Understanding ISO 22870 – A Comprehensive Guide

What is ISO 22870? — Overview of the Standard

ISO 22870 is an international standard for Point-of-Care Testing (POST)—medical diagnostic testing performed at or near the site of patient care. Its goal is to ensure the quality, competence, and reliability of test results generated outside a conventional laboratory, whether in hospital wards, clinics, or ambulatory settings.

Historically, ISO 22870 was not a standalone document but was designed to be used in conjunction with ISO 15189—the foundational standard for quality and competence in medical laboratories. ISO 15189 supplied the overarching quality management framework, while ISO 22870 layered on the specific, detailed requirements needed to address the unique risks and operational challenges of POST.

However, with the publication of ISO 15189:2022, the requirements from ISO 22870:2016 have been fully integrated into this single, comprehensive standard, rendering the older document obsolete. As a result, healthcare organizations seeking POST accreditation must now adhere to the specific clauses within ISO 15189:2022, which consolidates all requirements into one core document.

ISO 22870 and Point—of—Care Testing (POST)

The standard governs the unique POST environment, where testing is often performed by clinical staff rather than dedicated laboratory scientists.

Point-of-Care Testing presents distinct challenges compared to traditional laboratory work. For instance, equipment is decentralized, environmental conditions are less controlled, and the personnel performing tests have other primary clinical duties. The standard’s requirements were designed to address these risks by establishing a solid framework for quality assurance. This ensures that a blood glucose reading in the emergency room is as reliable as one processed in the central lab.

Achieving this reliability depends on several key areas: rigorous device management, comprehensive operator training and competency assessment, and strict quality control protocols. To bridge the gap between near-patient testing and laboratory medicine, the standard mandates that the laboratory must oversee the entire POST service, maintaining both clinical governance and technical oversight.

Integrating these Non-specific requirements directly into ISO 15189:2022 has streamlined the accreditation process. This change reinforces a key principle: POST is not a separate, lesser form of testing but an integral extension of an accredited medical laboratory’s services. For healthcare organizations, this means quality management for POST must be woven into their overall laboratory quality system to ensure consistent standards of care.

Key Applications of POST — Procedures and Devices

Common applications of POST enable rapid diagnostics across numerous clinical settings:

• Blood glucose monitoring in diabetes clinics

• International normalized ratio (INR) testing for patients on anticoagulation therapy

• Blood gas analysis in intensive care units

• Rapid strep tests in outpatient clinics

• Urine dipsticks on hospital wards

Regardless of the device’s apparent simplicity, its implementation is governed by strict quality principles. Before any POST device is introduced for patient testing, it must undergo thorough method performance verification. This process confirms that the device performs reliably and accurately within the specific clinical environment where it will be used.

The effectiveness of these technologies is directly linked to operator competency, especially since operators are often clinical staff rather than laboratory scientists. A strong training and competency framework is therefore a cornerstone of any successful POST program.

Strategically, healthcare organizations implement POST to improve patient outcomes and operational efficiency. Many hospitals initiate projects in collaboration with clinical departments to assess the clinical, operative, and economic benefits of POST. By analyzing these outcomes, organizations can justify the use of near-patient testing and continuously refine their services, ensuring that POST delivers clear benefits beyond just the convenience of a rapid result.

Accreditation Requirements for ISO 22870

The core requirements for POST accreditation focus on several critical areas:

• Method Performance Verification: Confirming that each device performs accurately and reliably in its intended clinical setting before patient use.

• Quality Assurance: Implementing robust internal quality control (IOC) procedures and participating in external quality assessment (ERA) or proficiency testing schemes.

• Staff Training and Competency: Ensuring all operators are thoroughly trained, their skills are regularly assessed, and comprehensive records are maintained.

• Continuous Improvement: Establishing processes to monitor performance, identify areas for enhancement, and implement corrective actions to maintain high standards.

The accreditation process for POST is about demonstrating a systematic approach to managing quality outside the central laboratory. It requires a documented quality management system that proves every aspect of the testing process—from device selection and staff training to quality control and result reporting—is meticulously controlled to guarantee patient safety and the delivery of reliable diagnostic data.

Staff Training and Competency in POST

Staff competency is fundamental to a successful POST program. Because POST is often performed by diverse healthcare professionals rather than laboratory scientists, a strong training and competency assessment program is essential to mitigate risks and ensure reliable test results.

The standard mandates a structured, multi-stage approach to training. Every operator must complete comprehensive initial training on each specific device they will use before performing any patient testing. This initial training must be reinforced through continuous education, which can include online modules or practical refreshers. The standard also requires a formal reassessment of each operator’s competence at least annually to confirm their skills remain current.

All training and competency activities must be meticulously documented. The laboratory must maintain detailed records for every individual operating a POST device, specifying the training received, completion dates, and annual assessment results. This documentation is the primary evidence an auditor will scrutinize to verify that the POST service is managed by a skilled, consistently evaluated team, thereby ensuring patient safety and data integrity across all testing locations.

Challenges and Key Points in ISO 22870 Accreditation

Achieving accreditation depends on a strong quality management system designed to address the unique challenges of testing outside a controlled laboratory. Key difficulties include ensuring consistent method verification across decentralized locations, managing the continuous training of diverse non-laboratory staff, and establishing a commitment to continuous improvement.

The Future of ISO 22870 — Trends and Developments

While the standalone ISO 22870 standard is being phased out, its legacy and core principles remain essential.