FIGURE 8.1 A model for translating research evidence into practice. (Adapted from Pronovost PJ, et. al. Translating evidence into practice: a model for large-scale knowledge translation. BMJ 2008;337:963–965, with permission from BMJ Publishing Group Ltd.)
Comprehensive Unit-Based Safety Program
Although measuring harm and implementing effective therapies are important for patient safety, they are insufficient without teamwork and creation of a concomitant culture that embraces these directives (68). Repeated examples have shown that the pertinent elements of culture, such as failures in communication, lead to sentinel events in health care (69).
The CUSP is a comprehensive and longitudinal program designed to improve local culture and safety (70). Supported by a web-based project management tool, the CUSP has evolved significantly since its inception from an eight-step (70) to a five-step (71) program (Table 8.1). CUSP is designed to be adopted by individual work units or care areas, and to involve every individual who provides care within a given unit, from physicians to nurses, pharmacists, administrative clerks, and other support staff. The program also leverages support from senior leaders in the health care organization to provide financial, administrative, and other resource assistance.
| TABLE 8.1 Comprehensive Unit-Based Safety Program | |
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The CUSP model, which was originally implemented in 2001 at two surgical ICUs at the Johns Hopkins Hospital, resulted in significant reductions in ICU length of stay, and medication errors, and even improvements in nursing turnover (72–74). This success was derived from emphasizing practical tools to investigate and learn from defects, improve teamwork and communication, and organize transitions of care within and between patient care areas. These elements empowered frontline staff with a strong baseline knowledge about the science of safety to recognize potential safety hazards and design interventions to eliminate them.
An intended byproduct of the CUSP initiative is gradual improvement in an individual unit’s safety culture. Embedding patient quality and safety tasks into daily practice—for physicians, nurses, and staff alike—shifts workflow focus away from risk-provoking behavior and automatically prioritizes those same quality and safety tenets. The staff is provided a platform to share experiences with everyone in the unit, and the group is empowered to solve local problems in care delivery. For example, the creation of interdisciplinary rounds created a setting wherein nurses can voice concerns, seek clarification regarding a patient’s management, and gain autonomy as the bedside caregiver. Interdisciplinary rounds lessen the hierarchy that usually occurs between physicians and nurses, a hierarchy that causes ineffective collaboration among clinical disciplines and prevents individuals from acting upon safety concerns.
The culture-based CUSP initiative was put into place before the CLABSI intervention to provide a foundation for safety awareness, to establish interdisciplinary teamwork, and to encourage the widespread use of evidence-based practices. This was instrumental in the long-term sustainability of the results (75). In the Keystone project and subsequent nationwide programs, the following occurred:
Step 1: Staff were educated about the patient safety as a science using a standard presentation and a series of interactive discussions.
Step 2: Staff were asked to identify how the next patient would be harmed on their unit, and what they would do to prevent this harm from occurring; a CUSP improvement team was formed to interpret the results and implement the work.
Step 3: Partnership with a senior hospital administrator was strongly encouraged. Their roles included reviewing the safety hazards identified by the unit staff with the improvement team, provide the institutional support and resources needed to implement appropriate risk reduction interventions, and hold staff accountable for mitigating hazards.
Step 4: Teams were trained to use a novel defect investigation tool, and asked to use it to address at least one defect each month.
Step 5: Teams were provided a variety of tools to improve communication and teamwork, and instructed to modify the tools to fit the local context and ensure ease of implementation.
Specific Tools for Quality Improvement
Briefings and Debriefings
Briefing and debriefing tools are designed to promote effective interdisciplinary communication and teamwork. A briefing is a structured review of the case at hand among all team members before any task is undertaken with the patient. A debriefing occurs after a procedure or situation in which the team reviews what worked well, what failed, and what can be done better in the future. Both have been used in the operating rooms (ORs), in hand-offs among the ICU nursing staff and intensivists, and between OR nursing and anesthesia coordinators (76–78).
A typical OR briefing will first introduce the relevant parties and establish anticipated roles of various team members. Next comes confirmation of the correct patient, site/side, and procedure, which coincides directly with the established JC “time-out” procedure, and assurance that all team members understand the important aspects of the intended procedure. A check of all necessary equipment (e.g., electrocautery) and medications (e.g., appropriate antibiotic) is then performed. Finally, to mitigate potential hazard, a concise discussion should take place regarding what plans are in place if procedure variables fall outside of intended practice parameters. A briefing will typically focus on a critical procedure, but it can also focus on unit management of a patient. Briefings may occur in an ICU setting, where attendings and nurse management meet to discuss (a) events that happened overnight, (b) admissions and discharges for the day, and (c) potential hazards that may occur during the day. This morning briefing organizes the ICU team, prioritizes the workflow for the unit, allocates resources, and mitigates potential hazards (78).
Debriefings occur after a formative event, regardless of the result. Often these are considered sessions for review of key elements of the procedure and discussion of relative merits and opportunities for improvement. Although constructive, this practice is often overlooked in the daily clinical care setting unless an unintended harm occurs or the consequence of a procedure is in question. Regular use of the debriefing strategy can serve not only to help establish root cause, but also to further educate providers for future similar patient encounters.
Learning from Defects
Most medical errors require the alignment of multiple failures within a system to occur. Reason’s “Swiss cheese” model (Figure 8.2) illustrates how multiple failures, though insufficient by themselves to cause harm to the patient, can align to cause and adverse event in aggregate. The Learning from Defects tool is a less intensive version of a root cause analysis, allowing it to be implemented more frequently and with fewer resources to look at near-misses that would not necessarily trigger a hospital-level investigation. It provides a structured approach to help caregivers and administrators investigate a case and identify elements of a given system that contributed to the defect, while also providing a follow-up mechanism to ensure safety improvements are achieved. It does so by asking four basic questions: (a) what happened; (b) why did it happen; (c) how will you reduce the likelihood of this happening again; and (d) how will you know the risk has been reduced (79). Use of such a tool allows staff to investigate more incidents closer to the time of occurrence and to identify and mitigate a larger number of contributory factors. The learning-from-defects process can be implemented as part of the CUSP framework or as a key element in educational programs that focus on QI (80).
This form of retrospective identification, which shares overlap with key elements of debriefing, can be used to identify medical errors and analyze contributing factors, thereby providing a learning opportunity, rather than just a way to recover from harm. The lessons will provide defense against recurrence of the same or similar harm and are essential to promoting a comprehensive culture of safety. The IOM has targeted incident reporting systems as a method to not only collect defect information, but also to investigate the causes, thereby improving safety (1,81). To make incident data useful, health care organizations can utilize a variety of formal (root cause analysis) or informal (Learning from Defects, case review) methods.
FIGURE 8.2 The “Swiss cheese” model of a medical error. The events leading up to an adverse event involving a medication error are illustrated. The Swiss cheese model is a concept that originates from the work of James Reason, in which he proposes that the alignment of multiple system failures allows harm to reach a patient. His premise is that system failures occur often, but that health care professionals and other systems are built in to catch a failure (e.g., final safety check at the pharmacy to catch medication allergies). Couched in this way, it takes the alignment of several failures or defects to pass by and harm a patient. (Adapted from Reason J. Understanding adverse events: human factors. In: Vincent C, ed. Clinical Risk Management. London: BMJ Publications; 1995.)
Checklists
As outlined, the care of any one patient may require any number of health care providers across multiple disciplines and levels of training. Hundreds of tasks, designed to implement dozens of therapies, may represent the balance of a single intensive care day. Given the natural limitations of human memory and attention, appreciation for and successful implementation of the associated choreography can prove nearly impossible.
These realities can lead to decreased compliance with proper protocols, increased error rates, and reduced efficiency (82,83). Using checklists to standardize processes ensures that all steps and activities are addressed, thereby reducing the risk of costly oversights or mistakes and improving outcomes. Checklists represent an organized list of essential elements or steps that need to be considered or performed for a given task. Lying somewhere between an informal cognitive aid and a protocol, checklists provide real-time guidance to users and serve as verification after task completion (84). Checklists are thus multifunctional as memory aids, evaluation frameworks, and tools to standardize and regulate processes. Ultimately, checklists facilitate care delivery by decreasing variability, and thus improving performance.
In large part, our understanding of checklist use in the workplace comes from industries outside of medicine. In aviation, checklists are now a mandatory part of routine operations and are highly regulated. They are used both in the course of normal practice and during emergency situations, providing a systematic approach to situation recovery. In product manufacturing, the smallest error during development can affect the quality of the final product, increase costs, and potentially harm the consumer. Checklists play a central role in ensuring that proper operating procedures are followed and quality standards are maintained. Quality assurance personnel use them routinely at multiple stages of the production process to evaluate whether required regulatory standards are being met. Checklists are an important component of standard operating procedures for manufacturing and distribution processes because they help to maintain product quality standards. A central theme among these exemplars is the reliance on precise execution to provide consistent quality and minimize error.
Although similar in enterprise, health care has been slow to adopt the use of checklists. Operationally, it can be challenging to standardize processes for the wide variability that exists between and even within patients. Nuanced patient comorbidities, individual physiology, and unforeseen events can continuously influence the approach to diagnosis, treatment, and even recovery, making the design and implementation of a standardized approach difficult. Socioculturally, health care providers, particularly physicians, are frequently resistant to standardized tools and approaches, viewing them as a restriction of their autonomy. Certainly, similar restraints have been overcome successfully in other industry, but universal adoption within health care will require a concerted effort focused on improving efficiency and outcome rather than catering to resistance.
Daily Goals Sheet
Since July 2001, the daily goals sheet has been used during multidisciplinary rounds in the ICUs at Johns Hopkins to improve communication (85). This tool is a one-page checklist that is completed every morning to document establishment of the care plan, set goals, and review potential safety risks for each patient. Posted at the bedside of the patient, the goals sheet is updated as needed based on the dynamic nature of patient care and used as an information sheet for all staff involved in the patient’s care. This checklist can be modified for use on regular floor units and during OR sign-out.
The ICU version of a daily goals sheet can include the following questions:
- What needs to be done to move the patient closer to transfer or discharge?
- What is the patient’s greatest safety risk?
- What are the plans for pain management, cardiovascular management, and respiratory management?
- Is it appropriate to evaluate the patient’s rapid shallow breathing index?
- Is there any planned diuresis and nutritional support?
- Are any antibiotic levels needed?
- Can any lines, tubes, or drains be discontinued?
- Are any tests or procedures planned? Have consents and orders been completed?
- Consider key local safety initiatives, including family updates, or implementation of local protocols.
To evaluate the impact of the daily goals sheet, all care team members should answer two simple questions after rounding at each patient’s bedside: (a) Do you understand the patient’s goals for the day?; and, (b) Do you understand what work needs to be accomplished on this patient today? These questions were the impetus behind the development of this checklist. When asked initially, fewer than 10% of the residents and nurses time actually knew the care plan for the day. Traditional bedside rounds tended to focus as much or more on teaching staff about the disease than what work needed to occur to treat the patient. Approximately 4 weeks after Johns Hopkins implemented the daily goals sheet, 95% of the residents and nurses understood the goals for each patient (85). Moreover, length of stay in a surgical ICU at Johns Hopkins decreased from a mean of 2.2 days to just 1.1 days (85). Implementation of a daily goals sheet can also help improve communication and collaboration among nurses and physicians for individual patients, and lead to more effective coordination of daily care plans, and efficient movement of patients to ICU and even hospital discharge.
FUTURE DIRECTIONS
Simulation
Simulation is a powerful tool/technique that has been used in high-risk industries to improve safety and reduce errors (86,87). The potential benefits of simulation in health care include (88):
- Frequent training for emergencies (crisis resource management)
- Teamwork training (which is a weak link in the whole process of patient safety)
- Skills training and evaluation of competency before a trainee touches a patient
- Testing of new procedures and usability of new devices.
Health care takes place in a complex, high-stress environment that can affect human performance and patient outcomes. High-fidelity simulation allows us to not only examine human performance, but also analyze system-based problems. Although most medical simulation is still relatively new, it provides an opportunity to reorganize our “see one, do one, teach one” method of clinical training and better prepare trainees before they practice medicine. Education of health care staff is a vital part of any strategy to prevent errors. The benefits of simulation-based education include a pragmatic approach involving greater degree of interaction than traditional didactic sessions. It allows for the development of nontechnical skills along with assessment of technical skills. It facilitates real-time evaluation and feedback, assessment of practical and clinical judgment, as well as development of psychomotor and communication skills to optimize understanding of material and improve task execution (89–91).
Although a more thorough evaluation of the effect of simulation on patient safety might be necessary, just like in other industries, the face validity of this tool is likely to drive change and impact outcome. This impact will be especially apparent in the training domain, for both technical and nontechnical, or behavioral, skills (communication skills, leadership, task management, teamwork, situational awareness, and decision-making) (92,93). These behavioral skills are common contributors to critical events in health care (94). Simulation allows trainees to practice in an environment that is safe for the trainee and the patient. In addition, trainees are exposed to common, rare, and crisis situations, and can practice learned competencies and receive immediate feedback about their performance (95,96). A simulation-based approach has the potential to not only prevent similar errors from recurring, but to improve health care provider awareness to improve detection of error and quality gaps in the first place.
Systems Engineering
The fields of patient safety and QI must look beyond individual interventions and instead appreciate the ultimate goal—ensuring universal delivery of evidence-based therapies to eliminate harm. Health care quality and patient safety initiatives succeed only when collaborative teams account for the aspects specific to the system in which they live and operate. However, no individual system exists in a vacuum. While an individual checklist or learning-from-defects discussion may serve a function at the time of its use, it is a static tool that may become irrelevant over the dynamic course of a patient’s care. The current siloed approach of targeting harms individually demonstrates a lack of understanding regarding when and where these synergies and discordances may be occurring, potentially leading to unintended, and sometimes harmful, consequences. Seemingly small personnel, resource, or architectural modifications can lead to domino effects at the individual and health system level given the interrelated nature of various systems. What’s more, with the rapidly growing nature of health care technologies, providers are expected to deliver care that remains efficient and cost-conscious, yet robust enough to cover a range of disease and therapeutic complexities. Industries such as aerospace, defense, and information technologies have managed to thrive under similar conditions by integrating highly complex systems to function optimally without sacrificing principles of safety and quality. In them, harm is not perceived as being inevitable, but rather as a problem that can be overcome through a systems engineering approach (97).
Systems engineering is the practice of using core principles – termed systems methodology – to design systems architecture, language, and integration to satisfy a pre-determined goal. This approach contrasts with current health care strategy, wherein providers often address newly evolving problems by trying to retrofit current systems through “patches” or “work-arounds” because they are constrained by time and/or resources. By adopting systems engineering practices used ubiquitously in other surrogate industries, health care may more comprehensively alleviate systems defects by simply preventing them from occurring in the first place. All systems engineering initiatives follow a set of phases to either improve upon an existing system or develop a new system to solve a problem:
- System Concept Development: To establish scope, the first phase in developing a new system is to define the problem, identify stakeholders and determine the goal. This step requires clear, concise language to adequately stage the overall initiative. Example: Surgeons, intensivists, and administrators (stakeholders) believe nursing and provider workflow is significantly impeded in the ICU by redundant tasking (problem). They believe vital sign monitors should automatically input vital signs into the electronic medical record (EMR) and reduce time burden to bedside personnel (concise goal).
- Requirements Analysis: Individual stakeholders, with the aid of systems engineers, establish the necessary requirements to successfully implement the system. They will make a rational appraisal of necessary financial, personnel, raw material and regulatory resources in order to provide a meaningful end product. Example: Collaborators create a requirements list that includes raw elements (monitors, cables, hardware elements), personnel (programmers, engineers, software developers, construction), and so on to properly address the necessary systems architecture.
- Functional Definition: Define the system through a variety of diagrams geared toward simulating or prototyping the anticipated system. Here you establish the input, the intermediate steps and the final output product as well as all relevant components and interrelated subsystems. Example: Numerous flow diagrams, object-oriented models, computer simulations, and even graphical user interfaces (GUIs) are prototyped to theoretically propose an optimal solution to the original problem.
- Implementation: Construct the system and properly integrate it among any pre-existing systems or subsystems in place. In the end, it should produce the expected output. Example: All makes and models of individual existing monitors must work seamlessly in the new system, which must also be modified to current workflow (establish appropriate timing and ranges of vital signs).
- Verification and Validation: Over the life cycle of the new system, researchers must verify that the system meets the stated goals and validate the system under constraints of real-world operation. Predefined metrics are employed to ensure both endpoints. Example: Intensivists review vital sign data to ensure accuracy, stakeholders observe workflow to comment on efficiency, and each provided feedback to systems architects to direct necessary modifications.
- Iteration: Through numerous cycles of the system, stakeholders may modify elements and improve upon them to optimize efficiency and integrate new goals. Example: After vital signs are automatically input into the EMR, system checks may be set on subsequent cycles to notify providers if they fall outside of a preset range. This addition satisfies the original stated goal and improves upon the system through iteration.
Application of such a systems engineering approach in health care has already begun in the ICUs in several settings. Project Emerge is an example of an active prototype developed at the Johns Hopkins Medical System and the University of California San Francisco to implement and track successful application of evidence-based practices to improve seven common harms in ICU patients. These include ICU-acquired delirium, venous thromboembolic events, CLABSI, ventilator-associated events, ICU-acquired weakness, provision of care inconsistent with patient goals, and loss of respect and dignity. Creating a model to address the chosen harms involved cataloging all the stakeholders, resources, and workflows associated with the evidence-based practices that contribute to the prevention of each harm. This detailed appraisal was necessary to gain insight regarding the interdependencies within the existing system. Based on this understanding, a generalizable, scalable framework was then developed, explicitly detailing the steps needed for harm reduction. A novel interface system was developed to allow providers to quickly visualize and assess successful application of known bundled elements of care to prevent the defined harms.
Similarly, researchers at the Mayo Clinic recognized issues surrounding burdensome interpretation of traditional electronic medical records; therefore, researchers created the Patient-centered Cloud-based Electronic System: Ambient Warning and Response Evaluation. This multicenter trial uses cloud-based technology to redesign the acute care interface system with built-in tools for prevention of provider error and practice surveillance.
Systems engineering principles can be applied within health care not only to establish new systems, but also to repair defects associated with existing ones. This practice has been successful across numerous industries with emphasis on safety amidst similarly complex infrastructure. Early returns in health care have been promising, and in an era of increasing emphasis on performance-based outcome, widespread utilization of systems methodology may be the link to engineering health care toward zero harm.
SUMMARY
Approaching QI and patient safety as a science is a relatively new concept and broad area of health care research that draws upon many disciplines. Many health care organizations have made concerted efforts to address the hazards that plague safety. Over the past several years, most of our efforts have been aimed at investigating causes and executing interventions to improve patient safety. Only now are researchers beginning to discuss how to evaluate these interventions and determine if patients are indeed safer. Evaluating our programs—and reliably answering whether patients are safer—will require valid measures and the ability to know whether we mitigated hazards, an area that is currently underdeveloped. Yet, the measurement model we describe in this chapter should move us in the right direction in developing new measures of safety.
To begin to improve patient safety and quality, we can implement collaborative projects that utilize proven models such as Translating Evidence into Practice (TRiP) and the Comprehensive Unit-based Safety Program (CUSP). Such initiatives foster a culture of safety where staff learns the interdependence between patient safety and quality, and why they are important, identify system failures in their workplace, and turn their efforts into safety and QI. Indeed, staff feels valued for their opinions and recognized when senior leaders listen. Once a more solid safety culture is established, interventions can be implemented more effectively through collaborative projects. The CUSP also provides feasible and reliable tools for collaboration to implement improvements in communication, teamwork, and adverse-event investigations. Collaborative projects are important because multiple sites that share the same goal can network to communicate successes and correct failures. The shared momentum increases sustainability.
Any QI program should provide a practical, goal-oriented toolset that will improve culture and lead to measurable improvements, using the principles described in this chapter as a guide. Additional research is necessary to identify other effective safety interventions. Links must be developed between the structural elements of health care delivery and patient safety outcomes. Given the evidence to date, it seems reasonable that all ICUs should be routinely assessing their culture of safety.
Although work is necessary at the organizational level, the question of whether our patients are safer and receiving the best quality of care possible can be meaningfully answered. Significant and very exciting improvements are beginning to be implemented throughout the United States and around the world. The critical care community must continue to develop the science of safety, but many of the foundations have clearly already been laid.
Key Points
- While providing care appropriate to the patient and their condition seems simple, doing so consistently requires proper adherence to QI principles including review and improvement of health delivery systems.
- Independent external evaluation and reporting systems are essential components in the evolution of a culture of safety and QI.
- Adoption of a common framework to evaluate and monitor safety is one of the greatest impediments to reforming health care quality and safety. The ideal initiative be designed to not only learn from past mistakes, but adapt to any unexpected present or future demands by being based on sound theory, using valid and objective metrics, application of a consistent methodology, and a systematic assessment of outcomes.
- A multidisciplinary approach involving all relevant stakeholders is necessary for successful QI initiatives. A conceptual framework of pertinent issues and solutions helps guide team efforts and ensure common point of dialogue. Examples of useful project frameworks include TRiP to operationalize safety intervention therapies, and CUSP to involve multiple levels of care providers in a work area while leveraging support from senior leaders.
- Using systems engineering to design system architecture, language, and integration with the existing health care environment to satisfy pre-determined QI and patient safety goals might help comprehensively alleviate systems defects by potentially preventing them from occurring in the first place.
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