Reforms sought in U.S. lab oversight

Organizations, experts examine medical issue after problems in Md.

September 06, 2004|By Julie Bell | Julie Bell,SUN STAFF

The nation's system for ensuring accurate medical tests is coming under intense scrutiny in the wake of severe problems at two Maryland laboratories, with public and private officials investigating possible reforms.

Thousands of patients at Maryland General Hospital and Reference Pathology Services of Maryland in Rosedale were offered retests for HIV and other diseases after inspectors found breakdowns in quality at their labs.

Critics say that sweeping reforms instituted in 1992 rely too heavily on industry organizations to handle inspections, allow cozy relationships between lab surveyors and those they inspect, and place too much emphasis on documents while ignoring the workers who carry out the tests.

Nationally, a number of organizations and individuals are scrutinizing the issue, including:

The federal Centers for Medicare & Medicaid Services, which plans a meeting of regulators, private inspection agencies and others to discuss it, according to Thomas Hamilton, who oversees federal government certification of labs.

Private inspection agencies, including one of the nation's largest, the College of American Pathologists, which oversaw the Maryland General and Reference Pathology labs. The Northfield, Ill., agency plans inspection reforms, including increased focus on interviews with the bench-level lab workers that critics say it has ignored.

Lab experts, from University of Wisconsin professor James O. Westgard, who is beginning a national review of test quality, to Kathleen L. Hansen, lab operations director at Fairview-University Medical Center in Minneapolis, where a recent employee newsletter detailed Maryland General's problems.

Government regulators and politicians, including Rep. Elijah E. Cummings, a Baltimore Democrat who is seeking an investigation by the federal Government Accountability Office and working on legislation to protect laboratory whistleblowers; state Sen. Paula C. Hollinger, who plans to hold hearings on the issue Nov. 9 before the health committee she heads; and Maryland Health Secretary Nelson J. Sabatini, who is preparing a state reform bill.

`A critical moment'

"This is a critical moment," said Cummings. "If we don't at least answer the question of whether it is the tip of the iceberg, I think it can only get worse."

The scrutiny comes as the lab industry wrestles with a shortage of qualified workers and the proliferation of tests made possible by technological advances. Some professionals worry that the U.S. Food and Drug Administration classifies many of the new tests as so simple to use that labs that conduct only those tests are exempt from regular federal inspections.

More than 100,000 of the nation's 185,000 laboratories handle only such "waived" tests.

Others say the concern about labs is overblown, that their regulation is adequate and testing quality has improved greatly.

"We have the best testing in the world," said Dr. Paul Fischer of Augusta, Ga., a family doctor who wrote a book on office laboratories and is a consultant for the American Academy of Family Physicians. "The technology for testing changed so much in the last 10 years; the quality of testing improved primarily because of that."

One major private inspector, the Joint Commission on Accreditation of Healthcare Organizations, had begun instituting changes before problems surfaced at the Maryland General and Reference Pathology labs. Beginning in January, the joint commission instituted a system that focuses less on paper and more on lab worker interviews as inspectors trace the path of randomly chosen specimens.

The accreditation organization, accused over the years in government reports of being too collegial and failing to detect problems, plans to use only unannounced inspections beginning in 2006. Still, the commission rejects the notion that it can't have a respectful, educational relationship with those it inspects.

"There is no relationship between collegiality and accuracy," said Dr. Russell Massaro, executive vice president for accreditation operations for the commission, whose membership includes three physicians organizations and a hospital trade group.

But Cummings and others remain concerned. The GAO report he is requesting would ask whether using the accrediting agencies is akin to the fox guarding the henhouse. Cummings insists that nothing is off the table, including the possible end to a process in which private organizations act as a government arm.

Last week, he and Rep. C.A. Dutch Ruppersberger, a Baltimore County Democrat, wrote asking the Centers for Medicare & Medicaid to explain how it is addressing the lab problems, including a failure of state, federal and private agencies to share information when notified that patients might be at risk.

Problems at Md. labs

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