Description
Laboratory Testing Services Performance Work Statement General. The Department of Veterans Affairs VA Northern California Health Care System (VANCHCS) requires the services of a Contractor to provide laboratory services described herein. Laboratory Testing Services include preanalytic processing as defined in its laboratory user's manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. Item # Description of Supplies\Services Lab Testing 1 Oncotype DX Service Breast 2 Oncotype DX Service Colon 3 Oncotype DX Service MMR Period of Performance: The period of performance for this contract shall be for a base year plus four 1 year options. Base Year: October 1, 2016 through September 30, 2017 Option Year 1: October 1, 2017 through September 30, 2018 Option Year 2: October 1, 2018 through September 30, 2019 Option Year 3: October 1, 2019 through September 30, 2020 Option Year 4: October 1, 2020 through September 30, 2021 Contract Type: This shall be an indefinite delivery indefinite quantity firm fixed-price contract. Place of Performance: Services involved shall be accomplished at the VA Northern California Health Care System located at 10535 Hospital Way, Mather, CA 95655. Contractor Qualifications: 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. The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request. Contractor shall have all licenses, permits, accreditation and certificates required by law. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA if contractor is engaged in interstate commerce. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. Contractor personnel must be able to provide proof of successful completion of training and certification as requested by the COR. Contractor Responsibilities: 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. I. Contractor shall provide the following services: A. 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 B. Contractor shall supply any special preservatives required for specimen preservation. Analyze samples. C. 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. D. Consult with Laboratory on test results by telephone as needed. E. Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests. F. Billing and test report summaries shall begin the first day of the month and include the last day of the month. II. System Requirements shall include: A. Oncotype DX testing which is a cancer assay used to predict whether certain patients will benefit from chemotherapy. B. Oncotype DX is the only multigene cancer assay incorporated into three major clinical guidelines as an option for this purpose. Because not all women benefit from chemotherapy equally, the Oncotype DX assay is a 21-gene assay that provides an individualized prediction of Hemotherapy benefit and 10-year distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer. C. Molecular diagnostic testing is highly specialized Procedures & Method of Delivery: Contractor shall provide transportation of patient specimens originating from Government facilities and destined to the contracted commercial laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the patient specimens is maintained. Routine transportation services shall occur once per day from the Government facilities. Specimen pick-up times will be negotiated after contract award. 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 abnormal " 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 a questionable validity of test results. " Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. Identification, Parking, Smoking and VA Regulations: Contractor personnel performing work onsite at VANCHCS facilities shall wear visible identification at all times while on the premises of VANCHCS, including wearing a temporary visitor's badge, which will be issued by VA police upon Contractor's arrival at VA NCHCS. All personnel entering the VA facility may have to consent to inspection of all categories of packages as a condition of admittance. It is the responsibility of contractor personnel to park in the appropriate designated parking areas. Information on parking is available from VA Police. VA will not invalidate or make reimbursement for parking violations under any conditions. Smoking is prohibited in any VANCHCS building and the surrounding grounds, including the parking lots. Smoking is permitted only in a designated shelter. Intoxication, debilitation resulting from drug use, insubordination, theft, patient abuse, dereliction or negligence in performing directed tasks and possession of weapons is prohibited and grounds for immediate removal from VANCHCS by the VA Police. All personnel entering the facility may have to consent to inspection of all categories of packages as a condition of admittance. Violations of VA Regulations may result in a citation answerable in the U.S. Federal District Court. RECORDS: 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 written request. PATIENT LISTS: The Contractor shall treat patient lists, no matter how developed, as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the participating VAMC without prior written permission by the VA COR or Chief of the Medical Staff. RELEASE OF MEDICAL INFORMATION: The Contractor shall not release any medical information obtained during the course of this contract to anyone outside the VA, unless authorized in writing by the VA COR and the patient, as required by applicable law. PROFESSIONAL LIABILITY INSURANCE: Professional liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request. SAFETY: The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required.