Background: In view of increasing attention focused on patient safety and the need to reduce laboratory errors, it is important that clinical laboratories collect statistics on error occurrence rates over the whole testing cycle, including pre-, intra-, and postanalytical phases. Methods: The present study was conducted in 2006 according to the design we previously used in 1996 to monitor the error rates for laboratory testing in 4 different departments (internal medicine, nephrology, surgery, and intensive care). For 3 months, physicians and nurses were asked to pay careful attention to all test results. Any suspected laboratory error was recorded with associated pertinent clinical information. Every day, a laboratory physician visited the 4 departments and a critical appraisal was made of any suspect results. Results: Among a total of 51 746 analyses, clinicians notified us of 393 questionable findings, 160 of which were confirmed as laboratory errors. The overall frequency of errors, 3092 ppm, was significantly lower (P <0.05) than in 1996 (4700 ppm). Of the 160 confirmed errors, 61.9% were preanalytical errors, 15% were analytical, and 23.1% were postanalytical. Conclusions: During the last decade the error rates in our stat laboratory have been reduced significantly. As demonstrated by the distribution pattern, the pre-and postanalytical steps still have the highest error prevalences, but changes have occurred in the types and frequencies of errors in these phases of testing.

Application of Total Quality Management concepts to laboratory testing requires that the total process, including preanalytical and postanalytical phases, be managed so as to reduce or, ideally, eliminate all defects within the process itself. Indeed a “mistake” can be defined as any defect during the entire testing process, from ordering tests to reporting results. We evaluated the frequency and types of mistakes found in the “stat” section of the Department of Laboratory Medicine of the University-Hospital of Padova by monitoring four different departments (internal medicine, nephrology, surgery, and intensive care unit) for 3 months. Among a total of 40 490 analyses, we identified 189 laboratory mistakes, a relative frequency of 0.47%. The distribution of mistakes was: preanalytical 68.2%, analytical 13.3%, and postanalytical 18.5%. Most of the laboratory mistakes (74%) did not affect patients’ outcome. However, in 37 patients (19%), laboratory mistakes were associated with further inappropriate investigations, thus resulting in an unjustifiable increase in costs. Moreover, in 12 patients (6.4%) laboratory mistakes were associated with inappropriate care or inappropriate modification of therapy. The promotion of quality control and continuous improvement of the total testing process, including pre- and postanalytical phases, seems to be a prerequisite for an effective laboratory service.

Introduction: Direct oral anticoagulant (DOAC) intra-and inter-individual variability was previously reported, but its magnitude is still considered negligible for patient management. Objective: To evaluate inter-and intra-individual variability in real-world atrial fibrillation patients on dabigatran, rivaroxaban or apixaban in four Italian anticoagulation clinics and to assess the correlation between DOAC plasma concentration and creatinine-clearance (CrCl). Materials and Methods: A total of 330 consecutive patients were enrolled, of which 160 were on dabigatran (70 and 90 taking 150 mg or 110 mg twice-daily, respectively), 71 on rivaroxaban (37 and 34 taking 20 mg or 15 mg once-daily) and 99 on apixaban (73 and 26 taking 5 mg or 2.5 mg twice-daily). Blood was taken at trough and peak within the first month (15-25 days) of treatment. Diluted-thrombin-time (dTT) calibrated for dabigatran and anti-FXa calibrated for rivaroxaban or apixaban was performed. Results: Mean inter-individual variability expressed as overall CV values for all drugs was lower at peak (CV = 46%) than at trough (CV = 63%). Mean CV% intra-individual variability was 36.6% at trough and 34.0% at peak. Correlation with CrCl was poor for all drugs and only dabigatran at trough showed a significant correlation. Conclusion: This multicenter study confirms high DOAC inter-individual variability that cannot be explained by the rate of renal clearance to which the three DOAC were subjected since the correlation with CrCl was relatively poor. This poor correlation suggests caution in using CrCl as the sole laboratory parameter to indirectly evaluate residual circulating DOAC.

No abstract

No abstract