College of American Pathologists

Statement on the Maryland General Hospital (MGH) Laboratory Issue

Published on: May 3, 2004

The CAP-accredited laboratory at Maryland General Hospital (MGH) in Baltimore is under investigation by the State of Maryland Department of Health and Mental Hygiene. In March, more than 400 patients at that hospital were identified as receiving questionable HIV and hepatitis test results during a 14-month period, ending last August.

After thorough investigation of the issues, the College has determined that what caused the errors appears to have been deliberate data manipulation by laboratory employees. The employees edited the quality control reports of the testing instrument used. This action caused unreliable patient results to be released and concealed MGH's problem from the CAP and state of Maryland laboratory inspectors. It should be noted that the state of Maryland conducted two inspections in 2002, one in October and one in November, which also did not detect the issues related to HIV and hepatitis testing that were later uncovered with news from a whistleblower.

The College of American Pathologists (CAP) is approved by the Centers for Medicare and Medicaid Services (CMS) to inspect and accredit laboratories in the United States. The laboratory community recognizes the CAP for having the most stringent quality standards among laboratory accrediting organizations. The College is committed to improving medical laboratory testing and continuously reviews its inspection process to improve patient care.

The College accredits the laboratory at Maryland General Hospital and conducted an on-site inspection in April 2003. Subsequently, a former laboratory employee alerted the state of Maryland to specific quality issues. Once notified, the College initiated an on-site re-inspection of this laboratory and is currently evaluating Maryland General's laboratory accreditation status. In an effort to understand what may have occurred in 2003, the College is reviewing the previous inspection findings and the overall inspection process.

The College is cooperating fully with the state of Maryland and other accrediting and regulatory organizations to strengthen the information exchange and the accreditation process in order to ensure quality laboratory testing

For more information, contact Public Affairs.