Updated standard to reduce errors in medical laboratories
The reliability of laboratory results in medical settings is essential for correct diagnoses and positive clinical outcomes, so implementing measures to reduce the risk of errors should be considered an essential part of business. To assist with this, a leading guidance document for risk management in medical laboratories has just been updated.
ISO 22367, Medical laboratories – Application of risk management to medical laboratories, specifies a process for a medical laboratory to identify and manage the risk to patients and service providers that are associated with medical laboratory examinations. It has been updated to align with other International Standards in the industry, such as ISO 14971 for risk management in medical devices, and to provide more effective guidance for the sector.
The standard replaces ISO/TS 22367, Medical laboratories – Reduction of error through risk management and continual improvement, a technical specification used by governments and laboratories around the world to help reduce and manage risks associated with medical laboratory services.
ISO 22367 was developed by ISO technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. Committee Chair Dr Jack J Zakowski said risk management in medical settings is complex because it involves the cooperation of many stakeholders, and each stakeholder may have a different perspective on the risk of harm; internationally agreed and adopted standards therefore ensure adequate safety levels.
“Activities in a medical laboratory can expose patients, workers or other stakeholders to a variety of hazards, which can lead directly or indirectly to varying degrees of harm,” he said.
“Effective risk management involves a planned, systematic process that addresses both the probability of harm occurring and the consequences of that harm.
“It works best when aligned with quality and safety management to cover all possible sources of risk, which is why ISO 22367 was updated to correspond with the latest version of ISO 14971 for risk management in medical devices and ISO 15190 that provides guidance on medical laboratory safety. It is also a key requirement of ISO 15189 for the quality and competence of medical laboratories.”
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