Functional_characterisitics.docx

Microbiology test system for bacteriology and drug sensitivity testing which is compatible with the Air Force Laboratory Information System (LIS) Composite Health Care System (CHCS) through middleware with the required PIT/DICAP letter and capable of multiple instrument connectivity simultaneously. Test system must provide a completely closed system once inoculated, preventing contamination. The instrument must not contain multiple reagents, pumps, tubes or moving parts to decrease the downtime rate. Instrumentation must provide on board back-up or confirmatory tests with little to no manual manipulation, i.e., ESBL. Automated nephelometry is necessary to alleviate the individual competency/experience errors enabling standardized McFarland solution. This analyzer must ensure workflow flexibility with staffing fluctuations. The test system needs to provide multiple workstations, system messaging to other clinical departments, provides CLSI based alerts, email alerts to the medical group Infection Control manager and allows for custom built quality assurance rules enabling the 72d MDSS/SGSAL greater compliance with the Individualized Quality Control Plan and other standards presented by the College of American Pathologist and the Centers for Medicare and Medicaid Services. This analyzer must maintain or surpass this standard of care that the 72d medical providers are accustomed to utilizing during patient care which is <10 hr turnaround time. The system must provide a reagent free closed system that is spill proof, produces a bacterial identification within 2-12 hrs with >90% confidence the first time and no off-line tests required and should utilize a 5-time specific method, reading organism growth at 2, 3, 4, 6 and 12 hours.This system should require very minimal maintaince no more complex than room tempurature and air filter checks. The analyzer must also come with its own stand and not need to sit on countertops.