Media Release

For: Immediate Release
Date: November 26, 2007

HEALTH Cites Deficiencies, Issues Compliance Order to Neurosurgery Department at Rhode Island Hospital

Today the Rhode Island Department of Health (HEALTH) issued a reprimand and a fine of $50,000 to Rhode Island Hospital for its third wrong site surgery this year. HEALTH also issued the second compliance order since August of this year due to this pattern.

On November 23, HEALTH was notified by the hospital that a wrong site surgery had been performed. Hospitals are required to report such events to HEALTH within 24 hours. The surgery follows a compliance order issued to the hospital on August 2, 2007 for a pattern of wrong site/side surgery dating back to 2001. This latest event is the hospital’s fourth wrong site surgery in six years. (Both compliance orders are available at the following link on HEALTH’s website: http://www.health.ri.gov/hsr/facilities/hospitals/index.php)

“We are extremely concerned about this continuing pattern”, said Director of Health, David R. Gifford, MD, MPH. “We have not seen an adequate response in the hospital’s system and protocols since the last compliance order was issued. While the hospital has made improvements in the operating room, they have not extended these changes to the rest of the hospital.”

Today’s compliance order was issued as the result of preliminary findings from an unannounced inspection at Rhode Island Hospital yesterday, following the report from Rhode Island Hospital about the incident on Friday. Several deficiencies were cited during the inspection, and the hospital has been fined. In response to the deficiencies, the compliance order requires the facility to ensure that an unrestricted licensed physician attends all neurosurgical type procedures from beginning to end. For all neurosurgery procedures, the operating physician must complete a time-out checklist that at a minimum confirms the correct patient, procedure, and surgery site by reviewing imaging, consent forms, and medical records before proceeding with the procedure. This information must be verified by both the physician and a nurse or technician assisting with the procedure. The checklist to be used for this protocol is to be given to HEALTH by November 28 for approval.  Emergency procedures that break from this protocol must be reported to HEALTH within 48 hours of the surgery.  HEALTH is also requiring the hospital to submit a plan for ensuring that all licensed professionals receive training in this protocol and checklist. 

The hospital has been working with an independent quality consultant and three expert physicians to review and monitor its neurosurgery practices since last August. Reports from these four experts are due to be delivered to HEALTH by December 15.  Results from these reports will be reviewed, as will regular updates from the quality monitor. As more information becomes available, new requirements may be imposed on the hospital.  HEALTH’s Board of Medical Licensure and Discipline and Board of Nursing will also investigate whether any disciplinary action should be taken against the individual healthcare professionals involved in Friday’s incident. The repeated nature of these events suggests a systems problem with patient safety that needs to be addressed.

HEALTH reminds patients to review surgery plans and consent forms with surgeons before undergoing any type of surgery or procedure. Of note, the Board of Medical Licensure and Discipline has determined that it is the physician’s responsibility to complete an operative consent form with a patient for all surgical procedures. More patient tips can be found on the Joint Commission’s website at www.jointcommission.org/PatientSafety/UniversalProtocol/wss_tips.htm