Automated Osmometer System for Medical Laboratory Use

Statement of Need: Automated Osmometer CPT SCOPE: The Contractor shall provide a two (2) fully automated Osmometer System, including, delivery, installation, training, reagents, consumables for the Tampa VA Healthcare Network (TVAHCN), Department of Pathology and Laboratory Medicine Service (P&LMS) located at 13,000 Bruce

B. Downs Blvd., Tampa, Florida 33612. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances. FDA and manufacturer's guidelines, with all terms, conditions, provisions, schedules, and specifications provided herein. The Contractor selected is responsible for system installation, maintenance coordination and supply procurement for all equipment. GENERAL

REQUIREMENTS: The contractor is required to furnish all of the following: All reagents and supplies necessary to operate the contractor's equipment, including calibrators and or calibration material, reagents, linearity testing material, at least 2 levels of test control material, disposables, consumables, cleaning solutions, diluent solutions, sheath fluids, and any instrument part required for operating all analyzers and equipment. ADDITIONAL NOTES: Contractor shall provide enough reagents sufficient to perform testing at each location for a minimum of 30 days. Reagent quality must be high enough to satisfy proficiency testing of the College of American Pathologists and the Joint Commission. Contractor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., Contractor is to provide all manpower and reagents/supplies to do correlation studies). Equipment must be able to Interface to the Lab Information System (Vista) / middleware (Data Innovations). All consumables and user-defined replacement parts necessary to operate the contractor's equipment, including secondary, aliquot tubes. On- and/or Off-site training for end users and key operators. Delivery and installation of equipment at no additional charge as well as return shipping costs at end of contract (removal). Contractor to perform equipment and assay installation including full validation of system hardware and software as well as assay performance studies as applicable (assay correlations to existing instrumentation, carryover, linearity, dilution validation, precision, accuracy, reference range studies, and normal range studies). Accuracy studies for each analyte. A minimum of 30 samples, spanning the reportable range, will be run by the present and the new contracted method. Contractors will analyze numbers and provide statistical data to accept the new method. Statistics will consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by CLSI. Linearity analysis will be performed on new contracted instrument(s) for each analyte to determine reportable range. A 5-point linearity analysis that adheres to the Beer­ Lambert Law should be performed as a minimum. Precision study utilizing normal and abnormal control material will be performed. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Calibration verification will be performed using samples of known value. These can be calibrators or CAP assayed survey samples, or equivalent. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications. Reference Range: Determine a reference range for each analyte following CLSI guidelines. Samples used for the reference range study shall be representative of the patient population being tested. Reference range assessment shall be performed for each lab. One of the following protocols should be used: A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer's range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer's range is not appropriate for the patient population, a reference range shall be established. Establishing a reference shall follow CLSI guidelines. This requires a minimum of 120 reference individuals be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test shall be provided. Therapeutic range validation studies shall be performed by Contractor for applicable analytes, using CLSI guidelines. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Contractor will provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms. All technical procedures shall be provided by Contractor on diskette in CLSI format, using software compatible with each Laboratory's computer system, for local modification to meet CAP

requirements. All shipping costs for reagents, consumables, supplies and equipment (install and removal at the end of contract) including delivery to the clinical laboratory at all sites. Note: includes emergency, overnight delivery as necessary. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the

requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery with no shipping expenses. EQUIPMENT SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES: The vendor must provide: One (1) Advanced Instruments OsmoPRO® MAX Automated Osmometer One (1) Advanced Instruments Osmo1® Single-Sample Micro-Osmometer Redundant equipment must use the same reagents, controls, calibrators, and consumables, and provide the same reference ranges. General System

Requirements OsmoPRO® MAX Automated Osmometer: All equipment provided must be new. Dimensions (W x D x H): 14.0 x 16.5 x 18 (+ or 2 inches in any direction). Electrical voltage: 100 to 240 VAC (50/60 Hz) Operating Conditions (must operate ranges below or better): Temperature 18°C to 35°C (64°F to 95°F); 5 to 80% relative humidity (non-condensing) Sample type: Serum, plasma, and urine Sampling must be from the primary tube, no pipetting or aliquoting required Measurement Principle: Freezing point depression Minimum Required Sample Volume: 190 L Sample Capacity: Must support continuous loading of at least 500 samples or more. Resolution: 1 mOsm/kg H2O Range: 0 to 2000 mOsm/kg H2O Display: Touchscreen with onboard video instructions Memory capacity: 1,000 results / 10,000 events (+ or 5% for each results / events) Temperature effects: Less than 1 mOsm/kg H2O per 5 °C (9 °F) ambient temperature change Accuracy specifications: Mean value ±2 mOsm/kg H2O from nominal value between 0 and 400 mOsm/kg H2O (1 SD) Mean value ± 0.5% from nominal value between 400 and 1500 mOsm/kg H2O (1 SD) Mean value ±0.75% from nominal value between 1500 to 2000 mOsm/kg H2O (1 SD) Precision (within run) specifications (must meet range for deviation/ variation below, or better): Standard deviation 2 mOsm/kg H2O between 0 and 400 mOsmo/kg H2O Coefficient of variation 0.5% mOsm/kg H2O between 400 to 1500 mOsm/kg H2O Coefficient of variation 0.75% mOsm/kg H2O between 1500 to 2000 mOsm/kg H2O Systems must be barcode driven, random access, and have a precision delivery system. Must be 100% walk-away system, monitoring during specimen analysis must be minimal. Must be capable of rules-based resulting of which the operator is notified when flags or warnings occur. The system shall come ready for Auto-verification of negative results. Must not introduce additional chemicals or other fluids to sample that would contaminate the sample which would preclude additional testing if needed. Shall have accurate capability of monitoring reagent usage, and provide reagent inventory upon request, in real time. Regent handling should include on board reagent stability greater or equal to 30 days. Shall have calibration and lot (calibrator and reagent) tracking. The systems shall deliver well established, standout performance on proficiency surveys. The vendor must offer peer group analysis program. The systems shall have minimal maintenance, <30 minutes, with walkaway capability and minimize staff hands-on and free technologists for more critical tasks. An electronic operator s manual shall be furnished with each model supplied. Temperature and Humidity