Analytical quality: an unfinished journey

Abstract

In laboratory medicine, a great forward step has been taken toward the pathway to a better understanding of quality, errors and risks to patient safety. An innovative approach for identifying all possible analytical errors, and systematically evaluating errors in individual patient results, is described in the paper by Michael Vogeser and Christoph Seger "Irregular analytical errors in diagnostic testing -a novel concept", in the current issue of the journal [1].A valuable source of information and a topic for further discussion, the paper (a) focuses on the need for a patient-centered approach for evaluating analytical quality; (b) reinforces the utility of appropriate metrics for measuring and improving upon quality in the analytical phase of laboratory testing; (c) stresses the importance of adequately defining the uncertainty of laboratory results and related "allowable uncertainty"; (d) stresses that a closer clinical-laboratory interface relationship, particularly in the post-post-analytical phase, is needed for adequately identifying the nature of "irregular (individual) analytical errors" -and providing valuable explanations and defining any corrective actions required; (e) is conducive to including the monitoring of "irregular analytical errors" as an additional quality indicator of the IFCC model of the quality indicator (MQI) project [2][3][4].The authors state that an "irregular analytical error is given when a test result generated from a sample using a routine method deviates from the reference measurement procedure (RMP) results generated for this sample more than the measurement error estimate of the routine method" [1]. They also state that an irregular analytical error should be generated, particularly in immunoassays, by: a cross-reaction, sometimes with compounds not listed by the manufacturer; anti-reagent antibodies (e.g. heterophilic antibodies); interference in signalgeneration (e.g anti-ruthenium antibodies); high levels of compounds (e.g. biotin in streptavidin/biotin binding-based immunoassays); matrix protein interferences (e.g. due to immunocomplexes, rheumatoid factors) and several other matrix effects (e.g. differential impact of matrix factors on target analyte and internal standard in LC-MS assays).

Consolidation Of the Quality Indicator System for Clinical Laboratory Performance Improvement

“…The six health improvement objectives have been successfully acknowledged by the scientific community. Therefore, they remain key areas of work striving for assurance of the quality of medicine (Plebani, 2018a). In laboratory medicine, quality should include patient safety and clinical effectiveness.…”

“…An analysis of the scientific literature (e.g. Aita et al, 2019;Plebani et al, 2014;Plebani, 2018a) reveals a lack of ongoing research related to the development of quality indicator systems and methodologies for laboratory medicine. In addition, the developed existing international quality indicator system is not popular and widely used in the laboratory community.…”

What information on measurement uncertainty should be communicated to clinicians, and how?

“…These contain the information and knowledge from laboratory specialists that should support clinical decision-making. Quality in laboratory medicine has been defined "an unfinished journey" as further efforts should be done for better establishing and monitoring analytical characteristics based on the hierarchy of performance specifications [23] and to perform valuable quality control and quality assurance procedures. In addition to a reliable analytical result, however, the evidence collected in the last few years highlights the need for valuable extra-analytical phases, major areas of concerns being inappropriate request of laboratory tests and inappropriate interpretation of laboratory results [24].…”

Clinical laboratory: bigger is not always better

“…Quality in laboratory medicine is a never-ending quest, being defined as "an unfinished journey". After focusing on internal indicators of analytical quality and efficiency, thanks to the evidence of the vulnerability of extra-analytical phases and the need for a more patient-centered approach, efforts are shifting toward indicators of total quality, clinical effectiveness and patient outcomes with an emphasis on the benefit created for patients by "value", defined as the "outcomes achieved relative to costs" [16]. As we stated elsewhere, "quality in laboratory medicine should be defined as the guarantee that each and every step in the total testing process is correctly performed, thus ensuring valuable decision making and effective patient care" [17].…”