Justification_Redacted.pdf

GeneXpert Infinity 80-80 System Lease and Reagents Request for Sole Source Justification Format >SAT

Effective Date: 02/01/2022 Page 3 of 5 difference in settings. The required system features are essential to the Government’s requirement, and market research indicates other companies’ similar systems lack the required features and cannot be modified to meet the agency’s needs. Utilizing consistent equipment decreases the possibility of human error, thereby increasing patient safety. This is contingent upon total time needed for preparation, creation, implementation, validation, and training. A lease vs. purchase analysis was conducted by MEDVAMC. As a result, it has been determined it is the best interest of the Government to lease this equipment. In addition, to lease a different system would require the facility to create new Standard Operating Procedures (SOP), specifications on design to outline all processing services requirement for use, in addition to time spent training assigned personnel on new equipment functions. The delay caused by required design, setup, and training on new equipment would cause a delay in providing patient care.

Lastly, Per GAO decision B-411904 and B-416195 where, as here, a requirement relates to human safety concerns, the agency has the discretion to set its minimum needs to achieve not just reasonable results, but the highest possible reliability and effectiveness. Therefore, a sole source approach is in the best interest of the Government.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An RFI/Sources Sought was issued on sam.gov September 27, 2023 with responses requested by October 04, 2023, with the posting remaining available through October 19, 2023. Additionally, the CO queried the following databases: VetCert, AbilityOne, General Services Administration (GSA) Federal Supply Schedule (FSS) e-Library, VA NAC, Medical Electronic Catalog (ECAT), VA Supply Chain Master Catalog (SCMC), System for Award Management (SAM), Federal Procurement Data System (FPDS), and SBA Dynamic Small Business Search (DSBS) per VHAPG Part 810.001 Market Research (all results documented in paragraph 8 below).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: One (1) quote is expected; therefore, a price analysis was conducted to determine price is fair and reasonable IAW FAR 13.106(a)(2). The CO compared proposed price to IGCE and market value of an award made for similar requirement. Federal Supply Schedule (FSS) Contract number GS07F0597T 36C25619F0159 awarded to Cepheid, a Large Business. This contract was awarded as a sole source award at a total contract value of . The period of performance for this contract is 12-01-2018 through 11-30-2023.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: VetCert was searched using the applicable NAICS code 334516. The search returned 199 certified SDVOSB/VOSBs. VHA strategic contracts and AbilityOne were searched but the required products are not available via those sources.

RFI/Sources Sought Notice 36C25623Q1982 was posted on SAM.gov September 27, 2023.

Responses were due by October 04, 2023 with the posting remaining available through October 19, 2023 prior to archiving. The intent of the RFI was to a) determine the availability of sources who could provide the exact brand name for the required equipment/reagents and b) determine the availability of sources who could provide items determined to be equivalent equipment/reagents. The posting was essentially an intent to establish sources and it was stated in the RFI that responses would be used to determine the future formal procurement strategy. Zero (0) responses were received from vendors stating they could provide the exact and/or an equivalent equipment/reagent as required. The CO then searched FPDS-NG for past purchases using keyword “GeneXpert Infinity 80-80 System Lease, Reagents and Consumables”, which revealed a similar requirement was previously procured via Federal Supply Schedule (FSS) Contract number GS07F0597T / 36C25619F0159. This action was awarded as a Sole Source to Cepheid, a Large Business, in the total amount of The CO determined only the equipment can be procured via FSS contract number GS07F0597T. GSA eLibrary, ECAT, and SCMC were all queried, however no results were located.

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Finally, the CO reached out to the manufacturer, Cepheid, to inquire about potential authorized SDVOSB/VOSBs and/or SB distributors of their equipment/supplies. Cepheid provided a sole source letter stating Cepheid is the sole seller/distributor of their products.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: MEDVAMC currently utilizes the Cepheid brand and to prevent delay in patient care, standardize systems, integration and training, all while minimizing patient safety, only this brand is recommended.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cepheid 904 Caribbean Drive Sunnyvale CA 94089

11. 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:

Prior to awarding future acquisitions for the same or similar product(s), additional market research will be conducted to determine if market conditions have changed which would enable the competition of manufactures for future requirements.

12. 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.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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b. One Level Above the Contracting Officer: I certify the justification meets requirements for

Other Than Full and Open Competition.

c. Director of Contracting Concurrence: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and recommend approval for Other Than Full and Open Competition.

d. VHA RPO HCA Review and Approval: 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 Other Than Full and Open Competition.