Draft Statement of Work 04282025.pdf

STATEMENT OF WORK

COST-PER-TEST AGREEMENT FOR HEMATOLOGY TESTING

Contractor shall provide all equipment, reagents, consumable, controls, and required services to the Department of Pathology at Weed Army Community Hospital, Fort Irwin, California, for the purpose of Hematology testing under a Cost- Per-Test (CPT) Agreement.

SPECIFICATIONS FOR A BLOOD CELL COUNTER SYSTEM

1. Contract will be a fixed cost contract billed monthly.

2. Cost will include the total system, service and maintenance to the system, reagents, controls, calibrators, consumables, anything unique to the analyzer, printer, and print cartridges.

3. Items specifically not included in the contract are blood or specimen collection tubes, tube/rack labels, capette, dilutors, cube spout kits, printer paper, cartridges and toner.

4. To estimate cost, the number of specimens will be approximately fifty to sixty per day (fewer on weekends, perhaps more on a busy weekday), consisting primarily of whole blood. Other body fluids may number one to five per week at most.

5. The analyzer and LIS interface must be fully installed and operational prior to the effective date of the award.

OVERALL SYSTEM

6. The system must consist of two identical state of the art analyzers, each capable of operating independent of each other, capable of using the same reagents, controls, calibrators, and consumables.

7. There must be a printer for each system, or a single printer must be capable of printing for both analyzers.

8. Must come with any other peripherals to make the system fully operational such as computer, keyboard, mouse, and any other peripherals necessary to fully operate the system.

9. System must come with one or more uninterrupted power sources capable of powering all components for at least ten minutes in the event of a power outage such that the system has time to switch back and forth to emergency power or stay operational long enough for the operator to power down the system.

SPECIMENS TO ANALYZE

10. System must analyze whole blood, synovial fluid, cerebral spinal fluid on 100 uL or less of sample.

COMPUTER COMPONENT

11. The system must have programmable, but also editable, rules so that the user can program normal values, high and low values, critical values.

12. The system must come with software and middleware (an ATO), and any other programs to allow it to automatically feed results into the federal government’s MHS Genesis system manufactured by the Cerner corporation.

ANALYTICAL COMPONENT

13. Automated loading, capable of loading more than one specimen at a time, preferably at least twenty at a time. Must also have manual loading capability (operator holds tube).

14. Must be capable of running at least ten specimens per hour.

15. Once specimens are loaded, the analyzer must be fully automated without help from the operator. It must:

a. Pierce the cap so that the sample remains closed at all times.

b. Run the sample.

c. Report a result on paper and to the hospital computer system.

16. Each analyzer in the system must be capable of analyzing for (whole blood samples):

White Blood Cells (WBC’s), Red Blood Cells (RBC’s), Hemoglobin (HGB), Hematocrit (HCT), Platelets (PLTS), Reticulocytes (RETICS). Nucleated Red Blood Cells (NRBC’s)

17. Each of the tests above must be capable of running from the closed vacutainer collection tube with no additional preparation or manipulation prior to running the sample. The exception is pediatric samples or body fluids, or any fluid not collected in a vacutainer.

18. The system must be capable of performing an automated six-part white blood cell differential consisting of the following cell lines and must report those tests or cell lines in both absolute numbers and percentages of the total white blood cell count. Those cell lines are:

Neutrophils

Lymphocytes

Monocytes

Eosinophils

Basophils

Immature Granulocytes

19. The system must also report reticulocytes in both absolute number and percentage of the red blood cells.

20. For samples other than whole blood, the system must perform a red blood cell count, white blood cell count, and a two-part white blood cell differential consisting of mononucleated cells and polynucleated cells.

21. Once cell lines are counted, the system must calculate the following mathematical indices:

MCV, MCH, MCHC, RDW, MPV

22. Reagents, Supplies and Consumables: Will be part of the cost per test.

SERVICE AND MAINTENANCE:

23. Contractor shall provide full maintenance services required, repairs and parts to assure the continued reliable operation of furnished equipment in accordance with the Original Equipment Manufacturer (OEM) specifications at no cost to the government. Contractor retains ownership of equipment throughout the life of the delivery order. Travel, per diem and other expenses shall be borne by the contractor.

24. Contractor shall provide any maintenance required beyond defined operator maintenance.

25. Response times for unscheduled maintenance will be within two work (Monday thru Friday) days of the service call if one analyzer is inoperable, or within six actual hours if both analyzers are inoperable.

26. Contractor shall provide a toll-free telephone 24/7 hotline at which the government may call for service or technical support.

27. Analyzer must be capable of analyzing platelets by at least two different methods. Must reflex to one method to the second method if an abnormality is detected without technologists’ assistance.

REGULATORY/EXTERNAL REQUIREMENTS

28. Must be approved for use in the United States by all required governmental agencies such as FDA, HHS, and any other federal regulatory agencies.

29. At the time of sale must have at least one hundred users using the same system reporting results to the College of American Pathologist (CAP) survey program.

30. The company must provide a peer data quality control program.

31. Waste must meet California and federal waste disposal laws to flush waste down the drain or put into a solid waste trash bin meeting California and federal waste requirements.

32. Any waste not meeting the criteria above must be picked up and disposed of by the vendor.

33. Contractor shall perform validation studies between the old analyzer and the new analyzer prior to the effective date of the award.

TRAINING

34. Contractor shall provide off site training at no expense to the government for at least two operators.

35. In lieu of off-site training the vendor will provide on-site training consisting of at least one on site trainer. The trainer will train up to fifteen operators one on one or in small groups of two or three in daily use, calibration, run controls, periodic maintenance, computer menu, troubleshooting, and any other training that the operators would receive at the vendor’s training site. Trainer will be required to train on both day shift and evening shift. (shifts run from 6:00 a.m. to 6:00 p.m. and 6:00 p.m. to 6:00 a.m.) Videos and online learning may be used by the trainer during training but are not considered sufficient by themselves to meet this requirement.

DELIVERY

36. Contractor shall deliver, install, and provide implementation of all equipment to the location indicated below. The government shall not incur delivery, installation or implementation costs.

Delivery Location:

Department of Pathology, Weed Army Community Hospital Building 390, Outer Loop Road Fort Irwin, CA 92310

(End Statement of Objectives)