Types and frequency of preanalytical mistakes in the first Thai ISO 9002:1994 certified clinical laboratory, a 6 – month monitoring

TLDR: Most mistakes occurred before samples were analysed, either during sampling or preparation for analysis, suggesting that co-operation with clinicians and personnel outside the laboratory is still the key to improvement of laboratory quality.

Abstract: Reliability cannot be achieved in a clinical laboratory through the control of accuracy in the analytical phase of the testing process alone. Indeed a "mistake" can be defined as any defect occuring during the testing process. In the analysis of clinical specimens, there are many possible preanalytical sources of error. Therefore, the application of quality system to laboratory testing requires total quality management throughout the laboratory process, including the preanalytical and postanalytical phases. ISO 9002:1994 is a model for quality assurance in production, installation, and servicing, which includes a number of clauses providing guidance for implementation in clinical laboratories. Our laboratory at King Chulalongkorn Memorial Hospital, the largest Thai Red Cross Society hospital, is the first clinical laboratory in Thailand with ISO 9002:1994 certified for the whole unit. In this study, we evaluated the frequency and types of preanalytical mistakes found in our laboratory, by monitoring specimens requested for laboratory analyses from both in-patient and out-patient divisions for 6 months. Among a total of 935,896 specimens for 941,902 analyses, 1,048 findings were confirmed as preanalytical mistakes; this was a relative frequency of 0.11 % (1,048/935,896). A total of 1,240 mistakes were identified during the study period. Comparing the preanalytical mistakes to other mistakes in the laboratory process monitored in the same setting and period, the distribution of mistakes was: preanalytical 84.52 % (1,048 mistakes), analytical 4.35 % (54 mistakes), and postanalytical 11.13 % (138 mistakes). Of 1,048 preanalytical mistakes, 998 (95.2%) originated in the care units. All preanalytical mistakes, except for 12 (1.15 %) relating to the laboratory barcode reading machine, were due to human error. Most mistakes occurred before samples were analysed, either during sampling or preparation for analysis. This suggests that co-operation with clinicians and personnel outside the laboratory is still the key to improvement of laboratory quality.