Officials at Virginia Mason Medical Center didn’t report an outbreak of ‘superbug’ infections tied to tainted medical devices to a state adverse-event system designed to track and prevent such problems, a report finds.
Virginia Mason Medical Center failed to properly notify state health officials about an outbreak of so-called “superbug” infections tied to contaminated medical scopes, investigators have found.
The hospital, which detected 39 infections and 18 deaths linked to the outbreak between 2012 and 2014, did not file a required report with the state system that tracks dangerous and deadly adverse events.
“Failure to report an adverse event may result in unrecognized patterns of device-related events in multiple facilities,” said a state Department of Health complaint report released late last week.
Virginia Mason officials declined an interview but said in a statement that the hospital engaged certain state health officials from the start in the complex investigation of rare, multidrug-resistant E. coli infections found to be spread by tainted devices.
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“Virginia Mason had anticipated that communications were occurring between the various departments within the Department of Health,” said Katerie Chapman, the hospital’s senior vice president and hospital administrator.
“This turned out not to be the case, so a formal report has now been filed with the Department of Health division that was not informed of what other divisions within the Department were intricately involved in and well aware of due to our collaborative efforts in the investigation.”
Since 2006, state law has required hospitals and other health-care facilities to report whenever they confirm any of 29 adverse events that can cause patient harm or death. It’s a system based on the National Quality Forum (NQF)’s so-called “never events,” a list of medical mistakes that should never happen.
In 2014, Washington hospitals and surgical centers reported nearly 500 adverse events, state records show. They included problems such as wrong-site surgery and objects mistakenly left in patients after operations. The Virginia Mason outbreak falls under category 2B, problems with device function or use.
Failure to report such problems may allow them to continue to occur, said Dr. Helen Burstin, chief science officer for the NQF, a group focused on patient safety and health-care quality improvement.
“Serious reportable events or ‘never events’ should be reported in a timely manner so that others can learn and avoid having the same thing happen to others,” she said in an email. “A core tenet of these events is that they are largely preventable. With the right evidence-based procedures, you should be able to prevent another injury.”
In addition to failure to report the device problems, state and federal investigators were looking into complaints that Virginia Mason failed to properly notify patients that their cases were part of an outbreak. Hospital officials have said they first realized the problem likely was connected to the scopes in November 2013.
Investigators also examined whether the contaminated devices, called duodenoscopes, led to multidrug-resistant infections after a procedure known as ERCP or endosocopic retrograde cholangiopancreatography.
The complaints were launched last February, a month after The Seattle Times first reported about the outbreak of scope-related infections, the report said. The investigation concluded after a June site visit by officials with the state health department and the Centers for Medicaid and Medicare Services (CMS). Investigators included state public-health officials Marcia Cook, Karen Krueger and Lisa Mahoney.
Investigators found that hospital officials did not violate state rules requiring notification about “unanticipated outcomes” because they told patients and family members about the infections and treatment at the time of the illnesses — and sent specific notifications about the problems with the scopes last March and April.
The report also concluded that although the medical scopes were found to be associated with the infections, the hospital was not at fault.
“The infections occurred even though the facility reported cleaning the duodenoscopes in accordance with the manufacturer’s recommendation,” the report said.
Virginia Mason must file the required report and a plan to avoid a similar omission in the future, state officials said.
Investigators noted that early media reports attributed the outbreak to CRE, or carbapenem-resistant enterobacteriaceae, a drug-resistant “superbug” referred to as a “nightmare bacteria” by officials at the Centers for Disease Control and Prevention (CDC).
The outbreak, in fact, was caused by what are known as carbapenem-resistant Hyper-AmpC-producing E. coli bacteria, which are dangerous bugs resistant to many common antibiotics, germs similar to, but different from CRE.
The Seattle outbreak is among several across the U.S. in which dangerous or deadly infections have been spread by tainted duodenoscopes, even after cleaning according to manufacturer’s directions. The federal Food and Drug Administration and the CDC have issued new warnings and guidelines regarding the problem.
Virginia Mason implemented a cutting-edge “culture-and-quarantine” process that holds duodenscopes after cleaning until they test free of dangerous bacteria. Since that plan was put in place in 2014, no additional infections have been detected, hospital officials said.
Virginia Mason is facing lawsuits by families of patients allegedly harmed by the bacteria, but the hospital is also suing the manufacturer of the devices.