Abstract
Part 2 of this study presents the results of the clinical audits of the "Arztliche Stelle" (AS) concerning process quality in the radiation therapy units in Baden-Württemberg, Germany. The process quality of nine main test groups (laws, organizations, technical equipment, GMP [Good Medical Practice] principles, radiotherapy, radiation procedure, follow-up, discharge report, physics) were questioned by the AS commission and evaluated in a four-stage classification (1-4; none to grave deficiencies). In 18 institutes (81%), the medical and physical-technical inspection, including radiation protection for patients and staff, revealed very high to high quality, safe treatment commensurate with current standards was guaranteed once the suggestions for improvement given by the experts had been implemented. In four institutes (18%), the inspection showed a still satisfactory quality but a shorter period for reinspection was recommended. The most frequent comments/deficiencies were found in staff structures (32%), in continuous education/training for staff (32%), in informed patient consent (41%), follow-up (45%), and/or a unclearly formulated discharge report for the referring physicians (45%). The medical and physical-technical examination of radiation treatment in the vast majority (81%) of the radiation therapy institutes in Baden-Württemberg showed a very high or high quality. Most of the comments and deficiencies concerned the sector of systematic continued training for staff, giving clear explanations to patients, structured follow-up, and the state of the medical discharge reports. These deficiencies, however, do not represent any immediate danger to the patient through any deficiencies in therapy. The experience gained by the AS could act as a model for quality improvement and could also be transmitted to other medical sectors to retain quality standards. The various specialist associations are called upon to gradually adopt the suggestions for quality improvements which are based on concrete as-is analyses by steadily aligning practice with theory. This would enable the steadily rising demands of quality assurance to be sustainably implemented through practicable models.
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