Designing for Patient Safety
Since the release of the 1999 Institute of Medicine report (Kohn, Corrigan, & Donaldson, 1999), “To Err is Human,” patient safety improvements have remained elusive, in spite of a host of interventions (Watcher, 2010). Recent studies have demonstrated no significant improvement for a number of healthcare-associated conditions, including the failure to reduce postoperative-, blood stream-, and catheter-associated urinary tract infections (AHRQ, 2010).
Landrigan and colleagues’ (2010) study of 10 North Carolina Hospitals over 10 years found 25.1 harms per 100 admissions; and Levinson’s (2010) Department of Health and Human Services’ Office of the Inspector General’s report found that 13.5% of hospitalized Medicare patients experienced adverse events and another 13.5% experienced temporary harm.
All of this harm significantly impacts the nation’s healthcare bill, with 1.5 million errors estimated to contribute an additional $19.5 billion dollars annually, as found in a medical claims study by The Society of Actuaries (2010). Perhaps these results reflect an incomplete understanding of the puzzle that quality healthcare represents. A growing body of research suggests that an understanding of the multiple components of the healthcare system (of which the built environment is one component) is crucial for improving patient safety.
A national seminar funded by the Agency for Healthcare Research and Quality (AHRQ) and the Facilities Guidelines Institute (FGI) brought together multidisciplinary experts to address the role of the built environment in improving patient safety in healthcare facilities. The primary focus of this meeting was on identifying the tools and processes that would support decision-making related to patient safety during the healthcare facility design process.
The two-day meeting conducted in October 2011, served as a catalyst for developing consensus around key issues to consider for the development of the Patient Safety Risk Assessment in the 2014 Guidelines for Design and Construction of Health Care Facilities from the Facility Guidelines Institute. The new Virtua Voorhees facility that opened in May 2011, was designed using a process-driven approach from the start and served as a case study and tour site during the seminar.
Why is it important to design for patient safety?
It has become increasingly clear that the problem of patient safety does not lie solely in the hands of clinicians or frontline healthcare staff. The healthcare system has many inherent latent conditions (holes and weaknesses) that interact in complex ways and result in adverse events (Reason, 2000). A growing body of research shows that features in the built environment—such as light, noise, air quality, room layout, and others—contribute to adverse patient safety outcomes, like healthcare-associated infections, medication errors, and falls in healthcare settings (Joseph & Rashid, 2007; Ulrich et al., 2008).
The conceptual model (Figure), based on Vincent (1998) and Reason’s (2000) work, shows the role of the physical environment as a latent condition that contributes to patient safety. Often, these latent conditions that adversely impact patient safety are built into the physical environment during the planning, design, and construction of healthcare facilities. For example, the location of emergency departments and intensive care units might necessitate the transport of critically ill patients over long distances, potentially causing patient complications. Handwashing sinks located in inconvenient or inaccessible locations might result in poor handwashing compliance among physicians and nurses.
Given the massive investment anticipated in healthcare facility construction in the next 10 years, there is an urgent need for a well-defined and standard methodology to identify and eliminate built environment latent conditions that impact patient safety during the planning, design, and construction of healthcare facilities. Design teams themselves are often unfamiliar with the possible built environment impact on patient safety and even less familiar with ways to incorporate these concerns into the design process.
While fields such as aviation and other high-risk industries have been able to harness human factors, engineering, and cognitive science that result in the preferred human response and consequent improved safety, no similar method exists for the design of new healthcare facilities or major renovation projects. A key focus of this seminar was on understanding the tools and techniques that would be most appropriate for identifying and removing undesirable built environment latent conditions during the healthcare facility design process.
Several resources were developed in preparation for this seminar, including a literature review of eight tools and methods that might be used to improve safety in design from fields such as human factors, engineering, and quality improvement. Industry experts contributed their perspectives around designing for patient safety through short opinion papers. The tool summaries and opinion paper compilation served as key background information for meeting attendees. In addition, a draft “safe design roadmap” and “patient safety design framework” was created for discussion and review during the meeting.
Different formats for discussion included presentations, tours, expert panels, and workgroup sessions, and some of the key questions that were debated through the course of the seminar included:
- What activities should be conducted at different points in the healthcare facility design process to ensure safety concerns are addressed?
- What should be the composition of the team involved to ensure patient safety is addressed during the healthcare facility design process?
- What sorts of documentation should be required for a patient safety risk assessment for the guidelines?
- Which existing tools and methods are relevant and applicable to the healthcare facility design process?
The meeting was multidisciplinary and participants provided insight from many points of view, with the goal to generate consensus on reasonable and feasible approaches. The second day of the meeting involved workgroup discussions. Meeting attendees were organized into seven workgroups, and each workgroup included clinicians, hospital administrators, facility managers, architects and designers, engineers, human factors specialists, researchers, authorities having jurisdiction, Health Guidelines Revision Committee members, and other healthcare consultants.
The discussions throughout the seminar, and specifically from the seven workgroups, produced rich insights into the issues around designing for patient safety. There was extreme consensus that time and effort needed to be dedicated to focusing on patient safety issues during the pre-design phase (strategic planning, master planning, operational planning, and programming) of the healthcare facility design project.
While all phases of the facility life cycle are critical, the decisions made during pre-design significantly impact the design parameters going forward and outcomes of the project from a safety perspective. The workgroups identified a range of activities that could be undertaken during pre-design and design/construction phases to improve patient safety outcomes for the project.
The top five activities that were identified through a consensus workshop as high priority for ensurin
g positive patient safety outcomes during the pre-design phase of a building project included:
- Articulation of project mission/vision around patient safety: The majority of the attendees felt that the articulation of a clear statement around patient safety at the start of the healthcare facility design project was of paramount importance as it sets the tone for the activities of the team through the course of the project.
- Operational/future state planning: Attendees identified the importance of clearly defining future states and planning processes that would help in achieving those states prior to even embarking on the actual design of the building.
- Simulation/mock-ups: The attendees identified the importance of using simulation and mock-ups very early in the design process to help visualize key concepts and to identify possible built environment latent conditions.
- Process-led design: The attendees highlighted the importance of designing the care processes in parallel to the building design. The importance of flexibility in design to accommodate changing processes was also discussed.
- Define measurable goals/metrics: The attendees discussed the importance of collecting baseline data around key patient safety outcomes such as falls, healthcare-associated infections, and medical errors, conducting a patient safety survey and developing goals for improving these outcomes.
The top four activities that were identified as high priority during design and construction phases of a healthcare facility design project included:
- Simulations/mock-ups: Simulations and mock-ups were considered the most important activity during the design and construction phases from the perspective of identifying built environment latent conditions.
- Ongoing team check-ins at every phase: Attendees felt that safety priorities needed to be institutionalized and the teams needed to have regular check-ins during all phases of the project to ensure that safe design features were being implemented as envisioned.
- Post-occupancy evaluations (POE): POEs were identified as a key activity to be undertaken once the building is completed and occupied to ensure that the building was effective in providing safe care and supporting the staff in conducting their work in a safe and efficient manner.
- Safety reviews: Similar to the check-in, attendees felt the safety reviews would enable the team to review plans and construction documents using a patient safety lens.
The Designing for Patient Safety Seminar attendees felt that the design team needed to be multidisciplinary to ensure that patient safety issues were effectively addressed and should include clinicians, administrators, facility managers, architects, consultants, human factors specialists, and researchers. Many different tools were identified for use at different facility design phases, including design FMEAs (failure mode and effects analysis), process mapping, spaghetti diagrams, link analysis, Pareto analysis, safety culture surveys, and more.
The attendees felt that conducting a Patient Safety Risk Assessment (PSRA, as currently referenced in the guidelines appendix) might involve healthcare design teams documenting their findings from using these tools as well as the documentation from other risk assessments, such as the Infection Control Risk Assessment (ICRA). Attendees also identified an operational plan that documents key processes in the new facility as another potential requirement for a PSRA. It was also noted that caregivers’ safety should be addressed simultaneously with patient safety.
Tools for designing for patient safety
The seven workgroups each analyzed one tool/method for its usability, relevance to the healthcare facility design process, feasibility, as well as generalizability to different types of settings, project scopes, and organizations. The tools reviewed included:
- Failure mode and effects analysis (FMEA);
- Balanced scorecard;
- Work sampling (time motion studies);
- Link analysis;
- Process analysis (process chart/flowchart);
- Simulation; and
- Root cause analysis (RCA).
Most of these tools were considered relevant and applicable to the healthcare facility design process. Balanced scorecard, process analysis (process mapping), and link analysis were ranked high on all key criteria. Simulation and FMEA were also ranked high, and workgroups felt that these methods were already being used in the facility design process and could be modified to make it feasible for projects of different scopes. Teams felt that these methods could readily support the design teams in making key decisions that impacted patient safety.
The balanced scorecard was suggested as helping with continuous monitoring for patient safety. Other tools, such as process analysis and RCA (aggregated data from RCAs being most beneficial), would be critical during pre-design and planning phases. FMEA, simulations, and link analysis could be effectively used at different design phases and could support decision-making at varying levels of design detail.
The key takeaway from this seminar was that the built environment significantly impacts patient and caregiver safety, and significant work needs to be done during the pre-design phase of a healthcare building project to ensure that safety concerns were addressed. This includes understanding the baseline safety metrics for the organizations, developing a mission statement around safety, and designing processes that would ensure safety for patients and staff. The seminar participants emphasized that this work was a prerequisite before the functional program can be finalized.
The ideas and consensus generated at this seminar helped with the further development of language for the Patient and Caregiver Safety Risk Assessment in the 2014 Guidelines. The findings from this conference will also help in developing whitepapers and tools to supplement the guidelines and support design teams during the facility design process. The resources, summaries, and tools developed for this seminar will be compiled and made available through The Center for Health Design and FGI websites. The energy and ideas generated through this seminar will be sustained through continuing discussions and involvement of participants in different aspects of this important work. HCD