Q301--NGS Malignancy Testing

DRAFT STATEMENT OF WORK Introduction: The Richard L Roudebush VA Medical Center (VAMC) requires a contract for Hematologic Malignancy Next Generation Sequence (NGS) complex specialized testing and IHC testing and analysis of patient specimens. Background: The VA National Precision Oncology Program (NPOP) initially covered the cost of this testing. Due to an evaluation nationally the NPOP may not cover repeat testing of NGS. For this reason, a Task Order needs to be available for the Hematology providers to obtain a repeat NGS for patients with changes in their diagnosis. Due to this change the Richard L Roudebush VAMC has determined that the testing plays an important role in providing quality care and diagnoses to the Veteran patient population. NGS testing is an advanced test methodology at the gene level for detecting various forms of diseases through patient blood specimens. It assists in diagnosing and developing treatment plans for conditions such as, but not limited to many types of cancer, heart disease and neurological diseases. The test can be specifically targeted for one or a multiple number of genes. Results from targeted tests can not only guide care for patients but also guide family members as well for specific therapies and other matters. NGS testing can examine over 20,000 genes. Objective: Maintain a high level of direct patient care with consistent testing methodology and results reporting that will assist in developing treatment plans. Period of Performance: One year. Scope: 1. Contractor shall provide specimen collection kits. 2. Contractor shall provide transport kits for use of transporting specimen tests in a safe manner. 3. Contractor shall provide appropriate shipping labels for UPS in accordance with the Department of Transportation (DOT) guidelines. 4. Contractor shall provide a portal for online test ordering. 5. VAMC accession numbers (VA identification number of order) and the contractor order number assigned shall be used as the common references for tracking tests on all documents. 6. Contractor policies and procedures, and employees shall comply with Health Insurance Portability and Accountability Act (HIPPA). 7. Contractor service personnel shall be accessible by telephone or email at all times. 8. Contractor shall only accept and perform tests that are ordered by VAMC authorized personnel listed in this contract. -- 1 of 4 -- DRAFT Contractor Requirements & Responsibilities: 1) Supplies: a) Contractor shall contact the COR within five (5) business days following award to coordinate the furnishing and delivery of all supplies, transportation supplies, collection supplies. b) Contractor shall provide written instructions for sample preparation, collection, and transportation of all specimens. c) Contractor shall provide the following supplies, and are not limited to: i) Leak-proof plastic tubes and containers for routine shipment of diagnostic specimens. ii) Transportation labels and packaging supplies. 2) Procedure Guidelines: a) Contractor shall have controls in place to be a certified laboratory per the regulatory agencies of the VA. b) Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy i. Upon request of the Contracting Officer Representative (COR) or Contracting Officer (CO), Contractor shall provide the requested quality assurance information on specific testing procedures. c) Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the Government. d) Contractor shall, whenever applicable or relevant, make a distinction between tests that are FDA approved versus research only use (ROU), invitro diagnostic (IVD), investigational use only (IUO), life science research (LSR), or emergency use authorization (EAU). i) In such cases, the distinction shall be printed on each result sheet. 3) Test Results: a. Primary reporting shall be via retrieval of results from the Contractors secure website. a) If the Contractors website is down, all reporting shall be faxed to 317-988-4146. b) Contractor shall provide a shipping service for transport of samples to the testing facility. i. Contractor shall deliver samples to the testing facility within the allowable time limits placed by the VAMC. i) The allowable time limit is 3 days as required by the VA. ii) If the sample arrives past the required 3 days, the sample is no longer usable. c) Contractor shall provide test results to the ordering facility in accordance with the testing specifications as defined in the Contractor’s commercial specimen collection guide. i. Testing requiring a turnaround time (TAT) longer than 14 days shall be identified by the Contractor before contract award and shall be approved and listed this Statement of Work by the Contracting Officer. d) Reporting of Results: A report is defined as a printed final copy of Next Generation Sequencing laboratory testing results, which shall include the Mutation Allele Frequency Report (MAF). i) This report shall be received electronically through the contractor’s secure website or faxed if the contractor website is down. 1. If the results of a test are reported via telephone, the electronic report shall state the name of the individual notified of the results. -- 2 of 4 -- DRAFT ii) Each report shall contain at minimum: (1) Patient’s name (2) Birth Date, Gender, and Age (3) Contractor Order Number (4) VAMC Accession Number (5) Provider Name (if specified on the order) (6) Medical Record Number (if specified on the order) (7) Account Information (8) Specimen Type (9) Test Indication (10) Mutations Detected (11) Interpretation (12) Facility Name (13) Date/time specimen was received in the Reference Lab (14) Reference Range if applicable per regulatory guidelines (15) Name of testing laboratory and address (Contractor and/or Subcontractor) (16) Any additional comments related…