Section 1200-06-03-.08 - PATIENT TEST MANAGEMENT(1) Condition: Each laboratory must employ and maintain a system that provides for proper patient preparation; proper specimen collection, identification, preservation, transportation, and processing; and accurate result reporting. This system must assure optimum patient specimen integrity and positive identification throughout the testing process and must meet the standards of this rule as they apply to the testing performed.(a) Standard: Procedures for specimen submission and handling: 1. The laboratory must have available and must follow written policies and procedures for each of the following, if applicable: methods used for the preparation of patients; specimen collection; specimen labeling; specimen preservation; and conditions for specimen transportation and specimen processing.2. Such policies and procedures must assure positive identification and optimum integrity of patient specimens from the time the specimens are collected until testing has been completed and the results reported.3. If the laboratory accepts referral specimens, written instructions must be available to clients and must include, as appropriate, the information specified in paragraph (a) 1. of this section.4. Oral explanation of instructions to patients for specimen collections, including patient preparation, may be used as a supplement to written instructions where applicable.(b) Standard: Test Requisition. 1. The laboratory must perform tests only at the written or electronic request of an authorized person. The laboratory must maintain the written authorization or documentation of efforts made to obtain a written authorization.2. Outpatient laboratory testing in Tennessee hospitals may be ordered by the following:(i) Any licensed Tennessee practitioner who is authorized to do so by T.C.A. § 68-29-121;(ii) Any out of state practitioner who has a Tennessee telemedicine license issued pursuant to rule 0880-02-.16; or(iii) Any duly licensed out of state health care professional as listed in T.C.A. § 68-29-121 who is authorized by his or her state board to order outpatient laboratory testing in hospitals for individuals with whom that practitioner has an existing face-to-face patient relationship as outlined in rule 0880-02-.14(7)(a) 1., 2., and 3.3. Records of test requisitions or test authorizations must be retained for a minimum of two (2) years. The patient's chart or medical record, if used as the test requisition, must be retained for a minimum of two (2) years and must be available to the laboratory at the time of testing and available to the Board upon request.4. The laboratory must assure that the requisition or test authorization includes all of the following: (i) The patient's name or other unique identifier.(ii) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for utilizing the test results or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminent life threatening laboratory results or panic values;(iii) The test(s) to be performed;(iv) The date of specimen collection;(v) For PAP smears, the patient's last menstrual period, age or date of birth, and indication of whether the patient had a previous abnormal report, treatment or biopsy, and(vi) Any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results.(c) Standard: Test Records: 1. The laboratory must maintain a record system to ensure reliable identification of patient specimens as they are processed and tested to assure that accurate test results are reported. These records must identify the personnel performing the testing procedure.2. Records of patient testing, including, if applicable, instrument printouts or electronic data storage, must be retained for at least two (2) years. Immunohematology and transfusion records must be retained for no less than five (5) years.3. The record system must provide documentation of information specified in Rule 1200-06-03-.08(1)(b) 3. (i) through (vi) and include all of the following:(i) The patient identification number, accession number, or other unique identification of the specimen;(ii) The date and time of specimen receipt into the laboratory;(iii) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability and(iv) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s), which are necessary to assure proper identification and accurate reporting of patient test results.(d) Standard: Test report. 1. The results of a laboratory test shall be reported promptly to the authorized person, the individual responsible for using the test results, the laboratory initially requesting the test, or other person required by statute or rule to receive test results.2. The original report or an exact duplicate of each test report, including final and preliminary reports, must be retained by the testing laboratory for a period of at least two (2) years after the date of reporting. This information may be maintained as part of the patient's chart or medical record which must be readily available to the laboratory and to the Board upon request. (i) Immunohematology reports must be retained by the laboratory for a period of no less than five (5) years.(ii) Pathology test reports must be retained for a period of at least ten (10) years after the date of reporting.3. The laboratory must have adequate systems in place to report results in a timely, accurate, reliable and confidential manner, and ensure patient confidentiality throughout those parts of the total process that are under the laboratory's control.4. Laboratories must comply with Rule 1200-14-01-.41, Reports of Sexually Transmitted Diseases, which states, in part, that the following diseases are declared to be sexually transmitted diseases and, upon their diagnosis or treatment, are subject to reporting requirements as designated in T.C.A. § 68-10-101. (i) Acquired Immune Deficiency Syndrome (AIDS) I(iii) Syphilis (by stage) I(iv) Chlamydia trachomatis(v) Nongonococcal Urethritis/NGU (Number of Cases)(vi) Human Immunodeficiency Virus - all types Confidential (opaque envelope) report required. All information and reports concerning persons infected with sexually transmitted diseases shall be confidential and shall be inaccessible to the public.
5. The test report must indicate the name and address of the laboratory location at which the test was performed, the test performed, the name of the medical laboratory director, the test result and, if applicable, the units of measurement.6. The laboratory must indicate on the test report any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.7. Pertinent "reference, or "normal" ranges, as determined by the laboratory performing the tests must be available to the authorized person who ordered the tests or the individual responsible for utilizing the test results.8. The results or transcripts of laboratory tests or examinations must be released only to authorized persons or the individual responsible for utilizing the test results.9. The laboratory must develop and follow written procedures for reporting imminent life-threatening laboratory results or "critical values." In addition, the laboratory must immediately alert the individual, entity requesting the test or the individual responsible for utilizing the test results.10. The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, in accordance with Rule 1200-06-03-.09(4), as applicable, the performance specifications of each method used to test patient specimens. In addition, information that may affect the interpretation of test results, such as test interference must be provided upon request.11. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results.12. The original report or exact duplicates of test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility.(e) Standard: Referral of specimens - A laboratory must refer specimens for testing only to an in state laboratory possessing a current Tennessee license and current CLIA certification, or an out of state laboratory having a CLIA certification authorizing the performance of testing in the specialty or subspecialty of service for the level of complexity in which the referred test is categorized. The laboratory shall maintain a copy of the current CLIA certification for the referral or reference laboratory.1. The referring laboratory must not revise results or information directly related to the interpretation of results provided by the testing laboratory.2. The referring laboratory may permit each testing laboratory to send the test result directly to the authorized person who initially requested the test. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report.3. The authorized person who orders a test or procedure must be notified by the referring laboratory of the name and address of each laboratory location at which a test was performed.Tenn. Comp. R. & Regs. 1200-06-03-.08
Original rule filed October 26, 1979; effective December 10, 1979. Repeal filed May 3, 1995; effective July 17, 1995. New rule filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed October 11, 2004; effective December 25, 2004. Amendment filed August 8, 2005; effective October 22, 2005.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-105, 68-29-107, 68-29-121, and 68-29-124.