Sec.19a-36-D20. Definitions

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.

(Adopted effective June 4, 1996)