The Universal Protocol is an integral part of practicing medicine, particularly in surgical and otherwise invasive procedures. The protocols were put in place to ensure that the right procedure is performed on the correct patient, so that not only are signs of adverse reactions to sedatives and medications aren’t missed until it’s too late or that the correct patient gets the right procedure at the right site. The idea behind the protocol is sound, but implementation has been spotty and things that should have been caught have not. So the question becomes, does the method work and work well. If it doesn’t work well, what can be done to improve it?
Whenever crucial steps have been reported in the process, they always point to human error as the major cause. Whether through carelessness or over-confidence, this seems to be the common thread. So it would seem that retraining of medical professionals is the only way to ensure that critical and possibly life threatening mistakes don’t happen.
The Universal Protocol was formally adopted in the United States in 2004 by The Joint Commission with the aim of lowering the risk of “wrong surgery”. The prompt for procedural guidelines was mostly in response to a 1998 study that found among specialties, twenty-five percent of orthopedic surgeons were at risk of a wrong surgery at least once in their careers, the Sign You Site campaign was born within the orthopedic surgery community, with the American Spine Society launching their own campaign soon thereafter. In the years since then, of all the hospitals observed for at least a year to ensure adherence to the protocol, the highest rate of compliance of any hospital was only seventy-two percent.
The formally adopted World Health Organization (WHO) Surgery Safety Checklist, a global checklist introduced in 2008, prescribes a three part phase for all surgical procedures. The Sign-In phase is the first and should be conducted when the patient is first arrived and before the introduction of anesthesia, the Time-Out phase before the start of the procedure to check that the correct surgery site has been marked and the patient is not showing adverse reactions to anesthesia, and the Check Out phase ensures that the patient is not in distress and capable of being discharged. Paradoxically the Joint Commission reported an uptick in wrong surgery after the implementation of the Universal Protocol.
Barriers to Compliance With the Universal Protocol
In response to the increase in wrong surgery, the WHO instituted an expanded preoperative checklist to determine what the reasons were for the trend. A 2011 study of compliant hospitals over a year found that many times the checklists were being used improperly by staff, when used they were only used compliance of both pre and post op checklist were done at a rate of between sixty and sixty-eight percent of the time, the Check Out phase was only used at a rathe of fifty-three percent over a year.
The failure in implementation of the checklist seem to be a combination of both patient and healthcare provider attitudes, and. Among the hospitals and staff observed, it was found that patients were often dismissive in regards to the questions asked and went unchallenged in their answers. Nurses often caved under time pressure from surgeons and anesthesiologists which resulted in incomplete checklists from start to finish. In some cases medical staff expressed unfamiliarity with the procedures of the checklist, their subsequent embarrassment often caused them to rush through the procedure and resulted in missed steps.
The power structure of operating rooms can also contribute to steps being missed when the nurse in charge of running the checklist is being or is unsupported in efforts by the surgeon and/or anesthesiologist. The Time-Out portion of the checklist can also be difficult to perform if the patient has already been draped or in an emergency situation as it makes them difficult to identify. By and large however, both anesthesiologist and nurses seem to think the checklist an integral part of a smooth running OR, conversely a high percentage of surgeons found it to be tedious and a waste of time.
When asked, many practitioners cited a prevalence of poorly worded checklists as another reason that many aren’t used or remain incomplete.
Effects of The Protocol on Patient Safety
Although on first glance it may look as if the checklist is failing, there is no denying that the improvement to patient safety has been boosted in the operating room by decreasing post surgical mortality rates as well as those complications that can arise post surgery. One of the biggest stumbling blocks to ensuring patient safety before, in and outside of the OR is team communication. The checklist forces teams to communicate and cuts down on wrong surgery procedures greatly.
A 2013 survey of seventeen surgical teams in Boston, found that higher adherence to the phases of the checklist helped in cutting down on surgical crises in the OR, and when they did arise were easier to control and diffuse. The pause that the checklist forces aids practitioners to look at each case individually, particularly in specialty fields where a surgery may be the fourth of its kind being performed that day.
Tweaking Checklists and Higher Compliance Going Forward
There really aren’t enough recent studies done to show just how effective or ineffective the checklist truly is, but it still remains that in all of the hospitals observed, compliance in all parts of the checklist does aid in higher patient safety, particularly when done in the OR.
The Time-Out phase is the step designed as a last stop before something perhaps irreversible happens. This is the point where the team should be reviewing everyone’s role in the surgery, making sure that the characteristics of the patient on the table matches the information they have. Going over the planned operation, making sure that all equipment and materials are in place and ready, as well as assessing any potential issues that may crop up for the patient. Yet this is the step that is most often dismissed and rushed through. There needs to be more stringent adherence to this particular step to in the form of having one dedicated team member that performs the step each time, in addition to more support from lead surgeons and anesthesiologists.
A suggested fix to helping teams become more compliant and comfortable using checklists would be to have them tweaked to a particular field with more relevant questions that team members can’t just skip or gloss over, because they’re more pertinent to the field. A Dutch study found that when checklist were thus relevant, teams tended to be more compliant and incidences of wrong surgery were greatly decreased. Harvard’s Dr. Atul Gawande one of the authors of the WHO checklist, maintains that even with the best of intentions though, a checklist not backed by formal training in how to complete, implement along with stressing the importance of the checklist is destined to fail. He advocates specialized training of at least three months in order for teams to become fully compliant.
The Universal Protocol is by no means foolproof, there is still a lot of work and improvement that can happen on the provider side. While almost widely recognized as essential to team communication and thus patient safety, the most pertinent issues facing practitioners now are ones of human error along with coming to terms with attitudes towards the protocols and addressing them to provide greater compliance and a safer patient environment.