Q301--FY27 Oncotype DX Genomic Cancer Assay Testing Services

VANCHCS Performance Work Statement Genomic Health Inc. VA Northern California Health Care System will periodically send specimens for Oncotype DX testing which is a cancer assay used to predict whether certain patients will benefit from chemotherapy. Oncotype DX is the only multigene cancer assay incorporated into three major clinical guidelines as an option for this purpose. Utilizing RT-PCR, Oncotype Dx for Breast measures the expression of 21 genes to provide clinicians with information on risk of cancer recurrence as well as likelihood of chemotherapy benefit versus whether hormone therapy alone will be effective. This test is used for early stage invasive breast cancer and provides results that are individualized for the patient. It is the most comprehensive test compared to others on the market and is utilized by the greatest number of Oncologic guidelines for patient care world-wide. It is the only test that provides information on chemotherapy benefit. The Oncotype DX for Colon is the only genomic test with Level 1 evidence that provides a recurrence risk assessment that helps clinicians choose an individualized post-surgery therapy approach. It looks at 12 genes in each individual tumor. There are no other tests on the market for this. Oncotype DX Breast DCIS Score test enables women and their doctors to personalize their treatment decisions and potentially forgo unnecessary treatment, such as radiation, when they have a low score and a low risk of local recurrence. For those with higher scores, the result confirms that they would indeed benefit from a more aggressive local approach to treatment, such as radiation therapy. Oncoytpe DX- Breast Oncoytpe DX- Colon Oncoytpe DX- Breast DCIS 1. SCOPE OF WORK 1. 1 Contractor shall provide laboratory services preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. The contractor shall provide the following services: 1.1.2. Provide all necessary supplies, not limited to the following: Requisition forms Specimen containers Special instructions Current list of tests with reference ranges and specimen requirements Specimen carriers All forms 1.1.3 Contractor shall supply any special preservatives required for specimen preservation. 1.1.4 Analyze samples. 1.1.5 Routine test results shall be reported within 24 hours of specimen testing. STAT test results shall be reported within 2 hours or less of specimen testing. Critical Value test results shall be reported immediately. 1.1.6 Consult with Laboratory on test results by telephone as needed. 1.1.7 Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests. 1.1.8 Billing and test report summaries shall begin the first day of the month and include the last day of the month. 2. LICENSING AND ACCREDITATION. 2.1. Contractor shall have all licenses, permits, accreditation and certificates required by law. 2.1.2. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA if contractor is engaged in interstate commerce. 2.1.3 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. 3. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information: -Patient's name and/or identification code (Social Security number if provided) -Physician's name (if supplied) -Medical record number (if supplied) - Facility Name -Patient's location (clinical/ward), (if supplied) -Date/time specimen received in Reference Lab -Test ordered -Date/time of specimen collection (when available) -Date test completed -Test result -Flag abnormals -Reference range -Testing laboratory specimen number -Name of testing laboratory (contractor and/or subcontractor) -Type of specimen -Any additional comments related to test provided by submitting labs. -Any other information the laboratory has that may indicate questionable validity of test results. -Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. 4. CONTRACTOR PERSONNEL. 4.1 The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologists, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months. 4.2 The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request. 5. RECORDS 5.1 The Contractor shall be responsible for creating, maintaining and disposing of only those government required records that are specifically cited in the work statement or required by the provisions of a mandatory directive listed in section (d) Applicable Publications and Forms. If requested by the VA COR, the Contractor shall provide the original record, or a reproducible copy of any such record, promptly of receipt of the writte…