External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

OBJECTIVES: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. METHODS: Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. RESULTS: These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. CONCLUSIONS: Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

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.

[EEQ in clinical embryology: a starting program]. / Évaluation externe de la qualité en embryologie clinique : intérêt, mise en place et retour d'expérience.

Every laboratory including those working in assisted reproductive technologies have to be accredited EN ISO 15189 before 2020. This standardisation includes an external quality evaluation (EQE). In order to work out an EQE tool, we used images extracted from our own database developed during daily practice. We achieved an easily online tool called: "EEQ en embryologie clinique", developed on Biologie prospective web site with ART French biologists Association (Blefco) expertise in evaluation of early human embryonic stages. In 2013, 38 ART laboratories participate to the first program with more than 90% of appropriates results. The present article aims at describing this tool and discussing its limits.

[Evaluation of schistocytes measurement guidelines]. / Évaluation de recommandations concernant l'identification et la numération des schizocytes : une enquête du Groupe francophone d'hématologie cellulaire.

The schistocytes are fragmented red blood cells mainly observed in the setting of hemolytic anemias and particularly among the thrombotic microangiopathies. The presence of schistocytes is an important criterion for the diagnosis of mechanical anemias, though the identification of these cells remains problematic. As a high variability of the morphologic identification criteria of the schistocytes among morphologists has been observed, some guidelines have been proposed after workshops (French and Italian groups). The International council for standardization in hematology published a consensus in November, 2011. The French group of cellular hematology (GFHC) aimed to recover the opinion of French biologists directly confronted to schistocytes measurements. 169 out 500 (34%) answered 10 questions dealing with the identification and measurements of schistocytes as proposed by the ICSH guidelines. A consensus was reached for the urgent need of guidelines documents, moreover in the current background of the European accreditation NF EN ISO 15189 rules. A traduction in native (French) language as warmly wished in order to facilitate the diffusion of the information. New fragmented red cell parameter recently provided by 2 manufacturers of automated blood cell counters remained doubtfull for routine use for half of the biologists.

[The virtual slide: a new tool for the External Quality Control for the spermatozoid assessment morphology]. / La lame virtuelle : un nouvel outil pour le contrôle externe de qualité de l'analyse morphologique des spermatozoïdes.

As part of the accreditation procedures, External Quality Control (EQC) must be performed for all biological determinations. In the exploration of male infertility, the spermocytogram is very important because it is often used as first line and an error of interpretation may have dramatic consequences. Alongside the EQC which usely consists of carrying out preparation slides (stained or not), we tested the use of a slide scanned from a stained specimen ("virtual slide"). All participants (n = 57) received a sample of the following supports: an unstained slide, a stained one and a virtual slide, all of them from a single human ejaculate. The required tests were the proportion of typical forms of spermatozoa and the degree of teratozoospermia using the Multiple Abnomalities Index (MAI) according to David's criteria. Results showed that for the two examinations, the dispersion of results remains similar regardless of the support. Furthermore, results seemed no to be influenced by the staining technique. This indicates that the discrepancy between results came from the quality of the observer. Moreover, the numerical values of half the participants were situated in the interval mean of ±â€Š30% for the evaluation of typical forms and ±â€Š15% for MAI. We recommend the virtual slide for EQC spermocytogram to evaluate and improve the reading ability. In addition, we propose to retain an interval of acceptability of ±â€Š30% for the evaluation of typical forms and ±â€Š15% for MAI.

Study of the Urinary Ratio of 6 beta-Hydroxycortisol/Cortisol as a Biomarker of CYP3A4 Activity in Egyptian Patients with Chronic Liver Diseases.

The urinary ratio of 6 beta-hydroxycortisol/cortisol (6 beta-OHC/C) as a biomarker of CYP3A4 metabolizing activity has been studied in Egyptian patients with chronic liver cirrhosis associated with previous hepatic Schistosomiasis infection to determine any possible alteration in enzyme activity. The ratio of 6-beta OHC/C was determined in morning urine samples collected from 8:00 a.m. to 12:00 p.m. in healthy adults (n = 36) and patients with liver cirrhosis (n = 57). The median age for control was 27 years (range: 18-50 years) and 50 years (range: 27-75 years) for patients. 6 beta-OHC was detected in urine by ELIZA kits (Stabiligen, France). Patients with liver cirrhosis were categorized according to Child Pugh Classification into Child B (n = 28) and Child C (n = 29) classes. Cholestasis was observed in 9/28 of Child B class and 8/29 of Child C class of patients. The control subjects showed gender-related difference in the urinary ratio of 6 beta-OHC/C. A significant reduction (P < 0.001) in 6 beta-OHC/C ratio was observed only in Child C patients in comparison with control subjects. Regression analysis showed a significant correlation (P < 0.05) between 6 beta-OHC/C ratio and serum albumin. The influence of cholestasis on the urinary ratio of 6-beta OHC/C was observed on cirrhotic patients of Child B class. In conclusion, patients with chronic liver cirrhosis might have a reduction of metabolizing activity of CYP3A4 enzymes which could be identified by measuring the urinary ratio of 6 beta-OHC/C. This reduction is more apparent in severe liver injury (Child C class). Therefore, it is important to understand the metabolic fate of drugs metabolized by 3A4 enzymes in patients with liver cirrhosis to avoid drug accumulation that might lead to development of drug toxicity.

Study of urinary 6 beta-hydroxycortisol/cortisol ratio in spot urine sample as a biomarker of 3A4 enzyme activity in healthy and epileptic subjects of Egyptian population.

The ratio of urinary 6 beta-hydroxycortisol/cortisol (6 beta-OHC/FC) in morning spot urine samples collected from 8:00 a.m. to 12:00 p.m. was studied using ELIZA kits (Stabiligen) in a group of healthy adult Egyptians (control group) of both sex (n=65, age range: 16-48 years). The frequency distribution of urinary 6 beta-OHC/FC ratio was widely distributed among subjects with higher values in males in comparison to females. No bimodality in either sex was observed. Another group of adult epileptic patients (n=16) was studied for the influence of chronic carbamazepine antiepileptic drug administration on urinary 6 beta-OHC/FC ratio in spot urine samples. The induction property of carbamazepine on CYP3A4 was observed through significant increase (p=0.01) in 6 beta-OHC/FC ratio among epileptic patients in comparison with control subjects. In conclusion, the frequency distribution of urinary 6 beta-OHC/FC ratio among Egyptians shows sexual dimorphism. Also, measurement of urinary 6 beta-OHC/FC ratio provides a simple non-invasive method to monitor CYP3A4 enzyme induction during administration of carbamazepine antiepileptic drug.