Risk management in medical laboratories

The healthcare sector is one of the world’s fastest growing industries, comprising medical science, biotechnology, medical devices, services and pharmaceuticals. Research by The Economist Intelligence Unit and Deloitte indicates that while global annual health spending reached USD 7.077 trillion in 2015, this figure will soar to USD 8.734 trillion by 2020. The data shows that “ a growing elderly population in both the United States and abroad, coupled with the high average cost of providing quality healthcare to members of these groups, suggests that it will drive heightened expenses in healthcare ”. 

When healthcare systems come under pressure, it is important to ensure that patient safety remains at the same high level. Nevertheless, error and adverse events can always occur in medical procedures. World Health Organization (WHO) data and statistics for the European Union, for example, show that “medical errors and healthcare-related adverse events occur in 8 % to 12 % of hospitalizations”. According to the WHO, infections associated with healthcare also take their toll with, on average, an estimated one in 20 hospital patients affected every year (estimated at 4.1 million patients overall). The UK’s National Audit Office has estimated the cost of such infections at one billion pounds a year. 

All of this underscores the need for efficient risk management systems, for example in medical laboratories, which are a key component in healthcare. Essential work is done in these laboratories in testing clinical specimens to get information about the health of a patient regarding the diagnosis, treatment and prevention of disease. The credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs.  

ISO 22367 (in development) deals with the reduction of error in medical laboratories through risk management and continual improvement. Willem Huisman, registered in Europe as a medical laboratory specialist in clinical chemistry, is an expert on the standard, being responsible for evaluating and incorporating any revisions suggested by the project team and responding to comments received during the various voting stages.

Huisman explains that the new edition of ISO 22367 lays out quite extensively in its annexes how risk management can be applied in the medical laboratory. “It helps to understand,” he says, “how the risk management approach can really contribute to patient safety without spending more money and efforts than is necessary. It helps to focus on the processes that are most risky and to be more lenient on others.” He cites as an example the frequency of internal quality control samples: frequent where needed and less frequent where possible. The end results, he says, “can lead to lower costs in total with higher quality for patients”.

In vitro diagnostics is an important sector of the global healthcare industry, which is undergoing rapid growth fuelled by technological advancements. These medical devices and accessories help to detect infection, diagnose a medical condition and prevent disease. Huisman goes on to say that the new standard is more explicit and more in accordance with the risk management standard for manufacturers of in vitro diagnostic medical devices. This stresses the shared responsibility for reliable laboratory results. He points out, too, that the name of the standard is “intentionally changed to risk management for medical laboratories instead of tests in the medical laboratory”. It clearly stresses, he says, the importance of the processes before the examination in the laboratory (taking samples in a proper way; transport conditions). 

Huisman sums up by saying : “ The new ISO 22367 will clearly show the  medical laboratories how the concept of risk management will help  to focus on all processes in the laboratory which need attention, to  deliver the service their patients deserve, and be aware that, in some  other processes, they can be more lenient. It helps the laboratories to be more cost-efficient.” This, in turn, enhances the well-being of the general public.

This article is an excerpt from the March-April 2019 edition of ISOfocus