Your Patient Safety Survival Guide

by Gretchen LeFever Watson

  Gawande told National Public Radio that when he first brought the Universal Protocol to surgeons for their use in the operating room, the predominant response was, “This is a waste of my time, I don’t think it makes any difference.”24 Of those Gawande was able to convince to give it a try, 80 percent did not want to give it up. Another 20 percent remained dead set against using it even though 93 percent of the latter group indicated that they would want it used if they were undergoing surgery!25

  Overcoming Resistance

  Despite its simplicity and the proven effectiveness of this behavioral tool, it has not been universally implemented in US hospitals and surgical centers26 or outpatient settings where invasive procedures are performed. Even in hospitals where use of the checklist has been adopted as policy, many physicians continue to resist using it or use it inappropriately. The resistance to its proper use is strong, as exemplified from this excerpt from The Checklist Manifesto:

  We doctors remain a long way from actually embracing the idea. The checklist has arrived in our operating rooms mostly from the outside in and from the top down. It has come from finger-wagging health officials, who are regarded by surgeons as more or less the enemy, or from jug-eared hospital safety officers, who are about as beloved as the playground safety patrol. Sometimes it is the chief of surgery who brings it in, which means we complain under our breath rather than raise a holy tirade. But it is regarded as an irritation, as interference on our terrain. This is my patient. This is my operating room. And the way I carry out an operation is my business and my responsibility. So who do these people think they are, telling me what to do?27

  In 2010, Gawande shared with National Public Radio listeners that he himself did not adopt it right away. After having convinced eight US hospitals to use the Universal Protocol and observe its value, he said he felt like a hypocrite for not using it. When he finally started using it, Gawande found the Universal Protocol “massively” improved the safety of his surgeries, noting, “I have not gotten through a week of surgery where the checklist has not caught a problem.”28

  While consulting with a hospital system that had (in theory) adopted the use of the Universal Protocol, I encountered a group of orthopedic surgeons who had experienced at least nine off-the-mark operations within a year. It quickly became evident that they—just like the physicians at Rhode Island Hospital where the three wrong-side brain surgeries occurred in a single year—had not incorporated the Universal Protocol into their workflow even though the hospital had adopted it as part of its policy. (As the saying goes, culture trumps policy.) After much pushback, a key hospital administrator settled on having orthopedic surgeons adopt parts of the Universal Protocol while allowing them to skip some steps associated with the first two time-outs before their patients were anesthetized. Not wanting to lose their business to another hospital in the area, the administrator caved to the surgeons’ complaint that strict adherence would require them to redesign their workflow and would cost them time and money.

  At the time, I was apoplectic with frustration. Later, I would learn that Gawande—perhaps the most prominent champion of the Universal Protocol—had discouraged hospitals from mandating obstinate surgeons from using the checklist or using it as it was designed. Gawande reasoned—correctly, I believe—that a backlash could form under a “forced regime.” A single surgeon with a soured attitude could disparage the checklist and discourage others from trying it or using it appropriately.29 While this might have been the best response when the Universal Protocol was a new checklist and in the early stages of implementation and testing, it is hard to imagine that informed patients would be equally tolerant today. Nonetheless, the manner in which the checklist becomes universally adopted is critical to its success.

  Think again about the three wrong-brain surgeries within the span of a year happening at an Ivy League teaching hospital. With the benefit of hindsight, it became clear that surgeon buy-in about the hospital’s Universal Protocol policy was lacking, and that this contributed to surgeons not using (or properly adhering to) the protocol. And as we know now, personnel outside the operating room had not been educated about the importance of getting things right before scheduling patients or sending patients to the operating room. To elicit full compliance will always require some modification of a hospital’s broader-care delivery system.

  Knowing that any surgical team is capable of committing an off-the-mark procedure and that the Universal Protocol is a powerful, efficient, and an essentially cost-free error prevention tool, it is hard to continue to excuse surgeons and other healthcare providers from using it. (Anecdotally, I am happy to report that the hospital where I recently underwent orthopedic surgery used the Universal Protocol in its entirety. Furthermore, it had incorporated the essential steps into information displayed on whiteboards on the wall in every patient’s preop area. And the information was easy for everyone to see, including the steps that have been completed or still need to be completed.)

  So, what can be done to ensure that the Universal Protocol is universally adopted in all hospitals and that referring clinics prepare patients to actively participate in the process? You can probably guess that generating interest in its use from the ground up is going to be the key to success. When healthcare providers begin to encounter patients who are sufficiently informed to request the Universal Protocol as part of their surgical or invasive care, they will shift from viewing its use as something forced on them from the-powers-that-be to considering it a choice they are willing to make to protect their business and their patients.

  Making Sure the “Stupid Stuff” Isn’t Missed

  The main purpose of the Universal Protocol is to eliminate off-the-mark procedures. However, this power-packed checklist also contains steps to ensure that potentially life-threatening details are not overlooked. During the preincision time-out, the checklist forces the surgical team to determine whether the correct and essential blood products, implants, devices, and special equipment are available before the first cut—the very things that could have made a difference in cases already discussed. While some have claimed that the Universal Protocol will not eliminate every single off-the-mark procedure, there is evidence that it can eliminate at least 73 to 75 percent of them.30 If referring clinics were to be included in implementation processes, success would probably be higher (perhaps close to 100 percent) because over 10 percent of off-the-mark procedures are due to the surgical facility receiving incomplete or inaccurate information from referring medical offices.31 Furthermore, there has been haphazard implementation of the checklist, lack of proper education regarding its use, and ongoing tolerance of an operating room culture with “tribal” affiliations between team members with clashing priorities.32

  Even surgeons, who believe the tool is unnecessary, agree it is nearly impossible to argue that its use could be harmful. Once patients begin to understand the power and protection offered by consistent and proper use of the Universal Protocol, they—just like nearly all surgeons who used it—would want it to be used as part of their care.

  Really, who can deny that modern medical care has become so complicated and fractured that it is simply not safe to perform an invasive procedure, including surgery, without conducting a preprocedure checklist? As surgeons and patients come to appreciate that the Universal Protocol is a checklist that is designed to make sure the “stupid stuff” isn’t overlooked while clinicians are focused on complex clinical decisions, we will be well on our way toward widespread adoption of this powerful tool.

  Greater Expectations

  The public gasps when they hear the occasional news stories about horrific off-the-mark procedures, like those experienced by Willie King, Susan Buchweiz, Baby Jessica, and Jésica Santillán. And rightfully so. Since the average person experiences seven surgeries in his lifetime, we all have skin in this game of getting things right. When the day arrives for your surgery or otherwise invasive procedure, you—like su
rgeons—are likely to be concerned about a lot of things (or overfocused on a few big things to the exclusion of some little things).

  Nonetheless, as a patient, you have the greatest opportunity to protect against an off-the-mark procedure33; most of us just don’t know it. That is why widespread understanding of the importance of the Universal Protocol, including performing preprocedure time-outs with patients’ active involvement, must become the established routine. We need to get to the point where beginning the procedure without these vital pauses will come to feel as awkward as driving a car without a seatbelt now feels to most Americans. But everyone—not just surgeons—needs a structured process to make sure the “stupid stuff” isn’t overlooked. Once you are wheeled into the operating room or procedural room, your ability to impact what transpires is limited. That is why there must be a “hard stop” to prevent the procedure from beginning without the third and last time-out.

  In The Checklist Manifesto, Gawande recounts a clever “hard stop” method a surgeon devised for making sure he remembered to perform the third and final time-out of the Universal Protocol. The surgeon designed a metallic tent that was six inches long—just long enough to cover a scalpel—that was stenciled with the phrase “Cleared for Takeoff.” He arranged for the tent to be placed in the surgical instruments kit. He instructed nurses to set the tent over the scalpel while laying out the instruments to be used in each surgery. This served as a cue—the sort of reminder that we all need—to run through the preincision time-out before the first cut. Furthermore, it also established that the surgeon could not begin the operation before the nurse gave her okay by removing the Cleared for Takeoff tent.

  As you will read in chapter 6, what Gawande stumbled upon was a good example of a solution that had been “invisible in plain sight.”

  Seize the Day!

  Compared to Semmelweis’s fate for championing change, Gawande’s has been golden. As described in chapter 3, Semmelweis, a surgeon in the early 1800s, was one of the first to proclaim that handwashing could eliminate the infections that were killing mothers who delivered their babies in Vienna hospitals. Semmelweis turned out to be correct, but his contemporaries never accepted his view. Rather, they declared him a lunatic, drove him out of town, and forced him into an insane asylum where he died from an infection. Fortunately for all of us, Dr. Gawande’s peers have heralded him as an accomplished surgeon, a superb writer, and an internationally renowned medical innovator.

  Carpe diem! Let’s seize the day by putting Dr. Gawande’s checklist manifesto into proper practice across the country and throughout the world. Let’s make universal use of the Universal Protocol.

  Taking It to the Streets

  Dr. Gawande’s work and leadership on checklists has set the stage for engaging surgeons in the use of the Universal Protocol. Just as it is true for the prevention of healthcare-associated infections and deadly medical errors, patients will need to become informed and active participants in efforts to promote consistent use of the Universal Protocol.

  In order to be able to confirm the correct procedure, physicians must learn to communicate clearly with patients about the name and nature of the planned procedure, and patients must learn the proper name of the procedure and what it involves. The days of passive patients who put blind trust in their physicians must come to a close. Patient passivity may never have been in the best interest of patients, but it most definitely is not a safe approach in today’s complex, complicated, and fragmented healthcare system.

  The tables below contain information that could be used to design educational campaigns and public alerts with corresponding sticky messages and sample language for communicating to prevent off-the-mark procedures. While it may not be advisable to adapt the Universal Protocol apart from systematic testing, the manner in which its material is communicated to the public can be adapted to meet a given hospital’s or community’s needs and preferences—a point discussed further in chapter 6.

  Table 4.2.

  what you need to know

  Off-the-Mark Procedures

  Information for Patients

  Each year thousands of surgeries and other invasive procedures are performed that involve the wrong patient, wrong body part, wrong place on a body part, or wrong procedure. These are called off-the-mark procedures (or wrong-site surgeries). When scheduling and performing surgery and other invasive procedures, minor errors can lead to major disasters.

  To prevent common mix-ups, you must know the name of the procedure and exactly where the procedure will be performed on your body. On the day of the surgery, the healthcare provider who is going to operate will speak with you before you are sedated. Together with you, that provider will verify your identity, the name of the procedure, and where it is to be performed. The provider will mark your body in the right place. If any of these steps are overlooked, it is important to speak up before you are sedated.

  Before allowing anyone to sedate you, make sure the provider who will be treating you takes a time-out to review your name and date of birth, the procedure you are to have, and marks your body accordingly. Speaking up for safety is not about challenging providers; it is about helping them. By participating in this process, you can help prevent tragic mishaps.

  Information for Providers

  When performing surgery and other invasive procedures, minor mix-ups are easily made, and such errors can have disastrous consequences. Therefore, the Joint Commission now requires use of the Universal Protocol to prevent off-the-mark procedures (also called wrong-site surgeries).

  Through meticulous testing and revision, the Universal Protocol has emerged as an efficient and effective checklist that has the capacity to eliminate most, if not all, off-the-mark procedures. The beauty of the Universal Protocol is its balanced brevity and effectiveness. In addition to preventing off-the-mark procedures, the Universal Protocol ensures relevant documentation is present, diagnostic and radiology tests results are labeled and properly displayed, and any required blood products, implants, devices, and special equipment are available. The two to three-minute process required to complete the Universal Protocol also builds cohesion among team members, which increases the likelihood that someone will speak up for safety if necessary.

  The Joint Commission now requires use of the Universal Protocol; however, it is your responsibility to use it consistently and in the manner that it was intended. Using a checklist is not an expression of weakness; it demonstrates your commitment to delivering the best care possible. Even highly competent surgeons and world-renown facilities have found the Universal Protocol frequently catches minor errors that could have led to tragic mistakes. After trying it, almost all surgeons say they would want the Universal Protocol used if they were to undergo surgery. Yet too many still resist using it (or resist using it properly) due to their denial of human and system fallibility. Don’t be in denial.

  Table 4.3.

  patient action plan

  Off-the-Mark Procedures

  TIMING

  ACTION

  ✓

  Before scheduling a surgery or other invasive procedure

  I know what an “off-the-mark procedure” is.

  I understand that minor scheduling and preoperative mix-ups can lead to serious problems.

  I am aware that even the best healthcare facilities and most competent providers sometimes make errors that can lead to major mistakes.

  I know the name of my surgery or procedure and where it will be performed on my body.


  I reviewed the Universal Protocol handout the clinic gave me, or I have considered reviewing the protocol online.

  When scheduling a surgery or other invasive procedure

  I made sure the office confirmed:

  my name

  date of birth

  name of my procedure

  where the procedure will be performed on my body.

  I asked what lab tests or radiographic images the facility needs and who is responsible for getting them there.

  I asked if the Universal Protocol would be used with me.

  Before the day of the surgery or other invasive procedure

  I practiced what to say if a time-out is not taken with me to confirm three important steps:

  confirm my identity

  review the name or location of my procedure, or

  mark my body with the provider’s initials.

  I have considered having someone with me on the day of the procedure who can assist with this patient action plan.

  On the day of the surgery or invasive procedure

  Before I am sedated, I will make sure my provider:

  verifies my identity