Iceberg revealed

December 10, 2004

FEDERAL and state officials who were shocked last spring to discover that Maryland General Hospital's lab had sent hundreds of patients potentially erroneous results from tests for HIV and hepatitis feared they had found just the tip of the iceberg of inspection oversights.

Recent findings of overlooked lab failings at Good Samaritan Hospital and Union Memorial suggest their concern was justified.

While most involved seem to be taking good-faith steps to correct flaws in the process for ensuring laboratory safety and accuracy, there is a clear need for tightened government standards.

The General Assembly should move swiftly after it reconvenes next month to approve legislation crafted by state Sen. Paula C. Hollinger that would mandate surprise inspections, sharing of findings between oversight agencies and protection for whistle-blowing staff members who report violations.

Maryland could thus serve as a model to help prod Congress into adopting similar legislation sponsored by Rep. Elijah E. Cummings that would build the reforms into federal inspection standards.

Those with the most to gain are obviously the patients. But bolstering confidence in regulatory safeguards would also enhance the reputations of hospitals around the nation, which all get tarnished when problems are found at any of them.

Officials at Good Samaritan and Union Memorial have already moved to correct deficiencies found by state regulators this fall. At Good Samaritan, the problem was a failure to follow up on labeling mistakes that put patients at risk of errors such as receiving the wrong blood type. Union Memorial's blood bank was found to be inadequately protecting the safety of transfusion patients.

What was particularly alarming is that the state inspectors discovered these errors after they were missed by the private inspection agency that had accredited both hospitals. That's also what happened in the case of faulty test results sent out by Maryland General, which might never have been discovered were it not for a whistle-blower report by a lab employee.

With only five state inspectors to oversee the 171 medical labs in Maryland, though, doing without private contractors is not an option. Mr. Cummings and Ms. Hollinger are focusing on trying to ensure that the contractors do a better job and that the federal and state agencies that oversee them have quick and ready access to the information they find.

The College of American Pathologists, which was the private accrediting agency in the case of all three Maryland hospitals, has promised lawmakers it will take corrective action on its own. But nothing would have changed without the pressure brought to bear after the Maryland General fiasco.

Legislation is necessary for that moment when the pressure inevitably lets up.

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