Urinalysis Salient Characteristics

The system will come equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control.  Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot#s, means, ranges, SD, and CVs%. Changing or modifying existing QC parameters can be performed during instrument operation (e.g. "on-the-fly").

Vendor shall provide one complete, automated, walk-away urinalysis system for urine chemistry analysis at WMH with the ability to measure quantitative specific gravity (1.000 - 1.050), and semi-quantitative glucose (0 - ≥500 mg/dL), blood (0 - ≥1mg/dL), leukocyte esterase (Trace - Large), bilirubin (0 - 4 mg/dL), urobilinogen (0-4 mg/dL), pH (5-9), protein (0 - ≥500mg/dL), ketones (0 - 80 mg/dL), and qualitative results for nitrites (positive - negative), color and clarity. Instrument must measure with precision as defined by current Clinical Laboratory Standards Institute (CLSI).  Urine microscopy must be capable of the semi-quantitative detection of formed sediment elements in urine, including RBCs, WBCs, SECs, bacteria, yeast, mucus, crystals, spermatozoa, and casts.  All tests must have FDA approval.

Instrument must possess the following capabilities:

-Analyze the aforementioned components of urine without interference due to color

-Prevent the use of expired reagents, QC, and calibrators

-Require a sample volume no greater than 3 mL

-Retransmit results after LIS downtime

-Run new and old lot numbers of QC concurrently for parallel testing

-Locate patient samples using patient name, SSN, or unique identifier

-Read barcoded patient samples and have the ability to enter/run patient samples manually

-Detect bubbles, clots, and incomplete sample aspirations

-Detect potential interfering substances

-Have a throughput of 50 samples per hour

-Be compatible to the government laboratory information system (CHCS) and will be able to recognize CHCS generated bar-code labels (code 128) on primary sample tubes.-The system will have an interface that is compatible to the government system (CHCS and MHS Genesis) and will be able to Recognize CHCS generated bar-code labels (code 128) on primary sample tubes.

Vendor will provide everything needed for testing, maintenance, calibration, repairs, and training on a Cost-Per-Reportable-Result basis, as a Lease.  This includes the equipment, service and consumables all reagents, control and calibrators necessary to operate the system, including UPS, excluding paper, toner cartridge, tube, and bar code labels. The vendor will provide maintenance (preventative and unscheduled) service during business hours (Monday - Friday from 0800 - 1700) within 1 business day of notification.