Oversight of labs at hospitals dissected

WASHINGTON — WASHINGTON - Maryland General Hospital whistleblower Kristin Turner testified before a congressional panel yesterday that supervisors in the hospital's laboratory went into near panic preparing for scheduled visits by private surveyors evaluating the lab.

"We knew weeks in advance they were coming," she told the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources, adding that supervisors ordered employees to tidy up their work areas in preparation for surveyors from the College of American Pathologists (CAP). "It was almost chaos trying to get ready."


Turner testified during the second of two congressional hearings on Maryland General's problems, which led the lab to give more than 450 people HIV and hepatitis C test results despite indications they might be invalid. The problems, which CAP failed to discover during its April 2003 routine inspection, were uncovered by the state after Turner filed a complaint later in the year.

Subsequently, the state's Medicaid fraud unit and the Office of the Inspector General of the federal Health and Human Services Department began investigations.


CAP's failure to discover the problems and the failure of state inspectors to do the same after getting a 2002 complaint from a different laboratory worker, were in the spotlight at yesterday's hearing. At issue in part was whether the nation's system of delegating many such inspections to private organizations such as CAP leads to a lenient, collegial system in which hospital workers have ample time to prepare for inspections and hide problems.

Turner's concerns, echoed by subcommittee member Elijah E. Cummings, a Baltimore Democrat, also were highlighted in a Congressional Research Service report released yesterday. Subcommittee member C.A. Dutch Ruppersberger, a Baltimore County Democrat, requested the report on the nation's laboratory inspection and accreditation process after the first hearing May 18.

The report said that "most inspectors get only a cursory view of how the process of testing works, with the potential for specific test-related problems to fall through the cracks."

The report also said that inspections most often are announced in advance and allow laboratories time to fix problems "for which they may have otherwise received a citation."

As a representative of the U.S. attorney's office listened, Turner also outlined how a laboratory supervisor had ordered her to override lab results that seemed to pose problems, rather than rerun the tests.

Hospital officials have retested many of the patients and say that the initial lab results turned out to be accurate in virtually all cases. Yesterday, Edmond Notebaert, president of Maryland General's parent institution, the University of Maryland Medical System, said rigorous new oversight and reporting procedures have been put into place at the hospital and throughout the system.

The bulk of the hearing centered on CAP, its effectiveness and its relationship to the state, the federal Centers for Medicare & Medicaid Services and the Joint Commission on the Accreditation of Healthcare Organizations, all of which have responsibility for overseeing hospitals and their labs.

Dr. Mary E. Kass, CAP's president, defended the organization, saying that "any claim that CAP accreditation is not rigorous or objective is not supported by the facts."


Nonetheless, she said, the Maryland General case has prompted CAP to look at changing its procedures nationally.