Sense and nonsense in the process of accreditation of a pathology laboratory.
The aim of accreditation of a pathology laboratory is to control and optimize, in a permanent manner, good professional practice in clinical and molecular pathology, as defined by internationally established standards. Accreditation of a pathology laboratory is a key element in fine in increasing recognition of the quality of the analyses performed by a laboratory and in improving the care it provides to patients. One of the accreditation standards applied to clinical chemistry and pathology laboratories in the European Union is the ISO 15189 norm. Continued functioning of a pathology laboratory might in time be determined by whether or not it has succeeded the accreditation process. Necessary requirements for accreditation, according to the ISO 15189 norm, include an operational quality management system and continuous control of the methods used for diagnostic purposes. Given these goals, one would expect that all pathologists would agree on the positive effects of accreditation. Yet, some of the requirements stipulated in the accreditation standards, coming from the bodies that accredit pathology laboratories, and certain normative issues are perceived as arduous and sometimes not adapted to or even useless in daily pathology practice. The aim of this review is to elaborate why it is necessary to obtain accreditation but also why certain requirements for accreditation might be experienced as inappropriate.
Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, University of Nice Sophia Antipolis, 30 Voie Romaine, 06001, Nice, Cedex 01, France.
Elodie
E
Long-Mira
Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, University of Nice Sophia Antipolis, 30 Voie Romaine, 06001, Nice, Cedex 01, France.|Hospital-Related Biobank (BB-0033-00025), Biobank06, Pasteur Hospital, University of Nice Sophia Antipolis, Nice, France.
Kevin
K
Washetine
Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, University of Nice Sophia Antipolis, 30 Voie Romaine, 06001, Nice, Cedex 01, France. hofman.p@chu-nice.fr.|Hospital-Related Biobank (BB-0033-00025), Biobank06, Pasteur Hospital, University of Nice Sophia Antipolis, Nice, France. hofman.p@chu-nice.fr.
Paul
P
Hofman
D000068:Accreditation / Q000592:standards*; D005062:European Union; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010338:Pathology, Clinical / Q000592:standards*; D057089:Pathology, Molecular / Q000592:standards*
Accreditation; Clinical pathology; Constraints; Molecular pathology; Norm ISO 15189