Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D20 - Definitions

Current through July 10, 2024
As used in sections
				  19a-36
				  -D20 through 19a-36-D39:
(1) "Advisory
				committee" means a group of consultants, appointed by the commissioner and
				serving in a voluntary capacity, to advise the department on matters relating
				to the regulation of clinical laboratories. The advisory committee shall
				consist of two hospital laboratory directors who are certified by the American
				Board of Pathology in both clinical and anatomic pathology; two private
				clinical laboratory directors; and four laboratory specialists specializing in
				the fields of cytopathology, clinical chemistry, hematology, and microbiology
				of which two shall represent laboratories in hospitals licensed in accordance
				with chapter 368v of the general statutes and two shall represent private
				clinical laboratories; and a physician who is not a pathologist and who has no
				financial interests in any laboratory licensed and/or registered with this
				department.
(2) "CLIA" means the
				Federal Clinical Laboratory Improvement Amendments of 1988, Title 42 Part 493
				of the code of federal regulations.
(3) "Commissioner" means the commissioner of
				public health.
(4) "Department"
				means the department of public health.
(5) "Director" means the person designated by
				the licensee to be responsible for the daily technical and scientific
				operations of the laboratory, including choice and application of methods,
				supervision of personnel and reporting of findings.
(6) "Examination" means an investigation, all
				or any part of which is necessary to obtain an accurate result, which includes
				the process of instructing the patient, preparing the specimen collection site,
				choosing the appropriate collection technique, obtaining a valid specimen,
				assuring the patient's well being, the judicious handling, transporting and
				processing of the specimen, and reporting the results in a clear and concise
				manner to the practitioner whose order initiated the process.
(7) "High complexity tests" means laboratory
				tests categorized as high complexity in accordance with CLIA.
(8) "Laboratory" means any clinical
				laboratory as defined in Section
				19a-30
				of the Connecticut General Statutes or other area, except those specifically
				exempted by the Connecticut General Statutes, where any type of specimen or
				material derived from a human being or body is examined to obtain findings
				bearing upon the presence, absence, prognosis or treatment of disease or upon
				susceptibility thereto.
(9)
				"Licensee" means the person or persons in whose name licensure of a laboratory
				has been sought and granted; this shall be the owner if an individual, the
				owners if a partnership of two, or a responsible officer of any other group,
				firm or corporation owning the laboratory.
(10) "Moderate complexity tests" means
				laboratory tests categorized as moderate complexity in accordance with
				CLIA.
(11) "Non-waived laboratory
				tests" means moderate and high complexity tests which are not included in the
				waived tests as set forth in Title 42 Part 493 of the code of federal
				regulations.
(12) "Owner" means any
				individual, partnership, group, firm or corporation holding or claiming
				ownership of or title to a laboratory.
(13) "Specimen" refers only to materials
				derived from a human being or body.