A.09.03_Exhibit_2_Salient_Characteristics_-_HTMC.pdf

Salient Characteristics

Hawks Troop Medical Clinic (TMC)

A. Be fully automated, microprocessor controlled, integrated instrument(s) that is an in vitro diagnostic device intended to measure a variety of analytes in human body fluids. All analyzers and supplies shall be FDA approved.

B. Have a bi-directional interface which is compatible with the current CHCS and the future Cerner

MHS Genesis hospital information systems.

C. Operate satisfactorily within a temperature range of 68°-80° F (Fahrenheit) and within a relative humidity range between 40-80%.

D. Be supported by an uninterruptable power source capable of providing electrical power to the analyzer and data management system.

E. Have a data management system for the storage of patient results and quality control data that:

1. Tracks calibration expiration times and alerts the user prior to expiration.

2. Tracks reagent expiration times and alerts the user when expiration has occurred.

3. Stores and provides graphical calibration data plots.

4. Stores and provides graphical Quality Control (QC) data plots.

F. Use reagents that are packaged and stored in a ready to use form.

G. Use a reagent inventory management system that provides for:

1. Multiple assays to be calibrated simultaneously using the same calibrator(s)

2. Bar coded reagent identification.

3. Inventory tracking and flagging

4. Calibration validity tracking and flagging

5. QC validity tracking and flagging

6. Lot number specific reagent on-board tracking of number of assays remaining, stability and expiration dates.

H. Have an instrument workflow that affords simultaneous processing of immunoassay and chemistry tests from one sample tube.

I. Provide discrete random, batch, and STAT testing access modes with a STAT interrupt processing capability.

J. Allow for samples, reagents and consumables to be added, while performing assays, without halting testing.

K. Use a sample management system that provides:

1. Positive patient identification and test ordering through an on-board barcode scanner request to host information system.

2. Clot, bubble, short sample detection and liquid level sensing and alert operator to these issues.

3. On-board auto dilution, auto repeat and auto reflex capabilities.

4. Ability to detect and flag hemolyzed, icteric, and lipemic samples. Be able to determine hemolysis, icterus and lipemia without additional patient sample, reagents, consumables and no effect on throughput.

5. Ability to handle sample sizes of 5, 7, and 10 mL tubes and, at a minimum, 1mL small sample cups.

6. Throughput of up to 300 results per hour.

7. Sample/reagent carryover prevention

L. An on-board test capacity of, at a minimum, 1000 tests

M. If the system utilizes a water source of specific standards, vendor must supply water purification system that meets those specific standards.

N. The system installed at Tuttle TMC laboratory shall be capable of performing the following FDA approved tests:

Alanine aminotransferase (ALT) Creatinine

Albumin (ALB) Glucose (GLU)

Alkaline phosphatase (ALKP) High Density Lipoprotein (HDL)

Amylase (AML) Lactate Dehydrogenase (LDH)

Aspartate aminotransferase (AST) Lipase (LIP)

Bilirubin, Direct (DBIL) Magnesium (MG)

Bilirubin, Total (TBIL) Neonatal Bilirubin

Blood Urea Nitrogen (BUN) Phosphorus (PHOS)

Calcium (CA) Potassium (K)

Carbon Dioxide (CO2) Sodium (Na)

Cholesterol (CHOL) Total Protein (TP)

Chloride (Cl) Triglycerides (TRIG)

Creatine Kinase (CK) Uric Acid (URIC)