Quality/risk management system in radiotherapy: Changes afoot.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

The Affordable Care Act at 10 Years: Evaluating the Evidence and Navigating an Uncertain Future.

The year 2020 marks the 10th anniversary of the signing of the Affordable Care Act (ACA). Perhaps the greatest overhaul of the US health care system in the past 50 y, the ACA sought to expand access to care, improve quality, and reduce health care costs. Over the past decade, there have been a number of challenges and changes to the law, which remains in evolution. While the ACA's policies were not intended to specifically target surgical care, surgical patients, surgeons, and the health systems within which they function have all been greatly affected. This article aims to provide a brief overview of the impact of the ACA on surgical patients in reference to its tripartite aim of improving access, improving quality, and reducing costs.

Strategies for Success in Regulatory Readiness.

This article describes the formation of a Regulatory Advisory Council to address regulatory preparedness. The council used quality improvement methods to address data and findings from previous mock surveys and created 2 categories of work, an environment of care and clinical standards group, with checklists and work streams to improve organizational success with regulatory readiness.

Advancing the Culture of Patient Safety and Quality Improvement.

The American health care system has many great successes, but there continue to be opportunities for improving quality, access, and cost. The fee-for-service health care paradigm is shifting toward value-based care and will require accountability around quality assurance and cost reduction. As a result, many health care entities are rallying health care providers, administrators, regulators, and patients around a national imperative to create a culture of safety and develop systems of care to improve health care quality. However, the culture of patient safety and quality requires rigorous assessment of outcomes, and while numerous data collection and decision support tools are available to assist in quality assessment and performance improvement, the public reporting of this data can be confusing to patients and physicians alike and result in unintended negative consequences. This review explores the aims of health care reform, the national efforts to create a culture of quality and safety, the principles of quality improvement, and how these principles can be applied to patient care and medical practice.

Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study.

BACKGROUND: The relationship between quality and safety regulation and resilience in healthcare has received little systematic scrutiny. Accordingly, this study examines the introduction of a new regulatory framework (the Quality Improvement Regulation) in Norway that aimed to focus on developing the capacity of hospitals to continually improve quality and safety. The overall aim of the study was to explore the governmental rationale and expectations in relation to the Quality Improvement Regulation, and how it could potentially influence the management of resilience in hospitals. The study applies resilience in healthcare and risk regulation as theoretical perspectives. METHODS: The design is a single embedded case study, investigating the Norwegian regulatory healthcare regime. Data was collected by approaching three regulatory bodies through formal letters, asking them to provide internal and public documents, and by searching through open Internet-sources. Based on this, we conducted a document analysis, supplemented by interviews with seven strategic informants in the regulatory bodies. RESULTS: The rationale for introducing the Quality Improvement Regulation focused on challenges associated with implementation, lack of management competencies; need to promote quality improvement as a managerial responsibility. Some informants worried that the generic regulatory design made it less helpful for managers and clinicians, others claimed a non-detailed regulation was key to make it fit all hospital-contexts. The Government expected hospital managers to obtain an overview of risks and to adapt risk management and quality improvement measures to their specific context and activities. CONCLUSIONS: Based on the rationale of making the Quality Improvement Regulation flexible to hospital context, encouraging the ability to anticipate local risks, along with expectations about the generic design as challenging for managers and clinicians, we found that the regulators did consider work as done as important when designing the Quality Improvement Regulation. These perspectives are in line with ideas of resilience. However, the Quality Improvement Regulation might be open for adaptation by the regulatees, but this may not necessarily mean that it promotes or encourages adaptive behavior in actual practice. Limited involvement of clinicians in the regulatory development process and a lack of reflexive spaces might hamper quality improvement efforts.

Nurses' experiences of ICU diaries following implementation of national recommendations for diaries in intensive care units: A quality improvement project.

OBJECTIVES: To evaluate critical care nurses' experiences of ICU diaries following the implementation of national recommendations for the use of diaries for critically ill patients. DESIGN: A quality improvement project describing the development and implementation of national recommendations (2011), as well as the assessment of the use of diaries in intensive care nursing practice (2014). SETTING: Norwegian intensive care units (ICUs). PARTICIPANTS: Thirty-nine Norwegian ICUs took part in the study. INTERVENTION: A multi-component process for developing national recommendations for the use of diaries in Norwegian ICUs, including recommendations for the target group, when to start, health professionals as authors, diary content, structure, language, use of photographs, handover, access and storage within patient medical records. MAIN OUTCOME MEASURE: A questionnaire asking about experiences of implementing national recommendations on diaries in Norwegian ICUs, as well as their impact and how they are used. RESULTS: Three years after the implementation of the national recommendations, diaries were provided in 24 (61.5%) of the responding ICUs. Fifty-six per cent of the ICUs had revised their routines, of which 62% had updated and 38% had developed new protocols. Most ICUs kept the diary along with other medical information describing patient care, but only 50% of the ICUs scanned handwritten diaries into the electronic medical records before handing them over to patients or the bereaved. ICU nurses reported that implementing national recommendations had increased their awareness and knowledge on patient and family needs, as well as the long-term effects of critical illness. CONCLUSION: The results of this quality improvement project indicate that access to national recommendations on the use of diaries for critically ill patients have a potential of changing routines and increase standardisation.

15 years of the model study course in medicine at the Ruhr University Bochum.

The Faculty of Medicine of the Ruhr University Bochum (RUB) introduced a model study course in medicine (MSM) in the winter semester 2003. For 9 consecutive years, 42 out of 280 first year students at the Ruhr University Bochum had the opportunity to begin their studies in the model study course in medicine. The places were allocated amongst the applicants internally through a raffle. The MSM was consistently problem-, practice- and patient-oriented and largely did away with lectures, broke with the distinction between a pre-clinical and clinical phase and tested basic knowledge in equivalent integrated exams focusing on clinical application. Following a comparative evaluation of the standard degree course (RSM) and the MSM, the faculty merged the two degree courses into the Integrated Reformed Medical Curriculum (IRMC), which has been on offer since 2013 and is characterized by a topic-oriented hybrid curriculum. This article examines experiences relating to the origins, conception and introduction of the MSM.

The Aachen model study course in medicine - development and implementation. Fifteen years of a reformed medical curriculum at RWTH Aachen University.

Objective: The Aachen model study course in medicine was developed in response to a negative appraisal of the Faculty of Medicine of the RWTH Aachen University by the Science Council in 2000. The aim is to create graduates who are capable of further training and can work in evidence-based and patient-centered health care while incorporating scientific findings. Methodology: In 2003 the medical degree was fully switched over to the model study course format. This means an annual cohort size of about 280 students. These go through a modularized and integrated curriculum, which is designed as a learning spiral. This requires a special interdisciplinary collaboration of teachers and curriculum planners. In addition to the modules, longitudinal elements such as workplace-based examinations, communication or practical skills are embedded in the curriculum. Results: The state exam results of the Aachen graduates have already improved significantly even for the first cohort and the university has been able to maintain an almost uninterrupted high level from 2008 to 2018. The students satisfaction with the model course is not only evident in the student course assessment and qualitative group discussions but also in various national rankings. Conclusion: The complete redesign of the course starting from the first semester onwards posed major challenges for all those involved in the faculty. The implementation of a completely reformed curriculum, such as the model study course, can only succeed through constructive cooperation of the various stakeholders at a faculty. The reorientation was able to address the major flaws of the 2002 report by the Science Council, student dissatisfaction and the poor performance in the nationwide state exams.

History and development of medical studies at the University of Witten/Herdecke - an example of "continuous reform".

Introduction: The University of Witten/Herdecke (UW/H) was founded in 1982 as the first privately run German university. In addition to economics, dentistry, a center for life sciences and the institute for general studies, the main focus from the inception of the University was the development of a model course in medical studies. Methodology: A description of the history of the development of medical studies in relation to the reasons for its founding, its founding ideals and their implementation; phases of development, transformations and influencing factors are presented in detail. External assessments are also used for this purpose. Result: The "Herdecke Model" was first implemented with the initial group of medical students in 1983. In the past 36 years the curriculum for medical education in Witten/Herdecke has evolved to meet internal and external requirements. The goals of the founders for a reform of medical studies and the founding ideals of the UW/H have continued to lead the University through a continuous reform process of medical training. From the first model of a reform degree course at UW/H 1983 to the current Model Study Course/Modellstudiengang (MSG 2018plus), these reforms have manifested themselves in four major phases spanning a 15 year period. Landmarks of the reforms include the first systematic introduction of problem-oriented learning in Germany, and clinical and practical training with real patients in both clinical and general medical elective blocks that far surpass the Medical Licensure Act's requirements. Additionally noteworthy are the introduction of PY training wards and the active participation and co-design role students may hold. Discussion: Due to the small size of UW/H, reforms can be tested quickly and implemented with ease and flexibility. This facilitates a "laboratory setting" for the testing of future-oriented innovations. The small size has allowed various concepts to be able to be used as models, thus serving as stimuli for larger change in medical studies in Germany.

The Berlin reformed curriculum in undergraduate medical education: a retrospective of the development history, principles, and termination.

The Reformed Medical Curriculum (RMC) at Charité-Universitätsmedizin Berlin was launched in autumn 1999, while medical schools in Canada, the United States, Scotland, the Netherlands, and Scandinavia already had adapted educational reforms in medical education many years before [1], [2]. For eleven years, 63 medical students per year trained at the Faculty in accordance with international standards governing the RMC. It was the first and perhaps most revolutionary reformed medical curriculum at a German university after the commencement of "Modellklausel", a new section in the Licensing Regulations for Doctors (Approbationsordnung für Ärztinnen und Ärzte) in 1999 that paved the way for fundamental reforms within undergraduate medical education in Germany. The idea was to establish and test a "pilot project of a fundamental reform of medical education in Germany" [3], thus aligning Germany with international developments and establishing a model for other reform initiatives. The first part of the article will provide an overview of how the RMC were able to emerge. It reports who initiated the project and why, who kept it running and encountered opposition and what were the social and political conditions. The second part of the article describes the principles that were fundamental for the development of the RMC. The third part illustrates the quality assurance measures, and the final section covers the termination of the RMC.

Bologna backstage - experiences from behind the scenes of the reforms of the Basel medical curriculum.

Based on a six-year degree in medical studies which was characterized by a series of lectures without an over-arching concept, Basel decided to embark on reforms in 1995. The first wave of reforms (1998-2003) produced a hybrid curriculum structure with PbL teaching units, organized according to organ systems, in years 1-4 of medical studies, which met the demand for "clinical content in the pre-clinical phase". A focus on General Practice medicine was achieved by implementing the "One to one tutorial" in the 3rd and 4th year of studies. Fixed weekly schedules provided space for instruction in the three learning dimensions - cognitive, affective and psychomotor learning - implemented in four longitudinal competence strands. The compulsory elective subject area "Early patient contact" was integrated into the elective degree courses of the Bachelor's degree by creating projects. From 2006 to 2012, the demands of the Bologna Declaration were implemented and a Bachelor's and a "consecutive" Master's degree program developed and then implemented. The PbL teaching units which had come in for criticism were replaced in the Master's Degree by the "Clinical Case" and in the Bachelor's degree by the "Tutorial on Scientific and Clinical Reasoning". To strengthen scientific competences, the "Science Month" and the compulsory elective subject area "Scientific Competences - Flexible Offers (WIKO.flex)" were introduced. Further curricular adjustments resulted in the development of an externally accredited integrated emergency curriculum, the establishment of feedback OSCEs and the intensification of the Skills Lab offer. In addition to content, organizational framework conditions for curricular development were key: Thus, the massive expansion of places on medical degree courses also had an impact on curriculum structure and examinations. In 2017, PROFILES, the new Swiss competence framework, was published, which presents curriculum planning with new challenges as a result of the introduction of the EPA concept. Due to the flexible structure of the curriculum, the faculty feels confident it will be able to handle these challenges. The re-accreditation of the degree program in 2018 provided important stimuli for the strengthening of interprofessional teaching and a focus on the competent handling of an increasing number of patients asking for complementary medical treatments.

Looking back: twenty years of reforming undergraduate medical training and curriculum frameworks in Switzerland.

Introduction: To date, hardly any reports exist that outline the reforms in medical studies in Switzerland from the first partial reforms in the 1970s until today. Methods: This article outlines the recent history of medical curricula, their reforms in the early 1970s and, based on these, the key reasons for the major curricular reforms of the 2000s from the perspective of the authors. Results: The various projects, initiatives and legislative elements at the national level include the introduction of new quality control instruments - federal examination and programme accreditation, the introduction of a national catalogue of learning objectives and its two follow-up editions, as well as the implementation of the Bologna reform in undergraduate medical curricula. Examples of the key new elements found in all medical training in Switzerland include: the interdisciplinary orientation of learning content in organ and functional system-oriented subject areas or modules, the enhanced valorisation of practical clinical training, as well as the introduction of problem-oriented formats and the integration of partly formative, partly summative exams according to the format of the objective structured practical examination (OSCE). Characteristics unique to the four medical faculties and their medical training programme are also highlighted. Discussion: The described projects, initiatives and legislative elements have led to a dynamic, continuous development of medical curricula in Switzerland. The close cooperation between the faculties and the Federal Office of Public Health (FOPH) has also resulted in a redefinition of the roles and responsibilities of universities and the Federal Government according to the new Law on Medical Professions. This guarantees the medical faculties a great deal of autonomy, without neglecting quality assurance.

Learning Health Systems and the Revised Common Rule.

Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

[Successful completion of an ISO 9001 v 2015 certification process in clinical investigation research]. / Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique.

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units. OBJECTIVE: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. METHODS: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. RESULTS: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. CONCLUSION: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

Health Literacy-How Do We Improve the Conversation at the Heart of Healthcare when We Know so Many People are Struggling with It?

The Scottish Government published "Making it Easy - A Health Literacy Action Plan for Scotland" in 2014, and in 2017 the next steps were set out in "Making it Easier - A Health Literacy Action Plan for Scotland 2017-2025." This article discusses what health literacy is, outlining the key points from these national action plans. The importance of understanding and addressing health literacy in relation to renal services, and dialysis in particular, is highlighted by use of an example of a Scottish renal unit's practice to outline the principles being used in a service.