Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart A - GENERAL › Section 450.10 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"Act" or "Clinical Laboratory Act" - the Illinois Clinical
				  Laboratory and Blood Bank Act.
"Approved Clinical Laboratory" - a laboratory certified under
				  the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988.
"CLIA Law" - the Clinical Laboratory Improvement Amendments
				  of 1988 (amendments to the Public Health Service Act (42 USC
				  263a)) and the related federal regulations.
				  Establishes quality standards for laboratory testing performed on specimens
				  from humans, such as blood, body fluid, and tissue, for the purpose of
				  diagnosis, prevention, or treatment of disease, or of assessment of
				  health.
"Clinical Laboratory" or "Laboratory" - a facility
				  which performs laboratory tests or issues reports resulting from
				  tests.
For the purposes of this Part, "Clinical Laboratory" or
				  "Laboratory" does not include forensic laboratories. (Section 2-103 of the
				  Act)
"Controlled Substance" - a drug, substance, or immediate
				  precursor as defined in the Illinois Controlled Substances Act.
"Demonstration of Proficiency" - when a laboratory meets the
				  standards for acceptable proficiency testing as stated in Section
				  450.720(a)
				  by means of on site analysis of specimens sent to the laboratory by agencies
				  approved by the Department for that purpose.
"Department" -
the Department of Public Health of the
				  State of Illinois
. (Section 2-105 of the Act)
"Director" - the Director of the Department of Public
				  Health.
"Director of Clinical Laboratory"
or
				  "Laboratory Director"
- an individual who administers the technical and
				  scientific operation of a clinical laboratory, including the reporting of the
				  findings of clinical laboratory tests.
(Section 2-104 of the
				  Act)
"FDA" - Food and Drug Administration within the United States
				  Department of Health and Human Services (HHS).
"Full-time Experience" - experience in the field being
				  referred to consisting of at least 35 hours per week conducting activities
				  required by the specific position or field such as conducting the tests
				  referred to in Section 2-103 of the Act.
"Health Screening" - tests or categories of tests set
				  forth in the Act
and this Part
that are performed for the
				  purpose of assessing a phase of the general state of health of human
				  subjects
(Section 2-120 of the Act).
"HHS" - the United States Department of Health and Human
				  Services.
"Licensed Clinical Laboratory" - a laboratory licensed by DPH
				  based on certification by the Centers for Medicare & Medicaid Services
				  (CMMS) in accordance with CLIA.
"Physician" - unless otherwise indicated in the
				  Act
and this Part
, a person licensed by the Department of
				  Professional Regulation, pursuant to the requirements of the Medical Practice
				  Act of 1987;
(i.e., a physician licensed to practice medicine in all
				  its branches and a chiropractic physician)
or a person licensed as a
				  physician under the laws of another state or territory of the United
				  States.
(Section 2-116 of the Act).
"Prepackaged Reagent Analyzer" - an automated instrument in
				  which a specimen or a diluted specimen is reacted with reagents contained
				  within individual packet(s) containing all of the measured reagents required
				  for the analysis for a given analyte.
"Single Practice" - a medical, dental or podiatric practice,
				  or a partnership, professional service corporation, or medical corporation of
				  one or more licensed practitioners who share facilities, personnel, income and
				  expenses for a clinical laboratory that is used solely as an adjunct to the
				  care of patients of the members of the single practice.
"Test" - laboratory examinations and issuance of
				  reports resulting from the biological, microbiological, serological, chemical,
				  immunohematological, radioimmunological, hematological, biophysical,
				  cytological, pathological, toxicological or other examination of materials
				  derived from the human body 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 humans including determining drug use by
				  humans.
(Section 2-117 of the Act).
"Toxicology Laboratory" - a licensed laboratory that performs
				  tests to detect drug abuse in the workplace, among job applicants, or for other
				  similar purposes.
"Waived Test" - a test system, assay or examination that HHS
				  has determined meets the CLIA statutory criteria as specified for waiver under
				  Section 353(d)(3) of the Public Health Service Act that has been determined to
				  be so simple as to pose no risk of harm if performed
				  incorrectly.