Inactive

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/20... VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021 Page 1 of 5 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36259-21-AP-2847 J &A Tracking Number: 2021-11-01T09:57:26 Contracting Activity: Department of Veterans Affairs Network Contracting Office (NCO) 19 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Organizational Activity: Rocky Mountain VA Medical Center 1700 N. Wheeling Street Aurora, CO 80045 2237: 554-22-1-023-0042 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). The proposed action is a request for approval for a new, limited source award to the incumbent contractor, Abbott Laboratories for reagents and consumables to continue testing on the Abbott Alinity-m analyzer for hepatitis and HIV molecular testing. This will be a firm-fixed price FSS BPA (Blanket Purchase Agreement). Order against: FSS Contract Number: V797D-40222 Name of Proposed Contractor: Abbott Laboratories Inc. Street Address: 1300 E. Touhy Ave. City, State, Zip: Des Plaines, IL, 60018 Phone: 224-361-7786 Description of Supplies or Services: This requirement is for reagent and consumables to ensure continuation of testing capabilities for the molecular analysis of hepatitis B, hepatitis C, and HIV disease states on the lab-owned Abbott Alinity-m analyzer. The incumbent Contractor, Abbott Laboratories, will continue to provide the proprietary reagents and consumables for which they are the sole manufacturer and distributor. The estimated value of the proposed action is $ 1,289,055.40 for base year of 12-months and four (4) 12-month option periods to follow. The estimated cost of each 12-month period of performance is $257,811.08. This sole source BPA will run from December 1, 2021 through November 30, 2022, followed by four (4) 12-month option periods to continue services without interruption and maintain critical patient care. The current Task Order expires on 11/30/2021 with no extensions available. This requirement is a sole source to Abbott Laboratories. 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; Abbott Laboratories provided a Proprietary letter stating that Abbott is the sole manufacturer, service provider, and distributor of the Abbott Alinity-m system and the HIV, HCV, and HBV assays for this analyzer. Molecular testing of these infectious diseases is critical to patient care. 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. 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: GSA has already determined the prices for Abbott Alinity-m reagents and consumables to be fair and reasonable. Additionally, the VA has been given discounted pricing on amplification kits, an expensive but necessary reagent for molecular testing. The VA has had satisfactory or better service performance from Abbott Laboratories on past and current contracts. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was performed and included two (2) Sources Sought listings, running reports on VetBiz, GSA eLibrary, and SBA, as well as verifying through responsibility checks their ability to receive an award. The CS reposted a Sources Sought solicitation (36C25922Q0016) on Contracting Opportunities from 10/6/2021 to 10/15/2021. Abbott was the only response received. The previous CS posed a Sources Sought solicitation (36C25921Q0221) on Contracting Opportunities from 1/20/2021 to 2/1/2021. Three responses were received from the request for information: Abbott (large), A2A Integrated Logistics (SBA 89a)), and Franklin Young International (SDVOSB). A2A Integrated Logistics and Franklin Young cannot provide reagents and consumables for the Alinity-m analyzer. Results from the Sources Sought included a proprietary letter from Abbott stating they are the sole manufacturer, service provider and distributor of HIV, HCV, HBV, and SARS-CoV-2 assays. This was confirmed by a second email from Mr. Bryant, owner of A2A Integrated Logistics on 1/21/2021 which restated that Abbott would only sell the required products directly to the VA. CS conducted search on eLibrary on 10/14/2021 using NAICS 334516 Analytical Laboratory Instrument Manufacturing and keyword molecular. The five possible vendors were Astrix Technology (GS-07F-147DA), Fisher Scientific Company (GS-07F-161BA), Government Scientific Source (GS-07F-5934R), Labconco (GS-07F-0441X), and Luminex (47QSWA20D0021). None of these companies are able to provide Abbott reagents. CS also searched for Abbott Laboratories contract V797D-40222 price list for Alinity-m reagents and supplies. There was no viable link on GSA-eLibrary, but FSS Contract Specialist, Elizabeth Green, directed CS to pricelist found at https://www.vendorportal.ecms.va.gov. CS conducted search on VetBiz on 10/14/2021 using NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) and keyword molecular which resulted in 0 results. SBA search: CS conducted 3 searches on SBA on 10/14/2021 using NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) and keywords molecular testing, Alinity, and Abbott reagents, respectively. No small businesses resulted from the search. Any Other Facts Supporting the Justification: N/A The Abbott Alinity-m is only compatible with Abbott reagents and consumables specifically manufactured for this analyzer. Using non-Abbott reagents or consumables for this system would void the warranty. Abbott Laboratories provided a Proprietary letter stating that Abbott is the sole manufacturer, service provider, and distributor of the Abbott Alinity-m system and the HIV, HCV, and HBV reagents and consumables for this lab-owned analyzer. 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: N/A 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.) KASEY A ZAKARE Digitally signed by KASEY A ZAKARE 1476187 1476187 Date: 2021.11.03 10:59:18 -06'00' Kasey Zakare, Medical Technologist, RMRVAMC DATE Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. RONNIE R JONES 209802 Digitally signed by RONNIE JONES 209802 Date: 2021.11.03 11:51:13 -06'00' R Ronnie Jones, Branch Chief, Services 2 DATE 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 Digitally signed by ALBERT 967361 WILLIAMS 967361 Date: 2021.11.03 13:33:03 -06'00' Albert Williams DATE 3 Nov 2021 Director of Contracting, NCO19 HIGHER LEVEL APPROVAL (Required for orders over $750,000): 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 597130 Digitally signed by CURTIS M. JORDAN 597130 Date: 2021.11.12 12:36:05 -07'00' Curtis M. Jordan Executive Director, Regional Procurement Office West DATE VHA Head of Contracting Activity (HCA)