Salient Features.docx
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- Attached to
- Pathology Lab and Area Testing Equipment Federal contract opportunity
- Solicitation number
- W81K02-20-Q-0122
- Issued by
- Department of the Army Medical Command
About this file
This document outlines requirements for a sources sought notice for pathology laboratory testing equipment. The Regional Health Contracting Office-Pacific is seeking information on potential sources that can provide equipment with the salient features listed in an attached document, including mass spectrometry, automated identification and antimicrobial susceptibility testing systems, nucleic acid extraction systems, and automated broth incubation and growth detection systems. Responses are due by May 20, 2020 and should be no more than ten pages, sent to the listed contracting officer. The applicable NAICS code is 325413 with a small business size standard of 1250 employees. The period of performance would be from October 2020 through September 2021, with options to extend annually through September 2023. The place of performance is Madigan Army Medical Center in Tacoma, Washington.
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Text version
Salient Features
1. Mass Spec
a) Must offer an FDA approved library for bacteria, and yeast as well as mycobacteria that includes M.
tuberculosis and clinically relevant non-tuberculous mycobacteria.
b) Walkaway functionality that requires no further technician time once the analyzer has started until it is complete.
c) The instrument must be able to process minimum of 100 individual specimens in an 8 hr shift.
d) The assay must include QC requirements in accordance with our accrediting bodies.
e) Consumables should be scalable and able to be used in for small or large sample run sizes.
f) Instrument must be able to interface bi-directionally with MHS-Genesis, the laboratory information system.
g) The system must provide a species ID and evaluation of the strength of the identification.
2. Automated ID and AST System
a) System must be able to identify clinically relevant Gram positive, Gram negative organisms and Yeast
b) Identification must include an evaluation of the confidence of the identification
c) Antimicrobial susceptibility testing (AST) of Gram positive and Gram negative organisms must follow guidelines set forth in the Clinical Laboratory Standards Institute M-100
d) System software must apply standard rules (e.g. intrinsic resistance, flagging of potential Extended Spectrum Beta Lactamase producers).
e) System software must allow for customized reporting rules based on institution specific reporting requirements.
f) Random access loading of specimens for identification and AST
g) Instrument must be able to interface bi-directionally with MHS-Genesis, the laboratory information system
3. Nucleic Acid Extraction System
a) System must have FDA IVD approved reagents and processes for the extraction of nucleic acids from various biological sources.
b) System must be capable of process more than twelve specimens at a time.
c) Walkaway functionality that requires no further technician time once the machine has started until it is complete.
d) System must be able to extract and elute into from various volumes.
e) System must be considered/approved for Center for Disease Control Emergency Use Authorizations.
4. Automated Broth incubation and growth detection System
a) System must have FDA IVD approved reagents specific for the recovery of mycobacterium.
b) System must be able to hold an incubation temperature of approximately 37 degrees Celsius (optimal temperature for growth of most clinical significant mycobacterium).
c) System must have around the clock monitoring of growth indicated and signal/alarm positive results.
d) System must be able to perform self-calibration at defined intervals.
(End of Salient Features)
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