Evaluation of analytical errors in a clinical chemistry laboratory: A 3 year experience

Abstract

Background:Proficient laboratory service is the cornerstone of modern healthcare systems and has an impact on over 70% of medical decisions on admission, discharge, and medications. In recent years, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes.Aim:We retrospectively analyzed data spanning a period of 3 years on analytical errors observed in our laboratory. The data covered errors over the whole testing cycle including pre-, intra-, and post-analytical phases and discussed strategies pertinent to our settings to minimize their occurrence.Materials and Methods:We described the occurrence of pre-analytical, analytical and post-analytical errors observed at the Komfo Anokye Teaching Hospital clinical biochemistry laboratory during a 3-year period from January, 2010 to December, 2012. Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA).Results:A total of 589,510 tests was performed on 188,503 outpatients and hospitalized patients. The overall error rate for the 3 years was 4.7% (27,520/58,950). Pre-analytical, analytical and post-analytical errors contributed 3.7% (2210/58,950), 0.1% (108/58,950), and 0.9% (512/58,950), respectively. The number of tests reduced significantly over the 3-year period, but this did not correspond with a reduction in the overall error rate (P = 0.90) along with the years.Conclusion:Analytical errors are embedded within our total process setup especially pre-analytical and post-analytical phases. Strategic measures including quality assessment programs for staff involved in pre-analytical processes should be intensified.

Highly accurate molecular genetic testing for HFE hereditary hemochromatosis: results from 10 years of blinded proficiency surveys by the College of American Pathologists

“…In addition, these published analytical error rates for molecular genetic tests are quite comparable to those found for other more automated diagnostic analytes in laboratory medicine, with well-documented analytical error rates ranging from 0.01 to 5%. [30][31][32][33][34][35][36] Prior publications have also documented findings analogous to this study concerning a higher variability in interpretive (compared with analytical) performance, with interpretive accuracy rates ranging from 92.5% for BRCA1/2 (ref. 25) to 99.7% for familial dysautonomia.…”

Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Labs in Sulaimani City of Iraqi Kurdistan

“…Interestingly, the International Federation of Clinical Chemistry and Laboratory Medicine Working Group for Laboratory Errors and Patient Safety (IFCC-WG-LEPS) organized a series of quality markers on the pre-analytical phase to highlight pre-analytical phase errors [4]. The most common extra-analytical errors include inappropriateness of test order, patient identification error, timing errors in sampling and preparation, hemolytic and lipemic blood samples, inappropriate transport, and inadequate and inappropriate sample collection tubes [5] (Table 1). …”

Recognizing and Reducing Analytical Errors and Sources of Variation in Clinical Pathology Data in Safety Assessment Studies

“…In general, the frequency of errors in the preanalytical phase and postanalytical phase comprise the vast majority (Bonini et al 2002;Sonntag 2009). Errors within the analytical phase are usually few, and results indicated that the number of errors within the analytical phase has continued to decrease over the last decade (Plebani 2006(Plebani , 2010Sakyi et al 2015).…”

“…Some examples of analytical errors include equipment malfunction, procedures (i.e., standard operating procedures and assay instructions) not followed, undetected failure of quality control, sample mixups, and test interference. In many studies of total testing errors, analytical errors are often <10% and their frequency is decreasing due to standardization of laboratory procedures and assays, automation within the clinical pathology laboratory, and advances in technology (Plebani 2006(Plebani , 2010Sakyi et al 2015). However, in human medicine, immunoassays remain a prime concern for analytical errors due to the presence of heterophilic antibodies, antianimal antibodies, and anti-idiotype antibodies within patient sera.…”