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.

Official Information Act investigation of the Ministry of Health's process to assess the Southern District Health Board's readiness to join the National Bowel Screening Programme in 2018.

We examined the documentation underlying the decision to permit the Southern District Health Board (SDHB) to join the National Bowel Screening Programme (NBSP) at a time when it was not providing an adequate colonoscopy service for symptomatic patients. A coordinated sequence of relevant Official Information Act 1982 (OIA) requests was lodged with the New Zealand Ministry of Health (MoH), which is responsible for determining the readiness of district health boards (DHBs) to join the NBSP. However, the MoH OIA process was obfuscating, unduly long and responded only after they anticipated imminent intervention by the Office of the Ombudsman. The amount of information provided was massive, partly irrelevant and presented in an inconvenient format. It revealed that the MoH readiness process was incomplete, and permission for the SDHB to join the NBSP was given prematurely without following due process and despite concerns expressed by some MoH staff. Subsequently, the MoH has failed to admit that they made errors in this case or have any weaknesses in their readiness assessment process. The MoH readiness process failed to determine that the SDHB was not ready to join the NBSP in 2018. Concerns have been expressed in the public media that such failures have occurred with the assessment of other DHBs. The process needs to be overhauled or replaced before further permissions are granted to DHBs. Requests for information under the OIA from the MoH, and similar public entities and agencies subject to the OIA, are too easily deferred, derailed or declined. The OIA is in need of revision.

Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.

In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.

Accreditation of endocrine surgery units.

BACKGROUND/PURPOSE: A key measure to maintain and improve the quality of healthcare is the formal accreditation of provider units. The European Society of Endocrine Surgeons (ESES) therefore proposes a system of accreditation for endocrine surgical centers in Europe to supplement existing measures that promote high standards in the practice in endocrine surgery. METHODS: A working group analyzed the current healthcare situation in the field of endocrine surgery in Europe. Two surveys were distributed to ESES members to acquire information about the structure, staffing, caseload, specifications, and technology available to endocrine surgery units. Further data were sought on tracer diagnoses for quality standards, training provision, and research activity. Existing accreditation models related to endocrine surgery were included in the analysis. RESULTS: The analysis of existing accreditation models, available evidence, and survey results suggests that a majority of ESES members aspire to a two-level model (termed competence and reference centers), sub-divided into those providing neck endocrine surgery and those providing endocrine surgery. Criteria for minimum caseload, number and certification of staff, unit structure, on-site collaborating disciplines, research activities, and training capacity for competence center accreditation are proposed. Lastly, quality indicators for distinct tracer diagnoses are defined. CONCLUSIONS: Differing healthcare structures, existing accreditation models, training models, and varied case volumes across Europe are barriers to the conception and implementation of a pan-European accreditation model. However, there is consensus on accepted standards required for accrediting an ESES competence center. These will serve as a basis for first-stage accreditation of endocrine surgery units.

[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.

[The new National Guidelines System in Italy: a first evaluation].

The so-called Gelli-Bianco Law (L 24/2017) recognizes the central role of Guidelines as far as decision-making in the health sector is concerned and establishes the Italian National Guidelines System (SNLG) as a "safe harbor", notwithstanding the specificities of each real-world case. The Italian National Center for Clinical Excellence, Quality and Security (CNEC) is responsible for the creation and the development of the SNLG. After considering the many issues revolving around the creation of shared Guidelines, both on the national and international level, we present here the activities of the SNLG to date, together with an evaluation of how the new rules and practices around the creation of National Guidelines have been received. We also provide a series of recommendations for scientific societies on how best to produce Guidelines in their own field and how to submit them to the SNLG.

The Legal Underpinnings of Medical Discipline in Common Law Jurisdictions.

Medical regulators have a responsibility to protect, promote, and maintain the health and safety of patients. Here, we compare and contrast the processes for addressing concerns about doctors in four countries with legal systems based on English common law: the UK, Australia, the United States, and Canada. The legal provisions underpinning each jurisdiction's disciplinary processes depict distinctive outlooks from the different authorities as each works toward the same goal. The initial stages of the investigation process are broadly similar in all of the jurisdictions examined. Each process, however, has subtle differences with regard to its comparators. Factors include how matters of discipline are framed, the constitution of disciplinary panels, and how the perceived independence of these panels all philosophically affect the public safety remit of each regulator. This work constitutes the first comparison of international regulatory frameworks for the profession of medicine.

Transition from a traditional to a comprehensive quality assurance system in Slovenian family medicine practices.

In Slovenia, quality of care at the primary healthcare level is formally a priority, but the legislation to ensure quality in this area is proceeding very slowly. The first steps towards a systematic quality control system in Slovenian family medicine were implemented with the initiation of an ongoing project of renewed family medicine practices in 2011 and the introduction of quality indicators. In 2017, an initiative by the Ministry of Health and the Department of Family Medicine at the Faculty of Medicine, the University of Ljubljana, aimed to develop a new approach to quality assurance and an improvement. It comprises four main parts: the family medicine practice team, a quality control group, a quality control office and the Ministry of Health. In this plan, quality is controlled and improved at the micro, mezzo and macro levels. The described system for quality assurance and improvement is still waiting to be implemented in practice, as there is a lack of human and financial resources.

La politique nationale des indicateurs de qualité et de sécurité des soins.

THE NATIONAL POLICY OF CARE QUALITY AND SAFETY INDICATORS: Care quality and safety indicators, piloted by the national health authority, are tools forming part of a global programme of improvement of quality and safety of care. The national scheme for measuring the quality and safety of care provides, for all healthcare facilities, dashboards for managing care quality and safety. Currently focused on the public and private hospital sector, it needs to evolve to widen its scope to include community care and the medical-social sector.

[Medical biology in the face of the evolution of health care needs]. / Rapport des Académies nationales de médecine et de pharmacie sur la biologie médicale La biologie médicale face aux défis de l'évolution des besoins de santé.

Since the publication of the ordinance of January 13th 2010, ratified by the law of May 30th 2013, medical biology in France has undergone a massive restructuration with the emergence of groups of several hundred laboratories. This evolution, which leads to a considerable reduction in the number of structures, causes numerous problems related to increased industrialization and financialization, difficulties of accreditation and disappearance of the proximity link between the biologist and the prescriber or the patient. It also leads to a clear disaffection of students, especially medical students, for this specialty whose medical character has been clearly affirmed by the law. This report takes stock of the current situation of medical biology and makes recommendations to strengthen the role of the medical biologist in the health system and patients' care.

[Real-time access via the patient portal; is this desirable for good care provision?] / Realtime-inzage via het patiëntenportaal.

More and more hospitals are opening patient portals, which enable patients to view their medical records online. Some hospitals take it one step further and offer patients real-time access. The right to digital access to data, either locally or at a distance, will be established in the course of the next few years in new European General Data Protection Regulation and in the Netherlands 'law for supplementary conditions for processing personal data in the care sector' ('Wet aanvullende bepalingen verwerking persoonsgegevens in de zorg'). These developments give relevancy to the question whether real-time access to medical records is desirable for good care provision. There are pros and cons to real-time access. Many of the pros also apply when access is provided after a short buffer period and more research, particularly into potential damaging consequences, is desirable. When all aspects are taken into consideration, a system of real-time access can be in conflict with good care provision in certain situations, for instance, if it is not possible to set up a buffer period.

[Medicolegal Assessment for Chronic Musculoskeletal Pain - 4th Update of the German Guideline for Medicolegal Assessment of Persons in Chronic Pain]. / Begutachtung chronischer muskuloskeletaler Schmerzen.

Medicolegal assessments of claimants with chronic muskuloskeletal pain conditions are frequent. The first German guideline published in 2005 for the medicolegal assessment of claimants in chronic pain is now available in its 4th version (AWMF register number 094 - 003). It gives recommendations for the procedure and serves to ensure the quality of expert opinions when complaints about chronic pain are the leading symptom. In the current version, the indications for ordering medical assessments in pain syndromes have been reformulated, the assessment criteria have been adapted to ICF specifications, and an unequivocal distinction has been introduced between questions of state and causal assessment. A separate chapter on symptom validity assessment has been engrafted.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.