MALDI-TOF Analyzer PM SingleSourceJustification.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 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 ($250K)

Acquisition Plan Action ID:

1. Contracting Activity: Laboratory Service, Microbiology Lab, Department of Veteran’s Affairs, VISN

02, Syracuse VA Medical Center, 800 Irving Avenue, Syracuse, NY 13210

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Syracuse VAMC requests a matrix-assisted laser desorption ionization -time of flight (Maldi-TOF) mass spectrophotometry for the identification of bacteria and yeast in the clinical Microbiology Laboratory. The estimated value of the proposed action is $237,500.00

The requirement is for a matrix-assisted laser desorption ionization -time of flight (MALDI-TOF) mass spectrophotometry for the identification of bacteria and yeast. Identification of microorganisms in a Clinical Microbiology Laboratory provides definitive knowledge regarding the cause of infection and plays an important role in patient management and choice of antimicrobial therapy. Traditionally, the identification of bacteria in clinical laboratories has relied on time consuming phenotypic methods such as growth on selective and non-selective media (>48 hours), morphology of colonies, Gram Stain and biochemical reactions, using multiple automated and/or manual testing methods. These methods are laborious, time consuming and require a relatively long turn- around time. In addition, unusual and difficult to identify organisms encountered in the clinical laboratory may need to be sent to a reference lab for final identification often using DNA sequencing. This process could add an additional two weeks before the organism is identified.

Thereby delaying appropriate and effective antibiotic therapy. The MALDI -TOF technology allows for these difficult organisms to be identified within 30 minutes from colonies isolated on agar plates.

The use of matrix-assisted laser desorption ionization -time of flight (MALDI-TOF) mass spectrophotometry has emerged as a revolutionary paradigm – shifting change in the improvement of patient care with accurate, cost effective, rapid identification of pathogenic microbes leading to appropriate antimicrobial therapy. This technology will allow for accurate drug/bug combination activity in patients who require antimicrobial therapy. This will significantly decrease length of patient stay, unnecessary administration of toxic antibiotics and increase positive patient outcomes.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies:

The timely and accurate identification of organisms is an underlying critical function of the clinical Microbiology Laboratory which will be enhanced by the usage of a MALDI-TOF MS. The Bruker MALDI Biotyper Sirius one CA System is an FDA approved mass spectrometer for use in a clinical laboratory to identify microorganisms. The Bruker instrument can be connected to an existing Microscan analyzer using the LabPro-MBT system, which is unique to this equipment. The Syracuse Microbiology Laboratory can only accommodate a tabletop instrument as there is limited space and https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 no budget for construction. The tabletop model that can connect to existing equipment makes the Bruker Biotyper Sirius one CA System the only equipment available that will meet all the needs of VA Syracuse Pathology and Laboratory Medicine.

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

Market research was conducted comparing the VITEK MS (BioMerieux) and the Bruker MALDI Sirius one. The Vitek MS will not connect to existing Beckman Coulter Microscan equipment.

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.

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