In light of the Coronavirus pandemic, the reliability and accuracy of medical laboratories have never been so critical. Faults and errors cannot be allowed to occur as false-negative COVID-19 tests can leade to further spread of the virus and can have a devastating effect on communities and entire countries. During the current global circumstances, robust risk management processes are a necessity as they are our best defence against these false results and errors from occurring. It is for this reason one of the world’s most trusted guidance documents for risk management in medical labs has been updated.
ISO 22367, Medical laboratories – Application of risk management to medical laboratories, is a standard that specifies a process for medical labs to identify and manage the risk to patients and service providers that are associated with lab examinations. The standard replaces ISO/TS 22367, Medical laboratories – Reduction of error through risk management and continual improvement which is used by governments and labs across the globe to ensure the reduction and management of risks associated with laboratories.
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The updated standard lays out how risk management can be applied in medical labs as well as helps to understand how risk management can contribute to the safety of patients without extra costs or more effort than is necessary. It helps those who adhere to the standard to focus on processes that are the riskiest as well as to be more lenient on others. This standard can lead to lower costs and higher quality for patients. This is due to the fact that activities in medical labs can expose patients, workers or stakeholders to a range of hazards which can directly or indirectly lead to varying degrees of harm.
The new standard has been designed to clearly show those working in medical laboratories how risk management can help to focus on all processes taking place within the labs which need attention and to be aware that in some processes, they can be a bit more lenient. This standard will help labs deliver the service their patients need and deserve as well as be more cost-effective, which can positively affect the general well-being of the public.
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