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Californian transplant conundrum
World Focus
Californian transplant conundrum On Dec 29, 2006, a story in the Los Angeles Times raised concern over the high death rate in patients undergoing liver transplants at the University of Southern California (USC) University Hospital, Los Angeles, CA, USA. The spectres of bad practice, improper patient selection, and use of below-par organs have all been invoked, but the centre has defended itself with a powerful argument: it accepts patients that most hospitals would turn down. Indeed, the USC is the USA’s leading centre for liver transplants in Jehovah’s Witnesses, who refuse blood transfusions. In this light, its 1-year survival rate of 76% does not sound so bad when compared with the national average of 86%. Unfortunately, however, this is another incident in a series of transplant troubles in different US cities, and raises the question of whether change is needed to respond to public and professional fears. California has been particularly hard hit. The St Vincent Hospital in Los Angeles was recently found guilty of improperly using a liver. On Sept 7, 2003, the centre received an offer of a liver for transplantation into a specific candidate, who at that time, was unavailable for surgery. The hospital should have informed the United Network for
Money follows transplants
96
Organ Sharing (UNOS), the US organ procurement and allocation body, which would have then offered the liver to the next person on the waiting list. The hospital, however, accepted the liver and transplanted it into another patient 50 steps down the ladder. It then claimed the liver had been transplanted into the intended recipient (who later died of liver cancer). The motives remain unclear, but St Vincent received the UNOS’ most serious sanction—member not in good standing—and the liver-transplant programme closed. UNOS President Francis Delmonico hoped this would “...call attention to the failure of the institutional control which allowed these serious violations to occur and be covered up for an extended period. [The Board’s] action should send a very clear message to the transplant community, and to the general public, that our responsibilities, as stewards of the gifts of donated organs, cannot be compromised”. Trouble later surfaced at the University of California Irvine (UCI) Medical Centre, also in Los Angeles. The centre lost financial support for its liver-transplant programme via the Medicare and Medicaid system because of the low number of transplants done, low survival figures, and the centre’s frequent refusal of livers. Patients awaiting a liver are generally very ill; although controversial, the only hope for some people with hepatobiliary cancer is a transplant, for which they can illafford to wait long. It has also been alleged that some people might have died because of transplant delays. A UNOS investigation indicated “potentially false representations about the on-site coverage of certain key personnel.” The centre shut down its programme in November, 2005. The UNOS placed it on probation, its second most serious sanction, pending presentation of a corrective
plan. UCI Chancellor Michael Drake assured that the communication problems that caused the trouble will be fixed. Communication problems have not been the only US liver-transplant woes. In 2003, the University of Illinois settled out-of-court over allegations of fraudulent practice by the University Medical Center’s liver-transplant programme that led to the improper receipt of federal funds. Hospitals in the USA can receive Medicare and Medicaid money for liver transplants as long as they do a threshold number and meet threshold survival rates. Among other things, the hospital was accused to have falsely identified patients as Status 1 or Status 2A for the purpose of making them eligible for liver transplants before others, and even of falsely diagnosing patients to justify their placement on the liver-transplant eligibility list. The US$2 million settlement states that conduct was proper at all times, although Attorney General Lisa Madigan still went on record as saying: “A hospital’s desire to receive additional state and federal healthcare dollars should play no role in whether or not a patient is eligible for an organ transplant. As our settlement makes clear, facilities that do so will be severely punished. Not only did the defendant defraud the state and federal governments, it endangered individuals.” The USC’s present troubles, however, could be to blame over the preparation of statistics, the very same on which the Medicare and Medicaid funding system relies. One might expect these figures to be fully adjusted for the risks associated with each patient and organ received, making them comparable between all centres, but they are not. “Our risk adjustment procedures are good but not perfect”, says Michael Abecassis, Professor of http://oncology.thelancet.com Vol 8 February 2007
World Focus
Transplant Surgery at Northwestern University Feinberg School of Medicine (Chicago, IL, USA). “Many risks are not taken into account. For example, under present procedures, heart disease is not adjusted for. Neither are fatty livers, which are much less likely to be successful. So if you have an aggressive department that tries to save people with serious concomitant health problems, or which uses below-par organs rather than let its patients die, its survival figures may simply not tell the whole story.” This dilemma could tempt some centres to safeguard their statistical prestige by selecting only those patients most likely to survive. Those that try to save more marginal patients—perhaps like the USC— would necessarily get poorer grades. Furthermore, although federal law requires centres to give data to the Scientific Registry of Transplant Recipients (SRTR) at Ann Arbor, MI, USA, so that numbers can be crunched “…there is no funding for this activity”, explains Abecassis. “Hospital personal have to find time for this; so is the SRTR receiving the best quality data? For proper risk adjustment, we need proper funding for collecting comprehensive data that better reflect patient and organ conditions.” In response to the concerns over the USC, Steven Campanini (Senior Director of Corporate Communications, Tenet Healthcare Corporation, the hospital’s owner) told The Lancet Oncology, “[The] USC University Hospital’s abdominaltransplant programme faces greater challenges in patient mortality and morbidity than most similar programmes as [it] serves critically-ill patients whose condition may not be accurately reflected in published data. Because USCUH is a Medi-Cal (Medicaid in California) provider, because of the hospital’s geographic location in central Los Angeles, because it takes high-acuity patients from the Los Angeles County Health http://oncology.thelancet.com Vol 8 February 2007
System, and because it treats difficult cases that other transplant programmes turn away, its patients are often significantly sicker, higherrisk transplant candidates”. To address the issue, the hospital is improving their data management so that official figures will more accurately reflect the severity of their patients’ disease. “The most recent data, published Jan 11, 2007, on the SRTR website with data for the second half of 2006, shows considerable improvement, from an 11-point differential between our observed and expected survival rate to a six-point differential”, says Campanini. The USC’s alleged use of livers that no one else wants in last ditch attempts to save lives might also have affected its results, and certainly highlights an important ethical question: at what point do you give up trying? “Allocation of donor organs for transplantation is always a thorny issue because demand consistently outstrips supply”, explains Stephen Wigmore, Chairman of the Ethics Committee of the British Transplantation Society. “There is a point, however, where transplantation becomes futile. Deciding where this lies is the problem. Using marginal donor livers in extremely sick patients requires both very careful consideration and consent, as the consequences can be fatal.” The atmosphere of uncertainty that has been generated has led the American press to criticise the UNOS (which also develops and enforces policies governing organ procurement and allocation) for being slow to detect and react to deficiencies. UNOS’ Executive Director Walter Graham reassures, however, that “The organ allocation system in the USA is always changing, and we continue to learn and apply new lessons as we improve it. We also learn a great deal from experience, both good and bad. Over time we have changed policies and procedures that
Comprehensive data collection is important
do not work as expected. We’ve also strengthened many requirements to ensure quality outcomes for patients. On a few occasions we have adopted or changed a policy in response to a single, specific event. More commonly we develop and improve policies based on broad issues and trends that affect everyone in transplantation.” Tom Mones, CEO of the southern Californian donor network OneLegacy, told The Lancet Oncology that “UNOS has responded very vigorously this past year to identify program variation and seek explanation or practice change…the timing of this increased oversight effort is benefited by the implementation this spring of the UNOS DonorNet system that will enable real-time audit of organ offers and acceptance, rather than retrospective review.” Meanwhile, people in Los Angeles are aware that a third of their original six liver-transplant centres is under suspicion. Although the workload is being handled, the time might be ripe for the US transplantation community to find extra ways to reassure the public—regardless of the outcome of investigations into the USC’s figures—and to prevent unfair criticism of medical centres and professionals that, within ethical limits, try longer shots to save lives.
Adrian Burton 97
Californian transplant conundrum On Dec 29, 2006, a story in the Los Angeles Times raised concern over the high death rate in patients undergoing liver transplants at the University of Southern California (USC) University Hospital, Los Angeles, CA, USA. The spectres of bad practice, improper patient selection, and use of below-par organs have all been invoked, but the centre has defended itself with a powerful argument: it accepts patients that most hospitals would turn down. Indeed, the USC is the USA’s leading centre for liver transplants in Jehovah’s Witnesses, who refuse blood transfusions. In this light, its 1-year survival rate of 76% does not sound so bad when compared with the national average of 86%. Unfortunately, however, this is another incident in a series of transplant troubles in different US cities, and raises the question of whether change is needed to respond to public and professional fears. California has been particularly hard hit. The St Vincent Hospital in Los Angeles was recently found guilty of improperly using a liver. On Sept 7, 2003, the centre received an offer of a liver for transplantation into a specific candidate, who at that time, was unavailable for surgery. The hospital should have informed the United Network for
Money follows transplants
96
Organ Sharing (UNOS), the US organ procurement and allocation body, which would have then offered the liver to the next person on the waiting list. The hospital, however, accepted the liver and transplanted it into another patient 50 steps down the ladder. It then claimed the liver had been transplanted into the intended recipient (who later died of liver cancer). The motives remain unclear, but St Vincent received the UNOS’ most serious sanction—member not in good standing—and the liver-transplant programme closed. UNOS President Francis Delmonico hoped this would “...call attention to the failure of the institutional control which allowed these serious violations to occur and be covered up for an extended period. [The Board’s] action should send a very clear message to the transplant community, and to the general public, that our responsibilities, as stewards of the gifts of donated organs, cannot be compromised”. Trouble later surfaced at the University of California Irvine (UCI) Medical Centre, also in Los Angeles. The centre lost financial support for its liver-transplant programme via the Medicare and Medicaid system because of the low number of transplants done, low survival figures, and the centre’s frequent refusal of livers. Patients awaiting a liver are generally very ill; although controversial, the only hope for some people with hepatobiliary cancer is a transplant, for which they can illafford to wait long. It has also been alleged that some people might have died because of transplant delays. A UNOS investigation indicated “potentially false representations about the on-site coverage of certain key personnel.” The centre shut down its programme in November, 2005. The UNOS placed it on probation, its second most serious sanction, pending presentation of a corrective
plan. UCI Chancellor Michael Drake assured that the communication problems that caused the trouble will be fixed. Communication problems have not been the only US liver-transplant woes. In 2003, the University of Illinois settled out-of-court over allegations of fraudulent practice by the University Medical Center’s liver-transplant programme that led to the improper receipt of federal funds. Hospitals in the USA can receive Medicare and Medicaid money for liver transplants as long as they do a threshold number and meet threshold survival rates. Among other things, the hospital was accused to have falsely identified patients as Status 1 or Status 2A for the purpose of making them eligible for liver transplants before others, and even of falsely diagnosing patients to justify their placement on the liver-transplant eligibility list. The US$2 million settlement states that conduct was proper at all times, although Attorney General Lisa Madigan still went on record as saying: “A hospital’s desire to receive additional state and federal healthcare dollars should play no role in whether or not a patient is eligible for an organ transplant. As our settlement makes clear, facilities that do so will be severely punished. Not only did the defendant defraud the state and federal governments, it endangered individuals.” The USC’s present troubles, however, could be to blame over the preparation of statistics, the very same on which the Medicare and Medicaid funding system relies. One might expect these figures to be fully adjusted for the risks associated with each patient and organ received, making them comparable between all centres, but they are not. “Our risk adjustment procedures are good but not perfect”, says Michael Abecassis, Professor of http://oncology.thelancet.com Vol 8 February 2007
World Focus
Transplant Surgery at Northwestern University Feinberg School of Medicine (Chicago, IL, USA). “Many risks are not taken into account. For example, under present procedures, heart disease is not adjusted for. Neither are fatty livers, which are much less likely to be successful. So if you have an aggressive department that tries to save people with serious concomitant health problems, or which uses below-par organs rather than let its patients die, its survival figures may simply not tell the whole story.” This dilemma could tempt some centres to safeguard their statistical prestige by selecting only those patients most likely to survive. Those that try to save more marginal patients—perhaps like the USC— would necessarily get poorer grades. Furthermore, although federal law requires centres to give data to the Scientific Registry of Transplant Recipients (SRTR) at Ann Arbor, MI, USA, so that numbers can be crunched “…there is no funding for this activity”, explains Abecassis. “Hospital personal have to find time for this; so is the SRTR receiving the best quality data? For proper risk adjustment, we need proper funding for collecting comprehensive data that better reflect patient and organ conditions.” In response to the concerns over the USC, Steven Campanini (Senior Director of Corporate Communications, Tenet Healthcare Corporation, the hospital’s owner) told The Lancet Oncology, “[The] USC University Hospital’s abdominaltransplant programme faces greater challenges in patient mortality and morbidity than most similar programmes as [it] serves critically-ill patients whose condition may not be accurately reflected in published data. Because USCUH is a Medi-Cal (Medicaid in California) provider, because of the hospital’s geographic location in central Los Angeles, because it takes high-acuity patients from the Los Angeles County Health http://oncology.thelancet.com Vol 8 February 2007
System, and because it treats difficult cases that other transplant programmes turn away, its patients are often significantly sicker, higherrisk transplant candidates”. To address the issue, the hospital is improving their data management so that official figures will more accurately reflect the severity of their patients’ disease. “The most recent data, published Jan 11, 2007, on the SRTR website with data for the second half of 2006, shows considerable improvement, from an 11-point differential between our observed and expected survival rate to a six-point differential”, says Campanini. The USC’s alleged use of livers that no one else wants in last ditch attempts to save lives might also have affected its results, and certainly highlights an important ethical question: at what point do you give up trying? “Allocation of donor organs for transplantation is always a thorny issue because demand consistently outstrips supply”, explains Stephen Wigmore, Chairman of the Ethics Committee of the British Transplantation Society. “There is a point, however, where transplantation becomes futile. Deciding where this lies is the problem. Using marginal donor livers in extremely sick patients requires both very careful consideration and consent, as the consequences can be fatal.” The atmosphere of uncertainty that has been generated has led the American press to criticise the UNOS (which also develops and enforces policies governing organ procurement and allocation) for being slow to detect and react to deficiencies. UNOS’ Executive Director Walter Graham reassures, however, that “The organ allocation system in the USA is always changing, and we continue to learn and apply new lessons as we improve it. We also learn a great deal from experience, both good and bad. Over time we have changed policies and procedures that
Comprehensive data collection is important
do not work as expected. We’ve also strengthened many requirements to ensure quality outcomes for patients. On a few occasions we have adopted or changed a policy in response to a single, specific event. More commonly we develop and improve policies based on broad issues and trends that affect everyone in transplantation.” Tom Mones, CEO of the southern Californian donor network OneLegacy, told The Lancet Oncology that “UNOS has responded very vigorously this past year to identify program variation and seek explanation or practice change…the timing of this increased oversight effort is benefited by the implementation this spring of the UNOS DonorNet system that will enable real-time audit of organ offers and acceptance, rather than retrospective review.” Meanwhile, people in Los Angeles are aware that a third of their original six liver-transplant centres is under suspicion. Although the workload is being handled, the time might be ripe for the US transplantation community to find extra ways to reassure the public—regardless of the outcome of investigations into the USC’s figures—and to prevent unfair criticism of medical centres and professionals that, within ethical limits, try longer shots to save lives.
Adrian Burton 97