CAREdx SOW.pdf

36C26122C0017

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 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

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. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

11.2.1. The FSC uses a

third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

11.2.2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

11.2.3. The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10:

11.2.3.1. OB10 e-Invoice Setup Information: 1-877-489-6135

11.2.3.2. OB10 e-Invoice email: VA.Registration@ob10.com

11.2.3.3. FSC e-Invoice Contact Information: 1-877-353-9791

11.2.3.4. FSC e-invoice email: vafsccshd@va.gov

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors (Amended October 25, 2021)

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests proved over-the-counter test.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

For indefinite delivery contracts: Contractor agrees to comply with FAR 52.232- 99 and VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.