Medical laboratories have historically been regulated at the local or national level, and since healthcare systems do not typically extend across borders, there was little external pressure to harmonize medical laboratory regulations.
Consequently, test results obtained in a hospital laboratory in one country were often not comparable to test results obtained in another country due to different calibration standards or laboratory practices.
Now that patients have become much more mobile and may live for extended periods in different countries, the need for consistently accurate test results has grown. Healthcare experts have estimated that as many as 70 %–80 % of medical decisions are influenced by diagnostic test results. At the same time, commercial chains of clinical laboratories have started to operate across national borders and may receive blood and tissue samples to be tested that were ordered and drawn by physicians in other countries.
International Standards for quality, competence and safety in laboratory medicine offer national regulatory authorities an important alternative to prescriptive regulations.
Who is involved?
International Laboratory Accreditation Cooperation
The International Laboratory Accreditation Cooperation (ILAC) is an international cooperation of laboratory and inspection accreditation bodies formed more than 30 years ago to help remove technical barriers to trade. Accreditation to recognized medical laboratory standards has become a regulatory requirement in some jurisdictions. This ensures the impartiality and competence of the laboratories and the accuracy of test results that are relied upon for medical decisions. ILAC is a Category A liaison to ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.
International Bureau of Weights and Measures
The International Bureau of Weights and Measures (BIPM) ensures worldwide uniformity of measurements and their traceability to the International System of Units (SI). BIPM coordinates the activities of the national metrology institutes that provide the basis for accurate medical laboratory measurements over time and space. BIPM is a Category A liaison to ISO/TC 212.
Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, provides a unique forum where medical laboratory specialists, IVD research and development scientists and engineers, laboratory accreditation professionals and regulatory authorities come together to agree on standards for the quality, competence and safety of medical laboratory testing.
Professional Associations in the Field of Laboratory Medicine
Organizations such as the World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have long developed standards and guidelines for quality assurance, safety and medical laboratory accreditation. In some countries, professional medical societies assume responsibility for regulating medical laboratories and monitoring their performance. WASPaLM, IFCC and several regional professional associations are Category A liaisons to ISO/TC 212.
World Health Organization
The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. A core function of WHO is setting norms and standards and promoting their implementation. The WHO programme on in vitro diagnostics and laboratory technology is aimed at strengthening laboratory services and systems and promoting universal access to high-quality laboratory diagnostic services. WHO is a Category A liaison to ISO/TC 212.
- Clinical laboratory testing and in vitro diagnostic test systems
How is regulatory cooperation in this ﬁeld achieved?
The need for international standardization in laboratory medicine led to the formation of ISO/TC 212 in 1995. Since then, ISO 15189, Medical laboratories – Requirements for quality and competence, has become the predominant standard for accreditation of medical laboratories throughout the world. Its rapid and widespread acceptance can be attributed to the fact that virtually all relevant stakeholders participated in its development and came to consensus on the requirements.
The World Health Organization (WHO) has actively participated in the work of ISO/TC 212 since its inception and was a strong advocate for a quality management system standard for medical laboratories. National health authorities from several countries, participating as experts through their ISO member bodies, ensured that patient needs and biosafety concerns were adequately addressed. ILAC was instrumental in ensuring that the standards could be used to accredit medical laboratories on the basis of quality and competence. Companion standards developed by ISO/TC 212 are ISO 15190, Medical laboratories – Requirements for safety, and ISO 22870, Point-of-care testing (POCT) – Requirements for quality and competence.
Technical standards to ensure accurate and comparable test results were also developed collaboratively by national experts from laboratories and manufacturers working together with regulators, including metrology institutes. These standards form the basis for a flexible international calibration system that accommodates new technologies and ensures comparability of a patient’s test results regardless of where the testing was performed.
The regulatory cooperation among ISO/TC 212 stakeholders continues to support the regulatory use of ISO 15189 and supporting standards.
WHO promotes ISO 15189 as one of the best methods of laboratory strengthening and offers medical laboratories a web-based planning tool to guide them through implementing a quality management system in accordance with the requirements of ISO 15189.
BIPM maintains an extensive database of higher-order reference materials, measurement methods/procedures, and reference laboratory services, based on the globally recognized standards developed by ISO/TC 212, to support the continued accuracy of medical laboratory test results. The role of International Standards in harmonizing the regulation of medical laboratories, and ultimately ensuring the quality and comparability of patient test results around the world, has been dramatic.
- ISO 15189:2012 [Withdrawn]Medical laboratoriesRequirements for quality and competence
- Medical laboratoriesRequirements for safety
- ISO 22870:2016 [Withdrawn]Point-of-care testing (POCT)Requirements for quality and competence