May 19, 2004
On Tuesday, the subcommittee of the House Government Reform Committee heard testimony indicating that persistent equipment problems, the lack of communication between lab inspection agencies, and whistleblower complaints that were ignored were to blame for suspect HIV and hepatitis test results issued by Maryland General Hospital. The hospital's lab sent nearly 460 questionable results to patients. Those testifying included the maker of the equipment used in the tests, the head of an accrediting agency that gave the lab a top rating even as the bad results were being produced, and a former hospital employee who alerted the state to the problems.
Maryland Health Secretary Nelson Sabatini said the four different organizations responsible for lab oversight rarely share information and have different approaches to inspection and enforcement. In Maryland General's case, all "dropped the ball," Sabatini said.
According to Rep. Elijah Cummings (D-Md.), who organized the session, the consensus is that changes may be needed in how hospital labs are monitored to ensure more information is shared among agencies. In addition, the testing machines -- about 170 of which are in use nationwide -- need more scrutiny, he said. "The Maryland General Hospital situation is just the tip of the iceberg that has national implications," Cummings said.
The College of American Pathologists (CAP), which reaccredited the lab in April 2003 without detecting the problems, has suspended its accreditation of two lab divisions. Sabatini said organizations like CAP typically perform "collegial" and "leisurely" inspections that often miss problems. But Ronald Lepoff, chair of CAP's lab accreditation commission, said its inspectors did not find the problems because lab personnel concealed them. CAP did not get copies of whistleblower complaints until one day before the hearing, he said.
More than 2,000 patients were retested as a result of the problems, and 99.6 percent of the HIV tests were correct, said Edmond Notebaert, president of the university medical system. Maryland General's president and two top lab officials were fired because of the problems.