Attachment_1-Requirement_Specifications.pdf

FA3010-16-R-0002 Attachment 1-Requirement Specifications

Dated: 20 Oct 2015

REQUIREMENT: CHEMISTRY AND SPECIAL CHEMISTRY TESTING, KEESLER AFB, MS

Need chemistry analyzers, special chemistry analyzers and fully automated bidirectional specimen track system including use of all equipment, services, supplies, consumables, calibrators and reagents needed to perform specimen processing that will consolidate and integrate approximately 676,500 reportable patient tests per year in chemistry, immunology, hemoglobin A1C and special chemistry. All analyzers, automated specimen track system and bidirectional vendor supplied computer interface must have bidirectional connection to Composite Health Care

System Lab Information System and approval for use on the Keesler network. Any connectivity issues will be the contractor’s responsibility to address and resolve. The solicitation response shall conform to the instructions in the solicitation including the addendum to 52.212-1, Instructions to Offerors (See the addendum in the clauses section of the solicitation for special instructions to offerors).

Chemistry and Special Chemistry analyzers shall meet the following minimum requirements:

1. If required for analyzer function, Dedicated Deionized water system to include all service, parts and supplies needed for the full contract period.

2. Sample, calibrator, control and Reagent bar-code reading capability.

3. The capability to store, print and retrieve calibration curves.

4. Perform calibration on other assays during test run without aborting the run.

5. Onboard test auto inventory.

6. Automatic dilution of patient samples with minimal offline dilutions.

7. User configurable automatic rerun/reflex patient testing.

8. Clot and short sample detection to include exclusion of results from tests affected.

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

10. The capability to perform all the tests listed in the Test Menu (see solicitation attachments/exhibits for Test

Menu/Estimated Usage).

11. No manual sample pretreatment or dilution for any assay including whole blood or urine specimen.

12. Ability to process Inter-operative PTH within 20 minutes of introduction to the analyzer.

13. Mirror image integrated chemistry analyzer backup: ability to load the full general/urine chemistry, electrolyte, urine drugs of abuse, therapeutic drugs, and cardiac tests listed in the test menu.

14. All analyzers must connect to automated track system.

15. All reagents ready to load and require no reagent preparation with continuous reagent loading with no interruption to patient sampling/testing and Auto calibration of newly installed reagents.

16. The capability of incorporating other manufacturer’s reagents.

17. Liquid calibrators - ready to use (no reconstitution required).

18. Full reagent tracking capability.

19. The ability to correlate reagent lot to lot runs by having simultaneous lots on board the analyzer.

20. Archiving of patient results.

21. Perform on board linearity without the need of external software.

22. Ability to change routine specimens to STAT specimens, as well as capability to introduce STAT specimens during a test run.

23. Ability to monitor patient moving averages in real time.

24. An extensive Quality Control system which uses:

Bar-code identification.

Quality Control timeout.

Patient sample lockouts for failed or timed out Quality Control and /or Calibration.

Ability to setup Multiple Quality Control lots and process simultaneously.

On board Quality Control statistical program to include daily/monthly Levy-Jennings quality control graphs available for review and printing or saving to backup disks.

25. Full tracking capability of all specimens through the entire analytical process.

26. Must comply with DOD Information Assurance Certification and Accreditation Process (DIACAP) and must have (or obtain within 12 months of installation) DOD Information Assurance Certification and

Accreditation Process (DIACAP).

27. Provide Middleware hardware with auto-verification capability to include set-up and assistance.

28. Contractor to provide 4 laboratory personnel off-site training (initial training in base period to be scheduled after award) with an annual off-site training for 2 laboratory personnel (annual training offered in each option period).

29. Contractor to provide a project manager to perform/oversee system installation, correlation, and validation.

Contractor also provides all validation reagent/materials needed to perform these tasks.

30. Provided with uninterruptible power supply for each instrument, computer and equipment.

31. Maintenance provided will:

Cover onsite service 24 hours per day 365 days per year.

Meet a 24 hour turnaround time on all service calls.

Conduct any preventive maintenance required for continued operation of the analyzer.

Perform all validations to new or modification of existing reagent and all software upgrades.

Include all labor, parts, supplies, reagents, consumables and shipping costs.

Cover 24 hour technical support via call center.

The automated track system must have the ability to:

32. Process multiple tube sizes.

33. Ability to connect and interface with all analyzers.

34. Front end processing to include:

Sample priority sorting.

At least one automated centrifuge attached to the automated track system.

Multiple tube size decapping.

Clot and short sample detection.

35. Automatic sample rerun and reflex.

36. Onboard test auto inventory.

37. Back end processing to include:

Automated recapping/resealing.

Automatic sample storage with archiving.

Automatic retrieval capabilities.

38. Provided with uninterruptible power supply.

39. Maintenance provided will:

Cover onsite service 24 hours per day 365 days per year

Meet a 24 hours turnaround time on all onsite service calls.

Conduct any preventive maintenance required for continued operation of the analyzer.

Perform all validations to new or modification of existing reagent and all software upgrades.

All labor, parts, supplies, reagents, consumables and shipping costs.

Cover 24 hour technical support via telephone.

40. If training for the automated track system is separate from the analyzer training, contractor to provide 2 laboratory personnel off-site training for track system (initial training in base period to be scheduled after award) with an annual off-site training for 1 laboratory personnel (offered during each option period).

41. Full patient tracking/storage capability:

Utilizing track system trays for refrigerator storage.

Provides enough system trays for 7 day sample storage.