Medical Research: What are the main findings of the study?
Dr. Loftus: This study demonstrated that a standardized safe surgery program effectively and systematically implemented across a diverse healthcare system resulted in a significant reduction in serious reportable events (SREs), thereby improving the quality of patient care and leading to significant cost avoidance. For the purposes of the study, SREs were defined as any reported retained surgical item, wrong site, wrong patient or wrong procedure event. Following implementation of the Safe Surgery Program there was a 52% reduction in the SRE rate in the operating rooms and L&D areas in our system. The most dramatic change and greatest area of improvement was in wrong site events which demonstrated a 70% reduction for this type of serious reportable events.
This was achieved through a Safe Surgery Program which consisted of three main components.
- The first component was patient focused procedures. These are steps designed to prevent wrong site, wrong patient or wrong procedure events.
- The second component was sponge, sharp and instrument count procedures. These are steps designed to prevent retained surgical items.
- The final component was monthly observational audits that were performed to assess program compliance.
Medical Research: What was most surprising about the results?
Dr. Loftus: A couple of things stood out. Despite improvements in the serious reportable events rate a subset analysis of robotic assisted surgery demonstrated a seven fold increase in the serious reportable events rate compared to non-robotic surgery. This was present during the baseline period and after the implementation of the Safe Surgery Program. It is difficult to say whether this higher risk is specifically due to the robotic technology or the types of cases being performed on the robot. Either way, we believe that an awareness of this concern is warranted despite the limitations of the data. We are currently evaluating additional processes that will need to be in place to address this issue.
Another finding that may not be apparent is the overall improved serious reportable events rate was achieved without the routine use of checklists. Much of the recent process improvement literature regarding serious reportable events has focused on the use of checklists. While a checklist was used for the observational audits, they were not routinely used during the implementation of the other components of the Safe Surgery Program. The key to this program was addressing the strengths and weaknesses of human information processing. Checklists may be one way to overcome these barriers however; as this study demonstrated they are not the only way.
Medical Research: What should clinicians and patients take away from your report?
Dr. Loftus: The most important thing to remember is that a standardized Safe Surgery Program that is effectively implemented is worth the effort in order to reduce serious reportable events. If you are concerned about the size or complexity of your system, keep in mind, this program was successfully implemented across a diverse healthcare system composed of twenty-two hospitals, ranging in size from an 18 bed critical access facility to a 668 bed Level 1 trauma center, along with 8 ambulatory surgery centers. It can be accomplished by focusing on the following overriding themes: a consistent message, engaged leadership, clearly articulated procedures, and expected performance standards for all personnel.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Loftus: Two immediate ideas come to mind.
The first is to recall that while we significantly decreased our serious reportable events rate, we did not reduce it to zero. There is still work to be done, especially in regards to retained surgical items. The one area we identified at high risk, robotic assisted surgery, will especially need to be addressed. We will need to better understand what is happening during these procedures to predispose them to a higher serious reportable events rate. Our program is currently investigating options to explore in this regards.
The second area of research is to understand if this program has a similar effect in other areas (Cath Lab, Interventional Radiology and Endoscopy) as it did in the operating room and L&D areas. We recently completed the implementation of the program in these areas and are waiting to complete the analysis.
Terrence Loftus, MD, MBA, FACS, Deb Dahl, BSE, MBA, FACHE, Bridget OHare, BS, MS, ASQ, SSBB, Karlene Power, RN, BSN, MSN, Yvette Toledo-Katsenes, BA, MBA, Ryan Hutchison, BSIE, MBA, David Jacofsky, MD Kathleen Harder, PhD