VENTILATOR ALLOCATION GUIDELINES

VENTILATOR ALLOCATION GUIDELINESExecutive SummaryI.IntroductionInfluenza pandemics occur with unpredictable frequency and severity. Recent influenzaoutbreaks, including the emergence of a powerful strain of avian influenza in 2005 and the novelH1N1 pandemic in 2009, have generated concern about the possibility of a severe influenzapandemic. While it is uncertain whether or when a pandemic will occur, the better prepared NewYork State is, the greater its chances of reducing associated morbidity, mortality, and economicconsequences.A pandemic that is especially severe with respect to the number of patients affected andthe acuity of illness will create shortages of many health care resources, including personnel andequipment. Specifically, many more patients will require the use of ventilators than can beaccommodated with current supplies. New York State may have enough ventilators to meet theneeds of patients in a moderately severe pandemic. In a severe public health emergency on thescale of the 1918 influenza pandemic, however, these ventilators would not be sufficient to meetthe demand. Even if the vast number of ventilators needed were purchased, a sufficient numberof trained staff would not be available to operate them. If the most severe forecast becomes areality, New York State and the rest of the country will need to allocate ventilators.II.Development of the Ventilator Allocation GuidelinesIn 2007, the New York State Task Force on Life and the Law (the Task Force) and theNew York State Department of Health (the Department of Health) released draft ventilatorallocation guidelines for adults. New York’s innovative guidelines were among the first of theirkind to be released in the United States and have been widely cited and followed by other states.Since then, the Department of Health and the Task Force have made extensive public educationand outreach efforts and have solicited comments from various stakeholders. Following therelease of the draft guidelines, the Task Force: (1) reexamined and revised the adult guidelineswithin the context of the public comments and feedback received (see Chapter 1), (2) developedguidelines for triaging pediatric and neonatal patients (see Chapters 2 and 3), and (3) expandedits analysis of the various legal issues that may arise when implementing the clinical protocolsfor ventilator allocation (see Chapter 4).To revise the adult clinical ventilator allocation protocol, a clinical workgroup comprisedof individuals from the fields of medicine and ethics was convened in 2009 to develop and refinespecific aspects of the clinical ventilator allocation protocol. To obtain additional publiccomment, the Task Force oversaw a public engagement project in 2011, which consisted of 13focus groups held throughout the State. Furthermore, based on the results of these focus groupsand its own analysis, the Task Force made additional recommendations to elaborate and expandcertain sections and to include a more robust discussion of the reasoning and logic behind certainfeatures of the protocol. These revisions appear as Chapter 1, the revised adult guidelines (theAdult Guidelines).1Executive Summary

The Task Force approached the pediatric ventilator allocation guidelines (the PediatricGuidelines) in two stages. First, the Task Force addressed the special considerations forpediatric and neonatal emergency preparedness and the ethical issues related to the treatment andtriage of children in a pandemic, with particular focus on whether children should be prioritizedfor ventilator therapy over adults. Second, the Task Force convened a pediatric clinicalworkgroup (including specialists in pediatric, neonatal, emergency, and maternal-fetal medicine,as well as in critical care, respiratory therapy, palliative care, public health, and ethics), todevelop a clinical ventilator allocation protocol for pediatric patients. Chapter 2 presents thesenew Pediatric Guidelines.The Task Force also organized a neonatal clinical workgroup, consisting of neonatal andmaternal-fetal specialists, to discuss and develop neonatal guidelines (the Neonatal Guidelines),which appear as Chapter 3.Finally, a legal subcommittee was organized in 2008, and the Task Force devotedsubstantial resources to exploring the various legal issues that may arise when implementing theclinical ventilator allocation protocols. Thus, the brief summary on legal issues from the 2007draft guidelines is replaced with a substantial discussion in Chapter 4.As a result of the Task Force’s efforts, the Ventilator Allocation Guidelines (theGuidelines) incorporate comments, critiques, feedback, and values from numerous stakeholders,including experts in the medical, ethical, legal, and policy fields. The Guidelines draw upon theexpertise of clinical workgroups and committees, literature review, public feedback, andinsightful commentary. Furthermore, in developing and revising the Guidelines, extensive effortswere made to obtain public input. For the public to accept the Guidelines, they must reflect thevalues of New Yorkers.Because research and data on this topic are constantly evolving, the Guidelines are a livingdocument intended to be updated and revised in line with advances in clinical knowledge andsocietal norms. The Guidelines incorporate an ethical framework and evidence-based clinicaldata to support the goal of saving the most lives in an influenza pandemic where there are alimited number of available ventilators.III.Chapter OverviewsThis report consists of four chapters, described below. Each chapter has an abstract thatsummarizes the chapter. While each chapter may stand alone, the underlying ethical frameworkand clinical concepts are discussed in more detail in Chapter 1, Adult Guidelines. For ease ofreference, at the end of the report are the adult (Appendix A), pediatric (Appendix B), andneonatal (Appendix C) clinical ventilator allocation protocols (the Clinical Protocols forVentilator Allocation). In addition, this report has a companion document, Frequently AskedQuestions, which is intended to supplement the Guidelines and answer commonly askedquestions.2Executive Summary

Chapter 1, Adult Guidelines. This chapter provides a detailed overview of thedevelopment of the Guidelines as a whole and a background on moderate and severe pandemicinfluenza scenarios. It also examines surge capacity, stockpiling ventilators, and creation ofspecialized facilities for influenza patients. An overview of the concepts used in triage (i.e.,modified definitions of triage and survival), the ethical framework underlying the Guidelines, theuse of triage officers or committees, pitfalls of an allocation system, and triaging ventilatordependent chronic care patients are also discussed. Next, the chapter reviews various nonclinical approaches to allocating ventilators, including distributing ventilators on a first-comefirst-serve basis, randomizing ventilator allocation (e.g., lottery), requiring only informalphysician clinical judgment in making allocation decisions, and prioritizing certain patientcategories (i.e., health care workers, patients of advanced age, and patients with certain socialcriteria) for ventilator therapy, and provides an analysis of other clinical ventilator allocationprotocols. New York’s clinical ventilator allocation protocol for adults is presented, followed bya discussion alternative forms of medical intervention and palliative care. Finally, the chapterconcludes with a discussion on communication about the Guidelines, real-time data collectionand analysis, and future modification of the Adult Guidelines.Chapter 2, Pediatric Guidelines. This chapter addresses the unique considerations forpediatric emergency preparedness, explores the ethical issues related to triaging children, anddiscusses the pediatric clinical ventilator allocation protocol. It begins by describing howchildren with influenza may respond better to treatment because they have fewer underlyingmedical conditions that hinder recovery, and continues by examining how triaging childrenrequires special attention. An overview of the concepts used in triage is repeated (i.e., modifieddefinitions of triage and survival) and the use of young age as a triage factor is discussed. Next,potential features of a pediatric protocol are examined (i.e., exclusion criteria, pediatric clinicalscoring systems, physician clinical judgment, time trials, response to ventilation, and duration ofventilator need/resource utilization), followed by summaries of various available pediatricguidelines (Ontario, Canada; Alaska; Florida; Indiana; Michigan; Minnesota; Wisconsin; andUtah). The chapter then discusses what age (pediatric age cut-off) should be used to determinewho is a pediatric patient and weighs how to triage chronic care pediatric patients who areventilator dependent. The second half of the chapter is devoted to the details of New York’spediatric clinical ventilator allocation protocol, including the logic and reasoning behind theinclusion and exclusion of particular features. The chapter also discusses alternative forms ofmedical intervention and pediatric palliative care. Finally, the chapter addresses communicationabout triage, real-time data collection and analysis, and future modification of the PediatricGuidelines.Chapter 3, Neonatal Guidelines. This chapter examines the unique challenges whentriaging neonates and discusses the neonatal clinical ventilator allocation protocol. It begins withan exploration of the special considerations involved when triaging neonates, including thepossible increase in the number of extremely premature neonates as a result of influenza-relatedcomplications from pregnant women. Next, the possible components of a neonatal protocol areanalyzed (i.e., neonatal clinical scoring systems, physician clinical judgment, Apgar score,gestational age, and birth weight). The second half of the chapter presents New York’s neonatalclinical ventilator allocation protocol, and includes detailed explanations of why the possiblefactors discussed earlier are not appropriate to include. The chapter closes with comments on3Executive Summary

alternative forms of medical intervention, palliative care, communication about triage, real-timedata collection and analysis, and future modification of the Neonatal Guidelines.Chapter 4, Implementing New York State’s Ventilator Allocation Guidelines: LegalConsiderations. This chapter addresses the various legal issues associated with effectivelyimplementing the Guidelines and presents recommendations to encourage adherence to theGuidelines. This chapter begins with a discussion of the form of the Guidelines themselves asvoluntary and non-binding. It then focuses on a number of constitutional considerations thatmay arise when implementing the clinical ventilator allocation protocols. It discusses the“trigger” for the implementation of the adult, pediatric,

guidelines, which presented a clinical ventilator allocation protocol for adults and included a brief section on the legal issues associated with implementing the guidelines. This update of the Guidelines consists of four chapters: (1) the adult guidelines, (2) the pediatric guidelines, (3) the neonatal guidelines, and (4) legal considerations.