Report finds Carilion Roanoke Memorial Hospital ‘failed’ standard of patient care due to stained surgical instruments. What changes have been made?

ROANOKE, Va. (WDBJ) – Nearly 1% of all surgical instruments in hospitals nationwide are rejected before they get to the operating room. They’re screened for blemishes left over from the sterilization process.

The Virginia Department of Health (VDH) received an anonymous complaint in September 2023 about Carilion Roanoke Memorial Hospital (RMH) not properly cleaning surgical instruments, impacting patient care and safety.

The complaint prompted an unannounced investigation and survey into the hospital’s procedures and policies for decontaminating and sterilizing surgical instruments, and the hospital administration’s response to staff complaints.

Two separate surveys done in September and November resulted in VDH investigators placing Carilion RMH on immediate jeopardy status, which was lifted within a few days after the hospital presented an acceptable plan of removal. VDH defines an immediate jeopardy status as a situation in which immediate corrective action is necessary because the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident receiving care in a facility.

The surveys found Carilion RMH was failing the standards of patient care and medical accountability.

Carilion Clinic received both of the survey results in February 2024. Hospital leaders, such as the medical director for infection prevention and control, explained they’ve learned from the surveys, and have made significant changes to the decontamination process.

“Instrument staining and discoloration is not new in the surgical world, but we want to be transparent about it,” Dr. Anthony Baffoe-Bonnie said.

Carilion RMH staff first started noticing more instruments with stains in June 2023. The hospital’s instrument rejection rate rose to nearly 2.5%, higher than the national average.

In September, nine surgeries were postponed or canceled because of concerns with blemished instruments.

VDH investigators found more than 700 reports of stained or contaminated trays from March to November 2023. The surveys outline contaminants as pieces of bone, hair, blood or trash found on a sterile surgical tray.

The VDH survey team observed four sterile trays during its September visit. Three of them were contaminated with “an unknown brownish red substance” that was easily removed with a gloved finger, plus stains and a candy wrapper.

Dr. Baffoe-Bonnie explained none of the reported contaminated trays were used on patients.

“When we start seeing any of these issues, the [frontline staff are the] first people to say ‘This instrument doesn’t look right, I’m going to take it out,’ so it never touches a patient,” Dr. Baffoe-Bonnie said. “We see a decline in infections rather than an uptick in infection, so I can say very confidently that [we] didn’t have any issue with regards to patient care and/or infections.”

Carilion RMH staffers were frustrated with the frequency of stained surgical instruments, according to the report. Multiple staff members told surveyors hospital administration was not listening to their concerns, and did not address the issue for months.

Carilion Clinic’s CEO explained administration became involved in June, but that was not clearly communicated to staff.

“It was frustrating to have to eliminate instruments and go through that process,” Nancy Howell Agee said. “In this case, we didn’t do enough with the staff to help them know what was going on in the background to figure all this out.”

Hospital leaders explained the issue of stained and contaminated surgical instruments is a complex one, and that made it hard to determine a single cause for the uptick.

“It was almost like peeling the onion back,” Howell Agee said. “It wasn’t just a simple solution; it became multifactorial.”

Carilion reports a combination of hard water issues and staff not properly spotting stains during the pre-sterilization process may be the reason behind the higher rate of stained instruments.

“What the surveys helped us do is probably three buckets. One is enhanced education and training of our staff, two is hiring more staff and three is an audit check, so that we have a process for continual auditing,” Howell Agee said. “It’s a really stepped up process and obviously it’s working.”

Since VDH alerted Carilion RMH of its brief immediate jeopardy status due to contaminated instruments and not communicating with staff, the hospital has changed the sterilization process. Staffers are now required to check instruments before they leave the operating room and before they go into the steam sterilization.

Dr. Baffoe-Bonnie explained the new process has decreased the instrument rate to 0.4%, which is lower than the national average.

“There really is no industry standard for how you should audit your process,” Dr. Baffoe-Bonnie said. “We have introduced significant amount of auditing to make sure that every instrument that comes out of sterilization is pristine.”

Instruments first are cleaned in the operating room after a surgery with a precleaning gel. Then the instrument cart is loaded to go to decontamination. Carilion added an audit check for staff to complete after loading the instrument cart. During decontamination, the instruments undergo a series of rinses and soaking including a deionized water rinse. The tools are then put in an instrument washer for several minutes. Carilion RMH staff will inspect and further clean the instruments. After that, staff will now complete another audit of the instruments before they are placed in the steam sterilization machine. The tools are loaded on a cart and are considered ready to go back into the operating room.

Howell Agee explained the surveys helped Carilion Clinic improve patient care and the standard for keeping staff informed.

“I think this showed me we’ve got to step it up even more than we’ve been doing, and I think that’s been happening,” Howell Agee said.

After VDH removed Carilion RMH’s immediate jeopardy status from the September and November surveys, the facility remained on the condition of noncompliance. The hospital has now submitted an action plan addressing the increase in blemished instruments and their solutions, including a complete glossary of surgical instrument staining for staff training.

Target 7 reached out to VDH for verification of the action plan.

“Carilion Roanoke Memorial Hospital has submitted an acceptable plan of correction with dates of alleged compliance,” a VDH spokesperson said in a statement. “VDH will conduct an unannounced follow-up survey [in the spring] to verify compliance.”

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