Attachment B - Essential Characteristics.pdf

ATTACHMENT B – Essential Characteristics & Specifications Lab Chemistry Analyzer

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 analyzer provided must have a current/approved Authority to Operate (ATO) certificate from Defense Health Agency (DHA) for the specific model of system being submitted.

B.1.2 One analyzer to perform all testing to include pre-analytical/post-analytical system.

B.1.3 Analyzer must be able to operate between 18-25 degrees Celsius.

B.1.4 In addition to regular power (110v/220v outlet) the unit must have an external power back-up (UPS), provided by Contractor. Power 110 VAC; 60Hz.

B.1.5 Shall be able to operate without the need of plumbing or drains. Drainage and hazardous waste handling (plumbing) – no external drainage for biohazardous/hazardous waste; not able to add dedicated drainage.

B.1.6 Shall possess 10 user-defined chemistry channels.

B.1.7 Shall use single-use tips for specimen and reagent metering.

B.1.8 Shall be able to operate without a water source (not able to add external water source).

B.1.10 Humidity – less than 70%.

B.1.11 Shall be able to store > 240,000 samples/2 years with digital storage capabilities and the ability to archive and retrieve through CD-ROM.

B.1.12 Shall be able to store reagents on-board listed in Appendix A.

B.1.13 Shall interface bi-directionally with the laboratory information system (LIS).

B.1.14 Shall have the capability to process tests either manually, STAT, or automatically.

B.1.15 Have positive patient identification via on-board barcode scanner.

B.1.16 Utilize Dry-Slide Technology: Direct ISE Potentiometric (Na/K/CI), Colorimetric/Rate, Immunorate testing methods and use the direct ISE method to measure sodium, potassium, and chloride.

B.1.17 Have on-board dilution. Specifically, auto dilution, auto repeat and auto reflex capability.

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

B.1.18 Provide sample management with clot detection, bubble detection, liquid Level-Sensing (Pressure Transducer), short-sample detection.

B.1.19 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 interferents. It must send flags and levels to the LIS or data management system.

B.1.20 The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) requirements.

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

B.2.1 The unit shall be able to fit in approximately 65.0” W x 43.0” D x 84.0” H space.

Additional space may be required to accommodate uninterrupted power supply (UPS), provided by the contractor.

B.2.2 No benchtop installed in space. If required, cart shall be provided at the contractor’s expense.

B.3 Water Requirements

B.3.1 Shall be in accordance with (IAW) manufacturer recommendations – no external water source; not able to add external water source.

B.4. Ventilation

B.4.1 Temperature - between 20-25℃

B.4.2 Humidity – less than 70%

B.5 Cost-Per-Test or Cost-Per-Reportable Test: Provides pricing for 100% of tests listed in Appendix A. The price shall include costs covering:

B.5.1 Analyzer, to include pre-analytical/post-analytical system.

B.5.2 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 CLSI.

B5.3 Single ship-to/single bill-to required/Drop-shipment

B.5.4 All necessary maintenance to keep the equipment in good operating condition. This includes both preventative, scheduled, and emergency repairs.

B.5.5 All supplied items and reagents shall be certified for use with the OEM equipment provided.

B.5.6 All supplied items and reagents shall be delivered IAW manufacturer’s shelf life recommendations. Deliveries will be based on volume of testing performed and coordinated with the Lab Supervisor.

B.6 Ordering

B.6.1 Customer will estimate annual test volumes in conjunction with their local Contractor Representative.

B.6.2 Annual delivery orders SHALL be established based on the estimated annual test volume including test necessary for repeats, calibration, and controls.

B.6.3 Supply item delivery will be divided into 12 months. 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.6.4 Customers may order via email to local Contractor representative.

B.6.5 All supplied items and reagents shall be certified for use with the OEM equipment provided.

B.6.6 All supplied items and reagents shall be delivered IAW manufacturer’s shelf-life recommendations. 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). Deliveries will be based on volume of testing performed and coordinated with the Laboratory Supervisor.

B.6.7 All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label that is easily read, understandable, and a minimum of 3” x 3” (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified. Note to Contractor: Failure to label material requiring special handling or refrigeration will result in request of new material at contractor’s expense and the Government is not responsible.

B.6.8 The contractor shall provide deliveries to the delivery point identified below:

Naval Health Clinic Charleston Attention: Laboratory Department 110 NNPTC Circle, Building 2418

Goose Creek, SC, 29445

B.7 Pricing

B.7.1 Prices are inclusive of equipment, reagents, consumables, services, training, and shipping.

B.7.2 Pricing will be established based on the set-cost estimated annual volume of slides/tests/wells to be shipped.

B.7.3 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.8 The Contractor shall provide all initial and new test validation reagents and materials needed to perform these tasks.

B.9. System Interface Requirements

B.9.1 The system shall be capable of bi-directionally interfacing with the Medical Health System Electronic Next-Generation Electronic System (MHS GENESIS).

B.9.2 The system shall have the ability to receive Health Level 7 (HL7) order messages (ORM) and information from the Laboratory Information System (LIS).

B.9.3 If the vendor is not already approved to connect to MHS GENESIS bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.

B.9.4 Government will provide the required middleware.