Building a Safer Unit: Using Proven Methodologies to Plan and Implement Change


Taking a vision for systemic change and turning it into reality is like building a home. Once the plans are decided upon, a foundation and framework must be constructed in order for the house to stand on its own. Similarly, when implementing sustained, system-wide change into complex healthcare organizations, it is critical to have a vision, strategies and tactics in place (as shared in the first article in the series), as well as a strong foundation and framework to bring about change and maintain it over time.

By Bradford Winters, PhD, MD, and Kathleen Kohut, RN, MS, CIC, CNOR

Editors Note: In early June, 55 healthcare professionals from across the country, including nurses, infection preventionists, physicians and other specialists in infection control, gathered at 3M Companys Customer Innovation Center for a two-day leadership training summit. Attendees learned from leading experts and each other about how to lead change in their facility and successfully implement best practices to reduce hospital-associated infections (HAIs). The following article is the second of a two-part series on some of the important lessons attendees learned that may help facilities across the country develop and implement change.

Taking a vision for systemic change and turning it into reality is like building a home. Once the plans are decided upon, a foundation and framework must be constructed in order for the house to stand on its own. Similarly, when implementing sustained, system-wide change into complex healthcare organizations, it is critical to have a vision, strategies and tactics in place (as shared in the first article in the series), as well as a strong foundation and framework to bring about change and maintain it over time.

The foundation in this case is a culture of patient safety. Without it, the best ideas for patient safety improvement may fall by the wayside. The framework that supports this foundation is evidence-based, proven methodologies that assist in prioritizating and implementing patient safety improvements. Two such methodologies that have proven successful for many organizations across the country are: Comprehensive Unit-Based Safety Program (CUSP) and Plan-Do-Study-Act (PDSA).

Comprehensive Unit-Based Safety Program (CUSP)

CUSP was designed to educate and improve awareness about patient safety and quality of care, to empower staff to take charge and improve safety of their work place, and to provide tools to both investigate and learn from defects in the system.

Developed at Johns Hopkins University School of Medicine in 2001, the CUSP process begins at the foundation understanding the current culture of safety within the unit. A critical first step to following CUSP is to survey the unit staff to determine their attitudes, practices, policies and behaviors. The results of this initial survey will serve as the baseline from which success is measured over time. Sample tools that are effective for measuring a units culture of safety are available at:

After analyzing the units foundation, the next step is to create your CUSP team, which should include not only nurses/techs and physicians, but also members from environmental services, other non-medical professionals, pharmacists, security, and anyone who may have an impact on patient safety on that particular unit. It is important to recognize that every unit will be different and will likewise produce a different CUSP team. Generally seven to 10 people form a strong CUSP team, however the number of members to have on your team will depend on factors specific to the unit, such as its size. Be sure to include a physician leader, who is well-respected by clinicians, and who supports change, since their participation will be critical to gaining the support of other physicians.

Finally, it is essential to invite a member of hospital administration to join the CUSP team. For administrations that are truly committed to improve patient safety, they will realize that their presence will provide a valuable connection between the efforts of the unit and the Administration. This individual also has access to resources the unit may need to implement change.

Using some of the communications tools outlined in the previous article, be sure to highlight what achieving your vision will mean for the organization overall, how it aligns with organizational goals, and what, if anything, it will mean to the short- and long-term bottom line.

With your CUSP team assembled and the baseline study done, its time to educate staff on the science of safety. Share the results of the survey, explain how information will be collected to measure success, and through that, create an environment that will be methodologically honest and accurate. This means taking the blame away from the clinician and focusing on what broke down in the system. For example, when a CLABSI occurs, it could be because the line wasnt inserted properly. While this is fundamentally the responsibility of the clinician, it may also signal an issue with the product, a lack of protocol or even inadequate training. Safety improvements for "every patient, every time" mean focusing on the system breakdowns, wherever they occur; but they will be difficult to identify if staff try to cover up their "mistakes." Its important that your staff recognizes and reports their mistakes and creates a collaborative environment aimed at affecting change.

Now its time to identify defects, defined as anything that has caused or could cause harm to patients. Based on your vision statement, there may already be a specific goal for the unit, but if not, gain your staffs input by asking them to make suggestions. Defects should then be prioritized and tactics developed to address them. To implement your tactics for counteracting the defects in your unit, remember to communicate early and often with staff in the unit about new protocols, products and procedures. Its often a good idea to start with a pilot test -- one room, one patient, one day -- and to look at the results before implementing unit-wide.

As the CUSP team implements new tactics to improve identified defects, it is critical to measure these interventions to determine whether they are working. It is normal for there to be signs of success followed by something going awry. Rather than becoming discouraged, look at what went wrong and determine if the intervention tactic needs to be refined. CUSP is a continuous process of checking and rechecking.

But how does CUSP make a formula for success?

Nowhere has CUSP been more successful than at Johns Hopkins, where it originated. Back in 2001, the hospital was experiencing a higher than average central line-associated bloodstream infection (CLABSI) rate in its ICU. Clinicians were determined to turn that around and drive their CLABSI rate to zero.

The CUSP team, comprised of nurses, doctors, pharmacists and infectious disease specialists first conducted a safety survey to determine their baseline CLABSI rate, including review and documentation of central line insertion practices and compliance with IV tubing changes. The team also conducted a survey of unit attitudes to determine the level of support that existed among staff to fulfill the teams vision. Next, the team brought the hospitals chief operating officer on board to represent the unit to Administration.

Based on what was learned, the team implemented a number of interventions using a tool called "The Five Evidence Based Behaviors Checklist" (found at ) and educated the team on the science of safety. For a few months, the rates went down. When they suddenly spiked, the team learned that staff inserting central lines often didnt have all of the necessary equipment in the room and had to break sterile barriers to get what they needed. The team purchased carts like those found at any home improvement store and stocked them with all of the supplies needed to insert a central line, from gowns to dressings. The carts were wheeled right to the room and were available for any immediate supply need. This important and relatively inexpensive intervention helped keep CLABSI rates down significantly for months.

By continuously checking the defect and measuring the impact of interventions, the unit has been able to keep its median CLABSI rates at nearly zero for more than seven years. When the occasional CLABSI does occur, the CUSP team and staff immediately reviews protocols and interventions to determine whether anything broke down, and how those defects need to be addressed.

The success of CUSP in the ICU unit has led to the development of additional CUSP teams to target other safety issues, including medication errors and pain management. CUSP is active in 40 units at Johns Hopkins and was also successfully implemented at more than 100 ICUs in Michigan. There are also pilot CUSP programs underway in England, Spain and Peru. Again, administrator participation is key, and in fact, administration participation has been so successful at Johns Hopkins that it is difficult to find administrators to serve on new CUSP teams since most already participate in a team.

There are a couple of important aspects of CUSP that you wont find in the checklist. The first is the culture shift that must occur wherein nurses are encouraged to speak up if they see a physician breaking protocol and jeopardizing patient safety. Considered blasphemous in earlier times, now it is known that every clinician has an equal voice when it comes to protecting patient safety. The second is the power of a story. Share a story in your facility of a patient that experienced a patient safety failure. By making it personal, it helps hospital staff realize the significant impact they have on the lives of patients and their families. A patient story helped the Hopkins team keeps their focus on their relentless pursuit of improving patient safety.

Plan-Do-Study-Act (PDSA)

Another methodology to guide and implement organizational change is a process called Plan- Do-Study-Act (PDSA). This process allows hospitals to test changes on a small scale and analyze results to validate improvements before implementing the change across the organization or on a more complex level.

Similar to CUSP, getting the right team in place is crucial, as well as taking a broad and multidisciplinary approach to ensure that anyone who directly impacts patient safety is involved in the process. It is also important to consider the points of view of those who may be resistant to systemic change. Understanding the barriers to change will prove fruitful to the group and may illuminate an important consideration crucial to the entire process. Therefore it is important to listen carefully to those people that may not appear engaged in the process. Taking note of and addressing their resistance to change up front will create a more fluid execution in the end, and make PDSA more effective.

Before beginning the PDSA cycle, the team should ask themselves the following questions:

What are we trying to accomplish?

Where are we now? What is the current process?

What change can we make that will result in an improvement?

How will we know when a change is an improvement?

The answers to these questions will help to define both the teams goals (in terms of leadership, manpower and potential barriers) and how success will be quantified. The vision statement is a crucial component that focuses the group throughout the entire process and should answer the first question, "What are we trying to accomplish?" The teams answer, as well as the resulting vision statement, should be succinct and measurable.

Step 1: Plan

Planning is the most involved phase of the PDSA process and provides the roadmap to achieving change. Planning should incorporate all of the current data and thought processes aimed at operationalizing the changes to take place. Teams should spend more time in this part of the cycle than any other. Its during the planning that teams should ask important questions such as: What will change? Where will it happen? Who will do it? What data will be collected? How will it be collected?

Planning first involves studying the current situation and analyzing possible causes for defects. Similar to CUSP, a survey or study may be conducted so the team has a baseline understanding of the current situation and the resulting impact on patient safety.

Next, brainstorm the specific areas that the team identified as opportunities and possible solutions to fixing these areas. This is the point at which the critical questions above should be addressed. There is always the natural tendency to fix as much as possible as quickly as possible. To keep teams motivated and success achievable, its recommended to start small by focusing on a few defined efforts and to build from there.

Developing diagrams like the Fishbone (Ishikawa) may help visually demonstrate cause and effect for staff, educate the group on the process and identify potential barriers. Other visual aids like flow diagrams help create a collective understanding of the current process and illuminate the possibilities for change. New processes and data collection points to evaluate proposed changes can be designed from these basic brainstorming tools.

Step 2: Do

Once the plan is developed, its time to carry it out. During this phase, the plan is implemented on a small scale, like making the change in one unit or only changing one part of the old process. The specific actions taken will depend entirely on the teams vision statement, but could include changing the steps in the workflow, utilizing a new product, developing new protocols or providing additional staff training. During the "Do" phase, communication with staff must occur at frequent intervals to keep them abreast of changes, to involve them in the change process and to provide the necessary information and tools to help them adapt to the changes.

As the team is implementing the plan, collect and collate data to keep track of your successes, as determined during the planning phase. While collecting data, make sure the team also documents any problems, barriers and unexpected results. This will serve as useful information as the team moves into the study phase.

Step 3: Study

Once the team has collected enough data to give an accurate picture of progress, the next steps is to study, or analyze, the results. For some improvements a week or two of data collection may be enough, while for others, a month or two of recorded data may be necessary. The most important step of the study/analyze step is to determine whether improvements are being made. Upon review and quantification of the data, ask your team if there are any barriers to change or if anything unexpected happened that should be addressed. As in the planning phase, some teams find it helpful to develop diagrams, run charts, or pie charts to illustrate progress.

Step 4: Act

Based on the data and what was learned from the small-scale implementation in Step 3, determine whether the action plans are helping the team to reach its ultimate goal. If they are, you may begin to standardize the change by expanding it through the rest of the unit, department or organization. Its very important to collect data at regular intervals, and when goals are met, to celebrate those milestones with the team and anyone that participated in the process! This celebratory occasion also provides an opportunity to share key learnings with other units who may benefit from the teams experience.

If you find that modifications to the process are needed, the team may need to run them through the PDSA cycle again to ensure that the modifications will make a difference. Like CUSP, PDSA is a continuous process of evaluating and re-evaluating.

PDSA in Action

Following is an actual example of how one hospital that attended the summit ran the PDSA cycle in their critical care unit.

Vision: Reduce CLABSIs in a critical care unit by 50 percent within a six-month period of time.

PLAN: The unit identified four projects through data and brainstorming, which would require four PDSA cycles. They divided the team into four groups to assess the following areas: nursing process, nursing practice, physician practice and products. Each team assessed the needs in their area and developed an action plan to achieve desired changes.

DO: Each team implemented their changes on the 17-bed med/surg ICU over the course of one month. The nursing process team focused on documentation issues. The nursing practice team focused on line care with a "Scrub the Hub" campaign. The physician practice team reviewed insertion technique and standardized their practice utilizing an insertion checklist. Finally the products team evaluated new dressings for central lines and chose a transparent dressing with an integrated gel pad containing chlorhexidine gluconate. Similar to the team at Johns Hopkins, they also put together a central line insertion cart to centralize supplies for the insertion process.

STUDY: The team measured monthly CLABSI outcomes and continued to trend them over time to help them determine opportunities for improvement. Data related to process measures were also collected such as compliance with dressing changes. Initially, compliance with changing dressings according to policy was low. Weekly data collection conducted every Monday on every central line provided valuable information on where the staff needed education and coaching.

ACT: The practice for labeling dressings was to date the dressing when it was changed, not when it was needed. It was determined that compliance would improve if the dressing was labeled with the date the dressing needed to be changed to standardize and take the guess work out of this important part of line care. Data continues to be collected in the critical care unit of this hospital after the change was made and dressing change compliance has increased significantly over time.

The Formula for Making Change Happen

Like building a house, bringing about change in complex healthcare organizations does not come quickly or easily. But having a vision of what is possible, maintaining a culture of safety as the foundation and using a proven methodology as the framework, it is possible for any leader to gather the right team together to bring about the changes that will make hospitals even safer for patients, one step at a time.

Bradford Winters, PhD, MD, is assistant professor of anesthesiology and critical care medicine, neurology and surgery at Johns Hopkins University School of Medicine. Kathleen Kohut, RN, MS, CIC, CNOR, is an independent infection prevention consultant with more than 15 years experience in the field of infection prevention. For more information and sample presentations, forms and statistics, visit

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