Location

VA Knoxville Community Based Outreach Clinic (CBOC)

1557 Downtown West Boulevard

Knoxville, TN 37919-5407

Performance Work Statement (PWS) – Urinalysis Analyzer & Support Services

1. Technical Features. Instrumentation shall perform all analyses with precision as defined by current

Clinical Laboratory Improvement Amendments (CLIA) and the Clinical and Laboratory Standards Institute

(CLSI).

2. Operational Features.

Instrumentation must be available at the time of proposal submission and shall:

a. Function as an automated, walk-away instrument for urine chemistry and microscopic analysis.

b. Provide identification for the following particles in urine: RBC, WBC, Bacteria, Hyaline Casts,

Pathological Casts, Crystals, Squamous Epithelial Cells, Non-Squamous Epithelial Cells, Yeast, WBC Clumps, Sperm and Mucus.

c. Provide reagent barcode capability and inventory control, to include data archiving and active reagent

volume monitoring and warning. Reagents shall have extended calibration stability.

d. Read bar coded patient samples using the VistA Universal Identification system and have the ability to

enter/run patient samples manually, with or without barcodes, during HIS/LIS downtime.

• This analyzer connects to VISTA via a DICOM interface.

• The contractor will have no access to patient information during anytime (i.e. during setup/

installation, routine maintenance, or service.

e. Minimize sample carryover: Carryover specifications shall be provided for each instrument.

f. Include a multitasking computer system with:

(1) User-friendly software. Operators of all skill levels should be able to use efficiently.

(2) Ability to locate patient samples using patient name, SSN, or unique ID, and determine when results

will be available.

(3) Ability to print patient reports -in a chartable/medical record format- that may be sent to providers

during HIS/LIS downtime.

(4) Ability to retransmit results after HIS/LIS downtime.

(5) Ability to easily add/update quality control and calibrator materials and values, and track the

changes.

(6) Ability to run new and old lot numbers of QC concurrently for parallel testing.

(7) Ability to use only one printer to print QC data, review screens, or print files while running patient

samples.

(8) Ability to review abnormal results on the instrument.

g. Include an interactive, on-board QC package with:

(1) Modified Westgaard rules and Levy-Jennings plots.

(2) Printable QC results that include meaningful information, such as Standard Deviation Index.

(3) Electronic archiving and corrective action documentation.

(4) Ability to evaluate and print QC results while the instrument is analyzing patient samples.

(5) Ability to monitor calibrations for slope, intercept, blank, etc.

(6) Ability to export values to a commercial quality control program.

h. Include bi-directional LIS host query interfacing through Data Innovations. The vendor shall provide additional equipment, such as middleware, needed to interface the analyzers. The analyzer shall be able to retransmit data after instrument downtime. The instrument should only require a single LIS Interface.

i. Provide true STAT interrupt.

j. Offer a throughput of at least 70 tests per hour.

k. Require minimal time to perform recurring maintenance (daily, weekly, monthly, etc.).

l. Require minimal start up time from standby mode to operation.

m. Require minimal reagent and calibration preparation.

n. System shall have detector system for bubbles, clots, and incomplete sample aspirations. System should be available for detecting interfering substances.

o. Include on-board electronic operating manuals and trouble shooting guide as well as a preventive maintenance guide and log.

p. Ensure ease of calibration with extended calibration stability and minimal calibration frequency.

q. System shall be totally self-contained excluding waste and will not require external water, pressure or vacuum. Vendor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal.

r. Require minimal time to perform recurring maintenance (daily, weekly, monthly, etc.). System must have a cleansing mechanism for small clots, electronic cleansing mechanism preferred.

s. Require minimal start up time from standby mode to operation.

t. System shall be calibrated on assayed material compatible with CAP guidelines. The analyzer shall compile all calculation. Cal factors shall be stored internally and activated internally at the operator’s discretion.

3. Optional Features. In addition to the base capabilities listed above, optional/desirable capabilities may be required as indicated below.

a. Touch screen.

b. Meter or computer printout for calibrators, controls, patient results, repeats.