SAM #36C25626Q1142

Procurement of Bruker MALDI Biotyper Sirius CA System or Equivalent for VA Medical Center

This procurement opportunity is for a clinical microbial identification system at the G.V. Sonny Montgomery VA Medical Center: - Government Buyer: - Department of Veterans Affairs - G.V. Sonny Montgomery VA Medical Center, Pathology and Medicine Laboratory Service - OEMs and Vendors: - Bruker (as the manufacturer of the specified MALDI Biotyper Sirius CA System) - Equivalent OEMs for MALDI-TOF mass spectrometry analyzers may also qualify - Products/Services Requested: - Bruker MALDI Biotyper Sirius CA System or equivalent MALDI-TOF mass spectrometry analyzer (1 unit) - Includes hardware, MBT Compass HT CA software, FDA-cleared reference database, reagents, consumables, controls, calibration materials - Must be FDA 510(k) cleared for clinical microorganism identification (bacteria, yeasts, anaerobes, bioterrorism organisms) - Must support 21 CFR Part 11 compliance and secure data handling - Mini centrifuge (1 unit): - 15,500 rpm, 16,100 g, holds 12 tubes (1.5/2.0 mL), timer, specific dimensions and weight - Color printer (1 unit): - Must comply with VA IT baseline and Section 508 documentation - Uninterruptible Power Supply (UPS) (1 unit): - Must comply with VA IT baseline and Section 508 documentation - On-site training for three key operators and VA technical staff - Covers operation, software, troubleshooting, validation, and method comparison - Optional offsite training for three operators - Extended warranty/service agreement (two years, optional): - 24/7 service, all parts and labor, no refurbished parts - Unique/Notable Requirements: - System must be FDA 510(k) cleared and support 24/7 operations - All components must comply with VA regulatory and IT standards - Training and installation must be completed within specified timeframes - Warranty includes one year standard, with an optional two-year extension - System must be capable of secure data handling and regulatory compliance

Description

Please see the draft Statement of Work (SOW), provided as Attachment A, and Sources Sought Notice (SSN) 36C25626Q1142 for additional background and technical information.

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