Tenn. Comp. R. & Regs. 1200-06-03-.08 - Standards and Requirements for Patient Test Management Systems

Standards and Requirements for Patient Test Management Systems

Each laboratory must maintain a system that sets a standard for properly preparing patient specimen, properly collecting specimen, and accurately reporting results. The standard set for proper handling of specimen shall include preparation of patients, specimen collection, specimen labeling, specimen preservation and conditions for specimen transportation and processing. These policies must ensure that specimens are positively identified and the integrity of the patient from whom the specimen is collected is protected from the time of collection until results are reported.

The Lab will perform tests only at the written or electronic request of an authorized person, which includes a licensed Tennessee practitioner, a licensed practitioner in Tennessee telemedicine, or a licensed health care professional.  Records of test requisitions, test authorizations, or patient records must be retained for two years. Test requisitions must include a way to identify the person, their address, and the individual who will be using the results or the name and address of the lab submitting the specimen in case someone needs to report imminent and life threatening laboratory results. The test requisition shall also include tests to be performed; the date of the specimen collection; and for PAP smears, the patient’s last menstrual period, age, and any abnormal reports, treatment, or biopsies.

The laboratory must also maintain a record keeping system in order to ensure that patient’s specimens are properly identified as they are processed and tested. These records must be retained for at least two years with immunohematology and transfusion records kept for at least five years. Documentation for this system must include the unique identification of the specimen, the date and time the laboratory received the specimen, the condition of specimen that do not meet the lab’s criteria, and records of all specimen testing including who performed the test.

Laboratory results shall be reported in a timely, accurate manner to an authorized person, whoever requested the test, or a person required by statute to receive the results. The report shall be retained for two years after the date of reporting with immunohematology reports kept for at least five years and pathology test reports for at least ten. The confidentiality of the patient shall be maintained. The following diseases shall be reported upon diagnoses as stated in Tenn. Code Ann. § 68-x10-101:

1.      (i)  Acquired Immune Deficiency Syndrome (AIDS) I

2.      (ii)  Gonorrhea I

3.      (iii)  Syphilis (by stage) I

4.      (iv)  Chlamydia trachomatis

5.      (v)  Nongonococcal Urethritis/NGU (Number of Cases)

6.      (vi)  Human Immunodeficiency Virus - all types

Any information that concerns a person infected with sexually transmitted diseases shall be confidential and inaccessible to the public. Reports shall include the name and address of the lab’s location where the test was performed, the test that was performed, the name of the lab director, the result, if applicable, the unit of measurements. The report must include the condition of specimen that do not meet the criteria of the lab, and “normal” ranges pertinent to rest results. The lab must develop procedures for reporting life threatening results or results that have “critical values” to the person requesting the test or responsible for utilizing the test. Labs may only refer specimen to labs that have current Tennessee licenses with a current CLIA certification or out of state labs that have CLIA certification.