§11-113-17 - Evaluation of performance testing.
§11-113-17 Evaluation of performance testing.
(a) Initial application for license:
(1) An applicant laboratory shall not report any false positive results during performance testing for initial certification.
(2) An applicant laboratory shall maintain an overall grade level of eighty per cent for the three cycles of performance testing required for initial certification, as determined by the performance testing program or by the director when applicable.
(3) An applicant laboratory shall obtain at least eighty per cent of its quantitative values for confirmatory testing which are within plus or minus twenty per cent or plus or minus two standard deviations of the reference group mean (whichever is larger). Failure to achieve eighty per cent will result in disqualification.
(4) An applicant laboratory shall not obtain any quantitative values that differ by more than fifty per cent from the calculated reference group mean. Any quantitative values that differ by more than fifty per cent will result in disqualification.
(5) For any individual substance of abuse or metabolite, an applicant laboratory shall successfully detect and quantitate in accordance with paragraphs (2), (3) and (4) at least fifty per cent of the total drug challenges. Failure to successfully quantitate at least fifty per cent of the challenges for any individual drug will result in disqualification.
(b) In order to remain licensed, laboratories must successfully complete four cycles of performance testing per year. Failure to maintain a grade of eighty per cent on any required performance test cycle may result in suspension or revocation of certification. The results of ongoing testing by licensed laboratories of performance test samples shall be sent by the scientific director to the department in a timely manner.
(c) A false positive result may be a basis for suspension.
[Eff 1/23/92; am and comp OCT 19 2007 ] (Auth: HRS §§329B-4, 329B-8) (Imp: HRS §329B-4)
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