§11-113-19 - Quality assurance and quality control.

§11-113-19 Quality assurance and quality control.

         (a) Laboratories shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain of custody, security and reporting of results, initial and confirmatory testing, and validation of analytical procedures. Quality assurance procedures shall be designed, implemented, and reviewed to monitor the conduct of each step of the process of testing.

         (b) Each analytical run of specimens to be screened shall include:

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         (1) Specimens certified to contain no drugs;

         (2) Specimens fortified with known standards; and

         (3) Positive controls with the drug or metabolite at or near the cutoff.

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         (c) In addition, with each batch of specimens a sufficient number of standards shall be included to ensure and document the linearity of the assay method over time in the concentration area of the cutoff. After acceptable values are obtained for the known standards, those values will be used to calculate specimen data.

         (d) Implementation of procedures to ensure that carryover does not contaminate the testing of an individual's specimen shall be documented.

         (e) A minimum of ten per cent of all test specimens shall be quality control specimens. Laboratory quality control samples, prepared from spiked samples of determined concentration shall be included in the run and should appear as normal samples to laboratory analysts.

         (f) Each analytical run of specimens to be confirmed shall include:

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         (1) Specimens certified to contain no drugs;

         (2) Specimens fortified with known standards; and

         (3) Positive controls with the drug or metabolite at or near the cutoff.

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         (g) The linearity and precision of the method shall be periodically documented.

        [Eff 1/23/92; comp OCT 19 2007 ] (Auth: HRS §§329B-4, 329B-8) (Imp: HRS §329B-4)

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