Tragic choices in intensive care during the COVID-19 pandemic: on fairness, consistency and community.

Tragic choices arise during the COVID-19 pandemic when the limited resources made available in acute medical settings cannot be accessed by all patients who need them. In these circumstances, healthcare rationing is unavoidable. It is important in any healthcare rationing process that the interests of the community are recognised, and that decision-making upholds these interests through a fair and consistent process of decision-making. Responding to recent calls (1) to safeguard individuals' legal rights in decision-making in intensive care, and (2) for new authoritative national guidance for decision-making, this paper seeks to clarify what consistency and fairness demand in healthcare rationing during the COVID-19 pandemic, from both a legal and ethical standpoint. The paper begins with a brief review of UK law concerning healthcare resource allocation, considering how community interests and individual rights have been marshalled in judicial deliberation about the use of limited health resources within the National Health Service (NHS). It is then argued that an important distinction needs to be drawn between procedural and outcome consistency, and that a procedurally consistent decision-making process ought to be favoured. Congruent with the position that UK courts have adopted for resource allocation decision-making in the NHS more generally, specific requirements for a procedural framework and substantive triage criteria to be applied within that framework during the COVID-19 pandemic are considered in detail.

COVID-19: legal implications for critical care.

The COVID-19 pandemic has caused an unprecedented challenge for the provision of critical care. Anticipating an unsustainable burden on the health service, the UK Government introduced numerous legislative measures culminating in the Coronavirus Act, which interfere with existing legislation and rights. However, the existing standards and legal frameworks relevant to critical care clinicians are not extinguished, but anticipated to adapt to a new context. This new context influences the standard of care that can be reasonably provided and yields many human rights considerations, for example, in the use of restraints, or the restrictions placed on patients and visitors under the Infection Prevention and Control guidance. The changing landscape has also highlighted previously unrecognised legal dilemmas. The perceived difficulties in the provision of personal protective equipment for employees pose a legal risk for Trusts and a regulatory risk for clinicians. The spectre of rationing critical care poses a number of legal issues. Notably, the flux between clinical decisions based on best interests towards decisions explicitly based on resource considerations should be underpinned by an authoritative public policy decision to preserve legitimacy and lawfulness. Such a policy should be medically coherent, legally robust and ethically justified. The current crisis poses numerous challenges for clinicians aspiring to remain faithful to medicolegal and human rights principles developed over many decades, especially when such principles could easily be dismissed. However, it is exactly at such times that these principles are needed the most and clinicians play a disproportionate role in safeguarding them for the most vulnerable.

Availability of Internationally Controlled Essential Medicines in the COVID-19 Pandemic.

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access.

[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".] / Considerazioni etiche, deontologiche e giuridiche sul Documento SIAARTI "Raccomandazioni di etica clinica per l'ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili".

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.

View. The Dutch Critical Care Triage Guideline on Covid-19: Not Necessarily Discriminatory.

Recently, the Dutch Medical Doctors Association (Federatie Medisch Specialisten en de Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst) drafted the 'Covid-19 triage guideline ICU admission' that has age cut-offs that deprioritise or exclude the elderly. Such an age limit for intensive care unit (ICU) admission in case of a national emergency seems discriminatory, and thus, is it inappropriate to use, or not? The question is whether age in itself can be considered as an acceptable selection criterion.

Age discrimination in critical care triage in South Africa: The law and the allocation of scarce health resources in the COVID-19 pandemic.

No one may be refused emergency medical treatment in South Africa (SA). Yet score-based categorical exclusions used in critical care triage guidelines disproportionately discriminate against older adults, the cognitively and physically impaired, and the disabled. Adults over the age of 60, who make up 9.1% of the SA population, are most likely to present with disabilities and comorbidities at triage. Score-based models, drawn from international precedents, deny these patients admission to an ICU when resources are constrained, such as during influenza and COVID-19 outbreaks. The Critical Care Society of Southern Africa and the South African Medical Association adopted the Clinical Frailty Scale, which progressively withholds admission to ICUs based on age, frailty and comorbidities in a manner that potentially contravenes constitutional and equality prohibitions against unfair discrimination. The legal implications for healthcare providers are extensive, ranging from personal liability to hate speech and crimes against humanity. COVID-19 guidelines and score-based triage protocols must be revised urgently to eliminate unlawful discrimination against legally protected categories of patients in SA, including the disabled and the elderly. That will ensure legal certainty for health practitioners, and secure the full protections of the law to which the health-vulnerable and those of advanced age are constitutionally entitled.

Do COVID-19 patients needing extended care in an intensive care unit fall under the 'emergency medical treatment' provisions of the South African Constitution?

Whether COVID-19 patients in need of extended care in an intensive care unit qualify for 'emergency medical treatment' is answered by considering the Constitution, the meaning of emergency medical treatment, and whether such patients are in an incurable chronic condition. Considering ethical guidelines for the withholding and withdrawal of treatment may assist a court in determining whether a healthcare practitioner has acted with the degree of skill and care required of a reasonably competent practitioner in his or her branch of the profession.

Health policy for telestroke in France: A retrospective description from 2003 to 2016.

INTRODUCTION: Stroke is a public health priority in France. The use of telemedicine for stroke known as telestroke, is a safe and effective practice improving access to acute stroke care including thrombolysis. Telestroke is currently being implemented in France. The objective was to describe the public health policy supporting telestroke implementation in France. METHODS: An external ex-post evaluation of telestroke policy in France was conducted through a retrospective descriptive study from 2003 to 31st December 2016. Process, content, and actors of the health policy were described at a national level. The logical framework of the telestroke policy was described. The stages model of public policy from the 'Institut National de Santé Publique du Quebec' was used. RESULTS: Agenda setting was produced from 2003 to 2007. Policy formulation lasted from 2008 to 2009 with official reports on telemedicine, telehealth and stroke. The decision-making stage included the national stroke plan, the national telemedicine implementation strategy and an administrative document in 2012 that described the organization of telestroke implementation. Implementation in 2011 was initiated with dedicated funding and methodological resources. No dedicated evaluation of policy for telestroke was defined. CONCLUSIONS: Using a health policy model allowed to describe the policies supporting telestroke implementation in France and to highlight the need for better evaluation.

Canadian Stroke Best Practice Recommendations for Acute Stroke Management: Prehospital, Emergency Department, and Acute Inpatient Stroke Care, 6th Edition, Update 2018.

The 2018 update of the Canadian Stroke Best Practice Recommendations for Acute Stroke Management, 6th edition, is a comprehensive summary of current evidence-based recommendations, appropriate for use by healthcare providers and system planners caring for persons with very recent symptoms of acute stroke or transient ischemic attack. The recommendations are intended for use by a interdisciplinary team of clinicians across a wide range of settings and highlight key elements involved in prehospital and Emergency Department care, acute treatments for ischemic stroke, and acute inpatient care. The most notable changes included in this 6th edition are the renaming of the module and its integration of the formerly separate modules on prehospital and emergency care and acute inpatient stroke care. The new module, Acute Stroke Management: Prehospital, Emergency Department, and Acute Inpatient Stroke Care is now a single, comprehensive module addressing the most important aspects of acute stroke care delivery. Other notable changes include the removal of two sections related to the emergency management of intracerebral hemorrhage and subarachnoid hemorrhage. These topics are covered in a new, dedicated module, to be released later this year. The most significant recommendation updates are for neuroimaging; the extension of the time window for endovascular thrombectomy treatment out to 24 h; considerations for treating a highly selected group of people with stroke of unknown time of onset; and recommendations for dual antiplatelet therapy for a limited duration after acute minor ischemic stroke and transient ischemic attack. This module also emphasizes the need for increased public and healthcare provider's recognition of the signs of stroke and immediate actions to take; the important expanding role of paramedics and all emergency medical services personnel; arriving at a stroke-enabled Emergency Department without delay; and launching local healthcare institution code stroke protocols. Revisions have also been made to the recommendations for the triage and assessment of risk of recurrent stroke after transient ischemic attack/minor stroke and suggested urgency levels for investigations and initiation of management strategies. The goal of this updated guideline is to optimize stroke care across Canada, by reducing practice variations and reducing the gap between current knowledge and clinical practice.

[Pharmacogenetics in anesthesia and intensive care medicine : Clinical and legal challenges exemplified by malignant hyperthermia]. / Pharmakogenetik in Anästhesie und Intensivmedizin : Klinische und juristische Herausforderung am Beispiel der Malignen Hyperthermie.

Pharmacotherapy is a key component of anesthesiology and intensive care medicine. The individual genetic profile influences not only the effect of pharmaceuticals but can also completely alter the mode of action. New technologies for genetic screening (e.g. next generation sequencing) and increasing knowledge of molecular pathways foster the disclosure of pharmacogenetic syndromes, which are classified as rare diseases. Taking into account the high genetic variability in humans and over 8000 known rare diseases, up to 20 % of the population may be affected. In summary, rare diseases are not rare. Most pharmacogenetic syndromes lead to a weakening or loss of pharmacological action. In contrast, malignant hyperthermia (MH), which is the most relevant pharmacogenetic syndrome for anesthesia, is characterized by a pharmacologically induced overactivation of calcium metabolism in skeletal muscle. Volatile anesthetic agents and succinylcholine trigger life-threatening hypermetabolic crises. Emergency treatment is based on inhibition of the calcium release channel of the sarcoplasmic reticulum by dantrolene. After an adverse pharmacological event patients must be informed and a clarification consultation must be carried out during which the hereditory character of MH is explained. The patient should be referred to a specialist MH center where a predisposition can be diagnosed by the functional in vitro contracture test from a muscle biopsy. Additional molecular genetic investigations can yield mutations in the genes for calcium-regulating proteins in skeletal muscle, e.g. ryanodine receptor 1 (RyR1) and calcium voltage-gated channel subunit alpha 1S (CACNA1S). Currently, an association to MH has only been shown for 35 mutations out of more than 400 known and probably hundreds of unknown genetic variations. Furthermore, MH predisposition is not excluded by negative mutation screening. For anesthesiological patient safety it is crucial to identify individuals at risk and warn genetic relatives; however, the legal requirements of the Patients Rights Act and the Human Genetic Examination Act must be strictly adhered to. Specific features of insurance and employment law must be respected under consideration of the Human Genetic Examination Act.

[SFBC guidelines on critical care testing]. / Recommandations de la SFBC sur la biologie d'urgence.

SFBC working group on critical care testing describes in this paper guideline for the management of laboratory medicine examination process in emergency conditions. After a summary on French standards and regulations, the critical care testing perimeter and definitions of stat levels are presented in different contexts. The complete examination process is described. Guidelines are proposed for each step, to manage sub-process in a risk management approach. The following steps were studied: ordering (by specialties), sampling, transport, reception, analysis, validation and release. In summary, we proposed a list of examinations allowed to be prescribed in stat conditions with a short list and complementary tests as a function of clinical setting. These guidelines need to be adapted in clinicobiological contracts.

Critical Care Implications of the Affordable Care Act.

OBJECTIVES: To provide an overview of key elements of the Affordable Care Act. To evaluate ways in which the Affordable Care Act will likely impact the practice of critical care medicine. To describe strategies that may help health systems and providers effectively adapt to changes brought about by the Affordable Care Act. DATA SOURCES AND SYNTHESIS: Data sources for this concise review include search results from the PubMed and Embase databases, as well as sources relevant to public policy such as the text of the Patient Protection and Affordable Care Act and reports of the Congressional Budget Office. As all of the Affordable Care Act's provisions will not be fully implemented until 2019, we also drew upon cost, population, and utilization projections, as well as the experience of existing state-based healthcare reforms. CONCLUSIONS: The Affordable Care Act represents the furthest reaching regulatory changes in the U.S. healthcare system since the 1965 Medicare and Medicaid provisions of the Social Security Act. The Affordable Care Act aims to expand health insurance coverage to millions of Americans and place an emphasis on quality and cost-effectiveness of care. From models which link pay and performance to those which center on episodic care, the Affordable Care Act outlines sweeping changes to health systems, reimbursement structures, and the delivery of critical care. Staffing models that include daily rounding by an intensivist, palliative care integration, and expansion of the role of telemedicine in areas where intensivists are inaccessible are potential strategies that may improve quality and profitability of ICU care in the post-Affordable Care Act era.

[Should nurses be managed by doctors or nurses?]. / La separazione tra clinica e assistenza o tra medici e infermieri?

A recent verdict of the administrative court of Lazio Region abrogated a Decree that originally stated that nurse managers (and not the head of the medical department) should be responsible for the management of the nursing personnel, and that had set up the premises for the Nursing Departments. The verdict contrasts with a previous pronouncement of the same court (same members, same president) that supported the wards organized by intensity of care and run by nurses. The organization should be flexible and be shaped not by power struggles but by patients needs: while patients in acute care require mostly medical interventions, chronic patients require more educational and nursing interventions. The verdict is the occasion for reflections on the never ending contrasts between doctors and nurse, that often move to the background patients' priorities and care.

[Forensic risk in emergency medicine]. / Risque médico-judiciaire en médecine d'urgence.

Activities in the emergency departments increase in all countries for many reasons: medical, social, economic, etc. In the same time, it is logical to observe an increase in claims; this is confirmed by the insurance companies. In this review, we describe the typology of claims according to the Reason model, also named Swiss cheese model. Thus weseparate the risk situations, the taking risk and the lack of information. When the three factors are associated, claims occur. Then it is easy to propose a method of prevention based on the compliance to the recommandations of good pratices written by the scientific societies.

Acute care hospitals' accountability to provincial funders.

Ontario's acute care hospitals are subject to a number of tools, including legislation and performance measurement for fiscal accountability and accountability for quality. Examination of accountability documents used in Ontario at the government, regional and acute care hospital levels reveals three trends: (a) the number of performance measures being used in the acute care hospital sector has increased significantly; (b) the focus of the health system has expanded from accountability for funding and service volumes to include accountability for quality and patient safety; and (c) the accountability requirements are misaligned at the different levels. These trends may affect the success of the accountability approach currently being used.

TRICARE; reimbursement of sole community hospitals and adjustment to reimbursement of critical access hospitals. Final rule.

This Final Rule implements for Sole Community Hospitals (SCHs) the statutory provision at title 10, United States Code (U.S.C.), section 1079(j)(2) that TRICARE payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This Final Rule implements a reimbursement methodology similar to that applicable to Medicare beneficiaries for inpatient services provided by SCHs. It will be phased in over a several-year period. This Final Rule also provides for special reimbursement for labor/delivery and nursery services in SCHs and creates a possible General Temporary Military Contingency Payment Adjustment (GTMCPA) for inpatient services in SCHs and for Critical Access Hospitals (CAHs).

[From medical complication to compensation for the prejudice]. / De la complication médicale à l'indemnisation du préjudice.

Claims in anesthesia and intensive care remains high, despite the reduction of morbidity and mortality associated with this activity. The absence of a national register makes it difficult to quantify. The Medical Committee of MACSF-Sou Medical Group, professional liability insurer of more than half of French physicians, provided us support. The amount of compensation paid is growing and the scope of compensated damage is expanded by the Dintilhac mission. The Act of March 4, 2002 has fully confirmed the principle of medical liability for misconduct. Generally, compensation for bodily injury is based on the demonstration of a causal link between a wrongful event and injury. The proof of fault lies with the applicant. Information accountable to patients and nosocomial infection are a particular setting. The Act of March 4, 2002 has also defined the concept of therapeutic risk. With the establishment of the Regional Commissions of Conciliation and Compensation (RCCI) and the National Office for Compensation of Medical Accident (Oniam), it is now possible for a patient to be compensated for an injury resulting from an accident Medical non-offending, while acknowledging the lack of accountability of the practitioner. The expertise conducted by an RCCI is adversarial. For the practitioner called to the cause, it is important to prepare for both substance and form, with the assistance of the medical board's insurance company.

Medicare and Medicaid programs; reform of hospital and critical access hospital conditions of participation. Final rule.

This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled "Improving Regulation and Regulatory Review.''