§ 493.1705 - Standard; Quality control assessment.

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The laboratory must have an ongoing mechanism to evaluate the corrective actions taken under § 493.1219, Remedial actions. Ineffective policies and procedures must be revised based on the outcome of the evaluation. The mechanism must evaluate and review the effectiveness of corrective actions taken for—

(a) Problems identified during the evaluation of calibration and control data for each test method;

(b) Problems identified during the evaluation of patient test values for the purpose of verifying the reference range of a test method; and

(c) Errors detected in reported results.

                    
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