Recommendations for the application and follow-up of quality controls in medical laboratories.

This is a translation of the paper "Recommendations for the application and follow-up of quality controls in medical biology laboratories" published in French in the journal Annales de Biologie Clinique (Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale. Ann Biol Clin (Paris). 2019;77:577-97.). The recommendations proposed in this document are the result of work conducted jointly by the Network of Accredited Medical Laboratories (LABAC), the French Society of Medical Biology (SFBC) and the Federation of Associations for External Quality Assessment (FAEEQ). The different steps of the implementation of quality controls, based on a risk analysis, are described. The changes of reagent or internal quality control (IQC) materials batches, the action to be taken in case of non-conform IQC results, the choice of external quality assessment (EQA) scheme and interpretation of their results as well as the new issue of analyses performed on several automatic systems available in the same laboratory are discussed. Finally, the concept of measurement uncertainty, the robustness of the methods as well as the specificities of near-patient testing and rapid tests are described. These recommendations cannot apply for all cases we can find in medical laboratories. The implementation of an objective alternative strategy, supported with documented evidence, might be equally considered.

[Recommendations for the application and the follow-up of quality controls in medical biology laboratories]. / Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale.

The recommendations that we formulate in this document come from LABAC, SFBC and FAEEQ. They describe the different steps from the initial application of quality controls, based on risk analysis: the changes of reagent batches or internal quality controls (IQC) batches, the course when IQC are not in accordance with references, the choice of external quality evaluation and the interpretation of its results, the comparability of results obtained in several analysers used in the same laboratory. Lastly, measurement uncertainty, robustness of methods and specificities of near-patient biology and rapid tests are described. Note that these recommendations cannot develop all cases that we could find in laboratories. It remains necessary to carry out an objective strategy, supported with documentary evidences.

Interest and limits of the six sigma methodology in medical laboratory.

The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.

Microdialysis monitoring of catecholamines and excitatory amino acids in the rat and mouse brain: recent developments based on capillary electrophoresis with laser-induced fluorescence detection--a mini-review.

1. Although microdialysis is a widely used approach for in vivo monitoring extracellular neurotransmitter concentrations, it has been previously limited in many cases by its poor temporal resolution. It is clear that when 10-30-min sampling is performed, short-lasting changes in extracellular neurotransmitter concentrations can be overlooked. Such a low sampling rate is necessary when combining microdialysis with the conventional analytical methods like high performance liquid chromatography. 2. Since capillary electrophoresis coupled to laser-induced fluorescence detection (CE-LIFD) allows the detection of attomoles of neurotransmitters, the temporal resolution of microdialysis may be significantly improved: high sampling rates, in the range of 5 s to 1 min, have been already reported by our group and others using CE-LIFD for simultaneously analyzing catecholamines and amino acids in microdialysates. 3. The power of combining microdialyis and CE-LIFD is shown, using examples of physiological and pharmacological studies dealing with the dynamics of in vivo efflux processes and/or interactions between neurotransmitters.