Description
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 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID:36C247-21-AP-1978 Contracting Activity: Department of Veterans Affairs, VISN 07, Atlanta VA Medical Center. PR#508-21-3-2043-000. Description of Action: Microbiology Molecular Reagent Rental Requirement for Analyzer and Corresponding PCR Kits to Perform QUALITATIVE MRSA, CDIF, FLU, and CT/NG (rectal throat) on a single random-access platform for a new 12-month contract. Anticipated Award date July 9, 2021. . Order against: FSS Contract Number: GS-07F-0597T Name of Proposed Contractor: Cepheid Street Address: 904 E. Caribbean Drive City, State, Zip: Sunnyvale CA, 94089 Phone: (408)400-4855 Description of Supplies or Services: Provide one-year with no option years procurement for the Atlanta VAMC mandates for infection control require rapid turnaround testing for infectious diseases such as MRSA, FLU, CDIFF, and CT/NG (throat/rectal sources). MRSA and CDIF rapid resulting are required to place patients in isolation rooms at the VA HCS hospital setting and in nursing homes. Batch testing delays these results from reaching providers in a timely manner. Cephid is the only source that can meet the facility needs. This will be a Firm Fixed Price contract. The estimated value of the proposed action is $537,463.40 ESTIMATED ANNUAL TEST VOLUMES: MRSA/MRSA swabs 12000 CDIF 960 FLU 2250 CT/NG (rectal and throat) 600 MRSA/SA BC 100 MTB/RIF 300 TV-IVD 100 Carba-R 100 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: Specify the urgency/compelling need. FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. Required salient features limit this highly complex laboratory equipment acquisition to only one vendor, the manufacturer, Cepheid. The salient features required for the P&LMS Microbiology Laboratory are as follows: RANDOM-ACCESS for all required test methods FDA-APPROVED qualitative molecular PCR analyzer platform, and FDA-APPROVED REAGENTs/tests. The system performs the following qualitative PCR tests on the same platform: MRSA, CDIFF, FLU (A/B), and CT/NG (throat/rectal specimens). The system interfaces with middleware capable of interfacing with VA s VISTA LIS. (But does not directly touch the network.) The system meets requirements for VA MANDATE on MRSA, CDIFF PCR rapid resulting requirements 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. Specify how the new work is a logical follow-on to the original order and confirm that the original order was not 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: specific to the manufacturer (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) These are direct replacements parts/components for existing equipment. Replacement for existing Cepheid GeneXpert system. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Fully compatible with existing equipment and reagents, Bridge contract term ending 3/31/2020. This replacement is intended to continue the government s requirement in the microbiology laboratory with little or no disruption to patient care. 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: Cepheid meets the specifications laid out in the SOW /PWS Salient Features, and of utmost importance: RANDOM ACCESS, allowing for stat prioritization of patient specimens, and all required qualitative test types MRSA, CDIF, FLU, and CT/NG (rectal-throat) are able to be performed on the same platform (FDA-Approved analyzer), saving time and money, while enhancing patient care. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Additionally, describe results of market research conducted pursuant to FAR Part 10 and VAAR 810.001-70: Market research was conducted using GSA schedule/GSA ADVANTAGE, and by reaching out to competitors listed in the Market Research documentation. The other vendors/manufacturers offer batch testing (not random access), or random-access mode but without the required approved test types all to be performed on SAME PLATFORM. The problem with these alternatives is that the microbiology laboratory would have to purchase or rent additional high complexity analyzers to perform these other tests, hire additional qualified and certified technologists, and spend time and effort to validate all the different test methods according to required CLIA LAW. Thus, the only piece of equipment / vendor offering the level of molecular testing necessary to meet the specific requirements laid out in the SOW/PWS and ATT.3 in the ATL VAMC P&LMS Microbiology Laboratory is the Cepheid Infinity 48-16 automated system. Any Other Facts Supporting the Justification: The Atlanta VAMC facility is mandated to provide infection control rapid turnaround testing for infectious diseases such as MRSA, FLU, CDIFF, and CT/NG (throat/rectal sources). MRSA and CDIF rapid resulting are required to place patients in isolation rooms at the VA HCS hospital setting and in nursing homes. Batch testing delays these results from reaching providers in a timely manner. 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: This contract is a reagent rental agreement to provide reagents for the instrument already put in place at the Atlanta facility and no other vendor could supply what is required per reagent test. 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.) Digitally signed by Nicole R. Darius Nicole R. Darius 734749 734749 Date: 2021.06.16 15:57:55 -04'00' 06/16/21 SIGNATURE Nicole Darius DATE Microbiology Supervisor Pathology and Laboratory Medicine NAME Atlanta VAMC TITLE SERVICE LINE/SECTION FACILITY 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. Gail D. Bargaineer 928718 Digitally signed by Gail D. Bargaineer 928718 Date: 2021.07.19 10:51:11 -04'00' July 7, 2021 Gail Bargaineer DATE NCO 7, Contracting Contracting Officer One Level Above the Contracting Officer (Required over the SAT but not exceeding Robert A. Stephens 410412 Digitally signed by Robert A. Stephens 410412 Date: 2021.07.14 13:43:41 -04'00' $750K): I certify the justification meets requirements for other than full and open competition. July 14, 2021 SIGNATURE DATE Robert A. Stephens NAME NCO/PCO XX Duty Title