension of the current contract. The quote provided was for both locations for the long-term BPA to be authorized by this document. This will be a sole source award to the manufacturer, Leica. Leica will deliver consumables at a lower price to the government than GSS, as well as provide knowledgeable Leica personnel to assist both locations with setup of new tests and lean processes. GSS is a distributor of consumables, but cannot setup testing (included in cost of reagents whether purchased from GSS or Leica) since this must be performed by specially trained representatives of Leica. Each site has the capability to expand their testing menus and plan to do so to better serve their patients. Any Other Facts Supporting the Use of Other than Full and Open Competition: See Section 5. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Leica Government Scientific Source Agilent 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: This system is proprietary in nature and requires compatible reagents, antibodies, detection kits, and supplies that are specifically designed and FDA-approved to be utilized on this highly specialized system. The market will continue to be monitored for any future developments. 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. Lorrielee Lee Date Pathology Laboratory Program Specialist & COR VA Salt Lake City Health Care System Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Ronnie Jones, Contracting Officer Date Branch Chief, Services 2 NCO 19 Two Levels Above the Contracting Officer or Director of Contracting (Exceeding $750K): I certify the justification meets requirements for other than full and open competition. Michelle T. Gray Date NCO 19, Director of Contracting (DoC) VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition. Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)