Healthcare Inspection – Alleged Unreported Surgical Incidents and Deaths, VA Caribbean Healthcare System, San Juan, Puerto Rico

OIG conducted a healthcare inspection in 2016 in response to complaints about the VA Caribbean Healthcare System, San Juan, Puerto Rico. An anonymous complainant alleged that surgical incidents and deaths were unreported because of a conflict of interest between a quality management employee and a senior leader. During interviews, we did not find evidence of a conflict of interest. We reviewed the validity of the allegation regarding the reporting of surgical incidents and deaths. We did not substantiate that surgical incidents or deaths were unreported. We compared information regarding surgical deaths extracted from the Corporate Data Warehouse with the facility morbidity and mortality committee minutes and found the data to be congruent with information in patients’ Electronic Health Records. We distributed a bilingual survey (English and Spanish) to 128 VA Caribbean Healthcare System Quality Management, operating room (OR), and Post-Operative Care Unit staff as well as surgeons. We asked the following survey questions: (1) “Do you have any concerns about the reporting of incidents in surgery?” and (2) “Are incidents in surgery being reported as required?” We had an 11 percent response rate to the survey; no employees reported concerns about incidents in surgery on the survey. For purposes of this review, we used the terms incident, adverse event, and occurrence interchangeably. Surgical Service staff completed a Critical Incident Tracking Notification report when incidents occurred, including deaths in the OR, incorrect surgery (wrong patient, wrong procedure, wrong side/site, wrong implant), retained surgical item, OR fire, and OR burn. This information was aggregated and included in the quarterly National Surgery Office report and reconciled with records from the National Patient Safety Office. We found the facility had an electronic system for reporting incidents. The facility Patient Safety Improvement Program described a “culture of safety,” which includes identification and reporting of incidents, review of incidents to determine underlying causes, and implementation of changes to reduce the likelihood of recurrence. The Patient Safety Officer provided us a copy of the training provided to all employees during facility orientation. We made no recommendations.