The Department of Health and Human Services and the Fire Department of New York have funded an organ harvesting program that deviates from medical and ethical standards. The critical concern surrounds the transition from life-saving to organ preserving measures. The organ team will follow the regular ambulance and if the normal paramedics fail to resuscitate a patient, after two minutes "hands-off," organ harvesting preparation begins. While in many cases the inability to resuscitate a patient probably does mean death, this outcome is not always the case. The high end of 5 minutes “hands-off” time is typically considered to be inadequate; after 10 minutes there has been "spontaneous return of both circulatory and neurologic function." The argument for the brief 2 minutes is to minimize warm ischemia time (restricting blood flow without cooling the kidneys) as some organs are only viable after 30-45 minutes. Even if a patient's heart has irreversibly stopped, the Institute of Medicine has questioned whether brain activity has fleeted. Not only does current practice not support the 2 minute transition, but current studies including one at the University of Pennsylvania indicate that cardiac arrest is not equivalent with death. In fact, revitalization may occur by reducing oxygen and adjusting the blood chemistry potentially through hypothermia.
Given that the standards used by New York's Rapid Organ Recovery Ambulance Program (RORA) for organ procurement do not necessarily signify that the patients are dead, then the following procedures are disturbing. The RORA crew preserves organs for procurement by administering heparin; a drug for cooling the body that New England Journal of Medicine indicates could theoretically hasten death and that has been the center of medical controversy. Typically, when used for organ procurement, heparin is not used until the family has provided consent and a doctor has declared the patient's death. In the ambulance case, however, family is not consulted to discuss organ donation prior to injection of heparin; there will be no doctors on the ambulance team and an on-line medical control physician (OLMC) will rely on the ambulance reports to declare death. Due to the dangerous nature of heparin, New York State previously only allowed doctors to administer it; paramedics and EMTs were prohibited. Nonetheless, RORA was able to gain approval for its crew of EMTs to administer the drug according to the March 2008 quarterly progress report.
At the same time that RORA deviates from medical standards, it potentially violates the law. While the law does not grant commercial property rights in corpses to prevent body selling, it does entitle the next of kin a property interest which court cases have affirmed. For example, Newman v. Sathyavaglswaran in 2002 determined that the next of kin had a property interest in their children's corneas according to the due process of the law guaranteed by the 14th amendment. Moreover, New York law also supports the next of kin's right to the cadaver; New York Public Health Law Sections 42 and 43 designate the next of kin as responsible for arrangement of the body and for having the authority under the uniform anatomical gifts act to donate organs if not contrary to the decedent's wishes. In the case of Colavito V. New York Organ Donor Network Inc., the legal discussion involved the next of kin's quasi-property right. Burial purposes have been extended to include preserving the body in original form for burial; meaning, parts cannot be removed, an autopsy under non-suspicious circumstances cannot be performed, and no mutilation can be executed without consent or justification that it is related to a life-saving measure for that particular individual. The RORA preservation technique appears to be in violation of these requirements. The proposal vaguely defines the preservation technique which consists of intraperitoneal routes (abdominal) for cooling and femoral artery cannulation. Intraperitoneal administration of the drug, heparin, consists of surgically making incisions into the abdomen to place a catheter and a chest drain. Femoral cannulation also consists of creating holes in the femoral, groin area, to insert a perfusion catheter.
(Picture copied from Oxford Textbook of Clinical Nephrology)
This entire technique will be performed without consent and arguably consists of damage to the patient (considering that after 2 minutes he may still have brain activity) and mutilation to the body. While the law on cadaver property interest is murky, the RORA program does not have a solid legal foundation to experiment with non-life saving measures on bodies without some form of consent; especially when the program deviates from medical standards. While the body may or may not be the next of kin's property, it is certainly not the state or consortium's property and so presumed consent to prepare organs is highly dubious.
Documents
2007 Extramural Grant Program: (4 pages) Discussion of applicants for HRSA grant.
RORA Application Materials: (16 pages) RORA application-HRSA form.
Emails: (4 pages) Emails between RORA and HRSA. Some discussion of funding and costs.
Goldfrank and Teperman Bios: (9 pages)
Grossman and Dubler Bios:(15 pages)
HRSA RORA application Federal Assistance: (4 pages)
HRSA Rora Clinical Intervention: (36 pages) Program guidance.
HRSA RORA Grant Award: (4 pages) Includes breakdown of grant funding)
Letters: (10 pages) Letters of support from participating doctors and institutions.
NY Conditions of Award: (10 pages) 10 questions posed, 3 questions responded to via email.
RORA application: (27 pages) Proposal and narrative of RORA application.
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