Lesson From the New York City Out-of-Hospital Uncontrolled Donation After Circulatory Determination of Death Program.

STUDY OBJECTIVE: In 2006, the Institute of Medicine emphasized substantial potential to expand organ donation opportunities through uncontrolled donation after circulatory determination of death (uDCDD). We pilot an out-of-hospital uDCDD kidney program for New York City in partnership with communities that it was intended to benefit. We evaluate protocol process and outcomes while identifying barriers to success and means for improvement. METHODS: We conducted a prospective, participatory action research study in Manhattan from December 2010 to May 2011. Daily from 4 to 12 pm, our organ preservation unit monitored emergency medical services (EMS) frequencies for cardiac arrests occurring in private locations. After EMS providers independently ordered termination of resuscitation, organ preservation unit staff determined clinical eligibility and donor status. Authorized parties, persons authorized to make organ donation decisions, were approached about in vivo preservation. The study population included organ preservation unit staff, authorized parties, passersby, and other New York City agency personnel. Organ preservation unit staff independently documented shift activities with daily operations notes and teleconference summaries that we analyzed with mixed qualitative and quantitative methods. RESULTS: The organ preservation unit entered 9 private locations; all the deceased lacked previous registration, although 4 met clinical screening eligibility. No kidneys were recovered. We collected 837 notes from 35 organ preservation unit staff. Despite frequently recounting protocol breaches, most responses from passersby including New York City agencies were favorable. No authorized parties were offended by preservation requests, yielding a Bayesian posterior median 98% (95% credible interval 76% to 100%). CONCLUSION: In summary, the New York City out-of-hospital uDCDD program was not feasible. There were frequent protocol breaches and confusion in determining clinical eligibility. In the small sample of authorized persons we encountered during the immediate grieving period, negative reactions were infrequent.

Uncontrolled organ donation after circulatory determination of death: US policy failures and call to action.

In the United States, more than 115,000 patients are wait-listed for organ transplants despite that there are 12,000 patients each year who die or become too ill for transplantation. One reason for the organ shortage is that candidates for donation must die in the hospital, not the emergency department (ED), either from neurologic or circulatory-respiratory death under controlled circumstances. Evidence from Spain and France suggests that a substantial number of deaths from cardiac arrest may qualify for organ donation using uncontrolled donation after circulatory determination of death (uDCDD) protocols that rapidly initiate organ preservation in out-of-hospital and ED settings. Despite its potential, uDCDD has been criticized by panels of experts that included neurologists, intensivists, attorneys, and ethicists who suggest that organ preservation strategies that reestablish oxygenated circulation to the brain retroactively negate previous death determination based on circulatory-respiratory criteria and hence violate the dead donor rule. In this article, we assert that in uDCDD, all efforts at saving lives are exhausted before organ donation is considered, and death is determined according to "irreversible cessation of circulatory and respiratory functions" evidenced by "persistent cessation of functions during an appropriate period of observation and/or trial of therapy." Therefore, postmortem in vivo organ preservation with chest compressions, mechanical ventilation, and extracorporeal membrane oxygenation is legally and ethically appropriate. As frontline providers for patients presenting with unexpected cardiac arrest, emergency medicine practitioners need be included in the uDCDD debate to advocate for patients and honor the wishes of the deceased.

A rationale in support of uncontrolled donation after circulatory determination of death.

In the United States, when people die unexpectedly, they are usually not considered as organ donors because of the difficulty of keeping organs viable when death occurs outside the hospital, in "uncontrolled" circumstances. New protocols to permit donation in these cases have renewed the debate about how we decide whether a person has died- and whether the moral imperative to help those in need of transplant should affect the determination of death.

The clinical ethics credentialing project: preliminary notes from a pilot project to establish quality measures for ethics consultation.

The Clinical Ethics Credentialing Project (CECP) was intiated in 2007 in response to the lack of uniform standards for both the training of clinical ethics consultants, and for evaluating their work as consultants. CECP participants, all practicing clinical ethics consultants, met monthly to apply a standard evaluation instrument, the "QI tool", to their consultation notes. This paper describes, from a qualitative perspective, how participants grappled with applying standards to their work. Although the process was marked by resistance and disagreement, it was also noteworthy for the sustained engagement by participants over the year of the project, and a high level of acceptance by its conclusion.

Success of organ donation after out-of-hospital cardiac death and the barriers to its acceptance.

It is well documented that transplants save lives and improve quality of life for patients suffering from kidney, liver, and heart failure. Uncontrolled donation after cardiac death (UDCD) is an effective and ethical alternative to existing efforts towards increasing the available pool of organs. However, people who die from an out-of-hospital cardiac arrest are currently being denied the opportunity to be organ donors except in those few locations where out-of-hospital UDCD programs are active, such as in Paris, Madrid, and Barcelona. Societies have the medical and moral obligation to develop UDCD programs.

Definitive care for the critically ill during a disaster: a framework for allocation of scarce resources in mass critical care: from a Task Force for Mass Critical Care summit meeting, January 26-27, 2007, Chicago, IL.

BACKGROUND: Anticipated circumstances during the next severe influenza pandemic highlight the insufficiency of staff and equipment to meet the needs of all critically ill victims. It is plausible that an entire country could face simultaneous limitations, resulting in severe shortages of critical care resources to the point where patients could no longer receive all of the care that would usually be required and expected. There may even be such resource shortfalls that some patients would not be able to access even the most basic of life-sustaining interventions. Rationing of critical care in this circumstance would be difficult, yet may be unavoidable. Without planning, the provision of care would assuredly be chaotic, inequitable, and unfair. The Task Force for Mass Critical Care Working Group met in Chicago in January 2007 to proactively suggest guidance for allocating scarce critical care resources. TASK FORCE SUGGESTIONS: In order to allocate critical care resources when systems are overwhelmed, the Task Force for Mass Critical Care Working Group suggests the following: (1) an equitable triage process utilizing the Sequential Organ Failure Assessment scoring system; (2) the concept of triage by a senior clinician(s) without direct clinical obligation, and a support system to implement and manage the triage process; (3) legal and ethical constructs underpinning the allocation of scarce resources; and (4) a mechanism for rapid revision of the triage process as further disaster experiences, research, planning, and modeling come to light.

HIPAA and patient care: the role for professional judgment.

Federal health privacy regulations, commonly known as the Health Insurance Portability and Accountability Act (HIPAA) regulations, came into effect in April 2003. Many clinicians and institutions have relied on consultants and risk managers to tell them how to implement these regulations. Much of the controversy and confusion over the HIPAA regulations concern so-called incidental disclosures. Some interpretations of the privacy regulations would limit essential communication and compromise good patient care. This article analyzes misconceptions regarding what the regulations say about incidental disclosures and discusses the reasons for such misunderstandings. Many misconceptions arise from gaps in the regulations. These gaps are appropriately filled by professional judgment informed by ethical guidelines. The communication should be necessary and effective for good patient care, and the risks of a breach of confidentiality should be proportional to the likely benefit for the patient's care. The alternative for communication should be impractical. We offer specific recommendations to help physicians think through what incidental disclosures in patient care are ethically permissible and what safeguards ought to be taken. Physicians should work with risk managers and practice administrators to develop policies that promote good communication in patient care, while taking appropriate steps to protect patient privacy.

Waiting for organ transplantation: results of an analysis by an Institute of Medicine Committee.

One of the most visible and contentious issues regarding the fairness of the original system of organ procurement and allocation is the argument that it resulted in great disparities in the total amount of time a patient waited for an organ (i.e. the time from registration at a transplantation center to transplant), depending on where he or she lived. In an attempt to resolve this debate, Congress charged the National Academy of Sciences, Institute of Medicine to perform an independent study of the original system and proposed rule changes. In an analysis of approximately 68,000 transplant waiting list records, the committee developed several conclusions and recommendations largely specific to liver transplantation policies. The purpose of this paper is to describe both the results of the study and the statistical foundations of the mixed-effects multinomial logistic regression model that led to the committee's conclusions.