[Effect of quality assessment assurance in 2002 (before starting the German colorectal cancer screening programme by colonoscopy) on the quality of reprocessing of flexible endoscopes--a nationwide analysis].

Background: International studies in the 1990 s and the HYGEA study from Germany in 2002 revealed prevalences of around 50 % of microbiological contaminations in reprocessed flexible endoscopes. Before introducing the colorectal cancer screening programme by colonoscopy in Germany in 2002, the Kassenärztliche Bundesvereinigung (KBV) and the key stakeholders of the public health insurance system agreed on a quality assessment assurance for reprocessing endoscopes where the qualification for refund for colonoscopies from the public health system was made conditional on adequate qualifications of the gastroenterologist; on a minimum number of performed procedures per year; and on adequate endoscope reprocessing documented by negative surveillance cultures two times per year. This study is an implementation and outcome evaluation of the quality assessment assurance in colonoscopy in Germany.
Methods: The following data - per year and per Kassenärztliche Vereinigung (KV) - were obtained from the KBV: the number of endoscopic units performing therapeutic and/or screening colonoscopies within each KV; the results of all microbiological surveillance tests of reprocessing quality (two per year per unit); the number of failed surveillance tests and re-tests; and the number of qualifications for refund from the public health system cancelled due to repeated failure of microbiological surveillance tests.
Results: The percentages of actually performed hygiene control tests (out of those prescribed by the assurance system) reached 95 % already in 2004 and remained above or close to this level thereafter. After the introduction of the quality assessment assurance, the percentage of failed microbiological surveillance tests dropped significantly and steadily from close to 17 % in 2003 to below 4 % in 2007.
Conclusions: This study evidences 1. the successful implementation of the quality assessment assurance in Germany and 2. a substantial improvement in the quality of reprocessing flexible endoscopes achieved by these measures with a drop from 50 % of failed tests observed before the introduction in 2000 - 2001 to below 4 % in 2007.