Section 11-110.1-5 - Applicability of subchapter 2 and exemptions Subchapter 2 applies to all clinical laboratories within the State, except laboratories that are:
(1) Operated by the United States government;(2) Operated and maintained exclusively for research and teaching purposes, involving no patient services whatsoever;(3) Certified by CLIA pursuant to 42 C.F.R. part 493 subpart A and operated by a licensed physician at a stated location where clinical laboratory tests are performed exclusively for the physician's own patients. The licensed physician shall serve as the laboratory director for this laboratory. Such clinical laboratories shall comply with section 11-110.1-16(e);(4) Operated by a police department of any county and perform breath alcohol analysis;(5) Certified as a clinical laboratory under 42 C.F.R. part 493 subpart A and perform laboratory testing for pulmonary function in a licensed medical facility; or(6) Conducting any study of public health importance with the written approval of the director.Haw. Code R. § 11-110.1-5
[Eff JUL 05 2007] (Auth: HRS §§ 321-1, 321-13) (Imp: HRS §§ 321-11, 321-13)