ISO 22870-2016 PDF

Full title and description

ISO 22870:2016 — Point-of-care testing (POCT) — Requirements for quality and competence. This International Standard sets out specific requirements for the quality and competence of point‑of‑care testing performed in healthcare settings and is intended to be used together with ISO 15189 (medical laboratories — requirements for quality and competence).

Abstract

ISO 22870:2016 provides requirements and guidance tailored to point‑of‑care testing (POCT) activities carried out in hospitals, clinics and other healthcare organisations that provide ambulatory care. It addresses management and technical aspects necessary to ensure reliable POCT results, including organisation, personnel competence, equipment and reagent management, quality assurance and performance monitoring. The standard excludes patient self‑testing in home/community settings, although some elements may be applicable to those contexts.

General information

• Status: Withdrawn (requirements incorporated into later editions of ISO 15189 and reflected in national/adopted versions).
• Publication date: November 2016 (Edition 2).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 03.120.10; 11.100.01 (quality management / laboratory medicine).
• Edition / version: Edition 2 (2016).
• Number of pages: 11 (official ISO publication summary).

Scope

The standard applies to point‑of‑care testing performed in healthcare organisations (for example hospitals, clinics and ambulatory care providers) and covers measurements performed at or near the patient, including transcutaneous measurements, analysis of expired air and in‑vivo monitoring of physiological parameters. It is intended to be used in conjunction with ISO 15189 and focuses on areas where POCT differs from central laboratory testing. Patient self‑testing at home or in community settings is explicitly excluded, although some requirements may be relevant.

Key topics and requirements

• Management requirements: roles and responsibilities for POCT governance, organisational structure, policies and documented procedures.
• Competence and training: initial competence assessment, ongoing training, authorization of operators and record keeping.
• Technical requirements: device selection, verification/validation of methods, maintenance, calibration and performance monitoring.
• Quality assurance and quality control: internal QC, external quality assessment / proficiency testing, corrective actions.
• Pre‑analytical and post‑analytical processes: specimen handling, patient identification, result recording and reporting, critical result management.
• Information management and connectivity: data capture, secure transfer, integration with laboratory/clinical information systems and traceability.
• Safety and environment: infection prevention, safe disposal of sharps and waste, suitable testing environment and ergonomics.
• Documentation and records: control of documents, retention of records and auditability for accreditation.

Typical use and users

Used by hospital laboratories, clinical departments, POCT coordinators/managers, quality and compliance teams, accreditation bodies, clinical engineers, device manufacturers and healthcare organisations implementing or auditing POCT services. It is applied during setup of POCT programmes, accreditation assessments, internal audits and when defining training and quality assurance processes for bedside testing.

Related standards

ISO 15189 (medical laboratories — requirements for quality and competence) — companion/superseding standard; earlier edition ISO 22870:2006 (previous edition); national/adopted versions (EN ISO 22870, NF EN ISO 22870, DIN/EN ISO 22870, etc.). Guidance documents and technical best practice from clinical laboratory and POCT organisations (for example CAP, CLSI and national accreditation bodies) are frequently used alongside this standard.

Keywords

point-of-care testing, POCT, bedside testing, quality management, competence, accreditation, ISO 15189, verification, quality control, training, clinical testing

FAQ

Q: What is this standard?

A: ISO 22870:2016 is an International Standard that specifies requirements for quality and competence in point‑of‑care testing performed in healthcare organisations; it is intended to be used with ISO 15189.

Q: What does it cover?

A: It covers management and technical requirements specific to POCT — including governance, operator competence, device selection and maintenance, method verification, quality control and result reporting — and clarifies how POCT activities should be managed to ensure reliable patient results.

Q: Who typically uses it?

A: Hospital laboratories, POCT programme managers, clinical departments performing bedside testing, accreditation assessors, quality managers and device manufacturers use the standard when establishing, operating or auditing POCT services.

Q: Is it current or superseded?

A: ISO 22870:2016 has been withdrawn as a standalone active standard in favour of aligning POCT requirements within the medical laboratory accreditation framework (notably ISO 15189 revisions). For implementation and accreditation purposes organisations should refer to the current ISO 15189 edition and national/adopted versions that incorporate POCT requirements.

Q: Is it part of a series?

A: It is a companion standard to ISO 15189 (medical laboratories) and has been published/adopted in regional forms (EN ISO 22870, national versions). It follows the laboratory/medical quality management suite rather than a numeric series of unrelated topics.

Q: What are the key keywords?

A: Point‑of‑care testing, POCT, bedside testing, quality assurance, competence, accreditation, verification, quality control, ISO 15189.