Clinical laboratories standards help to embed excellence in medical laboratory testing. Clinical laboratory services are a crucial part of the pharmaceutical industry. They find significant application in drug discovery and development, toxicology testing, bioanalytical and lab testing, clinical and preclinical services, and cell and gene therapies.
Upholding quality and safety in laboratory practices
Discover how standards support the work of clinical laboratories in the pharmaceutical sector
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How standards help manage risk in medical laboratories
The pharmaceutical sector is one of the world’s fastest growing industries. Research by The Economist Intelligence Unit and Deloitte 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, 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. However, errors 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 1 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 patients relying on the testing services provided by these labs. To read about the topic of managing quality within the pharmaceutical sector, click here. Key Risk Management Standards for Medical Laboratories Standard BS EN ISO 22367 covers the reduction of error in medical laboratories through risk management and continual improvement. This document specifies a process for risk management in medical laboratories to identify and control the risks to patients, laboratory workers, and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling, and monitoring the risks. The requirements of BS EN ISO 22367 are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record, and other technical and management processes described in BS EN ISO 15189. BS EN ISO 22367 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by BS EN ISO 31000, such as business, economic, legal, and regulatory risks. BS EN ISO 22367 lays out extensively in its annexes how to apply risk management best practices in medical laboratories. It helps healthcare organizations to understand how their risk management approach can contribute to patient safety, without requiring them to spend more money and effort than necessary. There is no doubt that using standards can help you to effectively manage risk in medical laboratories, building crucial trust between you and the rest of your supply chain. With a BSI Knowledge subscription, quality, risk management, and compliance are at your fingertips. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module for instant access to over 4,800 documents. Request to learn more. Ensure your laboratory is minimizing risks by adopting standard BS EN ISO 22367 today.Read more
Key Clinical Laboratories & Testing Standards for Pharmaceuticals
