HospitalInspections.org

Based on interview and record review the facility 1) failed to ensure their QAPI (Quality Assessment and Performance Improvement) program monitored implementation of an action plan that had been developed following a sentinel event (an unexpected occurrence involving the risk of, or actual death, or serious physical or psychological injury) for 1 patient (#1), and 2) failed to ensure a root cause analysis (RCA) that had been started for an adverse event (identified as a near miss) for 1 patient (#11) was completed. Not ensuring sentinel events and near misses were investigated, performance improvements implemented, and the process was reevaluated for effectiveness, placed other patients at risk for experiencing similar adverse events. Findings:


Patient #1


Record review on 9/4-6/12 revealed Patient # 1 received surgical services at the facility on 1/31/12. The Patient subsequently experienced increased pain and developed an infection at the surgical site. Follow up with the Patient's physician revealed a surgical sponge had been left inside the Patient during the surgical procedure.


Review of the QAPI documentation revealed the facility had identified Patient #1's event as a sentinel event and had initiated a root casual analysis (RCA), to determine the cause of the event and develop a plan to mitigate the risk of future reoccurrence.


Review of the RCA's "Risk Reduction Strategies" revealed the facility was to "Review count policy with staff quarterly", "Incorporate a demonstration, and reinforce expectations to comply with policy", and "Revise policy to state that count bags [a sponge containment system used for counting sponges in the operating room] will be used on all procedures". There was no information in the action plan about how the effectiveness of the interventions would be monitored.


Review of the facility's policy "Count-Sponges, Sharps [and] Instruments", effective date 3/2010, revealed it had not been revised as outlined in the RCA. It had not been updated to include the use of count bags.


Review of the documentation for "Sponge, Sharps [and] Instrument Counts" inservice provided to operating room (OR) staff on 4/4/12, revealed the original, unrevised policy was attached.


During an interview on 9/4/12 at 1:15 pm, when asked how the interventions were monitored, both the OR Director and Assistant OR Director replied they had monitored the sponge counts in the OR for 3 months.


On 9/5/12 documentation of the sponge count monitoring was requested from the QAPI Director. During an interview on 9/6/12 at 8:30 am, the QAPI Director stated there was no documentation that monitoring had been completed. In addition, she disclosed there was no documentation that any follow up staff education on sponge counts was completed 3 months later.


During a second interview on 9/6/12, at 9:10 am, the QAPI Director confirmed the revisions to the policy, to include use of bags for counting, had not been completed.


Patient #11


Review of the facility's event log for near misses on 9/4-6/12 revealed that on 3/12/12 a tourniquet had been discovered on Patient #11's left arm after 30 minutes in the post-anesthesia care unit. Further review of the log revealed the section to write the date the action plan was completed was blank.


Review of the documentation attached to the event log revealed an RCA meeting was held on 6/26/12, over 3 months after the event. Further review revealed "No action plan as of 8/31/12", over 5 months after the event.


During an interview on 9/6/12 at 8:30 am, the QAPI Director was asked about the RCA. The Director confirmed that, although it was the facility's policy to complete RCAs on near miss events, this RCA was not complete.


Review of the facility's policy "Sentinel Event/Root Cause Analysis", effective date 9/2011, revealed "Criteria for acceptable action plan" includes identification of "how the effectiveness of the actions(s) will be evaluated."