As used in this chapter of Rules the following terms and
acronyms shall have the following meanings ascribed to them:
(1) ASTC - Ambulatory Surgical Treatment
Center, specifically any institution, place or building devoted primarily to
the maintenance and operation of a facility for the performance of surgical
procedures or any facility in which a medical or surgical procedure is utilized
to terminate a pregnancy and is licensed by the Tennessee Board for Licensing
Health Care Facilities under Rule 1200-8-10.
(2) Anatomic laboratory - Any medical
laboratory performing only the biophysical examination of specimens pertaining
to the clinical specialty of pathology, to include histopathology, oral
pathology, and cytopathology. The examination of these specimens taken from the
human body are performed to obtain information for diagnosis, prophylaxis, or
treatment or where any examination, determination or test is made of any sample
used as a basis for health advice, or where any sample is collected for the
purpose of transfusion or processing of blood or blood fractions, or the
training of medical laboratory personnel. Compliance with Rule 1200-6-1-.20 is
required to be the director of an anatomic laboratory.
(3) Authorized person - A physician or intern
or resident in an American Medical Association approved training program or a
duly licensed optometrist or a duly licensed dentist or a duly licensed
chiropractic physician or other health care professional legally permitted to
submit to a medical laboratory a written request for tests appropriate to that
professional's practice or a law enforcement officer acting in accordance with
(4) Board - The Tennessee Medical Laboratory
(5) CLIA - The Clinical
Laboratory Improvement Amendments as found in 42 CFR 493.
(6) CLSI - The Clinical Laboratory and
(7) CMS - The
Centers for Medicare and Medicaid Services of the U.S. Department of Health and
(8) Center for
Disease Control (CDC) - The United States Center for Disease Control,
headquartered in Atlanta, GA.
Clinical Laboratory - see Medical Laboratory.
(10) Code of Federal Regulations (CFR) - The
documents that detail under Title 42, Chapter IV Part 493, the Laboratory
Requirements under CLIA, and under Title 21, Parts 600 to 799, the Food and
(11) Condition -
A specific requirement from the Board's rules that must be met for continued
possession of a license to operate a medical laboratory in Tennessee. Unmet
conditions of compliance with the Board's rules can result in harm to patients
or facility personnel.
Condition Level Deficiency - A significant deficiency of non-compliance with a
rule. A deficiency that must be corrected before a license is continued, issued
or is renewed.
(13) Days - Calendar
days unless otherwise designated.
(14) Department - The Department of Health,
State of Tennessee.
(15) FDA - The
U.S. Food and Drug Administration.
(16) HCF - The Department of Health, Division
of Health Care Facilities.
- The U.S. Department of Health and Human Services.
(18) Human Leukocyte Antigens (HLA) -
Identification of the human histocompatibility complex antigens on the surface
of nucleated cells.
Independent Lab - A medical laboratory performing patient tests that is
independent of both attending and consulting physician's offices and
independent of a hospital also known as a reference laboratory.
(20) Manufacturer's instructions -
Information found on the FDA approved product label.
(21) May - Discretionary.
(22) Medical Laboratory - Any institution,
building, or place in which operations and procedures for the microbiological,
serological, chemical, hematological, immunohematological, or biophysical
examination of specimens taken from the human body are performed to obtain
information for diagnosis, prophylaxis, or treatment or where any examination,
determination, or test is made on any sample used as a basis for health advice,
or where any sample is collected for the purpose of transfusion or processing
of blood fractions, or for the training of medical laboratory
(23) Must -
(24) Office for the
Medical Laboratory Board - The Office responsible for laboratory facility
Improvement (PI) - An ongoing process encompassing all facets of the laboratory
or collection station technical and nontechnical functions at all
locations/sites where testing is performed.
(26) Plan of Correction - The laboratory's or
collection station's response to any citation of non-compliance with
regulations. The Plan of Correction must be reasonable, contain specific
actions to correct deficiencies with estimated correction dates and contain the
signature of the Laboratory Director or his authorized Designee or collection
station director or his authorized designee.
(27) Point of Care Laboratory Testing - Those
tests performed by health care professionals, not licensed by this chapter,
upon approval by the board, provided that the testing is performed outside the
duly licensed laboratory, and under the auspices of a laboratory required to be
licensed by the division of health care facilities in the department of health,
pursuant to this chapter.
Physician Office Laboratory - A laboratory operated by a duly licensed
physician for the sole purpose of testing samples collected from their own
(29) Reference Laboratory
- A medical laboratory performing patient tests that is independent of both
attending and consulting physician's offices and independent of a hospital also
known as an independent laboratory.
(30) Shall - Mandatory.
(31) Standard - A specific requirement from
the state rules that must be met for continued possession of a license to
operate a medical laboratory or collection station in Tennessee. Unmet
standards of compliance usually reflect unsatisfactory performance of
laboratory or collection station operations according to accepted standards of
medical laboratory practice.
Standard Level Deficiency - A deficiency of non-compliance with a regulation
for which a license would be issued or renewed, provided an acceptable plan of
correction with an estimated completion date has been submitted and
(33) Statement of
Deficiencies - An official notification of non-compliance with one (1) or more
Unsatisfactory Proficiency Testing Performance - Failure to attain the minimum
satisfactory score for an analyte, test, subspecialty, or specialty for a
Proficiency Testing Performance - Failure to attain the minimum satisfactory
score for an analyte, test, subspecialty, or specialty for two (2) consecutive
or two (2) of three (3) consecutive testing events.