Abstract
The delivery of laboratory services has been described 40 years ago and defined with the foremost concept of “brain-to-brain turnaround time loop”. This concept consists of several processes, including the final step which is the action undertaken on the patient based on laboratory information. Unfortunately, the need for systematic feedback to improve the value of laboratory services has been poorly understood and, even more risky, poorly applied in daily laboratory practice. Currently, major problems arise from the unavailability of consensually accepted quality specifications for the extra-analytical phase of laboratory testing. This, in turn, does not allow clinical laboratories to calculate a budget for the “patient-related total error”. The definition and use of the term “total error” refers only to the analytical phase, and should be better defined as “total analytical error” to avoid any confusion and misinterpretation. According to the hierarchical approach to classify strategies to set analytical quality specifications, the “assessment of the effect of analytical performance on specific clinical decision-making” is comprehensively at the top and therefore should be applied as much as possible to address analytical efforts towards effective goals. In addition, an increasing number of laboratories worldwide are adopting risk management strategies such as FMEA, FRACAS, LEAN and Six Sigma since these techniques allow the identification of the most critical steps in the total testing process, and to reduce the patient-related risk of error. As a matter of fact, an increasing number of laboratory professionals recognize the importance of understanding and monitoring any step in the total testing process, including the appropriateness of the test request as well as the appropriate interpretation and utilization of test results.
©2011 by Walter de Gruyter Berlin Boston
Articles in the same Issue
- Editorial
- Method comparison: where do we draw the line?
- Review
- Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods
- Minireview
- Molecular diagnostics for pharmacogenomic testing of fluoropyrimidine based-therapy: costs, methods and applications
- Opinion Paper
- Preanalytical quality improvement: from dream to reality
- Point
- Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis
- Counterpoint
- Closing the brain-to-brain loop in laboratory testing
- General Clinical Chemistry and Laboratory Medicine
- Harmonization of growth hormone measurements with different immunoassays by data adjustment
- Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications
- High-throughput LC-MS/MS method for monitoring sirolimus and everolimus in the routine clinical laboratory
- Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients
- Diagnostic efficiency of truncated area under the curve from 0 to 2 h (AUC0–2) of mycophenolic acid in kidney transplant recipients receiving mycophenolate mofetil and concomitant tacrolimus
- Good performance of an immunoassay based method for nevirapine measurements in human breast milk
- Measurement of plasma amino acids by Ultraperformance® Liquid Chromatography
- Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers
- Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases
- Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease
- The antinuclear antibody assay: developing criteria for reflexive anti-dsDNA antibody testing in a laboratory setting
- A simple liquid chromatography-tandem mass spectrometry method for measuring metanephrine and normetanephrine in urine
- Monoclonal gammopathy missed by capillary zone electrophoresis
- Adaptation of the Diazyme Direct Enzymatic HbA1c Assay for a microplate reader at room temperature
- Validation and Outcome Studies
- Laboratory assessment of iron status in pregnancy
- Cardiovascular Diseases
- Blood cells characteristics as determinants of acute myocardial infarction
- No evidence for an association between the rs2824292 variant at chromosome 21q21 and ventricular fibrillation during acute myocardial infarction in a German population
- Letters to the Editor
- Letter to the Editor Reply: Statistical methods for assessment of added usefulness of new biomarkers
- Reply to Vavrova et al. Clin Chem Lab Med 2011;49:89–92
Articles in the same Issue
- Editorial
- Method comparison: where do we draw the line?
- Review
- Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods
- Minireview
- Molecular diagnostics for pharmacogenomic testing of fluoropyrimidine based-therapy: costs, methods and applications
- Opinion Paper
- Preanalytical quality improvement: from dream to reality
- Point
- Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis
- Counterpoint
- Closing the brain-to-brain loop in laboratory testing
- General Clinical Chemistry and Laboratory Medicine
- Harmonization of growth hormone measurements with different immunoassays by data adjustment
- Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications
- High-throughput LC-MS/MS method for monitoring sirolimus and everolimus in the routine clinical laboratory
- Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients
- Diagnostic efficiency of truncated area under the curve from 0 to 2 h (AUC0–2) of mycophenolic acid in kidney transplant recipients receiving mycophenolate mofetil and concomitant tacrolimus
- Good performance of an immunoassay based method for nevirapine measurements in human breast milk
- Measurement of plasma amino acids by Ultraperformance® Liquid Chromatography
- Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers
- Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases
- Direct chromogenic substrate immuno-capture activity assay for testing of factor VII-activating protease
- The antinuclear antibody assay: developing criteria for reflexive anti-dsDNA antibody testing in a laboratory setting
- A simple liquid chromatography-tandem mass spectrometry method for measuring metanephrine and normetanephrine in urine
- Monoclonal gammopathy missed by capillary zone electrophoresis
- Adaptation of the Diazyme Direct Enzymatic HbA1c Assay for a microplate reader at room temperature
- Validation and Outcome Studies
- Laboratory assessment of iron status in pregnancy
- Cardiovascular Diseases
- Blood cells characteristics as determinants of acute myocardial infarction
- No evidence for an association between the rs2824292 variant at chromosome 21q21 and ventricular fibrillation during acute myocardial infarction in a German population
- Letters to the Editor
- Letter to the Editor Reply: Statistical methods for assessment of added usefulness of new biomarkers
- Reply to Vavrova et al. Clin Chem Lab Med 2011;49:89–92