SOW Prostate Cancer Testing Non-Invasive.docx

Department of Veterans Affairs

STATEMENT OF WORK

Non-Invasive Urine Testing for Prostate Cancer

1. PURPOSE: Contractor shall provide a non-invasive urine based molecular liquid biopsy test for men such that the test provides a risk score that helps to differentiate patients with high risk from a low risk of aggressive prostate cancer and thus indicate the need for a prostate biopsy. The test risk score should be based on an analysis of RNA markers and should not incorporate PSA levels in its algorithm, nor require the DRE (digital rectal exam) prior to collection of the urine specimen.

The Contractor shall ship test kits directly to the patient’s home, which shall include a prepaid return label for return shipment to the vendor’s facility. Upon request from a VISN 19 facility, the contractor shall also ship test kits to that facility’s laboratory department for distribution to patients. All kits shipped to VISN 19 facilities shall include a prepaid return label to the vendor’s facility. Kits may be shipped to the following VISN 19 facilities:

a. Rocky Mountain Regional VA Medical Center (RMRVAMC), 1700 N. Wheeling St, Aurora, CO 80045

b. Fort Harrison VA Medical Center (FHVAMC), 3687 Veterans Drive, Fort Harrison, MT 59636

c. Benjamin Charles Steele VA Clinic (Billings), 1766 Majestic Lane, Billings, MT 59102

d. Grand Junction VA Medical Center (GJVAMC), 2121 North Ave., Grand Junction, CO 81501

e. Oklahoma City VA Medical Center (OKCVAMC), 921 NE 13th St., Oklahoma City, OK 73104

f. Salt Lake City VA Medical Center (SLCVAMC), 500 S. Foothill Dr., Salt Lake City, UT 84148

g. Jack C. Mongomery (VAMC), 1011 Honor Heights Drive, Muskogee, OK 74401

h. Ernest Childers VA Outpatient Clinic (ECVC), 8921 S. Mingo Rd. Tulsa, OK 74133

i. James Mountain Inhofe VA Medical Center (JMIVAMC), 440 S. Houston St., Tulsa, OK 74127

2. SCOPE: Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide genetic testing for prostate cancer to all facilities listed in Section 1. Genetic testing services may include, but are not limited to, the provision of test kits to VISN 19 facility laboratories, as well as direct mail delivery to patients following a provider request; advice on specimen preparation and storage; shipping costs for the transportation of clinical laboratory specimens to the testing laboratory; performance of analytical testing; reporting of analytical 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 laboratory genetic testing, analysis, and result interpretation on behalf of VISN 19 Facilities in accordance with the terms, conditions, and provisions. Services shall include the analytical testing as defined by the contractors reference test manual, reporting of analytical test results, and consultative services necessary to support the full scope of patient care.

a) The contractor shall perform testing and report results within five (5) business days of receipt of the sample by the testing laboratory. Business days exclude weekends and Federal Holidays.

b) The contractor shall provide all necessary requisition forms and any specialized supplies required for sample collection/test Kits to VISN 19 Facilities and/or directly to patients by mail following a Provider request shall be at no additional charge.

c) The contractor shall provide test results to VISN 19 Facility laboratories via FAX/eFax or by phone if requested.

d) Invoices must contain the following information. The contractor shall submit an invoice which includes:

1. Invoice Number

2. Purchase Order (PO) Number

3. Date of Service

4. Test Name and CPT Code

5. Unit Cost

6. Total Cost

e) 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 faxed/eFaxed into VISN 19 laboratories and phoned in (if requested) to the following numbers. 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