A state report released last week found significant deficiencies in the cleaning of surgical instruments at Carilion Roanoke Memorial Hospital between March and September of last year.
The facility was found to be in “immediate jeopardy,” a serious indicator that patient safety was at risk, and without correction, the hospital could have lost funding from the Centers for Medicare and Medicaid Services.
The Virginia Department of Health recently signed off on Carilion’s detailed action plan to correct the issue and new measures are now in place. There is no fine associated with the report.
No patients came into contact with sullied surgical instruments, said Nancy Agee, chief executive officer at Carilion Clinic, although about nine surgeries were rescheduled or transferred to another facility due to a shortage of instruments in August.
[Disclosure: Carilion Clinic is one of our donors, but donors have no say in news decisions; see our policy.]
Immediate jeopardy findings are rare, according to a 2021 study published in the National Library of Medicine. The study found that of about 30,000 deficiencies reported in hospitals in a 10-year period, only about 2% resulted in an immediate jeopardy finding.
An anonymous complaint filed with the health department alleged that a higher than normal number of surgical instruments were arriving in the operating room with blemishes, and in one case, with bits of suture and an alcohol pad stuck to the metal.
The complaint triggered three unannounced surveys at the facility, starting in September. Staff members were quoted in the report saying that at times dozens of trays of instruments were rejected prior to an operation.
Reports had started trickling in from employees in the cardiac surgery department that the number of stained instruments was higher than normal in March 2023. Over the following months the reports became more frequent, peaking around July and August.
Operating room staff are given complete authority to put an instrument aside if they suspect there could be contamination. Agee acknowledged that the number of instruments caught by staff was much higher than normal, but she said staining is not unusual.
“It’s not only common, it’s everyday,” Agee said. “And the good news is that the processes worked.”
Interviews with front line staff and a review of minutes from the quality leadership meetings led the Virginia Department of Health surveyor to report that the quality control team at Carilion had failed to act on the reports of increasing contamination concerns.
Jami Salzberg, who holds a supervisory quality control role for Carilion’s surgical departments, was the first to be notified of the issue. She said she usually waits until reports are clearly trending, about three to five times over a week, before elevating the issue.
When reports started increasing in June, she brought the concerns to the hospital’s senior leadership, Salzberg said in an interview last week.
Agee said that multiple departments are involved in cleaning and sanitation issues. She and others on the quality control team said that they failed to communicate with frontline staff about the measures leadership was taking.
“Leadership was involved from the very beginning. I think what we learned from this is that doing some things in the background was insufficient,” Agee said. “The idea was let’s not worry them, let’s get this work done for them. We should have communicated differently.”
New processes implemented
Carilion leaders consulted with experts from outside the organization to assess water quality and sterilization protocols, Agee said. This included Virginia Tech expert Marc Edwards, who helped expose toxic levels of lead in the Flint, Michigan water system in 2015.
No bacteria were reported in Carilion’s water, but higher levels of certain metals were found.
The majority of reports described discoloration or staining on the instruments, said Dr. Anthony Baffoe-Bonnie, chief of infectious disease services at Carilion.
As the frequency of reports increased, the discoloration was more often described as blood, tissue or bone. Organic material such as this is referred to as bioburden in the state report and by Carilion providers.
“Those would be extremely rare but conflate the picture. Someone you know may say they saw bone or something, and now all the staining is [bioburden],” Baffoe-Bonnie said. “It gets very complex very quickly.”
Blemishes may occur on stainless steel surgical instruments for a number of reasons. For example, Roanoke has hard water, which can leave calcified buildup in its wake. There are also heavy metals in the water that are safe to drink but may react in the nooks and crannies of surgical instruments, leaving behind a red stain. Something that may look like bone might actually be a piece of cement used in a medical procedure.
All tools go through the hospital’s autoclave, meaning when a tool arrives in a tray in the operating room, it has been through the sterilization process, even if it does have blemishes.
In response to the VDH investigation, Baffoe-Bonnie and his colleagues created a glossary of different types of staining and blemishes that might be seen on surgical instruments. Surgical staff then received training on identifying those issues, creating a baseline for identification. Now, information guides hang in every operating room.
“It gives everybody that level playing field,” Baffoe-Bonnie said. “And then it allows us to trend what is being seen, truly seen, properly identified. So now we can create action items around those things.”
Even at the end of the state investigation, it’s not clear what caused the increase in problems, Agee said, describing the situation as “multifactorial.”
The hospital has implemented additional audits at different stages of the cleaning and sterilization process, Salzburg said. This will help hospital leadership continue to monitor the situation.
A “point of use” feature, accessible on employee cellphones, requires users to take a photo of the instruments at the end of each step of the cleaning process.
The sterilization process
Instruments get an initial scrub-down in the operating room after a surgical procedure. OR staff spray on a pre-cleaning gel that prevents any remaining tissue or blood from drying on the instruments.
The tools are then loaded onto carts to be sent off to start the decontamination process. Here, Carilion has added an audit, requiring employees to take a photo of their work.
In the central sterile department where tools are cleaned and sterilized, the instruments are disassembled and disinfected using both manual and mechanical techniques.
Employees in full personal protective equipment set to work soaking and scrubbing the instruments in temperature-regulated, deionized water. Then tools are loaded into a washer, which operates similarly to a dishwasher.
Each tool is inspected for damage or other blemishes before being loaded into the autoclave to be sterilized under high-pressure steam. Carilion’s leadership added another audit following the inspection.
Employees now add biological indicators to every tray that runs through the autoclave. Biological indicators, or spore tests, validate that an autoclave is working by killing highly resistant microorganisms. It is the most effective way to ensure there are no issues with the sterilization step, according to the Centers for Disease Control and Prevention.
Even with the state report and the additional measures, hospital leadership still encourages a strong safety culture, said Dr. Suzanne Kraemer, an internal medicine physician and chief quality officer at Carilion.
“The frontline staff did exactly what we need them to do in health care every single day. It’s about having an exceptionally strong safety culture that if something is recognized, it doesn’t look right, you speak up on behalf of the patient. And that’s exactly what happened,” Kraemer said.