[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 the management of point-of care testing pre-examination, examination and post-examination phases according to the EN ISO 22870 standard]. / Recommandations pour la maîtrise des phases pré-analytique et analytique des examens de biologie médicale délocalisés.

Quality of point-of-care examinations depends on the quality assurance system settled. This paper describes the different tools used to control the pre-examination, examination and post-examination procedures taking part in the quality of patient care according to the requirements of the standard EN ISO 22870 and EN ISO 15189 as well. They include mainly: For the pre-examination phase, the sample traceability and for the analytical phase, the practice of internal quality control and the participation in external quality assessment programme.

[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.

[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.

[Management of pre-analytical nonconformities]. / Outils pour la gestion et la maîtrise des non-conformités pré-analytiques.

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. Then, methodology and indicators are proposed to assess nonconformity and to follow the quality improvements. The laboratory information system can be used instead of dedicated software. Tools for the follow-up of nonconformities scores are proposed. Finally, we propose an organization and some tools allowing the management and control of the nonconformities occurring during the pre-examination phase.

[Principles recommended to reassure the identification of the patient, the request of analysis and the report of biological results]. / Principes recommandés pour sécuriser l'identification du patient, de la demande d'analyse et du compte rendu des résultats biologiques.

The collection of a reliable identity is required for the constitution of any medical file, and biological file in particular. The regulation concerning the rights of the patient, the organization of the Social Security, and the respect of the private life must be applied. The biologist must comply with the GBEA with a special attention when it comes to transfusion. Each individual is unique and should be identified by a single number. Maximum precautions are essential as for the data confidentiality. Adapted procedures (Charter of patient collection of the identity, procedure of bringing together of the identities) with traceability of all the operations are essential but non-sufficient preliminaries. The identitovigilance recommended by the CNIL, must be implemented as well as all other already vigilances required by the law. In this context, the biologist must be particularly active. He must ensure the correct collection of the data, the description of the anomalies and the redundant data, and take into account the corrections. By its transverse position, he plays an important part and must be part of the cells of identitovigilance. It must respect its specific requirements for the corrections of identities and must be informed for any modification taking place after the biological validation. The principal recommendations making it possible to ensure the reliability of the identification of the patient and the biological file were joined together in this article by a working group from the National College of Biochemistry of the Hospitals (CNBH).