Letter to the editor july august 2007

   Letter to the Editor


Contributed by Manole Cojocaru MD, PhD

RoEQALM President
mcojocar@cmb.ro


How can we improve and guarantee the medical laboratory services? What are the differences between Romania and other countries from EU? What is the best way for learning from the European experience? How should quality assurance programmes be organized? How should quality assurance be undertaken? What should quality assurance programmes accomplish? The 5th edition of the successful series of Quality Assurance in Laboratory Medicine Symposia was programmed by the Romanian Society for External Quality Assurance in Laboratory Medicine (RoEQALM) in Sibiu between 11-13 May 2007. Sibiu is European Cultural Capital in 2007. This meeting was organized with participation of INSTAND-WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine, Germany under auspices IFCC.  An exciting programme of plenary lectures and workshops has been arranged on main topic �European regulations and standardization on internal and external quality control in laboratory medicine� The purpose of this symposium was to explain the principles and significance of the EQA schemes. From abroad presented lecture were following:  Hans Reinauer, Duesseldorf, Germany �Acceptability Criteria in EQAS-accuracy and precision�, Patricia Kaiser, Berlin, Germany �HbA1c and diabetes monitoring-the reference measurement procedure and standardization�, Hans-Peter Grunert, Berlin, Germany �Internal quality control for virus diagnostics based on the INSTAND external quality assessment schemes�, Sebastian Suerbaum, Hannover, Germany � Internal quality control in bacteriology�, Klaus Janitschke, Berlin, Germany �Internal quality control in parazitology�, Claus Heuck, Duesseldorf, Germany �Performance targets in laboratory medicine�, Heinz Zeichhardt, Berlin, Germany �Waived tests for virus diagnostics�, Folker Spitzenberger, Bonn, Germany �The role of EQAS in the European vigilence system for in vitro diagnostic devices�, Michael Spannagl, Munchen, Germany, �Recommendations for testing in haemostasis and blood transfusion�, Alexander Halliassos from Dade Behring with �External quality control in internet era�.

There was also the opportunity for Romanian colleagues to display their findings through plenary presentations.

Total quality management means that every variable that could possibly affect the quality of the test results has been controlled. RoEQALM promotes efficient and effective quality assurance. Quality assurance is simply a method to determine whether a system is organized, working, and producing to its optimum level. The concept of quality in laboratory medicine contains many facets ranging from housekeeping and waste disposal to safety and management. Clinical laboratory investigations have considerably progressed during the last decade with the use of high-quality instruments and reagents. Many laboratories have instituted measures to assure quality of their results by integrating essential internal quality control steps in their day to day working and also participating in appropriate external quality assessment schemes. The main objective of quality assurance is to provide reliable laboratory data in all health care activities and to ensure inter-laboratory comparability of results. An effective quality assurance programme should cover all aspects of the laboratory. The basic aim of quality assurance is to generate the confidence of the user in the final report. This can happen only if both the product and the laboratory personnel have performed in accordance with good laboratory practices and approved standards, and tests or analyses have been validated.

In conclusion, an effective quality assurance programme should cover all aspects of the laboratory. Internal and external quality controls need to be developed. For Romania, the European experience of quality assurance is highly relevant, and therefore an appreciation and understanding of the background is essential.

I thank INSTAND for its cooperation that will contribute to the realization of a great progress in Romania.