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HEALTH Signs Consent Agreement With Rhode Island Hospital Regarding Their Wrong-Sided Surgery

On May 11, the Rhode Island Department of Health (HEALTH) was notified by Rhode Island Hospital that a wrong-site surgery had been performed that day in their pediatric surgery department.

Preliminary findings of the hospital’s surgery program include failure to follow hospital policies, inconsistent interpretation of the time out policy, inadequate ongoing physician and nurse training about policy revisions, inadequate hospital-wide prospective assessment of the time out policy as it applies to specific surgeries (e.g. oral surgery, multi-site surgery, vaginal surgery) and inadequate identification and reporting of “near misses” by physicians , nurses and OR staff. (Note: “Near misses” are defined as clinical or administrative problems that could potentially cause or contribute to medical errors that were discovered and reported before an error ever occurs.) Today, HEALTH signed a consent agreement with Rhode Island Hospital for actions they will take to address issues identified to date about this case of wrong site surgery.

“HEALTH is very concerned that this is the fourth wrong-site surgery that has occurred at this facility in recent years,” said Director of Health David R. Gifford, MD, MPH. “Even one occurrence is too much. As in most cases, this is not the fault of one individual nor is this fixed by just introducing a checklist. It is clear that the hospital needs to be more diligent about assuring consistent implementation of patient safety standards and continuously evaluating and improving their policy based on feedback from staff who are using the policy. In addition, it is critical that all staff demonstrate competency about using these policies and procedures.”

In response to the preliminary findings, the hospital has signed a consent agreement to: · Suspend surgery for each surgical discipline at least two to three hours over the next two weeks to allow staff to complete an in-depth review of their surgical safety policies and procedures. · Contract with a patient safety organization within 60 days to develop a robust system for reporting near misses and incorporating those findings into their existing policies and procedures. · Create a plan to regularly confirm that all surgical staff are current in their understanding of time out and other surgical safety policies and procedures. · Make further modifications to their time out procedures to clarify the visualization of the site marking by the surgical team. The full consent agreement is available at (see http://www.health.ri.gov/hsr/facilities/hospitals/RIHInterimConsentAgreement051509.pdf). HEALTH is continuing its investigation, which may result in additional recommendations.

The physician involved in the incident has been referred to the respective professional Board (Board of Medical Licensure and Discipline) for investigation. No one else on the team has been referred for disciplinary action at this time.

HEALTH reminds all patients to closely review surgery plans and their consent forms with surgeons before undergoing any type of surgery or procedure. Patients should make sure the consent forms are legible, understandable and clearly delineate the site and side of surgery without use of abbreviations. In addition, whenever possible, patients should participate with their physician in site markings prior to surgery. More patient safety tips can be found on the Joint Commission’s website at www.jointcommission.org/PatientSafety/UniversalProtocol/wss_tips.htm.

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