The complexity of medicine has been acknowledged as one of the contributing factors of healthcare-acquired infections (HAIs), in that a greater use of medical devices and interventions invariably results in potential complications and infections. It is the acceptance of these adverse patient outcomes that consternates patient safety experts who are endeavoring to change the mindset of clinicians while using simple tools and strategies proved to fight HAIs.
A wry illustration in an issue of The New Yorker captured the essence of that bastion of complexity in hospitals, the intensive care unit (ICU) – it accurately portrays and skewers the tremendous tangle of wires and hoses that snake back to dozens of machines that lend life to the sickest and most vulnerable of patients. Gawande (2007) describes the chaos: “Machines break down; a team can’t get moving fast enough; a simple step is forgotten. Such cases don’t get written up in The Annals of Thoracic Surgery, but they are the norm. Intensive-care medicine has become the art of managing extreme complexity—and a test of whether such complexity can, in fact, be humanly mastered.”
Besides being complex, the ICU can also be a potentially dangerous place. As Gawande (2007) points out, “The average stay of an ICU patient is four days, and the survival rate is 86 percent. Going into an ICU, being put on a mechanical ventilator, having tubes and wires run into and out of you, is not a sentence of death. But the days will be the most precarious of your life ...A decade ago, Israeli scientists published a study in which engineers observed patient care in ICUs for 24-hour stretches. They found that the average patient required 178 individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them posed risks. Remarkably, the nurses and doctors were observed to make an error in just 1 percent of these actions but that still amounted to an average of two errors a day with every patient. Intensive care succeeds only when we hold the odds of doing harm low enough for the odds of doing good to prevail.”
The ICU has many insidious enemies, especially line-related infection. Catheter-related bloodstream infections (CRBSIs) cause considerable morbidity, mortality, and healthcare costs. An estimated 82,000 CRBSIs and up to 28,000 attributable deaths occur in intensive care units annually, and each infection costs about $45,000. (Pronovost et al., 2010) As Gawande (2007) observes, “This is the reality of intensive care: at any point, we are as apt to harm as we are to heal. Line infections are so common that they are considered a routine complication. ICUs put 5 million lines into patients each year, and national statistics show that after 10 days, 4 percent of those lines become infected. Line infections occur in 80,000 people a year in the U.S., and are fatal between 5 percent and 28 percent of the time, depending on how sick one is at the start. Those who survive line infections spend on average a week longer in intensive care. And this is just one of many risks. After 10 days with a urinary catheter, 4 percent of American ICU patients develop a bladder infection. After 10 days on a ventilator, 6 percent develop bacterial pneumonia, resulting in death 40 percent to 55 percent of the time. All in all, about half of ICU patients end up experiencing a serious complication, and, once a complication occurs, the chances of survival drop sharply.”
Gawande (2007) asks: “The ICU, with its spectacular successes and frequent failures, therefore poses a distinctive challenge: what do you do when expertise is not enough?”
One answer, according to a growing number of experts, is the humble checklist. It’s a tool used quite successfully in other industries, notably aviation, but its adoption in healthcare has been a slow process. A pioneer of the checklist is patient safety advocate Peter Pronovost, MD, PhD, a critical care specialist at Johns Hopkins University School of Medicine who in 2001, decided to tackle the problem of line-related bloodstream infections by first jotting down the five simple steps clinicians know they must take when inserting a line: engaging in proper hand hygiene, cleansing the patient’s skin with chlorhexidine gluconate, using sterile drapes, wearing proper personal protective equipment (PPE), placing a sterile dressing over the catheter insertion site when the line is in, and removing unnecessary catheters. While these steps, promulgated by the Centers for Disease Control and Prevention (CDC) are rooted in evidence-based practice and have been taught for years, Pronovost knew they were not being followed; he asked the ICU nurses to observe physicians and record how often the steps were completed. In more than one-third of the cases, at least one step was skipped. Pronovost convinced his institution’s leadership to allow nurses to question physicians if they saw them miss a step, and to intervene if necessary.
The experiment delivered unexpected results: a 10-day infection rate for lines dropped from 11 percent to zero. It was continued for another 15 months and during that time, just two line-related infections developed. Pronovost determined that this checklist and the empowerment of nursing staff may very well have prevented as many as 43 infections, eight deaths and saved the hospital as much as $2 million in complication-related costs. As Gawande (2007) notes, “Pronovost is hardly the first person in medicine to use a checklist. But he is among the first to recognize its power to save lives and take advantage of the breadth of its possibilities.”
The experiment was not without its detractors; some physicians balked at the checklists, while others questioned the evidence or whether the checklist concept would work outside of the well-resourced and staffed Johns Hopkins environment. Pronovost got his chance to expand his experiment in 2003 when he was invited by the Michigan Health and Hospital Association to apply his checklist in several Michigan ICUs and to then measure the outcomes to determine the validity of the process. Becoming known as the Keystone Initiative, in late 2006, it published its findings in the New England Journal of Medicine, and the paper was the talk of the medical community. The project substantially reduced infections in 103 participating ICUs; the median infection rate per 1,000 catheter days dropped from 2.7 at baseline to zero within three months after implementation of an evidence-based intervention. Eighteen months after implementation, infection rates had decreased by 66 percent from baseline.
Most importantly, Pronovost and his fellow researchers were able to show sustained reductions in CRBSIs. Pronovost, et al. (2010) conducted a cohort study to implement and evaluate interventions to improve patients’ safety by evaluating the extent to which ICUs participating in the initial Keystone ICU project sustained reductions in CRBSI rates. The intervention consisted of a model aimed at improving clinicians’ use of five evidence-based recommendations to reduce CRBSI rates, with measurement and feedback of infection rates. ICU teams were instructed to integrate this intervention into staff orientation, collect monthly data from hospital infection control staff, and report infection rates to appropriate stakeholders. The outcome measure of the study was the quarterly rate of CRBSIs per 1,000 catheter days during the 19 to 36 months after implementation of the intervention. According to the researchers, 90 of the original 103 intensive care units participated, reporting 1,532 ICU months of data and 300-310 catheter days during the sustainability period. The mean and median rates of CRBSI decreased from 7.7 and 2.7 at baseline to 1.3 and 0 at 16-18 months and to 1.1 and 0 at 34-36 months post-implementation. Pronovost, et al. (2010) concluded that the reduced rates of catheter related bloodstream infection achieved in the initial 18 month post-implementation period were sustained for an additional 18 months as participating intensive care units integrated the intervention into practice. They say that broad use of this intervention with achievement of similar results could substantially reduce the morbidity and costs associated with catheter related bloodstream infections.
Their study is significant, the researchers add, because of the dearth of robustly designed and evaluated large-scale quality improvement projects that have shown substantial improvements, as well as the paucity of projects that have evaluated the sustainability of their results. Equally important they say is the fact that in order for quality improvement initiatives in healthcare to be sustained, value must be demonstrated. The Keystone ICU project coupled a model to translate evidence into practice with a comprehensive patient safety intervention to improve culture, educate staff, learn from mistakes, and involve senior leaders. As Pronovost, et al. (2010) explain, “During interviews, ICU teams noted several factors that were important in sustaining this project, including continued feedback of infection data that the team perceived as valid, improvements in safety culture that occurred as part of the overall Keystone ICU project, an unremitting belief in the preventability of bloodstream infections, involvement of senior leaders who reviewed infection data and provided teams with the resources needed, and a shared goal rather than a competition to reduce infection rates throughout the state of Michigan. Other studies describe similar methods to facilitate sustainability, such as active support from leaders and an infrastructure that supports quality improvement methods, training of staff, involving key internal and external stakeholders, alignment of project and organizational goals, multidisciplinary teams and collaborations, and inclusion of change management that also encourages local adaptation and rewards innovation and change.”
What is at stake here is enormous. As Pronovost, et al. (2010) point out, “These findings have important public health consequences. If the multifaceted quality improvement intervention and collaborative model were implemented in all ICUs across the U.S., and the results were similar to those achieved in Michigan, substantial and persistent reductions could be made in the 82 000 infections, 28 000 deaths, and $2.3 billion costs attributed to these infections annually. Moreover, the use of this quality improvement model to reduce other complications may further improve quality and reduce costs of care.”
It’s not to say that the checklist is the end-all and be-all of patient safety initiatives. In the wake of Johns Hopkins’ success in virtually eliminating BRSIs in the ICU via the five-step checklist, the safety scientist who developed and popularized the tool cautions that they are no panacea. “Checklists are useful, but they’re not Harry Potter’s wand,” says Pronovost. “Without measuring infection rates, and without changing the culture where it’s alright if nurses and infection preventionists are empowered to speak up, checklists alone are not going to work. The checklist makes a great media story, but it’s a little too oversimplified. The science needed to best develop focused, unambiguous and succinct checklists for medicine’s thousands of diagnoses and procedures is in its infancy, and there can be unintended consequences of reliance on simple tools.” Pronovost continues, “The checklist is simply a tool to help someone complete a task, and they work best when they are linked in time and space; for example, at the moment when a catheter is inserted.”
Where checklists are exceedingly helpful is condensing the immense amount of information and guidance available for any given clinical intervention into an easy-to-implement strategy. “Medicine normally summarizes evidence in the form of practices and guidelines that are often elegant and scholarly, but they are long documents that aren’t really helpful at the bedside, which is where we live,” Pronovost says. “As an example, the Government Accountability Office (GAO) criticized the CDC for having something like 1,500 recommendations to prevent HAIs – who can do that many things? And if they are not prioritized, it’s hard for clinicians to know what to do and when. With a checklist, you can say, ‘OK, what things are most important and least harmful?’ and narrow it down. One of the main reasons guidelines aren’t used is their ambiguity; if they are vague with respect to who does what, when, where and how, they don’t get utilized. Sometimes guidelines are vague because the evidence is incomplete, so they say, ‘Well, we can’t really say what to do here,’ but the reality is, the poor doctor or nurse at the bedside doesn’t have that luxury, they have to make a decision. So the more I can incorporate that tacit knowledge into a checklist that is easy to follow, the better off we are going to be. So I see checklists as tools to help someone do their work by clarifying what’s important and reducing ambiguity about what needs to be done.”
While many safety principles are being adopted by healthcare from aviation, Pronovost says these tenets are derived from human factors engineering and can sometimes be too complicated for use at the patient bedside. He has whittled them down to three fundamental principles: standardize work whenever you can; create independent checks for things that are important; and learn when things go wrong. “Here’s how we apply that to reduced bloodstream infections,” Pronovost says. “Checklists clearly standardize what you do and then we asked hospitals to make sure they have line carts that have all the equipment to be used, and then we said to nurses, make sure the doctors actually comply with the checklist because they are human and we know they are going to forget a step. Then we say every infection that you have, you have to investigate and find out what went wrong -- by treating it as a defect you learn how to not do it again. These three simple principles, coupled with feedback about performance, are the essence of our program.”
But the principles cannot exist without a culture change that empowers staff to intervene when they see a step being missed. “We want to put this program in every hospital in the country but in some states, only 20 percent of hospitals are participating. When I ask them why, they say, ‘But we’re using your checklist,’ and I say ‘That’s great, but what are your infection rates?’ And the answer is uniformly that they don’t know or they are high. When I tell them they need to participate in the program they say, ‘But we’re using the checklist, I guess our patients are just sicker than yours.’ I always ask them, ‘In your hospital, if a new nurse were to see your most senior doctor placing a catheter who didn’t comply with the checklist, would she speak up and would he listen?’ I get laughed at – they say, ‘Are you nuts? Of course that wouldn’t happen.’ If people aren’t empowered, it’s not going to get done. There must be a culture change, and we must work together as a team. Far too often we treat each other as if we are doing battle instead of being on the same team, the patient’s team. Often it is the doctor against the nurse and what we don’t realize is, we are actually on the same team. “Central-line infection checklists work best, for example, when there is what we call a challenge and response, in which one person reads a series of items and a second person verifies that each item had been completed. With the check and balance of another person, the list is more likely to be completed properly.”
Despite what checklists can achieve, Pronovost also warns of checklist overload. “Creating too many checklists — especially those that are not proven to improve patient safety — or using checklists where they are not truly needed can be distracting and time-consuming,” he says, “and over-reliance on them can lead to a false sense of safety. Each step in the diagnosis, treatment and monitoring process poses risks for error that we need to defend against. We do not know how many checklists are too many, when they are most useful, when we have overloaded the checklist users or how strictly the benefits are being measured.”
In fact, the Johns Hopkins team says, the underuse of checklists that do work is a problem in part caused by the paucity of scholarly research on how best to use them, how to build and implement them, how to measure their effectiveness in improving patient outcomes, and how they can best be sustained in a culture that is slow to change. While standardization is at the heart of any checklist, Pronovost says checklists need to be continually assessed to be sure they are still accomplishing their goals.
A team of sociologists and healthcare researchers is calling for greater understanding of how checklists can be used to improve patient safety. Furthermore, say Bosk, et al. (2009), widespread deployment of medical checklists without an appreciation of how or why they work is a potential threat to patient safety and to high-quality care. According to the authors, the real threat to safety arises when a hospital thinks it has solved a problem by handing the workers a checklist and telling them to use it. The reality is that getting the checklist is just the beginning. The key, say the authors, is getting people motivated to cooperate.
“The big challenge is how to get staff to use checklists consistently,” says study co-author Charles Bosk, a professor of sociology at the University of Pennsylvania and senior fellow in Penn’s Center for Bioethics. “They’re not a magic pill. A checklist isn’t something a hospital can swallow and expect care to get better, safer or cheaper.” Bosk studies patient safety with funding from the Robert Wood Johnson Foundation and Veterans Affairs Health Services Research and Development Service.
The mistake most commonly made when introducing checklists is to assume that a checklist can solve a cultural problem. It is a mistake, the researchers contend, to think that you can get workers to use checklists just by insisting on it. Bosk says the Keystone Project study fails to prove the efficacy of medical checklists as much as it shows the need to create incentives for people to cooperate. This includes using audit and feedback to create reputational and social incentives and having advocates within the organization who act as champions.
Bosk also points out that simply having checklists in a hospital does not stop errors from occurring. He recounts the example of a 17-year-old girl who died in 2003 when she was given an organ transplant with a mismatched blood type. “That error happened even though there were checklists for checking blood type,” he says.
“Checklists can be a really good way of making healthcare safer,” says Pronovost. “There’s no doubt about that. They work by improving recall, prompting people to do all the necessary steps, and by making clear the minimum expectations. But they have to be used wisely.”
Pronovost also says there must be a change in the mindset of clinicians about not accepting infections as inevitable. Culture change, he says, insists that every single member of the healthcare team toss out long-held beliefs that infections are an inevitable cost of being in the hospital. “Just having a checklist on a piece of paper isn’t going to be enough,” he says.
Pronovost also rails against what he calls the arrogance of the medical community. “What the public cares about is not getting infected when they go to the hospital,” he says. “We have seen how the CEO of Toyota apologized for the people who died related to the acceleration problems with their cars. In healthcare, we have 100,000 people dying from infections in hospitals each year and I don’t see any apologies. We know from our work that we could virtually eliminate CRBSIs. People dying or suffering from infections need not happen.”
Pronovost and his team from the Hopkins Quality and Safety Research Group are taking the checklist system across the globe, with rollouts in the United Kingdom, Spain, parts of Peru and even Pakistan. They are also bringing the program to all 50 states. Last summer Health and Human Services (HHS) secretary Kathleen Sebelius called for a 75 percent reduction in these catheter-related infections over the next three years. Pronovost and his colleagues are partnering with state health departments and hospital associations across the country to make sure there is buy-in from the many stakeholders involved in preventing CRBSIs.
The key to success is not just following standardized checklist steps, Pronovost says. To change culture, what’s more important is that hospitals also search for errors on a continuing basis, know their infection rates and monitor them after implementing safety innovations. Doctors and nurses need to know the measures they are taking are working, to realize that the science behind the checklist is valid, he says. “The use of checklists is not the endgame. Reduced infection rates are.”
Bosk C, et al. Reality checklist for checklists. The Lancet. 374(9688):444-5. Aug 8, 2009.
Gawande A. The Checklist. The New Yorker. Dec. 10, 2007. Accessed at: http://www.newyorker.com/reporting/2007/12/10/071210fa_fact_gawande
Pronovost PJ, et al. Sustaining reductions in catheter related bloodstream infections in Michigan intensive care units: observational study. BMJ. 340:c309. Feb. 4, 2010.