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VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID:___36C261-21-AP-4269__

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office 21 on behalf of Southern Nevada VA Health Care System.

2237: 593-22-1-968-0009

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The VA Southern Nevada Health Care System (VASNHCS) has a requirement for fully automated blood culture instrumentation and reagents. The system detects bacteria and fungi in blood to rapidly detect and identify pathogens to treat bloodstream infections. Early intervention and initiation of appropriate treatment have been shown to improve patient outcomes. The instrument cost-per-test is based on patient volume.

The value of this procurement is

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The VASNHCS has a need for blood cultures to be drawn and are all submitted to the laboratory at the lab for processing. The time from collection to the laboratory can be 24 to 72 hours.

Biomerieux uses a Colorimetric system that detects Ph changes as a sign of a positive blood culture, while other vendors use Fluorometric for detection of turbidity as a detection of a positive blood culture. For a blood culture with a delayed entry into the blood culture system from a remote site that may already have turbidity due to organism growth that is put into a blood culture analyzer using fluorometric system will use this level of turbidity as a baseline, and it is possible to declare this blood culture bottle as a negative when it is really a positive blood culture. This is a significant truly has a positive blood culture will have delayed treatment that can lead to patient harm or even patient death.

The Colorimetric system used by Biomerieux uses PH to change the color of a disc at the bottom of the bottles. The color change is detected by the analyzer. If a bottle comes from a remote site with organism growth it may already have changed the color of this disc. The Biomerieux system will detect the change and report it as a positive blood culture right away or soon after. This eliminates and treatment of positive blood cultures.

Biomerieux also manufactures the Etest, which is used to determine the Minimum Inhibitory Concentration (MIC) of antibiotics, antifungal agents and antimycobacterial agents. The E-test

VHAPM Part 813.106 Page 2 of 3

Revision 02 Eff Date: 03/31/2020 provides a Minimum Inhibitory Concentration (MIC) which gives the patients provider and exact level (dosage) of antibiotic to use to combat an infection. This is critical to Antibiotic Stewardship by not exposing the patient to more antibiotic than necessary and to prevent organisms from becoming resistant to antibiotics, which can result in patient harm, including patient deaths.

The Vitek 2 is an automated instrument for microbial identification (ID) and antibiotic susceptibility testing (AST) to help clinicians select the most appropriate antibiotic treatment. The Vitek system reads the cards every 15 minutes to detect for a final results. This means that results can be obtained with 6-8 hours versus the 24 hours. Other systems use a traditional micro dilution method at the correct dose can be started quickly.

can produce cross contamination. The PreviColor system uses a spraying method. If a slide is contaminated due to the staining method then a positive organism identification on a gram stain can produce a false positive result. A false positive can cause a patient to receive antibiotic medication when it is not warranted.

Biomerieux is the only vendor that can provide all of these highly specialized instruments listed above according to the Statement of Work, which includes automated microbial detection system, automated instrument for microbial identification (ID) and antibiotic susceptibility testing (AST), and automated Gram staining system. Addtionally, they have a middleware product called MYLA that connects all the devices and can connect with Data Innovations to download results into Veterans Health Information Systems and Technology Architecture (VistA) Computerized Patient Record System (CPRS). Other vendors have a middleware that can connect only with certain analyzers that would not meet the needs of the requirement and is unable to interconnect into one middleware rden while providing a consolidated reporting platform for Blood Culture, ID and Sensitivity Data.

Accordingly, BioMerieux is the only firm capable of providing the supplies and services described in ration experiencing unacceptable delays in fulfilling its requirements and degredation of patient care.

4. Description of market research conducted and results or statement why it was not conducted:

A sources sought synopsis was issued in 05/26/2020 under 36C26120Q0634, which conducted a market research survey to identify potential qualified sources capable of providing reagents and supplies for blood culture analysis, identification of microorganisms, susceptibility testing, gram staining and MRSA screening at a fixed price for a 5 year ordering period (IDIQ) at VA Northern California Health Care System Mather. Contractor must be able to meet all requirements of the attached Statement of Work. No responses were received by the due date of 06/03/2020.

Based on previous market research conducted, there is no reason to believe that that two or more SDVOSBs/VOSBs have the capability to meet this requirement, and the Supreme Court not be met for small businesses either. A VIP search utilizing NAICS code 325413 and keyword Biomerieux yielded 0 SDVOSBs/VOSBs matches.

VHAPM Part 813.106 Page 3 of 3

Revision 02 Eff Date: 03/31/2020

Market research efforts also include FPDS, Contract Opportunities, VA NAC Pharmaceutical Catalog, GSA and SAM.

A query on the VA NAC catalog brought up no relevant results that match all items that are required that this facility can order off of under the proposed IDIQ. A GSA e-Library search under SIN 66/ 615 exists with any existing contracts.

The procurement history found on eCMS and FPDS shows that a contract for VA Northern California Health Care System- Mather was awarded to BIOMERIEUX , INC. under 36C26120P0095, a large business in the procurement value of $235,695.60 for a one-year contract on 10/10/2019. The procurement method was sole sourced in the open market.

A more recent award was made by VISN 15, 36C25520D0027, and was awarded on 04/28/2020 to BIOMERIEUX , INC. for a 5-year IDIQ in the contract value of $2,197,150.10. According to FPDS and Contract Opportunities this was competed in the open market under solicitation 36C25520Q0039.

This award was competed under SAP, unrestricted, and only received 1 offer.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date