Sense and nonsense in the process of accreditation of a pathology laboratory

Abstract

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.

ALK Status Assessment with Liquid Biopsies of Lung Cancer Patients

“…Currently, other approaches are being studied for determination of the ALK status in urine or with plasma microRNAs [ 49 , 50 ]. Finally, one of the major issues will be to propose robust and reproducible analytical tests to define the ALK status in blood, under the guise of quality control with accredited tests approved according to international norms [ 51 , 52 ].…”

ALK in Non-Small Cell Lung Cancer (NSCLC) Pathobiology, Epidemiology, Detection from Tumor Tissue and Algorithm Diagnosis in a Daily Practice

“…A delay in fixation also has an impact on the interpretation of ALK IHC when performed on tissue microarrays with cores removed at random from the center of a tumor that has had a delay in fixation with formalin. Thus, within the context of a quality process and accreditation of an IHC test, the validation of the method and inter-laboratory controls, which includes external evaluation of the quality, are important for this predictive marker of therapeutic response [ 61 ].…”

Liquid biopsies come of age: towards implementation of circulating tumour DNA

“…Tissue biopsies will continue to play a key role in cancer management, particularly for the histological diagnosis and classification of cancers. At present, specialised laboratories handle CTC and ctDNA samples 222 , though in future hospital laboratories may carry out analysis locally if appropriate processes can be established 223 .…”