BioMerieux Salient Characteristics_DRAFT.pdf
PDF 156 KB Posted
- Attached to
- Pathology Lab Testing Equipment Federal contract opportunity
- Solicitation number
- W81K0223Q0054
- Issued by
- Department of the Army Medical Command
About this file
This notice solicits capability statements for pathology laboratory testing equipment to support Madigan Army Medical Center. Products and services required include reagents, maintenance, training, and supplies for nucleic acid extraction, liquid media blood culture, mass spectrophotometry, and automated identification and susceptibility systems. Instruments must include the VITEK MS and have ATO capability to interface with the MHS Genesis and Myla middleware systems. Responses are due by May 5, 2023 and should include company information, point of contact, and capability statements with brochures describing offerings and options. The Army Medical Command intends to award a firm-fixed price contract using FAR Part 13.5 simplified procedures.
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| File | Type | Posted |
|---|---|---|
| BioMerieux Statement of Work_DRAFT.pdf |
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Text version
Salient Characteristics
Mass Spec
Must offer an FDA approved library for bacteria, and yeast as well as mycobacteria that includes M. tuberculosis and clinically relevant non‐tuberculous mycobacteria.
Walkaway functionality that requires no further technician time once the analyzer has started until it is complete.
The instrument must be able to process minimum of 100 individual specimens in an 8 hr shift.
The assay must include QC requirements in accordance with our accrediting bodies.
Consumables should be scalable and able to be used in small or large sample run sizes.
Instrument must be able to interface bi‐directionally with MHS‐Genesis, the laboratory information system.
The system must provide a species ID and evaluation of the strength of the identification.
Automated ID and AST System
System must be able to identify clinically relevant Gram positive, Gram negative organisms and Yeast
Identification must include an evaluation of the confidence of the identification.
Antimicrobial susceptibility testing (AST) of Gram positive and Gram negative organisms must follow guidelines set forth in the Clinical Laboratory Standards Institute.
System software must apply standard rules (e.g. intrinsic resistance, flagging of potential Extended Spectrum Beta Lactamase producers).
System software must allow for customized reporting rules based on institution specific reporting requirements.
Random access loading of specimens for identification and AST.
Instrument must be able to interface bi‐directionally with MHS‐Genesis, the laboratory information system.
Nucleic Acid Extraction System
System must have FDA IVD approved reagents and processes for the extraction of nucleic acids from various biological sources.
System must be capable of process more than twelve specimens at a time.
Walkaway functionality that requires no further technician time once the machine has started until it is complete.
System must be able to extract and elute into from various volumes.
System must be considered/approved for Center for Disease Control Emergency Use Authorizations.
Automated Broth incubation and growth detection System
System must have FDA IVD approved reagents specific for the recovery of mycobacterium.
System must be able to hold an incubation temperature of approximately 37 degrees Celsius (optimal temperature for growth of most clinical significant mycobacterium).
System must have around the clock monitoring of growth indicated and signal/alarm positive results.
System must be able to perform self‐calibration at defined intervals.
Automated Blood and Body fluid specimen incubation and growth detection System
• System must have FDA IVD approved reagents specific for the recovery of organisms from Blood and Body fluid specimen.
• System must be able to hold an incubation temperature of approximately 37 degrees Celsius.
• System must have around the clock monitoring of growth indicated and signal/alarm positive results.
• System must be able to perform self‐calibration.
• System must be able to load Blood and Body fluid culture bottles automatically.
• System must be able to measure volume of Blood and Body fluid patient specimen in culture bottles automatically.
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