Provide STAT laboratory testing service and after hour lab testing for the VA Northern Indiana Healthcare System (VANIHCS), Fort Wayne, Indiana campus regular working hours laboratory testing service and transfusion services to include all testing required to provide compatible blood and/or blood products for transfusion at the VANIHCS facility as well as appropriate follow up testing and investigation for suspected transfusion reactions. - Contractor shall provide laboratory services for laboratory testing after the VANIHCS regular hours. Currently, this includes the hours of 11:00 pm and 6:00 am Monday through Friday, weekends, and Federal Holidays between the hours of 3:00 pm and 7:00 am. - Contractor is to provide STAT testing which cannot be performed at the VANIHCS laboratory. STAT testing will be available 24 hours a day, 7 days a week. - Contractor is to provide transfusion service to include all pre and post transfusion testing required to insure a compatible blood product is available for transfusion at the VANIHCS facility. This service will be provided after the VANIHCS regular hours. Currently, this includes the hours of 11:00 pm and 6:00 am Monday through Friday and weekends and Federal Holidays between the hours of 3:00 pm and 7:00 am. - Contractor will provide appropriate follow up testing and investigation for suspected transfusion reactions associated with those blood products provided by the contractor for transfusion at the VANIHCS facility. Service is to include pickup and transport of specimens to the reference laboratory; preanalytic processing as defined in its laboratory users manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. The contractor must provide the following services: a. Contractor must provide: Requisition forms Special instructions Current list of tests with reference ranges and specimen requirements Current critical value list b. Provide specimen pick up services as defined in the contract. c. Transport samples in such a manner as to ensure the integrity of the specimen. d. Analyze the samples. e. Routine test results generally shall be reported within 24 hours of specimen pickup. The submitting laboratory recognizes that certain test procedures shall require a longer turnaround time (TAT) than 24 hours. The contractor is required to provide a list of those tests that routinely have a TAT in excess of 24 hours. Test results shall be received no later than 12 hours after completion of a test. f. STAT test results shall be reported within 2 hours or less of the telephone request for STAT service unless otherwise stated by the reference lab as not available. Critical value test results shall be immediately reported to VANIHCS. (1) Reporting during regular working hours - STAT and/or Routine test results are printed/faxed to VANIHCS Pathology and Laboratory Medicine service on a contractor provided printer or designated fax machine. (2) Reporting during other than regular working hours - STAT and/or Routine test results are printed/faxed to VANIHCS Emergency Department on a contractor provided printer or designated fax machine. (3) Critical value test results are reported by telephone to Pathology & Laboratory Medicine Service during regular working hours at 260-460-1422 and to the Medical Officer of the Day during other than regular working hours at 260-460-1337. g. Consult with the VANIHCS Pathology & Laboratory Medicine Service regarding test results as needed. h. Provide VANIHCS a means of communication to permit immediate inquiry regarding the status of pending tests. i. Transfusion Services will be provided during other than regular working hours. When the blood and/or blood products are ready for transfusion, the reference laboratory will deliver the compatible units to the VANIHCS Emergency Room. 2. Licensing and Accreditation (Mandatory Criteria). a. Shall have all licenses, permits, accreditation and certificates required by law. b. Shall be accredited by the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), or the Joint Commission. c. Accreditation by the Centers for Disease Prevention and Disease Control (CDC) is required if the contractor is engaged in interstate commerce. d. Laboratory Director is a licensed physician or a licensed bioanalyst. 3. Changes. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the contracting officer. Contractor shall be responsible for finding an outside laboratory with appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify laboratory of any change in subcontract laboratory. Any changes shall be submitted to the Contracting Officer Technical Representative (COTR) for review and approval. 4. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received via a contractor provided printer or VANIHCS fax if a printer is not available or by request of VANIHCS. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum contain the following information: a. Patient's full name b. Social Security number or Date of Birth c. Medical Record number or unique identification code d. Physician Name e. Patient Location f. Date/Time specimen received by the reference lab g. Test Ordered h. Date/Time of specimen collection i. Date test completed j. Test result k. Flag abnormals l. Reference range m. Toxic and/or therapeutic range when applicable n. Testing laboratory specimen identifier o. Name of Testing Laboratory (contractor and/or subcontractor) p. Type of Specimen q. Critical value test reports shall include documentation of the person notified at VANIHCS, the date and time of notification and the name of the person at the contract laboratory completing the notification. r. Any additional comments related to test, provided by the submitting lab s. Any other information the laboratory has that may indicate a questionable validity of test results. t. Unsatisfactory specimen shall be reported with regard to its suitability for testing. u. Documentation for all corrected reports to include the originally reported result. 5. Quality Control. To ensure proper handling and test performance, the contractor shall provide the following information upon request during the life of the contract: a. For quality purposes, tests routinely performed in duplicate should be indicated. b. Indication of average monthly volume of specified tests in Part I that the laboratory performs. c. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. d. Proficiency testing data shall include a list of tests outside the + 2SDI range for the past 2 years. Contractor shall notify laboratory of any tests with unsatisfactory proficiency testing during the contract period. e. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites. f. The VANIHCS facility will maintain an Internal Quality Control program to monitor the quality of test results received from the contractor. Unidentified split specimens may be sent periodically to the contractor for testing. A split specimen may also be sent to another reference laboratory for comparison. The laboratory sending split specimens shall notify the contractor of such specimens only for the purpose of nonpayment. Split specimen testing shall not exceed 1 percent of the total annual test volume and shall be processed free of charge by the contractor. g. The contractor(s) facilities, methodologies (defined as the principle of the method and the references), and quality control procedures may be examined by representatives of the VANIHCS at any time during the life of the contract. 6. Service. a. The contractor shall provide telephone number(s) and contact person(s) to be used by the VANIHCS to make specimen problem inquiries and problem solving at all times, including weekends and holidays. NOTE: Also, include names and telephone number(s) of Technical Director(s) and Pathologist(s) available for consultation. b. 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 VANIHCS upon adverse action by a regulatory agency. c. Contractor shall submit with this proposal a percentage discount off the specified published price list for all tests other than those detailed in Part I. Any new tests or tests sent to a subcontractor should be covered under the discounts. d. Contractor shall assign a specific local account representative. e. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced. In the event the contractor changes the assay procedure or a critically important component of an assay (e.g. an antibody, purified antigen, etc), the contractor shall notify the contracting officer and the laboratory director prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the contracting officer. The contractor is liable for excess procurement costs. 7. Testing Methodology. Testing methodology for a new test must be defined in the laboratory users manual. 8. Bench Mark Reference. VANIHCS may submit, as part of the proposal evaluation process, a number of specimens for analysis as a bench mark reference. These tests shall be performed and reported without charge to VANIHCS. 9. Sample Preparation. The VANIHCS shall provide laboratory specimens prepared according to the contractor's laboratory users manual, identified and labeled for testing. The contractor shall provide an adequate supply of requisition forms, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory users manual. The contractor shall be responsible for transporting and storing specimens for at least 7 days from the completed date of testing in such a manner as to ensure the integrity of the specimen where applicable. Contractor shall supply any special preservatives required for specimen preservation. 10. Location. Address and telephone number for the VANIHCS Fort Wayne campus laboratory is: 2121 Lake Avenue Building 1, Room 240 Fort Wayne, IN 46805 (260) 460-1422 NAICS Code, 621511, size standard $13.5 million. Contractor shall furnish all labor, equipment, and materials, and facilities to provide Lab Test described in the solicitation. The solicitation will be available on or about December 29, 2008. For a copy of the solicitation please contact the Administrative Contract Officer, Matthew Hamilton at 317-988-1853 or
[email protected]. Quotations are due no later than 3:30 PM (EST) on January 16, 2009. Mail or deliver to Matthew Hamilton, VISN 11 Contract Service Center (90CSC), Department of Veterans Affairs, 1481 W. 10th St., Indianapolis, IN 46202. Contractors MUST be registered in Central Contractor Registration (CCR) at ccr.gov in order to be awarded the contract