SOW AI Prostate Cancer Testing.docx

DEPARTMENT OF VETERANS AFFAIRS

STATEMENT OF WORK

PROSTATE CANCER ARTIFICIAL INTELLIGENCE (AI) TESTING

1. PURPOSE: Contractor shall provide artificial intelligence (AI)–based prognostic and predictive prostate cancer diagnostic testing via biopsy slide, including metastatic risk assessment and identification of patients who may benefit from combined radiation therapy and Androgen Deprivation Therapy (ADT), as well as those who have a more favorable prognosis and may be candidates for Active Surveillance, all of which improves clinical decision making for Veterans.

The Contractor shall provide shipping kits to the Rocky Mountain Regional VA Medical Center (RMRVAMC), 1700 N. Wheeling St, Aurora, CO 80045 (Laboratory Department). These shipping kits shall include a prepaid return label for shipment back to the vendor.

2. SCOPE: Contractor shall provide all labor, supplies, information technology, and supervision necessary to provide artificial intelligence (AI)–based prognostic and predictive prostate cancer diagnostic testing. Testing services may include, but are not limited to, the provision of kits to the listed facility; advice on specimen preparation and storage; shipping costs for the transportation of patient biopsy slide(s) to the testing laboratory; performance of diagnostic testing; reporting of diagnostic test results; and consultative services. The contractor shall be approved to provide clinical diagnostic laboratory tests under both Medicare and Medicaid regulations, and in compliance with all applicable federal and state laws.

3. GENERAL REQUIREMENTS: The contractor shall be responsible for performing artificial intelligence (AI)–based prognostic and predictive prostate cancer diagnostic testing via biopsy slide, analysis, and result interpretation on behalf of the listed Facility in accordance with the terms, conditions, and provisions. Services shall include the performance and diagnostic testing as defined by the contractors reference test manual, reporting of diagnostic test results, and consultative services necessary to support the full scope of patient care.

Testing must:

· Support NCCN‑consistent risk stratification

· Demonstrate Level I clinical validity evidence from multiple studies

· Provide a 10‑year risk assessment of distant metastasis and mortality

· Identify when Active Surveillance is appropriate for low‑risk cases

· Predict response to ADT when combined with radiotherapy per NCCN guidelines

· AI algorithms must utilize existing patient data, including PSA levels, age, tumor stage, and Gleason grade slide imaging.

· Testing should not require consumption of patient tissue samples for expensive and time-consuming molecular testing and must be less expensive than alternate molecular tests.

a) The contractor shall provide all necessary requisition forms and any specialized supplies required for sample Shipping Kits to the listed facility by request shall be at no additional charge.

b) The contractor shall provide test results to the listed facility via eFax.

c) The Contractor shall advise Government personnel on slide suitability and perform testing only as requested by the listed facility.

d) The Contractor shall Perform tests as requested by by the listed facility.

e) The Contractor shall Furnish all necessary shipping materials for specimen submission.

f) The Contractor shall cover all shipping expenses and provide clear instructions, including requisition forms, slide storage boxes, specimen shipping containers, and prepaid labels.

g) The Contractor shall Provide quality control documentation for all testing performed in accordance with applicable accreditation standards.

h) The Contractor shall Not charge for “Quantity Not Sufficient” (QNS) specimens and shall notify the Government in writing when this occurs.

i) The Contractor shall Comply with all regulations governing handling, transport, delivery, packaging, and shipment of laboratory specimens.

j) The contractor shall submit invoices electronically to the VA Financial Services Center for payment processing, and include:

1. Invoice Number

2. Purchase Order (PO) Number

3. Date of Service

4. Test Name and CPT Code

5. Unit Cost

6. Total Cost

k) Each test report shall, at minimum, include the following information:

1. Patient’s name and/or social security number

2. Physician’s name (if provided)

3. Date/time specimen was received in the reference laboratory

4. Test ordered

5. Date/time of specimen collection (when available)

6. Date test was completed

7. Test result

8. Flag for abnormal results (when applicable)

9. Reference range

10. Testing laboratory specimen number

11. Name and address of testing laboratory (contractor and/or subcontractor)

12. Type of specimen

13. For unsatisfactory specimens, a statement indicating the reason the specimen is unsuitable for testing shall be provided

4. CONFORMANCE STANDARDS: The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement ACT (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). A valid, in-date CLIA certificate must be supplied showing the address and CLIA registration number of the testing lab. The Contractor shall be HIPAA compliant.

5. REPORTING: Results shall be eFaxed to the listed facility. Alternate numbers may be provided by the VA Facility, depending on the situation. Tests will be performed and reported within five (5) calendar days.

Facility Contacts for Reporting