Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES
Section 11-113-17 - Evaluation of performance testing
Universal Citation: HI Admin Rules 11-113-17
Current through February, 2024
(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.
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