HospitalInspections.org

Based on the review of documentation and interviews, it was determined that the facility failed to maintain high standards of medical practice. Specifically, after a known incident of the dislodging and patient retention of a piece of a robotic surgical instrument, the hospital failed to implement processess to avoid the reoccurance of such an incident.
Findings:
During an interview with the Operating Room Supervisor for the Robotics Team on 03/13/2014 at 1245, when asked if there was a form or area in the electronic medical record that documents that the circulating nurse or other staff inspects the tip of the instrument he/she stated "There is no documentation of the check of instruments done before or after each use."

During this interview it was determined that each of the "Mega Needle Drivers" have a limited lifespan of 10 uses. When asked how the staff determines how many times a particular driver has been used he/she stated "they must go into instrument management [software from Intuitive Surgical] to find that out. The machine will not work if there are no lives left." After it is determined that the instrument is on it's last life it is discarded by the circulator at the end of the case. This being the case, the instrument did not go to Central Sterile where it would have been inspected.

During an interview with the OR Manager on 03/13/2014 at 1445, the root cause analysis that was completed by the hospital related to this incident was reviewed. The root cause analysis revealed that "Indeed adequate staffing was in place, the staff had followed established practices and those involved were familiar with the equipment. The piece was said to have fallen off unnoticed and that it was likely that the da Vinci arm was on its last life and discarded at the end of the case. Therefore the broken piece was not detected. In response to the root cause analysis, the actions that were taken were to increase awareness that the inserts have a potential to fall off and go unnoticed, to share the incident with all staff, and to educate OR staff."

The OR Staff created the "Patient Safety Lesson" that described what happened and what patient safety lessons they wanted to share which stipulated:
? "Recognize and take action on a potential hazard. Check instruments for parts that could become dislodged and left behind.
? If you cannot eliminate the potential hazard, strengthen communication and build in safety processes that will help minimize the risks.
? This OR team created a checklist list of items to account for at the end of the procedure.
-Write a reminder on the white board.
-LH [Legacy Health] policy calls for an x-ray before closure if there is question of a retained piece."

When asked at the end of the review of the root cause analysis if they had documentation that the instrument check was being completed as described, the OR Manager replied "no." When asked if the OR Manager had any documentation of training/education given to the staff and any related sign in sheets or rosters of training he/she stated "I cannot put my hands on them."

The hospital failed to design, implement, monitor and evaluate a mechanism to assure that surgical services were provided in accordance with acceptable standards of practice as required by this regulation.