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.

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.

[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.

Filling Voice Promotion Gaps in Healthcare through a Comparative Analysis of Error Reporting and Learning Systems and Open Communication and Disclosure Policies in the United States and Germany.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

[Glasses as Relevant Factor in Expert Opinions]. / Die Brille als Bewertungsfaktor im Gutachten.

Optical correction is an independent factor in expert opinions. It is outlined how this should be considered in different legal areas.

[Bone banks : The state-of-the-art]. / Knochenbanken : State-of-the-Art.

Bone banks are responsible for the collection, production, testing, packaging, storage and delivery of osseous grafts. In compliance with legal and quality requirements, it is their main task to ensure the biological properties and the microbiological safety of the transplants as well. German legal requirements for bone banking are explained and current standards with respect to donor selection, laboratory tests and tissue processing, as well as labeling are discussed. Production and preparation procedures should include a validated microbiological inactivation method that largely preserves the biological properties of the tissue.

Development of indicators for a nationwide cross-sectoral quality assurance procedure for mental health care of patients with schizophrenia, schizotypal and delusional disorders in Germany.

PURPOSE: This paper describes the development of quality indicators for an external statutory and cross-sectoral quality assurance (QA) procedure in the context of the German health care system for adult patients suffering from schizophrenia, schizotypal and delusional disorders (F20-F29). METHODS: Indicators were developed by a modified RAND/UCLA Appropriateness Method with 1) the compilation of an indicator register based on a systematic literature search and analyses of health care claims data, 2) the selection of indicators by an expert panel that rated them for relevance and for feasibility regarding implementation. Indicators rated positive for both relevance and feasibility formed the final indicator set. RESULTS: 847 indicators were identified by different searches. Out of these, 56 were selected for the indicator register. During the formal consensus process the expert panel recommended another 45 indicators so that a total of 101 indicators needed to be considered by the panel. Of these, 27 indicators rated both relevant and feasible were included in the final set of indicators: this set included 4 indicators addressing structures, 19 indicators addressing processes and 4 indicators addressing outcomes. 17 indicators of the set will be reported by hospitals and 8 by psychiatric outpatient facilities. Two indicators considered to be cross-sectoral will be reported by both sectors. DISCUSSION: F20-F29 and its treatment show some specific features which so far have not been addressed by any procedure within the statutory QA program of the German health care system. These features include: Schizophrenia and related disorders a) are potentially chronic conditions, b) are mainly treated in outpatient settings, c) require a multi-professional treatment approach and d) are treated regionally in catchment areas. These specific features in combination with the peculiarities of some legal, political and organizational characteristics of the German health care system and its statutory QA program have strongly influenced the development of indicators. The result was a seemingly "imbalanced" set of indicators with a greater number of indicators for inpatient than for outpatient care despite the fact that clinical reality is otherwise. CONCLUSIONS: The circumstances of the German health care system that restricted the development of this cross-sectoral QA procedure addressing care for F20-F29 are also most likely to emerge with the development of cross-sectoral QA procedures for other (potentially) chronic conditions that are mainly treated in the outpatient setting by multi-professional teams or by networks of different providers. In order to be able to develop a QA procedure that mirrors the reality of service provision for (potentially) chronic diseases such as F20-F29 we need to explore further current and new data sources, diminish sectoral borders, and implement health care responsibility on the level of catchment areas.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making changes relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.

[Principles of the EU Clinical Trials Regulation No 536/2014 : What will change?] / Grundzüge der EU-Verordnung 536/2014 : Was wird sich ändern?

The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human use will replace the still valid European Directive 2001/20/EC in the future. The new regulation aims to further harmonise authorisation and reporting procedures for clinical trials and introduces of a joint European assessment for multinational clinical trials in the EU. Despite the joint assessment administered by a reporting member state, each member state continues to authorise clinical trial applications nationally. In the future, applications and any communication will be submitted paperlessly via a new electronic EU portal, which is still being developed. The regulation provides detailed information on the implementation of multinational clinical trials. In particular, the complex processing procedures and shorter time limits are to be stressed in comparison to the previously valid regulations. This is a major challenge for all stakeholders, but on the other hand it should contribute to the future role of the EU in the development of innovative medicines.