TITLE 31 HEALTH

Section 22. Clinical Laboratories, 31-22-1 through 31-22-13.

ARTICLE 3 OFFENSES

31-22-1. Definitions.

As used in this chapter, the term:

1. "Board" means the Board of Community Health.
2. "Clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immunohematological,hemato- logical, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis of, recommendation of treatment of, or for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings; the term "clinical laboratory" shall include specimen collection stations and blood banks which provide through their ownership or operation a system for the collection, processing, or storage of human blood and its component parts unless such human blood and its component parts are intended as source material for the manufacture of biological products and regulated by the Center for Biologics Evaluation and Research (CBER) within the federal Food and Drug Administration; the term "clinical laboratory" shall include tissue banks which procure, store, or process human or animal tissues designed to be used for medical purposes in human beings. The term "clinical laboratory" shall not include laboratories which are nondiagnostic only and regulated pursuant to the federal Clinical Laboratory Improvement Amendments (CLIA) whose sole function is to perform examination of human blood or blood components intended as source material for the manufacture of biological products.

   (2.1) "Commissioner" means the commissioner of community health.

   (2.2) "Department" means the Department of Community Health.

3. "Director" means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures for testing and the reporting of results.
4. "Person" means any individual, firm, partnership, association, corporation, the state or any municipality or other subdivision thereof, or any other entity whether organized for profit or not.
5. "Specimen collection station" means a place having the primary purpose of either collecting specimens directly from patients or bringing specimens together after collection for the purpose of forwarding them either intrastate or interstate to a clinical laboratory for examination.
6. "Supervisor" means an assistant director and a person who, under the general supervision of a clinical laboratory director, supervises technical personnel and performs tests requiring special scientific skills.
7. "Technician" means any person other than the clinical laboratory director, supervisor, technologist, or trainee who functions under the supervision of a clinical laboratory director, supervisor, or technologist and performs only those clinical laboratory procedures which require limited skill and responsibility and a minimal exercise of independent judgment. The degree of supervision by the clinical laboratory director, supervisor, or technologist of a technician shall be determined by the director, supervisor, or technologist based on:
   1. The complexity of the procedure to be performed;
   2. The training and capability of the technician; and
   3. The demonstrated competence of the technician in the procedure being performed.
8. "Technologist" means a person who performs tests which require the exercise of independent judgment and responsibility, with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which he is qualified by education, training, and experience.

(Ga. L. 1970, p. 531, § 2; Ga. L. 1971, p. 247, § 1; Ga. L. 1982, p. 1081, §§ 1, 2, 6, 7; Ga. L. 1991, p. 94, § 31; Ga. L. 1991, p. 349, § 1; Ga. L. 2005, p. 1190, § 1/SB 51; Ga. L. 2009, p. 453, § 1-5/HB 228; Ga. L. 2011, p. 705, § 4-16/HB 214; Ga. L. 2016, p. 318, § 1/SB 273; Ga. L. 2017, p. 547, § 1/HB 210.)

The 2011 amendment, effective July 1, 2011, added paragraphs (2.1) and (2.2).

The 2016 amendment, effective July 1, 2016, added the last sentence in paragraph (2).

The 2017 amendment, effective July 1, 2017, in the middle of the first sentence of paragraph (2), deleted "shall include" preceding "blood banks", and substituted "unless such human blood and its component parts are intended as source material for the manufacture of biological products and regulated by the Center for Biologics Evaluation and Research (CBER) within the federal Food and Drug Administration; the term 'clinical laboratory' shall include" for "as well as".