Table 6. Position of curative maintenance.
Recommended practice | The laboratory must verify by a method of its choice the absence of drift before failure: re-testing of patient samples, use of mean values of results, or any other means that must be justified. In case of re-testing of samples, the number depends on the size of the series (N) (square root of N, 10%, “rolling back the series” to determine when the system malfunction had an impact on the results, etc.). The impact study is recorded and corrective measures are implemented. |
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Acceptable practice | Review of all patient samples (subject to measurand stability) since the last valid IQC (or other relevant practice), but no reflection or strategy. |
Unacceptable practice | No impact study and therefore potential release of erroneous results. |
IQC – internal quality control. |