Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 1 - GENERAL PROVISIONS › Section 11-110.1-2 - Definitions

Current through June, 2024
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 ).