Prompted by serious lapses at three California organ transplant programs, federal inspectors have documented broad failings by the agencies that oversee the nation's transplant system and raised doubts about the pace of promised improvements.
In a soon-to-be-released report, the Government Accountability Office confirms findings by The Times in 2005 and 2006 that transplant regulators failed to spot problem programs and didn't step in quickly to protect patients.
Sen. Charles Grassley (R-Iowa), who ordered the investigation, said he was pleased with proposed reforms but cautioned that they could stall without continued scrutiny. "I've found too often that changes don't come very fast, sometimes don't come at all," said Grassley, ranking member of the Senate Finance Committee.
With organs an increasingly scarce commodity, the stakes are high. Nearly 100,000 people are waiting for potentially life-saving transplants, and more than 6,000 die each year before they get one. Subpar programs put patients, who often have scant knowledge of how the system works, at increased risk of harm or death.
The scandals in California in 2005 and 2006 show the need for increased oversight of transplantation, the GAO found.
In September 2005, St. Vincent Medical Center in Los Angeles halted liver transplants after conceding that its doctors had improperly arranged for a transplant to a Saudi national using an organ intended for a higher-priority patient. Dozens of people whose conditions were considered more dire were bypassed on the regional waiting list.
UCI Medical Center in Orange closed its liver transplant program in November 2005, the same day The Times reported that it did not have a full-time transplant surgeon and that it had been turning down a disproportionately high number of organs as patients died on its waiting list.
Then in May 2006, Kaiser Permanente closed its kidney transplant program in San Francisco after a series of stories in The Times found that it had endangered hundreds of patients, in some cases delaying critical surgeries or losing track of patients altogether. Kaiser later agreed to pay a $2-million fine to the California Department of Managed Health Care and contribute $3 million to promote organ donation in the state.
The Times also found that four dozen federally funded transplant programs, about 1 in 5, failed to meet the government's minimum standards for patient survival or performed too few operations to ensure competency.
The GAO's report added new details about deficiencies in oversight. The U.S. Centers for Medicare and Medicaid Services, for instance, went a decade without inspecting more than 30 kidney transplant programs. Some programs had gone more than 20 years without a review, the report found.
Medicare funds most of the nation's transplant centers.
The GAO inspectors also determined that the United Network for Organ Sharing, which oversees the quality of the national system, did not have the means to identify programs that were understaffed or those that were turning down donated organs at "markedly" high rates.
Rather than take punitive action against programs with high patient death rates, the United Network preferred to work with them confidentially, sometimes for years. Of the 72 programs identified as having low survival rates in 2005, about 40% still were not meeting basic survival standards by August 2007, the report said.
Since the California cases came to light, the Medicare agency put in place new rules for all transplant programs and pledged to perform more frequent inspections, the report said. The United Network and the federal agency that oversees it are developing a method to flag programs whose patients wait too long for transplants.
All of the regulators say they are planning to share information about poorly performing programs, something that had not taken place in the past.
But the GAO said the changes still were incomplete, so "their full effect remains to be seen." The Medicare agency has not developed a process for ensuring that programs continue to meet minimum standards. And, more than two years after the scandals, transplant regulators from the different agencies have yet to determine exactly how they will share information, the GAO inspectors said.
In an interview, Medicare officials said they were acting with "unprecedented" speed to implement new rules, train inspectors and begin reviews of transplant programs.
"With the amount of national attention that this has received, we've gotten everyone's attention," said Thomas Hamilton, director of Medicare's survey and certification group.