Dr. Santosh Pradhan MD, FADLM is an assistant professor at People’s Dental College and Hospital. Quality Officer and Head of Clinical Biochemistry Department at Samyak Diagnostic Pvt. Ltd., Nepal.
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Abstract 1
Laboratory quality management systems: From compliance to excellence
The clinical laboratory plays a crucial role in the health care system. Up to 85 percent of diagnosis and treatment decisions are based on laboratory results. Clinical laboratory testing hence heavily impacts clinical decision making by providing physicians and health care providers with important information needed for the prevention, diagnosis, treatment and monitoring of disease. Clinical laboratory process is not just to run a specimen through an analyzer to get a result, rather numbers of steps including pre-pre-analytical, pre-analytical, analytical, post analytical, post-post analytical phases, termed as total testing processes, need to be considered. Errors are possible in any step of these total testing processes which might impair the clinical decision-making process to great extent. So, for the accurate, reliable and timely test results and to guarantee valuable decision making and effective patient care, laboratory quality must be ensured at each and every step in the total testing process.
A laboratory quality management system (QMS) is a systematic, integrated set of activities to establish and control the work processes from pre-pre-analytical through post-post-analytical processes, manage resources, conduct evaluations, and make continual improvements to ensure consistent quality results in clinical laboratory. Total QMS ensures technical and managerial competency of a testing laboratory, with the primary focus on patient safety. Implementation of an effective QMS can help minimize the laboratory errors significantly, leading to increase in laboratory quality, consequently improving the patient care.
Abstract 2
Achieving compliance with ISO 15189 in clinical laboratories
ISO 15189: 2022 standard promotes the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories and it contains requirements for the medical laboratory to plan and implement actions to manage risks and opportunities for improvement. Benefits of this document’s approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, reducing potential harm to patients, laboratory personnel, the public and the environment. This document is intended for use in medical laboratory disciplines, including Point-of-Care Testing (POCT) supporting services; however it can be applied to users, vendors, regulatory authorities, accreditation bodies, other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services. Use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures. On top of that patient examination results get comparable between medical laboratories, regardless of city or country, when medical laboratories conform to this document.
Abstract 3
Key considerations for establishing a newborn screening program
While several countries have implemented a comprehensive Newborn screening program, numbers of developing countries are still struggling to establish it. The reasons for this might be the lack of awareness regarding the burden of undiagnosed and untreated congenital disorders including inborn errors of metabolism, the cost of newborn screening (NBS), socio cultural aspects, lack of facilities for NBS testing, accessibility to health care centers, and difficulties in follow up. There are lots of studies done in these countries which show quite high prevalence of disorders including congenital hypothyroidism, congenital adrenal hyperplasia, hemoglobinopathies. The disability rates of these countries are also significantly high. On top of these, developing countries are facing challenges to reduce the neonatal and infant mortality rate as per United Nation Sustainable Development Goals. Overlooking NBS might have some associations with this. Early diagnosis and intervention will definitely make it possible to decrease neonatal morbidity and mortality. The World Health Assembly resolution 2024 encourages member states to develop newborn screening for birth defects, including defects in body chemistry. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00335-8/fulltext
Achieving significant health gains from newborn screening requires development of a system comprising healthcare professionals (paediatrics, obstetric/maternity, public health, laboratory medicine), healthcare funders (government, insurance, charitable foundations), communities and families. Organizing close country meetings will establish the foundation for newborn screening in these countries by formalizing links between the various entities working to establish screening and providing Continuing Medical Education (CME) to the wider medical community to bridge the current knowledge gap and lay the foundation for a national screening strategy.