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-.03 - Definitions

Current through Rules and Regulations filed through June 27, 2024
Unless a different meaning is required by the context, the
				  following terms as used in these rules and regulations shall have the meaning
				  here in after respectively ascribed to them:
(a)
Analyte
means a substance or
				constituent for which the laboratory conducts testing;
(b)
Board
means the Board of
				Community Health of the State of Georgia;
(c)
Clinical Laboratory
means a
				facility for the biological, microbiological, serological, chemical,
				immunohematological, hematological, 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.
(d)
CLIA-exempt state
means a
				state where the Centers for Medicare & Medicaid Services (CMS) has
				determined that the state has enacted laws/rules relating to laboratory
				requirements that are equal to or more stringent than CLIA requirements. All
				laboratories subject to state licensure will be considered as "CLIA exempt"
				where the state has been determined to be CLIA exempt;
(e)
Commissioner
means the
				Commissioner of the Department of Community Health of the State of
				Georgia;
(f)
Department
means the Georgia Department of Community
				Health;
(g)
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;
(h)
Evaluation Program
means a
				state-conducted or state-approved proficiency testing program;
(i)
Facility
means a building,
				structure, institution, place, or entity, which may be fixed or
				mobile;
(j)
Laboratory
				Advisory Council
means the Clinical Laboratory, Blood Bank and Tissue
				Bank Committee authorized and required by law and appointed by the
				Board;
(k)
Laboratory
				Test
means any examination and/or manipulation performed on a specimen
				produced by the human body, by procedures such as phlebotomy or blood diverted
				from a normal or life-sustaining circulatory path, or in vivo testing of body
				fluids for the purpose of diagnosis, treatment, monitoring or the assessment of
				the health of human beings;
(l)
Limited specialty laboratory
or
limited laboratory
				specialty
means a clinical laboratory, or part of a clinical laboratory,
				in which testing is restricted (limited) to a designated category or
				subcategory, including but not necessarily limited to the following examples:
				cytology, histology, tissue banking, special chemistries (radio bioassay, blood
				gases, toxicology, etc.), cytogenetics and histocompatibility;
(m)
Other Personnel
means
				non-technical personnel who may be employed in the laboratory such as aides,
				clerks, etc. These persons may assist laboratory technical staff, but do not
				themselves qualify as technical staff or perform tests;
(n)
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;
(o)
Pertinent Laboratory
				Experience
means full time or equivalent work in a clinical laboratory,
				directing, supervising or performing tests in all categories, or, when limited
				to laboratory specialty(ies), work is restricted to that
				category/subcategory;
(p)
Plan of Correction
means a written plan submitted by the
				laboratory director, owner, or other controlling authority, for approval by the
				Department. The plan shall identify the existing noncompliance of the
				laboratory and the proposed procedures, methods, means and reasonable period of
				time needed to correct the noncompliance;
(q)
Point of Care Technician
means a medical professional person subject to these rules, who has received
				special training in point of care testing as defined by these rules. Medical
				professional staff authorized to perform point of care testing are limited to
				registered professional nurses, certified nurse practitioners, licensed
				practical nurses, certified respiratory care professionals, physician
				assistants, certified paramedics, certified emergency medical technicians,
				perfusionists, laboratory technologists, laboratory technicians and certified
				cardiovascular technologists, radiologic technologists certified by a
				professional credentialing organization approved by the Department, and
				phlebotomists, certified by a professional credentialing organization approved
				by the Department;
(r)
Point
				of Care Testing
means testing performed in the immediate proximity of
				the patient. All point of care testing must be approved by and under the
				supervision of a Georgia-licensed laboratory, unless the test site meets the
				requirements for exemption. All such point of care testing shall be approved
				only in the specialties for which the laboratory holds a license. Testing shall
				be limited to procedures which meet all current Georgia rules for quality
				control, quality assurance and Point of Care Testing personnel requirements.
				Point of Care Testing is exclusive of screening and monitoring tests;
(s)
Quality Assurance
means a
				comprehensive process used by the laboratory to prevent and control errors that
				may occur at any interval from the time a test is ordered until it is reported
				and charted;
(t)
Quality
				Control Program
means those quality control requirements established for
				clinical laboratories as provided in applicable federal law and regulations and
				in Georgia law and regulations;
(u)
Screening and Monitoring Tests.
Screening tests mean those simple
				laboratory tests, approved by the Board as screening tests, used to aid in the
				detection of previously undiagnosed conditions. Monitoring tests mean those
				simple laboratory tests, approved by the Board as monitoring tests, with
				performance characteristics (accuracy and precision) that allow the tests to be
				used for evaluation of the status of previously diagnosed conditions and/or for
				evaluation of response to medical management;
(v)
Specimen Collection Station
means a place or entity, without regard to location, that either collects
				specimens directly from patients or brings specimens together after collection
				for the purpose of forwarding them either intrastate or interstate to a
				licensed/certified clinical laboratory for examination;
(w)
Specimen Collector and/or
				Phlebotomist
means any person who has been trained in procedures
				requiring understanding and skills in the procurement of specimens for clinical
				laboratory analysis in Clinical Chemistry, Hematology, Immunohematology,
				Microbiology, and Immunology/Serology and who works under the general
				supervision of the laboratory director, supervisor or technologist;
(x)
Supervisor
means an
				assistant to the director and a person with special scientific skills, who,
				under the general supervision of a clinical laboratory director, supervises
				technical personnel;
(y)
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 as described
				in 111-8-10-.06(5)(a).
				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;