Q301--Intent to Sole Source - VISN Reference Lab Testing - Bridge

Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor s requirements. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. If a medico legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain a valid chain-of-custody possession and develop the formal documentation necessary for that purpose. Contractor s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government. D. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. Transportation Services for Reference Testing Specimens Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference 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 biomedical material is maintained. Routine transportation services shall occur once per day from the Government facilities. Specimen pick-up times will be negotiated after contract award. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Test request forms, preprinted with the appropriate Shipping Section details and account information. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.). Emergency transportation services shall be available 24 hours per day, seven days per week including Federal holidays. The estimated number of emergency transportations per facility per year is one (1). Response time for emergency transportation services shall be within 4 hours for those Government facilities within the metropolitan Chicago, Milwaukee, and Madison areas and 6 hours for the Tomah and Iron Mountain VA Medical Centers. Emergency response time refers only to the transportation of the specimen(s) and does not include the time for test performance. Specimen Testing The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment A. Contractor shall make available the following test information: Requisition form requirements Alphabetized test name list Test order code Specimen collection and preservation requirements Test method employed (indicate if testing performed in duplicate) and interpretations Test reference intervals adjusted for age, sex, or race, when required Test specific sensitivity, specificity, and interferences, when required Result code Test critical values, if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a Government facility Schedule of test performance (specific days of week indicated) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited) Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. Additional tests may be added to the contract through modification by the Contracting Officer. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials. Specimen Retention A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA and sent to the Contractor laboratory for testing and diagnostic evaluation shall be returned within 7 days after final diagnosis is reported. Reporting of Results The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information. A report of laboratory testing results must be transmitted as a printed copy to the dedicated printer at the ordering Government facility and when possible, through electronic host to host computer interface. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery via the dedicated printer is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the Telecommunication Requirements below. Each test report generated in hard copy form or through electronic transmission shall, at minimum, include the following information: Patient's full name Patient s identification number, e.g. social security number (SSN) Physician s name (if supplied) Government laboratory accession number (if supplied) Submitting facility name Submitting facility account number Patient's location (clinic/ward) (if supplied) Test(s) ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals (adjusted for age, sex or race, when appropriate) Toxic and therapeutic ranges, if applicable Flagged abnormal results Reference labora