Haw. Code R. § 11-110.1-2
As used in this chapter:
"Accredited college or university" means a regionally accredited college or university in the United States. This definition includes any foreign institution of higher education that the department determines meets substantially equivalent requirements.
"Accredited program" means a structured training program or curriculum in a college or university accredited by a nationally recognized accrediting agency or an association recognized and accepted by the department.
"Authorized person" means a physician licensed pursuant to HRS Chapter 453, osteopath licensed pursuant to HRS Chapter 460, dentist licensed pursuant to HRS Chapter 448, veterinarian licensed pursuant to HRS Chapter 471, naturopathic physician licensed pursuant to HRS Chapter 455, podiatrist licensed pursuant to HRS Chapter 463E, advanced practice nurse practitioner licensed pursuant to HRS Chapter 457, therapeutically certified optometrist licensed pursuant to HRS Chapter 459, physician assistant licensed pursuant to HRS Chapter 4 53 under the supervision of a licensed physician, pharmacist licensed pursuant to HRS Chapter 461 in collaboration with a licensed physician, chiropractor licensed pursuant to HRS Chapter 442 to determine referral to an internal medical physician or other health care practitioner for supportive patient care management, or designee of an authorized person, and others deemed qualified by the department to order, receive and interpret laboratory test results within the scope of their practice. 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.
"Department" means the department of health, State of Hawaii.
"Director of health" or "director" means the director of the department of health, State of Hawaii, or the director's designee.
"Foreign certifying agency" means a certifying agency of laboratory personnel educated in a country outside of the United States and its territories.
"Full-time experience" means employment or activity that constitutes at least forty hours a week or its equivalent. For instance, one year of full-time experience is equivalent to two years of half-time experience.
"High complexity tests" means laboratory tests categorized as high complexity pursuant to 42 C.F.R. part 493 subpart A.
"Laboratory acceptable to the department" means a clinical laboratory licensed by the department or licensed by another state whose requirements are equal to or more stringent than the requirements of this chapter, a clinical laboratory certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, 42 C.F.R. part 493, a clinical laboratory certified under 21 C.F.R. parts 600 - 680, or a clinical laboratory acceptable to the U. S. Department of Health and Human Services.
"Laboratory consultant" means a clinical laboratory director or medical technologist licensed under this chapter.
"Laboratory specialty" means clinical chemistry, hematology, immunohematology, microbiology, immunology, cytology, cytogenetics, histocompatibility, molecular biology and other specialties recognized by a certifying agency acceptable to the department.
"Moderate complexity tests" means laboratory tests categorized as moderate complexity pursuant to 42 C.F.R. part 493 subpart A.
"Person" means an individual, firm, association, corporation, partnership, organization, municipality, political subdivision, or any other forms of entity, whether organized for profit or not.
"Pertinent laboratory experience" means experience performing laboratory tests in a clinical laboratory acceptable to the department, and which are appropriately complex for the category of licensure sought, as determined by the director.
"Point of care test" or "POCT" means a test that is performed using a portable laboratory testing system, analytical instrument, kit or procedure that may be transported to the site of a patient and is classified as a waived or moderate complexity test pursuant to 42 C.F.R. part 493 subpart A.
"Provider-performed microscopy procedures" or "PPMP" means a procedure meeting the specifications described in 42 C.F.R. part 493 subpart A.
"Waived test" means a test system, assay, or examination that the U.S. Department of Health and Human Services has determined meets the CLIA statutory criteria as specified for waiver under section 353(d)(3) of the Public Health Service Act ( 42 U.S.C. 263 a).
Haw. Code R. § 11-110.1-2