Inactive
Notice ID:36C25719Q0791
The below Sample Statement of Work is being included with the Sources Sought Notice: SAMPLE Statement of Work Reference Testing Laboratory Scope of Work The reference laboratory shall provide, in acco...
The below Sample Statement of Work is being included with the Sources Sought Notice: SAMPLE Statement of Work Reference Testing Laboratory Scope of Work The reference laboratory shall provide, in accordance with all applicable federal, state and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, reference laboratory testing. The reference laboratory shall provide services to include the performance of analytical testing as defined by the Laboratory s test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of laboratory operations. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e., branch, division, sub-Reference Laboratory, etc. performing reference testing on behalf of the Reference Laboratory. Contractor shall provide laboratory services to include pickup and transportation of specimens to its laboratory; pre-analytic processing as defined in its laboratory user manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. The contractor shall provide the following services: Provide all necessary supplies, not limited to the following: Specimen containers Dry ice and appropriate container Special Instructions Current list of tests with reference ranges and specimen requirements Specimen carriers All forms Special media or tubes for viral samples All supplies for special tests (e.g. not limited to, viral studies) Provide specimen pick -up services as defined in the contract. Transport samples in such a manner as to ensure the integrity of the specimen. Contractor shall supply any special preservatives required for specimen preservation. Analyze samples Test results shall be reported within specified turnaround times. Consult with Laboratory on test results by telephone as needed. Provide Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests. Billing and test report summaries shall begin the first day of the month and include the last day of the month. The reference laboratory shall provide to the Laboratory: A list of current testing performed and any specimen requirements for each test, A current fee schedule which reflects pricing, and A list of further discounted pricing for high volume tests. Licensing and Accreditation Contractor shall have all licenses, permits, accreditation and certificates required by law. Contractor shall be accredited by the College of American Pathologists (CAP). Contractor shall be accredited by the 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. Procedure Guidance The Contractor shall perform pathology procedures compatible with the participating VA operating capacity and equipment. The contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the authorized laboratory representative. The contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or Contracting Officer's Representative. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the Government requesting physician opinion; fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered. The Contractor shall notify the VA representative or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested. Test Results Telephone Consultation. The contractor shall consult with the VA Representative, requesting clinician or designee by telephone as needed. The contractor shall immediately telephone the respective VA Representative, requesting clinician or designee to Report Critical Values or test results that may indicate a life threatening condition. The laboratory requires reporting critical lab results directly and only to the laboratory and its personnel. Reference laboratories may not report critical results directly to clinical personnel. When calling with critical results, the report must be called to the specimen processing area, and or a pathologist. 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 and transmitted to the VA via the Laboratory Electronic Data Interchange (LEDI) according to the published turnaround times of the reference laboratory. If results are telephoned the report must include the name of the individual, notified of the results. Each test report shall at a minimum indicate the following information: Patient's name and/or identification code (Social Security Number) 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 completed Test results Flag abnormal Reference range Toxic and/or therapeutic range where applicable Testing laboratory specimen number Name of testing laboratory (contractor or subcontractor) Type of specimen Any additional 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. Service The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. The Contractor shall submit with this proposal a percentage discount off the specified published price list for all tests other than those detailed in the Schedule. A copy of the published price list shall be submitted and maintained throughout the life of the contract. Records. The contractor shall be responsible for creating, maintaining and disposing of only those Government required records. If requested, the contractor shall provide the original record, or a reproducible copy of any such record, within two (2) business days of receipt of the request. Release of Information. The Contractor shall not release any medical information obtained during the course of this contract to anyone unless authorized by the VA in writing. Safety. The contractor shall comply with all applicable OSHA, Federal, State laws and regulations as required for performing the type of services required.
