Q515--Notice of Intent to Sole Source CareDx Allomap Allosure genetic blood tests

36C26122C0017 Page 17 of 43 Post Heart Transplant Rejection Surveillance CareDx Specialty Lab Services STATEMENT OF WORK 1. Scope of work 1.1. Reference Laboratory testing services for the AlloMap and AlloSure post heart transplant rejection surveillance tests. VA Palo Alto will request approximately 30 AlloMap and 15 AlloSure blood tests per year from CareDx Inc. to perform specialized genetic blood testing on veteran patients who have undergone heart transplant surgery. The FDA approved tests determine if a heart transplant patient has a stable transplant and is not rejecting the new heart. By identifying patients that have a stable transplant at the time of testing, we avoid performing invasive biopsies on this group. Biopsy procedures carry a certain level of patient risk and require hospital stay during recovery; the risks to the patient are from the invasive procedure itself plus the possibility of hospital acquired infections during recovery. 1.2. Provide all necessary supplies free of charge when required and not limited to the following: 1.2.1. Requisition forms 1.2.2. Specimen containers 1.2.3. Special instructions 1.2.4. Current list of tests with reference ranges and specimen requirements 1.2.5. All forms, including Chain of Custody forms 1.2.6. Special media or tubes 1.2.7. All supplies for special tests (e.g., but not limited to, viral studies) 1.2.8. Contractor shall supply any special preservatives required for specimen preservation. 2. Location of work 2.1. CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005 3. Period of Performance 3.1. Base year, plus 4 option years. 4. Laboratory Licensing and accreditation 4.1. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA. 4.2. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. 5. Contractor personnel 5.1. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have -- 1 of 4 -- 36C26122C0017 Page 18 of 43 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. 6. Malpractice claims 6.1. The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an, investigation or suspension. 7. Reporting results 7.1. 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: 7.1.1. Patient's name and/or identification code (Social Security number if provided) 7.1.2. Physician's name (if supplied) 7.1.3. Medical record number (if supplied) 7.1.4. Facility Name 7.1.5. Patient's location (clinical/ward), (if supplied) 7.1.6. Date/time specimen received in Reference Lab 7.1.7. Test ordered 7.1.8. Date test completed 7.1.9. Test result 7.1.10. Flag abnormal 7.1.11. Reference range 7.1.12. Testing laboratory specimen number 7.1.13. Name of testing laboratory (contractor and/or subcontractor) 7.1.14. Type of specimen 7.1.15. Any additional comments related to test provided by submitting labs. 7.1.16. Any other information the laboratory has that may indicate a questionable validity of test results. 7.1.17. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. 7.2. The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries. 7.3. The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation. 7.4. Contractor shall advise facility of any changes in methodology, procedure, reference ranges delays in testing, and any new tests introduced. 8. Sample preparation 8.1. Each VA facility is responsible for packaging and mailing the specimens. 8.2. Each VA facility will provide laboratory specimens prepared according to the shall provide an adequate supply of requisition forms, specimen containers, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements. 9. Hours of operation -- 2 of 4 -- 36C26122C0017 Page 19 of 43 9.1. Monday through Friday, 8 am to 430 pm. 10. Contract complaince 10.1. Contract compliance and clinical performance will be monitored by the Contracting Officer Representative (COR). COR nomination Dan McLean, Budget Analyst, daniel.mclean1@va.gov, 650-493-5000 ext. 63299. 11. Billing 11.1. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the following month. Subsequent changes or corrections shall be submitted by separate invoice. In addition 52.212-4 (g), all invoices must include: 11.1.1. Name and Address of Contractor 11.1.2. Invoice Date and Invoice Number 11.1.3. Purchase/Task Order Number 11.1.4. Date of Service 11.1.5. Total Price 11.2. Vendor Electronic Invoice Submission Methods. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. …