HAR §11-110.1-2
HAR §11-110.1-2. the scope of their practice
Length: 284 wordsOfficial source
Cite as Haw. Code R. § 11-110.1-2
Qualifications shall include successfully completing an accredited training program and passing a certification examination that demonstrates competency in ordering and interpreting laboratory test results.
"Certifying agency acceptable to the department" means a national certifying agency of laboratory personnel that is acceptable to the Secretary of the United States Department of Health and Human Services, including, but not limited to, the American Society of Clinical Pathologists and the National Credentialing Agency for Laboratory Personnel.
"CLIA" means Clinical Laboratory Improvement Amendments of 1988. 42 C.F.R. Part 493 sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens. 42 C.F.R. Part 493 implements sections 1861 (e) and (j), the sentence following section 1861(s)(13), and 1902(a)(9) of the Social Security Act, and section 353 of the Public Health Service Act.
"Clinical laboratory" means a facility where the microbiological, serological, chemical, hematological, biophysical, toxicological, cytological, pathological, or other examinations of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment of a disease or assessment of a medical condition.
"Clinical laboratory director" or "laboratory director" means a person who is responsible for the administrative, technical, and scientific operation of a clinical laboratory including the supervision of procedures for testing and the reporting of the test results.
"Clinical laboratory owner" means a person or entity in whom is vested the ownership rights of control, possession, and dominion of a clinical laboratory.
"Clinical laboratory sciences" include clinical chemistry, clinical microbiology, hematology, clinical immunology, immunohematology, cytology, cytogenetics, and histology.
"Collecting depot" means a place separate from patient care facilities and where specimens are received or taken from the body of an individual for laboratory examination elsewhere.
110.1-4
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