Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL
Subchapter 2 - CLINICAL LABORATORIES
Section 11-110.1-7 - Requirements for a class I clinical laboratory permit
Current through February, 2024
(a) A person intending to operate a clinical laboratory may apply for a class I permit if the laboratory:
(b) A person applying for an initial class I clinical laboratory permit and renewal shall complete application forms provided by the department. The application shall include at a minimum:
(c) The laboratory director of a class I clinical laboratory shall:
(d) The laboratory director of a class I clinical laboratory may delegate the laboratory director's duties in writing to the laboratory's laboratory consultant.
(e) The department may inspect the laboratory for initial approval and renewal of its class I permit. A clinical laboratory with a class I permit shall allow the inspection of its premises, records, materials, equipment, and methodology by a representative of the department at any time during the laboratory's working hours. The department may accept the on-site inspections of the College of American Pathologists, Joint Commission on Accreditation of Healthcare Organizations, U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services, and other agencies, provided that these agencies have standards that are substantially equal to or more stringent than the requirements of subparts 1 and 2 of this chapter.