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.

ROP Risk Management 2021.

PURPOSE OF REVIEW: It is important for ophthalmologists to keep current with up-to-date recommendations for screening, treating, and follow-up of infants with retinopathy of prematurity (ROP). This paper will review updated ROP Safety Net protocols and Policy Statements to stress that following risk management principles can avoid claims that could arise from poor visual outcomes. RECENT FINDINGS: Ophthalmic Mutual Insurance Company (OMIC) has been proactive in ROP risk management with development of the ROP Safety Net in 2006. The most recent updates in 2018 and 2019 address OMIC's claims experience and the factors leading to these claims. Clinical, systems, physician, and parent factors will be clarified. In addition, when to stop ROP screening has evolved and will be delineated and discussed to further aid in the process of care of these high-risk infants. SUMMARY: Ophthalmologists that screen and treat infants with ROP must keep updated with safety net protocols and institute them in their Neonatal Intensive Care Units (NICU) and offices as they take care of these babies to minimize legal risks from a claim. In addition, keeping up with policy statements is essential to successfully following these infants in the most appropriate fashion.

Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU.

Introduction: Risk Management Plans (RMPs) aim to optimize a medicinal product's benefit/risk balance for the individual patient and the target population. Despite differences in regulatory RMP requirements between jurisdictions worldwide, their ultimate aim is to protect public health.Areas covered: The review presents findings of different RMP requirements by different regulatory authorities and additional risk minimization measures (issued between January 2010 and December 2018) indicate how RMPs and additional risk minimization measures translate into actions to protect public health within the European Union (EU) member states and worldwide. Areas covered also include the different International Council for Harmonization (ICH) regional requirements of RMPs by the different regulatory authorities as well as data regarding the number of RMP assessments carried out by the EMA, FDA and Japan, and number of safety communications issued in Malta (taken as an example of a typical small EU member state) and in the United States of America (USA).Expert opinion: The EU legislation adopted in 2010 required RMPs to be included in all new applications for medicinal products in the EU, both for EU centrally authorized and nationally authorized medicinal products. Lessons learnt by EU regulators during this process are discussed in this review.

Mandatory reporting legislation in Canada: improving systems for patient safety?

Patient safety is a complex systems issue. In this study, we used a scoping review of peer-reviewed literature and a case study of provincial and territorial legislation in Canada to explore the influence of mandatory reporting legislation on patient safety outcomes in hospital settings. We drew from a conceptual model that examines the components of mandatory reporting legislation that must be in place as a part of a systems governance approach to patient safety and used this model to frame our results. Our results suggest that mandatory reporting legislation across Canada is generally designed to gather information about - rather than respond to and prevent - patient safety incidents. Overall, we found limited evidence of impact of mandatory reporting legislation on patient safety outcomes. Although legislation is one lever among many to improve patient safety outcomes, there are nonetheless several considerations for patient safety legislation to assist in broader system improvement efforts in Canada and elsewhere. Legislative frameworks may be enhanced by strengthening learning systems, accountability mechanisms and patient safety culture.

Risk management and Healthcare responsibility. How to guarantee legal protection in Medicine.

Having regard to the increasing attention to the issue of safety and health of patients and workers by low, the hypothesis that this topic will be the growing trend in the next years does not seem to be manifestly unfounded. For this reason, it is wise for healthcare professionals to already be aware that any violation of the interests underlying the legislation in question entails a ruling on civil and/or criminal liability. It is therefore necessary to identify the most suitable means to prevent undue harm occurring, partly to exempt healthcare professionals and hospitals from compensation costs, thereby providing them with recourse to insurance coverage. Healthcare facility organisations must adopt Risk Management techniques as a tool to simultaneously guarantee the effectiveness of health services (in this case), the efficiency of the management economy, and finally compliance with all legally required precautions. This will relegate the occurrence of an adverse event to remote and unpredictable hypotheses, thus guaranteeing useful recourse to insurance coverage to compensate any harm that does occur.

Leaving Hospital: A Step too Far for Risk-Based Regulation?

Discharges from hospital are internationally recognised as a dangerous time in the care pathway of a patient, posing a risk to both their physical wellbeing and dignity. This article examines the effectiveness of risk-based regulation as a tool to address patient safety incidents linked to the hospital discharge process within the English National Health Service. It examines how the risk of this process is identified, conceptualised, and prioritised amongst the relevant statutory regulators, and argues that the risk is neither uniformly recognised by the statutory regulators within the English NHS, nor sufficiently addressed. Professional regulators in particular appear to have a poor awareness of the risk and their role in addressing it. Until these issues are resolved, patients leaving hospitals will continue to be exposed to patient safety incidents which should be avoidable.

Risk Corridors, COVID-19, And The ACA.

The Supreme Court holds that the government owes insurers the full risk corridors payments due under the Affordable Care Act.

How case law impacts risk management.

Published decisions by federal and state appellate courts impact health care risk management in a number of ways, including overruling precedents, explaining and clarifying new laws and regulations, describing new and novel rules, describing new performance standards, and describing new civil rights.

Learning the developments in EMTALA jurisprudence through the lens of John West's "case law update".

This article covers three recurring issues concerning the federal law known as the Emergency Medical Treatment and Labor Act (EMTALA) that keep popping up in John West's Case Law Update case updates, and consistently bedevil hospital risk managers. First, what exactly constitutes an "appropriate" medical screening examination; second, when is a patient actually "stabilized' under EMTALA; and third, does the EMTALA obligation really "disappear" when a patient is admitted to the hospital? The editors wanted to analyze topics that challenge the courts to "get it right" on the law and that drive risk managers crazy. EMTALA is the "poster child" for such a topic.

Options to Reform the European Union Legislation on GMOs: Risk Governance.

Here, we discuss options to reform the EU genetically modified organism (GMO) regulatory framework, to make risk assessment and decision-making more consistent with scientific principles, and to lay the groundwork for international coherence. We discussed the scope and definitions in a previous article and, thus, here we focus on the procedures for risk assessment and risk management.

Risk Management and Avoiding Legal Pitfalls in the Emergency Treatment of High-Risk Orthopedic Injuries.

Many orthopedic injuries can have hidden risks that result in increased liability for the emergency medicine practitioner. It is imperative that emergency medicine practitioners consider the diagnoses of compartment syndrome, high-pressure injury, spinal epidural abscess, and tendon lacerations in the right patient. Consideration of the diagnosis and prompt referrals can help to minimize the complications these patients often develop.

Targets and mechanisms of chemically induced aneuploidy. Part 1 of the report of the 2017 IWGT workgroup on assessing the risk of aneugens for carcinogenesis and hereditary diseases.

An aneuploidy workgroup was established as part of the 7th International Workshops on Genotoxicity Testing. The workgroup conducted a review of the scientific literature on the biological mechanisms of aneuploidy in mammalian cells and methods used to detect chemical aneugens. In addition, the current regulatory framework was discussed, with the objective to arrive at consensus statements on the ramifications of exposure to chemical aneugens for human health risk assessment. As part of these efforts, the workgroup explored the use of adverse outcome pathways (AOPs) to document mechanisms of chemically induced aneuploidy in mammalian somatic cells. The group worked on two molecular initiating events (MIEs), tubulin binding and binding to the catalytic domain of aurora kinase B, which result in several adverse outcomes, including aneuploidy. The workgroup agreed that the AOP framework provides a useful approach to link evidence for MIEs with aneuploidy on a cellular level. The evidence linking chemically induced aneuploidy with carcinogenicity and hereditary disease was also reviewed and is presented in two companion papers. In addition, the group came to the consensus that the current regulatory test batteries, while not ideal, are sufficient for the identification of aneugens and human risk assessment. While it is obvious that there are many different MIEs that could lead to the induction of aneuploidy, the most commonly observed mechanisms involving chemical aneugens are related to tubulin binding and, to a lesser extent, inhibition of mitotic kinases. The comprehensive review presented here should help with the identification and risk management of aneugenic agents.

[What regulations have launched autonomous communities to going forward on patient safety culture in healthcare organizations?] / ¿Qué normativas han desarrollado las comunidades autónomas para avanzar en cultura de seguridad del paciente en sus organizaciones sanitarias?

INTRODUCTION: Patient Safety Culture is based on learning from incidents, developing preventive strategies to reduce the likelihood to happen and recognizing and accompanying those who have suffered unnecessary and involuntary harm derived from the health care received. To go ahead on patient safety culture entails facilitating the implementation of these behaviors and attitudes in healthcare professionals. Objective was to describe the regulations of some autonomous communities and national proposals for regulations changes. MATERIAL AND METHODS: Search of normative changes made in the autonomous communities of Catalonia, Navarra and the Basque Country. Proposals for legislative changes at national level were agreed. RESULTS: Activities and normative changes made in the autonomous communities of Catalonia, Navarre and the Basque Country are described and proposals for normative changes at the national level at short-term and long-term changes are made. In such a way that it is easier to advance in creating culture of patient safety in the whole National Health System CONCLUSION: Currently there is no global regulation that facilitates to advance in patient safety culture. Changes at the national legislation level are essential. It is at the Inter-territorial Council where the proposed legislative amendment should be defined, promoted by the representatives of the health systems of the autonomous communities.

Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial.

OBJECTIVE: We conducted a randomized trial aiming at improving patients' informed consent for undergoing endoscopic retrograde cholangiopancreatography (ERCP) in clinical care by comparing the efficacy of an additional educational video to written informed consent with that of written informed consent alone. METHODS: This was a single-center, randomized controlled trial. Consecutive patients undergoing ERCP were randomized to a video education or a control group. An educational video detailing ERCP procedure plus standard written informed consent was administered to the video education group, while the control group reviewed standard written informed consent only. The primary outcome was the patients' perception of the risk or possibility of ERCP complications. Their perception of the benefits of ERCP, alternative treatments and overall satisfaction with the process of informed consent were also compared. RESULTS: In total 205 patients were included in the study (104 in the control group and 101 in the video education group). Patients' comprehension of ERCP-related complications in the video education group was significantly increased (P < 0.001), and these patients were more likely to correctly identify the incidence of such complications. Significantly more patients in the video education group were very satisfied with informed consent process (87.1% vs 76.0%, P = 0.040) and fewer patients needed additional explanations (31.7% vs 47.1%, P = 0.024). CONCLUSIONS: A supplementary educational video could greatly improve patient's understanding of ERCP procedure, in particular, its potential risks and complications, as well as their overall satisfaction with the process of informed consent (ClinicalTrials.gov no. NCT02810379).