A-202 Quality control design survey reveals 399 ways to do it wrong

Abstract

Abstract Background The effectiveness of statistical quality control processes to detect unacceptable patient risk depends on the choices that laboratory professionals make for the design of quality control charts and acceptable patient risk. Recommended best practice consists of putting a meaningful recent mean and SD on the QC chart, selecting rules based on the method’s margin for error to unacceptable risk or Sigma value, and basing acceptable risk on clinical need. Methods A survey was circulated through LinkedIn and Labvine. Forty respondents who included their credentials were included in the final analysis. Respondents were asked to select the one most correct answer four questions regarding the parameters that govern the effectiveness of quality control processes. 1. The best source of the mean on the QC chart? (Four choices) 2. Best source of the SD on the QC chart? (Five choices) 3. Best way to select QC rules for each QC sample? (Six choices) 4. If an analytical process “fails,” we should stop reporting before [errors are reported.] (Five choices) A total of 400 potential patterns of QC selections were chosen. (4 * 5 * 5 * 4). Results When asked acceptable error rate if an analytical process “fails,” responses were More than 5% errors are reported - 11%. Any errors are reported - 66% It varies with clinical use of the test - 16% It varies with capabilities of our method - 8% While most respondents chose at least one of the recommended answers for QC chart design and rules, only three chose the best choice for all parameters. Conclusions Despite decades of recommendations of best practice for quality control, typical practice throughout the laboratory community in general does not reflect this. It is time to consider a new approach to teaching, validating and certifying competency in medical laboratory quality control.