Thyroseq Anatomic Pathology Lab Services
Please include commitment letter stating that you can handle what's in the statement of work, capability statement, and active UEI SAM registration. Description of Services: Statement of Work Contract... Please include commitment letter stating that you can handle what's in the statement of work, capability statement, and active UEI SAM registration. Description of Services: Statement of Work Contractor shall provide laboratory services to include specimen packaging and transport of specimens to its laboratories; pre-analytic processing as defined in its Laboratory Testing Manual; performing test for Thyroseq molecular testing for SFVAMC patients. After the sample is collected from the patient and received in the Anatomic pathology laboratory, the container is labeled with patient name, accession number along with the completed requisition form with patient information and type of tests. The correct patient’s name, accession number and proper tests are always verified by SFVAMC staff for each request. Clinical molecular Thyroseq testing is performed to determine if surgery is appropriate for abnormal thyroid nodules. Results from this will frequently determine a patient has low risk of malignancy and the patient will not have to undergo surgery. This test is important in preventing overtreatment, avoiding potential surgical complications, and saving medical center resources. Place of Performance: Services shall be provided at the outside laboratory. Pricing Instructions: The total cost shall base on number of tests submit to outside laboratories for processing including the courier service cost provides by Contractor. There is an increase of specimens received in Pathology laboratory for processing from other clinical services within the SFVAMC. The tests are submitted to be performed by outside laboratory and accurate results mean increased satisfaction which is more effective for our veterans care. There is an increase of specimens received in the anatomic laboratory and these tests are more important for our veterans care. The SFVAMC pathologists evaluate the tissue and determine the best type of testing depending on the amount of tissue available for processing and testing. The total monthly cost depends on number of thyroid cases received within the pathology laboratory which is approximately 1-3 tests in a month. It is difficult to estimate the exact number of tests required because this depends on the number SFVAMC patients diagnosed with abnormali of thyroid nodules. 1. SCOPE OF WORK 1 Contractor shall provide laboratory shipping materials to Fed-Ex specimens to its laboratory; preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, shipping and result interpretation. The contractor shall provide the following services: 1.1.2. Provide all necessary shipping requirements, not limited to the following: Requisition/order forms Specimen/slide holders Special instructions if any to transport paraffin blocks/slides safely Current list of tests with reference ranges and specimen requirements Fedx clinical lab packs All forms, including Chain of Custody forms 1.1.3 Provide specimen shipping material as defined in the contract. 1.1.4 Transport samples in such a manner as to ensure the integrity of the specimen. 1.1.5 Contractor shall supply any special preservatives required for specimen preservation if required. 1.1.6 Analyze samples to perform Thyroseq testing. Thyroseq test looks for unique genetic alterations in patient thyroid nodules to determine malignant potential and whether surgery is appropriate. 1.1.7 Routine test results shall be faxed and reported within 2 to 3 weeks. 1.1.9 Consult with Laboratory on test results by telephone as needed. 1.1.10 Provide SFVAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests. 1.1.11 Billing and test report summaries shall begin the first day of the month and include the last day of the month. 2. LICENSING AND ACCREDITATION. 2.1. Contractor shall have all licenses, permits, accreditation and certificates required by law. 2.1.1. All testing facilities providing laboratory services under the contract must possess a valid state license, CLIA license and full accreditation from the College of American Pathologists (CAP). Contractor shall provide evidence of such accreditation upon receipt of a written request. 2.1.2 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst. 3. CHANGES. 3.1. Contractor shall be responsible for assuring all subcontractors have appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the CO and the COR of any change of subcontract laboratory. Any change shall be submitted to the CO for review and approval. 3.2. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee. 3.3. The VA may need to add test to the test list during the contract term without contract modification. This may be due to a change or discontinued test previously done by another laboratory. Requests may be made for pricing, specimen requirements and methodology. The CO, COR or designee will make the final decision on the appropriateness of moving the test to the contractor. 4. PROCEDURE GUIDANCE 4.1. The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the COR, or authorized laboratory representative. 4.1.1. 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 (per all applicable regulatory agency [RA] guidelines). The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer’s representative. 4.1.2. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's 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. 4.1.3. The Contractor shall notify the SFVAMC COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested. 4.1.4. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. 4.1.5. The Contractor shall contact the SFVAMC COR to coordinate the furnishing and delivery of specimen collection and shipping materials to Fed-Ex tissue blocks and slides. 5. TRANSPORTING SPECIMENS. 5.1. The Contractor shall provide all necessary shipping material to transport specimens/paraffin blocks/glass slides. 6. TEST RESULTS. 6.1. The Contractor shall provide routine test results to the ordering SFVAMC facility within 2 to 3 weeks. 6.2. Telephone Consultation. The Contractor shall consult with the SFVAMC COR, requesting Clinician or designee at the VAMC by telephone as needed. 6.3. The Contractor shall immediately telephone the respective SFVAMC COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life threatening condition. SLIDES. 7.1 The Contractor shall return all blocks and slides to SFVAMC for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to SFVAMC. 8. STORAGE OF SPECIMENS. 8.1 The Contractor shall store all specimens as required by regulatory agencies (RA) 8.1.1 Upon request by the SFVAMC COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. 8.1.2. In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed: clinical specimens seven (7) days, surgical specimens six (6) months, cytology and histopathology slides indefinitely; and paraffin blocks for five (5) years. 9. MONTHLY TESTS SUMMARY. 9.1 The Contractor shall provide to SFVAMC a cumulative (year-to-date) and monthly report of all tests received during the month and for all outstanding results. The report will also include turn around statistics, cost per test (including any additional charges) and specimen or testing issues. 10. SERVICE. 10.1 The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times excluding weekends and holidays. 10.2 The contractor shall include names and telephone numbers of technical Directors available for consultation. 10.3 Contractor shall assign a specific local account representative to each VA facility. 10.4 Contractor shall advise facility of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes are made. 10.5 In the event that the contractor changes the assay procedure of a critically important component of an assay the contractor shall notify the SFVAMC COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes. 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 CO/COR. 10.5.1. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee. 11.1 PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT (QI). 11.1.1 To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of contract: 11.1.2 Indication of average monthly volume of specified tests in the Schedule that the laboratory performs. 11.1.3 For quality purposes routinely performed in duplicate should be indicated. TAT and accurate in test results. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. 11.1.4 Proficiency testing data shall include a list of tests outside of the acceptable range for past 2 years. The contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government upon prior written notice and during normal business hours during the life of the contract. 11.1.5 Maintains licensing and registration information kept current. 11.1.6 Privacy, Confidentiality and HIPAA. Contractor tenchnician and pathologists comply with all laws, regulation, policies and procedures relating to Privacy, Confientiality and HIPPA. . 12. HOURS OF OPERATION. 12.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract 8 to 10 hours a day, 5 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR. 13. RECORDS. 13.1. 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. 14. RELEASE OF MEDICAL INFORMATION. 14.1 The Contractor shall not release any medical information obtained during the course of this contract to anyone outside the SFVAMC, unless authorized in writing by the SFVAMC COR and the patient, as required by applicable law. 15. SAFETY. 15.1 The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required. 16. END OF CONTRACT PERFORMANCE. 16.1 At the end of the period of contract performance, the participating medical treatment facility will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractor provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days. 17. GENERAL DEFINITIONS. Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to each VA facility upon request. Frozen Section. A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination. Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility. Reference Value. A range of test values expected for a designated population of individuals. Slides. Glass surface containing biological material to be analyzed. Specimen. A body fluid or tissue sample removed for medical examination and analytical testing. Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing. Tests. Diagnostic assays to evaluate patients with history of abnormal thyroid nodules. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so. 18. SAMPLE PREPARATION. 18.1 Each VA facility will provide laboratory specimens prepared according to the contractor's laboratory specimens according to industry standards. Contractor shall supply the transportation kits and any special preservatives required for specimen preservation and transport when necessary. All the blocks should be returned to SFVAMC after testing is complete.
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