Attachment B - Essential Characteristics.pdf

Attachment B – Essential Characteristics

B.1. Analyzer: The Contractor shall provide an analyzer that meets the requirements stated in this PWS and the performance characteristics for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA'88) and the Clinical Laboratory Institute (CLSI formerly NCCLS).

The analyzer shall meet the following criteria:

B.1.1 The contractor shall provide an analyzer that has a current/approved Authority to Operate (ATO) certificate from Defense Health Agency (DHA) for the specific model of system being submitted.

B.1.2 Shall be able to operate without a water source. Have no plumbing, drains, stirring mechanisms, mixing assemblies floor vents or deionized water. Have waste contained within the system and disposed of daily.

B.1.3 Shall be able to store >20,000 samples with ability to archive and retrieve through CD-

ROM.

B1.4 Shall be able to store >120 reagents on-board

B.1.5 Shall possess 10 user defined chemistry channels.

B.1.6 Shall use single-use tips for specimen and reagent metering.

B.1.7 Shall be able to operate in temperatures of 59-86 degrees Fahrenheit, and humidity ranges between 15 – 75 RH%

B.1.8 Shall interface bi-directionally with the laboratory information system (LIS)

B.1.9 Shall operate at an electrical voltage of 100-120V

B.1.10 Shall have the capability to process tests either manually, STAT or automatically.

B.1.11 Have positive patient identification via on-board barcode scanner.

B.1.12 Utilize Dry-Slide Technology: Direct ISE Potentiometric (Na/K/CI), Colorimetric/Rate, lmmuno-rate testing methods and use the direct ISE method to measure sodium, potassium and chloride.

B.1.13 Have on-board dilution. Specifically, auto dilution, auto repeat and auto reflex capability.

Be self- monitoring and alert operators to prompt action, avoiding testing delays.

B.1.14 Provide sample management with clot detection, bubble detection, liquid Level-Sensing (Pressure Transducer), short-sample detection.

B.1.15 Be able to determine hemolysis, icterus and turbidity levels without additional patient sample, reagents, consumables and no effect on throughput. It must flag only assays affected by the interferent. It must send flags and levels to the LIS or data management system.

B.2 Footprint: Equipment shall not be larger than exact footprint required for analyzer, monitor, keyboard, CPU, printer.

B.3 Cost-Per-Test: Provides Cost-Per-Test (CPT) pricing for 100% of tests listed in Appendix A. The cost-per-test price shall include costs covering:

B.3.1 Analyzer, to include pre-analytical/post-analytical system.

B.3.2 Reagents needed to perform the total of all tests specified for a full 12 months. All reagents, standards, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor's equipment and necessary for the generation of a test reportable result.

This cost per test result will also encompass all costs associated with dilution; repeat and confirmatory testing required, producing a single test reportable; and include the materials and all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI formerly NCCLS).

B.3.3 Single ship-to/single bill-to required

B.3.4 All necessary maintenance to keep the equipment in good operating condition. This includes both preventive maintenance and emergency repairs.

B.4 Ordering

B.4.1 Customer will estimate annual test volumes in conjunction with their local Contractor representative.

B.4.2 Annual delivery orders SHALL be established based on the estimated annual test volume including those tests necessary for repeats, calibration and controls.

B.4.3 Shipments of reagents and consumables SHALL BE made either quarterly or biannually (it is imperative for laboratory efficiency and longest calibration stability to have minimum quarterly shipments).

B.4.4 Customers may, at their choice, allow shipment of product per the pre-determined schedule, order via phone, or use the Contractor website.

B.4.5 Shipments of reagents and consumables SHALL BE made either quarterly or biannually (it is imperative for laboratory efficiency and longest calibration stability to have minimum quarterly shipments).

B.5 Pricing

B.5.1 Prices are inclusive of equipment, reagents, consumables, service, training, and shipping.

B.5.2 Any additional accessories will be added on to the cost per test for one year based on the attached pricing.

B.5.3 Pricing will be established based on the total estimated annual volume of slides/tests/wells to be shipped.

B.5.4 Prices will be billed per slide/test/well shipped multiplied by the number of slides/tests/wells contained in each shipping unit of measure. Bi-annual reviews will be conducted to confirm/adjust shipment quantities.

B.6 The Contractor shall provide all initial and new test validation reagents & materials needed to perform these tasks.