Checklists and Bundles: Patient Safety Tools Require Appropriate Implementation

Evidence-based practice is being implemented through a variety of patient-safety tools, but perhaps checklists and bundles remain one of the best ways to drive down infection rates and boost compliance among healthcare personnel that leads to better patient outcomes. Atul Gawande, MD, in his book The Checklist Manifesto, analyzes the positive impact of checklists in healthcare and in other industries, to handle “the volume and complexity of what we know.” As Gawande (2010) explains, "Know-how and sophistication have increased remarkably across almost all our realms of endeavor, and as a result so has our struggle to deliver on them … Avoidable failures are common and persistent, not to mention demoralizing and frustrating, across many fields-from medicine to finance, business to government. And the reason is increasingly evident: the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correctly, safely, or reliably. Knowledge has both saved us and burdened us."

By Kelly M. Pyrek

Evidence-based practice is being implemented through a variety of patient-safety tools, but perhaps checklists and bundles remain one of the best ways to drive down infection rates and boost compliance among healthcare personnel that leads to better patient outcomes. Atul Gawande, MD, in his book The Checklist Manifesto, analyzes the positive impact of checklists in healthcare and in other industries, to handle “the volume and complexity of what we know.” As Gawande (2010) explains, "Know-how and sophistication have increased remarkably across almost all our realms of endeavor, and as a result so has our struggle to deliver on them … Avoidable failures are common and persistent, not to mention demoralizing and frustrating, across many fields-from medicine to finance, business to government. And the reason is increasingly evident: the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correctly, safely, or reliably. Knowledge has both saved us and burdened us."

The Agency for Healthcare Research and Quality (AHRQ) defines a checklist as an algorithmic listing of actions to be performed in a given clinical setting, the goal being to ensure that no step will be forgotten. The agency adds that "Although a seemingly simple intervention, check-lists have a sound theoretical basis in principles of human factors engineering and have played a major role in some of the most significant successes achieved in the patient safety movement."
AHRQ acknowledges that many tasks are performed reflexively or "on autopilot," and that the types of error associated with various behaviors are different: "Failures of schematic behavior are called slips and occur due to lapses in concentration, distractions, or fatigue, whereas failures of attentional behavior are termed mistakes and often are caused by lack of experience or insufficient training. In healthcare, as in other industries, most errors are caused by slips rather than mistakes, and checklists represent a simple, elegant method to reduce the risk of slips. Flight preparation in aviation is a well-known example, as pilots and air-traffic controllers follow pre-takeoff checklists regardless of how many times they have carried out the tasks involved. By standardizing the list of steps to be followed, and formalizing the expectation that every step will be followed for every patient, checklists have the potential to greatly reduce errors due to slips."

In their review, Hales, et al. (2008) identified several types of checklists:
- Laundry list: Items, tasks or criteria are grouped into related categories with no particular order. An example would be a medical equipment checklist 
- Sequential or weakly sequential checklist: The grouping, order and overall flow of the items, tasks or criteria are relevant in order to obtain a valid outcome. An example would be a procedure checklist (equipment must be gathered before procedure can begin)
- Iterative checklist: Items, tasks or criteria on the checklist require repeated passes or review in order to obtain valid results, as early check-points may be altered by results entered in later checkpoints
- Diagnostic checklist: Items, tasks or criteria on the checklist are formatted based on a ‘flowchart’ model with the ultimate goal of drawing broad conclusions. An example would be clinical algorithms.
- Criteria of merit checklist: Commonly used for evaluative purposes, in which the order, categorization and flow of information is paramount for the objectivity and reliability of the conclusions drawn
Hales, et al. (2008) also recommend that checklist designers should understand the conditions under which the clinician would be referring to or completing the checklist in order to determine the appropriate content and flow; the following should be taken into consideration:
- Ensuring that the time required to complete the revised checklist is feasible, practical and does not interfere with time-to-delivery of appropriate and safe patient care
- Ensuring that the checklists pass through appropriate administrative or regulatory authorities
- Provide clinicians with freedom to use their clinical judgment
- Checklists should be reviewed frequently to reflect updates in the evidence-based medicine, published guidelines and institutional policies and procedures

They emphasize that checklists are an entity that should evolve with an institution's needs and imperatives: " Legitimacy of the content will depend on the process for its development, and should include a thorough review and evaluation of the literature, evaluation of current practices and consideration of expert consensus, as well as a thorough validation of the checklist in the target user population prior to implementation of the final document. Checklist development should not be static, but an ongoing process involving expert groups, up-to-date literature, and feedback from the intended users as well as the target audience. When all staff members that might interact with the checklist have been involved in the process of creating and designing the checklist, there is a feeling of ownership of the checklist. The items contained in the final checklist represent a consensus between all members of the team, and improve implementation and uptake of a checklist into daily practice." 

The American Hospital Association and the Health Research & Educational Trust (2013) observe that "Checklists used in the medical setting can promote process improvement and increase patient safety. Implementing a formalized process reduces errors caused by lack of information and inconsistent procedures. Checklists have improved processes for hospital discharges and patient transfers as well as for patient care in intensive care and trauma units. Along with improving patient safety, checklists create a greater sense of confidence that the process is completed accurately and thoroughly." 

Sue Hohenthaner, the enterprise infection prevention director, PPS hospitals and clinics for Dakotas-based Sanford Health, says that check-lists and bundles are very effective tools based on reliability science. "Both have been proven in many high-reliability/high risk industries outside of medicine such as nuclear power and the defense industry – and are crucial to basic standardization efforts as relating to the daily care of patients," she says. "Checklists such as the 'time out' prior to any surgical procedure - enable processes of patient care to have the right people and the right materials available every time, in every place and with every patient encounter. They are therefore foundational to process improvement and promote and increase overall quality at the bottom of which is patient safety.  The surgical time out has been proven conclusively and internationally to reduce mortality and morbidity in surgical patients. Bundles in conjunction with the checklist capture all elements that should occur every time and so mitigate errors caused by our human factors dense industry. Checklists and bundles are therefore routinely a part of best practice/evidence-based healthcare delivery – because we are humans caring for humans."

Hohenthaner says that bundles and checklists are used for central line/Foley catheter placement and ongoing care as well as ventilator management in her facility. "The goal of both is to promote compliance with best practices," she says. "When an infection is identified, a group of unit leadership, direct care givers, infection preventionists and quality improvement staff meet and utilize a defect tool (mini RCA) to help identify opportunities for improvement such as gaps in communication, reliability of processes, and education. Always a part of these efforts is to look at compliance with the bundles that are in place (CLABSI, CAUTI and VAP). Currently, we are able to run reports from the defect tools for CLABSI and CAUTI. This assists in looking at common themes and/or trends. Checklists are also routinely used for competencies for nurses and other healthcare staff members. Some examples of competencies that are used include Trophon, high-level disinfection, accessing and de-accessing central lines and insertion of Foley catheters." 

To attain the best possible results, Hohenthaner advises institutions to "Engage staff and leadership, and make it a priority.  Share success stories both internal and external. Be transparent about adverse events and how these tools can be maximized. Look to organizations that have been successful in implementing checklists and bundles and seek to replicate what they have implemented."

Critics of checklists claim they encourage healthcare personnel to merely check boxes on technical elements while ignoring "socio-adaptive" elements. As Bosk, et al. (2009) explain their concerns, "Safer care is achieved when all three-not just one-of the following are realized: summarize and simplify what to do; measure and provide feedback on outcomes; and improve culture by building expectations of performance standards into work processes. We propose that widespread deployment of checklists without an appreciation of how or why they work is a potential threat to patients' safety and to high-quality care."
Chopra and Shojania (2013) emphasize that technical elements of checklists and bundles -- such as the use of chlorhexidine for skin antisepsis -- "comprise discrete, easily implemented actions. Socio-adaptive elements (e.g., removal of unnecessary CVCs, or the preoperative time-out to discuss critical steps in a surgical plan) involve more than simple actions: they require true engagement in the tasks. Implementation efforts must, therefore, address teamwork, communication and culture."

Bosk, et al. (2009) concur and note, "To improve safety, healthcare needs to get the technical and adaptive work right. Without attention to adaptive work, checklists would probably suffer the same fate as guidelines-often left unused, even when very robust. Summarizing evidence is a necessary but not sufficient step for translating evidence into practice. Evidence summaries need to be combined with an under-standing of, and a strategy for, mitigating the technical and social/political and psychological (even emotional) barriers to using the evidence, and with feedback about performance. Emphasizing checklists as the explanatory mechanism for the reduction in catheter-related infections obscures the complex labor necessary to create a collective local faith in checklists."

In what was to become one of the most-cited studies on the benefits of patient-safety-tools, Berenholtz and Pronovost, et al. (2004) de-signed a quality improvement model for central line-associated infections (CLABSI) that featured a checklist and a bundle of evidence-based practices, which included proper hand hygiene, chlorhexidine for skin antisepsis, use of maximal sterile barriers, and avoidance of the femoral site. The bundle was accompanied by the provision of education regarding these infection control practices, a catheter-insertion cart, daily re-view and prompt removal of unwarranted CVCs and empowerment of nurses to enforce adherence to these practices.

Chopra and Shojania (2013) point to several evaluations of this bundled intervention; the first revealed a decrease in CVC-BSIs from 11.3 infections/1,000 catheter days to 0/1,000 catheter days at Johns Hopkins; a second evaluation of the CVC-BSI bundle in 103 intensive care units (ICUs) across 77 hospitals by the Michigan Keystone Health and Hospital Association showed a large and statistically significant reduction in CVC-BSIs -- from a baseline mean of 7.7 infections/1,000 catheter days to 1.4/1,000 catheter days.  As Chopra and Shojania (2013) note, "The success of the CVC-BSI bundle stimulated interest in checklists for surgical safety. WHO’s Surgical Safety Checklist led to substantial improvements in operative outcomes in diverse clinical settings. A study of multiple checklists at different stages in the perioperative period showed impressive improvements in surgical complications and mortality at six hospitals in The Netherlands. These dramatic results-in ICUs and operating rooms- made checklists virtually synonymous with safer innovative care."

What worked in the Hopkins and Keystone experiences was more than just a simple checklist story, say Bosk, et al. (2009, who observe, "What happened in Michigan involved the creation of social networks with a shared sense of mission, whose members were each able to rein-force the efforts of the other to cooperate with the interventions. Implementing the entire program occurred over nine months-it was not simply the case that the units were handed the checklist and immediately fell in line. The work was arduous and often laden with emotions. Before ICU units were allowed to take part in the intervention, each hospital had to assign a senior executive to work with participating units. Each ICU was required to identify a physician and nurse team leader. The executives were required to meet monthly with unit workers, listen to problems, and work with team members to solve them. Team leaders received instruction in the science of safety as well as each component of the comprehensive intervention. Team leaders were responsible for schooling their colleagues on the principles of safety in general and the components of the study intervention in particular, and they stayed in touch with study leaders and each other through conference calls and meetings. Infection control practitioners collected valid rates of bloodstream infections and reported results to the ICU staff, and frontline care-givers were asked for their feedback regarding the impact of their efforts. The checklists were thus themselves just one component of a more comprehensive program to alter the culture of the ICUs, which included, among other things, empowering nurses to stop procedures if guide-lines were not followed."

The Keystone study did provide a solid roadmap for how to achieve results in wider contexts, Bosk, et al. (2009) say, adding that the following action steps have value for any healthcare organization:
- recruit advocates within the healthcare institution
- keep the team focused on goals
- create an alliance with central administration to secure resources
- shift power relations
- create social and reputational incentives for cooperating
- open channels of communications with units that face the same challenges
- use audit and feedback.

As Bosk, et al. (2009) emphasize, "Taken together, what the Keystone program did was change workers' motives for cooperating so that they internalized new norms: the new way became taken for granted as 'the way we do things around here.'"

The AHRQ emphasizes that healthcare personnel must be fully aware that implementing a checklist is a complex socio-technical endeavor, requiring frontline providers to not only change their approach to a specific task but to engage in cultural changes to enhance safety. The agency notes that "Successful implementation of a checklist requires extensive preparatory work to maximize safety culture in the unit where checklists are to be used, engage leadership in rolling out and emphasizing the importance of the checklist, and rigorously analyze data to assess use of the checklist and associated clinical outcomes. Failure to engage in appropriate preparatory and monitoring before and after checklist implementation may explain why checklist use in real-world settings is often poor, contributing to disappointing results. Ethnographic studies of successful and unsuccessful checklist implementation have been instrumental in enhancing understanding of the barriers that can limit checklist utility."

Chopra and Shojania (2013) say that the CVC-BSI bundle blends purely technical items with ones that require socio-adaptive changes: "Conistent use of chlorhexidine gluconate requires a commitment from hospital leadership to purchase this agent instead of povidone-iodine. Achieving this commitment may initially call for socio-adaptive measures. Once accomplished, however, physicians will necessarily use chlorhexidine for skin disinfection as it will be the only antiseptic available. The socio-adaptive behaviors required to successfully implement chlorhexidine, thus occur upstream to checklist deployment … Some aspects of the CVC-BSI bundle do require ongoing socio-adaptive behaviors. Nurses must feel comfortable pointing out non-compliance with full barrier precautions, and physicians must heed nurses’ reminders to do so. Similarly, prompt removal of unnecessary CVCs requires physicians to evaluate the necessity of central venous access and solicit inputs from nurses on this point. Recognizing the degree to which checklists differ in their dependence on socio-adaptive elements is important for two reasons. First, the variation in the ‘active ingredients’ of checklists (technical elements alone vs technical plus socio-adaptive ones) underscores the importance of theory in developing and evaluating patient safety interventions. Second, while improving teamwork and culture holds clear appeal, the active ingredients of some checklists may consist entirely of specific technical elements. The use of chlorhexidine and a full sterile drape, by themselves, pro-duce reductions in CVC-BSIs comparable with those reported for the CVC-BSI bundle. Any accompanying changes in teamwork and communi-cation that occur during implementation may simply represent epiphenomena."

Logic tells us that checklists in and of themselves are not panaceas to healthcare problems, but when used appropriately and as part of a larger quality improvement initiative, they can offer safety benefits for patients and healthcare personnel. The AHRQ notes that "As checklists have been more widely implemented, it has become clear that their success depends on appropriately targeting the intervention and utilizing a careful implementation strategy."

Bosk, et al. (2009) remind us that checklists are "suited to solving specific kinds of problems, but not others," and that "using checklists re-quires focused effort that is properly informed by a scientifically grounded understanding of how organizations and people work, based on theory and evidence … They are simple reminders of what to do, and unless they are coupled with attitude change and efforts to remove barriers to actually using them, they have limited impact." They add, "When we begin to believe and act on the notion that safety is simple and inexpensive, that all it requires is a checklist, we abandon any serious attempt to achieve safer, higher quality care. Reporting the Keystone initiative as a success of checklists teaches the wrong lesson: namely, that reliable, safe care requires nothing more than insisting upon routine, standardized procedures. Nothing threatens safety so much as the complacency induced when an organization thinks that a problem is solved. A chilling reminder of this is the phenomenon of wrong site surgery, which persists despite the broad recommendation to use checklists. “If we just tell the workers to use checklists, we will have solved the problem of catheter-related blood stream infections” is quite simply the wrong conclusion to draw from the Keystone study. The “simple checklist” stories in the press created excitement about progress in achieving patients' safety and reassurance for the public and policy makers, but the real story of Keystone is messier and more complex. Although we all hope for the simple solution that with ease and no additional expense makes a stay in the ICU safer, there is some danger in mistaking hope for reality. The answer to the question of what a simple checklist can achieve is: on its own, not much."

The AHRQ emphasizes that errors in clinical tasks that involve primarily attentional behavior-such as diagnostic errors or handoff errors-may require solutions focused on training, supervision and decision support rather than standardizing behavior, and thus may not be an appropriate subject for a checklist. The agency adds that "An effective checklist also requires consensus regarding required safety behaviors. The success of checklists in preventing central line infections and improving surgical safety resulted from the strong evidence base supporting each of the individual items in the checklist, and therefore checklists may not be successful in areas where the 'gold standard' safety practices have yet to be determined."


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