Qualitätsmanagement in den medizinischen Laboratorien der Schweiz / Quality management in Swiss diagnostic laboratories

Abstract

Abstract Since 1994, efforts to maintain quality assurance in Swiss medical laboratories have had a legal basis in Switzerland which allows the enforcement of measures to improve efficiency in all types of laboratories. Proof of an adequate quality assurance program is a prerequisite for all laboratories which are reimbursed by the social security system. The first phase defined measures with regard to quality assurance and quality control. In the second phase, a continuous education program was established which allowed people with different educational backgrounds PhD, MD, pharmacist) to enter the program. In Switzerland, half of the analytical volume of medical diagnostics is carried out in the practitioners laboratory. By establishing a continuous education program especially designed for practitioners and by enlarging the number of hours of training for the students in medical school, the basis of laboratory medicine should become familiar to care providers as well. Using random spot checks, the laboratories are checked annually to see if they comply with legal requirements. Laboratories which do not meet the minimum requirements are subject to sanctions: these are primarily of educational nature, but can result in the suspension of remuneration by the social security system. More than 100 laboratories from different disciplines of laboratory medicine were accredited on a voluntary basis by the end of 2003. The number of newly accredited laboratories has been declining since 2001, since most of the labs which initially wanted to implement a quality management system are already accredited. As the next step, the authorities intend to improve the quality management of the pre-analytical phase.