Stricter oversight of labs sought

Maryland official calls regulatory system 'broken'

Increased inspections planned

August 28, 2004|By Julie Bell and Dennis O'Brien | Julie Bell and Dennis O'Brien,SUN STAFF

The state's top health official and a key legislator said yesterday that they want to revamp the system for regulating medical laboratories in the wake of serious testing breakdowns affecting thousands of patients in the Baltimore area.

"The evidence is the regulatory system is broken," said state Health Secretary Nelson J. Sabatini.

State Sen. Paula C. Hollinger, chairwoman of a Senate health panel, said the system is "falling apart."

"We have to come up with more stringent rules for the state of Maryland, and that's exactly what we're going to do," said Hollinger, a Baltimore County Democrat, who has scheduled a hearing for Nov. 9.

Hollinger said the problems at a Rosedale lab and at Maryland General Hospital - which cast doubt on the accuracy of test results for HIV, cancer and other ailments - might be "the tip of the iceberg."

State inspectors found such severe problems in the spring at Reference Pathology Services of Maryland, the Rosedale lab, that they took action to close it by Sept. 5, The Sun reported yesterday. The lab, which serves many physicians' offices in North Baltimore and the northern part of the state, passed inspection by an independent accrediting agency last year.

The agency, the College of American Pathologists, accredited Maryland General Hospital's lab while it was sending to more than 400 people HIV and hepatitis test results that could have been inaccurate, state regulators say.

3,000 offered retests

In both cases it took whistleblowers to bring problems to the attention of the state and CAP. Rosedale's lab was so poorly run that 3,000 patients are being offered retesting to check the accuracy of tests for sexually transmitted diseases.

Maryland General, where problems were made public in the spring, says its retesting of patients has shown that its original results were relatively accurate.

Sabatini said he is considering legislative options that include having state inspectors accompany private evaluators and posting results on the Internet.

He also said the state plans to increase its inspections of the 150 laboratories accredited by CAP and those inspected by another private agency.

"Using an accreditation process as a substitute for regulatory oversight is flawed," Sabatini said.

Sabatini said another option is to do away with the current system, in which state regulators presume that any accredited laboratory complies with licensing requirements. The state conducts some "validation" inspections to double-check the accrediting agencies' work.

Few state inspectors

The state would have to vastly expand its inspection teams to handle the load. It has six inspectors to oversee Maryland's 2,000 licensed laboratories.

Critics long have complained that private inspection organizations such as CAP have cozy relationships with the laboratories and hospitals they accredit. They also say the states and the federal government don't have enough inspectors to double-check the organizations' work.

Th CAP says that it annually inspects and accredits more than 6,000 labs worldwide, using standards in the United States that exceed those required by the federal government and that problems are rare.

Hospital accreditation also is under fire nationally. Recently legislation was introduced in Congress to give the government more direct oversight of the organization that accredits the majority of the nation's hospitals, a stamp of approval that makes them eligible for Medicare.

Rep. C.A. Dutch Ruppersberger, a Baltimore County Democrat, and Rep. Elijah E. Cummings, a Baltimore Democrat, said yesterday that they plan to write a letter to federal regulators next week urging them to bring together the lab accrediting agencies and state regulators to resolve problems.

Ensuring accurate test results is crucial to all aspects of health care. Doctors rely on them to determine whether patients have illnesses including the human immunodeficiency virus, hepatitis and cancer.

The scandals in recent months at the two unaffiliated laboratories and the University of Pittsburgh Medical Center - all accredited by the College of American Pathologists - have reignited debate over how to monitor the labs.

CAP has maintained that the problems are an aberration and that what happened at Reference Pathology Services of Maryland shows that the system works, not that it's flawed.

The college received a whistleblower complaint, immediately informed the state and responded by inspecting the lab and revoking its accreditation, said Dr. Ronald Lepoff, chairman of the CAP's commission on laboratory accreditation.

'Limited resources'

Reference Pathology's owner declined to comment through an office spokeswoman yesterday. In a statement, Timothy Frank said he was never formally ordered to close by the state but agreed to close Sept. 5 because of the lab's "limited resources."

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