ST. LOUIS — Addressing long-held concerns about whether organ donors have adequate protections, the country’s transplant regulators acted late Monday to require that hospitals thoroughly inform living kidney donors of the risks they face, fully evaluate their medical and psychological suitability, and then track their health for two years after donation.
Enactment of the policies by the United Network for Organ Sharing, which manages the transplant system under a federal contract, followed six years of halting development and debate.
Meeting at a St. Louis hotel, the group’s board voted to establish uniform minimum standards for a field long regarded as a medical and ethical Wild West. The organ network, whose initial purpose was to oversee donation from people who had just died, has struggled at times to keep pace with rapid developments in donations from the living.
“There is no question that this is a major development in living donor protection,” said Dr. Christie P. Thomas, a nephrologist at the University of Iowa and the chairman of the network’s living donor committee.
Yet some donor advocates complained that the measures did not go far enough, and argued that the organ network, in its mission to encourage transplants, has a conflict of interest when it comes to safeguarding donors.
Three years ago, the network issued some of the same policies as voluntary guidelines, only to have the Department of Health and Human Services insist they be made mandatory.
Although long-term data on the subject is scarce, few living kidney donors are thought to suffer lasting physical or psychological effects. Kidney donations, known as nephrectomies, are typically done laparoscopically these days through a series of small incisions. The typical patient may spend only a few nights in a hospital and feel largely recovered after several months.
Kidneys are by far the most transplanted organs, and there have been nearly as many living donors as deceased ones over the last decade. What data is available suggests that those with one kidney typically live as long as those with two, and that the risk of a donor dying during the procedure is roughly 3 in 10,000.
But kidney transplants, like all surgery, can sometimes end in catastrophe.
In May at Montefiore Medical Center in the Bronx, a 41-year-old mother of three died when her aorta was accidentally cut during surgery to donate a kidney to her brother. In other recent isolated cases, patients have received donor kidneys infected with undetected H.I.V. or hepatitis C.
Less clear are any longer-term effects on donors. Research conducted by the United Network for Organ Sharing shows that of roughly 70,000 people who donated kidneys between late 1999 and early 2011, 27 died within two years of medical causes that may — or may not — have been related to donation. For a small number of donors, their remaining kidney failed, and they required dialysis or a transplant.
The number of living donors — 5,770 in 2011 — has dropped 10 percent over the last two years, possibly because the struggling economy has made it difficult for prospective donors to take time off from work to recuperate. With the national kidney waiting list now stretching past 94,000 people, and thousands on the list dying each year, transplant officials have said they must improve confidence in the system so more people will donate.
The average age of donors has been rising, posing additional medical risks. And new ethical questions have been raised by the emergence of paired kidney exchanges and transplant chains started by good Samaritans who give an organ to a stranger.
Brad Kornfeld, who donated a kidney to his father in 2004, told the board that it had been impossible to find good information about what to expect, leaving him to search for answers on unreliable Internet chat rooms. He said he had almost backed out.
“If information is power,” said Mr. Kornfeld, a Coloradan who serves on the living donor committee, “the lack of information is crippling.”
Under the policies approved this week, the organ network will require hospitals to collect medical data, including laboratory test results, on most living donors to study lasting effects. Results must be reported at six months, one year and two years.
Similar regulations have been in place since 2000, but they did not require blood and urine testing, and hospitals were allowed to report donors who could not be found as simply lost.
That happened often. In recent years, hospitals have submitted basic clinical information — like whether donors were alive or dead — for only 65 percent of donors and lab data for fewer than 40 percent, according to the organ network. Although the network holds the authority, no hospital has ever been seriously sanctioned for noncompliance.
“It’s time we put some teeth into our policy,” said Jill McMaster, a board member from Tennessee.
By 2015, transplant programs will have to report thorough clinical information on at least 80 percent of donors and lab results on at least 70 percent. The requirements phase in at lower levels for the next two years.
Dr. Stuart M. Flechner of the Cleveland Clinic, the chairman of a coalition of medical societies that made recommendations to the organ network, said 9 of 10 hospitals would currently not meet the new requirement.
Donna Luebke, a kidney donor from Ohio who once served on the organ network’s board, said the new standards would matter only if enforcement were more rigorous. She noted that the organization was dominated by transplant doctors: “UNOS is nothing but the foxes watching the henhouse,” she said.
Another of the new regulations prescribes in detail the medical and psychological screenings that hospitals must conduct for potential donors. It requires automatic exclusion if the potential donor has diabetes, uncontrolled hypertension or H.I.V., among other conditions.
The new policies also require that hospitals appoint an independent advocate to counsel and represent donors, and that donors receive detailed information in advance about medical, psychological and financial risks.
Kidney Donors Given Mandatory Safeguards
This article
Kidney Donors Given Mandatory Safeguards
can be opened in url
http://variationsnews.blogspot.com/2012/11/kidney-donors-given-mandatory-safeguards.html
Kidney Donors Given Mandatory Safeguards
