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ROCHESTER GENERAL HOSPITAL
INFECTION CONTROL PROFESSIONAL
Tag No.: A0748
Based on document review and interview, the facility does not ensure that facility policies and procedures are followed regarding event reporting of "near miss" events and the packaging of surgical instruments for terminal sterilization.
Findings include:
Review of facility Policy and Procedure entitled "Event Reporting" last revised 9/18 stated any incident, including near miss events is to be reported via the online event reporting system. Near miss events are potential errors which did not reach the patient and/or where the patient was not involved in any way.
Interview with Staff (C), Manager Sterile Processing Center on 1/29/19 at 11:00 AM revealed that on 9/11/18 surgical trays were sent to the operating room that had not completed the sterilization cycle. The trays were immediately recalled and returned to sterile processing for re-sterilization. Staff (C) stated that event reporting was completed through the facility's safe connect system.
Review of event reporting from September 2018 did not reveal evidence of report of the near miss event that occurred on 9/11/18.
Review of facility Policy and Procedure entitled "Packing Items for Terminal Sterilization" last revised 1/16 stated items packaged for terminal sterilization will be done so in a manner that allows for proper sterilization, provides an adequate barrier to microorganisms and allows for ease of aseptic presentation. Procedure for sterilization containers includes placing an internal steam chemical indicator strip in the tray before being wrapped. Single item instruments are placed in a pouch with appropriate internal chemical indicator strip that is visible to the user of the item.
Review of OR (Operating Room)/SPC (Sterile Processing Center) Issues Log dated 1/29/19 revealed no chemical indicators were found in one instrument tray and one instrument package by Operating Room staff. Instruments were returned to sterile processing for re-sterilization.
Interview with Staff (B), Manager Clinical Regulatory Compliance and Staff (C), Manager Sterile Processing Center on 1/31/19 at 10 AM verified the above findings.