Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-8 - HEALTHCARE FACILITY REGULATION › Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES › Rule 111-8-10-.06 - Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records

Current through Rules and Regulations filed through June 27, 2024
(1)
Laboratory Personnel
				Requirements
:
(a)
General
. The laboratory shall perform tests in only those
				categories, subcategories or procedures for which it is licensed and for which
				there is either a director, supervisor, or technologist having minimum
				qualifications as outlined for Clinical Laboratory Technologists in Rule
				111-8-10-.06(4).
				(Special personnel requirements for donor screening and plasmapheresis and
				whole blood donor centers are outlined in Rule
				111-8-10-.28). In addition, the
				following criteria shall be minimum personnel qualifications for the
				supervision of the categories and subcategories below:
1. Clinical Chemistry, Hematology,
				Immunohematology, Microbiology, Clinical Immunology and Serology: Supervisory
				requirements for these categories are those requirements for Clinical
				Laboratory Supervisor, outlined in Rule
				111-8-10-.06(3).
2. Exfoliative Cytology. For the purpose of
				these rules, exfoliative cytology is defined as that part of laboratory science
				dealing with the examination of cells obtained from human body fluids,
				surfaces, tissues, and other sources. This service must be provided by either a
				licensed physician who is certified or eligible for certification in anatomic
				pathology or cytopathology by the American Board of Pathology or the American
				Osteopathic Board of Pathology or by applicants who have a doctoral degree and
				whose special field is cytology. Unless the physician/Ph.D. also serves as
				cytology general supervisor, the supervisor must meet the minimum
				qualifications outlined in Rule
				111-8-10-.06(3)(b)5
				or current federal regulations of § 353 of the Public Health Service Act
				and Title 42 U.S.C.
				263 a, whichever is more stringent.
3. Anatomic Pathology. For the purpose of
				these rules, anatomic pathology is defined as the examination and diagnosis of
				human tissues whether removed during life or after death. It deals with the
				morphologic study of normal or abnormal structure of tissues. For the purpose
				of these rules, this definition includes performance of all autopsies including
				medical-legal, and forensic autopsies. The laboratory director, if not so
				qualified, shall engage the services of a licensed physician who is certified
				or eligible for certification in an anatomic pathology by the American Board of
				Pathology or the American Osteopathic Board of Pathology.
4. Oral Pathology. For the purpose of these
				rules, oral pathology is defined as a branch of anatomic pathology (see (a)3.
				above). The laboratory director, if not qualified in oral pathology, shall
				engage the services of a licensed physician who is certified or eligible for
				certification in anatomic pathology by the American Board of Pathology or the
				American Osteopathic Board of Pathology or those of a dentist, licensed in the
				State of Georgia, who is certified or eligible for certification by the
				American Board of Oral Pathology.
5. Radiobioassay. For the purposes of these
				rules, radiobioassay is defined as the diagnostic in vivo study involving
				administration of radioactive materials to a human subject (with the exclusion
				of organ scanning). Laboratories performing tests in radiobioassay must have a
				director or supervisor who is a physician working in Georgia in the field of
				radiobioassay at the time of the adoption of these rules and regulations or is
				qualified and trained in nuclear medicine or radioisotopic pathology and/or is
				certified or eligible for certification by the American Board of Nuclear
				Medicine or the subspecialty of radioisotopic pathology by the American Board
				of Pathology or the American Osteopathic Board of Pathology. If not so
				qualified, the laboratory must engage the services of one so qualified:
(i) In vitro studies of organs, tissues, or
				fluids, using radioactive materials are considered in the licensed category of
				Clinical Chemistry (special) and may be handled by those appropriately
				qualified in this area.
(ii) For
				both in vivo and in vitro studies, all users of radioactive material must
				comply with Georgia "Rules and Regulations for Radioactive Material", Chapter
				290-5-23.
6.
				Qualifications for test areas not included in above general categories may be
				established as Department policy.