Extra-Analytical Clinical Laboratory Errors in Africa: A Systematic Review and Meta-Analysis.

BACKGROUND

Clinical laboratory testing is a highly complex process involving a different procedure. Laboratory errors may occur at any stage of the test process, but most errors occur during extra-analytical phases. The magnitude of clinical laboratory errors, in particular extra-analytical errors, was inconsistent in different studies.

METHODS

A systematic review and meta-analysis were conducted based on the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The extracted data were entered into a Microsoft Excel spreadsheet and transferred to STATA version 11 for the analysis. Random effect model was used to estimate pooled prevalence of extra-clinical laboratory errors and I statistic was used to assess heterogeneity between the studies. Funnel plot analysis and Egger weighted regression test were performed to detect the publication bias. Egger weighted regression test with P-value <0.05 was considered to be a statistically significant publication bias.

RESULTS

A total of 1,381 studies were searched, 19 were included in this systematic review and meta-analysis. A total of 621,507 pre-analytical and 51,859 post-analytical outcomes of quality indicators were reported. A total of 145,515 samples were assessed for rejection and 62,513 laboratory requests were evaluated for incompleteness. The pooled prevalence of pre-analytical and post-analytical errors in Africa was 17.5% (95% Cl: 11.55, 23.45) and 10.99% (95% Cl: 5.30, 16.67) respectively. The pooled prevalence of specimen rejection and laboratory request forms incompleteness in Africa was 2.0% (95% Cl: 0.86, 3.14) and 7.55% (95% Cl: 2.30, 12.80) respectively.

CONCLUSION

The study found high prevalence of pre- and of post-analytical clinical laboratory errors in Africa. In addition, the study showed that the standard completion of the laboratory request forms was poor and there were significant numbers of specimen rejections. Therefore, clinical laboratories should ensure compliance with standard operating procedures, the laboratory information system, the cooperation of the entire staff and the targeted training of sample collectors.