DC Medical Malpractice & Patient Safety Blog

The story begins in 2011, when a young Florida man died of brain inflammation from an unknown cause, and organs from his body were transplanted into four recipients. Fifteen months later, a Maryland man died of rabies, and now it turns out to have come from the transplanted kidney he got from the Florida donor. The question now is, could anything have been done to prevent this tragic outcome?

The Centers for Disease Control and Prevention just confirmed the link after DNA testing matched the disease in the two victims. The recipient received his transplant at Walter Reed National Medical Center in Bethesda, Maryland and just died at the Veterans Hospital in Washington, DC.

Organ donation officials stress that rabies is extremely rare -- you can count the number of human deaths in the United States each year on one hand. The other problem is that there is no simple test that can be done quickly enough to get an answer while the organ being transplanted is still viable.

But why would anyone take organs from a donor who died of a mysterious brain infection like encephalitis, as this donor did?

Even that question has no easy answers.

A takeout by Betsy McKay in the Wall Street Journal reports that symptoms of encephalitis can be hard to distinguish from other causes. This is according to Dr. Michael Green, chair of the disease transmission advisory committee for the United Network for Organ Sharing. Dr. Green, a professor of pediatrics and surgery at the University of Pittsburgh School of Medicine, told Ms. McKay:

"If you knew someone had encephalitis, the recommendation would be to be extremely cautious before using any organs. The problem is identifying everyone who has encephalitis."

The Journal report said that seven disease transmissions are reported for every 5,000 donations, and death is very rare.

The other three recipients of organs from the infected donor are being treated and are reportedly doing okay.

UNOS is urging closer scrutiny of potential organ donors for encephalitis, which it says has been underecognized in donors but is highly transmissible.

Why were more than 2,600 kidneys recovered from deceased donors and discarded last year while 4,720 people in the U.S. died awaiting kidney transplants?

According to a story last month in the New York Times, a significant number of discarded kidneys—maybe as many as half—could be transplanted if the system for allocating them was more efficient at matching the right organ to the right recipient.

Many industry observers say that outdated computer technology, over-regulation, over-reliance by doctors on inconclusive tests and laws against age discrimination all contribute to a system of organ rationing that puts fairness above saving lives.

The waiting list for deceased donor kidneys is more than 93,000 and has been for 25 years because of the federal policy of first come, first served. The Organ Procurement and Transplantation Network is managed under federal contract by the nonprofit United Network for Organ Sharing (UNOS). The system is considered simple and transparent, but many experts say it’s wasteful. For the first time in 25 years, UNOS is trying to revise it while satisfying multiple masters.

As The Times explains, the U.S. is divided into 58 donation districts. When a deceased donor kidney becomes available, the rules say it must be offered first to the compatible candidate within the district who has waited the longest. Other priorities are children, candidates with particularly difficult-to-match blood chemistry and to people particularly well matched to the donor. If there’s no local candidate, the electronic search expands.

But the kidney matching system ignores the projected life expectancy of the recipient and the urgency of the transplant. Those factors are considered by systems for allocating livers, hearts and lungs.

So kidneys that might function for decades can be transplanted into elderly patients with a short lifespan. When older, lower-quality kidneys become available, candidates atop the list and their doctors can decline them, and wait for better organs. Sometimes, those organs develop a reputation as unwanted when, in fact, they might suit some candidates perfectly well.

Time is always a factor in organ transplant. Even though recovered kidneys are placed on ice for evaluation, they begin to degrade. Surgeons want to transplant within 24 to 36 hours of harvest.

During that small window, organs are tested, recipient searches are conducted and the organs might undergo long drives or flights for transplant.

Last year, nearly 18 in 100 recovered kidneys were discarded. About one-fifth of them—nearly 500—were not transplanted because a recipient could not be found. Transplant surgeons speculate that as many as half of discarded kidneys could be transplanted.

Older donors are responsible for more than half the discarded kidneys. Age and health problems make them suspect. But last year, nearly 1,000 discarded kidneys came from donors younger than 60.

Transplant officials want to boost efforts to encourage people to register as donors, increase donor registration rates, remove financial and logistical obstacles and narrow extreme differences in wait-list time among states.

But the disconnect between need and the ability to meet it also involves doctors who decline an available kidney because they lack good diagnostic tools and succumb to pressure from regulators and insurers to maintain high transplant-success rates.

Recovered kidneys are analyzed for a variety of functions, and are discarded most often because hospitals reject the test results. But studies suggest that tests don’t always predict how long a transplanted organ might survive.

Federal scrutiny, transplant authorities say, further impairs transplant success rates. Federal oversight of Medicare requires that survival data for transplanted organs and recipients be made public. If a transplant program exceeds the acceptable number of failures by 50 percent twice in 30 months, it’s under probation. If it doesn’t improve, it can be decertified.

Medicare is the primary insurer for kidney transplants, but commercial insurers also use the survival ratings to make transplant contract decisions. The threat of government penalties and loss of business has made surgeons more cautious about the organs and patients they accepted, leading to more discards.

One transplant surgeon’s kidney program was cited by Medicare in 2008 after several unlikely failures. To avoid decertification, the surgeon cut the number of transplants by 40 percent and became far choosier about the organs and recipients he accepted.

The one-year transplant survival rate rose to 96 percent from 88 percent, but, as he told The Times, “Which serves America better? A program doing 100 kidneys and 88 percent of them are working, or a program that does 60 kidneys and 59 of them are working? It’s rationing health care under the guise of quality, and it’s a tragedy that we are throwing away perfectly good organs.”

An official with the Centers for Medicare and Medicaid Services agreed that individual hospitals had grown more cautious, but said there was no evidence that had led to more discards nationally because other hospitals picked up the slack. He refused to ignore that poor outcomes deserved scrutiny.

There’s that word: rationing. It’s in play whenever there is more organ demand than supply. But eight years after the UNOS asked its kidney transplantation committee to improve the system, there has been no change.

One proposal, The Times noted, called for rating each organ based on the donor’s age, height, weight and medical history. The top 20 percent of those kidneys would be allocated to recipients expected to live the longest. The rest would be matched to give priority to candidates within 15 years of the donor’s age.

The idea was rejected because the feds warned that discrimination laws would prohibit the use of age to determine who gets a transplant.

In Europe, which has no such age barrier, the number of older kidney donors has more than tripled since 1999, and discard rates are less than one-third of that in the U.S. There is no significant difference in survival rates for older patients in Europe and the U.S.

Last month, the kidney committee proposed that the top 20 percent of kidneys still would be matched to the recipients expected to survive the longest, but the remaining 80 percent would be allocated primarily by how long someone has been on the waiting list.

In August, a group of researchers proposed a different allocation in the American Journal of Transplantation. It would give individuals in different age bands an equal chance to get an organ in a given year. But it would reserve the best kidneys to the youngest recipients.

If you have an opinion about the system that delivers organs to people who need them, you may participate in the UNOS public comment period. Make your feelings known here.

Cancer of the trachea--or windpipe--is extremely rare, representing only 1% of all cancers. One patient, who had been diagnosed in 2008, had undergone chemotherapy, radiation and surgery, but his tumors were threatening to block his windpipe when technology came to the rescue last month.

The first-ever synthetic windpipe was transplanted on June 9, and last week the patient left the hospital. Created in a lab without using donor tissue, the new trachea was made only of synthetic material and the patient's own stem cells. The process took fewer than two weeks, versus waiting months for an organ donor, CNN reported.

In addition to bringing this patient back from the brink, the landmark procedure means he won't require immune-suppressing drugs, which have significant side effects and can render subjects vulnerable to infection.

After transplanting a kidney into the wrong patient, the University of Southern California University Hospital has shut down its kidney transplant program pending an investigation.

While this may be a unique event at USC, mixups in transplants unfortunately pop up around the country on a regular basis, because of the lack of rigorous safeguards to check and double-check to avoid tragedies. In this case, luck prevailed.

The patient escaped harm apparently because the mistake involved a kidney that happened to have universal blood type “O,” making it a close enough match to avoid harming its unintended recipient.

Kidney transplants are often performed on short notice and outside of normal hours, and the number of people involved -- surgeons, anesthesiologists, nurses, transporters and patients (donor and recipient) -- make them a challenge to coordinate.

Although safeguards are in place to prevent such occurrences, there is never a direct one-on-one relationship between any two individuals involved, which means miscommunications remain possible. Ultimately, the surgeon is responsible for making sure that the patient who's now in the operating room is indeed a patient on this list and is the patient that they wanted to be calling in from this list.

After the hospital realized its mistake, the organ procurement organization performed a cross-match test using blood samples they already had to determine the transplant's compatibility. The hospital then began looking for a suitable recipient for the other kidney, which was later transplanted at a local hospital. The intended recipient of the misplaced kidney received another organ a few days later.

The mixup reportedly occurred after two kidneys from separate donors arrived at the transplant center simultaneously on Saturday, Jan. 29. According to an official with the One Legacy kidney transplant program, the kidney’s packaging and documentation was accurate, suggesting the mistake was the result of human error.

In a statement, the hospital confirmed that it had temporarily and voluntarily halted transplants and said no patients were harmed as a result of the mistake. But it did not provide any details as to the nature of the error and declined to answer questions. The state Department of Public Health is investigating the incident.

“The hospital inactivated the program while clinical protocols are assessed and additional safeguards to the kidney transplant program are developed," the hospital said in statement. The hospital also notified United Network for Organ Sharing (UNOS), a federal program that organizes the distribution of organs for transplant, that the kidney program had been halted. As of Feb. 11, USC had 508 patients waiting for kidneys, including 313 men and 195 women, according to UNOS.

Source: ABC News

The American Red Cross collects and gives out about 43 percent of the blood given to medical patients in this country, which is why it may be unnerving to learn that the organization has not been following federal quality-control standards.

From the article:

The F.D.A. found shortcomings in the way the Red Cross screens donors for possible exposure to infectious diseases, failures to swab arms properly before inserting needles, failures to test for syphilis and failures to discard potentially risky blood, among other deficiencies.

There is no evidence of actual harm resulting from the Red Cross's failure to abide by federal standards. However, the reason for this lack of evidence is partly because Red Cross has failed to investigate potential harm. If nobody looks for evidence of harm, then naturally it will not be found.

Again, from the article (which should be read in its entirety):

All told, the Red Cross failed to investigate more than 130 cases of suspected post-transfusion hepatitis between 2000 and mid-2002.

Often the problem is bureaucratic. Just this week, the F.D.A. chided the Red Cross for distributing more than 200 blood products that the organization itself had identified as problematic but failed to intercept before distribution. Other times the failure is deliberate. A blood facility in Philadelphia, with approval from a senior national executive, decided not to recall some 600 units of blood that had been collected using improper methods.

What can a patient do to limit the possibility of receiving improper blood? Very little. In an emergency situation, there may not be any time to inquire closely into the origins of a blood donation. However, the Red Cross is taking steps to ameliorate its problems by re-vamping its blood donation services and creating a centralized database to track the blood.