STI Molecular NAAT

The Department of Pathology is requesting a contract for reagents and instrumentation for the detection of Chlamydia trachomatis, Neisseria gonorrhea, and Mycoplasma genitalium at Madigan Army Medical Center (MAMC). The system will include an automated, random-access nucleic acid testing analyzer with FDA-approved assays for C. trachomatis, N. gonorrhea, and M. genitalium; workstation with LCD touchscreen; uninterruptable power supply; and vacuum pump.

Due to the high volume of this testing, two systems will be part of the contract to ensure uninterrupted patient care during downtime and/or maintenance requirements of the system. The platform may not be limited to C. trachomatis, N. gonorrhea, and M. genitalium testing and may be expanded to include amplification-based molecular testing for other pathogens in the future depending on the patient testing needs at MAMC.

Instrumentation should perform molecular diagnostics with excellent quality, consistency, 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). Contractor must be able to perform bi-annual calibrations and/or preventive maintenance. Contractor must be able to perform emergency services within 24 hours of service call and completed within 48 hours of arrival.

Contractor must follow any requirements dictates by the AT/OPSEC Standard Contract Provision, be able to meet requirements for an Authority to Operate (ATO) on the DHA network, and be able to bi-directionally interface with the LIS. Contractor must provide all equipment, consumables, and supplies.

Contractor must have system in place, validated, and able to produce results on 1 October 2025. This contract shall be a 5 year IDIQ (Delivery Orders issued annually), beginning 1 October 2025. Contractor access to JBLM is only required to perform mandatory maintenance or troubleshooting.