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 11-110.1-6 - Requirements for a clinical laboratory permit or license
Current through February, 2024
(a) No person shall establish, conduct, maintain, or operate a clinical laboratory in the State without a valid and effective clinical laboratory permit or license issued by the department.
(b) An application shall be submitted for each address in which clinical laboratory tests are performed.
(c) The following laboratories shall be exempt from the requirements of subsection (b):
(d) All completed applications shall be approved or denied no later than sixty calendar days following the date that the complete application is received.
(e) A clinical laboratory license or permit shall be effective for a period of not more than twenty-four months.
(f) The clinical laboratory director shall display the permit or license issued to the laboratory by the department in a prominent place in the laboratory.
(g) The clinical laboratory director shall notify the department in writing of a change in name, location, director, or owner of the laboratory within thirty days of the actual change.