Maryland Hospital’s HIV, Hepatitis C Testing Problems ‘More Widespread Than Previously Indicated,’ State Report SaysMaryland General Hospital's HIV and hepatitis C testing problems are "far more widespread than previously indicated," and equipment failures at the "poorly run" laboratory could have led to thousands of incorrect test results, according to a report recently released by state health officials, the AP/Asbury Park Press reports (AP/Asbury Park Press, 4/3). 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 (Kaiser Daily HIV/AIDS Report, 3/22).
The report, which was compiled by state regulators, CMS and the Joint Commission on the Accreditation of Healthcare Organizations, is based on an inspection conducted from March 16 to March 24, the Baltimore Sun reports. The report indicates problems with the hospital's use of Labotech analyzers to test blood samples for HIV and hepatitis, noting that problems with the analyzer began in June 2002, when the hospital started using the technology. The hospital stopped using the analyzers last year. The report also states that inspectors "also found fault with the use of other HIV test equipment and said basic testing procedure manuals contained incomplete and sometime inaccurate instructions," the Sun reports. According to the Sun, inspectors found that the hospital used "chemical reagents for a variety of routine tests after they had passed their expiration date." In addition, the lab had a lack of sufficient staffing and failed to train lab workers adequately, the report says (Roche, Baltimore Sun, 4/3). The report says that problems at the hospital's laboratory were "so bad" that the hospital "failed" to investigate when opposite test results were given for the same samples, according to the AP/Park Press (AP/Asbury Park Press, 4/3). The report faults lab Director Dr. Philip Whelan for "failing to follow up on problems and to report those problems to his superiors," according to the Associated Press (Associated Press, 4/3).
In a letter to hospital President Timothy Miller, Carol Benner, director of the state Office of Health Care Quality, wrote, "The deficiencies which are enclosed with this letter are serious in nature and require immediate corrective action. ... If the hospital fails to correct these serious deficiencies, the department may impose a civil money penalty of $10,000 per instance or $10,000 per day" (Baltimore Sun, 4/3). Nelson Sabatini, Maryland's health secretary, said that he was "disturbed" by the report, adding, "It shows pervasive problems." The hospital on Friday released a statement, saying it would notify more than 2,100 patients whose HIV or hepatitis C test results could be erroneous, according to the AP/Park Press. The hospital said it has retested many of the original 460 patients who were identified as receiving "questionable" test results and is continuing to try to contact 180 of them. Maryland General spokesperson Lee Kennedy said in a statement, "This type of performance is unacceptable," adding, "For the past three weeks, we have been working virtually round the clock to ensure that Maryland General's laboratory operations going forward are sound and operating in accordance with all appropriate regulations" (AP/Asbury Park Press).