Quality Assurance in Radiation Therapy in Germany – Attempt to Assess the Current Status and Challenges Using an Example of a German Hospital

Purpose The aim of this paper is to identify requirements for quality assurance in radiation therapy in Germany. Method The identification of quality assurance requirements in radiotherapy is based on an example of a radiotherapy provider of maximum care in Germany. The requirements were identified by analyzing the regulatory literature and the two most common certifications in radiotherapy in Germany by OnkoZert and according to the DIN EN ISO 9001:2015. The measures are placed in a hierarchy regarding their legal obligation and structured based on an inductively formed category system. Results 89 measures for quality assurance in radiotherapy were identified. 70% of the measures are legally binding, while 30% are based on certifications by OnkoZert and certifications in accordance with DIN EN ISO 9001:2015. Most measures are required in patient management. 53 out of 89 measures are required or reviewed by one institution. 27 are checked by two separate institutions. Conclusion Requirements for quality assurance in radiotherapy are extensive and cause high bureaucratic burden, caused by the high number of tasks. There is currently insufficient evidence for the effectiveness of many of the required quality assurance measures. Germany also lacks a generally recognized standard for the organization of quality assurance programs in radiation oncology. In future, evidence for efficiency and a consensus for a valid standard of quality assurance should be found.