[Impact of a in situ laboratory on physician expectancy].

Biological examinations are essential for clinicians' medical care. The aim of this study is to assess clinicians' expectations in healthcare facilities and their perception of medical biology in different types of organization. We performed a prospective transversal study by electronic questionnaire conducted among 242 practitioners in four healthcare facilities.

[Hemolysis interferences on frequently required stat analysis: a French multicentric study].

Hemolysis should lead to changes in test results. Our study evaluated the impact of hemolysis on 26 blood measurements of stat biochemistry markers (sodium, potassium, chloride, urea, creatinine, glucose, total protein, calcium, magnesium, inorganic phosphorus, uric acid, C-reactive protein, total bilirubin, ASAT, ALAT, LDH, creatine kinase, alkaline phosphatase, γ glutamyl-transferase, lipase, alcohol, iron, β hCG, troponins, natriuretic peptides) determined with 13 different types of instruments in 17 hospital laboratories. Four pools of samples (collected from lithium heparin or EDTA or sodium fluoride tubes, according to the measured parameters) were overloaded with five increasing concentrations of whole blood lysate (final concentration from 0 to 2.

Gender and gender role differences in self- and other-estimates of multiple intelligences.

This study examined participant gender and gender role differences in estimates of multiple intelligences for self, partner, and various hypothetical, stereotypical, and counter-stereotypical target persons. A general population sample of 261 British participants completed one of four questionnaires that required them to estimate their own and others' multiple intelligences and personality traits. Males estimated their general IQ slightly, but mathematic IQ significantly higher than females, who rated their social and emotional intelligence higher than males.

[Supplies: inventory control and reagents].

The main relevant features useful for the management of reagents and consumables as well as documents to be developed to meet the requirements of the accreditation standard ISO/FDIS 15189-2012 are listed. This article is intended to help the medical laboratory to get mandatory accreditation.

[Recommendations for the control of purchasing procedures].

The main relevant and useful process purchase choice of equipments and supplies as well as supplier evaluation are presented. Documents to develop to meet the accreditation standard ISO/FDIS 15189-2012 are listed. This article is intended to assist the biologist in his approach to mandatory certification.

[Recommendations for the prescription, implementation and interpretation of medical examinations in biology in the context of severe poisoning].

A multidisciplinary working group named "Toxicology and clinical biology" and whose members belong to the French Society of Clinical Biology (SFBC), Critical Care Medicine Society of French Language (SRLF), the French Society of Medical Emergency (SFMU), the French Society of Analytical Toxicology (SFTA), the Society of Clinical Toxicology (STC), and the National College of Biochemistry (CNBH) updated the professional practice recommendations published in 2003. These recommendations aimed the biologists who are not specialized in toxicology and more largely all the health professionals involved the management of severely poisoned patients. Among the data published in the initial edition, only the major table dealing with severe poisonings was updated, as all other supplements remained valid.

[Guidelines for the point-of-care testing post-examination phase management].

For point-of-care-testing (POCT), the French regulation on medical biology states allows a unique situation where a delayed validation of results is possible. This paper proposes guidelines to organize POCT post-analytical phase in agreement with the local regulation and ISO 22870 requirements. In the first part, organization of POCT validation is detailed (since analysis results reading by the physician until validation of results by the medical biologist and their integration into the patient record).

[Guidelines for the management of point-of care testing nonconformities according to the EN ISO 22870].

In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events are proposed. In the second part, we propose recommendations in case of unavailability of a point-of-care testing device from the occurring of the adverse event, to the restarting of the device.

[Guidelines for documentation management mastery according to the EN ISO 22870].

This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit.

[Guidelines for point-of-care testing quality management according to ISO 22870].

In this paper, we focus on the additional requirements of EN ISO 22870 compared to those described in Chapter 4: Quality Management of EN ISO 15189. They concern the quality policy, the management reviews and the audits. Thus, we propose a template of quality policy statement, and specific requirements for conducting management review of POCT are given.

[Guidelines for selection and implementation of a point-of-care testing device according to the EN ISO 22870 and French regulation].

Implementation is the main step of the point-of-care testing (POCT) device installation process to comply with EN ISO 22870. The multidisciplinary POCT management group is in charge to align that process with the standards but also with the French regulation (ordinance 2010-49 of 13 January 2010) which authorizes POCT only in case of urgent therapeutic decisions. This article defines two reports to be prepared during the deployment of a POCT device : a report that justifies the use of a POCT device, taking into account a risk-benefit analysis and a report that justifies the choice of the device including proofs of conformity of its installation.

[Guidelines for the formation of a multidisciplinary group for point-of-care testing supervision according to EN ISO 22870].

EN ISO 22870 requires the medical laboratory director to form a multidisciplinary group for the management of point-of-care testing activities and to appoint a person responsible for this group. This article proposes to define the composition (representatives of the medical laboratory, care units owning point-of-care devices, administration), missions (introduction, follow-up and evaluation of point-of-care devices) and the decision circuit of this group and to describe the profile of the head and the tasks assigned.

[Self assessment grid for the post-analytical phase].

This document is a proposal of questionnaire for a self-assessment of the post-examination phase: results validation, reporting and transmitting, post-examination samples keeping and documents archival storage. The questions allow to check that the laboratory fulfils the ISO 15189 Standard and COFRAC SH REF 02 document, French regulatory requirements and more generally, satisfaction of its clients. This document can be used as it is or can be adapted to implement internal audit grids.

[Guidelines for records control and documents retention].

The quality management system is based on records to maintain, according to the requirements of ISO 15189 standard and those of the French regulation as well, to ensure traceability of data. This article provides the nature of information and documents to be stored by the laboratory and the time they have to be maintained according to the French regulation. Moreover, it provides recommendations for the management and the control of records.

[Guidelines for advisory services and results interpretation of biological examinations].

The "medical biologist" has to play a role as a consultant for the relevant use of biological examinations and to provide comments for their interpretation, comprehensible and useful to physicians. Advisory activities of the medical laboratory may help physician in diagnosis or therapeutic algorithm, avoiding ordering incomplete or useless examinations. After presentation of regulation and requirements of the EN ISO 15189 standard, this paper gives proposals for recommendations to apply in the context of accreditation.

[Guidelines for validation of the results in laboratory medicine].

The validation of the results is defined as the review and verification of the coherency and likelihood of the whole results of the examination for a patient, taking into account needed clinical data, uncertainty of measurement and anteriority's as well. The signature of the authorized person certifies this validation according to the requirements of the French regulation and ISO standard as well. Recommendations are given for the organization of this step specially for duty periods and in case of utilization of an expert system software.

[Post-examination phase: description and management control of the process].

This article defines the scope of the post-analytical process. This process transforms the results after quality control review into validated results, interpreted by authorized "medical biologists", reported and communicated to the clinicians and patients. This phase includes the treatment of the samples after analysis, their storage and disposal and records archiving.

[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out.

[Evaluation of the AFSSAPS clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine (2009), in comparison with those of the American College of Chest Physicians (ACCP 2008) with the help of the AGREE tool].

We have evaluated the methodological quality of the AFSSAPS French clinical practice guidelines on prevention and treatment of thrombo-embolic disease in medicine, published in 2009. We have evaluated in parallel the similar recommendations from north-America on the subject (ACCP 2008). Our evaluation tool was the AGREE instrument which is consensual at an international level, in particular at the WHO (World Health Organisation) and at the European Union.

[Useful web sites for information about the recommendations of good practices in laboratory medicine].

In this paper are presented some useful web sites to find updated reference tables concerning the recommendations of professional practices in laboratory medicine. The knowledge of these reference tables can allow the biologist to develop its role of advice to the clinicians. It can also help him to assure a relevant interpretation of the laboratory results and to value the interest for the patient.

[Self assesment grid for pre-examination phase].

This document is a proposal of questionnaire for self-assessment of pre-analytical phase referring to the different steps described in the document SG1-01. The questions are aimed at verifying that what is examined fulfills ISO 15189 standard requirements or in general tends towards client satisfaction. This questionnaire has been elaborated using 5 M risk assessment tool for exhaustiveness purpose.

[Interpretative analysis of the ISO 15189 standard: pre-examination phase].

We described the requirements of chapters 4.7 and 5.4 of the standard into action to be realized, documents to be drafted, traceability to be assured with proofs, mandatory.

[Guidelines concerning stat laboratory process].

After a definition of the various emergency situations, vital or organizational, the paper describes the process of urgent laboratory tests requests from the medical prescription until the return of the interpreted results to the clinician. The intervention options of the various professionals to optimize and assure the control of the process 24 hours a day and 7 days/7 are presented. Then, a list of validated available stat tests is proposed.

[Management of pre-analytical nonconformities].

The main nonconformities enumerated to facilitate consensual codification. In each case, an action is defined: refusal to realize the examination with request of a new sample, request of information or correction, results cancellation, nurse or physician information. A traceability of the curative, corrective and preventive actions is needed.

[Guidelines for the pre-examination processing and transport of medical laboratory samples].

We resume here the guidelines about sample processing and transport for laboratory tests. All the steps of the pre-examination phase process, downstream to the recording of the requests, are described in this document. The purpose is to assure a secure and optimal sample management.