In the wake of serious problems at two Maryland medical labs, the accrediting agency responsible for their oversight said yesterday that it will tighten rules for inspection and approval of thousands of laboratories around the world.
The College of American Pathologists announced that it will spend $9 million to improve its inspection system for 6,000 labs. It will also routinely conduct unannounced inspections and set up protections for whistleblowers.
More than a year ago, inspectors found problems with handling of lab tests for HIV and other diseases at Maryland General Hospital and Reference Pathology Services in Rosedale.
The problems at Maryland General, highlighted in a series of articles in The Sun, involved the distribution of questionable test results, safety violations at the lab and general management turmoil. A subsequent article this summer reported that many of those problems had been resolved.
Both facilities were inspected and accredited at the time the problems were occurring, prompting critics to question CAP's effectiveness in protecting the public health. CAP's approval automatically qualified the labs for state licensing and federal reimbursements.
Announcing changes that will occur over the next two years, CAP officials said a review of the Maryland General situation convinced them that there were problems to be addressed.
"MGH was an alert for us. We recognized that something happened there that we didn't want to happen," said Dr. Bruce Williams, chairman of CAP's commission on lab accreditation.
U.S. Rep. Elijah E. Cummings, the Baltimore Democrat who held hearings on the issue and introduced a bill in Congress to reform the inspection system, said he was pleased by CAP's actions.
"These acts, on the part of CAP, go a long way toward what we're trying to achieve in the legislation," Cummings said. "This is something that affects every single American."
Cummings said that if a pending Government Accountability Office report shows a need for additional steps to improve lab monitoring, he will continue to push for them. The GAO report is due out early next year.
Maryland regulators also applauded CAP's announcement.
"This sounds like really promising information, and CAP, it sounds like, is really taking some positive steps," said Wendy A. Kronmiller, acting director of the Office of Health Care Quality.
She said state regulators routinely conduct unannounced inspections on the labs they oversee. CAP routinely announced its inspections, giving lab personnel time to prepare.
Accurate test results are critical to all aspects of health care, experts say. Doctors rely on them to determine whether patients have illnesses, including the human immunodeficiency virus, hepatitis and cancer.
Medical labs in Maryland may choose to be inspected by any of several approved accrediting agencies, including CAP, or by the federal government. If they opt for a federal inspection, state employees conduct the inspections on the government's behalf.
Of about 2,000 labs in Maryland, about 400 - mostly smaller operations - submit to a direct state review rather than pay costly accrediting fees.
CAP, based in Northfield, Ill., accredits about 50 medical labs in the state and 6,000 labs worldwide.
Regulators found that in spring 2004, Maryland General sent patients the results of hundreds of HIV and hepatitis tests despite indications that the results might be inaccurate. The hospital later said that retesting showed the original results were generally accurate.
In the case of Reference Pathology Services, regulators reported that workers rinsed and reused filters used to capture potentially cancerous cells from Pap smear slides and failed to make regular quality-control checks of equipment. Reference Pathology, facing disciplinary action by state regulators, agreed to close last year.
Beginning next year, CAP's Williams said, all reinspections of labs will be unannounced, except for facilities that conduct only specialized testing, such as forensic drug work. He said that inspectors will place more emphasis on interviewing lab managers and technicians.
Inspectors also will be required to complete additional training within two years, including sessions on how to elicit more detailed information from lab staffers.
"The training will include better techniques for asking questions," Williams said.
CAP also will spend $9 million over the next two years on an updated information system to ensure that inspectors have the best information on the labs they inspect. That includes details of any complaints filed against the labs, as well as the results of routine tests of lab equipment between inspection cycles.
"In the past, sometimes that information has been put on a shelf," Williams said.
In addition, signs will be posted in every lab, with a toll-free phone number that encourages lab workers to report any safety or testing problems. The lab whistleblowers will be promised anonymity - and if supervisors learn their identities, the lab may lose its accreditation if supervisors retaliate against them, Williams said.
He said that a lack of information for potential whistleblowers was a major problem in the case of Maryland General. A worker there alerted the state health department to problems at the hospital, but that information was never relayed to CAP inspectors, he said.
"All they would've had to do was pick up the phone and call us, and we would've responded," he said.