Ga. Comp. R. & Regs. R. 111-8-10-.03 - Definitions
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;
(z)
Technologist
means a person who performs clinical laboratory procedures 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 they are qualified by education, training, experience, and
certification.
(aa)
Trainee means a person who is enrolled in an accredited training
program or who, in a limited laboratory specialty(ies) for which there is no
accredited training program available, trains under the supervision of a
director, supervisor, or technologist qualified in the specialty(ies), but does
not report actual patient test results without prior supervisory
approval.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.