Attachment_1-Specifications.pdf

Specifications FA3010-16-R-0008 Attachment 1

22 Mar 2016

SUBJECT: CHEMISTRY, SPECIAL CHEMISTRY & A1C HEMOGLOBIN COST PER TEST

SPECIFICATIONS:

Need chemistry analyzers, special chemistry analyzers and automated specimen track system including use of all equipment, services, supplies and reagents needed to perform automated specimen processing that will consolidate and integrate approximately 58,378 reportable patient tests per month in chemistry, immunology, hemoglobin A1C and immunoassay special chemistry. All analyzers, automated specimen track system and bidirectional vendor supplied computer interface must have ability to connect to Composite Health Care System Lab Information

System. Tests billed in monthly installments per year. Testing analyzers must be in place, validated by the vendor and ready to use no later than 01 APR 2016. See “Addendum to FAR 52.212-1 Instructions to Offerors” in the solicitation for instructions for submitting pricing of tests.

Chemistry /Special Chemistry analyzers must be supplied with:

1. Dedicated Deionized water system

2. Sample and Reagent bar-code reading capability

3. Onboard test auto inventory, automatic dilution of patient samples and user configurable automatic rerun/reflex

4. Clot and short sample detection

5. Hemolysis, lipemia and Icteria detection with no impact on sample throughput

6. Ability to perform all tests in current inventory with no manual sample pretreatment or dilution for any assay including whole blood or urine specimen

7. Mirror image chemistry analyzer backup with capability of running the full test menu

8. All analyzers connected to automated track system with ability to run independently of non-operational track system

9. All reagents ready to load and require no reagent preparation and allow for open channel testing with no limitations and have full tracking capability

10. Ability to load chemistry reagent packs during analyzer operation

11. No carry over potential between samples

12. Quality Control, Linearity and Precision program that will meet regulatory documentation requirements

13. Duration of multipoint calibrations no less than 4 weeks before expiration

14. Random access mode for special chemistry immunoassays

15. Assay times for routine immunoassays under 20 minutes

16. Assay times for cardiac markers (CK-MB, Troponin, pro-BNP) less than 10 minutes

The automated track system must have the ability to:

1. Process multiple tube sizes

Specifications FA3010-16-R-0008 Attachment 1

22 Mar 2016

2. Ability to connect and interface with all analyzers and CHCS

3. Front end processing to include sample priority sorting, centrifugation and decapping

4. Customized aliquot labeling

5. Onboard test auto inventory

6. Color coded rack system for urine, body fluid, whole blood specimen types

7. Back end processing to include recapping and automatic sample storage with archiving capabilities