Standards Development

Scope

This Technical Specification provides guidance to anatomic pathology laboratories on implementing a quality system to meet technical and management requirements for quality and competence of ISO 15189.

Purpose

Anatomic pathology is often practiced in entities separate from clinical laboratories throughout the world. Although ISO 15189 is generally applicable to anatomic pathology and is successfully used by anatomic pathology laboratories, most countries use additional documents besides ISO 15189 to address accreditation of anatomic pathology. A recent online poll of ISO 15189 stakeholders initiated by the TC 212 WG1 convener found that about two thirds of the more than 1000 respondents would appreciate guidance on how to apply ISO 15189 to anatomic pathology.

Traditionally, three components comprise anatomic pathology services: histopathology (examining pieces of more or less intact tissue obtained by biopsy or excision), cytopathology (examining exfoliated or aspirated single cells or groups of cells whose architectural context is lost) and autopsy (examinations of deceased patients, usually to confirm or document extent of known disease or uncover previously undiagnosed conditions). These traditional components of anatomic pathology are often complemented by ancillary techniques such as immunohistochemical or (fluorescence) in-situ hybridization studies. Such ancillary techniques can be considered part of anatomic pathology since they utilize the tissue samples subject to anatomic pathology examinations and (fluorescent) light microscopy for evaluation. They are also typically performed by the personnel in anatomic pathology laboratories. Together with advanced genomic and proteomic testing (such as next-generation sequencing, RNA expression, mass spectrometry), in-situ hybridization to evaluate gene amplifications or rearrangements is at the increasingly blurry interface between anatomic and clinical pathology. Anatomic pathology is different from clinical pathology (or laboratory medicine, the core of which includes chemistry, microbiology and hematology) in the following ways. First, samples submitted for evaluation are usually solid and, in many instances, unique, i.e. if the sample is lost it cannot be replaced by another sample. Second, the structural integrity at the macroscopic scale matters to determine margins status or orientation. The examination process therefore almost always requires at least two steps, macroscopic and microscopic examination, and these two examinations occur at different times, usually different days. Third, processing of the sample involves many manual steps, introducing many risk points along the process. Fourth, the analytical testing phase is interpretive, performed by humans with intra- and interobserver variability and with no universally accepted biological reference intervals. The international standard ISO 15189, Medical laboratories — Requirements for quality and competence, applies to anatomic pathology. Although it has been applied successfully to anatomic pathology laboratories worldwide, uncertainty remains whether all requirements of ISO 15189 apply and how to ensure conformance with ISO 15189.

This Technical Report would provide guidance to anatomic pathology laboratories on how to meet the requirements for competence and quality particular to medical laboratories contained in ISO 15189. As a Technical Report, this document would be entirely informative in nature and not contain any requirements or recommendations. It would contain data on the “state of the art” in anatomic pathology, including process steps and risks that anatomic pathology laboratories consider when implementing ISO 15189. This document would strive to help clarify requirements in ISO 15189, especially those leaving room for interpretation in anatomic pathology (such as reference interval or measurement uncertainty), by using language and concepts familiar to anatomic pathologists. The users of this document would find central themes of ISO-based management systems (process orientation, nonconformity management, auditing, risk-based thinking) and how they can be applied to each area of anatomic pathology. 

Anatomic pathology is often practiced in entities separate from clinical laboratories throughout the world. Although ISO 15189 is generally applicable to anatomic pathology and is successfully used by anatomic pathology laboratories, most countries use additional documents besides ISO 15189 to address accreditation of anatomic pathology. A recent online poll of ISO 15189 stakeholders initiated by the TC 212 WG1 convener found that about two thirds of the more than 1000 respondents would appreciate guidance on how to apply ISO 15189 to anatomic pathology. Traditionally, three components comprise anatomic pathology services: histopathology (examining pieces of more or less intact tissue obtained by biopsy or excision), cytopathology (examining exfoliated or aspirated single cells or groups of cells whose architectural context is lost) and autopsy (examinations of deceased patients, usually to confirm or document extent of known disease or uncover previously undiagnosed conditions). These traditional components of anatomic pathology are often complemented by ancillary techniques such as immunohistochemical or (fluorescence) in-situ hybridization studies. Such ancillary techniques can be considered part of anatomic pathology since they utilize the tissue samples subject to anatomic pathology examinations and (fluorescent) light microscopy for evaluation. They are also typically performed by the personnel in anatomic pathology laboratories. Together with advanced genomic and proteomic testing (such as next-generation sequencing, RNA expression, mass spectrometry), in-situ hybridization to evaluate gene amplifications or rearrangements is at the increasingly blurry interface between anatomic and clinical pathology. Anatomic pathology is different from clinical pathology (or laboratory medicine, the core of which includes chemistry, microbiology and hematology) in the following ways. First, samples submitted for evaluation are usually solid and, in many instances, unique, i.e. if the sample is lost it cannot be replaced by another sample. Second, the structural integrity at the macroscopic scale matters to determine margins status or orientation. The examination process therefore almost always requires at least two steps, macroscopic and microscopic examination, and these two examinations occur at different times, usually different days. Third, processing of the sample involves many manual steps, introducing many risk points along the process. Fourth, the analytical testing phase is interpretive, performed by humans with intra- and interobserver variability and with no universally accepted biological reference intervals.

The international standard ISO 15189, Medical laboratories — Requirements for quality and competence, applies to anatomic pathology. Although it has been applied successfully to anatomic pathology laboratories worldwide, uncertainty remains whether all requirements of ISO 15189 apply and how to ensure conformance with ISO 15189.

This Technical Report would provide guidance to anatomic pathology laboratories on how to meet the requirements for competence and quality particular to medical laboratories contained in ISO 15189. As a Technical Report, this document would be entirely informative in nature and not contain any requirements or recommendations. It would contain data on the “state of the art” in anatomic pathology, including process steps and risks that anatomic pathology laboratories consider when implementing ISO 15189. This document would strive to help clarify requirements in ISO 15189, especially those leaving room for interpretation in anatomic pathology (such as reference interval or measurement uncertainty), by using language and concepts familiar to anatomic pathologists. The users of this document would find central themes of ISO-based management systems (process orientation, nonconformity management, auditing, risk-based thinking) and how they can be applied to each area of anatomic pathology.