Title 31, Chapter 22, Section 4
( 31-22-4)
(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. |