[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 results reports of biological examinations]. / Recommandations concernant la transmission des résultats d'examens de biologie médicale.

This article presents recommendations for results reports after release by authorized person to fulfill the French regulation and ISO 15189 requirements. This document points out who can be authorized to communicate the reports and to whom. The advantages and disadvantages of the different ways to use for results report are discussed, as traceability and confidentiality rules to apply. Particular situations as critical values to report and correction of transmitted erroneous results. A table summarizes the different modalities available to communicate the results of examinations performed by the laboratory.

[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.