Cape Fear Valley Health System values the trust you place in us as your healthcare provider. That’s why we acted swiftly when we discovered several surgical instrument trays that had been cleaned, disinfected and packaged, but had not gone through the final step of steam sterilization.
    Fortunately, thus far we have found no evidence that harm has occurred to any of our patients. We mailed letters to 160 patients who potentially could have been treated with these trays to let them know what happened. Then we called each of them or their family members. We will investigate any reported infection to determine whether it is linked to this incident.{mosimage}
    Within 48 hours, we notified our entire medical staff of 500 physicians and subsequently formed a team to investigate. New procedures were in place within 48 hours to assure this type incident does not happen again.
    Though it was not required, we voluntarily reported this potential exposure to the state the following week. A comprehensive corrective action plan was submitted to state officials on Oct. 16. Many of the actions outlined in the plan have already been implemented.
    Fortunately, the likelihood that any patient was actually treated with these trays is very low. Many checks and balances are already in place to prevent that from happening. For example, surgical techs in the operating rooms check the trays to assure instruments are sterilized prior to surgery. At least three color indicators are located on the outside of the metal boxes, called surgical trays. Two more visual indicators are located on the inside.
    The instruments in these trays were properly cleaned and disinfected, which is the most essential step in preparing instruments for surgery. Then they were packaged and placed in a wire basket inside the metal box or tray.
    When the outside of the metal box is steam sterilized, indicators on the outside of the box change color, indicating the final step has occurred. On Oct. 6, we found three trays sitting on a shelf in the Central Supply Department, with markers on the outside that had not changed color to indicate that steam sterilization had occurred.
    We then researched the last known date on which we could document that steam sterilization had occurred. From that point forward, we notified 160 patients who had surgical procedures over a 72-hour span of time. We also notified the physicians of those patients within 72 hours of discovering the issue, so that they could contact their patients and discuss this matter with them personally.
    To prevent this type of incident from happening again, we have improved the way we identify zones in the Sterile Processing Department. We catalogue instruments in the Processing Zone to reduce the possibility of mixing clean and sterilized instruments. A two-person check is used to verify that instruments have been sterilized before they move to the Distribution Zone.
    All staff and supervisors in the Central Sterile Supply Department have been educated on these new procedures. We also have initiated a Root Cause Analysis to determine how this event happened. Appropriate corrective actions will be taken to address the cause of the incident, along with education and coaching of employees.
    We are also taking the innovative step of creating new Patient Safety Response Teams to address any future patient safety issues. Any patient, family member or staff member will be able to activate this system, and a team will form immediately to respond.
    Fortunately, most surgical patients receive antibiotics within an hour prior to surgery, and most receive antibiotics after surgery. This further minimizes the risk. Cape Fear Valley’s compliance rate with this procedure exceeds both state and national hospital averages.
Cape Fear Valley also has surgical infection rates that are “similar to or lower than” overall rates of infection among hospitals in the Duke Infection Control Outreach Network. In its most recent report, Duke congratulated Cape Fear Valley for its “excellent outcomes that were observed at your facility last year.”
    We know that your healthcare is a matter of great personal trust and confidence that you place in us. We apologize for any concerns that this issue may have caused for our patients and their families. We are taking the necessary actions to assure your continued trust and confidence, as your preferred healthcare provider of choice.

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