For the past 15 years, the laboratory medicine field has continued to exponentially evolve from one based on local and national practice to one based on globally harmonised best practices. Achieving and maintaining accreditation from an internationally recognised agency is one invaluable milestone for meeting essential quality practices. Simply stated, globally applicable standards are the international language for such a global transformation, and their use is essential to laboratories seeking accreditation. As a general rule, while accreditation requirements communicate to laboratories what to do, documentary standards frequently advise them how to do it.
Using Standards for Accreditation Preparedness
Annually, the United States Centers for Medicare & Medicaid Services Division of Laboratory Services publishes a Clinical Laboratory Improvement Amendments (CLIA) list of the top laboratory deficiencies cited during the accreditation process. The most recent summary from 2017 aggregates accreditation data from over 17,000 inspections. The most commonly cited deficiencies included such items as improper specimen storage and adequacy, improper equipment calibration verification, inadequate reagent and culture media storage, and improper patient identification. Deficiencies in personnel competency assessment were also at the top of the list.
Medical laboratory standards and guidelines provide practical advice to help laboratories address and correct deficiencies in order to achieve or maintain accreditation. These documents provide the guidance to successfully implement quality practices and address non-conformances. While accreditation requirements vary from country to country, globally accepted standards can be implemented in any laboratory, regardless of the accrediting body.
The Importance of Global Standards Harmonisation
The global harmonisation of standards is essential to the laboratory medicine field. The world has become a smaller place as a result of rapid advances in technology and ease and frequency of travel; people expect the same quality laboratory results, no matter where a test is performed. Additionally, responses to global disease outbreaks require the implementation of fast, reliable, and accurate medical laboratory testing. Indeed, every major communicable disease in the world can and should be diagnosed, monitored, and treated based on medical laboratory testing. Standards are essential tools for public health agencies responding to global epidemics (e.g., Ebola, MERS, SARS, Avian flu).
How are Best Practice Standards Developed?
There are two traditional paths to the development of international standards. One is the development of standards by national viewpoints within international forums—one nation, one vote. The International Organisation for Standardisation (ISO) is the largest standards development organisation in the world and is an example of this model. Standards developed by ISO in the field of laboratory medicine offer broad-based guidance and can be used by governments, industry, and practicing healthcare professionals to set strategy and direction for national, regional, and local best practices. The second path to global standards development involves direct participation by individuals—one person, one vote. One example is the Clinical and Laboratory Standards Institute (CLSI). CLSI is a not-for-profit, volunteer-led and driven organisation that brings together global experts to develop its standards in laboratory medicine. CLSI’s standards are developed using a consensus process which is open, inclusive and transparent. The authors of CLSI’s standards are expert volunteers and include balanced representation from government, industry, and the healthcare professions.
ISO and CLSI, as two examples, offer excellent standards and have a high degree of compatibility. In general, because of the national positions taken to develop ISO standards, they tend to be high level overarching documents which can be adapted for use at either the national or regional level. The best example of this is ISO 15189:2012; Medical laboratories—requirements for quality and competence, a quality management standard which has become the foundational standard for many national accreditation bodies. CLSI standards provide practical solutions for laboratories, and often include step-by-step processes and procedures.
Originally chartered as a US-based organisation, CLSI has evolved into a global association of 1,700+ organisational and individual members, as well as more than 2,000 volunteers—all working together to advance quality in healthcare testing. CLSI categorises its standards into nine expert committee areas:
- Automation and Informatics
- Clinical Chemistry and Toxicology
- Evaluation Protocols
- Immunology and Ligand Assay
- Molecular Methods
- Point-of-Care Testing
- Quality Systems and Laboratory Practices
At his recent talk at the MedLab Dubai Laboratory Management general session, the CEO of CLSI, Glen Fine, MS, MBA spoke about preparation for laboratory accreditation. He highlighted the importance of using best practice standards in the laboratory and researching an accreditor’s sources for top cited deficiencies. In his talk, Mr. Fine noted, “As laboratorians we should never forget that accreditation is not a destination. Rather, it is one milestone in the journey of continual improvement that we undertake for all patients.”