The 2023 Roman Lecturer is Professor Sverre Sandberg from Norway.
Professor Sverre Sandberg is director of the Norwegian Quality Improvement Laboratory examinations (Noklus) (www.noklus.no and www.skup.org), the Norwegian Diabetes Registry, a consultant of the Norwegian Porphyria Centre (NAPOS) (www.napos.no ), and he is a professor at Institute of Global health and primary health care, University of Bergen.
He was the first chair of the Committee on Evidence-Based Laboratory Medicine and chair of The Global Campaign of Diabetes Mellitus in IFCC. From 2019-24 he is the president of the International Porphyria Network (IPNET) association. He is the current chair of the council of the International cooperation for harmonization of clinical laboratory results (ICHCLR), www.harmonization.net.
From 2012 -2014 he was president of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM). From 2009 – 2013 he was chair of the Scientific Committee in EFLM, in 2014-2015 vice president, in 2016-17 president and in 2018-19 past president of EFLM. Board member of IFCC: 2018-20. He chairs the Working Group on biological variation in EFLM and participates in some WGs and committees in EFLM and IFCC.
He has published more than 450 papers in international peer reviewed journals and has given international lectures in his fields of interest: porphyria, photobiology, evidence-based laboratory medicine, quality improvement of point of care instruments, biological variation, external quality assurance and analytical performance specifications.
LECTURE: ASPECTS OF HOW LABORATORIANS CAN CONTRIBUTE TO BETTER MEDICAL DECISIONS AND IMPROVE PATIENT OUTCOMES.
In this lecture Prof Sandberg will deal with topics that help improve the care medical laboratories provide to the patients:
- How laboratories can improve the analytical performance and the clinical interpretation of tests used for the diagnosis and monitoring of patients, with special emphasis on the importance and use of biological variation data and setting sensible analytical performance specifications which can help to guarantee that laboratory tests are fit for their intended purpose(s).
- How laboratories can provide more accessible and efficient service at the POC?
Most measurands in an individual display random variation around homeostatic set points and this is termed within-subject biological variation. The homeostatic set points vary between individuals and the variation between the set points of different individuals is termed between-subject biological variation. An understanding of these sources of variation is required to enable appropriate application of clinical laboratory measurements. Sources of evidence-based data on biological variation and tools for the appraisal of the quality of biological variation studies will be presented in the lecture. In addition, an overview of what applications biological variation data have in laboratory medicine such as the index of individuality, personal reference intervals and reference change value and where the latter is used to assess if changes in serial results from an individual can be explained by analytical and within-subject biological variation only.
How to set analytical performance specifications APS) was discussed on the 1st Strategic conference of EFLM in Milan 2014. Four models were recommended: Model 1: Based on the effect of analytical performance on clinical outcomes; Model 2. Based on components of biological variation of the measurand; and Model 3. Based on state-of-the-art. Preference has been given to models 1 and 2. In recent years a lot of work have been carried out to translate these models into useful tools for the laboratory. There are several ways of setting imprecision and bias APS. The concept of total error is heavily debated, and measurement uncertainty should be simplified for use in laboratory medicine.
POCT is the most rapidly growing field in laboratory medicine. With the advancement of technology, an increasing number of analyses can now be carried out on POC instruments. Although the costs of POC instruments are less than hospital instruments, the number of users of POC instruments are much larger, ranging from wards in the hospitals, GP offices, nursing homes to home care. The ultimate goal of using POC testing is that patient outcomes should be improved and/or that it should be more cost/effective than the use of conventional laboratory testing. To achieve this, the role of POCT in the different clinical settings as well as the responsibility for introducing and manage the instruments and use of the instruments should be clearly defined. The main reason for using a POC instrument is that a rapid result is more useful than waiting for a result from a central laboratory. The lecture will include information on how to set up a POCT quality system, who has the responsibility, should APS be the same for POC instruments as for instruments in the central laboratory and and how should quality control be carried out.