The Transplant Surgeon's Perspective on the Bungled Transplant
The Transplant Surgeon's Perspective on the Bungled Transplant
Abstract and Keywords
Tom Diflo is a clinical transplant surgeon who has performed almost 1,000 kidney, liver, and pancreas transplants in the United States. In this chapter, Dr. Diflo provides insight on the complexities and crucial aspects of transplantation. The chapter describes the buying and selling of organs, or “transplant tourism”, particularly the problem of Americans stepping outside the system and going abroad to purchase organs in the black and gray markets of other countries. The root cause analysis on the Jessica Santillan case at Duke University Medical Center and the changes they implemented are also examined.
On the evening of February 6, 2003, Dr. James Jaggers received a telephone call from Carolina Donor Services, the local organ procurement organization (OPO) that services Duke University Medical Center and the surrounding area.1 Dr. Jaggers was the head of pediatric heart and heart-lung transplantation at Duke, and a donor had been identified in New England for one of the patients on the Duke heart-lung transplant list. Heart-lung transplants are rare—only 39 were done in the United States in 2004, as compared to 6,200 liver transplants and 16,000 kidney transplants.2 This is partly due to the relative paucity of conditions that require a combined heart-lung, and partly due to the stringent requirements for matching the donor and recipient. Not only is it a requirement that the blood types be compatible, but there also must be a rough correlation between the body sizes of the donor and recipient. A heart-lung bloc from a large donor may not even fit into the chest cavity of a small recipient, and a small donor's organs may not be large enough to function adequately for a bigger recipient. In addition, not infrequently the first people on the list for any organ prove untransplantable for any of a variety of reasons—they may be too sick, or even too well; they may have a cold or other infection, or they may refuse.
For whatever reason, the number one patient on Duke's list was not transplantable on that night. Dr. Jaggers thought that the organs would be appropriate for another of his patients, Jesica Santillan. When Dr. Jaggers heard back several hours later that the organs were Jesica's if he wanted them, two tragic assumptions had been made. The first was on Jaggers's part when he assumed that the organs would only be offered to Jesica if the blood type were compatible. The second was on the opo's part when it assumed that Jaggers had a good reason for using the organs from a blood-type incompatible donor. There certainly is precedent for the use of such donors, but usually in a dire life or death situation or in a living-donor transplant in which the recipient (p.71) has undergone an exhaustive and rigorous preconditioning regimen. This case clearly did not fall under either of these conditions.
The Surgeon's Role
We have all made mistakes, some trivial, some tragic. Many, if not all, surgeons have at one time made a mistake that proves to be significant and irreversible. It may be a fraction of a second slip of the knife, or an agonizing hours-long ill-fated operation. Once realization sets in, the reaction is almost instantaneous, and quite visceral. In polite terms, I would characterize this as the “Oh, No!” moment. One immediately becomes light-headed, short of breath, sweaty, and nauseated. Being surgeons, who are used to handling disasters and tragedies quickly, our “fix-it” mode kicks in. Sometimes, however, there is no “fix.”
If there is indeed no “fix,” the next line of thought is “damage control,” mostly for the patient, but also, eventually, for the surgeon. Over the past decade or so, a key concept in the operative management of severely injured patients has moved away from the “let's fix everything” approach and toward the “let's just fix the life-threatening problems” approach. This “damage control” technique allows the patient to be taken to the intensive care unit, warmed up, transfused, and otherwise optimized and made a better candidate for further operative therapy. There was no “damage control” possible for Jesica.
I write this essay as a busy clinical transplant surgeon, having performed almost 1,000 kidney, liver, and pancreas transplants. My clinical experience and involvement with various transplant organizations makes me acutely aware of the astonishing complexities of transplantation in the United States. In addition, a major interest of mine is the international trade in organs, and donors. Therefore, my perspective is that of both a practitioner and an analyst, similar to several of my co-authors in this volume.
The Organization of Transplantation
Much has been made of the “experimental” nature of transplantation-common perceptions exist that the field is in its infancy and that we are still finding our way, technically, scientifically, and ethically. In some sense, since every patient is unique, and since we never know beforehand how an individual transplant procedure will turn out, every transplant could be considered (p.72) an “experiment,” although no more so than any other surgical or medical procedure. However, while the ethical issues continue to proliferate, the scientific and practical aspects of the field have become well established in the fifty years of modern transplantation history. Transplantation in the United States, particularly deceased-donor transplantation, has become an exquisitely choreographed dance between the listed patients, their transplant physicians and surgeons, the OPOS, the hospitals where the donors have been treated, and the donor families. The logistics are staggering, and I am frequently amazed that the system works at all. In fact, it not only works, it works quite well. It is worthwhile to look into the evolution of organ transplantation in the United States (see also Jed Adam Gross's essay in this volume) to give us some perspective on “the system.”3
The first successful kidney transplant in the world was performed in Boston on December 23,1954, between two identical twins, the Herriclc brothers, by a team at the Peter Bent Brigham Hospital led by Dr. Joseph Murray, eventual Nobel laureate. In these early days the numbers of transplants were few, since there were relatively few identical twin pairs with one-half in need of a kidney. In 1961, azathioprine was introduced as one of the first antirejection medications, and in 1962 the first deceased-donor (cadaveric) kidney transplant was performed. The first successful liver and heart transplants followed in 1967 and 1968, respectively. Also in 1968 the South-Eastern Organ Procurement Foundation (SEOPF) was formed to help standardize transplantation procedures, exchange scientific information, and organize the way in which deceased-donor organs were allocated.
By 1977 the advances in computer technology allowed SEOPF to introduce the first computer-based matching system, which was called the United Network for Organ Sharing. By 1982 SEOPF established the Kidney Center, which operated twenty-four hours a day, seven days a week, to provide assistance in placing donated organs. The year 1984 was a landmark in transplantation in that the National Organ Transplant Act (NOTA, or “The Gore Law,” after its sponsor, Senator A1 Gore) codified into law the various aspects of transplantation. One of its provisions involved the separation of the United Network for Organ Sharing (UNOS) from SEOPF into a nonprofit entity with responsibility for overseeing transplantation in the United States. Two years later, UNOS was given the federal contract to operate the Organ Procurement and Transplantation Network (OPTN). By 1992, UNOS had begun to gather data on transplant rates, survival rates, and other such information, which it reported and made available to the transplant centers and the general public. As time has gone by, UNOS has become the most recognizable authority in transplantation in (p.73) the United States. It sets and modifies policy after exhaustive internal and external review, certifies transplant centers and transplant surgeons and physicians, and, in a very real sense, “runs” transplantation in this country. It is a crucial and exceedingly complex role, a role required to maintain credibility of and trust in the system (see the Gross essay in this volume).
Transplantation worldwide has become very big business, for hospitals, practitioners, OPOS, and governments, not to mention the thousands of patients who benefit annually. The business trades not only with common currency but also with the currency of prestige and innovation. Transplant programs can bring their sponsoring hospitals a great deal of money, as well as the type of recognition that can set them apart from other similar institutions that do not have such programs. This quite naturally leads to competition between centers for patients and practitioners. There is also significant competition among them for the scarce and precious resource of donor organs. Larger centers can overwhelm smaller centers, but, perhaps not surprisingly, they frequently have better survival and graft function statistics. Programs open and close based on their success rates, and UNOS plays a crucial role in collecting these results and policing programs. Not surprisingly, UNOS has had a great deal to say about the Santillan case.
Where Did the System Fail?
During Jesica's transplant procedure, after the organs had been implanted but before the incisions were closed, the blood bank at Duke informed the operating room and Dr. faggers that there was a blood type incompatibility—the donor was blood type A, and the recipient was blood type O.4 This clearly would have been Jaggers's “Oh, No!” moment. In certain rare circumstances this seeming incompatibility might be inconsequential (a small percentage of blood type A patients have a so-called subtype A2 blood type that, immunologically, acts like blood type O). Unfortunately, this was not the case with Jesica. When organs of an incompatible blood type are transplanted, the recipient experiences a rare type of rejection called “hyperacute.” This is distinguished from the more common “acute” rejection, which has a time course on the order of five to seven days and is mediated or controlled by cells of the immune system. Hyperacute rejection occurs within minutes to hours after the transplant and results when antibodies that already exist in the recipient bind to the cells of the transplanted organ, initiating a cascade that can destroy the organ rapidly. In this case, the antibodies were the “anti-A” antibodies that all people with blood type Ο have.
(p.74) When facing a situation involving hyperacute rejection, the usual approach in attempting to save the organs and the patient involves reducing the antibody levels. This is generally done, as in Jesica's case, by using plasma-pheresis—a technique akin to dialysis that removes plasma from the patient (in which antibodies reside) and replaces the plasma either with donated plasma from the blood bank or with human albumin. If the organ cannot be salvaged, it needs to be removed (in the case of a non-life-sustaining organ like a kidney), or the patient must be retransplanted, to save his or her life. After Jesica's first transplant, her team made the wildly optimistic assessment that, when the second set of organs became available, she had a 50-50 chance of recovery with the new organs. Unfortunately, by the time Jesica was retransplanted, she was already too far gone, and shortly thereafter she expired. In some circles, much has been made of the fact that Jesica's mother refused to allow her daughter to be an organ donor when she died after her second transplant.5 First, it is not clear that the mother understood what was being requested. From a more pragmatic point of view, however, the organs of a person who had just undergone two transplants and who had been critically ill in the intensive care unit are frequently unusable in any case. Castigating her mother for this seems harsh, particularly since she has subsequently become a spokesperson for organ donation in speeches and advertisements.
From all accounts, the surgical procedures performed on Jesica were perfect, her care in the intensive care unit top-notch, and the rapid institution of plasmapheresis completely appropriate. In fact, Duke has objected to the use of the term “bungled transplant” because they maintain that the operation itself was flawless.6 This notion plays into the popular misconception that transplantation is “just” an operation. Certainly a perfect operative procedure is helpful for a good outcome, but the other crucial aspects of transplantation, such as immunosuppression, peri-operative care, the prevention of infections, and the like are as important, or even more so, than the technical aspects of the operation. In Jesica's case, the cause of her demise was not poor care in the hospital, it was the error made at 3 A.M. on February 7.7 This was an egregious error in and of itself, akin to failing to ascertain a donor's age, cause of death, comorbidities, or HIV status.
However, most medical errors are not the result of one person's mistake or incompetence. They are a result of a failure of the systems, as eloquently described by Charles Bosk in his essay in this volume, as well as his other works on the topic. Now when medical errors are detected, they are not dealt with by finger-pointing or assigning blame—they are subjected to “root cause analyses,” which attempt to ferret out where and how the systems broke (p.75) down and, more important, how to prevent the same errors in the future (see also Cook this volume). The root cause analyses at both Duke and UNOSrevealed how the systems, both locally and nationally, broke down.
The Jesica Santillan story raised other, more common issues in organ transplant—“transplant tourism,” the purchasing of organs and “beating the list.” Some commentators speculated that there was some impropriety in Jesica's first transplant, and particularly in her second.8 Unfortunately, transplantation is not infrequently the subject of such speculation, especially in the situation of famous patients receiving transplants “ahead of others.” The well-publicized cases of Mickey Mantle and Larry Hagman come to mind, even though both of those transplants were performed in a completely appropriate and legitimate way. There are, however, many people who have found ways to circumvent the organ allocation system and, in some way, “beat the list.”
How to Buy an Organ, and Other Nefarious Doings
As of May 2005, there were 88,068 candidates for transplantation en-rolled with UNOS, and in 2004 there were a total of 27,033 transplants performed in the United States, according to the UNOS Web site.9 Given the wide, and widening, discrepancy between the number of people on our transplant waiting lists and the number of transplants done, many patients have lost faith in the system and have taken matters into their own hands. Those who have are generally the wealthy and the well connected. The transplant community works hard at maintaining equity, but the system, as it exists, is inherently inequitable. The country is divided into eleven geographical regions by UNOS, and organs are generally allocated within regions. The rapidity with which a patient is transplanted after being listed can vary markedly from region to region and is based on two variables: the number of patients enrolled on the list within the region, and the number and rate of donations in the region. Because these figures vary widely from region to region, so do the transplant rates and waiting times. It is not unusual for some renal failure patients to wait eight or nine years for a kidney transplant in some urban centers in the Northeast, whereas the same patient might wait half that time only thirty miles away in a nearby state, or one-quarter of that time at some southern centers.
Anyone who has access to the Internet can easily find these figures, and many patients use the information to their own advantage. While I mentioned above that there are 88,068 patients enrolled with UNOS, there are a (p.76) total of 95,508 registrations with UNOS.10 A patient who is listed at more than one center is counted only once, but each registration is counted separately. This means that as many as 7,440 patients are enrolled at more than one center. In all likelihood, the number is smaller, in that many patients who enroll at more than one center enroll at more than one additional center.
Who are these patients on multiple lists? Put simply, most are the ones with money. In order to be listed at a center other than the local one, patients have to have either insurance to cover the procedure or the ready cash to pay for the evaluation and transplant. They also have to have the ability to travel to other centers and pay for lodging and other expenses. Any patients with Medicaid as their primary insurance are out of luck—Medicaid will only cover patients within the state in which they are enrolled. Many of the diseases for which we transplant, particularly liver failure and renal failure, have significantly higher incidences in the poorer population. Effectively this prevents the vast majority of patients from pursuing the multiple listing option.
That being said, why do we allow it? The simple answer is that, over time, it just happened, and it became a part of the system without anyone really taking notice, or taking action. Periodically UNOS has floated the concept of eliminating the possibility of multiple listing, only to be roundly rebuffed by many transplant centers and patient advocacy groups. Basically, momentum is carrying the multiple listing concept along.
Far more sinister is the participation of some patients in the buying and selling of organs from living donors, as described by Scheper-Hughes in her essay in this book, where she chronicles her remarkable studies of the world-wide organ trade. There are many variations of the theme, but the underlying engine driving the trade is the flow of organs from those economically less fortunate toward those more fortunate. There are numerous reports of Americans traveling worldwide for organs—to the slums of Central and South America, the Philippines, India, the Middle East—and even to China, to benefit from the particularly egregious practice of using the organs of executed Chinese prisoners for transplantation.11
In China in the mid-1980s it became clear to the government and some hospitals that a possible resource was being wasted by burying potentially useful organs in the bodies of prisoners who had been executed. In 1984, the government issued a directive giving instructions for the disposition of the organs from these prisoners (“The 1984 Provisional Rules on the Use of Dead Bodies or Organs from Condemned Criminals”),12 which allows the removal of the organs under three conditions: the prisoner's body is not claimed, the prisoner has given prior consent, or the prisoner's family has (p.77) given prior consent. Investigating all of the details of this practice is best left to another forum, but most commentators consider this a gross violation of human rights. Nonetheless, it has proven to be very popular both in China and throughout the world. Numerous patients have traveled from the United States (most are Chinese American immigrants) in order to purchase a pris-oner's organ from the state or the hospital. In many ways, there are parallels between those patients who have traveled to China and Jesica and her family. Both were immigrants who traveled to America in the hopes of improving their lots in life. Both had acquired enough money (or had enough insurance) to allow transplantation to occur. Jesica, however, stayed within the system.
Unfortunately, American medicine cannot declare itself free of these practices. Some American physicians actively encourage their patients to pursue such options. In addition, there are well-documented reports of Americans receiving kidneys at American transplant centers from “relatives” who have been brought to this country by brokers solely for the purpose of selling their organs.13 The great irony in the Santillan case is obvious. Usually the story would be that of a young Latino woman who had sold her kidney to a wealthy American for enough money to buy some clothes, some food, and maybe a television set; or, even more commonly, the story would be that of a young illegal immigrant who had suffered some terrible accident and had become a deceased multi-organ donor.
Addressing the Problem
Clearly the Santillan tragedy could have been avoided by the simple question, “What's the blood type?” Anyone could have asked: Dr. Jaggers, the procuring surgeon, the team from the New England OPO, the team from the North Carolina OPO, the transplant coordinator at Duke, the circulating ORnurse, the anesthesiologist, the transplant fellow…. No one did.
Duke performed a root cause analysis for both their own quality assurance and to fulfil UNOS's requirements.14 Simply put, the facts were as follows: the transplant surgeon did not recall either receiving or requesting blood type information from the procurement coordinator, the procuring surgeon went to New England and procured the organs, also without specifically noting the blood type, and back at Duke, no confirmation of donor and recipient blood type was made until the transplant was almost complete.15
Duke's response to these findings was rapid, substantive, and very comprehensive. UNOS, in addition to placing specific requirements on Duke, instituted numerous changes in procedures nationwide, most of which incorporated (p.78) redundancy into the systems. In summary, Duke implemented the following changes:16
In the transplant division:
• The divisions of pediatric cardiac transplantation and pediatric lung transplantation were reorganized and integrated into the respective adult divisions.
• The requirements for certification as a procuring surgeon were made more stringent.
• Two attending transplant surgeons are required to perform all pediatric thoracic organ transplants.
• The transplant surgeon will accept an organ based on recipient characteristics (including blood type) available in an online database. The transplant coordinator will independently confirm these characteristics.
• The procuring surgeon will confirm donor and recipient compatibility with source documents at the donor hospital.
• Dedicated parking spaces are defined for the procuring team, to solidify the chain of custody of the procured organs.
• On arrival at the OR suite, the donor organs will be logged in at the operating room desk.
• Prior to induction of anesthesia in the recipient, the attending anesthesiologist and transplant coordinator will have a “time-out” during which ABO compatibility will be confirmed. The confirmation will be recorded by the circulating OR nurse.
• On arrival of the organs at the OR, a second “time-out” will occur, to reconfirm the donor UNOS number, the integrity of the organs, and the blood type of the donor and recipient.
• Donor blood will be delivered to the Duke blood bank for a final reconfirmation of the donor's blood type.
• In the circumstance when a transplant will be done with an incompatible organ, a second transplant surgeon will confirm that this is the case in the medical record.
In the Medical Center, the administration:
• Established a Patient Safety Action Task Force.
• Initiated a safety review of patient procedures.
• Established a pediatric safety program.
• Hired a full-time expert in patient safety.
• Hired an associate chief information officer for patient safety.
• Hired a senior executive patient safety officer.
• Established a partnership with the quality improvement organization for the local region designated by the Centers for Medicare and Medicaid Services.
• Developed a computerized drug order entry system.
• Developed a computerized monitoring system for adverse drug events.
• Launched an Internet site for anonymous reporting of medical errors.
In addition to the wide-ranging changes instituted at Duke, UNOS changed numerous policies and instituted several new policies, which have been implemented at all transplant centers nationwide, for all organs transplanted.17 In sum:
• Potential transplant recipients will have their blood types checked at least two separate times during their evaluations.
• When recipients are registered in UNET (UNOS's Web-based registration tool), the blood type will need to be entered twice, by two separate individuals.
• At the time of organ procurement, the blood types of donor and recipient will be verified by at least two different staff members at both the host OPO and the transplant hospital.
• Transplant programs will check the donor blood type on arrival of the organ and compare it to that of the recipient.
• The attending transplant surgeon will re-check the blood types of the donor and recipient, and document the results in the recipient's medical chart.
• Transplant centers and OPOS must keep records of these verification procedures, which will be examined during UNOS audits.
Clearly Duke and UNOS took seriously their responsibility to address the systems errors; the changes are comprehensive and thorough, perhaps even overwhelming. Most of the recommendations and new rules are appropriate, but some seem to have spilled over into the outlandish, and certainly the unenforceable. It is difficult to imagine that providing a dedicated parking space to the procuring team will enhance patient safety more than it will make the transplant fellow's life a little easier. Some of the recommendations won't even work—the second “time-out” when the organs arrive will occur well after the recipient's surgery has begun. In addition, although it might prevent the (p.80) placement of inappropriate organs into a patient, it will not prevent the operation from happening at all, which is obviously what should happen.
Jesica Santillan is not the only patient who has undergone an errant transplant with incompatible organs, but she is certainly the most famous. The remedies put into place after her heartrending death, both locally at Duke and nationwide through UNOS, highlight the complex issues of protecting patient safety and improving outcomes in the transplant community. In his essay, Bosk makes the trenchant observation that, as is frequently the case, these changes have been made to address the last disaster, not the next one. Unfortunately, few of us are sufficiently visionary to anticipate the unimaginable.
(4) . DukeMedNews, “Background Information on Jesica Santillan.”
(5) . Stormfront White Nationalist Community, “How Little Yesica Got Bumped Ahead of White Kids & on TV for 2 Heart/Lung Transplants, 2003, 〈http://www.stormfront.org/forum/showthread.php?t=57159〉.
(6) . K. Wailoo, personal communication, 2005. In an email communication with Wailoo, a Duke University news office director wrote that the term “bungled transplant” was incorrect. He noted: “To correct the record on the title of your conference, this was an organ bloodtype mismatch case. The transplants were not bungled or botched, because the surgeries were performed up to appropriate surgical standards” (Correspondence from Jeffrey Molter to Keith Wailoo, January 12, 2004).
(7) . DukeMedNews, “Background Information on Jesica Santillan.”
(11) . E. Baard and R. Cooney, “China's Execution, Inc.,” Village Voice 46 (2001): 36–40; J. D. Briggs, “The Use of Organs from Executed Prisoners in China,” Nephrol Dial Transplant 11 (2) (1996): 238–40; C. Chelala, “China's Human-Organ Trade High-lighted by U.S. Arrest of “Salesman,” Lancet 351 (9104) (1998): 735; T. Diflo, “The Use of Executed Prisoners' Organs for Transplantation in China,” In Ethical, Legal, and Social Issues in Organ Transplantation, edited by T. Gutmann, ASD, R. A. Sells, and W. Land, 500–506 (Lengerich, Germany: Pabst Science Publishers, 2004). T. Diflo, “Use of Organs from Executed Chinese Prisoners,” Lancet 364 (2004): 30–31.
(12) . Diflo, “Use of Executed Prisoners' Organs”; Laogai Research Foundation, “Communist Charity: A Comprehensive Report on the Harvesting of Organs from the Executed Prisoners of the People's Republic of China,” 2001, p. 16.
(13) . N. Scheper-Hughes, personal communication, 2004.
(14) . DukeMedNews, “Background Information on Jesica Santillan.”
(16) . DukeMedNews, “Background Information on Jesica Santillan.”
(17) . unos News Bureau, “OPTN/UNOS Review of Transplant Error Continues,” 2003, 〈http://www.unos.org/news/newsDetail.asp?id=251〉; UNOS News Bureau, “OPTN/UNOS Recommends Additional Safeguards for Patient Safety in Organ Transplants,” 2003, 〈http://www.unos.org/news/newsDetail.asp?id=273〉; UNOS News Bureau, “OPTN/UNOS Continues to Improve Accuracy in Donor/Recipient Matching,” 2004, 〈http://www.unos.org/news/newsDetail.asp?id=308〉.