Mapping the process of ICU care delivery to improve treatment decisions in acute respiratory failure.

Evidence suggests system-level norms and care processes influence individual patients' medical decisions, including end-of-life decisions for patients with critical illnesses like acute respiratory failure. Yet, little is known about how these processes unfold over the course of a patient's critical illness in the intensive care unit (ICU). Our objective was to map current-state ICU care delivery processes for patients with acute respiratory failure and to identify opportunities to improve the process. We conducted a process mapping study at two academic medical centers, using focus groups and semi-structured interviews. The 70 participants represented 17 distinct roles in ICU care, including interprofessional medical ICU and palliative care clinicians, surrogate decision makers, and patient survivors. Participants refined and endorsed a process map of current-state care delivery for all patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation. The process contains four critical periods for active deliberation about the use of life-sustaining treatments. However, active deliberation steps are inconsistently performed and frequently disrupted, leading to prolongation of life-sustaining treatment by default, without consideration of patients' individual goals and priorities. Interventions to standardize active deliberation in the ICU may improve treatment decisions for ICU patients with acute respiratory failure.

Design thinking to improve healthcare delivery in the intensive care unit: Promise, pitfalls, and lessons learned.

Design thinking is a problem-solving approach characterized by the empathetic lens through which designers integrate perspectives of end-users and key stakeholders throughout the entire process of developing solutions. This approach is rooted in diverse fields including engineering, computer science, psychology, and business and is increasingly widespread in healthcare. Herein, we describe the promise of design thinking to help solve intractable problems in healthcare delivery, including those within the complex social and technical intensive care unit system. We highlight our team's experience using design thinking to address the complex problem of aligning the delivery of life-sustaining treatments with patients' individual goals, values, and preferences. However, given the high stakes of design failure in healthcare, we also discuss the limitations of this approach and the potential consequences of inadequate application. Finally, we suggest a pathway forward that combines the philosophy and tools of design thinking with existing methods within healthcare delivery science, such as qualitative research, quality improvement methods, and implementation science. Ultimately, we argue that design thinking is a valuable approach to guide designers, clinicians, researchers, and administrators towards a more genuine understanding of the healthcare experience, through the lens of patients, their families, and frontline clinicians.

Door-In-Door-Out Process Times at Primary Stroke Centers in Chicago.

STUDY OBJECTIVE: Acute stroke patients often require interfacility transfer from primary stroke centers to comprehensive stroke centers. Given the time-sensitive benefits of endovascular reperfusion, reducing door-in-door-out time at the primary stroke center is a target for quality improvement. We sought to identify modifiable predictors of door-in-door-out times at 3 Chicago-region primary stroke centers. METHODS: We performed a retrospective analysis of consecutive patients with acute stroke from February 1, 2018 to January 31, 2020 who required transfer from 1 of 3 primary stroke centers to 1 of 3 affiliated comprehensive stroke centers in the Chicago region. Stroke coordinators at each primary stroke center abstracted data on type of transport, medical interventions and treatments prior to transfer, and relevant time intervals from patient arrival to departure. We evaluated predictors of door-in-door-out time using median regression models. RESULTS: Of 191 total patients, 67.9% arrived by emergency medical services and 57.4% during off-hours. Telestroke was performed in 84.2%, 30.5% received alteplase, and 48.4% underwent a computed tomography (CT) angiography at the primary stroke center. The median door-in-door-out time was 148.5 (interquartile range 106 to 207.8) minutes. The largest contributors to door-in-door-out time, in minutes, were CT to CT angiography time (22 [7 to 73.5]), transfer center contact to ambulance request time (20 [8 to 53.3]), ambulance request to arrival time (20.5 [14 to 36]), and transfer ambulance time at primary stroke center (26 [21 to 35]). Factors associated with door-in-door-out time were (adjusted median differences, in minutes [95% confidence intervals]): CT angiography performed at primary stroke center (+39 [12.3 to 65.7]), walk-in arrival mode (+53 [4.1 to 101.9]), administration of intravenous alteplase (-29 [-31.3 to -26.7]), intubation at primary stroke center (+23 [7.3 to 38.7]), and ambulance request by primary stroke center (-20 [-34.3 to -5.7]). CONCLUSION: Door-in-door-out times at Chicago-area primary stroke centers average nearly 150 minutes. Reducing time to CT angiography, receipt of alteplase, and ambulance request are likely important modifiable targets for interventions to decrease door-in-door-out times at primary stroke centers.

Risk Assessment of the Door-In-Door-Out Process at Primary Stroke Centers for Patients With Acute Stroke Requiring Transfer to Comprehensive Stroke Centers.

Background Patients with acute stroke at non- or primary stroke centers (PSCs) are transferred to comprehensive stroke centers for advanced treatments that reduce disability but experience significant delays in treatment and increased adjusted mortality. This study reports the results of a proactive, systematic, risk assessment of the door-in-door-out process and its application to solution design. Methods and Results A learning collaborative (clinicians, patients, and caregivers) at 2 PSCs and 3 comprehensive stroke centers in Chicago, Illinois participated in a failure modes, effects, and criticality analysis to identify steps in the process; failures of each step, underlying causes; and to characterize each failure's frequency, impact, and safeguards using standardized scores to calculate risk priority and criticality numbers for ranking. Targets for solution design were selected among the highest-ranked failures. The failure modes, effects, and criticality analysis process map and risk table were completed during in-person and virtual sessions. Failure to detect severe stroke/large-vessel occlusion on arrival at the PSC is the highest-ranked failure and can lead to a 45-minute door-in-door-out delay caused by failure to obtain a head computed tomography and computed tomography angiogram together. Lower risk failures include communication problems and delays within the PSC team and across the PSC comprehensive stroke center and paramedic teams. Seven solution prototypes were iteratively designed and address 4 of the 10 highest-ranked failures. Conclusions The failure modes, effects, and criticality analysis identified and characterized previously unrecognized failures of the door-in-door-out process. Use of a risk-informed approach for solution design is novel for stroke and should mitigate or eliminate the failures.

Redesigning Transplant Organ Labeling to Prevent Patient Harm and Organ Loss.

BACKGROUND: In 2012, the Health Resources and Services Administration and the United Network for Organ Sharing launched the "Electronic Tracking and Transportation" (ETT) project, in response to "labeling and packaging issues" being a frequently reported safety incident. This article describes an improvement project conducted as part of this United Network for Organ Sharing project. METHODS: An interdisciplinary team conducted a Process Failure Modes and Effects Analysis, laboratory simulations of organ labeling during procurement, and a heuristic evaluation of a label software application to inform the design of TransNet, a system that uses barcode technology at the point of organ recovery. A total of 42 clinicians and staff from 10 organ procurement organizations and 2 transplant centers in the United States participated. Processes Addressed: Key features of the redesigned labeling system include independent, double entry of label information into the software application, a machine-readable barcode on each organ's label, and a handheld printer for at "point of use" label printing. OUTCOMES: The new labeling system, TransNet, has become mandatory since June 2017. A survey conducted on early adopters (N = 11), after 1 year of use, indicates the process is safer and more efficient. IMPLICATIONS FOR PRACTICE: The findings from this study suggest that the application of quality planning methods, common in other industries, when redesigning a health-care process, are valuable and revelatory and should be adopted more extensively. Future evaluation of TransNet effectiveness to reduce safety incidents is critical.

Risk assessment of the hospital discharge process of high-risk patients with diabetes.

OBJECTIVES: Describe the application of a risk assessment to identify failures in the hospital discharge process of a high-risk patient group, liver transplant (LT) recipients with diabetes mellitus (DM) and/or hyperglycaemia who require high-risk medications. DESIGN: A Failure Modes, Effects and Criticality Analysis (FMECA) of the hospital discharge process of LT recipients with DM and/or hyperglycaemia who required DM education and training before discharge was conducted using information from clinicians, patients and data extraction from the electronic health records (EHR). Failures and their causes were identified and the frequency and characteristics (harm, detectability) of each failure were assigned using a score of low/best (1) to high/worst (10); a Criticality Index (CI=Harm×Frequency) and a Risk Priority Number (RPN=Harm×Frequency×Detection) were also calculated. SETTING: An academic, tertiary care centre in Chicago, Illinois. PARTICIPANTS: Healthcare providers (N=31) including physicians (n= 6), advanced practice providers (n=12), nurses (n=6), pharmacists (n= 4), staff (n=3) and patients (n=6) and caregivers (n=3) participated in the FMECA; EHR data for LT recipients with DM or hyperglycaemia (N=100) were collected. RESULTS: Of 78 identified failures, the most critical failures (n=15; RPNs=700, 630, 560; CI=70) were related to variability in delivery of diabetes education and training, care coordination and medication prescribing patterns of providers. Underlying causes included timing of patient education, lack of assessment of patients' knowledge and industry-level design failures of healthcare products (eg, EHR, insulin pen). CONCLUSION: Most identified critical failures are preventable and suggest the need for the design of interventions, informed by the failures identified by this FMECA, to mitigate safety risks and improve outcomes of high-risk patient populations.

Fault Tree Analysis.

The purpose of this study was to use fault tree analysis to evaluate the adequacy of quality reporting programs in identifying root causes of postoperative bloodstream infection (BSI). A systematic review of the literature was used to construct a fault tree to evaluate 3 postoperative BSI reporting programs: National Surgical Quality Improvement Program (NSQIP), Centers for Medicare and Medicaid Services (CMS), and The Joint Commission (JC). The literature review revealed 699 eligible publications, 90 of which were used to create the fault tree containing 105 faults. A total of 14 identified faults are currently mandated for reporting to NSQIP, 5 to CMS, and 3 to JC; 2 or more programs require 4 identified faults. The fault tree identifies numerous contributing faults to postoperative BSI and reveals substantial variation in the requirements and ability of national quality data reporting programs to capture these potential faults. Efforts to prevent postoperative BSI require more comprehensive data collection to identify the root causes and develop high-reliability improvement strategies.

Failure mode and effects analysis: a comparison of two common risk prioritisation methods.

BACKGROUND: Failure mode and effects analysis (FMEA) is a method of risk assessment increasingly used in healthcare over the past decade. The traditional method, however, can require substantial time and training resources. The goal of this study is to compare a simplified scoring method with the traditional scoring method to determine the degree of congruence in identifying high-risk failures. METHODS: An FMEA of the operating room (OR) to intensive care unit (ICU) handoff was conducted. Failures were scored and ranked using both the traditional risk priority number (RPN) and criticality-based method, and a simplified method, which designates failures as 'high', 'medium' or 'low' risk. The degree of congruence was determined by first identifying those failures determined to be critical by the traditional method (RPN≥300), and then calculating the per cent congruence with those failures designated critical by the simplified methods (high risk). RESULTS: In total, 79 process failures among 37 individual steps in the OR to ICU handoff process were identified. The traditional method yielded Criticality Indices (CIs) ranging from 18 to 72 and RPNs ranging from 80 to 504. The simplified method ranked 11 failures as 'low risk', 30 as medium risk and 22 as high risk. The traditional method yielded 24 failures with an RPN ≥300, of which 22 were identified as high risk by the simplified method (92% agreement). The top 20% of CI (≥60) included 12 failures, of which six were designated as high risk by the simplified method (50% agreement). CONCLUSIONS: These results suggest that the simplified method of scoring and ranking failures identified by an FMEA can be a useful tool for healthcare organisations with limited access to FMEA expertise. However, the simplified method does not result in the same degree of discrimination in the ranking of failures offered by the traditional method.

Academic-Community Hospital Comparison of Vulnerabilities in Door-to-Needle Process for Acute Ischemic Stroke.

BACKGROUND: Although best practices have been developed for achieving door-to-needle (DTN) times ≤60 minutes for stroke thrombolysis, critical DTN process failures persist. We sought to compare these failures in the Emergency Department at an academic medical center and a community hospital. METHODS AND RESULTS: Failure modes effects and criticality analysis was used to identify system and process failures. Multidisciplinary teams involved in DTN care participated in moderated sessions at each site. As a result, DTN process maps were created and potential failures and their causes, frequency, severity, and existing safeguards were identified. For each failure, a risk priority number and criticality score were calculated; failures were then ranked, with the highest scores representing the most critical failures and targets for intervention. We detected a total of 70 failures in 50 process steps and 76 failures in 42 process steps at the community hospital and academic medical center, respectively. At the community hospital, critical failures included (1) delay in registration because of Emergency Department overcrowding, (2) incorrect triage diagnosis among walk-in patients, and (3) delay in obtaining consent for thrombolytic treatment. At the academic medical center, critical failures included (1) incorrect triage diagnosis among walk-in patients, (2) delay in stroke team activation, and (3) delay in obtaining computed tomographic imaging. CONCLUSIONS: Although the identification of common critical failures suggests opportunities for a generalizable process redesign, differences in the criticality and nature of failures must be addressed at the individual hospital level, to develop robust and sustainable solutions to reduce DTN time.

Operating room to intensive care unit handoffs and the risks of patient harm.

BACKGROUND: The goal of this study was to assess systems and processes involved in the operating room (OR) to intensive care unit (ICU) handoff in an attempt to understand the criticality of specific steps of the handoff. METHODS: We performed a failure modes, effects, and criticality analysis (FMECA) of the OR to ICU handoff of deceased donor liver transplant recipients using in-person observations and descriptions of the handoff process from a multidisciplinary group of clinicians. For each step in the process, failures were identified along with frequency of occurrence, causes, potential effects and safeguards. A Risk Priority Number (RPN) was calculated for each failure (frequency × potential effect × safeguard; range 1-least risk to 1,000-most risk). RESULTS: Using FMECA, we identified 37 individual steps in the OR to ICU handoff process. In total, 81 process failures were identified, 22 of which were determined to be critical and 36 of which relied on weak safeguards such as informal human verification. Process failures with the greatest risk of harm were lack of preliminary OR to ICU communication (RPN 504), team member absence during handoff communication (RPN 480), and transport equipment malfunction (Risk Priority Number 448). CONCLUSION: Based on the analysis, recommendations were made to reduce potential for patient harm during OR to ICU handoffs. These included automated transfer of OR data to ICU clinicians, enhanced ICU team member notification processes and revision of the postoperative order sets. The FMECA revealed steps in the OR to ICU handoff that are high risk for patient harm and are currently being targeted for process improvement.

Applying fault tree analysis to the prevention of wrong-site surgery.

Wrong-site surgery (WSS) is a rare event that occurs to hundreds of patients each year. Despite national implementation of the Universal Protocol over the past decade, development of effective interventions remains a challenge. We performed a systematic review of the literature reporting root causes of WSS and used the results to perform a fault tree analysis to assess the reliability of the system in preventing WSS and identifying high-priority targets for interventions aimed at reducing WSS. Process components where a single error could result in WSS were labeled with OR gates; process aspects reinforced by verification were labeled with AND gates. The overall redundancy of the system was evaluated based on prevalence of AND gates and OR gates. In total, 37 studies described risk factors for WSS. The fault tree contains 35 faults, most of which fall into five main categories. Despite the Universal Protocol mandating patient verification, surgical site signing, and a brief time-out, a large proportion of the process relies on human transcription and verification. Fault tree analysis provides a standardized perspective of errors or faults within the system of surgical scheduling and site confirmation. It can be adapted by institutions or specialties to lead to more targeted interventions to increase redundancy and reliability within the preoperative process.