Inactive

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 09 Original Date: 03/22/11 Revision 09 Date: 04/17/20... VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 09 Original Date: 03/22/11 Revision 09 Date: 04/17/2020 Page of 4 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-20-AP-2164 Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center, 10701 East Boulevard, Cleveland, OH 44106 / Network Contracting Office 10 2237: 541-20-2-250-0288 Nature and/or Description of the Action Being Processed: Procurement of additional GeneXpert instruments for the Cleveland VAMC Pathology & Laboratory Medicine Service (P&LMS) and surrounding outpatient clinics. The action will be awarded as a new open market firm-fixed price purchase order. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Cepheid GeneXpert instruments in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Description of Supplies/Services Required to Meet the Agency s Needs: Cleveland VAMC P&LMS requires the following additional Cepheid GeneXpert instruments and quantities to compliment existing Cepheid instrumentation at the Wade Park campus and surrounding outpatient clinics. The anticipated delivery date is approximately 30 days after receipt of order. The total cost is estimated at $265,625.00. GENEXPERT II R2 SYSTEM, XPRESS GeneXpert Xpress II, 2 Testing Site with 6 Color Modules, Tablet Computer & Xpress Software Item Number: GXII-CLIA-L Quantity: 15 Each Price: $15,725.00/EA GENEXPERT IV R2 SYSTEM, XPRESS GeneXpert Xpress IV, 4 Testing Site with 6 Color Modules, Tablet Computer & Xpress Software Item Number: GXIV-CLIA-L Quantity: 1 EA Price: $29,750.00/EA 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; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This procurement is for commercial item equipment manufactured and solely distributed by Cepheid. The Cepheid GeneXpert Xpress II and Cepheid GeneXpert Xpress IV instruments will be used for the Polymerase Chain Reaction (PCR) rapid testing of influenza A/B and strep throat for use at the Wade Park campus and the surrounding outpatient clinics. Due to the high specificity and sensitivity of the Cepheid GeneXpert PCR testing, there will be no need for reflex strep throat testing, which eliminates another test kit. The testing instruments must also be Clinical Laboratory Improvement Amendments (CLIA) waived due to licensing requirements for the outpatient clinics. The instruments must also be capable of performing 2 tests at once. The main lab at the Wade Park Campus currently uses Cepheid instrumentation on a much larger scale with a greater variety of testing platforms; the additional instruments will complement the existing suite of instruments used throughout the Cleveland VAMC area. In addition, the test kits used on the current instrumentation are compatible with the smaller instruments being ordered for the outpatient clinics. The acquisition of GeneXpert instruments for the surrounding outpatient laboratories will enable all Cleveland area VA laboratory facilities to utilize the same test kits, eliminating the need for separate test kit contracts. Accordingly, Cepheid is the only firm capable of providing the supplies and services described in Section III above without the Veteran s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Research of past Cepheid GeneXpert purchases resulted in a letter from Cepheid stating the GeneXpert systems are manufactured exclusively for Cepheid and Cepheid is the sole authorized distributor of Cepheid GeneXpert Systems in the acute care market in the United States. Search of FPDS-NG using keywork GeneXpert shows hundreds of purchases, all made from Cepheid. A Notice of Intent to Sole Source with Cepheid was posted to Contract Opportunities from 06/11/2020 through 06/18/2020 with zero responses received. Competition cannot be expected for the Cepheid GeneXpert systems. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer anticipates cost will be considered fair and reasonable based on cost comparisons to previous open market Government purchases as indicated in FPDS which have been determined to be fair and reasonable, and comparisons to similar models available on Cepheid s FSS contract GS-07F-0597T where pricing has already been determined to be fair and reasonable by GSA. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Search of VA Vendor Information Pages and the SBA DSBS using NAICS 334516 and keyword Cepheid resulted in zero SDVOSB/VOSB/Small Business concerns. Search of FPDS-NG using keyword GeneXpert resulted in hundreds of past Government purchases, all from Cepheid. Also, there are no existing VA or other Government contracts from which to source the required instruments. Email to Cepheid on 06/10/2020 confirms the two GeneXpert instruments needed are not available on Cepheid s FSS contract GS-07F-0597T and are only available via the open market. Memo from Cepheid states that Cepheid is the sole authorized distributor of the GeneXpert Systems in the acute care market within the United States. Finally, a Notice of Intent to Sole Source with Cepheid was published on Contract Opportunities 06/11/2020 06/18/2020, with no additional sources responding. Based on market research, the Rule of Two is not attainable, the acquisition cannot be set-aside for any socioeconomic group, and the instruments are only available from one source. Any Other Facts Supporting the Use of Other than Full and Open Competition: Cepheid has previously demonstrated a high level of customer service, timeliness of their product, and has met or exceeded all expectations. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid 904 Caribbean Dr. Sunnyvale, CA 94089 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: At such time the Louis Stokes Cleveland VA Medical Center Pathology & Laboratory Medicine Service replaces its system in its entirety, the market will be surveyed to determine if a competitive acquisition can be accomplished. 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. Evelyn D. Digitally signed by Evelyn D. Bennett 401967 Bennett 401967 Date: 2020.06.29 15:17:23 -04'00' Evelyn Bennett Date Assistant Lab Manager, P&LMS Louis Stokes Cleveland VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Kellie J. Konopinski 480975 Digitally signed by Kellie J. Konopinski 480975 Date: 2020.06.30 08:33:58 -04'00' Kellie J. Konopinski Date Contracting Officer NCO 10, 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200, Ann Arbor, MI 48105 One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. Digitally signed by ADAM P. WEBER ADAM P. WEBER 977305 977305 Date: 2020.06.30 09:07:14 -04'00' Adam P. Weber Date Branch Chief NCO 10 Supplies Team #1 3140 Governors Place Blvd., Suite 210, Kettering OH 45409