Maryland General Hospital May Have Reported Incorrect HIV, Hepatitis C Test Results to Hundreds of Patients, Report Says

Approximately 460 patients at Maryland General Hospital in Baltimore may have received incorrect results for HIV or hepatitis C tests after hospital laboratory personnel overrode controls in the testing equipment that indicated the results might be in error, according to state officials, the Baltimore Sun reports. 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. Maryland General President Timothy Miller said that hospital executives were unaware of the problem until the state notified them in late January. State health officials said that during their hospital inspections, hospital supervisors had said that the test results should not have been mailed to the patients, according to the Sun (Roche, Baltimore Sun, 3/11).

Letter
However, former Maryland General employee Kristen Turner on Thursday said that on Dec. 7, 2003, she sent a letter to her former boss "reminding him he had known for many months of equipment defects" that could cause patients to receive inaccurate results, according to the Sun. Maryland General spokesperson Joan Shnipper acknowledged that the hospital had received the letter, adding, "We took the complaint very seriously and began an investigation in anticipation of a lawsuit." Turner on Thursday in Baltimore Circuit Court filed a multimillion dollar lawsuit against Maryland General and Adaltis, which manufactured the testing equipment, claiming that when a piece of the testing equipment malfunctioned, blood splattered on her face, infecting her with hepatitis C and HIV, according to the Sun. Turner claims in the suit that she was infected despite wearing the protective goggles and mask recommended by Adaltis, according to the Sun. The suit -- in which Turner is seeking $10 million in compensatory damages and $20 million in punitive damages -- also names her former boss Dr. James Stewart, laboratory director at Maryland General, as a defendant. Citing the lawsuit, Shnipper said she could not comment further or "directly address the conflict" between Turner's letter and Miller's statements, the Sun reports. Stewart on Thursday did not respond to requests for comment from the Sun, and Pennsylvania-based Adaltis officials also could not be reached for comment, according to the Sun (Roche, Baltimore Sun, 3/12).

Next Steps
Miller said that the hospital is attempting to notify patients of the errors and encourage them to be retested at no charge. In addition, the hospital has set up a hotline for people to call if they have questions. "We want to make this right," Miller said. Nelson Sabatini, secretary of state for the state Department of Health and Mental Hygiene, said that it is too early to determine whether the state would impose fines on the hospital, but he added that a complete review of the hospital's lab operations likely will be conducted, the Sun reports. He added, "I am adamant that each and every one of the people that could possibly be affected be contacted and urged to come in for a retest. ... They have a right to know and a right to be retested" (Roche, Baltimore Sun, 3/11).

Corrective Action Plan, Hearing
The hospital on Friday 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 tests, the Sun reports. Rep. Elijah Cummings (D-Md.) on Friday said that the problems are "shocking to the conscience" and called for a U.S. House Government Reform Committee human rights and wellness subcommittee hearing to address the issue. He said that the hearing would offer a forum to examine the "manufacture and use" of the equipment used to test patients at Maryland General, according to the Sun. Cummings said that he was concerned that the hospital failed to act "immediately" when problems with the equipment were first identified, the Sun reports (Roche, Baltimore Sun, 3/13). He added, "It's one thing to not know something. It's another thing to have knowledge and fail to act" (Washington Times, 3/14). Cummings said that HIV/AIDS is the "number one priority" for the Congressional Black Caucus, which he chairs, the Sun reports (Baltimore Sun, 3/13).

Editorial
Although the "full dimensions" of the "appalling use of faulty equipment and procedures" to conduct HIV and hepatitis C tests at Maryland General remains unknown, the "impact could be severe," according to a Sun editorial. The editorial says that patients who are HIV-positive but who were told they are HIV-negative have "lost valuable treatment time" and "innocently" could have infected others with the virus. According to the Sun, Maryland General faces a "huge challenge" in its effort to find patients who received inaccurate test results and an "even more ambitious effort will be required to repair the damage to 20 years' worth of convincing those at risk of the value of HIV testing." The editorial says that the problems could have an effect not only on individual patients but "also on the entire campaign to encourage people at risk for these infectious diseases to be tested." The editorial concludes, "Now perhaps the message should be: Get tested twice" (Baltimore Sun, 3/14).