CMS, JCAHO, State Officials Conduct Unscheduled Inspection of Maryland General Hospital After Inaccurate HIV Test Reports
Nine inspectors from CMS, the Maryland Office of Health Care Quality and the Joint Commission for the Accreditation of Healthcare Organizations on Tuesday conducted an unscheduled, on-site inspection of Maryland General Hospital in response to reports of inaccurate HIV laboratory test results that may have affected more than 400 patients, according to a hospital spokesperson, the Baltimore Sun reports (Roche, Baltimore Sun, 3/17). State officials last week said that some patients who underwent HIV or hepatitis C testing at the Baltimore hospital may have received incorrect test results after hospital laboratory personnel overrode controls in the testing equipment that indicated the results might be in error. Maryland 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 may have produced inaccurate results.
The hospital on March 12 submitted to the state Office of Health Care Quality a formal plan of corrective action to address the problems with the HIV and hepatitis C test results. In addition, Maryland General President Timothy Miller said that the hospital is attempting to notify patients of the errors and encourage them to be retested at no charge, and the hospital has set up a hotline for people to call if they have questions (Kaiser Daily HIV/AIDS Report, 3/15). Thus far, 36 patients who initially received a negative result have come to the hospital for retesting, and the hospital expects to conduct 100 retests by the end of the week, the Sun reports. Maryland General spokesperson Lee Kennedy said that although the inspection was unscheduled, it was not "a surprise," according to the Sun. He added, "We expected them to do a survey once we reported the incident." He said that some inspectors were focusing on the laboratory, but he added that other hospital programs also could be inspected, according to the Sun. Kennedy said he did not know how long the inspection would last, the Sun reports. Miller said that hospital officials were "cooperating fully" and ensuring that the inspectors "have the information they need." JCAHO spokesperson Mark Forstneger said that the agency was making an "unannounced inspection" in response to a complaint, and the group would have a report completed in approximately two weeks, the Sun reports (Baltimore Sun, 3/17).