Quality management: illuminating the path to ISO 15189 accreditation - A view from the Republic of North Macedonia

Abstract

In the Republic of North Macedonia the work of the diagnostic medical laboratories is regulated by the Law of Health Care. There is an urgent need for better development of an evidence-based, scientific, and sustainable national strategy for the improvement of health laboratory service. Clear indicators of improvement must be established. A key indicator should be the number of laboratories that have achieved, and can maintain accreditation. The Macedonian Society of Medical Biochemistry and Laboratory Medicine (MSMBLM) recommends that the quality system established meet the requirements of the International Standard for medical laboratories (‘Medical laboratories: Requirements for quality and competence ’[EN ISO 15189:2012]), which has been accepted as the fundamental standard for the accreditation of medical laboratories in European countries. EN ISO 15189 was developed as a baseline standard for the Quality Management System (QMS) in medical laboratories and is recognised as the connecting standard for all disciplines in laboratory medicine. With the acceptance of the ISO standard, the need of countries for their own QMS for laboratory medicine no longer existed. In 2013, the Standardisation Institute of the Republic of North Macedonia accepted the standard as the Macedonian norm for quality assessment of medical laboratories (MKS EN ISO 15189:2013). MSMBLM, as the professional society of specialists in medical biochemistry, is responsible for the translation of international guidelines into national guidelines. These guidelines have to be in agreement with the standard EN ISO 15189. For that purpose, cooperation between MSMBLM and the National Accreditation Body (Institute for accreditation of the Republic of North Macedonia), as well as cooperation between international medical laboratory organisations, such as International Federation of Clinical Chemistry (IFCC), European Federation of Laboratory Medicine (EFLM) and international accreditation bodies, such as International Laboratory Accreditation Cooperation (ILAC) is essential. The accreditation of Macedonian medical laboratories is not mandatory; the decision for accreditation is voluntary. Accreditation is accessible to every client submitting an accreditation application to the Institute of Accreditation, which has been a member of ILAC since 2008. In 2013, the first medical biochemistry laboratory was accredited in the country. So far, nine medical laboratories have been accredited according the MKS EN ISO 15189:2013. Four of them are public sector laboratories. Flexible scope is not yet started for the ISO 15189 accreditation process in North Macedonia. The medicalized steps, including test’s selection advice and interpretation of results are not included in accreditation process. Diagnostic laboratories of the Institute of pathology, Medical Faculty-Skopje and Research Center for Genetic Engineering and Biotechnology “Georgi D. Efremov (Macedonian Academy of Sciences and Arts) are also using ISO 17025 as additional standard. The low number of accredited laboratories could be the result of the shortage of financial resources, poor government attention to laboratory service, the shortage of qualified personnel and/or the lack of a national laboratory policy. The experiences of laboratory professionals from accredited laboratories, who have a high level of knowledge, skills, and competence, are crucially important to the process of developing a competent laboratory service within the national health system. The implementation of the Laboratory Quality Management system (LQMS) requires support of laboratories by the MSMBLM and close collaboration between specialists in laboratory medicine (medical biochemistry), technical assessors, and consultants. Each of them will give a different perspective on what should be prioritised. Implementation of a QMS should be a stepwise process but it is necessary to start with changes that can be easily accomplished and have the biggest impact. All quality essentials must be addressed. Appropriate laboratory facilities, infrastructure, and equipment for each laboratory tier level are essential to enable safely and efficient performance. Strong programs supporting quality assurance, quality control, and quality improvement should exist. They are fundamental for the establishment, maintenance and improvement of laboratory quality systems. SOPs must be well-written, understood, and implemented; laboratory personnel should routinely perform IQCs; and laboratories must be required to participate in EQA or proficiency testing (PT) programmes. Future directions: The globalisation of markets and migration of health professionals requires improving the laboratory diagnostic process. A quality laboratory system is the foundation of a strong national health system. Laboratory workforce, infrastructure, and quality management system are vital for the delivery of quality laboratory services. Coordination with the Ministries of Education and Health is essential for maintaining standards of education and levels of knowledge. The competency of laboratory professionals has to be maintained through mandatory participation in continuous medical education (CME). For Government, Ministry of Health, professional association(s) and stakeholders, accreditation of medical laboratories according to ISO 15189:2012 should be a high priority. They should act together and undertake coordinated efforts to integrate accreditation programs into national health policy, planning, and health development programmes.