[Recommendations for the control of purchasing procedures]. / Recommandations pour la maîtrise des procédures d'achat.

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.

[Supplies: inventory control and reagents]. / Recommandations pour la maîtrise des stocks et des réactifs.

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.

[Post-examination phase: description and management control of the process]. / Description et maîtrise du processus post-analytique en biologie médicale.

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. This phase is a key step of the examination involved often in dysfunctions that could hardly harm the patient. These errors are usually the consequence of failing in the control of organization, lack of communication with the clinicians and defect of adaptation to their needs. Examples of quality indicators are proposed, as well as a model of clinico-biological contract.

[Guidelines for validation of the results in laboratory medicine]. / Recommandations pour la validation des résultats d'examens de biologie médicale.

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. Requirements about the content, the release and the signature of the reports are given. A quality indicator applied to the control of the validation process is proposed.

[Guidelines for advisory services and results interpretation of biological examinations]. / Recommandations concernant les prestations de conseil et l'interprétation des résultats des examens de biologie médicale.

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. A proven and regular continuing education program is needed and professional practices must be supported by recognized and recent guidelines. This document provides suggestions for advisory services traceability and reports a list of websites and articles to use in defining standardised comments as well.

[Guidelines for records control and documents retention]. / Recommandations concernant la gestion des enregistrements et l'archivage documentaire.

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. Auditing the traceability of activities being a part of the elements of verification by COFRAC evaluators, a frame form for audit is also provided for self-assessment and preparation of accreditation.

[Self assessment grid for the post-analytical phase]. / Proposition de grille d'auto-évaluation de la phase post-analytique.

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 the formation of a multidisciplinary group for point-of-care testing supervision according to EN ISO 22870]. / Recommandations pour la constitution d'un groupe d'encadrement des examens de biologie médicale délocalisés.

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.

[Guidelines for selection and implementation of a point-of-care testing device according to the EN ISO 22870 and French regulation]. / Recommandations pour le choix et la mise en place d'un dispositif de biologie médicale délocalisé.

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 point-of-care testing quality management according to ISO 22870]. / Recommandations pour la mise en place d'un système de management de la qualité des examens de biologie médicale délocalisés.

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. Finally, a questionnaire for performing an audit of POCT activities is proposed. The composition and activities of the multidisciplinary group for the supervision of POCT activities, which is also a specific requirement of EN ISO 22870, is discussed in another article of this volume.

[Guidelines for documentation management mastery according to the EN ISO 22870]. / Recommandations pour la gestion documentaire des examens de biologie médicale délocalisés.

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. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT.

[Guidelines for the management of point-of care testing nonconformities according to the EN ISO 22870]. / Recommandations pour la gestion des non-conformités des examens de biologie médicale délocalisés.

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 the point-of-care testing post-examination phase management]. / Recommandations pour la maîtrise de la phase post-analytique des examens de biologie médicale délocalisés.

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). In a second part, elements to include in POCT presentation of results are discussed and a model is proposed.

[Screening and diagnosis of gestational diabetes. Evaluation of the methodological quality of the guidelines of the Haute Autorité de Santé, of the American Diabetes Association, and of the World Health Organisation]. / Dépistage et diagnostic du diabète gestationnel: évaluation de la qualité méthodologique des avis de la Haute autorité de santé, de l'American diabetes association et de l'Organisation mondiale de la santé

We critically appraised the methodological quality of the clinical practice guideline (CPG) published by the Haute autorité de santé (HAS) about screening and diagnosis of gestational diabetes, and we compared its quality with that of two other CPGs, i.e. that of the American diabetes association (ADA) and that of the World health organisation (WHO). According to the AGREE criteria, HAS and ADA have produced CPGs that have approximately got the same levels of quality. Both these CPGs obtain AGREE scores that are better than those of WHO. Although the CPG of the HAS suffers from a few methodological drawbacks, regarding more particularly stakeholder involvement (AGREE domain n degrees 2), applicability (AGREE domain n degrees 5) and editorial independence (AGREE domain n degrees 6), this CPG summarises, and allows to compare most, if not all, other CPGs available with each other, with their possible benefits or harms, which may be useful for professionals involved in the care of the patient.

[Pre-examination phase: perimeter and process description]. / Périmètre et description de l'étape pré-analytique.

This document describes the perimeter and the content of the pre-examination phase using a process approach, i.e. a transversal and functional description of this activity. Pre-examination phase progresses trough steps differently combined according to the circumstances. Each step may be described as a sub-process characterized by an objective, intrinsic elements (beginning/end, input and output elements, upstream and downstream process, actors and technical means) and specific requirements. Ten steps have been defined from customer (patient and prescriber) information to transport. This process approach of pre-examination phase has several advantages: exhaustiveness, customer expectations listing at each step, risk to be prevented and anticipation of potential failures. We propose a tool allowing afterwards to optimize one or the other step and to secure it using procedures and monitoring based upon indicators.

[Guidelines for medical prescription of medical laboratory tests]. / Recommandations concernant la prescription d'examens de biologie médicale.

The implementation of a computer-assisted prescription is interesting for the laboratory to achieve requirements of NF EN ISO 15189 standard. The test redundancies are also studied and guidelines, founded on validated studies, are proposed. Some solutions concerning the management of orally-formulated prescriptions are given. Finally, a model of collaboration contract between the medical laboratory and the clinical unit is proposed.

[Guidelines for the order process of medical laboratory tests]. / Outils pour l'élaboration et la gestion des formulaires de demande d'examens de biologie médicale.

This document presents the requirements enumerated in the ISO 15189 standard to make reliable the formulation of a medical laboratory test order. The contents and the filling conditions of the request laboratory tests form are described, to clarify the interest of the information required. The purpose is to help to construct a specific formulation allowing the adequate realization of the laboratory tests but also to collect the needed clinical information essential to allow a relevant interpretation of the results with a goal of improvement of patient care. We present also the main forms required for special laboratory tests, particularly concerning the human genome. Finally, the criteria to be reviewed at the entry of the laboratory (contract review) during the request acceptation before its registration are enumerated.

[Guidelines relative to the collection and handling management of biological samples]. / Recommandations pour la maîtrise de l'étape de prélèvement des échantillons biologiques.

Guidelines relative to the management of samples collection and handling for common tests are proposed with a list of websites to improve knowledge concerning the practices of biological sampling. Then, methodology is given for the creation of an electronic primary sample collection manual for medical laboratory tests. A list containing the medical laboratory tests for which the information and/or particular documents are needed either for the request or interpretation is presented. Another list for some specific laboratory tests with special individual requirements is proposed. We give also items allowing a standardized description of laboratory tests to help to create a personalized list of the available examinations, facilitating the information of professionals.

[Guidelines for the pre-examination processing and transport of medical laboratory samples]. / Recommandations concernant le traitement pré-analytique et le transport des échantillons de biologie médicale.

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. The traceability of all the steps of the process is needed for the sample treatment and preservation. Then, we propose guidelines for the transport management step, according to the regulations and conditions to be applied to guarantee the sample integrity.

[Guidelines concerning sample reception and request recording of laboratory tests]. / Recommandations concernant l'accueil et l'enregistrement des échantillons de biologie médicale.

The process is described to help to achieve the requirements of the ISO 15189 standard. The precautions to be respected for a correct recording of the request are specified. The criteria for traceability are formalized. A logogram illustrates the propositions of attitude to be followed when occurs nonconformities. Then, we propose guidelines for the treatment of the identification uncertainties of the primary sample. An algorithm is proposed to formalize the process and treat the situations which can be met with an irreplaceable or critical sample.