College of American Pathologists

Update on the Maryland General Hospital Laboratory Issue

Published on: May 11, 2004

On May 6, the College of American Pathologists suspended accreditation of Maryland General Hospital (MGH) laboratory's chemistry and point-of-care testing services for a 30-day period beginning April 26 and ending May 25.

This action was taken after careful review of all information pertinent to this laboratory, its compliance with CAP Standards for Laboratory Accreditation, and the results of an April 26 CAP re-inspection. This decision was based on the seriousness and recurrence of deficiencies identified during a recent investigation.

Accreditation of all other areas of the laboratory remains in effect during the period of suspension.

In addition to contacting Baltimore's Maryland General Hospital directly, the College also contacted the Department of Health and Human Services/Centers for Medicare and Medicaid Services (CMS), the Maryland Department of Health and Mental Hygiene, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), alerting them to these actions.

The status of the laboratory's accreditation will be re-evaluated upon review of the responses and supporting documentation of the April 26 inspection. In addition, the CAP will carry out an unannounced inspection prior to May 25, 2004. The results of this unannounced inspection will be used in evaluating the status of the laboratory's accreditation. The College will also conduct a complete re-inspection later this year to ensure continued compliance with all CAP accreditation requirements.

Investigation into the situation at Maryland General Hospital's laboratory was initiated in March, after a whistleblower had filed a complaint.

Since that time, the CAP-accredited laboratory has been 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, the College determined that what caused the errors appeared 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 the 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 CAP conducted an on-site inspection in April 2003, as part of the accreditation process. 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 the laboratory.

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 Maureen Buckley Jones (1-800-323-4040 ext. 7439) or Sandra Grear (1-800-323-4040 ext. 7536).