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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 17, 2018 FBO #5958
DOCUMENT

66 -- MALDI-TOF Mass Spectrometer - Attachment

Notice Date
3/15/2018
 
Notice Type
Attachment
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
Department of Veterans Affairs;Network Contracting Office (NCO) 10;Service Area Office (SAO) Central;3140 Governor ™s Place Blvd. Suite 210;Kettering OH 45409-1337
 
ZIP Code
45409-1337
 
Solicitation Number
36C25018Q9012
 
Response Due
3/26/2018
 
Archive Date
4/25/2018
 
Point of Contact
Stacy Massey
 
E-Mail Address
8-6511x3135<br
 
Small Business Set-Aside
N/A
 
Description
This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to obtain information from qualified vendors with special interest relative to the North American Industry Classification Code (NAICS) 334516, Analytical Laboratory Instrument Manufacturing. Requirement The Clinical Microbiology Laboratory at the Louis Stokes VA Medical Center requires a matrix-assisted laser desorption/ionization time-of-flight mass spectrometer (MALDI-TOF) instrument to enhance the testing and turnaround time capabilities of organism identification. The matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has become a standard tool for rapid and reliable microbial identification in clinical and food laboratories. Timely identification of pathogenic organisms leads to faster susceptibilities, which are actionable results. This consequently will provide better patient outcomes and improved infectious disease management. The recommend equipment shall be compatible with the VITEK II which is already in use in the laboratory. Salient Characteristics: Technical Features: Shall be FDA approved for clinical use Shall meet CLIA and CLSI regulations Shall possess the capability of performing analysis using mass spectrometry technology for rapid organism identification of isolated colonies Database shall include clinically relevant microorganisms for identification samples commonly found in humans to include bacteria, mycobacteria, molds and possibly Nocardia The system shall be able to determine between Streptococcus pneumonia from non-pneumococcal species of Streptococcus mitis group Shall have the capability of accurately analyzing isolates 18-72 hours old The system shall be compatible with the VITEK II (which is already in use in the laboratory) to transmit organism identification to the susceptibility card The system shall have a bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system The system shall be able to connect to at least 4 work stations The system shall have disposable slides to avoid cross contamination and streamline processing time Extraction steps (if needed) shall be carried out on the slide used in the process Traceability of each sample on the slide shall be easy and flexible System shall have a throughput of over 50 clinical samples plus QC controls in a single run The system shall be able to analyze raw spectral data not by only comparing a spectrum with a reference spectrum database, but using methods that assign probability values to individual peaks in the spectrum and calculating the confidence levels for single ID Operational Features: Shall have safety features sufficient to avoid unnecessary exposure to biohazardous and chemical materials The exposure to and volume of biohazardous and chemical material generated by the equipment shall be minimal and require minimal handling Shall require minimal sample pretreatment Method Validation Requirements: The Contractor shall assist the site in the performance of all comparison and validation studies to include providing any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations and service chief s requirements. Support Features: The Contractor shall provide an instrument training program that is coordinated with and timely to the lab testing equipment installation for two personnel. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Scheduling of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices Interface Requirements: System shall be interfaceable with VHA computer systems. In addition, software must be able to communicate with the VITEK II software, which is currently in use. The Contractor shall provide all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. OFFERORS SHALL PROVIDE DESCRIPTIVE LITERATURE, TO INCLUDE CURRENT WARRANTY PROVISIONS TO SUPPORT THE GOVERNMENT S EVALUATION OF THE OFFERED PRODUCT(S). (See Clauses FAR 52.211-6 Brand Name or Equal and VAAR 852.211-73 Brand Name or Equal) This Sources Sought is for new items only; no remanufactured or "gray market" items. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment, verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and services are provided and maintained by the OEM. All warranty and service associated with the equipment shall be in accordance with the OEM terms and conditions. Place of Performance The Contractor shall deliver the quoted items, FOB Destination. Delivery shall be completed within thirty (30) calendar days after award, to the following address: Louis Stokes VA Medical Center 10701 East Boulevard Cleveland, OH 44106-1702 Interested vendors are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. Registration is available at www.sam.gov. To be eligible to respond as an SDVOSB or VOSB, a firm must be Center for Veterans Enterprise (CVE) registered in VetBiz. Registration may be accomplished at http://www.vip.vetbiz.gov. Responses to this sources sought notice must contain the following information: (1) Company name and address, point of contact with phone number, and DUNS number; (2) Business type (SDVOSB/VOSB, Small Business, etc.) (3) Capability statement Responses to this notice must be made via e-mail to Stacy.Massey@va.gov. Responses may be submitted as attachments, or contained in the body of the e-mail, and must be clearly marked 36C25018Q9012 MALDI-TOF Mass Spectrometer - Sources Sought" in the subject line and document header. The deadline to respond is March 26, 2018, at 5:00 pm (Local). As a reminder, this is a Sources Sought announcement only.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/DaVAMC552/DaVAMC552/36C25018Q9012/listing.html)
 
Document(s)
Attachment
 
File Name: 36C25018Q9012 36C25018Q9012.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4152978&FileName=36C25018Q9012-000.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4152978&FileName=36C25018Q9012-000.docx

 
Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 
Place of Performance
Address: Louis Stokes VA Medical Center;Clinical Microbiology Laboratory;10701 East Boulevard;Cleveland, OH
Zip Code: 44106-1702
 
Record
SN04856519-W 20180317/180315232259-86fc650492acfb65c98f2d7d2eada7e6 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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