RISK MANAGEMENT
Introduction to risk management frameworks in clinical laboratories
Stephen MacDonald returns to the pages of Pathology in Practice with the first in a new series of articles. Here, he begins with an introduction to the subject of management of risk in the pathology laboratory environment.
Previous articles on measurement uncertainty, statistical quality control and method comparison studies have had a statistical basis for managing quality in medical laboratories. This next series is going to take these concepts to the next level – demonstrating how they reduce risk of clinical harm to our patients when implemented properly. We start with a gentle introduction to risk management here, then move onto the tools and interpretation of our processes in the context of risk in future articles. In medical laboratories, risk
management is an essential element for ensuring reliable results and safeguarding patient safety. This has always been the focus for us in the laboratory, but the transition to ISO 15189:2022 has solidified this link, with a focus very much on clinical risk. ISO 15189:2022 and ISO 22367:2020 guide laboratories with systematic approaches to identify, evaluate and control risks throughout the entire testing process.
ISO 15189:2022 establishes a
comprehensive framework for embedding risk management into the operations
of medical laboratories. This standard ensures that risk is identified, evaluated and mitigated across all phases of the laboratory testing process, enabling laboratories to deliver reliable results while minimising the potential for harm to patients. ISO 22367 offers the methodology for identifying hazards, assessing their potential impacts, and implementing controls to mitigate risks. The pre-analytical phase includes all activities leading up to the actual testing process, including patient identification, sample collection and transportation that may occur before the sample even gets to the laboratory. Common risks include incorrect patient identification, mislabelled specimens, or improper storage conditions during transport. During the analytical phase, risks are linked to method performance, equipment calibration, reagent quality, and operator competence. A lapse in method validation or equipment calibration can lead to systematic errors, potentially affecting large volumes of patient results. To address these risks, ISO 15189 prescribes regular quality
In medical laboratories, risk management is an essential element for ensuring reliable results and safeguarding patient safety
WWW.PATHOLOGYINPRACTICE.COM FEBRUARY 2025
control (QC), following validated standard operating procedures (SOPs), and continuous competence assessments for laboratory staff. In the post-analytical phase, risks emerge from the interpretation and communication of results. Transcription errors, delays in reporting critical results, or ineffective communication with clinicians can adversely affect patient outcomes. ISO 15189 calls for the establishment of clear protocols for result validation, structured pathways for urgent result escalation, and robust communication channels between laboratories and clinicians.
Embedding risk management in quality management systems A feature of ISO 15189 is the integration of risk management into the laboratory’s quality management system (QMS). Risk management under ISO 15189 is not a standalone process but an integral component of laboratory operations. Laboratories are required to develop documented risk management plans. These should include hazard identification, risk evaluation, and mitigation strategies tailored to specific laboratory workflows. Activities including internal audits and monitoring key performance indicators (KPIs) measure the impact of risk control measures and how effective they have been. By regular review, it helps to foster a risk-aware culture that prioritises actions based on identified risks, and gaps in controls to manage those risks.
Methodology for risk management
While ISO 15189:2022 defines the requirements for quality and competence in medical laboratories, ISO 22367:2020 provides a detailed methodology for implementing risk management. This
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