1209.5. (a) “Autoverification” means the use of a computer algorithm in conjunction with automated clinical laboratory instrumentation to review and verify the results of a clinical laboratory test or examination for accuracy and reliability.
(b) The laboratory director or authorized designee shall establish, validate, and document explicit criteria by which the clinical laboratory test or examination results are autoverified.
(c) The laboratory director or authorized designee shall annually revalidate the explicit criteria by which the clinical laboratory test or examination results are autoverified. The laboratory director shall approve and annually reapprove the computer algorithm.
(d) An authorized designee may be appointed by the laboratory director for the purposes of this section. The authorized designee shall be licensed to engage in clinical laboratory practice pursuant to this chapter and shall be qualified as a clinical consultant, technical supervisor, general supervisor, or technical consultant pursuant to regulations adopted by the department.
(e) A person licensed to perform the applicable type and complexity of testing pursuant to Section 1206.5 shall be physically present onsite in the clinical laboratory and shall have documented competency pursuant to Section 1209 in all tests being autoverified, and shall be responsible for the accuracy and reliability of the results of the clinical laboratory test or examination when the results are autoverified and reported.
(Amended by Stats. 2007, Ch. 61, Sec. 1. Effective July 12, 2007.)
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