When Seattle Children’s Hospital reopened its operating rooms after a cluster of Aspergillus infections, it relied on air testing to alert it to the presence of the potentially life-threatening mold.
But it wasn’t air monitoring that revealed the return of Aspergillus to the sterile environment. It was an infant.
The baby was born with a heart defect that required surgical insertion of a tube, a procedure that was done in operating room No. 11 on Oct. 1, according to newly released state records. The infant’s condition worsened after discharge. A blood test showed on Nov. 7 that the baby had an Aspergillus infection, and its location – in the operative wound – indicated it had happened during the surgery.
Air-sampling data for operating room No. 11 didn’t show any positive results for Aspergillus since the hospital had reopened its operating rooms on July 4, according to an investigation by the Washington state Department of Health (DOH).
But on Nov. 7, the day the baby was diagnosed with an Aspergillus infection, hospital staff collected air samples that tested positive for the mold when the results came back three days later, the department found. Children’s then closed its ORs.
The state’s investigation shows that Children’s monitoring – while more than what is required by law – failed to detect Aspergillus in its ORs for more than a month after the surgery in which the baby apparently contracted the infection.
The DOH spent portions of six days on site in November and December, and didn’t cite Children’s for any violations.
“Seattle Children’s instituted air sample testing and patient surveillance for this type of infection as part of their process, which is in excess of any regulatory requirement,” said Lisa Stromme Warren, a department spokeswoman. “We assessed if they were following their process and they were.”
Children’s has linked 14 Aspergillus infections – including six patient deaths – since 2001 to problems with the air-filtration system serving its operating rooms. The revelations of the infections, a rare complication from surgery, have dealt a blow to the celebrated pediatric institution and touched off a flurry of lawsuits.
Hospital leadership — including Chief Executive Jeff Sperring, board members and other executives — distanced themselves from any mold problems before 2018 when speaking to state investigators.
“The CEO and the board members state that they were not on the board prior to the recently identified mold issues and that they were made aware of the issues beginning with the 2018 cases,” the reported stated.
Seattle Children’s did not respond to questions about DOH’s report.
The most recent Aspergillus infections emerged in June 2018 and resurfaced last May, with Children’s attributing the problem to small gaps in the walls of operating rooms and in the array of air filters that serve them. The hospital reopened operating rooms on July 4, with its chief medical officer saying then that the risk to patients “is incredibly low.”
Inside the hospital, though, the infection-prevention department preferred restricting high-risk surgeries to operating rooms with high-efficiency particulate air – or HEPA – filters, according to the health department’s investigation. In September, the chief medical officer and chief surgeon decided to open the operating rooms to heart cases, the report shows, with the chief executive agreeing.
The rationale for the decision, according to the department’s report, was based on negative air samples, statistical analysis and space and staffing considerations that could affect patient safety. Ultimately, Children’s leadership concluded that “the air sampling data and analysis, plus clinical risks, suggested that moving cases to the ORs was the safest option.”
Operating room No. 11 did not have a HEPA filter, according to the report. After the infant contracted Aspergillus during an initial surgery, the hospital performed a second surgery in November to replace the inserted tube. The baby remained in Children’s cardiac intensive-care unit at the time the DOH regulator concluded the investigation within the last month.
Aspergillus is a common mold that most people breathe daily without getting sick, but its risk to hospital patients has been known for decades. Patients with lung disease or weakened immune systems — especially organ- or stem-cell transplant patients — are at higher risk of developing Aspergillosis. In the most serious cases, symptoms range from a fever to coughing up blood, according to the Centers for Disease Control and Prevention.
Children’s has been hit with a number of lawsuits since early December including one that seeks class-action status for patients who were sickened by Aspergillus at Children’s between 2005 and 2017.
Last week, 5-month-old Beth Hutt was added to the lawsuit, expanding the range into 2019.
She was admitted to Children’s the day she was born in August because of a problem with her heart; her first surgery was five days later. She underwent a second procedure on Nov. 7., three days before Children’s administrators closed three of the hospital’s operating rooms due to two possible cases of Aspergillus infections.
When Children’s announced the closure of three of the operating rooms in November the hospital said that one case of Aspergillus had been confirmed and another patient was being monitored.
Karen Koehler, one of the attorneys handling the potential class-action lawsuit, said she does not believe Hutt is the child identified in the state’s report.