Title 31, Chapter 22, Section 2
( 31-22-2)
(a) No clinical laboratory shall be operated without a license
issued and in force pursuant to this chapter; provided, however,
that the department may promulgate rules and regulations by which a
facility or a part of a facility in which laboratory testing is done
may qualify for exemption from licensure when only specific tests or
techniques, designated by the department and used for screening and
monitoring purposes only, are performed. (b) Application for licenses shall be made to the Department of
Human Resources on forms prescribed by it. The application shall
indicate the categories of procedures to be performed and shall
contain such additional information as the department may require.
Each application shall be accompanied by a nonrefundable fee
prescribed by the department. (c) The license applied for shall be issued if the department finds
that all requirements are met or, in the case of a new clinical
laboratory not yet in operation, that the owner is in a position to
meet them. A license shall authorize the performance of one or more
procedures or categories of procedures and shall be valid for one
year from the date of issue unless sooner canceled, suspended, or
revoked. (d) A clinical laboratory license may be denied, revoked, suspended,
limited, or renewal thereof denied on the following grounds: (1) Making false statements of material information on an
application for clinical laboratory license or any other documents
required by the department; (2) Permitting unauthorized persons to perform technical
procedures or to issue or sign reports; (3) Demonstrating incompetence in the performance or reporting of
clinical laboratory examinations and procedures; (4) Performing a test for or rendering a report to a person not
authorized by law to receive such services; (5) Referring a specimen for examination to a clinical laboratory
in this state which has not been licensed pursuant to this chapter
unless such referral laboratory is exempted from coverage of this
chapter; (6) Making a report on clinical laboratory work actually performed
in another clinical laboratory without designating the name of the
director and the name and address of the clinical laboratory in
which the test was performed; (7) Lending the use of the name of the licensed clinical
laboratory or its personnel to an unlicensed clinical laboratory; (8) Violating or aiding in the violation of any provision of this
chapter or the rules or regulations promulgated hereunder; or (9) Violating any other provisions of law applicable to the proper
operation of a clinical laboratory.
(e) Each clinical laboratory shall have a licensed director. An
individual shall be permitted to direct no more than three clinical
laboratories. No individual shall function as a director of a
clinical laboratory unless he is a physician licensed to practice
medicine and surgery pursuant to Chapter 34 of Title 43; provided,
however, that the director of a clinical laboratory restricting its
practice to dental pathology may be either a physician licensed to
practice medicine and surgery or a dentist licensed to practice
dentistry; provided, further, that the board may promulgate rules
and regulations which authorize persons who possess doctorate
degrees in biology, microbiology, and related fields to be directors
of clinical laboratories when the proper circumstances and
qualifications are present. (f) A clinical laboratory license shall specify on the face thereof
the names of the owner and director, procedures or categories of
procedures authorized, the location at which such procedures are to
be performed, and the period for which the license is valid. The
license shall be displayed at all times in a prominent place where
it may be viewed by the public. (g) Licenses issued pursuant to this chapter shall be subject to
renewal in accordance with rules and regulations of the department. (h) The board shall fix and publish and from time to time revise
schedules of fees for applications and renewals. Such fees for
clinical laboratory licenses shall be in amounts calculated to
defray the costs of necessary inspections, evaluations, and
investigations related thereto. (i) The board shall promulgate rules and regulations which specify
minimum standards for laboratory supervisors; provided, however,
that nothing in this chapter shall be construed to affect any
director, supervisor, technologist, or technician who is holding any
such position on July 1, 1970. (j) For the purposes of licensure, specimen collection stations
which have a parent clinical laboratory licensed by the State of
Georgia may be considered by the department to be part of that
laboratory. |