SOW Hematology 5.22.26.pdf

Statement of Work (SOW) GPA IHS AO Hematology Equipment Procurement

1. Purpose

This Statement of Work (SOW) is to establish the requirements and responsibilities for the procurement, delivery, installation, training, and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Indian Health Service (GPA IHS) healthcare facilities. Facilities include hospitals at Pine Ridge, SD; Rosebud, SD; Eagle Butte, SD; Ft. Yates, ND; Belcourt, ND; and clinics at Ft.

Thompson, SD; Lower Brule, SD; Wagner, SD; McLaughlin, SD; Sisseton, SD; Kyle, SD; and Wanblee, SD. The vendor will provide installation and operational training at the customer's facility

2. Background

GPA IHS facilities require reliable, high-quality hematology analyzers to support patient care. Equipment must meet CLIA standards, interface with the facility’s laboratory information system (LIS), and handle projected test volumes.

This procurement shall ensure continuity of care, improved diagnostic accuracy, and compliance with federal and tribal health regulations.

3. Scope of Work

The Contractor shall provide new hematology analyzers and all associated equipment, consumables, installation, validation, training, and warranty support.

Deliverables include:

• Hematology analyzer(s) and peripherals

• Reagents, controls, calibrators (initial supply)

• Installation, calibration, and verification

• User training for clinical personnel

• Integration with LIS (if required)

• Warranty and service coverage

4. Equipment Requirements

4.1 Analyzer Specifications

The hematology analyzer(s) must include:

• Automated CBC with 6-part differential (Immature Granulocyte count)

• Abnormal cell flagging and alerts

• Automated reagent management

• Processing speed suitable for workload (see Appendix A for test volumes)

• Open and Closed-tube sampling (see Appendix B System Requirements by Facility)

• Pediatric (microtainer) tube sampling capability

• STAT capability

• Barcode scanning

• Adequate onboard storage

• LIS/HL7 compatibility

4.2 Physical & Operational Requirements

• Bench-top model

• Environmental tolerances for clinical use

• User-friendly interface

5. Deliverables

Deliverable Description Due

Equipment Delivery Analyzer(s), peripherals At contract start

Installation & Setup Installation, calibration, verification Within 10 days

Method Verification CLIA-compliant accuracy and precision checks Within 30 days

LIS Interface Setup Interface build + validation As scheduled

Training Onsite training + materials At installation

Documentation Package Manuals, QC, maintenance guides At installation

Warranty Documentation Written warranty At award/installation

6. Training Requirements

Training must include:

• Operation

• Maintenance

• Troubleshooting

• QC and proficiency testing

• Safety protocols

7. Warranty, Service & Maintenance

7.1 Warranty

Minimum 12-month full warranty, including:

• All parts

• Labor

• Travel

• Reagents (if applicable under a cost-per-test model)

7.2 Preventive Maintenance

• Scheduled PM at least annually (or as manufacturer requires)

• PM report provided within 5 business days

• Include Software upgrades and all accessories including printers.

7.3 Repairs

• Onsite response within 48 hours of service request for hospitals and next business day for clinics (see Appendix C – Core Business Hours)

• Remote support available 24/7 via toll free hot line

8. Quality & Compliance Requirements

The Contractor must ensure all equipment:

• Meets Clinical Laboratory Improvement Amendments (CLIA) standards

• Meets FDA device requirements (510k or equivalent)

• Complies with OSHA, CDC, and IHS biosafety guidelines

• Includes documentation for QC, calibrations, maintenance logs

• Proficiency testing compatibility must be supported (e.g., CAP, API)

9. Acceptance Criteria

Acceptance requires:

1. Delivery and inspection

2. Successful installation

3. Verified performance meeting CLIA and manufacturer standards

4. LIS interface validation

5. Completion of staff training

6. Final approval by the Laboratory Director

10. Period of Performance

This request is for Base plus 4 (B+4) contract from the date of award.

Covers:

• Procurement, delivery, installation

• Training and validation

• Warranty services

• Optional service/maintenance periods

11. Roles and Responsibilities

Contractor

• Deliver equipment

• Install and validate

• Provide training, warranty, and maintenance

• Ensure compliance with standards

Government (IHS)

• Provide installation environment

• Provide LIS access

• Assign staff for training

• Conduct final acceptance

“Pursuant to FAR 1.602-1, only duly appointed Contracting Officers are authorized to enter into, administer, or terminate contracts and make related determinations and findings on behalf of the United States Government.”

12. Pricing Structure

All products ordered are issued by Task Orders/Delivery Order and placed by the individual service unit.

The pricing for this contract shall be based on a firm fixed Cost-Per-Test (CPT) model.

The CPT rate shall include:

• All equipment

• All reagents, controls, and consumables

• All maintenance and repairs

• All training

• All interface support (if applicable)

• All software and middleware

No additional charges shall be billed. A firm fixed Cost-Per-Test price must be proposed.

13. Security & Data Requirements

• Must meet HHS/IHS cybersecurity standards

• PHI may not be stored outside approved systems

• Devices must support secure data wipe procedures

14. Salient Characteristics

1. Size of instrumentation is small footprint (40" W X 24"D) tabletop models and other configurations available as needed.

2. Body Fluid Capabilities are FDA approved assays.

3. Instruments have single aspiration pathways.

4. Compatible with standard microtainer tubes.

5. Analyzer programmable features allow for reduced need for manual differentials.

6. Available slide maker and strainer on selected units, if needed.

7. Continuous automated/real-time calibration and verification.

8. Vendor uploaded quality control values.

9. Automatic manufacturer downloaded quality control ranges.

15. Section 508 and Accessibility Requirements

This product must conform to the Revised Section 508 Standards (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines) and the WCAG 2.0 Level AA standards as outlined below.

Solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template, available at:

https://www.itic.org/policy/accessibility/vpat.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.itic.org/policy/accessibility/vpat

APPENDIX A:

Annual Test Volume by Facility – GPA IHS Hospitals

*Estimate 5% volume increase per year from base period

Parameter Cheyenne River Pine Ridge Rosebud Ft. Yates Belcourt

WBC 10,023 22,030 14,299 4,569 14,911

RBC 10,023 22,030 14,299 4,569 14,911

HEMOGLOBIN 10,023 22,030 14,299 4,569 14,911

HEMATOCRIT 10,023 22,030 14,299 4,569 14,911

MCV 10,023 22,030 14,299 4,569 14,911

MCH 10,023 22,030 14,299 4,569 14,911

MCHC 10,023 22,030 14,299 4,569 14,911

PLATELET COUNT 10,023 22,030 14,299 4,569 14,911

MPV 10,023 22,030 14,299 4,569 14,911

RDW 10,023 22,030 14,299 4,569 14,911

LY%, AUTO 10,023 22,030 14,299 4,569 14,911

NE%, AUTO 10,023 22,030 14,299 4,569 14,911

MO%, AUTO 10,023 22,030 14,299 4,569 14,911

EOS%, AUTO 10,023 22,030 14,299 4,569 14,911

BASO%, AUTO 10,023 22,030 14,299 4,569 14,911

LY# 10,023 22,030 14,299 4,569 14,911

NE# 10,023 22,030 14,299 4,569 14,911

MO# 10,023 22,030 14,299 4,569 14,911

ESO# 10,023 22,030 14,299 4,569 14,911

BAS# 10,023 22,030 14,299 4,569 14,911

IG% 10,023 4,569 14,911

IG ABS 10,023 4,569 14,911

RET%

APPENDIX A: Annual Test Volume by Facility – GPA IHS Clinics

Parameter FT.

Thompson Kyle Lower Brule McLaughlin Sisseton Wanblee Wagner

WBC 2,468 2,448 1,376 937 4,404 1,327 3,492

RBC 2,468 2,448 1,376 937 4,404 1,327 3,492

HEMOGLOBIN 2,468 2,448 1,376 937 4,404 1,327 3,492

HEMATOCRIT 2,468 2,448 1,376 937 4,404 1,327 3,492

MCV 2,468 2,448 1,376 937 4,404 1,327 3,492

MCH 2,468 2,448 1,376 937 4,404 1,327 3,492

MCHC 2,468 2,448 1,376 937 4,404 1,327 3,492

PLATELET COUNT 2,468 2,448 1,376 937 4,404 1,327 3,492

MPV 2,468 2,448 1,376 937 4,404 1,327 3,492

RDW 2,468 2,448 1,376 937 4,404 1,327 3,492

LY%, AUTO 2,468 2,448 1,376 937 4,404 1,327 3,492

NE%, AUTO 2,468 2,448 1,376 937 4,404 1,327 3,492

MO%, AUTO 2,468 2,448 1,376 937 4,404 1,327 3,492

EOS%, AUTO 2,468 2,448 1,376 937 4,404 1,327 3,492

BASO%, AUTO 2,468 2,448 1,376 937 4,404 1,327 3,492

LY# 2,468 1,376 937 4,404 3,492

NE# 2,468 1,376 937 4,404 3,492

MO# 2,468 1,376 937 4,404 3,492

ESO# 2,468 1,376 937 4,404 3,492

BAS# 2,468 1,376 937 4,404 3,492

IG% 2,468 2,448 1,376 937 4,404 1,327 3,492

IG ABS 2,468 1,376 937 4,404 3,492

RET% N/A N/A N/A N/A N/A N/A N/A

Appendix B System Requirements by Facility

Closed tube sampling w/Automated Sample Loader

Closed tube sampling, Single tube

Back-up Analyzer Body Fluids Reticulocytes

Cheyenne River X X Pine Ridge X X Rosebud X X Ft. Yates X X Belcourt X X FT. Thompson X Kyle X Lower Brule X McLaughlin X Sisseton X Wanblee X Wagner X

ATTACHMENT C: Core Business Hours for each GPA IHS Laboratory

Facility Hours of Operation

Eagle Butte Service Unit Cheyenne River Health Center 24276 166th Street, Airport Rd. Eagle Butte, SD. 57625 Phone 605-964-7724

24/7

Fort Thompson IHS Health Center 1323 BIA Route 4, PO Box 200, Fort Thompson, South Dakota Phone: 605-245-1500

Monday - Friday 8:00 a.m. to 4:30 p.m. (Daily)

Kyle Health Center P.O. Box 540, Kyle, South Dakota 57752 Phone 605-455-2451

Monday – Friday: 07:00 a.m. – 5:30 p.m.

Lower Brule Indian Health Center Address: 601 Gall St, Lower Brule, SD 57548 Phone: (605) 473-5526

M, T, Th, F: 08:00 – 4:30 Wed: 12:15 – 4:30 Closed 11:45 – 12:15 (Lunch)

McLaughlin Health Center 701 East 6th St., PO. Box 879, McLaughlin, South Dakota 57642 Phone: 605-823-2610

Monday – Friday: 8:00 a.m. to 4:30 p.m.

Pine Ridge Hospital P.O. Box 1201, East Highway 18, Pine Ridge, South Dakota 57770 Phone 605-867-5131

24/7

Rosebud Comprehensive Health Care Hospital P.O. Box 400, 400 Soldier Creek Dr. Rosebud, South Dakota 57570 Phone: 605-747-2231

24/7

Sisseton Service Unit Woodrow Wilson Keeble Memorial Health Care Center (WWKMHCC) 100 Lake Traverse Drive, Sisseton, South Dakota 57262 Phone 605-698-7606

Monday - Friday & Holidays: 8:00 a.m. – 8:00 p.m.

Saturday and Sunday: 1:00 p.m. to 5:00 p.m.

Ft. Yates Service Unit (Standing Rock) 10 Standing Rock Avenue, P.O. Box J, Fort Yates, North Dakota 58538 Phone: 701-854-3831

Monday – Friday: 0800 a.m. .to 4:30 p.m.

On-Call: Monday – Friday: 4:30 p.m. to 8:00 a.m.

Saturday & Sunday: On-Call

Belcourt Service Unit Quentin N. Burdick Memorial Health Care Facility Moonlight Drive Highway 5, Belcourt, North Dakota 58316 Phone (701) 477-6111

24/7

Yankton Service Unit 111 Washington Ave NW, Wagner SD, 57380 Phone: 605-384-3621

Monday – Friday: 8:00 a.m. to 5:00 p.m.

Wanblee Health Center 210 First Street, P.O. Box 290, 100 Clinic Drive, Wanblee, South Dakota 57577 Phone 605-462-6155

Monday – Friday: 7:30 am to 6:00 pm

1. Authority

1.1. No person other than the Contracting Officer has authority to bind the Government with respect to this contract.

1.2. No action or omission of any government employee or representative other than the Contracting

Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

1.3. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

1.3.1. An understanding or agreement between the Contractor and anyone other than the Contracting Officer;

1.3.2. A purported modification or change order issued by anyone other than the Contracting Officer;

1.3.3. A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

1.3.4. An order, direction, consent, or permission from anyone other than the Contracting Officer to:

1.3.4.1. Incur costs in excess of a specified estimated cost, allotment of funds, or other ceiling; or

1.3.4.2. Expend hours in excess of a specified level of effort.

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