§11-113-8 - Licensing of laboratories.
§11-113-8 Licensing of laboratories.
(a) Laboratories in this State performing substance abuse testing shall be licensed by the department for that purpose.
(b) A laboratory seeking a license shall submit to the department a request in writing for an application form.
(c) Each license issued pursuant to this chapter shall be issued to the owner of the laboratory and shall expire within twenty-four months from the date of issuance.
(d) A laboratory must meet all of the following provisions to qualify for a license:
(1) The laboratory is located in this State.
(2) Laboratory personnel meet the qualifications specified in section §11-113-15.
(3) The laboratory facility performing substance abuse testing shall be secured.
(4) The laboratory shall use proper chain of custody procedures.
(5) The laboratory shall use screening or confirmatory testing procedures, or both, which are acceptable to the director.
(6) The laboratory shall have a quality assurance program which is acceptable to the director.
(7) The laboratory must be enrolled in a performance testing program which is acceptable to the director, at no cost to the department.
(e) As conditions to obtaining the license, the laboratory must agree to and execute the following:
(1) Submit to the department all results of performance testing in a timely manner;
(2) Receive, test, and submit reports to the department on performance testing samples which may be supplied by the department, at no cost to the department.
(3) Notify the department within thirty days of any significant change in personnel, procedures, or operations which may affect the reliability and accuracy of testing and the accurate reporting of test results.
(4) Submit to onsite inspections by the director or the director's representative. A laboratory will be given at least twenty-four hours' oral or written notice, or both, before any inspection.
(f) The director may issue a license to any laboratory that meets the provisions of subsections (d) and (e) and passes:
(1) An official laboratory inspection conducted by the department, and
(2) A performance test acceptable to the director.
(g) Under interim conditions, the director may issue a provisional license of limited duration to any laboratory in the State which meets the provisions of subsection (d).
(h) A license shall be forfeited prior to its expiration date if one or more of the following occurs:
(1) The owner sells or otherwise transfers the ownership of the laboratory.
(2) There is a change in the location of the laboratory or structural alteration without prior written approval by the department, which may affect adversely the quality of testing.
(3) The license holder surrenders the license to the department.
(4) The license holder fails to make full payment of the license fee.
(i) Upon any change in the ownership of a laboratory, the director may issue a provisional license, upon written application by the new owner pursuant to subsection (b);
(1) For a period not to exceed ninety days from the date of the change in the ownership of the laboratory;
(2) Upon written assurance by the new owner that the operation of the laboratory will continue to meet all provisions of subsection (d); and
(3) Upon onsite inspection by the director or the director's representative.
(j) The license shall specify the name and address of the laboratory, the name of the owner, types of specimens and tests which the licensee is allowed to perform and the substances of abuse for which the licensee is allowed to analyze, and the designated cutoff levels. The licensee must apply to the director of health for written approval of any changes or additions of tests of substances of abuse.
(k) The director shall keep a current listing of all laboratories performing substance abuse tests in the State. This listing may be sent to any third party upon written request.
[Eff 1/23/92; am and comp OCT 19 2007 ] (Auth: HRS §§329B-4, 329B-8) (Imp: HRS §329B-4)
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