6550--Salt Lake City and Billings VA BDMAX Reagents and Maintenance

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-22-AP-2156 J&A Tracking Number: 2022-08-22T05:56:16 (1) Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Organizational Activity: VA Salt Lake City Health Care System George E. Wahlen Department of VA Medical Center 500 Foothill Drive Salt Lake City, UT 84148 VA Montana Healthcare System Billings Vet Center 2795 Enterprise Avenue, Suite 1 Billings, MT 59102 2237 s# Billings VA: 436-22-1-994-0003 Salt Lake City VA: 660-22-4-071-0153 (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 is to review and approve the limited sources justification for a new base, plus four option year Federal Supply Schedule-Blanket Purchase Agreement for BDMAX Reagents and Maintenance to Becton, Dickinson and Company (BD), for VA Salt Lake City Health Care System and VA Billings Clinic. Order against: FSS Contract Number: V797D-40095 Name of Proposed Contractor: Becton, Dickinson and Company (BD) 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 $1,865,401.90 The VA Salt Lake City Health Care System and the Billings Vet Center have the need to purchase BD Max SARS CoV 2 reagents, BD Max cartridges, and comprehensive maintenance to ensure continuation of COVID testing on their Government lab owned BD Max Systems (BDMAX). The proposed procurement will be a new firm fixed price, Federal Supply Schedule, Blanket Purchase Agreement (FSS-BPA) for reagents, cartridges, and comprehensive maintenance of the analyzers.  The incumbent contractor, Becton, Dickinson and Company (BD), will provide proprietary reagents, cartridges and comprehensive maintenance for which they are the sole manufacturer, distributor, and seller, and are the only ones able to provide certified, licensed service engineers. This is a base plus four option year proposed action valued at $1,865,401.90. The period of performance for this FSS-BPA will be September 15, 2022 September 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; 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. This proposed action is for the BD Max SARS-COV-2 reagents, the BD Max cartridges, and comprehensive maintenance coverage for BDMAX analyzers located at the VA laboratories in Salt Lake City, UT and Billings, MT. The manufacturer of the BDMAX analyzer, reagents, and cartridges for Covid 19 molecular testing is BD. The incumbent indicated via email correspondence that due to proprietary reasons, all Government orders must be direct through BD and that no other company or business is able to conduct maintenance on the BDMAX instruments, and only BD approved/manufactured reagents and cartridges are approved for usage and testing on the BDMAX. Using any other manufacturer s reagents or cartridges would not be physically compatible and would result in malfunction of the analyzer and/or unreliable patient results. (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: The pricing for the reagents and maintenance has been deemed fair and reasonable by the General Services Administration (GSA). The reagent 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 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) corresponded with BD on 24 January 2022 and asked three pertinent questions: a. Are there approved sellers or approved distributors for BD reagents and test kits (for example for the BD Max SARS-COV-2 reagents)? BD answered No. b. Can any other company or business perform maintenance and repairs on the BD Max analyzer? BD answered No. c. Can any other company or business reagents be used on the BD Max analyzer? BD answered No. The CO confirmed on 02 August 2022, that Salt Lake City VA and Billings VA both have one (1) each a (Government purchased/Government owned) BD Max analyzer manufactured by BD. This requirement is to purchase the BD Max SARS-COV-2 reagents and cartridges that can only be tested and used on the BD MAX analyzer. The BD SARS-COV-2 reagent is proprietary to BD and is manufactured, distributed and sold solely by BD. No other seller, distributor or company can sell this reagent. And no other company s SARS-COV-2 reagents will work on the BD Max analyzers. This requirement is to also obtain maintenance and repair services for the BD Max analyzers owned by the Government and located at Salt Lake City VA and Billings VA labs. Due to the proprietary nature of laboratory diagnostic analyzers, only the manufacturers have the authority to perform maintenance and repairs on their equipment. BD confirmed this in their correspondence on 24 January 2022. The CO searched VetBiz on 02 August 2022. The keywords BDMAX COVID reagents returned nine (9) results but the nine results all showed companies offering general laboratory reagents and COVID tests and not BD Max reagents. The keyword search for BDMAX COVID Tests returned two (2) results but it showed companies that offered general COVID testing and not BDMAX specific COVID reagents. The keyword BDMAX maintenance returned ninety-six (96) results but all the results showed companies offering various general maintenance services, and not laboratory or maintenance on the BD Max analyzer. The CO searched GSA eLibrary on 02 August 2022. BD has a Federal Supply Schedule, V797D-40095, that is valid through 30 April 2024. The CO also confirmed on GSA eLibrary that BD is a large business. The CO searched SAM on 02 August 2022 which showed BD to have a valid SAM Registration, active through 06 November 2022. In searching HHS on 02 August 2022, the CO found no exclusions for BD. (7) Any Other Facts Supporting the Justification: No additional facts. (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. _______________________ Anthony Horton Administrative Officer VA Salt Lake City Health Care System Pathology and Laboratory (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)