A number of famous writers have been touting the use of checklists as a way to create patient safety. Here's the problem with this thinking told in the form of a real life story.
Years ago when I was still CEO I was alerted by the president of the hospital that a wrong sided surgery had occurred. She assured me a root cause had been started and we would know shortly the cause. Two days later another wrong sided surgery occurred. The President called me again this time noticeably shaken, and said she had no idea what was going on and she had consulted her Toyota Production System sensei and he had recommended a containment process that essentially meant we had to shut down all the operating rooms until the problem was isolated and "contained". The purpose of containment is to stop the production process and solve the problem so the same problem can't be passed on to the next customer. Despite a lot of political push back from doctors who didn't think this drastic action was necessary she shut down all the ORs with my full support.
What does this have to do with checklists? The analysis of the above real life story showed that part of a checklist called the "timeout" was not being followed. The timeout is the few seconds before surgery is started during which all members of the surgical team stop and a series of questions are asked regarding the surgery including the patient's name,type of procedure, and where the procedure is going to be done,right side vs. left side for example. There had not been a wrong sided surgery in the organization for nine years so why all of a sudden were there two? We found the surgical teams were not following their documented timeout procedure? The question was why?
This is where it becomes more than just a checklist. A process such as a timeout is what lean leaders and practitioners know as standard work which checklists can be considered a form of. But the key to standard work is actually doing it. How do we know if the standard work is being followed? The only way to know is to actually observe the work and understand whether standard work is being followed or not. So a checklist is great if it's being followed. What we found was that we didn't know whether the timeout procedure was being followed by every team in this critical time just prior to surgery.
Process observation is an important management tool which involves a person in the organization,manager, supervisor, or front line staff member, actually observing other staff do work. This is not done for punitive purposes but for understanding where improvement can occur. If, for example, a process observation shows that no staff member is actually following the established standard work a number of conclusions can be drawn. In our experience the most common reason is the standard work does not work. In other words, the process established either is missing critical steps or there has been a change in the patient environment making the standard work obsolete. This requires the staff members to re-write standard work with the new appropriate steps and then determine if this standard work delivers the desired outcome. In the example above the outcome is zero wrong sided surgeries. Another common reason we have found for standard work not to be followed is the staff have not been trained. In healthcare there is a lot of turnover and part time players. Sometimes there are gaps in education and process observation can identify these gaps in.
This is a management process called Kamishibai and is an important component to improving performance. This is not the only important management process leading to 100% reliability in patient safety outcomes but it is one critical component.
So what happened in our story. Once the management team realized standard work was not being followed a team of doctors and technicians quickly came together and redesigned the initial timeout procedure from nine years prior and then at an emergency meeting of the medical executive committee of the medical staff it was approved. The medical staff leadership voted to make this new timeout procedure part of the requirement of doing surgery in our surgery centers(which it had been before but they wanted to reinforce the point). They also agreed to update the standard work as new ideas were surfaced in the ORs for improvement but made it clear this was not negotiable, all surgeons would be performing the timeout procedure. 99.9% of surgeons were on board and agreed, a couple didn't and left. The ORs were reopened and 100% of all surgeries for the next several months had an independent process observer to determine whether standard work was being followed. Once there was 100% compliance the audit process became random but still part of a standard work process observation calender led by front line managers and audited several times a month. The timeout process has changed slightly over the years but essentially is quite similar to the process established by surgeons nine years before the two wrong sided surgeries.
As you can see, delivering zero defects in patient safety is about more than simply checklists. The lean management system is required to actually sustain results and identify improvement. If you are interested in more details about this management system and other real life examples of patient safety problems I refer you to our book "On the Mend".
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