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

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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. Radiotherapy quality assurance quality management structure certification Figures Figure 1 Figure 2 Figure 3 Introduction Radiotherapy, especially in the context of treating oncological patients, is multifaceted and associated with great responsibility. Due to the technical and clinical complexity, the potential for harm to patients and practitioners from radiation, and the fact that these therapeutic procedures are often of critical importance to oncological patients, quality assurance is highly relevant in radiotherapy [ 5 , 6 , 7 ]. Requirements in quality assurance in radiotherapy depend on different characteristics of the radiotherapy, e. g. the hospital owner, range of treatment or certifications. The aim of this paper is to illustrate as much intersection as possible of the required measures. The following regulatory documents contain requirements for every radiotherapy in Germany and measures because of two often achieved certifications. One exception is the Landeskrebsregistergesetz NRW (LKRG NRW) (State Cancer Register North Rhine-Westphalia). Every Federal State in Germany has its own law regarding the Landeskrebsregister (State Cancer Register), so the LKRG NRW is used as an example in this paper. The Strahlenschutzverordnung (Radiation Protection Ordinance) stipulates that medical indications must be justified and determined in accordance with current scientific knowledge [ 8 ]. The increasing interdisciplinarity as well as recent developments in personalized medicine have led to increasingly complex treatments. To comply with the current state of scientific knowledge, official guidelines have been drawn up, such as the Leitlinie der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF) (Guidelines of the Association of the Scientific Medical Societies in Germany), which has been developed in collaboration with the German Society of Radiation Oncology. These guidelines serve as a basis on which treatment indications can be justified [ 9 , 10 ]. In addition, medical staff in radiation oncology is obligated having constantly updated specialist knowledge through regular training courses. In parallel to medical conceptual aspects, the increasing technical complexity of radiotherapy must be considered. Technically and physically high-quality treatment devices and image-guided planning options allow medical staff to have more precise treatment options. However, they also require a continuously increasing level of understanding and maintenance. The physical quality control of devices is a major component of radiation therapy and includes condition and constancy tests, as well as regular external testing by experts to ensure precise and reliable delivery of irradiation. In addition, radiation planning is checked by the department's internal medical physics department as part of physical quality control [ 8 , 10 ]. Finally, radiation protection is of great importance for both patients and practitioners due to the use of high-energy radiation from radioactive sources, accelerators or teletherapy devices. The risk of misuse of radiation sources must also be counteracted [ 11 ]. The increasing importance and complexity of quality management in radiotherapy is reflected by the development in legal specifications. The Gesetz zur Neuordnung des Rechts zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Act on the Reorganization of the Law on Protection Against the Harmful Effects of Ionizing Radiation) was passed in 2017 and contains the Strahlenschutzgesetz (StrlSchG) (Radiation Protection Act). Requirements for radiation protection are formulated in 218 paragraphs. The first Strahlenschutzverordnung (StrlSchV) (Radiation Protection Ordinance) was passed in 1960 with 58 pages [ 12 ]. Since 2011, the StrlSchV has been concretized by the Richtlinie Strahlenschutz in der Medizin (Radiation Protection in Medicine Directive) [ 10 ]. In 2018, the Verordnung zur weiteren Modernisierung des Strahlenschutzrechtes (Ordinance on the Further Modernization of Radiation Protection Law), known as the StrlSchV, was adopted. It contains 74 pages and replaces the first StrlSchV [ 13 ]. In addition, the Qualitätsmanagement-Richtlinie (QM-RL) (Quality Management Guideline) of the Gemeinsame Bundesausschuss (G-BA) (Federal Joint Committee) took effect in 2016. It describes requirements for internal quality management for panel doctors, panel psychotherapists, medical care centers, panel dentists and approved hospitals (in Germany, a hospital is approved if it has been included in the state`s hospital plan or has concluded a supply contract with the health insurances) [ 14 ]. The relevance of quality assurance is also reflected by the increasing number of certified oncology centers. The standardized and nationwide certification of oncological care facilities is formulated in the National Cancer Plan as a specific objective, intended to promote quality: "Transparent information on the results of cancer treatment is necessary in order to recognize and ensure good quality. The certification of cancer centers is a suitable option" [ 15 ]. In 2012, 52 certified oncology centers existed in Germany. As of 2022, the number increased to 145 [ 16 , 17 ]. So far, the benefits of quality assurance measures in healthcare systems have not been sufficiently verified. For this reason, approaches and methods in quality assurance have been derived from the economic sector and applied to health care systems. In DIN EN ISO 9000:2015, quality is defined as "the degree to which a set of inherent characteristics [...] of an object [...] meets requirements [...]" [ 1 ]. The quality of a product, service, process, or system is defined based on how previously determined requirements are met [ 1 , 2 ]. Quality management serves to organize measures for the "implementation, assurance, review and improvement" [ 3 ] of an institution's products, processes, or services. Quality assurance is part of quality management systems. The aim of quality assurance is to maintain and improve the quality of products, services, processes, and systems [ 4 ]. In this paper, the current requirements for quality assurance were identified using the example of a regional maximum care radiotherapy provider with full authorization for training prospective specialists in the field of radiation therapy in Germany, NRW. The Department of Radiotherapy operates both as a department in the hospital and as an independent outpatient provider in the form of a Medizinisches Versorgungszentrum (MVZ) (Medical Care Center) which is part of a certified oncology center, officially certified by German Cancer Aid. The requirements are hierarchically structured according to their binding nature and presented in a separate categorization system for clarity. Methods Quality assurance requirements were investigated based on existing structures in quality assurance as implemented at a regional radiotherapy provider of maximum care which is in transition to a university hospital. First, the existing requirements for quality assurance, as implemented in the ward itself, were determined. In addition, the results were supplemented by a survey of the staff responsible for quality assurance in radiotherapy and by an examination of the hospital's general internal quality assurance standards. A hierarchy was then used to structure the requirements in terms of the binding nature of the requirements. The hierarchy level of a requirement depends on the hierarchy level of the document containing the measure (Fig. 1 ). All requirements should be met, but a hierarchy is created by different levels of legal obligation and different consequences in the case of non-compliance. Legislation is at the highest level of the hierarchy. The implementation of requirements formulated in the law is mandatory for radiotherapy. The second level contains statutory orders, e.g. StrlSchV. At the third level of hierarchy, there are specifications from other institutions. These includes requirements from guidelines, issued by legally authorized institutions, e.g. Deutsche Gesellschaft für Radioonkologie e.V. (DEGRO) (German Society of Radiation Oncology) or the AWMF. Guidelines are effective in their area of application [ 18 , 10 ]. They describe the current state of scientific knowledge and provide recommendations for diagnosis and treatment of specific diseases. Guidelines do not necessarily have to be followed by radiotherapy, but if the patient's treatment deviates from the guideline, this must be explained in the treatment documentation [ 19 ]. Also, the third level contains the requirements established by the hospital`s quality management. The certification requirements are at the lowest level of the hierarchy. They can be implemented on a voluntary basis. The requirements due to the certification are binding if certification is available or pending [ 20 ]. There are numerous certifications and certification bodies. In our evaluation, we have focused on the most common ones. The first step was to identify possible relevant documents describing requirements for quality assurance in radiotherapy. These documents do not contain information about patients. Following Mayring’s qualitative content analysis – a proven, frequently used method for analyzing and evaluating texts – [ 21 , 22 ], the documents were examined regarding the assigned hierarchy level. It was then investigated which institution is responsible for checking the requirements in the respective document. On this basis, the specific documents and sub-documents describing the required measures were identified. To obtain a compact overview of the requirements, the summary technique developed by Mayring was used. This summarizing analysis was conducted in three phases (Fig. 2 ). First, a category system was created inductively to sort the requirements in a structured manner. Secondly, relevant parts of the material were paraphrased to make specific statements. The documents are analyzed based on their structure. The requirements were determined chronologically according to the course of the text, e.g. in the order of the paragraphs or chapters. The statements were subsequently standardized linguistically and grammatically. Thematically matching statements were merged. Thereby some measures contain only one task, others include several tasks. The results are presented in a table. Results Hierarchy of the possible relevant documents Legislation and statutory orders Laws and regulations determining the principles of quality assurance in radiotherapy contain binding provisions in radiation protection, quality management and tumor documentation. The Radiation Protection Act and the Radiation Protection Ordinance provide regulations for radiation protection. The Radiation Protection Act contains regulations intended to protect the population from damage caused by ionizing radiation [23]. Furthermore, the current Radiation Protection Ordinance regulates radiation protection in radiotherapy. The StrlSchV supplements the StrlSchG and is therefore legally binding [8]. The Fünftes Sozialgesetzbuch (SGB V) (Fifth Social Code) requires quality management specifications for approved hospitals. This results in mandatory requirements for radiotherapy. According to § 135a SGB V, every approved hospital is obliged to "introduce and further develop an internal quality management system, including the obligation to implement a patient-oriented complaints management system in hospitals" [24]. In addition, § 136 SGB V specifies that the G-BA is should develop a guideline containing quality assurance requirements for panel doctors and approved hospitals [24]. The SGB V also requires tumor documentation through the establishment and management of clinical cancer registries. Resulting requirements are described in § 65c SGB V and supplemented by the Bundeskrebsregisterdatengesetz (BKRG) (Federal Cancer Registry Data Act). Each federal state is obliged to maintain a cancer registry and to forward the data to the Centre for Cancer Registry Data (ZfKD) [25, 26]. In North Rhine-Westphalia (NRW), the Landeskrebsregistergesetz (LKRG NRW) (State Cancer Registry Act NRW) obliges doctors and dentists to report "malignant neoplasms including their early stages, neoplasms of unknown character and uncertain behavior as well as benign neoplasms of the central nervous system" [27, 28]. According to § 15 LKRG NRW, data must be transmitted "within six weeks of date on which the person subject to reporting obligation became aware of facts subject to the reporting obligation". Specification by other institutions In addition to laws and ordinances, other institutions have issued requirements for radiotherapy in the form of guidelines. A general quality management of the Joint Federal Committee applies to approved hospitals, resulting in specific guidelines for radiotherapy [18]. This includes the legal requirements for the establishment of an internal quality management system [24]. Clinical guidelines of the Association of Scientific Medical Societies apply to radiotherapy. The development and publication of official clinical guidelines is coordinated by AWMF. It is an association of medical societies and scientific medical associations in Germany, improving the quality of medical care by developing evidence-based guidelines [29]. Guidelines are not legally binding. Nevertheless, it is stated in legislation that the treatment of a patient should be carried out in accordance with the current state of scientific knowledge or in accordance with the guidelines. Deviations from guidelines should be justified [10]. Certification In radiotherapy there are various certification procedures. An often-used certification program requires the implementation of a quality management system in accordance with DIN EN ISO 9001:2015. Therefore, the requirements because of a certification in accordance with the DIN EN ISO 9001:2015 are analyzed in this paper. DIN EN ISO 9001:2015 is a standard for quality management systems and meets quality assurance standards over and above the requirements of G-BA's guideline [30]. Radiotherapy centers also can be certified as organ cancer centers, oncology centers and oncology centers of excellence by OnkoZert (German abbreviation for “oncological certification”). This is a quality management and certification system for oncological facilities in Germany that aims to improve the quality of care for cancer patients and ensure that it meets the highest medical standards. The National Cancer Plan describes the certification of oncological facilities as a method of recognizing and ensuring the quality of care [31, 32]. To achieve certification, the respective department must meet the Fachliche Anforderungen an Onkologische Zentren (FAO) (Professional Requirements for Oncology Centers). These cover various areas of oncological care such as diagnostics, therapy, aftercare, patient care, interdisciplinary cooperation, training, and research. OnkoZert carries out certifications on behalf of the German Cancer Society (DKG) in collaboration with experts [31, 32]. Institutions responsible for checking the requirements Various institutions are commissioned to check compliance with legal requirements for quality assurance in radiotherapy. Compliance with the Radiation Protection Act, the Radiation Protection Ordinance and the Radiation Protection Ordinance Directive is monitored by the responsible, legally defined Ärztliche Stelle (Medical Center) [33]. The Heilberufegesetz (Medical Professions Act) of the respective federal state, e.g. the Heilberufegesetz Nordrhein-Westfalen (HeilBerG NW) (North Rhine-Westphalia Medical Professions Act), obliges the Ärztekammer (Medical Association) to set up Medical Centers (Ärztliche Stelle) in accordance with the Radiation Protection Ordinance. All medical associations in Germany are subordinated to the Bundesärztekammer (German Medical Association) and are legally anchored by the Gesetz zur Sicherstellung der ärztlichen Versorgung und zur Regelung der Berufe in der Gesundheitsversorgung (Act to Ensure Medical Care and to Regulate the Professions in Health Care). Among other responsibilities, the German Medical Association is involved in the development and implementation of quality assurance measures in healthcare. These include e.g. the certification of further training programs for doctors and the participation in the development of quality standards in medical care [34]. Every two years, the Kassenärztliche Vereinigung (Associations of Statutory Health Insurance Physicians) carries out a random sample survey to check whether the approved hospitals are implementing the requirements of the QM-RL. While the directive contains a list of questions for panel doctors and panel dentists, there is currently no such list for approved hospitals. To address this issue, the G-BA has defined a transitional regulation in its QM-RL. Until the catalogue of questions for approved hospitals is published, hospitals must describe "the respective status of implementation and further development of the facility's internal quality management" [18] in their annual quality report. According to §136b SGB V, the annual quality report is mandatory for all approved hospitals. In addition to checking compliance with legal quality assurance requirements, audits are also carried out as part of certification procedures if certification is to be established or extended. The procedure differs depending on the specific certification. Identified relevant documents and sub-documents Legal requirements and guidelines applicable to radiotherapy are reviewed by the Medical Center. The Medical Center uses checklists for its assessment. In this paper, documents of the Ärztekammer Westfalen-Lippe (ÄKWL) (Westphalia-Lippe Medical Association) are analyzed as an example. The checklists were last updated in January 2023. The documents were created to assess mandatory requirements for radiotherapy [35]. During data collection, the LKRG NRW was identified as a relevant document. This act is legally binding for radiotherapy in Nordrhein-Westfalen. QM-RL is another relevant document for the present analysis. Since the guideline contains legally binding quality management requirements for hospitals and for associated radiotherapy centers, it was included in this analysis. Each radiotherapy department must formulate radiation protection instructions in accordance with §45 StrlSchV and submit them to the responsible authority for radiation protection of the associated district government. It is a precondition for obtaining operating license. Changes to radiation protection instruction must be reported to the responsible authority. It must be updated regularly to accommodate internal changes and to ensure compliance with the latest international regulations and standards. The radiation protection instruction contains specific measures for quality assurance not explicitly checked by the Medical Center, witch instead checks the existence of instruction and an operating or handling license. Therefore, the radiation protection instruction of the exemplary radiotherapy was generated as additional material for this analysis. The analyzed radiation protection instruction was last updated in October 2022. In the process of establishing the radiotherapy department as a cooperation partner of a certified oncology center, further quality assurance requirements had to be determined. The specific requirements a radiotherapy center must meet as part of certification are described in detail in the radio oncology survey questionnaire, created by DKG. The radiation oncology questionnaire was therefore included in the analysis. The questionnaire does not contain information about patients. It was last updated in September 2022. Further standards are established when certification in accordance with DIN EN ISO 9001:2015 occurs. The requirements of the exemplary radiotherapy department were implemented based on specified framework conditions of DIN EN ISO 9001:2008, which is why DIN EN ISO 9001:2015 was defined as a relevant document. In summary, the following nine documents were included in the analysis: First Bulletin of the Medical Center Second Bulletin of the Medical Center Checklist „Technik“ of the Medical Center Checklist „Medizin“ of the Medical Center QM-RL LKRG NRW Radiation Protection Instruction OnkoZert Survey Questionnaire DIN EN ISO 9001:2015 Summarizing analysis To organize the content of these documents, a system of categorization was created (Fig. 3). The system contains five main categories: Ward structure and documentation Radiation protection, medical physics and devices Employees Patient management Treamtent standards The relevant parts of the documents were then paraphrased and standardized to be presented in a table. Overview of the requirements A total of 89 required measures for quality assurance in radiotherapy were identified (Table 1). Unless otherwise stated, the measures refer to every treatment in radiotherapy. 70% of the requirements were legally binding, 30% of the requirements resulted from certifications (marked in blue). Most measures concerned patient management. 53 out of 89 of measures were required or reviewed by one institution. 27 were checked by two separate institutions. Some measures were subject to time limits. These are often applied to regular inspections in device safety. For some requirements, a period was specified in which the procedure had to take place, e.g. when reporting to the cancer registry. Additional data are given in Online Resource 1. Table 1 : Overview of required quality assurance measures in radiotherapy Category Requirement Ward structure and documentation Internal, Center and cooperation, Tumor documentation Regular meetings with employees 1,3 Quality targets from central quality management are considered, measures are taken 1,3 Quality-relevant data and the quality management system are reviewed, necessary improvements are identified, the review is documented 1.3 Risk management is introduced, including fault management 1,3 Responsibilities for different areas and processes are defined 1,3 Measurement and evaluation of patient satisfaction 1,3 Measurement and evaluation of anonymous employee surveys 1 Regular survey of status and further development of quality management in accordance with requirements of QM-RL 1 A hygiene management system is introduced 1 Fall prevention measures are introduced 1 Assessment of Medical Center with level 1, 2 or even 3, deficiencies are demonstrably rectified 1 Documentation of relevant information is structured: definition of storage locations, creation and updating of documents, document protection 3 Existing cooperation agreement in accordance with OnkoZert 4 Tumor conferences are held in accordance with OnkoZert specifications 4 Quality circle is conducted and recorded 4 Information is exchanged immediately 1,4 If applicable, alliance of radiation oncology practices / institutes (if number of accelerators / radiation treatments is not met independently) 4 Tumor documentation shows whether patient is being treated and at which center 4 Follow-up data is systematically reported to the center and used to improve quality 4 Side effects are systematically recorded, evaluated, and analyzed 4 Malignant neoplasms and benign neoplasms of the central nervous system are reported to the cancer registry 1 Radiation protection, medical physics, and devices Radiation planning, Irradiation technology, Device safety Simulation or CT-supported simulation is carried out 2,4 Irradiation planning system is tested 2 Irradiation plan is drawn up in accordance with DIN 6827-1 2 Seed application: CT follow-up planning is performed 2 X-ray therapy: MPE is involved in radiation planning 2 Brachytherapy: Isodose calculation in target volume and risk area standardized with the aid of tables (level 1) or individually with aid of a radiation planning system using radiographic reconstructions (level 2) or after three-dimensional localization and 3-D planning with the aid of sectional image procedures (level 3) with separate archiving of sectional image data, digital reconstruction radiographs and, if applicable, dose volume histograms 2 X-ray therapy of inflammatory / degenerative diseases: physical radiation parameters are determined using a standard plan 2 Radiation planning documents are expertly checked and approved by MPE and physician 1,2 A Planed CT is created 4 Access to planning devices, systems, and methods ensured 4 Number of linear accelerators corresponds to the specifications of OnkoZert 4 Techniques to be provided: IGRT, IMRT, 3D conformal radiotherapy, other specific techniques for organ cancer centers / modules 4 Operating permit / handling permit / notification confirmation is available 2 Expert inspection is carried out 2,3 Metrological control certificate available, equipment of measuring devices is sufficient 2,3 Condition and constancy test / constancy test is performed and recorded 2,3 Examination of IGRT procedures 2,3 Testing of IMRT / IMAT procedures 2,3 Maintenance of linear accelerators and afterloading devices by the manufacturer 1,3 Operating diaries are kept 1 Employees Expertise, Further education, etc., Structure, Safety At least 800 tumor patients treated with complete treatment series 4 At least 200 tumor patients treated in oncology center 4 Tumor-specific case numbers and requirements regarding case numbers of systemic therapies are met according to OnkoZert 4 Doctors, MPEs, MTRAs have valid specialist knowledge 1,2,3,4 Qualification plan is drawn up and implemented for doctors, nursing, and other staff 1,3,4 There is a briefing concept, new employees are fully and systematically briefed, briefing is documented and recorded 1,3,4 Presence of specified number of medical specialists, MPEs and MTRAs is ensured, written substitution regulation in place, 24-hour on-call service of a medical specialist 1,2,4 A list of signature abbreviations is available 2,3 Radiation protection officer and representative appointed 1 A radiation protection commissioner is available and on call 1 Persons, who regularly work at the irradiation facility wear an official whole-body dosimeter 1 Patient management Documentation of treatment, Treatment process, Consultation & waiting time, Case related information & dialogue with patients Complete, guideline-compliant treatment documentation 1,2,4 Complete medical report is created 2 Requirements of radiation protection legislation and the Guideline for Radiation Protection in Medicine, current standard of generally accepted practice (guidelines, DEGRO), reference recommendations, registry recommendations, and, if applicable, results of therapy optimization studies are complied with, deviations are justified 2,4 Therapies are carried out according to corresponding work instructions, deviations are justified 2 Irradiation is carried out according to radiation planning and instructions 1 A test run is carried out for every motion irradiation 1 Initial adjustment is carried out by a specialist doctor, possibly with the involvement of a MPE 2 During initial appointment, a check is made to see whether the patient is included in the radiation list 1,2 Gonad protection, storage aid, access to block production available if treatment requires it 2 In case of combined therapies, medical and medical-physical responsibility does not alternate 4 During brachytherapy, device and applicators and position of applicators are checked and documented by the operating doctor 1,2 Proof of irradiation is recorded in accordance with DIN 6827-1 2 Paediatric oncology: Possibility to perform therapy under anesthesia / sedation 4 Gynaecological center: Patients are only treated in one Gynaecological center 4 Systemic tumor therapy is not carried out in radiation oncology: Responsibilities are defined; radiotherapy specialist also signs the treatment plan 4 During radiation treatment, contact is maintained with the patient via a television and intercom system from the control room 1 Expert decision on completion of radiotherapy, information provided on further treatment, follow-up examinations are organized and carried out in accordance with the guidelines, efforts are made to obtain follow-up information 2 Drug therapy safety is ensured 1,3 Pain management is introduced 1 Adequate medical presentation is ensured for each patient 4 Prompt treatment of the patient is ensured from the time of registration, the total treatment time is adhered to 4 Patient waiting times are randomly recorded and statistically evaluated 4 Discussion regarding diagnosis and therapy is conducted and documented 1,2 A legally binding declaration of consent from the patient is available 2 Discharge interview is conducted and documented 4 Written patient information on conduct during radiotherapy is available 1,4 An application management system is introduced 1 Treatment standards Work instructions & descriptions, SOP Work instructions for physicians, medical physics, MTRAs, and, if applicable, other affected departments and staff are available 1,2,4 Work instructions available for most common medical entities / treatments performed 1,2,3,4 Guideline-based supportive measures for individual therapy concepts are described 3,4 Process descriptions for respective patient treatment areas are available 1,3,4 Incident instructions for after-loading are created and visibly displayed 1 Procedure description for sequential / simultaneous radio-chemotherapy are available 3,4 A written contingency plan is in place 1,3 A written emergency plan is available for prompt treatment of palliative patients to alleviate symptoms 3,4 A guideline-compliant overall therapy concept for radiotherapy of breast carcinoma is available and is signed by a specialist doctor before treatment (IntraBeam radiotherapy) 2,4 Radiation planning and treatment according to the corresponding SOP, deviations are justified 2,4 There are standardized radio-oncological SOPs between the network partners 3 Standard operation procedures for patients with myelon compression and neurological symptoms for care within 24 hours ,4 Legend: (1) Authority; (2) Medical Center; (3) DIN EN ISO 9001:2015; (4) OnkoZert; requirements marked in blue: resulting from certification (Own illustration based on [32]; ÄkWL, 2023a [36]; ÄkWL 2023b [37]; Ärztliche Stelle 2019 [38]; Ärztliche Stelle 2023 [39]; DIN 2015b [30]; Kahla-Witzsch, 2019 [40]; G-BA, 2023 [18]; LKRG NRW [28]); CT = Computer tomography, MPE = Medical physics expert, MTRA = Medical-technical radiology assistant, IGRT = image guided radiotherapy; IMRT = Intensity-modulated radiotherapy, IMAT = intensity modulated arc therapy, QM-RL = Qualitätsmanagement-Richtlinie (quality management guideline); DIN = Deutsches Institut für Normung (German institute for standardization); EN = Europäische Norm (European standard); ISO = Internationale Norm (International standard) Discussion 89 requirements for quality assurance in radiotherapy were identified. The requirements were categorized and analyzed. Most of the requirements are legally binding. Most measures are required in “patient management”. Some requirements are subject to time limits. One third of the requirements are checked by two institutions. The Extent of Measures In Germany, the state of quality assurance in radiotherapy is complex. Neither quality management guidelines nor DIN EN ISO 9001:2015 describe most of the requirements in specific terms. The implementation of requirements and the allocation of responsibilities must currently be developed and issued by each radiotherapy facility individually. This corresponds to the concept of the QM-RL: "The concrete organization of internal quality management systems is carried out specifically in each facility" [ 18 ]. The following requirement "an application management system is introduced" e.g. does not contain any further detailed regulations on how to be implemented. Other requirements, such as "a guideline-compliant overall therapy concept for radiotherapy of breast carcinoma is available and is signed by a specialist doctor before treatment (IntraBeam radiotherapy)" only apply to a specific treatment in a cancer center certified as a breast center. Nevertheless, the specific requirement is listed in the checklist of the medical center and radiation oncology questionnaire by OnkoZert. The advantage of the more general wording of the DIN EN ISO 9001:2015 is the possibility of applying this standard to many differently structured organizations in different sectors because of its adaptability. However, when measures are defined in more general terms, the comparability of treatment results is not as easily given, as would be in the case of more specific requirements. Also, those who are responsible for their realization must decide on how and to what extent they are to be concretized. This can create an additional workload and, consequently, result in less time for patients. While thus, the implementation of the requirements may be beyond the original intention or be insufficient. When a more specific wording is to be created, it should be checked beforehand whether these requirements would make it more difficult for hospitals to adjust them to their individual situation. Testing frequency around device safety in radiotherapy sometimes exceeds the necessity. In addition, some modern devices have integrated testing systems that considerably simplify testing. This applies to basic parameters such as controlling the absolute dose or checking positioning accuracy of mulitleave collimator. Particularly when new technologies are introduced, there are often no current requirements or test equipment for quality assurance available. Therefore, an independent procedure for testing devices must be developed by the users themselves. This procedure is provided for by the Medical Centre, for example. In the technical checklist of the Medical Centre, it is noted that there are currently no test requirements for constancy test of kilovolt-imaging, e.g. in form of a DIN, and that constancy tests should therefore be carried out analogously to another standard of a similar procedure [ 38 ]. This analysis has shown that the number of requirements issued by various institutions is increasing. For example, in May 2024, the Leitlinie zur Qualitätssicherung der Computertomographie in der Strahlentherapie (Guideline for quality assurance of Computed tomography in radiotherapy) was published by DEGRO. This guideline describes measures in general as well as measures associated with the treatment of specific organs and areas of the body. The increasing number of requirements creates a high level of documentation. Documentation is a significant stress factor in healthcare: "Almost half of both senior physicians and practice managers identify documentation requirements as the main cause of stress in day-to-day care" [ 41 ]. Consequently, either the amount of documentation needs to be reduced, or existing systems need to be more efficient. In September 2023, the Association of Statutory Health Insurance Physicians criticized the high level of bureaucracy in outpatient care and presented nine steps to reduce bureaucracy: "The aim is to create more time for patient care. Currently, each practice spends more than one day a week performing bureaucratic tasks" [ 42 ]. One of the proposals is the certification of software for quality assurance [ 42 ]. Software can be used to implement digital document management systems. It is important to ensure legal data protection and the security of documents and to have the necessary technical infrastructure in place. Another possible solution could be the financing of personnel responsible for quality assurance in the respective radiotherapy to reduce the workload of medical staff and physicists. Furthermore, the establishment of a central body responsible for auditing all quality assurance requirements may help to reduce the workload. The unintentional duplication of auditing requirements could thus be avoided. The Effectiveness of Measures The objective of quality assurance is to maintain and improve the quality of products, services, processes, and systems. The requirements identified above are used in radiotherapy to achieve this object. The potential benefits of many requirements have not yet been scientifically proven. The StrlSchG was adopted in 2017. The draft law states that "Radiation Protection Act [will] be adapted to the current state of scientific knowledge" [ 43 ]. The Technical Committee on Radiation Protection is part of the Länderausschuss (National Committee) and is responsible for preparing amendments and extensions to the regulations [ 44 ]. The public institutes do not explain how requirements are developed and to what extent measures for quality assurance are evidence-based. According to QM-RL, approved hospitals are temporarily obliged to describe the status of their quality management in an annual quality report. The Institut für Qualitätssicherung und Transparenz im Gesundheitswesen (IQTIG) (Institute for Quality Assurance and Transparency in Healthcare) is commissioned by the G-BA to develop methods for determining and describing the status of quality management. The data is an important basis for optimizing the requirements of the QM-RL. According to the report on the status of quality assurance and effectiveness of measures pursuant to § 136d SGB V, “[t]he expenditure on the service providers [...] shall be in an appropriate relation, to personnel and structural equipment” [ 45 ]. Therefore, the reporting and random review of contractual (dental) health care institutions is carried out every two years. There is no such regulation for approved hospitals. According to the G-BA, “good to high implementation of requirements” [ 45 ] takes place. The effectiveness of requirements is not described in the report. Adaptations to QM-RL are made based on quality reports and results of current research projects of the Innovation Committee [ 45 ]. In the final report Methodological Notes and Recommendations for Collection and Presentation of State of Implementation of Quality Management Directive of the IQTIG, the evaluation of the implementation of QM-RL in hospitals through quality reports is assessed as follows: “The quality reports of hospitals [...] represent a comprehensive data collection, which, however, is not aligned with the current QM guidelines “[ 46 ]. Both the IQTIG status report and the IQTIG final report describe requirements taken to collect and describe the status of quality assurance. It is mentioned that quality reports are not adjusted to the QM-RL, therefore no conclusions regarding the effectiveness of the requirements can be made. The assessment of requirements or methods of assessing requirements are not discussed. Studies suggest benefits of certified oncology centers in terms of patient care. A study of the University Hospital Dresden in cooperation with the UniversitätsCentrum (Center of the University) Evidenzbasierte Gesundheitsversorgung (evidence-based health care), the Arbeitsgemeinschaft Deutscher Tumorzentren (Association of German Tumor Centers), the Tumorzentrum Regensburg (Tumor Center Regensburg) and the Wissenschaftliche Institut der AOK , (Scientific Institute of the AOK), funded by the G-BA and tilted Effectiveness of Care in Oncological Centers [ 47 ] examines the overall survival of around 22 million adult cancer patients from 2006–2017. A distinction is made as to whether a patient was treated in a certified hospital or a non-certified hospital. The study shows that patients treated in certified cancer centers have a higher survival expectancy regardless of the type of cancer [ 47 ]. Further studies highlight the positive impact of cancer center certification on treatment quality [ 48 , 49 , 50 ]. Additionally, studies emphasize the importance of the multidisciplinary tumorboards, included in the certified oncology centers. These are used to make differentiated and individualized treatment decisions, increasing the success of treatment [ 51 , 52 ]. However, the effect of the individual measures for certified oncology centers was not investigated. Clinical guidelines used for the treatment of patients are largely evidence-based [ 29 ]. A recommendation within guideline is considered evidence-based if the “underlying evidence for the issue of recommendation has been systematically searched, the inclusion of studies has been made based on prospectively defined inclusion and exclusion criteria, a critical evaluation of reliability of the studies has been made, and an evidence or quality level has been assigned” [ 9 ]. The creation of SOPs for the treatment of patients based on these guidelines is therefore the implementation of requirements based on scientific evidence. Quality assurance plays an important role in radiotherapy. However, it is unclear which requirements improve the health care and safety of patients and staff. The high number of measures required and the lack of transparency regarding their effectiveness makes it difficult to implement requirements in the right way. This gives rise to fears that most of the measures will not be implemented in the departments according to their usefulness but will end up as a legal administrative burden. This can apply to fault management, for example. It may only be formally implemented to comply with legal requirements. The faults are not processed in detail and the benefits of fault management are lost, e.g. the solution to a problem or the reduction of errors. This effect is caused, for example, by the fact that employees are not aware of the benefits of fault management combined with time pressure. Conclusion Quality assurance in radiotherapy is crucial due to the complexity of treatments and the high demands of technology and radiation protection. Several requirements from various laws and institutions are either defined in detail or not described in specific terms and the degree of obligation of different measures is often non-transparent. The extent of requirements and documentation obligations as well as redundancies lead to an increased bureaucratic workload, reducing patient care time without evident improvement in treatment outcomes. The paper serves as an orientation and starting point for improving the quality assurance structure, emphasizing the need for optimized standardized solutions to reduce bureaucratic burdens. Future efforts should focus on reviewing the evidence supporting individual requirements. Declarations Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Competing: The authors have no relevant financial or non-financial interests to disclose. Author Contributions: Deborah Wöstenfeld and Hendrick Dapper were responsible for the conceptualization and methodology of the study. The investigation and analysis were conducted by Deborah Wöstenfeld and Hendrick Dapper. The first draft of the manuscript was written by Deborah Wöstenfeld and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Ethics statement Not needed References Deutsches Institut für Normung e.V (2015a) Qualitätsmanagementsysteme – Grundlagen und Begriffe (ISO 9000:2015); Deutsche und Englische Fassung EN ISO 9000:2015. Beuth Verlag GmbH Geiger W (1998) Qualitätslehre: Einführung, Systematik, Terminologie. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6687918","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":475404591,"identity":"20df8cea-a224-414a-a181-f2d4974ae162","order_by":0,"name":"Deborah Wöstenfeld","email":"data:image/png;base64,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","orcid":"https://orcid.org/0009-0000-7173-2418","institution":"Department of Radiation Oncology, Cyberknife and Radiation Therapy, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Germany","correspondingAuthor":true,"prefix":"","firstName":"Deborah","middleName":"","lastName":"Wöstenfeld","suffix":""},{"id":475404592,"identity":"5c969587-ac56-413c-8729-f8cf28222ead","order_by":1,"name":"Dietmar Hahm","email":"","orcid":"","institution":"Department of Radiotherapy and Radiation Oncology, Public Hospital of Bielefeld, University Medical Center East Westphalia-Lippe, Bielefeld, Germany","correspondingAuthor":false,"prefix":"","firstName":"Dietmar","middleName":"","lastName":"Hahm","suffix":""},{"id":475404593,"identity":"b2646c9a-37b0-4689-9279-88f8c1fdd623","order_by":2,"name":"Emmanouil Fokas","email":"","orcid":"","institution":"Department of Radiation Oncology, Cyberknife and Radiation Therapy, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Germany","correspondingAuthor":false,"prefix":"","firstName":"Emmanouil","middleName":"","lastName":"Fokas","suffix":""},{"id":475404594,"identity":"b3c017d5-dfd6-479d-930c-5fd4b64d9238","order_by":3,"name":"Florian Kamp","email":"","orcid":"","institution":"Department of Radiation Oncology, Cyberknife and Radiation Therapy, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Germany","correspondingAuthor":false,"prefix":"","firstName":"Florian","middleName":"","lastName":"Kamp","suffix":""},{"id":475404595,"identity":"15925bec-147f-4501-a0a8-7de3a1ba45f2","order_by":4,"name":"Hendrik Dapper","email":"","orcid":"","institution":"Department of Radiation Oncology, Cyberknife and Radiation Therapy, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Germany","correspondingAuthor":false,"prefix":"","firstName":"Hendrik","middleName":"","lastName":"Dapper","suffix":""}],"badges":[],"createdAt":"2025-05-17 15:30:42","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6687918/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6687918/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85724954,"identity":"761b67dc-6c57-4534-99c4-a9896dcbf12b","added_by":"auto","created_at":"2025-07-01 06:24:04","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":28871,"visible":true,"origin":"","legend":"\u003cp\u003eOverview of hierarchy of requirements (own illustration, based on G-BA, 2023; Richtlinie Strahlenschutz in der Medizin, 2011; IQWiG, 2020; BMG, 2016)\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6687918/v1/082b9b81bf06adcd3a0b0953.png"},{"id":85724964,"identity":"6047be20-d1f7-4d11-8c19-4488112c5682","added_by":"auto","created_at":"2025-07-01 06:24:05","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":92435,"visible":true,"origin":"","legend":"\u003cp\u003eSummarizing analysis\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6687918/v1/0ef28c0c8bfda22aca063814.png"},{"id":85724962,"identity":"b05a88f1-fe57-464f-8082-edbdc82892a8","added_by":"auto","created_at":"2025-07-01 06:24:05","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":175807,"visible":true,"origin":"","legend":"\u003cp\u003eCategory system for systematizing required quality assurance measures\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6687918/v1/9fca05660e142264f0a849cc.png"},{"id":89331170,"identity":"9d4b3354-a3e2-4450-ab46-13dd5d10f578","added_by":"auto","created_at":"2025-08-18 23:20:48","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":808249,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6687918/v1/be053766-9646-4861-a71f-4e51a2ca63b1.pdf"}],"financialInterests":"","formattedTitle":"Quality Assurance in Radiation Therapy in Germany – Attempt to Assess the Current Status and Challenges Using an Example of a German Hospital","fulltext":[{"header":"Introduction","content":"\u003cp\u003eRadiotherapy, especially in the context of treating oncological patients, is multifaceted and associated with great responsibility. Due to the technical and clinical complexity, the potential for harm to patients and practitioners from radiation, and the fact that these therapeutic procedures are often of critical importance to oncological patients, quality assurance is highly relevant in radiotherapy [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Requirements in quality assurance in radiotherapy depend on different characteristics of the radiotherapy, e. g. the hospital owner, range of treatment or certifications. The aim of this paper is to illustrate as much intersection as possible of the required measures.\u003c/p\u003e \u003cp\u003eThe following regulatory documents contain requirements for every radiotherapy in Germany and measures because of two often achieved certifications. One exception is the \u003cem\u003eLandeskrebsregistergesetz NRW (LKRG NRW)\u003c/em\u003e (State Cancer Register North Rhine-Westphalia). Every Federal State in Germany has its own law regarding the \u003cem\u003eLandeskrebsregister\u003c/em\u003e (State Cancer Register), so the LKRG NRW is used as an example in this paper.\u003c/p\u003e \u003cp\u003eThe \u003cem\u003eStrahlenschutzverordnung\u003c/em\u003e (Radiation Protection Ordinance) stipulates that medical indications must be justified and determined in accordance with current scientific knowledge [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The increasing interdisciplinarity as well as recent developments in personalized medicine have led to increasingly complex treatments. To comply with the current state of scientific knowledge, official guidelines have been drawn up, such as the \u003cem\u003eLeitlinie der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF)\u003c/em\u003e (Guidelines of the Association of the Scientific Medical Societies in Germany), which has been developed in collaboration with the German Society of Radiation Oncology. These guidelines serve as a basis on which treatment indications can be justified [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In addition, medical staff in radiation oncology is obligated having constantly updated specialist knowledge through regular training courses.\u003c/p\u003e \u003cp\u003eIn parallel to medical conceptual aspects, the increasing technical complexity of radiotherapy must be considered. Technically and physically high-quality treatment devices and image-guided planning options allow medical staff to have more precise treatment options. However, they also require a continuously increasing level of understanding and maintenance. The physical quality control of devices is a major component of radiation therapy and includes condition and constancy tests, as well as regular external testing by experts to ensure precise and reliable delivery of irradiation. In addition, radiation planning is checked by the department's internal medical physics department as part of physical quality control [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Finally, radiation protection is of great importance for both patients and practitioners due to the use of high-energy radiation from radioactive sources, accelerators or teletherapy devices. The risk of misuse of radiation sources must also be counteracted [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe increasing importance and complexity of quality management in radiotherapy is reflected by the development in legal specifications. The \u003cem\u003eGesetz zur Neuordnung des Rechts zum Schutz vor der schädlichen Wirkung ionisierender Strahlung\u003c/em\u003e (Act on the Reorganization of the Law on Protection Against the Harmful Effects of Ionizing Radiation) was passed in 2017 and contains the \u003cem\u003eStrahlenschutzgesetz (StrlSchG)\u003c/em\u003e (Radiation Protection Act). Requirements for radiation protection are formulated in 218 paragraphs.\u003c/p\u003e \u003cp\u003eThe first \u003cem\u003eStrahlenschutzverordnung (StrlSchV)\u003c/em\u003e (Radiation Protection Ordinance) was passed in 1960 with 58 pages [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Since 2011, the StrlSchV has been concretized by the \u003cem\u003eRichtlinie Strahlenschutz in der Medizin\u003c/em\u003e (Radiation Protection in Medicine Directive) [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. In 2018, the \u003cem\u003eVerordnung zur weiteren Modernisierung des Strahlenschutzrechtes\u003c/em\u003e (Ordinance on the Further Modernization of Radiation Protection Law), known as the StrlSchV, was adopted. It contains 74 pages and replaces the first StrlSchV [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. In addition, the \u003cem\u003eQualitätsmanagement-Richtlinie (QM-RL)\u003c/em\u003e (Quality Management Guideline) of the \u003cem\u003eGemeinsame Bundesausschuss (G-BA)\u003c/em\u003e (Federal Joint Committee) took effect in 2016. It describes requirements for internal quality management for panel doctors, panel psychotherapists, medical care centers, panel dentists and approved hospitals (in Germany, a hospital is approved if it has been included in the state`s hospital plan or has concluded a supply contract with the health insurances) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe relevance of quality assurance is also reflected by the increasing number of certified oncology centers. The standardized and nationwide certification of oncological care facilities is formulated in the National Cancer Plan as a specific objective, intended to promote quality: \"Transparent information on the results of cancer treatment is necessary in order to recognize and ensure good quality. The certification of cancer centers is a suitable option\" [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. In 2012, 52 certified oncology centers existed in Germany. As of 2022, the number increased to 145 [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSo far, the benefits of quality assurance measures in healthcare systems have not been sufficiently verified. For this reason, approaches and methods in quality assurance have been derived from the economic sector and applied to health care systems. In DIN EN ISO 9000:2015, quality is defined as \"the degree to which a set of inherent characteristics [...] of an object [...] meets requirements [...]\" [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The quality of a product, service, process, or system is defined based on how previously determined requirements are met [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Quality management serves to organize measures for the \"implementation, assurance, review and improvement\" [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] of an institution's products, processes, or services. Quality assurance is part of quality management systems. The aim of quality assurance is to maintain and improve the quality of products, services, processes, and systems [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this paper, the current requirements for quality assurance were identified using the example of a regional maximum care radiotherapy provider with full authorization for training prospective specialists in the field of radiation therapy in Germany, NRW. The Department of Radiotherapy operates both as a department in the hospital and as an independent outpatient provider in the form of a \u003cem\u003eMedizinisches Versorgungszentrum (MVZ)\u003c/em\u003e (Medical Care Center) which is part of a certified oncology center, officially certified by German Cancer Aid. The requirements are hierarchically structured according to their binding nature and presented in a separate categorization system for clarity.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eQuality assurance requirements were investigated based on existing structures in quality assurance as implemented at a regional radiotherapy provider of maximum care which is in transition to a university hospital. First, the existing requirements for quality assurance, as implemented in the ward itself, were determined. In addition, the results were supplemented by a survey of the staff responsible for quality assurance in radiotherapy and by an examination of the hospital's general internal quality assurance standards. A hierarchy was then used to structure the requirements in terms of the binding nature of the requirements. The hierarchy level of a requirement depends on the hierarchy level of the document containing the measure (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). All requirements should be met, but a hierarchy is created by different levels of legal obligation and different consequences in the case of non-compliance. Legislation is at the highest level of the hierarchy. The implementation of requirements formulated in the law is mandatory for radiotherapy. The second level contains statutory orders, e.g. StrlSchV. At the third level of hierarchy, there are specifications from other institutions. These includes requirements from guidelines, issued by legally authorized institutions, e.g. \u003cem\u003eDeutsche Gesellschaft für Radioonkologie e.V.\u003c/em\u003e (DEGRO) (German Society of Radiation Oncology) or the AWMF. Guidelines are effective in their area of application [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. They describe the current state of scientific knowledge and provide recommendations for diagnosis and treatment of specific diseases. Guidelines do not necessarily have to be followed by radiotherapy, but if the patient's treatment deviates from the guideline, this must be explained in the treatment documentation [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Also, the third level contains the requirements established by the hospital`s quality management. The certification requirements are at the lowest level of the hierarchy. They can be implemented on a voluntary basis. The requirements due to the certification are binding if certification is available or pending [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. There are numerous certifications and certification bodies. In our evaluation, we have focused on the most common ones.\u003c/p\u003e\u003cp\u003eThe first step was to identify possible relevant documents describing requirements for quality assurance in radiotherapy. These documents do not contain information about patients. Following Mayring’s qualitative content analysis – a proven, frequently used method for analyzing and evaluating texts – [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], the documents were examined regarding the assigned hierarchy level. It was then investigated which institution is responsible for checking the requirements in the respective document. On this basis, the specific documents and sub-documents describing the required measures were identified. To obtain a compact overview of the requirements, the summary technique developed by Mayring was used. This summarizing analysis was conducted in three phases (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). First, a category system was created inductively to sort the requirements in a structured manner. Secondly, relevant parts of the material were paraphrased to make specific statements. The documents are analyzed based on their structure. The requirements were determined chronologically according to the course of the text, e.g. in the order of the paragraphs or chapters. The statements were subsequently standardized linguistically and grammatically. Thematically matching statements were merged. Thereby some measures contain only one task, others include several tasks. The results are presented in a table.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eHierarchy of the possible relevant documents\u003c/p\u003e\n\u003cp\u003eLegislation and statutory orders\u003c/p\u003e\n\u003cp\u003eLaws and regulations determining the principles of quality assurance in radiotherapy contain binding provisions in radiation protection, quality management and tumor documentation.\u003c/p\u003e\n\u003cp\u003eThe Radiation Protection Act and the Radiation Protection Ordinance provide regulations for radiation protection. The Radiation Protection Act contains regulations intended to protect the population from damage caused by ionizing radiation [23]. Furthermore, the current Radiation Protection Ordinance regulates radiation protection in radiotherapy. The StrlSchV supplements the StrlSchG and is therefore legally binding [8].\u003c/p\u003e\n\u003cp\u003eThe \u003cem\u003eF\u0026uuml;nftes Sozialgesetzbuch (SGB V)\u0026nbsp;\u003c/em\u003e(Fifth Social Code) requires quality management specifications for approved hospitals. This results in mandatory requirements for radiotherapy. According to \u0026sect; 135a SGB V, every approved hospital is obliged to \u0026quot;introduce and further develop an internal quality management system, including the obligation to implement a patient-oriented complaints management system in hospitals\u0026quot; [24]. In addition, \u0026sect; 136 SGB V specifies that the G-BA is should develop a guideline containing quality assurance requirements for panel doctors and approved hospitals [24].\u003c/p\u003e\n\u003cp\u003eThe SGB V also requires tumor documentation through the establishment and management of clinical cancer registries. Resulting requirements are described in \u0026sect; 65c SGB V and supplemented by the \u003cem\u003eBundeskrebsregisterdatengesetz (BKRG)\u003c/em\u003e (Federal Cancer Registry Data Act). Each federal state is obliged to maintain a cancer registry and to forward the data to the Centre for Cancer Registry Data (ZfKD) [25, 26]. In North Rhine-Westphalia (NRW), the \u003cem\u003eLandeskrebsregistergesetz (LKRG NRW)\u003c/em\u003e (State Cancer Registry Act NRW) obliges doctors and dentists to report \u0026quot;malignant neoplasms including their early stages, neoplasms of unknown character and uncertain behavior as well as benign neoplasms of the central nervous system\u0026quot; [27, 28]. According to \u0026sect; 15 LKRG NRW, data must be transmitted \u0026quot;within six weeks of date on which the person subject to reporting obligation became aware of facts subject to the reporting obligation\u0026quot;.\u003c/p\u003e\n\u003cp\u003eSpecification by other institutions\u003c/p\u003e\n\u003cp\u003eIn addition to laws and ordinances, other institutions have issued requirements for radiotherapy in the form of guidelines. A general quality management of the Joint Federal Committee applies to approved hospitals, resulting in specific guidelines for radiotherapy [18]. This includes the legal requirements for the establishment of an internal quality management system [24].\u003c/p\u003e\n\u003cp\u003eClinical guidelines of the Association of Scientific Medical Societies apply to radiotherapy. The development and publication of official clinical guidelines is coordinated by AWMF.\u0026nbsp;It is an association of medical societies and scientific medical associations in Germany, improving the quality of medical care by developing evidence-based guidelines [29]. Guidelines are not legally binding. Nevertheless, it is stated in legislation that the treatment of a patient should be carried out in accordance with the current state of scientific knowledge or in accordance with the guidelines. Deviations from guidelines should be justified [10].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCertification\u003c/p\u003e\n\u003cp\u003eIn radiotherapy there are various certification procedures. An often-used certification program requires the implementation of a quality management system in accordance with DIN EN ISO 9001:2015. Therefore, the requirements because of a certification in accordance with the DIN EN ISO 9001:2015 are analyzed in this paper. DIN EN ISO 9001:2015 is a standard for quality management systems and meets quality assurance standards over and above the requirements of G-BA\u0026apos;s guideline [30]. Radiotherapy centers also can be certified as organ cancer centers, oncology centers and oncology centers of excellence by OnkoZert (German abbreviation for \u0026ldquo;oncological certification\u0026rdquo;). This is a quality management and certification system for oncological facilities in Germany that aims to improve the quality of care for cancer patients and ensure that it meets the highest medical standards. \u0026nbsp;The National Cancer Plan describes the certification of oncological facilities as a method of recognizing and ensuring the quality of care [31, 32]. To achieve certification, the respective department must meet the \u003cem\u003eFachliche Anforderungen an Onkologische Zentren\u003c/em\u003e \u003cem\u003e(FAO)\u003c/em\u003e (Professional Requirements for Oncology Centers). These cover various areas of oncological care such as diagnostics, therapy, aftercare, patient care, interdisciplinary cooperation, training, and research. OnkoZert carries out certifications on behalf of the German Cancer Society (DKG) in collaboration with experts [31, 32].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eInstitutions responsible for checking the requirements\u003c/p\u003e\n\u003cp\u003eVarious institutions are commissioned to check compliance with legal requirements for quality assurance in radiotherapy. Compliance with the Radiation Protection Act, the Radiation Protection Ordinance and the Radiation Protection Ordinance Directive is monitored by the responsible, legally defined \u003cem\u003e\u0026Auml;rztliche Stelle\u003c/em\u003e (Medical Center) [33]. The \u003cem\u003eHeilberufegesetz\u0026nbsp;\u003c/em\u003e(Medical Professions Act) of the respective federal state, e.g. the \u003cem\u003eHeilberufegesetz Nordrhein-Westfalen (HeilBerG NW)\u0026nbsp;\u003c/em\u003e(North Rhine-Westphalia Medical Professions Act), obliges the \u003cem\u003e\u0026Auml;rztekammer\u0026nbsp;\u003c/em\u003e(Medical Association) to set up Medical Centers \u003cem\u003e(\u0026Auml;rztliche Stelle)\u0026nbsp;\u003c/em\u003ein accordance with the Radiation Protection Ordinance. All medical associations in Germany are subordinated to the \u003cem\u003eBundes\u0026auml;rztekammer\u0026nbsp;\u003c/em\u003e(German Medical Association) and are legally anchored by the \u003cem\u003eGesetz zur Sicherstellung der \u0026auml;rztlichen Versorgung und zur Regelung der Berufe in der Gesundheitsversorgung\u003c/em\u003e (Act to Ensure Medical Care and to Regulate the Professions in Health Care). Among other responsibilities, the German Medical Association is involved in the development and implementation of quality assurance measures in healthcare. These include e.g. the certification of further training programs for doctors and the participation in the development of quality standards in medical care [34].\u003c/p\u003e\n\u003cp\u003eEvery two years, the \u003cem\u003eKassen\u0026auml;rztliche Vereinigung\u003c/em\u003e (Associations of Statutory Health Insurance Physicians) carries out a random sample survey to check whether the approved hospitals are implementing the requirements of the QM-RL. While the directive contains a list of questions for panel doctors and panel dentists, there is currently no such list for approved hospitals. To address this issue, the G-BA has defined a transitional regulation in its QM-RL. Until the catalogue of questions for approved hospitals is published, hospitals must describe \u0026quot;the respective status of implementation and further development of the facility\u0026apos;s internal quality management\u0026quot; [18] in their annual quality report. According to \u0026sect;136b SGB V, the annual quality report is mandatory for all approved hospitals.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition to checking compliance with legal quality assurance requirements, audits are also carried out as part of certification procedures if certification is to be established or extended. The procedure differs depending on the specific certification.\u003c/p\u003e\n\u003cp\u003eIdentified relevant documents and sub-documents\u003c/p\u003e\n\u003cp\u003eLegal requirements and guidelines applicable to radiotherapy are reviewed by the Medical Center. The Medical Center uses checklists for its assessment. In this paper, documents of the \u003cem\u003e\u0026Auml;rztekammer Westfalen-Lippe (\u0026Auml;KWL)\u0026nbsp;\u003c/em\u003e(Westphalia-Lippe Medical Association) are analyzed as an example. The checklists were last updated in January 2023. The documents were created to assess mandatory requirements for radiotherapy [35].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring data collection, the LKRG NRW was identified as a relevant document. This act is legally binding for radiotherapy in Nordrhein-Westfalen.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eQM-RL is another relevant document for the present analysis. Since the guideline contains legally binding quality management requirements for hospitals and for associated radiotherapy centers, it was included in this analysis.\u003c/p\u003e\n\u003cp\u003eEach radiotherapy department must formulate radiation protection instructions in accordance with \u0026sect;45 StrlSchV and submit them to the responsible authority for radiation protection of the associated district government. It is a precondition for obtaining operating license. Changes to radiation protection instruction must be reported to the responsible authority. It must be updated regularly to accommodate internal changes and to ensure compliance with the latest international regulations and standards. The radiation protection instruction contains specific measures for quality assurance not explicitly checked by the Medical Center, witch instead checks the existence of instruction and an operating or handling license. Therefore, the radiation protection instruction of the exemplary radiotherapy was generated as additional material for this analysis. The analyzed radiation protection instruction was last updated in October 2022.\u003c/p\u003e\n\u003cp\u003eIn the process of establishing the radiotherapy department as a cooperation partner of a certified oncology center, further quality assurance requirements had to be determined. The specific requirements a radiotherapy center must meet as part of certification are described in detail in the radio oncology survey questionnaire, created by DKG. The radiation oncology questionnaire was therefore included in the analysis. The questionnaire does not contain information about patients. It was last updated in September 2022.\u003c/p\u003e\n\u003cp\u003eFurther standards are established when certification in accordance with DIN EN ISO 9001:2015 occurs. The requirements of the exemplary radiotherapy department were implemented based on specified framework conditions of DIN EN ISO 9001:2008, which is why DIN EN ISO 9001:2015 was defined as a relevant document.\u003c/p\u003e\n\u003cp\u003eIn summary, the following nine documents were included in the analysis:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eFirst Bulletin of the Medical Center\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSecond Bulletin of the Medical Center\u003c/li\u003e\n \u003cli\u003eChecklist \u0026bdquo;Technik\u0026ldquo; of the Medical Center\u003c/li\u003e\n \u003cli\u003eChecklist \u0026bdquo;Medizin\u0026ldquo; of the Medical Center\u003c/li\u003e\n \u003cli\u003eQM-RL\u003c/li\u003e\n \u003cli\u003eLKRG NRW\u003c/li\u003e\n \u003cli\u003eRadiation Protection Instruction\u003c/li\u003e\n \u003cli\u003eOnkoZert Survey Questionnaire\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eDIN EN ISO 9001:2015\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eSummarizing analysis\u003c/p\u003e\n\u003cp\u003eTo organize the content of these documents, a system of categorization was created (Fig. 3). The system contains five main categories:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eWard structure and documentation\u003c/li\u003e\n \u003cli\u003eRadiation protection, medical physics and devices\u003c/li\u003e\n \u003cli\u003eEmployees\u003c/li\u003e\n \u003cli\u003ePatient management\u003c/li\u003e\n \u003cli\u003eTreamtent standards\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe relevant parts of the documents were then paraphrased and standardized to be presented in a table.\u003c/p\u003e\n\u003ch2\u003eOverview of the requirements\u003c/h2\u003e\n\u003cp\u003eA total of 89 required measures for quality assurance in radiotherapy were identified (Table 1). Unless otherwise stated, the measures refer to every treatment in radiotherapy. 70% of the requirements were legally binding, 30% of the requirements resulted from certifications (marked in blue). Most measures concerned patient management. 53 out of 89 of measures were required or reviewed by one institution. 27 were checked by two separate institutions. Some measures were subject to time limits. These are often applied to regular inspections in device safety. For some requirements, a period was specified in which the procedure had to take place, e.g. when reporting to the cancer registry. Additional data are given in Online Resource 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e: Overview of required quality assurance measures in radiotherapy\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" style=\"width: 74px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCategory\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRequirement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"21\" valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003eWard structure and documentation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"21\" style=\"width: 42px;\"\u003e\n \u003cp\u003eInternal, Center and cooperation, Tumor documentation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRegular meetings with employees\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eQuality targets from central quality management are considered, measures are taken\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eQuality-relevant data and the quality management system are reviewed, necessary improvements are identified, the review is documented\u003csup\u003e1.3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRisk management is introduced, including fault management\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eResponsibilities for different areas and processes are defined\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eMeasurement and evaluation of patient satisfaction\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eMeasurement and evaluation of anonymous employee surveys\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRegular survey of status and further development of quality management in accordance with requirements of QM-RL\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA hygiene management system is introduced\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eFall prevention measures are introduced\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eAssessment of Medical Center with level 1, 2 or even 3, deficiencies are demonstrably rectified\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eDocumentation of relevant information is structured: definition of storage locations, creation and updating of documents, document protection\u003csup\u003e3\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eExisting cooperation agreement in accordance with OnkoZert \u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eTumor conferences are held in accordance with OnkoZert specifications\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eQuality circle is conducted and recorded\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eInformation is exchanged immediately\u003csup\u003e1,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eIf applicable, alliance of radiation oncology practices / institutes (if number of accelerators / radiation treatments is not met independently)\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eTumor documentation shows whether patient is being treated and at which center\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eFollow-up data is systematically reported to the center and used to improve quality\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eSide effects are systematically recorded, evaluated, and analyzed\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eMalignant neoplasms and benign neoplasms of the central nervous system are reported to the cancer registry\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"20\" valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003eRadiation protection, medical physics, and devices\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"20\" style=\"width: 42px;\"\u003e\n \u003cp\u003eRadiation planning, Irradiation technology, Device safety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eSimulation or CT-supported simulation is carried out\u003csup\u003e2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eIrradiation planning system is tested\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eIrradiation plan is drawn up in accordance with DIN 6827-1\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eSeed application: CT follow-up planning is performed\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eX-ray therapy: MPE is involved in radiation planning\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eBrachytherapy: Isodose calculation in target volume and risk area standardized with the aid of tables (level 1) or individually with aid of a radiation planning system using radiographic reconstructions (level 2) or after three-dimensional localization and 3-D planning with the aid of sectional image procedures (level 3) with separate archiving of sectional image data, digital reconstruction radiographs and, if applicable, dose volume histograms\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eX-ray therapy of inflammatory / degenerative diseases: physical radiation parameters are determined using a standard plan\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRadiation planning documents are expertly checked and approved by MPE and physician\u003csup\u003e1,2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eA Planed CT is created\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eAccess to planning devices, systems, and methods ensured\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eNumber of linear accelerators corresponds to the specifications of OnkoZert\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eTechniques to be provided: IGRT, IMRT, 3D conformal radiotherapy, other specific techniques for organ cancer centers / modules\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eOperating permit / handling permit / notification confirmation is available\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eExpert inspection is carried out\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eMetrological control certificate available, equipment of measuring devices is sufficient\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eCondition and constancy test / constancy test is performed and recorded\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eExamination of IGRT procedures\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eTesting of IMRT / IMAT procedures\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eMaintenance of linear accelerators and afterloading devices by the manufacturer\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eOperating diaries are kept\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"11\" style=\"width: 32px;\"\u003e\n \u003cp\u003eEmployees\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"11\" valign=\"top\" style=\"width: 42px;\"\u003e\n \u003cp\u003eExpertise, Further education, etc., Structure, Safety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eAt least 800 tumor patients treated with complete treatment series\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eAt least 200 tumor patients treated in oncology center\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eTumor-specific case numbers and requirements regarding case numbers of systemic therapies are met according to OnkoZert \u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDoctors, MPEs, MTRAs have valid specialist knowledge\u003csup\u003e1,2,3,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eQualification plan is drawn up and implemented for doctors, nursing, and other staff\u003csup\u003e1,3,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eThere is a briefing concept, new employees are fully and systematically briefed, briefing is documented and recorded\u003csup\u003e1,3,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003ePresence of specified number of medical specialists, MPEs and MTRAs is ensured, written substitution regulation in place, 24-hour on-call service of a medical specialist\u003csup\u003e1,2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA list of signature abbreviations is available\u003csup\u003e2,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRadiation protection officer and representative appointed\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA radiation protection commissioner is available and on call\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003ePersons, who regularly work at the irradiation facility wear an official whole-body dosimeter\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"27\" style=\"width: 32px;\"\u003e\n \u003cp\u003ePatient management\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"27\" style=\"width: 42px;\"\u003e\n \u003cp\u003eDocumentation of treatment, Treatment process, Consultation \u0026amp; waiting time, Case related information \u0026amp; dialogue with patients\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eComplete, guideline-compliant treatment documentation\u003csup\u003e1,2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eComplete medical report is created\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRequirements of radiation protection legislation and the Guideline for Radiation Protection in Medicine, current standard of generally accepted practice (guidelines, DEGRO), reference recommendations, registry recommendations, and, if applicable, results of therapy optimization studies are complied with, deviations are justified\u003csup\u003e2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eTherapies are carried out according to corresponding work instructions, deviations are justified\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eIrradiation is carried out according to radiation planning and instructions\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA test run is carried out for every motion irradiation\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eInitial adjustment is carried out by a specialist doctor, possibly with the involvement of a MPE\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDuring initial appointment, a check is made to see whether the patient is included in the radiation list\u003csup\u003e1,2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eGonad protection, storage aid, access to block production available if treatment requires it\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eIn case of combined therapies, medical and medical-physical responsibility does not alternate\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDuring brachytherapy, device and applicators and position of applicators are checked and documented by the operating doctor\u003csup\u003e1,2\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eProof of irradiation is recorded in accordance with DIN 6827-1\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003ePaediatric oncology: Possibility to perform therapy under anesthesia / sedation\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eGynaecological center: Patients are only treated in one Gynaecological center\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eSystemic tumor therapy is not carried out in radiation oncology: Responsibilities are defined; radiotherapy specialist also signs the treatment plan\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDuring radiation treatment, contact is maintained with the patient via a television and intercom system from the control room\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eExpert decision on completion of radiotherapy, information provided on further treatment, follow-up examinations are organized and carried out in accordance with the guidelines, efforts are made to obtain follow-up information\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDrug therapy safety is ensured\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003ePain management is introduced\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eAdequate medical presentation is ensured for each patient\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003ePrompt treatment of the patient is ensured from the time of registration, the total treatment time is adhered to\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003ePatient waiting times are randomly recorded and statistically evaluated\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eDiscussion regarding diagnosis and therapy is conducted and documented\u003csup\u003e1,2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA legally binding declaration of consent from the patient is available\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eDischarge interview is conducted and documented\u003csup\u003e4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eWritten patient information on conduct during radiotherapy is available\u003csup\u003e1,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eAn application management system is introduced\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"12\" valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003eTreatment standards\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"12\" style=\"width: 42px;\"\u003e\n \u003cp\u003eWork instructions \u0026amp; descriptions, SOP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eWork instructions for physicians, medical physics, MTRAs, and, if applicable, other affected departments and staff are available\u003csup\u003e1,2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eWork instructions available for most common medical entities / treatments performed\u003csup\u003e1,2,3,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eGuideline-based supportive measures for individual therapy concepts are described\u003csup\u003e3,4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eProcess descriptions for respective patient treatment areas are available\u003csup\u003e1,3,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eIncident instructions for after-loading are created and visibly displayed\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eProcedure description for sequential / simultaneous radio-chemotherapy are available\u003csup\u003e3,4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA written contingency plan is in place\u003csup\u003e1,3\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eA written emergency plan is available for prompt treatment of palliative patients to alleviate symptoms\u003csup\u003e3,4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eA guideline-compliant overall therapy concept for radiotherapy of breast carcinoma is available and is signed by a specialist doctor before treatment (IntraBeam radiotherapy)\u003csup\u003e2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003eRadiation planning and treatment according to the corresponding SOP, deviations are justified\u003csup\u003e2,4\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eThere are standardized radio-oncological SOPs between the network partners\u003csup\u003e3\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 550px;\"\u003e\n \u003cp\u003e\u003cem\u003eStandard operation procedures for patients with myelon compression and neurological symptoms for care within 24 hours\u003csup\u003e,4\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eLegend: (1) Authority; (2) Medical Center; (3) DIN EN ISO 9001:2015; (4) OnkoZert; requirements marked in blue: resulting from certification\u003c/p\u003e\n\u003cp\u003e(Own illustration based on [32]; \u0026Auml;kWL, 2023a [36]; \u0026Auml;kWL 2023b [37]; \u0026Auml;rztliche Stelle 2019 [38]; \u0026Auml;rztliche Stelle 2023 [39]; DIN 2015b [30]; Kahla-Witzsch, 2019 [40]; G-BA, 2023 [18]; LKRG NRW [28]); CT = Computer tomography, MPE = Medical physics expert, MTRA = Medical-technical radiology assistant, IGRT = image guided radiotherapy; IMRT = Intensity-modulated radiotherapy, IMAT = intensity modulated arc therapy, QM-RL = Qualit\u0026auml;tsmanagement-Richtlinie (quality management guideline); DIN = Deutsches Institut f\u0026uuml;r Normung (German institute for standardization); EN = Europ\u0026auml;ische Norm (European standard); ISO = Internationale Norm (International standard)\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e89 requirements for quality assurance in radiotherapy were identified. The requirements were categorized and analyzed. Most of the requirements are legally binding. Most measures are required in \u0026ldquo;patient management\u0026rdquo;. Some requirements are subject to time limits. One third of the requirements are checked by two institutions.\u003c/p\u003e \u003cp\u003eThe Extent of Measures\u003c/p\u003e \u003cp\u003eIn Germany, the state of quality assurance in radiotherapy is complex. Neither quality management guidelines nor DIN EN ISO 9001:2015 describe most of the requirements in specific terms. The implementation of requirements and the allocation of responsibilities must currently be developed and issued by each radiotherapy facility individually. This corresponds to the concept of the QM-RL: \"The concrete organization of internal quality management systems is carried out specifically in each facility\" [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The following requirement \"an application management system is introduced\" e.g. does not contain any further detailed regulations on how to be implemented. Other requirements, such as \"a guideline-compliant overall therapy concept for radiotherapy of breast carcinoma is available and is signed by a specialist doctor before treatment (IntraBeam radiotherapy)\" only apply to a specific treatment in a cancer center certified as a breast center. Nevertheless, the specific requirement is listed in the checklist of the medical center and radiation oncology questionnaire by OnkoZert. The advantage of the more general wording of the DIN EN ISO 9001:2015 is the possibility of applying this standard to many differently structured organizations in different sectors because of its adaptability. However, when measures are defined in more general terms, the comparability of treatment results is not as easily given, as would be in the case of more specific requirements. Also, those who are responsible for their realization must decide on how and to what extent they are to be concretized. This can create an additional workload and, consequently, result in less time for patients. While thus, the implementation of the requirements may be beyond the original intention or be insufficient. When a more specific wording is to be created, it should be checked beforehand whether these requirements would make it more difficult for hospitals to adjust them to their individual situation.\u003c/p\u003e \u003cp\u003eTesting frequency around device safety in radiotherapy sometimes exceeds the necessity. In addition, some modern devices have integrated testing systems that considerably simplify testing. This applies to basic parameters such as controlling the absolute dose or checking positioning accuracy of mulitleave collimator. Particularly when new technologies are introduced, there are often no current requirements or test equipment for quality assurance available. Therefore, an independent procedure for testing devices must be developed by the users themselves. This procedure is provided for by the Medical Centre, for example. In the technical checklist of the Medical Centre, it is noted that there are currently no test requirements for constancy test of kilovolt-imaging, e.g. in form of a DIN, and that constancy tests should therefore be carried out analogously to another standard of a similar procedure [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis analysis has shown that the number of requirements issued by various institutions is increasing. For example, in May 2024, the \u003cem\u003eLeitlinie zur Qualit\u0026auml;tssicherung der Computertomographie in der Strahlentherapie\u003c/em\u003e (Guideline for quality assurance of Computed tomography in radiotherapy) was published by DEGRO. This guideline describes measures in general as well as measures associated with the treatment of specific organs and areas of the body. The increasing number of requirements creates a high level of documentation. Documentation is a significant stress factor in healthcare: \"Almost half of both senior physicians and practice managers identify documentation requirements as the main cause of stress in day-to-day care\" [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. Consequently, either the amount of documentation needs to be reduced, or existing systems need to be more efficient. In September 2023, the Association of Statutory Health Insurance Physicians criticized the high level of bureaucracy in outpatient care and presented nine steps to reduce bureaucracy: \"The aim is to create more time for patient care. Currently, each practice spends more than one day a week performing bureaucratic tasks\" [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. One of the proposals is the certification of software for quality assurance [\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. Software can be used to implement digital document management systems. It is important to ensure legal data protection and the security of documents and to have the necessary technical infrastructure in place. Another possible solution could be the financing of personnel responsible for quality assurance in the respective radiotherapy to reduce the workload of medical staff and physicists.\u003c/p\u003e \u003cp\u003eFurthermore, the establishment of a central body responsible for auditing all quality assurance requirements may help to reduce the workload. The unintentional duplication of auditing requirements could thus be avoided.\u003c/p\u003e \u003cp\u003eThe Effectiveness of Measures\u003c/p\u003e \u003cp\u003eThe objective of quality assurance is to maintain and improve the quality of products, services, processes, and systems. The requirements identified above are used in radiotherapy to achieve this object. The potential benefits of many requirements have not yet been scientifically proven.\u003c/p\u003e \u003cp\u003eThe StrlSchG was adopted in 2017. The draft law states that \"Radiation Protection Act [will] be adapted to the current state of scientific knowledge\" [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. The Technical Committee on Radiation Protection is part of the \u003cem\u003eL\u0026auml;nderausschuss\u003c/em\u003e (National Committee) and is responsible for preparing amendments and extensions to the regulations [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. The public institutes do not explain how requirements are developed and to what extent measures for quality assurance are evidence-based.\u003c/p\u003e \u003cp\u003eAccording to QM-RL, approved hospitals are temporarily obliged to describe the status of their quality management in an annual quality report. The \u003cem\u003eInstitut f\u0026uuml;r Qualit\u0026auml;tssicherung und Transparenz im Gesundheitswesen (IQTIG)\u003c/em\u003e (Institute for Quality Assurance and Transparency in Healthcare) is commissioned by the G-BA to develop methods for determining and describing the status of quality management. The data is an important basis for optimizing the requirements of the QM-RL. According to the report on the status of quality assurance and effectiveness of measures pursuant to \u0026sect;\u0026nbsp;136d SGB V, \u0026ldquo;[t]he expenditure on the service providers [...] shall be in an appropriate relation, to personnel and structural equipment\u0026rdquo; [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. Therefore, the reporting and random review of contractual (dental) health care institutions is carried out every two years. There is no such regulation for approved hospitals. According to the G-BA, \u0026ldquo;good to high implementation of requirements\u0026rdquo; [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e] takes place. The effectiveness of requirements is not described in the report. Adaptations to QM-RL are made based on quality reports and results of current research projects of the Innovation Committee [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. In the final report Methodological Notes and Recommendations for Collection and Presentation of State of Implementation of Quality Management Directive of the IQTIG, the evaluation of the implementation of QM-RL in hospitals through quality reports is assessed as follows: \u0026ldquo;The quality reports of hospitals [...] represent a comprehensive data collection, which, however, is not aligned with the current QM guidelines \u0026ldquo;[\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e]. Both the IQTIG status report and the IQTIG final report describe requirements taken to collect and describe the status of quality assurance. It is mentioned that quality reports are not adjusted to the QM-RL, therefore no conclusions regarding the effectiveness of the requirements can be made. The assessment of requirements or methods of assessing requirements are not discussed.\u003c/p\u003e \u003cp\u003eStudies suggest benefits of certified oncology centers in terms of patient care. A study of the University Hospital Dresden in cooperation with the \u003cem\u003eUniversit\u0026auml;tsCentrum\u003c/em\u003e (Center of the University) \u003cem\u003eEvidenzbasierte Gesundheitsversorgung\u003c/em\u003e (evidence-based health care), the \u003cem\u003eArbeitsgemeinschaft Deutscher Tumorzentren\u003c/em\u003e (Association of German Tumor Centers), the \u003cem\u003eTumorzentrum Regensburg\u003c/em\u003e (Tumor Center Regensburg) and the \u003cem\u003eWissenschaftliche Institut der AOK\u003c/em\u003e, (Scientific Institute of the AOK), funded by the G-BA and tilted Effectiveness of Care in Oncological Centers [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e] examines the overall survival of around 22\u0026nbsp;million adult cancer patients from 2006\u0026ndash;2017. A distinction is made as to whether a patient was treated in a certified hospital or a non-certified hospital. The study shows that patients treated in certified cancer centers have a higher survival expectancy regardless of the type of cancer [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. Further studies highlight the positive impact of cancer center certification on treatment quality [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]. Additionally, studies emphasize the importance of the multidisciplinary tumorboards, included in the certified oncology centers. These are used to make differentiated and individualized treatment decisions, increasing the success of treatment [\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e, \u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e]. However, the effect of the individual measures for certified oncology centers was not investigated.\u003c/p\u003e \u003cp\u003eClinical guidelines used for the treatment of patients are largely evidence-based [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. A recommendation within guideline is considered evidence-based if the \u0026ldquo;underlying evidence for the issue of recommendation has been systematically searched, the inclusion of studies has been made based on prospectively defined inclusion and exclusion criteria, a critical evaluation of reliability of the studies has been made, and an evidence or quality level has been assigned\u0026rdquo; [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. The creation of SOPs for the treatment of patients based on these guidelines is therefore the implementation of requirements based on scientific evidence.\u003c/p\u003e \u003cp\u003eQuality assurance plays an important role in radiotherapy. However, it is unclear which requirements improve the health care and safety of patients and staff. The high number of measures required and the lack of transparency regarding their effectiveness makes it difficult to implement requirements in the right way. This gives rise to fears that most of the measures will not be implemented in the departments according to their usefulness but will end up as a legal administrative burden. This can apply to fault management, for example. It may only be formally implemented to comply with legal requirements. The faults are not processed in detail and the benefits of fault management are lost, e.g. the solution to a problem or the reduction of errors. This effect is caused, for example, by the fact that employees are not aware of the benefits of fault management combined with time pressure.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eQuality assurance in radiotherapy is crucial due to the complexity of treatments and the high demands of technology and radiation protection. Several requirements from various laws and institutions are either defined in detail or not described in specific terms and the degree of obligation of different measures is often non-transparent. The extent of requirements and documentation obligations as well as redundancies lead to an increased bureaucratic workload, reducing patient care time without evident improvement in treatment outcomes. The paper serves as an orientation and starting point for improving the quality assurance structure, emphasizing the need for optimized standardized solutions to reduce bureaucratic burdens. Future efforts should focus on reviewing the evidence supporting individual requirements.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eFunding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\n\u003cp\u003eCompeting: The authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003cp\u003eAuthor Contributions: Deborah Wöstenfeld and Hendrick Dapper were responsible for the conceptualization and methodology of the study. The investigation and analysis were conducted by Deborah Wöstenfeld and Hendrick Dapper. The first draft of the manuscript was written by Deborah Wöstenfeld and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot needed\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDeutsches Institut f\u0026uuml;r Normung e.V (2015a) Qualit\u0026auml;tsmanagementsysteme \u0026ndash; Grundlagen und Begriffe (ISO 9000:2015); Deutsche und Englische Fassung EN ISO 9000:2015. Beuth Verlag GmbH\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGeiger W (1998) Qualit\u0026auml;tslehre: Einf\u0026uuml;hrung, Systematik, Terminologie. Vieweg, Wiesbaden\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesministerium des Inneren und f\u0026uuml;r Heimat (undated) Qualit\u0026auml;tsmanagement. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bmi.bund.de/DE/themen/moderne-verwaltung/verwaltungsmodernisierung/qualitaetsmanagement/qualitaetsmanagement-node.html\u003c/span\u003e\u003cspan address=\"https://www.bmi.bund.de/DE/themen/moderne-verwaltung/verwaltungsmodernisierung/qualitaetsmanagement/qualitaetsmanagement-node.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 04 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHensen P (2022) Qualit\u0026auml;tsmanagement im Gesundheitswesen, Grundlagen f\u0026uuml;r Studium und Praxis. Springer Gabler, Wiesbaden\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesamt f\u0026uuml;r Strahlenschutz (2023) Wie wirkt ionisierende Strahlung? \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bfs.de/DE/themen/ion/wirkung/einfuehrung/einfuehrung_node.html\u003c/span\u003e\u003cspan address=\"https://www.bfs.de/DE/themen/ion/wirkung/einfuehrung/einfuehrung_node.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 05 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesministerium f\u0026uuml;r Umwelt Naturschutz, nukleare Sicherheit und Verbraucherschutz. (undated). Grunds\u0026auml;tze des Strahlenschutzes. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nuklearesicherheit.de/wissen/physikalische-grundlagen/grundsaetze-des-strahlenschutzes/\u003c/span\u003e\u003cspan address=\"https://www.nuklearesicherheit.de/wissen/physikalische-grundlagen/grundsaetze-des-strahlenschutzes/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 05 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesamt f\u0026uuml;r Strahlenschutz (2019) Grunds\u0026auml;tze des Strahlenschutzes. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bfs.de/DE/themen/ion/strahlenschutz/einfuehrung/grundsaetze/grundsaetze.html\u003c/span\u003e\u003cspan address=\"https://www.bfs.de/DE/themen/ion/strahlenschutz/einfuehrung/grundsaetze/grundsaetze.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 05 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eErstes Gesetz zur \u0026Auml;nderung des Strahlenschutzgesetzes (2021) Bundesgesetzblatt 27:1194\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V (undated) Deutsche Gesellschaft f\u0026uuml;r Radioonkologie e.V. (DEGRO). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.awmf.org/fachgesellschaften/deutsche-gesellschaft-fuer-radioonkologie-e-v-degro\u003c/span\u003e\u003cspan address=\"https://www.awmf.org/fachgesellschaften/deutsche-gesellschaft-fuer-radioonkologie-e-v-degro\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 05 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStrahlenschutz in der Medizin \u0026ndash; Richtlinie zur Strahlenschutzverordnung (StrlSchV) (2011) Gemeinsamens Ministerialblatt, (44\u0026ndash;47) p. 867\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesamt f\u0026uuml;r Strahlenschutz (2022) Missbrauch radioaktiven Materials in Verbindung mit konventionellem Sprengstoff (\u0026bdquo;Schmutzige Bombe). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bfs.de/DE/themen/ion/notfallschutz/bfs/gefahrenabwehr/schmutzige-bombe.html\u003c/span\u003e\u003cspan address=\"https://www.bfs.de/DE/themen/ion/notfallschutz/bfs/gefahrenabwehr/schmutzige-bombe.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 04 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eErste Verordnung \u0026uuml;ber den Schulz vor Sch\u0026auml;den durch Strahlen radioaktiver Stoffe (Erste Strahlenschutzeverordnung) (1960) Bundesgesetzblatt, 1, pp. 430\u0026ndash;452\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVerordnung zur weiteren Modernisierung des Strahlenschutzrechts (2018) Bundesgesetzblatt, 1(41), p. 2079\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGemeinsamer Bundesausschuss (2020) Richtlinie des Gemeinsamen Bundesausschusses \u0026uuml;ber grunds\u0026auml;tzliche Anforderungen an ein einrichtungsinternes Qualit\u0026auml;tsmanagement f\u0026uuml;r Vertrags\u0026auml;rztinnen und Vertrags\u0026auml;rzte, Vertragspsychotherapeutinnen und Vertragspsychotherapeuten, medizinische Versorgungszentren, Vertragszahn\u0026auml;rztinnen und Vertragszahn\u0026auml;rzte sowie zugelassene Krankenh\u0026auml;user (Qualit\u0026auml;tsmanagement-Richtlinie/QM-RL)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesministerium f\u0026uuml;r Gesundheit (2017) Nationaler Krebsplan, Handlungsfelder, Ziele, Umsetzungsempfehlungen und Ergebnisse. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bundesgesundheitsministerium.de/fileadmin/Dateien/5_Publikationen/Praevention/Broschueren/Broschuere_Nationaler_Krebsplan.pdf\u003c/span\u003e\u003cspan address=\"https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/5_Publikationen/Praevention/Broschueren/Broschuere_Nationaler_Krebsplan.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 20.08.2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutsche K (2017) Jahresbericht 2017 der zertifizierten Onkologischen Zentren\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutsche K (2023) Jahresbericht 2023 der zertifizierten Onkologischen Zentren\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGemeinsamer Bundesausschuss (2023) Richtlinie des Gemeinsamen Bundesausschusses \u0026uuml;ber grunds\u0026auml;tzliche Anforderungen an ein einrichtungsinternes Qualit\u0026auml;tsmanagement f\u0026uuml;r Vertrags\u0026auml;rztinnen und Vertrags\u0026auml;rzte, Vertragspsychotherapeutinnen und Vertragspsychotherapeuten, medizinische Versorgungszentren, Vertragszahn\u0026auml;rztinnen und Vertragszahn\u0026auml;rzte sowie zugelassene Krankenh\u0026auml;user (Qualit\u0026auml;tsmanagement-Richtlinie/QM-RL)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eInstitut f\u0026uuml;r Qualit\u0026auml;t und Wirtschaftlichkeit im Gesundheitswesen (2020) Was sind Leitlinien? \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.gesundheitsinformation.de/was-sind-leitlinien.html\u003c/span\u003e\u003cspan address=\"https://www.gesundheitsinformation.de/was-sind-leitlinien.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 06 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesministerium f\u0026uuml;r Gesundheit (2016) Unterschied zwischen f\u0026ouml;rmlichen Gesetzen und Rechtsverordnungen. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/unterschied-zwischen-foermlichen-gesetzen-und-recht.html\u003c/span\u003e\u003cspan address=\"https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/unterschied-zwischen-foermlichen-gesetzen-und-recht.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 06 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMayring P (2022) Qualitative Inhaltsanalyse, Grundlagen und Techniken. Beltz, Weinheim\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMayring P, Fenzl T (2019) Qualitative Inhaltsanalyse. In: Baur N, Blasius J (eds) Handbuch Methoden der empirischen Sozialforschung. Springer Nature, Berlin, pp 633\u0026ndash;648\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGesetz zur Neuordnung des Rechts zum Schutz vor der sch\u0026auml;dlichen Wirkung ionisierender Strahlung (2017) Bundesgesetzblatt 1(42):1966\u0026ndash;2067\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGesetz zur Strukturreform im Gesundheitswesen (Gesundheits-Reformgesetz \u0026ndash; GRG) (1988) Bundesgesetzblatt (62) pp 2477\u0026ndash;2597\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOnko Internetportal (2022) Krebsregister. Onko Internetportal. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.krebsgesellschaft.de/onko-internetportal/basis-informationen-krebs/basis-informationen-krebs-allgemeine-informationen/krebsregister.html\u003c/span\u003e\u003cspan address=\"https://www.krebsgesellschaft.de/onko-internetportal/basis-informationen-krebs/basis-informationen-krebs-allgemeine-informationen/krebsregister.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 30 March 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZentrum f\u0026uuml;r Krebsregisterdaten (2021) Das ZfKD. ZfKD. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.krebsdaten.de/Krebs/DE/Content/ZfKD/zfkd_node.html\u003c/span\u003e\u003cspan address=\"https://www.krebsdaten.de/Krebs/DE/Content/ZfKD/zfkd_node.html\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 30 March 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLandeskrebsregister (undated) Meldepflicht (ed) (2023) LKR. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.landeskrebsregister.nrw/melder/krebsregistrierung-inhalte-der-meldung/meldepflicht/\u003c/span\u003e\u003cspan address=\"https://www.landeskrebsregister.nrw/melder/krebsregistrierung-inhalte-der-meldung/meldepflicht/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 30 March\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGesetz zur Weiterentwicklung der Krebsfr\u0026uuml;herkennung (2013) zur Qualit\u0026auml;tssicherung durch klinische Krebsregister (Krebsfr\u0026uuml;herkennungs- und -registergesetz \u0026ndash; KFRG). Bundesgesetzblatt 1(16):619\u0026ndash;621\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLeitlinienprogramm Onkologie (undated) Leitlinienprogramm Onkologie. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.leitlinienprogramm-onkologie.de/home\u003c/span\u003e\u003cspan address=\"https://www.leitlinienprogramm-onkologie.de/home\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 06 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutsches Institut f\u0026uuml;r Normung e. V (2015b) Qualit\u0026auml;tsmanagementsysteme \u0026ndash; Anforderungen (ISO 9001:2015); Deutsche und englische Fassung EN ISO 9001:2015. Beuth Verlag GmbH, ORT\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOnkoZert (undated) Das Unternehmen. OnkoZert. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.onkozert.de/unternehmen/\u003c/span\u003e\u003cspan address=\"https://www.onkozert.de/unternehmen/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 04 March 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutsche Krebsgesellschaft (2022) Erhebungsbogen Radioonkologie\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztekammer Westfalen-Lippe (undated a) \u0026Auml;rztliche Stelle Westfalen-Lippe. \u0026Auml;rztekammer Westfalen-Lippe. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.aekwl.de/fuer-aerzte/qualitaetssicherung/aerztliche-stellen/\u003c/span\u003e\u003cspan address=\"https://www.aekwl.de/fuer-aerzte/qualitaetssicherung/aerztliche-stellen/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 04 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundes\u0026auml;rztkammer (undated) \u0026Uuml;ber uns. Bundes\u0026auml;rztkammer. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bundesaerztekammer.de/baek/ueber-uns\u003c/span\u003e\u003cspan address=\"https://www.bundesaerztekammer.de/baek/ueber-uns\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 03 May 2024\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztekammer Westfalen-Lippe (undated b) \u0026Auml;rztliche Stelle Strahlentherapie/R\u0026ouml;ntgentherapie. \u0026Auml;rztekammer Westfalen-Lippe. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.aekwl.de/fuer-aerzte/qualitaetssicherung/aerztliche-stellen/aerztliche-stelle-strahlentherapie/\u003c/span\u003e\u003cspan address=\"https://www.aekwl.de/fuer-aerzte/qualitaetssicherung/aerztliche-stellen/aerztliche-stelle-strahlentherapie/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 04 September 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztekammer Westfalen-Lippe (2023a) Qualit\u0026auml;tssicherung Strahlentherapie nach Strahlenschutzverordnung (StrlSchV) vom 29.11.2018\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztekammer Westfalen-Lippe (2023b) Qualit\u0026auml;tssicherung Strahlentherapie nach Strahlenschutzverordnung (StrlSchV) vom 29.11.2018\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztliche S (2019) Checkliste Technik Gesamt\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e\u0026Auml;rztliche S (2023) Checkliste Medizin Gesamt\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKahla-Witzsch HA (2019) Zertifizierung im Krankenhaus nach DIN EN ISO 9001:2015: Ein Leitfaden. W. Kohlhammer, ORT\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWallenfels M (2018) Stressfaktor Nummer eins: die B\u0026uuml;rokratie, hautnah dermatologie, 1:56\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKassen\u0026auml;rztliche B (2023) KBV legt Vorschl\u0026auml;ge zur Entb\u0026uuml;rokratisierung der ambulanten Versorgung vor \u0026ndash; Hofmeister: Lauterbach muss jetzt handeln. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.kbv.de/html/1150_65276.php\u003c/span\u003e\u003cspan address=\"https://www.kbv.de/html/1150_65276.php\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 23 October 2023\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutsche Bundesregierung (2017) Entwurf eines Ersten Gesetzes zur \u0026Auml;nderung des Strahlenschutzgesetzes\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBundesministerium f\u0026uuml;r Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz (2023) L\u0026auml;nderausschuss f\u0026uuml;r Atomkernenergie. Bundesministerium f\u0026uuml;r Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGemeinsamer Bundesausschuss (2023) Bericht gem\u0026auml;\u0026szlig; \u0026sect; 136d SGB V \u0026uuml;ber den Stand der Qualit\u0026auml;tssicherung \u0026ndash; Wirksamkeit der eingef\u0026uuml;hrten Ma\u0026szlig;nahmen und Weiterentwicklungen \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.bmuv.de/themen/nukleare-sicherheit/atomrechtliche-behoerden-gremien-und-organisationen/laenderausschuss-fuer-atomkernenergie\u003c/span\u003e\u003cspan address=\"https://www.bmuv.de/themen/nukleare-sicherheit/atomrechtliche-behoerden-gremien-und-organisationen/laenderausschuss-fuer-atomkernenergie\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 27 March 2024\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGemeinsamer Bundesausschuss (2020) Beschluss des Gemeinsamen Bundesausschusses \u0026uuml;ber die Freigabe des Abschlussberichts des IQTIG zu methodischen Hinweisen und Empfehlungen zur Erhebung und Darlegung des Umsetzungsstands der Qualit\u0026auml;tsmanagement-Richtlinie. QM-RL). zur Ver\u0026ouml;ffentlichung\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchmitt J, Schoffer O, Klinkhammer-Schlake M, Bobeth C, Roessler M, Bierbaum V, Gerken M, van Kleihues K, Dr\u0026ouml;ge P, G\u0026uuml;nster C (2023) Krebserstbehandlung in zertifizierten versus nichtzertifizierten Krankenh\u0026auml;usern, Ergebnisse der vergleichenden Kohortenstudie WiZen. Deutsches \u0026Auml;rztebl 120. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps//doi.org/10.3238/arztebl.m2023.0169\u003c/span\u003e\u003cspan address=\"10.3238/arztebl.m2023.0169\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoessler M, Schmitt J, Bobeth C, Gerken M, Kleihues-van Tol K, Reissfelder C, Rau BM, Distler M, Piso P, G\u0026uuml;nster C, Klinkhammer-Schalke M, Schoffer O, Bierbaum V (2022) Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study. 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Dtsch Arztbl Int. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3238/arztbl.m2023.0195\u003c/span\u003e\u003cspan address=\"10.3238/arztbl.m2023.0195\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Radiotherapy, quality assurance, quality management structure, certification","lastPublishedDoi":"10.21203/rs.3.rs-6687918/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6687918/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003ePurpose\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe aim of this paper is to identify requirements for quality assurance in radiation therapy in Germany.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethod\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003e89 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.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eRequirements 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.\u003c/p\u003e","manuscriptTitle":"Quality Assurance in Radiation Therapy in Germany – Attempt to Assess the Current Status and Challenges Using an Example of a German Hospital","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-01 06:23:50","doi":"10.21203/rs.3.rs-6687918/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8ac95c15-d6f9-4528-bf3e-031ea2fe98e0","owner":[],"postedDate":"July 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-18T23:12:41+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-01 06:23:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6687918","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6687918","identity":"rs-6687918","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}