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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 19, 2013 FBO #4255
DOCUMENT

66 -- MASS SPECTROMETER as Brand Name or Equal for STL VAMC Small Business Vendors - Attachment

Notice Date

7/17/2013
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office (NCO) 15;4101 S 4th Street Trafficway;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25513I1273
 

Response Due

7/19/2013
 

Archive Date

7/24/2013
 

Point of Contact

Donald Hannah
 

Small Business Set-Aside

Total Small Business
 

Description

Statement of Requirements The Saint Louis VAMC is soliciting quotes to provide an automated testing system that identifies microorganisms using Matrix Assisted Laser Desorption Ionization- Time of Flight Mass Spectrometry and has the capability of interfacing with the Biomerieux Vitek 2 system currently in the laboratory for antimicrobial susceptibility testing of these microorganisms. Vendors that can provide this system or equal shall include a copy of the equipment brochure which clearly defines the system or equal. Any information submitted by an offeror for consideration will not be returned and will remain the property of the VA. The testing system must be able to identify a variety of microorganisms as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Instrument and testing methods need not be FDA approved, but should have submitted for approval from the FDA and be available for implementation. The testing system must include the instrumentation necessary to identify common microorganisms encountered in clinically relevant patient samples. All reagents and related consumables, supplies, controls and calibrators must be available for purchase. Matrix Assisted Laser Desorption Ionization - Time of Flight (MALDI-TOF) Mass Spectrometry (MS) is the technique is used to measure unique protein signatures from microorganisms, allowing for the identification of the organisms. This technology allows for the identification of organisms from these cultures in a significantly reduced time from the current systems that are utilized in the Microbiology laboratory. The quality of care for our patients will be increased because the time for identification of pathogens would be greatly reduced, allowing for proper antibiotic therapy to be initiated sooner. The introduction of MALDI-TOF for microbial identification transforms the microbiology lab by providing organism identification within minutes, higher accuracy than conventional methods, consolidation of testing (bacteria, yeast, fungi, etc.), and significant reduction in the cost per test. The advantage for clinicians is the huge reduction in time that it takes to identify organisms. Minimum Technical Specifications: "The system must provide the capability of performing rapid bacterial identification using MALDI TOF technology for common, clinically relevant organisms including (but not limited to) GN, GP and Yeast without an offline extraction process. "The system and database including GP, GN and Yeast must have been submitted to the FDA for 510(k) clearance. "The system must come with a closed IVD database and an open RUO database whereas the user software will allow the end-user the option to run the system in either IVD or RUO mode. "The system must have the ability to be connected to up to ten work stations (sample prep stations) installed at individual benches in the lab for the set-up of the target slides. "The system must allow for full sample traceability using uniquely barcoded disposable target slides and software based guidance to deposit samples. "The system must be able to accept up to four (4) target slides with a total throughput of up to 192 clinical samples plus QC controls in a single, uninterrupted run. "Each target slide should have a dedicated QC control spot per acquisition group of 16 clinical samples. "The system must not need any further manual sample extraction steps other than on target slide addition of matrix (CHCA) for GP and GN or formic acid (FA) and matrix (CHCA) for Yeast. "The matrix (CHCA) and formic acid (FA) must be ready to use and light stable at +4C. "The system must (when FDA cleared) be able to connect to the VITEK2 through MYLA to link the ID result to the AST result and report results to the LIS. "The system must report the ID result with a confidence value. "The system must be able to distinguish Streptococcus pneumonia from non-pneumococcal species of the Streptococcus mitis group. "The mass spec system must provide a mass range no less than 1Da - 500kDa. "The MALDI TOF system must have a linear flight tube (TOF) length of greater than 1.19 meters. The "time of flight" tube must accommodate a larger spectrum than is required for organism identification, so that the technology has the potential for expansion (i.e. antimicrobial susceptibility testing). "The MALDI TOF system must have the ability to run in both positive and negative ion modes (standards). "The MALDI TOF system must meet the minimum sensitivity of 250 amol Glu-Fib peptide, 250 fmol BSA protein with a resolution of 5000 FWHM ACTH 18-39 peptide. "Instrument is currently RUO, when it is FDA approved for clinical use all upgrades, databases, etc included in initial purchase. "Instrument must be a "floor" model, or be able to be placed on a cart. "Vendor led training must be provided. Training shall include system operations, data manipulation, as well as basic trouble shooting and repair. If training is to be conducted off site, the cost shall be all-including, (e.g. air fare, auto rental, room and board, training materials, etc) for each participant. "Expiration dating period of the consumables shall not be less than six months at the time of delivery to the facility "The system shall use disposable slides to avoid cross contamination. "Extraction steps (if needed) must be able to be carried out on the slide used in the process. "Traceability of each sample on the slide is easy and flexible. "The system shall not require cleaning materials or decontamination of target slides for reuse. "The database must include clinically relevant microorganisms for the identification of samples from a clinical microbiology laboratory (common organisms isolated from human samples). "The contractor shall provide standard warranty response on instrumentation, and software as required which should include preventative maintenance during the warranty period. "The contractor shall provide applicable manuals and schedules upon delivery and installation of equipment. "The contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state of the art technology at no additional charge to the customer. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to "system upgrades" that enhance the model of equipment being offered, i.e. new version of software, including database upgrades, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. " Optional/Value Added Features: "Instrument can be serviced/calibrated remotely. "Instrument software that eliminates the need for paper log books through the ability to record all culture results and perform statistical analysis is ideal. "Since the instrument and its accompanying software has the potential for a dramatic impact on the turnaround times for culture results, a method to evaluate testing processes pre and post instrument implementation would be very valuable. Required Interfaces: Instrument/software must be able to communicate with the following instruments/interfaces: VITEK2/Observa, Data Innovations, Vista
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25513I1273/listing.html)
 

Document(s)

Attachment
 

File Name: VA255-13-I-1273 VA255-13-I-1273.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=876181&FileName=VA255-13-I-1273-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=876181&FileName=VA255-13-I-1273-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03119686-W 20130719/130718010248-4913e35bd01802d49b80c879dbfb09db (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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