[Presentation for the use of a clinical laboratories of standards of metrology (Document A)]. / Présentation, à l'usage des laboratoires d'analyses de biologie médicale, des normes de métrologie (Document A).

Clinical laboratories shall have a perfect control of "in vitro diagnostic medical devices" to ensure the quality of their analytical results. This introductory presentation to a serie of documents of recommendations tackles the different standards of metrology concerning the requirements to reference materials, metrological traceability, metrological confirmation, management of measurement as well as uncertainty of measurement. The standards concerning clinical laboratories are then succinctly described.

Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.

Recent activities of EC4 in the harmonization of clinical chemistry in the European Union.

This article describes the recent activities of the European Communities Confederation of Clinical Chemistry (EC4). Main goal of EC4 is harmonization of clinical chemistry in the European Union and Europe. EC4's actions connected to that are training and registration of professionals, and accreditation of laboratories. The 35000 professionals practising clinical chemistry in the EU have different backgrounds (medical, pharmaceutical, science-oriented, veterinary, or microbiological). Thus, for the harmonization of training of clinical chemists, EC4 has published a European Syllabus for Postgraduate Training, and instituted a European Union Register for Clinical Chemists. The Syllabus is an indication of the level of requirements in postgraduate training. The EC4 initiative to implement the European Register for Clinical Chemists is based on the 8 years vocational training necessary to obtain sufficient knowledge in clinical chemistry according to the European Syllabus. A guide to the EC4 Register has been published; registration leads to the title European Clinical Chemist (EurClinChem). The accreditation of laboratories must be based on a total quality management system. EC4 has described guidelines (essential criteria) which it judges appropriate for establishing the quality of medical laboratory service; it does not wish to fulfil the role of an accrediting body. Moreover, a working group has been set up to seek to harmonize the work of national accrediting bodies. Therefore, it is logical that EC4 monitors the activities of the different standardizing bodies that might influence the practice of clinical chemistry in the EU. Finally, some aspects concerning the future strategy of EC4 are brought forward.

Additional Essential Criteria for Quality Systems of Medical Laboratories. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

Essential Criteria for Quality Systems of Medical Laboratories have been published recently by the European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation. The Essential Criteria address the majority of critical aspects of quality management in the medical laboratory. They have been accepted by the EC4 General Assembly and are endorsed by the Forum of European Societies for Clinical Chemistry (FESCC). However, a supplement to the Essential Criteria was necessary, addressing two aspects, which are only partly covered by the Essential Criteria: the management of resources and point of care testing. Thus, the EC4 Working Group on Harmonisation of Quality Systems and Accreditation has decided to formulate Additional Essential Criteria for Quality Systems of Medical Laboratories, directed at the issues of management of resources and point of care testing. Criteria on management of resources address financial aspects, information logistics and acceptance by clients. Criteria on point of care testing address responsibilities, education of non-laboratory staff and operational aspects. The Additional Criteria are supplementary to the previously published Essential Criteria and should be read as an integral part of these.

The influence of psychological factors on the outcome of the fertilization step of in vitro fertilization.

Our objective was to determine whether psychological factors have an influence on the outcome of the fertilization step of in vitro fertilization (IVF) trials. The design was a prospective cohort study. We studied 48 women and 32 of their spouses. Each subject was assessed psychologically on the day before oocyte retrieval (OR) with the Child Project Questionnaire (CPQ) and the Ways of Coping Checklist. In addition, the State-Trait Anxiety Inventory was filled in by subjects 2 days before OR, and the State form was completed again for 6 additional days. The outcome measure was the success of the fertilization step. Logistic regression analysis was used to test the influence of psychological factors while taking into account the effect of medical and sociodemographic variables. The following variables were found to be statistically significant predictors of fertilization: normal sperm; tubal lesions or occlusion; women's factor II of the CPQ, i.e. Perception of Marital Harmony in the Project to Conceive a Child. We conclude that, even when the influence of biomedical variables is taken into account, the women's Perception of Marital Harmony in the Project to Conceive a Child, is a statistically significant predictor of the success of the fertilization step of IVF.

[Seasonal variation in sperm characteristics]. / Variations saisonnières des caractéristiques du sperme.

In all species, seasonal patterns in fertility are observed. In humans, seasonal variations of pregnancies are observed in spontaneous reproduction or in IVF. The most important factor seems to be sperm values and specially the morphology. Our study, on 188,075 cases (FIVNAT 1987-1995) shows significant variations of semen characteristics: we observe, in August, an improvement of sperm morphology.

Essential criteria for quality systems in medical laboratories.

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accrediation schemes are also operating. The standards of these schemes have much in common although several differences exist. There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards. Particulary in the European Union, harmonisation of criteria for quality systems is desirable. In the present paper, the document entitled "Essential Criteria for Quality Systems in Medical Laboratories" is presented. The document has been accepted in the general Assembly of the European Communities Confederation of Clinical Chemistry (EC4) and by the working group on Good Laboratory Services of the European Council on Laboratory Medicine (ECLM). The criteria in the document are focussed on the particular situation of medical laboratories, including pre- and post-analytical aspects. Reference is made, where applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.

[Microinjection in France: report of the BLEFCO multicentric study]. / La micro-injection en France: rapport de l'enquête multicentrique des BLEFCO.

In order to evaluate the assisted fertilizations in France, BLEFCO association has analysed 436 and 1,781 attempts for SUZI and ICSI respectively. For SUZI, the transfer rate was 62% and the pregnancy per attempt rate was 10%. For ICSI, whatever indications, the transfer rate was 86% and the pregnancy per attempt rate was 21%. ICSI in cases of altered sperm without previous IVF represented 46% of ICSI attempts. No relationship between the transfer rate and the indication of ICSI has been observed. However, in case of unexplained fertilization failures, the pregnancy per attempt rate is significantly lower when compared to the other indications.