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Montana VA MRSA/COVID Cost per Test Last Updated: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-22-AP-0348 Justification & Approva... Montana VA MRSA/COVID Cost per Test Last Updated: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-22-AP-0348 Justification & Approval Tracking Number: 2022-03-28T11:06:23 (1) Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 S Willow Dr., Suite 300 Greenwood Village, CO 80111 Organizational Activity: Department of Veterans Affairs Montana VA Health Care System 3687 Veterans Drive Fort Harrison, MT 59636 Identify purchase request (i.e. 2237) number, if applicable: 436-22-3-112-0440 (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This action to be reviewed is for a new requirement, base plus four option years, Federal Supply Schedule-Blanket Purchase Agreement (FSS-BPA) with Becton, Dickinson and Company (BD). Order against: FSS Contract Number: V797D-40095 Name of Proposed Contractor: Becton, Dickinson and Company Street Address: 7 Loveton Circle City, State, Zip: Sparks, MD 21152 Phone: 201-838-5057 (3) Description of Supplies or Services: The estimated value of the proposed action is $ 2,445,000.00 Fort Harrison VA Medical Center is needing a Methicillin-resistant Staphylococcus aureus (MRSA), other Infectious Diseases and COVID testing on a cost per test (CPT) basis. The CPT price structure includes two mirror analyzers (mirror = the same model), reagents, controls, supplies, and services such as maintenance, repairs and training on a CPT basis. The period of performance is June 15, 2022, through June 14, 2023 (base year), with four, one-year options through June 14, 2027. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; See response to (6) Describe the Market Research Conducted below. Market research revealed that only BD is capable of fulfilling the requirement. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. The Fort Harrison analyzer for MRSA/COVID testing would have to match the analyzer at Billings VA Clinic. Billings VA Clinic owns the BDMAX analyzer from BD. If an emergency was to occur at Billings VA Clinic, wherein the MRSA and COVID tests couldn t be completed at the Billings lab, Billings would have to send samples to the Fort Harrison lab to conduct the tests. To keep the needed test sample requirements, the test menu, testing measurements, the testing results and reporting requirements the same, Fort Harrison would need to conduct the tests of Billings samples on an analyzer with the same specifications and menu as the one in Billings lab. In essence, Fort Harrison is Billings backup in case the BDMAX at Billings malfunctions, is down or if the VA clinic or lab is down. Therefore, the Fort Harrison MRSA/COVID analyzer must be compatible in all aspects to the Billings VA BDMAX analyzer which is manufactured and distributed by BD. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: In accordance with the market research results, BD is the only company that can fulfill the requirement. The CPT pricing is FSS pricing that is considered fair and reasonable after initial competition on the national GSA level. Also, BD s quote can be compared to two previous contract pricing in addition to the FSS pricing to determine best value to the Government. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The Contracting Officer (CO) searched VetBiz on July 9, 2021, using the keyword Molecular and the North American Industry Classifcation System (NAICS) code 334516 which showed zero results. The CO searched the Strategic Acquisition Center (SAC) on July 9, 2021, under Laboratory Equipment and Supplies which showed only purchases of analytical laboratory reagents and consumables and not a lease of the analyzer. The Cepheid GeneXpert Xpress analyzer listed in SAC is only for purchase and the analyzer cannot do all the tests required in this requirement (according to the Fort Harrison lab manager). The CO searched the National Acquisition Center (NAC) on July 9, 2021, using keywords, Molecular analyzer, Molecular, and MRSA which showed that no molecular analyzers were available and the molecular tests that came up were not for MRSA/COVID and infectious disease testing. The NAC search results were for test kits and not for a cost per test requirement. The CO searched the General Services Administration (GSA) eLibrary on July 9, 2021, under Multiple Award Schedules (MAS) and NAICS code 334516 which showed numerous results for various laboratory equipment but not specifically for MRSA molecular and COVID testing. The CO posted a Sources Sought to Contracting Opportunities from 16 July 2021 to 23 July 2021, and three responses were received. Arc Point Labs is a Service-Disabled Veteran-Owned small business (SDVOSB) but the company is a reference testing company and does not offer any cost per test analyzers. Luminex Corporation is a large business and they stated they are unable to provide all the tests on a single analyzer/platform and can only provide testing capabilities for all tests using multiple analyzers. Also, Luminex Corporation does not offer cost pert test type agreements since the analyzer, reagents/consumables and maintenance are all offered on three separate FSS contracts. Hologic, a large business, has analyzers that are of much higher footprint than the space available at Fort Harrison VA Labs; it is twice the size of the available space. Therefore, none of the sources sought responders can fulfill the requirement. The incumbent, BD, is capable of conducting all MRSA, infectious disease and COVID tests on a single platform/analyzer on a cost per test basis that fits into the available laboratory space. (7) Any Other Facts Supporting the Justification: The Fort Harrison lab manager requires a CPT versus buy option. With the buy option, a whole new analyzer would need to be purchased at the end of its life cycle which is about seven to ten years. Technology in the lab industry is continuously advancing. In order to stay on top of quality care via the usage of the most up to date technology, a cost per test option is best wherein the analyzer is replaced every five years without a full commitment that is required with a purchase. With the CPT option, all needed supplies and services are covered under a cost per test structure, and every five years a new analyzer can be installed, which allows the lab to stay on top of technological advances and acquire the most updated version of the equipment. (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The Agency will survey the market again when this requirement comes up for renewal to see if market conditions have changed. (9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) RACHAEL ABELIN Laboratory Information Manager Montana VA Health Care System (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. RONNIE JONES Contracting Officer Network Contracting Office 19 b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. ALBERT WILLIAMS Director of Contracting Network Contracting Office 19 HIGHER LEVEL APPROVAL (Required for orders over $750,000): c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)