A.09.03_Exhibit_4_Salient_Characteristics_-_Winn.pdf

Winn Army Community Hospital

Department of Pathology

Chemistry Analyzer(s)

Salient Characteristics

The Winn ACH Department of pathology requires two identical chemistry analyzers located within the main lab, Building # 302, 1061 Harmon Ave, Fort Stewart, GA 31314.

A. Be fully automated, microprocessor controlled, integrated instrument(s) that are in vitro diagnostic devices 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

8. Automated/Direct testing with no manual sample preparation that includes HDL, LDL, and HbA1c assays.

L. An on-board test capacity of, at a minimum, 2000 tests

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

III. TEST MENU:

1. The system(s) installed at Winn ACH laboratory shall be capable of performing the following FDA approved tests:

Acetominophen (ACET) High Density Lipoprotein (HDL)

Alanine aminotransferase (ALT) Human chorionic gonadotropin (HCG)

Albumin (ALB) Intact parathyroid hormone (iPTH)

Alcohol (ETOH) Iron (FE)

Alkaline phosphatase (ALKP) Lactate (LAC)

Ammonia Lactate Dehydrogenase (LDH)

Amylase (AML) Lipase (LIP)

Aspartate aminotransferase (AST) Lithium

Bilirubin, Direct (DBIL) Low-density lipoprotein (LDL)

Bilirubin, Total (TBIL) Magnesium (MG)

Blood Urea Nitrogen (BUN) Neonatal Bilirubin

Calcium (CA) Phenobarbital

Carbamazepine (CRBM) Phenytoin

Carbon Dioxide (CO2) Phosphorus (PHOS)

Cholesterol (CHOL) Potassium (K)

Chloride (Cl) Prostate specific antigen (PSA)

C-Reactive Protein (CRP) Salicylate (SALI)

Creatine Kinase (CK) Sodium (Na)

Creatine Kinase MB (CKMB) Theophylline

Creatinine Total Protein (TP)

Digoxin Total Thyroxine (Total T4)

Estradiol Total Triiodothyrine (Total T3)

Ferritin Triglycerides (TRIG)

Folic Acid Troponin I

Free Thyroxine (Free T4) Thyroid Stimulating Hormone (TSH)

Free Triiodothyrine (Free T3) Uric Acid (URIC)

Gamma Glutamyl Transferase (GGT) Valproic Acid

Gentamicin (GENT) Vancomycin (VANC)

Glucose (GLU) Vitamin B12

Hemoglobin A1c (HbA1c) N-terminal pro B-type natriuretic peptide (NT-pro

BNP)