Medical Labs Get Scrutiny Nationwide After Mistakes in Maryland

Flawed testing for HIV and other diseases in the labs at Maryland General Hospital and Rosedale-based Reference Pathology Services of Maryland have prompted increased scrutiny of the system that monitors medical labs nationwide. Reforms instituted in 1992, critics say, rely too heavily on industry organizations for inspections, thus promoting cozy relationships between labs and inspectors. Further, they contend the reforms place too much emphasis on documents while ignoring the workers who perform the tests.

Thomas Hamilton, who oversees federal government certification of labs, said the federal Centers for Medicare and Medicaid Services, private inspection agencies and others are discussing the matter. Additional responses to the problems include:

• The Northfield, Ill.-based College of American Pathologists, which oversaw the two Maryland labs, plans inspection reforms, including an increased focus on interviews with lab workers.
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• University of Wisconsin professor James O. Westgard is launching a national review of test quality.

• Rep. Elijah E. Cummings (D-Md.) is seeking an investigation by the federal Government Accountability Office. He is also drafting legislation to protect lab whistleblowers.

• Maryland state Sen. Paula C. Hollinger plans hearings on the matter on Nov. 9 before the health committee she chairs.

• Maryland Health Secretary Nelson J. Sabatini is preparing a state reform bill.

• The Joint Commission on Accreditation of Healthcare Organizations had begun instituting reforms prior to the revelation of problems at the Maryland labs. Its new system, launched in January, focuses less on paperwork and more on worker interviews as inspectors chart the path of randomly chosen specimens.

Back to other news for September 8, 2004