§ 31-22-4 - Examination of human specimens - Georgia Statutes

O.C.G.A. 31-22-4 (2010)
31-22-4. Examination of human specimens

(a) A clinical laboratory shall examine human specimens only at the request of a licensed physician, dentist, or other person authorized by law to use the findings of laboratory examinations.

(b) All specimens accepted by a clinical laboratory shall be tested on the premises or in another laboratory or location under the responsibility of the director unless forwarded to another properly licensed clinical laboratory.

(c) The results of a test shall be reported only to or as directed by the licensed physician, dentist, or other authorized person requesting such test. Such reports shall include the name of the director and the name and address of the clinical laboratory in which the test was performed.

(d) No person shall represent or maintain an office or specimen collection station or other facility for the representation of any clinical laboratory situated in this state or any other state which makes examinations in connection with the diagnosis and control of diseases unless the clinical laboratory so represented shall meet or exceed the minimum standards issued by the department pursuant to this chapter and the regulations issued under this chapter.

(e) The department may require laboratories to show evidence that specimens shipped through the mails and accepted by them for analysis are sufficiently stable for the determinations requested.

(f) Records involving clinical laboratory services and copies of reports of laboratory tests shall be kept for the period of time and in the manner prescribed by the department.

(g) Each clinical laboratory shall establish its own quality assurance program designed to ensure testing accuracy and in accordance with the rules and regulations promulgated by the department. The quality assurance program shall also include the use of, where applicable, calibration and control practices designed to ensure accurate and reliable test processes.

(h) Subsections (a) through (c) of this Code section shall not apply to the taking, examining, or testing of specimens by a clinical laboratory or its personnel solely in order to test the accuracy or sufficiency of its procedures or in order to make improvements in such procedures.