Standard NF en ISO 15189: Comparative analysis with GBEA and implementation of the new reference support [Norme NF EN ISO 15189: Analyse comparative avec le GBEA et mise en place du nouveau référentiel]
Rogowski J.,Center Hospitalier |
Annaix V.,Laboratoire Pole Sante Sarthe et Loir
Annales de Biologie Clinique | Year: 2010
Within reflexions of the healthcare system in France, Ballereau's report published in 2008 suggests modifications of medical biology supports by quality. The new reference system will be ISO 15189 which provides requirements for competence and quality. It differs from GBEA (Guidelines to Good Execution of Analysis) on the requirement of a quality system management. We accomplished a comparative study of these two standards of reference to identify differences, therefore elements to be worked or supported for accreditation process.
Non-conformities management in laboratory of medical biology: Application to non-conformities of biological samples during 2009 [Gestion des non-conformités au laboratoire de biologie médicale: application aux non-conformités des prélè vements pour l'année 2009]
Annaix V.,Laboratoire Pole Sante Sarthe et Loir |
Rogowski J.,Laboratoire Pole Sante Sarthe et Loir |
Joyau M.,Laboratoire Pole Sante Sarthe et Loir |
Jaouen E.,Laboratoire Pole Sante Sarthe et Loir
Annales de Biologie Clinique | Year: 2011
The non-conformity management is required for the ISO 15189 standard. The laboratory of medical biology has to carry out suitable acts and procedures to exploit different indicators through the framework of continuous improvement. We particularly study the indicator of biological samples nonconformities and we report 2009 results to the nurses' team managers to find solutions for quality of care to the patient. Copyright 2010 American Association for Clinical Chemistry, Inc.