On September 19, HEALTH was notified by the hospital that a wrong-site surgery had been performed that day in their ambulatory surgical center.
Several problems in the hospital’s surgery program were identified during HEALTH’s inspection, including failure to follow The Miriam Hospital’s (TMH) policy to visually inspect the surgical site during the time-out, (which is the last step prior to starting surgery to verify the correct patient, surgery and surgical site) to use indelible ink to mark the site and to verify the original source of information related to the surgery and site. A detailed description of the findings from the inspection can be found in the deficiency report (see www.health.ri.gov/discipline/MiriamHospitalFindings1008.pdf).
Yesterday, the Rhode Island Department of Health (HEALTH) signed a consent agreement with The Miriam Hospital for its wrong site surgery in September. Subsequently, CMS requested that HEALTH conduct a full survey of The Miriam Hospital to review compliance with conditions of participation in the Medicare program. Following the full inspection, the hospital must submit an acceptable plan of correction to CMS and HEALTH.
“While the hospital and the Board of Directors have taken many of the appropriate first steps to address the problems identified with this wrong-side surgery,” said Director of Health David R. Gifford, MD, MPH. “we are extremely concerned about any wrong-site surgery that happens.”
In response to the deficiencies, the hospital has signed a consent agreement to: • Fix several problems related to their time-out process, • Change the pens used to mark the surgical site to make sure the marking cannot be washed off during preparation of the surgical site, • Hire a consultant to evaluate their policies and protocols for compliance with national best practices in safety and clinical outcomes, to complete on-sight inspections for the next 12 months and to submit reports to HEALTH and TMH Board of Trustees, • Design and implement a near miss reporting program for its staff and • Educate the Hospital Board by having patients and families come to Board meetings on a quarterly basis for the next 24 months to share their experiences. Additional conditions are described in the full consent agreement (see www.health.ri.gov/discipline/MiriamHospitalCA1008.pdf ).
“It is critical that all physicians, nurses and healthcare staff in operating rooms understand the importance of the time out process and that it is not just an administrative function,” said Gifford. “The external consultant will provide both HEALTH and the hospital’s Board of Directors with valuable feedback on the hospital’s compliance with protocol changes and new safeguards.”
HEALTH’s Board of Medical Licensure and Discipline and Board of Nursing is currently investigating whether any disciplinary action should be taken against the individual healthcare professionals involved in the incident.
HEALTH reminds patients to review surgery plans and consent forms with surgeons before undergoing any type of surgery or procedure. More patient safety tips can be found on the Joint Commission’s website at www.jointcommission.org/PatientSafety/UniversalProtocol/wss_tips.htm.