03. SOW GPA IHS PR-RB Hematology_2025.docx

STATEMENT OF WORK (SOW)

Hematology Firm Fixed Price Pine Ridge & Rosebud SUBJECT: SOW Hematology Firm Fixed Price Pine Ridge & Rosebud

A. Project Scope:

This Brand Name fixed firm price Base+4 contract includes hematology analyzers, reagents, controls, consumables, and maintenance service agreement. The vendor will install one XN-550 hematology analyzer and one XN-450 hematology analyzer at Pine Ridge IHS Hospital and two XN-450 hematology analyzers at Rosebud IHS Hospital. The vendor will provide installation and operational training at the customer's facility.

B. Contractor Responsibilities:

1. The Contractor will be responsible for the following:

1. Firm Fixed Price (FFP) BPA.

2. Installing two hematology analyzers each at Pine Ridge and Rosebud IHS hospitals, capable of meeting their testing capacity.

3. Instruments will have automated Complete Blood Count testing with a 6-part differential.

4. The analyzers will be LIS (Laboratory Information System) interfaceable, which means that the system used will be able to talk to our system and download results into the patient's medical record. The vendor will supply LIS specifications and assist with the interface connections.

5. Instruments will have remote access capability through the internet.

6. The analyzers will have programmable rules and/or rule packages that alert the operator to abnormal and critical result parameters.

7. The Quality Control Software on the analyzers and ancillary computers is Windows-based or equivalent and presents data to the operator.

8. The analyzers will have minimal maintenance required.

C. Equipment:

a. The vendor will install one XN-550 hematology analyzer and one XN-450 hematology analyzer at Pine Ridge IHS Hospital and two XN-450 hematology analyzers at Rosebud IHS Hospital.

b. Analyzers will be new and not remanufactured/recertified.

D. Implementation/transition timeframe: The implementation of the services/requirements described in this solicitation shall be completed no later than 60-days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 60-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

E. Reagents, Controls and Supplies:

1. The vendor will provide the reagents, controls, and consumables for analyzing a Complete Blood Count (CBC).

2. Reagents for the analyzer are marked for easy recognition by the operator.

3. The vendor will supply a list of reagents, controls, and consumables that will be shipped as part of the agreement.

4. Supplies will be shipped according to a standing order schedule agreed upon by the customer and vendor. Up to 10 days before the scheduled ship date, all or part of a future standing order may be advanced.

5. The vendor will provide consumables on demand if the consumable allotments are insufficient to meet the facility's needs.

6. The customer may purchase additional supplies according to the agreed price schedule.

7. Other Special orders are subject to shipping charges.

8. The vendor will supply all changes in maintenance schedules that affect reagent or cleaning reagent volumes, which the vendor will change per the manufacturer's recommendations.

F. Services:

1. The contractor shall provide telephone number(s) for technical issues.

2. The vendor’s service agreement provides access via a toll-free hotline 24 hours a day, 7 days a week.

3. The vendor will provide all warranty and post-warranty service of all instrumentation.

4. The service agreements are comprehensive, with a response the next business day, Monday through Friday. The vendor will provide field service support per the terms and life of the contract.

5. Should any facility's primary and backup analyzers be inoperable simultaneously, this is elevated to an emergency call, and a field service representative will be dispatched immediately.

6. The vendor supplies all replacement parts (excluding accessories and disposables) after one (1) year's warranty.

7. Preventive maintenance will be scheduled according to the manufacturer's recommendations for each instrument at least every six months.

8. Parts and supplies shall be available from 7 years after the discontinuance of the instrument manufacture.

9. Service includes software upgrades and all accessories, including printers.

G. Uptime Guarantee:

1. Vendor agrees that all equipment provided shall be operable no less than 98% of operational time. Each instrument at each site shall be computed separately.

a. Operational time is 24 hrs. a day, 7 days a week.

b. Downtime, excluding scheduled maintenance, is defined as when a customer cannot produce clinically acceptable results on the system. Downtime is computed from the time the customer notifies the hotline during normal working hours until the Field Service Engineer returns the instrument to the customer and the customer can produce acceptable clinical results.

H. Other Services:

1. Once the instrument has been installed according to the vendor specifications at the customer's location, the vendor will supply a technical representative to assist with method verification studies.

2. The method verification will meet the requirements of the Clinical Laboratory Information Act (CLIA), The Joint Commission (TJC), and the Commission of Office Laboratory Accreditation (COLA).

3. Verification studies will be presented in binders, including the necessary laboratory staff approval and dates. The GPA IHS will not accept equipment until it passes initial verification testing.

4. The GPA IHS will provide all the samples necessary for the verification studies.

I. Training:

1. The Contractor shall provide, at no cost to the government, on-site operator training prior to installation.

2. The vendor will provide competency assessments protocols for use at each site consistent with federal (CLIA) and TJC training requirements.

J. Pricing:

1. Terms and conditions according to the Federal Supply Schedule V797D-40235.

2. Pricing will be a flat monthly fee as outlined in section J, payment options of FSS contract V797D-40235.

3. Price includes analyzer lease, all reagents, control, and calibration materials

4. Business hours service with remote calibration support

5. Service agreement for the full term of the contract.

K. Value Added Items:

1. Uninterruptible power Supplies (UPS).

2. Operating Manual for each analyzer at the time of installation.

3. Printer and maintenance for printer at each location; (printers shall be replaced if inoperable).

L. Salient Characteristics:

1. Hematology System able to provide a reportable Complete Blood Count (CBC) & Automated WBC Differential to include (All parameters must be FDA approved.)

a. WBC, RBC, HGB HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT #, LYMPH #, MONO #, EO #, BASO #, IG #, NEUT %, LYMPH%, MONO %, EO %, BASO %, IG %

2. Preferred Hematology System should provide open/closed tube, cap piercing, or autoloading sampling options

3. Preferred Analyzer must allow small aspiration volumes, preferred to be less than 30µl

4. Preferred system should offer fully reportable, FDA approved extended 6-part WBC differential to reduce the need for unnecessary slide reviews and manual counts.

5. Preferred system should offer a WBC differential with minimal manual microscopy. No parameter should require an automatic manual review based on listed limitations.

6. Tri Level controls should include all instrument measurements for all whole blood parameters to minimize tech time and expense of managing multiple lots.

7. Real time QC peer group data & automatic electronic data upload capability preferred

8. Vendor should provide unlimited online user training and live instruction

9. 24-hour online customer resource center and technical assistance center provided

10. Should provide manufacturer-assisted calibration onsite verification

11. Onboard customizable rules preferred to facilitate rerun/reflex testing

12. Maintenance that is automated preferred with total analyzer downtime of <15 minutes

13. Preferred analyzer should provide the widest linearity range possible for all results.

14. Analyzer shall have small footprint to allow installation on counter and prevent unnecessary construction: 20” W x 26” D x 20” H

15. Preferred analyzer should have technology to minimize result interference.

APPENDIX A: Annual Test Volume by Facility

IG%

IG ABS

APPENDIX B: System requirements by facility

Primary Analyzer Closed tube sampling w/automated sample loader Primary Analyzer Closed tube sampling, Single tube Back-up Analyzer Required?

Yes

Rosebud