WASHINGTON -- Despite efforts to improve oversight of medical laboratories, varying inspection standards and methods make it nearly impossible to gauge the extent of serious problems, according to a report released yesterday by the investigative arm of Congress.
Oversight is "not adequate" to ensure that these labs are meeting federal requirements, the report by the Government Accountability Office says. In addition, the report says, fears among lab employees about retaliation and a lack of understanding of how to file a complaint suggest that "some quality problems are not being reported."
Rep. Elijah E. Cummings, who joined other lawmakers in requesting the report after major problems arose in the lab at Maryland General Hospital in Baltimore, called the GAO's findings "less than encouraging." The Baltimore Democrat said he would continue to push for legislation to provide whistleblower protection for workers and tighten other standards, even as the inspection agencies try to shore up the system.
"We've got a lot to do here," Cummings said, "but one thing I do feel good about is we are seeing movement in the right direction."
The report makes a number of recommendations to the Centers for Medicare and Medicaid Services, the federal agency in charge of ensuring that labs are properly inspected, and to the state agencies and industry associations that conduct many of the lab inspections. The suggestions include strengthening whistle-blower protections and switching to a system in which required quality checks are done with little or no notice.
At a congressional hearing yesterday, GAO investigator Leslie G. Aronovitz said that many of the recommendations have been embraced by CMS and some of the industry groups, such as the College of American Pathologists. In some cases, some of the changes have been put in place, she said, adding that much more needs to be done. "They all do seem to be very anxious to move forward," Aronovitz said. "But that's just the first step."
Cummings was among those who asked the GAO to look at the issue after revelations, which began in March 2004, about problems at Maryland General. The hospital's lab sent dubious test results for HIV and hepatitis to more than 450 patients, and complaints were ignored until a former worker notified the state health department.
The College of American Pathologists, or CAP, had given the hospital its highest rating less than a year earlier.
After a broad outcry and a brief revocation of accreditation for parts of the lab, Maryland General's lab underwent major changes and was later found to be in compliance by federal regulators.
But the impact of the scandal has continued to reverberate around the nation. For example, CAP plans to switch to a system of unannounced inspections of almost all of the labs it examines by early next month. That group and others have stepped up training and added requirements that labs educate their workers on how to file complaints if they see problems.
Thomas Hamilton, a top CMS official, compared the effects of the Maryland General problem to the impact of Hurricane Katrina on plans for disaster preparation.
"I think only Rip Van Winkle could have slept through the wake-up call caused by Maryland General," he said.
Aronovitz emphasized, however, that the different evaluation tools and standards used by the state and private inspectors make it difficult for CMS to analyze data. When the agency revised its inspection requirements in 2004, the data tangle got worse, she said, because the new standards aren't easily compared to the old ones. "Right now, it really leaves CMS in a position where it cannot really look at lab quality," Aronovitz said.
The state agencies and private groups that monitor labs sometimes emphasize education over enforcement, the report says, resulting in few sanctions even for repeat offenders. According to the report, between 1998 and 2004 sanctions were proposed for 9,000 labs, but only 501 were sanctioned. In addition, only 30 of the 274 labs identified as repeat offenders were punished.
CMS is allowing labs to skirt the laws, the report says, by requiring "proficiency testing" only three times a year; the original statute requires that such tests happen quarterly.
Cummings said that while he remains concerned about the standards at laboratories nationwide, he has been impressed with the way Maryland General has recovered from the disastrous events of two years ago. "I think Maryland General has become, probably, the model for the country," he said.
To read the full report by the Government Accountability Office on oversight problems at medical laboratories, go to www.baltimoresun.com/labreport.