Healthcare Inspection Patient Safety Issues VA Caribbean Healthcare System San Juan, Puerto Rico

The purpose of this review was to determine the validity of allegations regarding disinfection of endovaginal transducers at the Mayaguez Outpatient Clinic (OPC), leak testing of endoscopes in the hospital and at the Ponce OPC, certifications of compliance with reusable medical equipment (RME) reprocessing procedures and training, and management responsiveness to warnings of unsafe practices in reprocessing RME. We substantiated that: (a) endovaginal transducers were not properly disinfected, (b) leak testing was not performed on colonoscopes in the Operating Room or on laryngoscopes in Radiotherapy and at the Ponce OPC, (c) the system inaccurately certified compliance on three occasions, and (d) senior managers were aware of these issues and took no action to assess the risk to patients. We also learned that laryngoscopes in Radiotherapy were not properly pre-cleaned and a leak was discovered in one that was in service during this period. As a result of our findings, issue briefs (IB) were provided for pre-CRAAB (Clinical Risk Assessment Advisory Board) review. The Radiotherapy IB did not contain information about improper pre-cleaning. Following our visit, an Administrative Investigation Board (AIB) was completed to address management responsiveness. We recommended that an appropriate risk assessment, based upon findings of improper laryngoscope cleaning in Radiotherapy, be performed and appropriate actions taken. We also recommended that the VISN Director follow up on all recommendations from the AIB and take appropriate administrative action.