Maryland Hospital Officials Resign After Patients Receive Incorrect HIV, Hepatitis C Test Results Processed in Lab

Officials from Maryland General Hospital and the University of Maryland Medical System on Tuesday announced the resignations of Maryland General Hospital President and CEO Timothy Miller and Philip Whelan, medical director of the MGH laboratory, citing "widespread" laboratory problems that resulted in incorrect HIV and hepatitis C test results for hundreds of patients, the Baltimore Sun reports (Roche, Baltimore Sun, 4/21). Last month, Maryland officials said that approximately 460 patients might have received incorrect test results after hospital laboratory personnel overrode controls in the testing equipment that indicated the results might be in error. State officials discovered the problem in January after a former hospital employee filed a complaint. State inspectors, who conducted interviews with hospital personnel and reviewed medical records, discovered that as a result of the laboratory staff's failure to follow standards set by the manufacturers of the tests, 10% to 15% of the HIV tests performed during the 14-month period ending in August 2003 might have produced inaccurate results. However, hospital officials reported in an official statement that they believe the analyzer itself -- not improper employee methodology -- could have caused inaccurate test results. According to a report compiled by state regulators, CMS and the Joint Commission on the Accreditation of Healthcare Organizations and based on an inspection conducted from March 16-24, operations at the hospital's laboratory were so poor that the hospital failed to investigate when the same samples produced different test results. The report faulted Whelan for "failing to follow up on problems and to report those problems to his superiors" (Kaiser Daily HIV/AIDS Report, 4/5).

'Significant Problems'
UMMS President Edmond Notebaert said in a statement that state and federal inspections as well as an internal review of the MGH lab demonstrated "significant problems related to the operation and management of Maryland General Hospital's laboratory." He added, "Such shortcomings are not acceptable." Miller said in a 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, the Sun reports. MGH this week is expected to file a corrective plan with state and federal administrators, according to the Sun. The facility was told to "fix the problems" at the laboratory, and could face fines of up to $10,000 a day if it fails to do so, the Sun reports (Baltimore Sun, 4/21). The hospital earlier this month said it would notify the more than 2,100 patients whose HIV or hepatitis C results could be erroneous, and it has already retested many of the original 460 patients who were identified as receiving questionable test results (Kaiser Daily HIV/AIDS Report, 4/5).