The president and chief executive officer of Maryland General Hospital has resigned as a result of widespread laboratory problems that undermined patient safety and went unaddressed until a former employee alerted the state.
Hospital and University of Maryland Medical System officials announced yesterday the resignations of Timothy D. Miller, the president and CEO, and the medical director of the laboratory, Dr. Philip Whelan.
In a two-page statement, Edmond Notebaert, president of the University of Maryland Medical System, said an internal review and the inspections by state and federal regulators showed "significant problems related to the operation and management of Maryland General Hospital's laboratory."
"Such shortcomings," he said, "are not acceptable."
Miller said in the statement that his resignation was "necessary in order to help the hospital move forward in restoring the full faith and confidence of the full community in the institution." Whelan issued a similar statement.
Notebaert said Dr. John Braun, a board-certified pathologist, is replacing Whelan. He said Miller has agreed to assist in a transition while his successor is sought.
Miller, who became president of Maryland General three years ago, has been at the hospital since 1985. Before then he served as a hospital administrator in Prince George's County.
Miller's departure had been rumored for days but repeatedly denied by hospital officials. Last week, hospital officials confirmed the first major change in management, saying that James Stewart, the administrative director of the laboratory, was placed on paid administrative leave April 5. He has since resigned.
A team of state, federal and private inspectors concluded that the 243-bed, acute care Baltimore hospital was "rife with equipment failures" and issued hundreds of HIV and hepatitis test results despite instrument readings that showed the results might be inaccurate.
Though Miller insisted he didn't know about the problems until state inspectors finished an on-site inspection in January, a former lab worker, Kristin Turner, later disclosed that she sent a letter detailing the problems to Miller late last year.
Turner, whose letter was sent by e-mail to state officials and triggered the inspections, made clear the problems had been going on for many months. State officials agreed.
"Despite a pattern of poor performance in laboratory services as documented by the state Office of Health Care Quality survey of 2002, the hospital leadership neglected to provide the oversight necessary to monitor lab activities and improve performance," the inspectors found.
Turner, who has filed suit against the hospital and the lab equipment manufacturer, Adaltis USA Inc., later said in an interview that repeated complaints by laboratory workers about the accuracy of tests and the safety of workers were ignored. In her suit, pending in Baltimore Circuit Court, she said she became infected with HIV and hepatitis when the machine known as a Labotech malfunctioned and splattered her with infected blood.
The problems at Maryland General became public in mid-March when the first critical state report was issued and hospital officials acknowledged that about 460 suspect test results had been sent out.
A second inspection by state and federal regulators in March uncovered more problems, including suspect tests for sexually transmitted diseases such as chlamydia and gonorrhea. Among other errors, the inspectors found the hospital used chemical reagents for a variety of routine tests after they had passed their expiration date.
The report specifically cited Stewart and Whelan for failure to detect and correct the widespread problems. Patients, the report concluded, were put at risk because the lab was so poorly run.
The highly critical report was the result of a joint inspection March 16-24 by the state Office of Health Care Quality, the federal Centers for Medicare and Medicaid Services and the Joint Commission on the Accreditation of Healthcare Organizations.
So severe were the problems in the lab, the report states, that even when two tests on the same samples provided opposite results, the hospital did nothing to find out why.
The hospital is expected to file a corrective action plan with state and federal regulators this week. A private firm was brought in to oversee the laboratory operations, the hospital said in March.
Free retests have been offered to thousands of patients who had tests performed on the Labotech equipment, which was in use at Maryland General for a 14-month period ending in August of last year.