Metrology in an ISO 15189 accredited medical biology laboratory

¹ PROCORAD Association, Commissariat à L’Énergie Atomique et aux Énergies Alternatives (French Atomic Energy and Alternative Energies Commission), Bureau du Conseiller Médical (Medical Advisor’s Office) MR/CM BP 16 92265 Fontenay aux Roses Cedex, France
² CEA DAM Laboratoire de Biologie Médicale (Medical Biology Laboratory), Île-de-France Bruyères le Châtel 91297 Arpajon Cedex, France

^⋆ Correspondence: claude.guichet@cea.fr

Received: 11 March 2014
Accepted: 17 June 2014

Abstract

All French medical biology laboratories must be accredited according to ISO 15189 for all tests conducted. Metrology is therefore critical and covers a wide variety of areas. This presentation will focus on the metrology manager’s role which is tailored to the medical biology laboratory: human resources in place, methods used, parameters followed, equipment used and strategies implemented when using equipment which is not connected to the International System of Units. It will be illustrated by examples of in vitro and in vivo clinical biochemistry, biological haematology, human toxicology and radiotoxicology. The presentation will cover the exploitation of results of internal controls and interlaboratory comparisons in order to calculate uncertainties and provide doctors with a result along with an interpretation or opinion to ensure optimum patient care. The conclusion will present the steps carried out at the Laboratoire National d’Essai (French National Testing Laboratory) to provide medical biology laboratories with certified clinical biology standards.