CEO SUMMARY: An extraordinary story is unfolding in a Baltimore hospital laboratory. Maryland state health officials have uncovered serious operational deficiencies, particularly with HIV and HCV testing performed over a 14-month period. During this same time, a medical technologist now infected with both HIV and HCV claims a malfunctioning laboratory instrument was the source of her infection.
IT’S THE LABORATORY MANAGEMENT nightmare always lurking in the backs of the minds of laboratory administrators and pathologists.
On March 10, 2004, first news broke in Baltimore about problems in the laboratory at Maryland General Hospital. The Baltimore Sun reported that state health officials had determined that, during the period June 2002 through 2003, HIV and HCV testing performed at the hospital’s laboratory had produced unreliable results.
Within days of this disclosure, public health officials estimated that at least 460 individuals tested for HIV and HCV had been given potentially inaccurate results during the 14-month period of flawed testing. “I’m really quite disturbed. They [laboratory personnel] apparently knew there was a problem,” stated Baltimore Health Commissioner Peter C. Beilenson.
Beilenson and Secretary of the Maryland Department of Health Nelson J. Sabatini both stated that two inspections of the laboratory by state officials in January had uncovered other potential problems in how the laboratory was operated.
Two days later, on March 12, came another startling disclosure. A medical technologist formerly employed by the hospital laboratory had sent a letter to state health officials in December describing serious safety and accuracy problems in the Maryland General Hospital laboratory. Moreover, this med tech was now infected with both HIV and HCV, which she attributed to exposure while operating the HIV/HCV testing instrument in the laboratory.
Public news that hundreds of patients may have received inaccurate results from their HIV and HCV testing created a public relations disaster for Maryland General Hospital. Timothy D. Miller, President of the hospital, offered free testing for patients affected by the lab’s problem. He also explained that an internal review and the report of an outside consultant had identified no other problems in the laboratory. His explanation for the HIV/HCV testing deficiencies was a combination of “human error and equipment problems.”
Lab Management Lessons
From a laboratory management perspective, many lessons will emerge from this still-unfolding story. THE DARK REPORT is in communication with a range of individuals with knowledge of specific elements of the situation at Maryland General Hospital, a 245-bed hospital.
What is known at this point is that the hospital laboratory acquired an instrument called the LABOTECH Open Microplate Blood Testing System to do HIV, HCV, and other similar tests. It is manufactured in Italy by Adaltis Inc. Worldwide, more than 2,000 of these instruments are in labs. In the United States, between 200 and 240 instruments are in labs.
Maryland General’s lab put its instrument into operation in June 2002. Problems with the instrument surfaced immediately. A preliminary nine-page state inspection report states that staff at Maryland General Hospital’s laboratory did not follow the manufacturer’s standards for the LABOTECH instrument. Whenever tests on known samples fell outside the acceptable limits, laboratory staff edited the data to bring results within normal ranges. Such specimens were not retested and the suspect test results were reported to patients.
The report also noted that “there were no records to show that correction of errors were made in a timely manner; and no records to show that testing personnel, both past and pre- sent, were trained properly and evaluated for competency.”
State health officials further noted that, during a meeting in late January, laboratory staff had acknowledged their failure to heed another warning sign of inaccurate test results. When certain HIV and HCV samples were sent to a reference laboratory for confirmation testing, the results reported often conflicted with the hospital lab’s test results.
In August 2003, the laboratory ceased using the Adaltis LABOTECH instrument. “We were having challenges with the instrument itself,” explained Miller. He again affirmed that his laboratory’s problems with HIV and HCV testing were the result of a combination of both “human error and equipment problems.”
Maryland General Hospital has tried to put a positive spin on this situation. But as of early December 2003, it had taken no internal action to address the testing problems generated on HIV and HCV tests performed during the 14-month period ending August 2003.
Alerted By Whistle-Blower
Action to rectify this situation did not occur until a whistle-blowing med tech, who, after failing to get the attention of hospital administration to these problems, then sent letters to the Maryland Department of Health in December. Alerted by her letters, state officials inspected the laboratory in January 2004.
The medical technologist is Kristin S. Turner, 32. She filed a $30 million lawsuit against Maryland General Hospital, laboratory director Dr. James Stewart, and Adaltis. In a public interview, Turner stated she began working at the laboratory in October 2002. She noticed problems with the Adaltis LABOTECH immediately.
“Every run had different errors. three of every five tests were wrong. The machine failed its own self test,” observed Turner. She also noted that the instrument, an automated “load and walk away” microplate system, would often skip required steps during testing. As a result, lab techs had to constantly watch the machine during operation to catch such events. “None of the techs had confidence in the machine,” she declared.
Turner estimates that about 150 tests for HIV, HBV, and HCV were done weekly, which would represent about 8,400 tests during the 14 months that the LABOTECH was in use in the laboratory. Turner stated that Adaltis was contacted several times each week about problems and sent technicians into the laboratory regularly. Turner said that she provided warnings and complaints to laboratory management, but there was no response to her efforts. “Every single test that came off that machine should be in question, from its first day in use,” stated Turner.
More Competition Ahead
Turner believes that she became infected with HIV and HVC as a result of operating the LABOTECH instrument. On March 12, 2003, she responded to an error message on the machine. She opened the top and during the repair procedure, the washer- head fell off the control arm. It fell on the plates and material from both specimens and controls splashed up onto her face, running down behind her protective mask and protective goggles.
Turner was rushed to the emergency room and tested negative for HIV and HCV. However, by June, Turner tested positive for both diseases.
One issue which disappointed state health officials in Maryland is the fact that neither laboratory management nor hospital administration had taken steps, as of early December 2003, to accurately evaluate the problems with testing integrity. Nor did the hospital attempt to contact patients who potentially were given inaccurate results to offer retesting until after government authorities ordered the hospital to take corrective action.
New Revelations Ahead
Indications are that more trouble areas in the management and operation of this hospital laboratory will be made public in coming weeks. It is known that the hospital has retained Park City Solutions to operate the laboratory on a interim basis, evaluate operational deficiencies, and bring the laboratory back into full operational compliance.
The Baltimore Sun has already singled out hospital administration for criticism, writing in an editorial that “it was dismaying that hospital executives have sought to minimize this tragedy and blame it on low-level workers—one of whom was the whistleblower who alerted city and state officials.”
Along with the medical technologist who now tests positive for HIV and HCV, it is known that, among the first 60 patients retested, at least one individual was found to be HCV-positive, even though his original test result was negative. This extraordinary episode is a reminder that the human cost is immeasurable anytime things go wrong within any of the nation’s clinical laboratories.