Abstract
AbstractA number of improvement proposals and corrections of the German Rili-BAEK (Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations) are discussed with special focus on the internal and external quality assurance (IQA/EQA) as well as reference intervals for quantitative results. Particular attention is paid to reconsider the retrospective analysis of control measurements. Such an analysis can be very useful to monitor establishing errors of measurement even before they become critical. The present method “Quadratischer Mittelwert der Messabweichung (QMMA)” has proved to be ineffective. Furthermore, the current idea of a common limit for single control measures and the retrospective statistics must be revised. As a more sophisticated concept, the novel Adaptive Retrospective Monitoring (ARM) has been developed. ARM is recommended as the new minimum requirement for the entire internal quality assurance. Further proposals to enhance clarity are given concerning the release decisions of medical devices and the EQA. Individualized medicine begins with a patient-specific interpretation of analytic results. This requires standardized subgroup-specific reference intervals with smooth age-related adaptations. Only large laboratories are able to ensure the desired specificity and a sufficient statistical significance of self-developed in-laboratory reference intervals. Hence, the need of a central database for harmonized reference intervals is discussed and recommended. Suitable and consistent reference intervals are also an essential prerequisite for unitless laboratory values like the zlog value.
Highlights
Adaptive Retrospective Monitoring (ARM) is recommended as the new minimum requirement for the entire internal quality assurance
A central database of harmonized, reliable and subgroupspecific reference intervals is strongly recommended
Since the early 1970s, the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-BAEK [1, 2] contains all legally binding regulations to run a medical laboratory in Germany
Summary
Since the early 1970s, the Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations – Rili-BAEK [1, 2] contains all legally binding regulations to run a medical laboratory in Germany. The present regulations of the internal quality assurance prescribe single measurements of a control sample (SMC) and a statistical retrospective analysis (RA) of quantitative SMC data at the end of an evaluation period. Using such control samples, the internal quality assurance is able to evaluate both the imprecision and bias (i.e. inaccuracy) with regard to a predefined target value of each analyte on each platform in use.
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