Wolf, Dwayne A. MD, PhD; Derrick, Sharon M. PhD
Organ and tissue donation is a potentially life-saving endeavor. The lack of sufficient transplantable organs and tissue (o/t) to fulfill the needs of the nearly 100,000 prospective recipients on the United Network for Organ Sharing (UNOS) waiting list is an issue of concern worldwide (based on UNOS OPTN data as of October 7, 2008).1 Approximately 6500 people die each year waiting for an organ transplant, and researchers have estimated that 70% of o/t donors are those whose death is investigated under medical examiner and coroner (me/c) jurisdiction.2,3 Therefore, the operational activities of agencies involved in o/t recovery for transplantation necessarily intersect with the mission of me/c, which is to determine and certify the cause and manner of death, to document and preserve evidence relating to the decedent in accordance with statutes, and to provide unbiased expert witness testimony in courts of law. To maximize the benefits of o/t donation without compromising the legal responsibility of me/c, the interaction of these entities must be guided by a solid rapport between the agencies, and with donors' families.
Harris County, Texas is proactive with regard to o/t donation and supportive of the concept that o/t recovery should be facilitated whenever feasible. The Harris County Medical Examiner's Office (HCME) strives to augment the number of cases that are approved for o/t donation through the development of standardized protocol agreements with the local organ and tissue recovery agencies (O/TPO). Clearly written procedures for o/t requests, decedent release and transport, and chain of custody management increase the potential for successful donation. It is the policy of the HCME to review each request for o/t based on the circumstances of the individual case, rather than issuing a blanket denial for certain categories of cases. Further, within the context of each case the HCME reviews the feasibility of donation of each particular organ or tissue, so even when a particular tissue or organ is denied others may be recovered from the same donor. Additionally, the HCME is able to approve organ release for many cases that might otherwise be denied by working with the surgeon to adjust recovery methods in a way that preserves potential evidence or diagnostic findings.
In addition to the careful attention that is given each request for o/t, the HCME gives the O/TPO access to the HCME facility to review cases. The HCME brought the multiple recovery agencies together to decide on a single designated agency to approach next of kin for consent in nonhospital cases. This maximizes efficient recovery of useable o/t while minimizing intrusion into the family's grieving process. Further, a staff position providing 24-hour access to the O/TPO has been established to facilitate and monitor agency/HCME interaction to streamline the donation process and quickly address agency needs.
The results of HCME efforts to facilitate the o/t donation process are seen in the volume of approved requests for o/t release. For the first 6 months of 2008 (January 1–June 30), the HCME released 192 organs from 40 medicolegal donors, 26% (40/152) of all deceased donors in the TXGC-OP1 Region, and 12% (40/324) of all deceased donors in the state of Texas (rates based on UNOS OPTN data as of October 7, 2008).1 The HCME also makes a concerted effort to provide agency access to approved tissue cases in a timely manner. The HCME approved release for 176 tissue requests in the first 6 months of 2008.
Previous literature indicates that o/t donation rarely, if ever, interferes with the primary mission of me/c; a position paper by NAME furthers this idea by advocating consent by me/c for organ and tissue donation in “virtually all cases.”3–5 It is important to be aware that recovering o/t does limit examination of those respective organs and tissues at autopsy, and in some cases this limitation will interfere with determination of cause and manner of death or will hamper documentation of evidence. Pinckard et al state that, “The medical examiner is the person best qualified to balance these sometimes competing interests of medicine and law and should not devolve the responsibility for deciding whether a body under medical examiner jurisdiction may be an organ/tissue donor to treating physicians, organ/tissue procurement organization personnel . . . attorneys (italics added).”3 This statement articulates an essential concept that forms the basis for this manuscript.
O/t recovery and donation in medical examiner decedents is both desirable and feasible in the majority of requested cases. For cases that require an autopsy, including many natural death cases, there are certain circumstances in which the me/c is best qualified to make the necessary decision regarding potential loss of evidence or diagnostic criteria if o/t is approved. This decision must take into account the balance between saving the lives of those potential recipients waiting for o/t, the legal responsibilities of me/c, and the ability to give families the reasons why a loved one has died. Providing families with cause of death information may also save lives, for example, when a congenital cardiac defect is discovered that might be present but undetected in other family members. Additionally, donation of o/t from individuals whose cause of death is unknown constitutes a risk to the recipient(s), since the transmission of undiagnosed infectious or neoplastic diseases has been documented.6–9
Despite the close working relationship between several recovery agencies in Harris County and the HCME, there have been instances in which an agency has recovered o/t against the objection of the Medical Examiner. These actions contributed to an inability to determine cause and manner of death in these cases. We present here a representative sampling of these cases to demonstrate the crucial need for recognition of the limitations that o/t donation may impose if communication between the agencies and me/c does not result in a reasoned compromise that is acceptable to both parties.
This female infant was born term and had a history of impetigo and eczema. The mother, a 22-year-old student, had only one prior pregnancy that was electively terminated at the end of the first trimester; her medical history included impetigo, eczema, and asthma. The child had 2 prior episodes of apnea, one at 5 months, and the other at 6 months of age. She was hospitalized for both of those episodes, for 4 days and for 3 days, with no clear diagnosis. Each of those episodes occurred while in the mother's arms. The terminal event at 8 months of age initiated when the child became limp and apneic while in the mother's arms, similar to the prior episodes of apnea. The paramedics reported that the mother made repeated statements at the scene regarding her fear of being sent back to jail because of this. The child was taken to the hospital and maintained on a respirator for 2 days before being pronounced dead. Police investigation was unfruitful at the time, but continues even at the time of this writing. Consent was obtained by the recovery agency to recover all visceral organs, including heart, lungs, liver, kidneys, and pancreas. The Medical Examiner approved recovery of all organs except the heart. However, the agency removed all organs, including the heart, over the objection of the Medical Examiner.
Postmortem, the infant's body was at the 50th percentile for height and weight (post organ donation); skin ulcers in several locations were nonspecific and probably related to bacterial impetigo. Scalp and subscalp hemorrhages were noted, but were unaccompanied by intracranial injury. The brain was markedly edematous with hypoxic-ischemic changes. The spinal cord likewise was swollen and edematous but additionally had microglial nodules, indicative of a viral infection. Retinal hemorrhages were in one eye, localized to the posterior pole. Because of numerous uncertainties in this case the cause and manner of death remain undetermined.
This female infant was born term; the only reported medical history was recent nasal congestion, for which the mother had given an unknown over-the-counter medication. At 2½ months of age, the child was placed alone in a crib after a feeding and several hours later was discovered unresponsive. She was transported to the hospital, resuscitated and maintained on a respirator for 3 days. Diagnostic studies did not elucidate a cause for her sudden collapse. After death, the clinicians expressed interest in autopsy findings, and suggested to the Medical Examiner that genetic or metabolic studies may be of interest. The recovery agency approached the family and obtained consent to recover heart, lungs, kidneys, liver, pancreas, adrenals, spleen, and dura. The Medical Examiner approved donation for all organs except the heart. The agency recovered lungs and the heart over the objection of the Medical Examiner.
Autopsy evidence of a hypoxic-ischemic event included a swollen brain, with acute renal tubular necrosis and granular cast formation. Chronic otitis media was found, but no other abnormalities were noted. Because the presentation was not typical for sudden infant death syndrome (delayed, hospital death) and because the autopsy was incomplete, the cause and manner of death are undetermined.
The 7 month-old female infant had a complicated birth history, including failure to progress with conversion to C-section delivery, and subsequent group B streptococcal infection. However, after an initial 1-week hospitalization, the history was unremarkable, except for recent symptoms of an upper respiratory infection for which the child had been given over-the-counter remedies. On the day of admission to the hospital the child, 7 months of age, was at home with the grandmother and father. The father wrapped the child in a blanket, and then took a nap on an adult sized bed with the child. Upon awakening, the father discovered the child not breathing and summoned EMS. After successful resuscitation, full diagnostic studies were conducted over the course of the 2½ day hospitalization. The brain was swollen, consistent with a hypoxic-ischemic insult, but no etiology was determined. Because no etiology for this event was determined and because no cause of death was evident, the Medical Examiner requested that the recovery agency not recover organs or tissues. The agency recovered the heart, liver, and kidneys. The lungs were deemed unsuitable for transplantation and were not recovered. After excision of the liver, the agency was not able to place the organ so it was returned with the body to the Medical Examiner.
Autopsy of the residual body revealed a swollen edematous brain with hypoxic-ischemic changes and herniation. Acute bilateral bronchopneumonia was noted, as was evidence of a coagulopathy. Viral cultures were negative. Because the presentation (delayed hospital death) is not typical for “sudden infant death syndrome” and because the autopsy was incomplete, the cause and manner of death are undetermined.
This 6 day-old male neonate was reportedly breast-feeding when he became unresponsive. The mother started resuscitative efforts and called for paramedics. A pulse was regained and the child was transported to the hospital where he remained on a respirator, unresponsive until brain death was pronounced 37 hours after admission. During hospitalization, an echocardiogram revealed a patent foramen with left to right shunting, and mitral regurgitation that was deemed “trivial.” The recovery agency obtained consent from the family for organ donation. The Medical Examiner considered a cardiac problem as a likely etiology for this sudden death; therefore approval was given for recovery of lungs, liver, kidneys, pancreas, and small intestine, but not heart. The procurement agency did not recover the lungs, liver, kidneys, pancreas, or small intestine, but did recover the heart against the objection of the Medical Examiner.
Autopsy confirmed hypoxic-ischemic injury of the brain. Other findings included adrenal gland hemorrhage and renal medullary infarction. Metabolic and toxicologic studies were also not enlightening regarding the cause of death. In large part because the heart could not be examined, the cause and manner of death remain undetermined.
This decedent was a 36-year-old woman with a history of prescription drug abuse with several remote drug overdoses. She had a psychiatric history of bipolar disorder. On the day of her terminal hospital admission, her husband reported that she was in her usual state of health at 7:00 am. He left the home briefly, and returned approximately 1½ hours later to find her sitting up but slumped to the side in the bed, pulseless, and apneic. Paramedics were summoned; she was resuscitated and transported to the hospital where an initial urine drug screen was positive for benzodiazepines and opiates. She remained in an unconscious state with anoxic-ischemic encephalopathy for 2 days. The clinical diagnosis was drug overdose. Based on a seeming secure diagnosis of drug overdose, the Medical Examiner granted release for the recovery agency to recover organs; the heart, right lung, liver, spleen small bowel, adrenal glands, and pancreas were removed. In subsequent review of the recovery procedure documents, a surgical note refers to a liver laceration. The laceration was described as a 2 cm, 0.5 cm deep injury of the umbilical fissure in segment III. No indication of presence or absence of free blood in the abdomen was mentioned. However, of possible significance is that on admission the liver enzymes were elevated (AST [SGOT] 323 and ALT [SGPT] 255) and she developed an anemia (hemoglobin 8.1 with a hematocrit of 23.8) by the second hospital day which required a transfusion.
Toxicology analysis was done on the admission blood samples. Several medications were found. These included hydrocodone, carisoprodol, and a benzodiazepine (qualitatively identified as diazepam). These drugs had been prescribed for this decedent, and the levels were not in the toxic range (0.05 mg/L for hydrocodone, and <2.0 mg/L for carisoprodol).
Therefore, in this case, the clinical diagnosis of drug overdose could not be confirmed by laboratory analysis. Further, the significance of an injury documented at the time of organ donation is difficult to determine, and the possible etiology of the injury is equally elusive. The inability to examine the injured organ(s), and the inability to evaluate other organs for possible significant natural diseases directly hindered the determination of cause and manner of death. The cause and manner were accordingly classified as undetermined.
The 5 cases that we have described in this manuscript were received by the HCME over a 2-year span of time. This is a small percentage of HCME donor cases. Cases in which an organ or tissue is denied consist primarily of infants who died suddenly and unexpectedly. Unless there is traumatic injury that must be assessed at autopsy, the heart is usually the only organ that is denied release in these cases. The HCME understands that the denial of even one heart for transplantation is a serious matter to a potential recipient. However, the inability to determine the cause of death in a child who has died suddenly and unexpectedly has a number of potentially serious ramifications. These include: (1) lack of closure for the grieving family, (2) inability to diagnose a condition with familial implications, and (3) inadvertent transmissal of undiagnosed infectious or neoplastic disease to the recipient(s).6–9 These are apart from the more often cited consequences such as interference with the me/c legal responsibility to determine cause and manner of death, or interference with prosecution of cases where autopsy evidence is crucial (even negative autopsy evidence in some cases). The lack of a concrete reason for the death of an infant can also be emotionally devastating for the parents. In our experience, families of potential donors are not told that o/t donation may interfere with determination of cause or manner of death. The next of kin are sometimes surprised by the undetermined classification once the autopsy of residual organs is finished.
In most cases, some follow-up information can be obtained from the O/TPO regarding placement and subsequent viability of transplanted organs. In the case of cardiac abnormalities such as coronary artery anomalies, valvular abnormalities, and functional arrhythmias individuals may be asymptomatic for long periods of time, only presenting with sudden death or syncope in their teen years or even later. Therefore, the short term viability of an organ in a recipient does not constitute unequivocal evidence that the organ does not harbor a lethal functional or structural abnormality. Furthermore, in many instances the reason for failure of an organ donation is unclear. Failures attributed to rejection for example may well be related to intrinsic abnormalities of the donated organ. Follow-up information was sought in these cases and is presented in Table 1. The information presented in this table is limited, but the information is reflective of the follow-up obtained from the O/TPO. Of note, several of the recipients are now deceased, but in most of these the cause of death of the recipient is unknown (liver recipient case 1, heart recipient case 3, and lung recipient case 5). In all of the cases with a fatal outcome it is unknown whether the recipient was autopsied.
In summary, we agree with the position paper of NAME that the number of o/t donations should be maximized. The NAME position paper does not, however, advocate that every organ from every potential donor should be released for donation. In fact, Pinckard et al argue that the me/c should not give up their authority to use their expertise to intervene in this process when donation may interfere with determination of cause and manner of death. Most of the cases we present here are examples of cases where specific organs were denied by the Medical Examiner but were donated over the Medical Examiner's objection. One of the cases was approved for donation but the information upon which that approval was granted was erroneous or incomplete. In each case, the cause and manner of death are undetermined. In some or all of these cases if the autopsy had been complete the cause of death may well have been undetermined. This possibility does not negate the importance of the ability of the Medical Examiner to examine these organs.
The basis of our position is that the me/c is best qualified to make the decision regarding release of o/t. If a complete autopsy cannot be performed without a full examination of the requested o/t, the me/c must have both the legal and practical ability to make that decision. After all, “the primary function of the medical examiner is to determine the cause and manner of death.”3 This function can be severely compromised in the absence of essential evidence.
© 2010 Lippincott Williams & Wilkins, Inc.