• Stephen Harden

Why the Universal Protocol Hasn’t Eradicated Patient Harm

...And the Three Things You Must Do About


According to a recent report in the Archives of Surgery, patients undergoing surgery still risk being victims of stunning medical mistakes including procedures done on the wrong surgical site and undergoing surgery intended for another patient.



To try to curb the rate of surgical errors, the Joint Commission in 2004 introduced a Universal Protocol for all hospitals, ambulatory care facilities, and office-based surgical facilities to follow. However, even though these steps have largely been adopted, errors continue to happen.


The study’s author, Dr. Philip F. Stahel, a visiting associate professor at the University of Colorado-School of Medicine in Denver, had this to say about the research: “What is shocking about the data is that each and every one of those wrong-site, wrong-patient errors is really an event that should never happen. These happen much more frequently than we think.”


“This is just the tip of the iceberg” he said, “introducing the Universal Protocols has not reduced the frequency of these events.”


During the research done in Colorado, doctors reported 27,370 adverse events that happened between January 2002 and June 2008. Among these, the researchers identified 25 wrong-patient and 107 wrong-site operations. The report cites the reasons for these mistakes.


Not surprisingly, 100 percent had poor communication as a root cause.


And 72 percent were due to not performing a “Time Out” as required by the Universal Protocol.


At LifeWings, we’ve helped almost 250 organizations create and implement a successful Time Out process that really does eliminate patient harm. From that experience, here are three things you can do to fix these problems with your Universal Protocol.


  1. Make sure your physicians lead the Time Out. In aviation, the Captain of the aircraft always “calls” for the checklist at the appropriate time. The Captain has the responsibility to start the checklist and to make sure that it is accomplished correctly and in its entirety. Once the checklist is started, he can delegate portions of the checklist to others, but the Captain has the ultimate and final responsibility to lead the checklist process. If you are unsure how to get your physicians to take this responsibility and to lead the Time Out, see Bonus Tip number 1 below.

  2. To cure communication failures during the Universal Protocol, give as many folks as possible a “speaking part” in your Time Out process. Knowing that they have a speaking part and will have to verbally respond to a checklist item creates mindfulness, focus on the process, and participation. No one wants to be the person not prepared and gumming up the works.

  3. Make sure your Time Out is a true “challenge and response” checklist, requiring a real cross check with two or more sets of eyeballs confirming critical items--and not just a “tick sheet” where one staff member independently puts a check in the box when they think an item has been completed. A “tick sheet” mentality is the number one reason we see for failing to complete the Time Out as required.


As Dr. Stahel, the author of the report notes, “... Now we hide behind a safety system that should cover the problem. The Time Out is performed, but people are not mentally involved--the system alone cannot protect you from wrong-site surgery.”


Dr. Stahel is absolutely spot on. The Universal Protocol is not going to protect your patients if your teams are not going to use the safety system correctly.




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