Even after the resignation of its president and chief executive officer, the fallout from questionable HIV test results continued at Maryland General Hospital last week as the hospital faced possible fines of $10,000 per day and loss of its Medicare funds.
Timothy Miller, who had led the Baltimore facility since 2001, stepped down last week along with Philip Whelan, director of the hospital's laboratory and department of pathology, and James Stewart, administrative director of the lab. The resignations came in the wake of a debacle in which nearly 500 patients may have received incorrect results from HIV and hepatitis tests taken from June 2002 to August 2003.
"Based on our own review and those conducted by regulatory agencies, it is evident that there were significant problems related to the operation and management of Maryland General Hospital's laboratory," Edmond Notebaert, president and CEO of the University of Maryland Medical System, the hospital's parent, said in a news release.
Miller said the hospital staff "has worked diligently in recent weeks to address the issues ... my resignation is necessary in order to help the hospital move forward in restoring the full faith and confidence of the entire community."
State, federal and private inspectors have found numerous problems with the hospital's laboratory equipment and earlier this month, the state Office of Health Care Quality ordered 216-bed Maryland General to immediately begin correcting the problems or face fines of $10,000 per day. The hospital also faces the possibility of losing its Medicare funding if it does not give the CMS a plan of correction this week, a CMS spokeswoman said.
The hospital is now working with PCS Laboratory Solutions, which has expertise in laboratory management, in an effort to correct problems with its lab operations.
The problem first came to light late last year when a former lab worker informed city officials that thousands may have received invalid test results. In subsequent inspections, the state health department found that 460 people may have been incorrectly told their test results were either negative or positive.
The problem, said a spokeswoman for the Maryland system, stems from one piece of equipment. She declined to identify the specific issue, but in March the hospital was going to ask the Food and Drug Administration to investigate the reliability of the equipment, a Labotech blood analyzer made by Adaltis US.
Though state officials identified 460 people who may have received invalid results, they suggested to hospital officials they retest everyone who had been tested during the 14-month period in which test results may have been faulty-about 2,000 patients. The hospital is doing so, the spokeswoman said, adding the vast majority of those who have been retested had their original results confirmed.
In July 2003, the hospital lab was given the highest rating, "Accredited with Distinction" by the College of American Pathologists. While the Joint Commission on Accreditation of Healthcare Organizations examines a broad spectrum of healthcare facilities, the JCAHO has a formal agreement to have the college inspect hospital laboratories. The agreement is sanctioned by the federal government.
Ron Lepoff, chair of the commission on laboratory accreditation for the college, said in order for its inspectors to have discovered the problems, they would have had to examine each piece of equipment, which is not generally part of the process, or have followed up on a specific filed complaint.
"My guess is that any usual accreditation process would not have uncovered this problem," he said. The college is reviewing its accreditation process as a result of the incident.