J A MS Microbial Final.pdf

Simplified Acquisition Procedures for Certain Commercial Items VHAPG Part 813.5

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C24722AP4487,

1. Contracting Activity: Department of Veterans Affairs, VISN, Ralph H. Johnson VA Medical Center, 109 Bee St, Charleston, SC 29401, PR - 534-22-4-025-0273

2. Nature and/or Description of the Action Being Processed: This procurement is a Cost Per Test agreement for a VITEK MS automated mass spectrometry microbial identification system that uses Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology. This justification is 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. This will be a new supply order as a follow-on to delivery order 36C24718F1929. The equipment provided under the previous order is to remain in place and this order will encompass the required testing supplies and usage fees.

3.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

: The Charleston VA Medical Center Lab requires the continued use of a previously installed Biomerieux VITEK MS automated mass spectrometry microbial identification system that uses Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) bacterial/microbial identification technology and Antimicrobial Sensitivity (AST). The MALDI-TOF technology reduces time for bacterial Identification by 24 - 48 hours, allowing patients to be treated for life threating infections in an expeditious manner. The MALDI-TOF and AST platforms, must include middle-ware software for connectivity which allows the two systems to communicate test information with the already installed Biomerieux Myla computer server. The middleware must promote efficient retrieval of microbial/antimicrobial data and statistics in order to expedite testing. The vendor shall provide technical support to assist laboratory personnel with middleware connectivity issues, provide training to clinical laboratory staff for use of the test system, and provide instrument service/repair and routine maintenance. Unscheduled instrument downtime must be less than 24 hours. Total contract cost, $449,647.85.

POP Sep-15-2022 - Sep-14-2027

Effective Date: 02/01/2022 Page 2 of 3

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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Requires the Use of the Authority Cited Above (applicability of authority): This requirement is a follow-on purchase order for the continued use of previously installed highly specialized equipment. BioMérieux, Inc. is the sole manufacturer and exclusive provider of for the VITEK MS system, middleware, and consumable items. Charleston VA Pathology and Laboratory Medicine currently implements blood culture detection methods using BioMérieux, Inc. instrumentation; a vendor other than BioMérieux, Inc. would prevent the continued utilization of this major system, specifically, our blood culture instrument cannot communicate with another vendors middleware. BioMérieux, Inc. does not have authorized vendors outside of their company that provide the required products and or services.

Therefore, there are no other sources capable of meeting the requirement at this time.

BioMérieux, Inc. is the only responsible source that can satisfy the governments requirement.

A proprietary letter is attached to the Market Research Report.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source was posted to SAM on 30 June 2022. No responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The requirement is in support of laboratory instrumentation that is currently on site and validated for use in patient care. Validation of laboratory instrumentation is labor intensive and consumes considerable time and financial resources. The continued use of the current system is in the best interest of the government, both financially and considering continuity of patient care.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research included speaking with the Charleston Assistant Lab Manager, speaking with Biomerieux, and conducting an internet search for the required equipment and supplies. The Charleston Assistant Lab Manager, Robert Haynes confirmed that the BioMerieux solution is the only equipment that will interface the labs other existing equipment. Becky Dixon, BioMerieux Accounts Manager provided documentation confirming the proprietary nature of the required items.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

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

BioMerieux, Inc.,100 Rodolphe St., Durham, NC 27712.

Effective Date: 02/01/2022 Page 3 of 3

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: None at this time. Once all associated components reach the end of their life cycle, market research will be conducted to determine if a competitive acquisition of the entire system is appropriate.

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.

Robert Haynes Assistant Lab Manager

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

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jason Compton Contracting Officer, NCO 7

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Millicent Ball Branch Chief, NCO 7