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In order to ensure the quality in clinical laboratories and meet the low risk requirements of patients and clinicians, a risk analysis and assessment model based on Sigma metrics and intended use was constructed, based on which differential sigma performance ( σ ) expectations of 42 analytes were developed.    Materials and methods  Failure mode and effects analysis was applied to produce an analytic risk rating based on three factors, each test of which was graded as follows: 1) Sigma metrics; 2) the severity of harm; 3) intended use. By multiplying the score of Sigma metrics by the score of severity of harm by the score of intended use, each was assigned a typical risk priority number (RPN), with RPN ≤ 25 rated as low risk. Low risk was defined as acceptable standards; the sigma performance expectations were calculated.    Results  Among the 42 analytes, tests with  σ  ≥ 6, 5 ≤  σ  < 6, 4 ≤  σ  < 5, 3 ≤  σ  < 4,  σ  < 3 were 21, 5, 5, 6, and 5, respectively; there were 7 high-risk tests, 8 of them medium risk tests. According to the risk assessment conclusion, 13 tests had sigma performance expectations ≥ 6; 15 test items had sigma performance expectations ≥ 5, while 3 test items had sigma performance expectations ≥ 4; 11 test items had sigma performance expectations ≥ 3.    Conclusions  Constructing the risk analysis and assessment model based on Sigma metrics and intended use will help clinical laboratories to identify the high-risk tests more objectively and comprehensively. Such model can also be used to establish the sigma performance expectations and meet the low risk requirements of patients and clinicians.

Risk analysis and assessment based on Sigma metrics and intended use