Serious Safety Events Research Articles

A Process-Based Standardization of an Intraoperative Escalation Protocol in Anesthesiology.

Prompt recognition and management of critical events is pivotal for the provision of safe anesthetic care. This requires a well-functioning team that focuses on effective communication, timely decision-making, and escalation of potential complications. We believe that variation in bedside care leads to "near-misses," adverse outcomes, and serious safety events (SSEs). The principles of an escalation culture have been used successfully in other highly reliable industries such as aviation, military, and manufacturing. We discuss here the introduction of a unique and compelling thought-process for developing an intraoperative escalation protocol that is specifically tailored for our institution. Inspired by a critical intraoperative event, this departmental protocol was developed based on an analysis of multispecialty literature and expert opinion to decrease the incidence of SSEs. It includes a stepwise approach and incorporates patient-specific information to guide team members who encounter dynamic clinical situations. The implementation of the protocol has facilitated continuous quality improvement through iterative education, improving communication, and enhancing decision-making. Concurrently, we have plans to incorporate technology and electronic decision support tools to enhance real-time communication, monitor performance, and foster a culture of safety.

Impact of a Daily Huddle on Safety in Perioperative Services

Communication failures contribute to quality gaps and may lead to serious safety events (SSEs) in the operating room (OR). Our perioperative services team experienced an increased rate of SSEs in 2020. Event analysis revealed clustered causes: communication failures and lack of timely information to prepare for cases. Consequently, the team implemented a daily morning OR safety huddle conducted before bringing patients into the OR to reduce quality gaps and improve communication. The attending surgeon and anesthesiologist, circulating nurse, and scrub staff are required to be present. Cases are discussed using a standard format designed by the OR team with built-in time for questions and clarifications. The surgeon initiates the huddle; the circulating nurse leads and records the discussion. OR leadership initially performed daily audits but gradually reduced them when huddles became standard operating procedure (SOP). SSEs were recorded from December 2015 to September 2020 preintervention and October 2020 to July 2023 postintervention. Following the implementation of huddles, there were no SSEs for more than 900 days (2.0 SSEs/year preintervention vs. 0.0 SSEs/year postintervention). The first SSE during the postintervention period occurred in March 2023. Huddle compliance was consistently > 95%. No delays were observed in first-case on-time starts postintervention. The huddle is now SOP for all general OR teams and interventional radiology. Implementing the morning safety huddle contributed to a reduction in the rate of SSEs without introducing delays to first-case start-times.

Variability in Serious Safety Event Classification among Children's Hospitals: A Measure for Comparison?

Hospitals have no standard for measuring comparative rates of serious safety events (SSE). A pediatric hospital safety collaborative has used a common definition and measurement system to classify SSE and calculate a serious safety event rate. An opportunity exists to evaluate the use of this measurement system. A web-based survey utilizing 7 case vignettes was sent to 132 network hospitals to assess agreement in classifying the vignettes as SSEs. Respondents classified the vignettes according to the taxonomy used at their respective organizations for deviations and SSE classification. Of the 82 respondents, 67 (82%) utilized the same SSE classification system. Respondents did not assess deviations for 2 of the 7 vignettes, which had clear deviations. Of the remaining 5 vignettes, 3 had a substantial agreement of deviation (>85%, Gwet's AC ≥ 0.68), and 2 had fair agreement (<70%, Gwet's AC ≤ 0.39). Four of the 7 vignettes had a substantial agreement on SSE classification (>80%; Gwet's AC ≥ 0.80), and 3 had slight to moderate agreement (<70%, Gwet's AC ≤ 0.78). Results demonstrated agreement and variability in determining deviation and SSE classification in the 7 vignettes. Although the SSE methodology and metric used by participant pediatric hospitals yields generally similar review results, one must be cautious in using the SSE rate to compare patient safety outcomes across different hospitals.

Improving Discharge Safety in a Pediatric Emergency Department.

Discharge from the emergency department (ED) involves a complex series of steps to ensure a safe transition to home and follow-up care. Preventable, discharge-related serious safety events (SSEs) in our ED highlighted local vulnerabilities. We aimed to improve ED discharge by implementing a standardized discharge process with emphasis on multidisciplinary communication and family engagement. At a tertiary children's hospital, we used the model for improvement to revise discharge care. Interventions included a new discharge checklist, a provider huddle emphasizing discharge vital signs, and a scripted discharge review of instructions with families. We used statistical process control to evaluate performance. Primary outcomes included elimination of preventable, discharge-related SSEs and Press Ganey survey results assessing caregiver information for care of child at home. A secondary outcome was number of days between preventable low-level (near-miss, no or minimal harm) events. Process measures included discharge checklist adoption and vital sign acquisition. Balancing measures were length of stay (LOS) and return rates. Over the study period, there were no preventable SSEs and low-level event frequency improved to a peak of &gt;150 days between events. Press Ganey responses regarding quality of discharge information did not change (62%). Checklist use was rapidly adopted, reaching 94%. Vital sign acquisition increased from 67% to 83%. There was no change in the balancing measures of median LOS or return visit rates. The development and implementation of a standardized discharge process led to the elimination of reported discharge-related events, without increasing LOS or return visits.

Serious Experience Events: Applying Patient Safety Concepts to Improve Patient Experience

Pediatric healthcare systems have successfully decreased patient harm and improved patient safety by adopting standardized definitions, processes, and infrastructure for serious safety events (SSEs). We have adopted those patient safety concepts and used that infrastructure to identify and create action plans to mitigate events in which patient experience is severely compromised. We define those events as serious experience events (SEEs). The purpose of this research brief is to describe SEE definitions, infrastructure used to evaluate potential SEEs, and creation of action plans as well as share our preliminary experiences with the approach.

Factors Related to Serious Safety Events in a Children's Hospital Patient Safety Collaborative.

Serious safety events (SSEs) occur infrequently at individual hospitals, making it difficult to establish trends to improve patient care. Patient safety organizations, such as the Child Health Patient Safety Organization (CHILDPSO), can identify trends and support learning across children's hospitals. We aim to describe longitudinal trends in SSE rates among CHILDPSO member hospitals and describe their sources of harm. SSEs from 44 children's hospitals were assigned severity and reported to CHILDPSO from January 1, 2015, to December 31, 2018. SSEs were classified into groups and subgroups based on analysis. Events were then tagged with up to 3 contributing factors. Subgroups with <5 events were excluded. There were 22.5 million adjusted patient days included. The 12-month rolling average SSE rate per 10 000 adjusted patient days decreased from 0.71 to 0.41 (P < .001). There were 830 SSEs reported to CHILDPSO. The median hospital volume of SSEs was 12 events (interquartile range: 6-23), or ∼3 SSEs per year. Of the 830 events, 21.0% were high severity (SSE 1-3) and approximately two-thirds (67.0%, n = 610) were patient care management events, including subgroups of missed, delayed, or wrong diagnosis or treatment; medication errors; and suboptimal care coordination. The most common contributing factor was lack of situational awareness (17.9%, n = 382), which contributed to 1 in 5 (20%) high-severity SSEs. Hospitals sharing SSE data through CHILDPSO have seen a decrease in SSEs. Patient care management was the most frequently seen. Future work should focus on investigation of contributing factors and risk mitigation strategies.

Pediatric Patient Safety: Shared Learning to Improve Patient Outcomes.

Two decades ago, the seminal Institute of Medicine (now the National Academies of Sciences, Engineering, and Medicine) report To Err Is Human: Building a Safer Health System first highlighted the influence of poorly designed health care delivery systems and suboptimal processes as contributors to patient safety.1 Substantial progress has occurred since then, including creation of a federally mandated Child Health Patient Safety Organization,2 which uses a standardized taxonomy for patient safety events, contributory factors, and severity of harm,3 with shared learning by dissemination of reports to individual institutions and to the public.4 In this issue of Pediatrics, Burrus et al analyze and report on 4 years of serious safety events (SSEs) from 44 Child Health Patient Safety Organization–participating hospitals regarding the types of safety events, severity of harm, and contributory factors.5 Their results underscore the overall improvement in pediatric safety in these institutions during the study period as demonstrated by a downward trend in SSEs from 0.71 to 0.41 per 10 000 adjusted patient days. The strengths of this study are the learnings from a collaborative, which can be disseminated publicly, the spectrum of harm among the reported SSEs (with one-fifth of SSEs having the highest severity defined as death or permanent harm), and the identification of more important contributory factors, such as lack of situational awareness. However, the study results also reveal there is still much to be done to mitigate pediatric patient harm.Organizations must continue to implement strategies to eliminate harm related to procedures (eg, retained foreign objects, wrong procedures). Recently there has been controversy regarding the pursuit of zero harm because it might lead to provider burnout, which can lead to harm and increased health care costs.6 Regardless, as stated by the legendary football coach Vince Lombardi, “Perfection is not attainable, but if we chase perfection we can catch excellence.” Hospitals need to remain laser-focused on all causes of preventable patient harm, especially those resulting from procedures, medications, and other products and devices. There are also important lessons to be learned from non-SSEs that were excluded from this analysis.Furthermore, patient safety needs to be understood in the context of the care setting. Several studies have revealed that certain settings such as emergency departments, operating rooms, and ICUs are more prone to safety events. Indeed, several reports from the federally supported pediatric research network Pediatric Emergency Care Applied Research Network highlight the types, contributory factors, and severity of harm in the context of pediatric emergency care.7–10 Finally, as the number of procedural events and medication errors decrease, the hidden impact of missed, delayed, or wrong diagnosis was justifiably identified in the Burrus et al article. Diagnostic errors have been considered for a long time as the “blind spot” in patient safety and the National Academies of Sciences, Engineering, and Medicine report Improving Diagnosis in Health Care highlighted that most individuals will experience at least 1 diagnostic error in their lifetime, sometimes with devastating consequences.11 Similar to other safety events, diagnostic safety needs standardized taxonomy, validated and accepted definitions, and robust study designs, including prospective, multicenter studies to understand the epidemiology, contributory factors, severity of harm, and impact of interventions to mitigate harms.12 Ultimately, patient safety (avoidance of negative outcome) and quality (achievement of positive outcome) need to be at the center of all health care services. The imperative to support multidimensional approaches to reduce patient harm, including research, education, training, and policy, has never been greater.

Healthcare Worker Serious Safety Events: Applying Concepts from Patient Safety to Improve Healthcare Worker Safety.

Introduction:Patient safety has improved pediatric healthcare by defining when patient safety events meet criteria as serious safety events (SSEs). Similar concepts apply to healthcare worker (HCW) safety. We describe the newly designed process for HCW injury reporting, the process for evaluating HCW SSEs, and early experience with the new systems.Methods:The work to redesign our approach to HCW safety included 2 parts: (1) process flow mapping and redesigning the work for HCW injury reporting; and (2) creating a process to categorize HCW injuries and determine when such injuries rise to a HCW SSE level. We evaluated the mean time per month from HCW injury to reporting and compared those values during the postimplementation time. We also evaluated the team’s experience with the first 4 potential HCW SSEs.Results:By improving the process flow, the mean time to reporting decreased significantly from 28 days implementation time-period (September–October 2019) to 9 days during the postimplementation time-period (November 2019–May 2020) (P = 0.0002). Of the first 4 HCW events identified and reviewed as possible HCW SSE events, there were 2 defined as HCW SSE level 4, one defined as a precursor event, and one defined as a nonsafety event.Conclusion:Adapting infrastructure and definitions used previously to improve patient safety can improve HCW safety.

Establishment of a Perinatal Quality Network

The guiding premise of care at University Hospitals is based on high reliability organization (HRO) principles. With the acquisition of six community hospitals that provided obstetric services and an established regional perinatal leader, the opportunity was created to integrate standardized practice to decrease variation and improve patient outcomes. The establishment of an obstetric network that fosters collaborative inter- and intrahospital efforts and partnerships that promoting HRO principles. These partnerships form the basic governance of the UH OB Network. The foundation of this unique network is the equal ownership of vision and design shared by the chief of systems quality, obstetrics, and the senior quality improvement nurses. This team recruited self-identified obstetric champions (nurses, providers, quality and risk) from each institution to generate consensus and lead process improvement at the local level The adoption of multidisciplinary care guidelines informed by best evidence and internal expert opinion serves as the lynchpin for consensus-driven practice. Customization of the electronic record to reflect care guidelines provides additional crucial support integral to their implementation. The formation of robust local quality assurance committees focused on perinatal care identifies unique risk to drive process improvement. Participation in an online learning and individual risk assessment is required for all nurses and providers. The inception of rigorous quality assurance processes has led to a significant decrease in the rate of patient serious safety events (SSE) using the American Society for Healthcare Management preventable-harm classification system. A reduction in the number of malpractice suits and a decrease in total obstetric litigation costs occurred after the formation of the UH OB Network. Clinician knowledge and judgment scores demonstrated improvement in all modules of the system’s online learning platform. The interprofessional collaborative approach to perinatal care advances the science of health and the art of compassion while maximizing team cohesiveness. The shared partnership model engenders equal ownership of patient care and subsequent patient outcomes. The multidisciplinary approach empowers nurses to advocate and innovate on behalf of patients and their families in achieving best possible outcomes.

Serious safety events in rituximab-treated multiple sclerosis and related disorders.

IntroductionStudies investigating rates and risk factors for serious safety events (SSEs) during rituximab treatment of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and related disorders are limited.MethodsRituximab‐treated patients with MS, NMOSD, or related disorders at the Rocky Mountain and New York University MS Care Centers were included. The follow‐up period was defined as the time from the initial dose of rituximab up to 12 months of last dose of rituximab or ocrelizumab (in patients who switched). Clinician‐reported and laboratory data were retrospectively collected from electronic medical records.ResultsOne‐thousand patients were included comprising 907 MS, 77 NMOSD, and 16 related disorders. Patients had a mean follow‐up of 31.1 months and a mean cumulative rituximab dose of 4012 mg. Of the 169 patients who switched to ocrelizumab, the mean ocrelizumab dose was 1141 mg. Crude incidence rate per 1000 person‐years (PY) for lymphopenia was 19.2, neutropenia 5.6, and hypogammaglobulinemia 17.8. Infections resulting in either hospitalization, IV antibiotics, or using antibiotics ≥14 days occurred at a rate of 38.6/1000 PY. Risk factors for infection were duration of therapy, male gender, increased disability, prior exposure to immunosuppression/chemotherapy, lymphopenia, and hypogammaglobulinemia. Particularly, wheelchair‐bound patients had 8.56‐fold increased odds of infections. Crude incidence rates of malignant cancer were 3.5, new autoimmune disease 2.3, thromboembolic event 3.1, and mortality of 5.4 per 1000 PY.InterpretationRates of SSEs in patients with MS, NMOSD, and related disorders were low. Through properly assessing risk:benefit of B‐cell depleting therapy in neuroinflammatory disorders and continual monitoring, clinicians may decrease the risk of serious infections.

Creating a Defined Process to Improve the Timeliness of Serious Safety Event Determination and Root Cause Analysis.

Introduction:Serious Safety Events (SSEs) are defined as events in which there is a deviation from clinically accepted performance standards, causation, and significant patient harm or death. Given the nature of SSEs, it is important that the processes for declaration of SSEs, the performance of a root cause analysis (RCA), and action plan formation occur quickly, such that the window for potential recurrence of similar events is as small as possible. This manuscript describes a process put in place to improve the timeliness of SSE determination and RCA conduction and evaluates the effect of the process change on these parameters.Methods:A causal analysis was performed of the baseline process to determine factors contributing to long process times. A new process was created and implemented both for the SSE determination process and the RCA completion process. We calculated the mean time for the pre-implementation phase (April 2016–December 2017) and the post-implementation phase (March 2018–January 2019) for both SSE determination and RCA completion. We evaluated differences with a two-sided t test assuming unequal variances.Results:Comparing pre- versus post- implementation phases, the mean time for SSE determination for events that met the SSE criteria decreased from 38.4 to 4.8 days (P < 0.0001), determination for events that did not meet the SSE criteria decreased from 38.4 to 3.8 days (P < 0.0001), and RCA completion time dropped from 118.0 to 26.2 days (P < 0.0001).Conclusions:A targeted intervention can significantly reduce SSE determination and RCA conduction times.

Reducing Serious Safety Events and Priority Hospital-Acquired Conditions in a Pediatric Hospital with the Implementation of a Patient Safety Program

A freestanding children's hospital evaluated the impact of a patient safety program on serious safety events (SSEs) and hospital-acquired conditions (HACs). The No Harm Patient Safety Program was developed throughout the organization using a multifaceted approach that included safety moments, leadership rounding, cause analysis changes, event reporting enhancements, error prevention training, leadership training, identifying priority HACs, Eye on Safety Campaign, and safety coaches. The organization set strategic goals for improvement of SSEs and priority HACs. The rate of SSEs decreased from 0.19 in 2014 to 0.09 in 2015. The rate significantly declined from 2015 to 2016 to a rate of 0.00, for a rate difference of -0.00009 (95% confidence interval [CI]: -0.00016, -0.00002; p = 0.012). The organization reached two years without an SSE in July 2017. The central line-associated bloodstream infection rate significantly declined from 2.8 per 1,000 line-days in 2015 to 1.6 in 2016, for a difference of -0.00118 (95% CI: -0.002270, -0.00008; p = 0.036). Surgical site infection rates declined from a 2015 rate of 3.8 infections per 100 procedures to a 2016 rate of 2.6 (p = 0.2962), and catheter-associated urinary tract infection rates declined from a 2015 rate of 2.7 per 1,000 catheter-days to a 2016 rate of 1.4 (p = 0.2770). The No Harm Patient Safety Program was interwoven into the organization's strategic mission and values, and key messaging was used to purposefully tie the many interventions being implemented back to it. These interventions were associated with improvements in patient safety outcomes.

Children's Hospitals' Solutions for Patient Safety Collaborative Impact on Hospital-Acquired Harm.

To determine if an improvement collaborative of 33 children's hospitals focused on reliable best practice implementation and culture of safety improvements can reduce hospital-acquired conditions (HACs) and serious safety events (SSEs). A 3-year prospective cohort study design with a 12-month historical control population was completed by the Children's Hospitals' Solutions for Patient Safety collaborative. Identification and dissemination of best practices related to 9 HACs and SSE reduction focused on key process and culture of safety improvements. Individual hospital improvement teams leveraged the resources of a large, structured children's hospital collaborative using electronic, virtual, and in-person interactions. Thirty-three children's hospitals from across the United States volunteered to be part of the Children's Hospitals' Solutions for Patient Safety collaborative. Thirty-two met all the data submission eligibility requirements for the HAC improvement objective of this study, and 21 participated in the high-reliability culture work aimed at reducing SSEs. Significant harm reduction occurred in 8 of 9 common HACs (range 9%-71%; P < .005 for all). The mean monthly SSE rate decreased 32% (from 0.77 to 0.52; P < .001). The 12-month rolling average SSE rate decreased 50% (from 0.82 to 0.41; P < .001). Participation in a structured collaborative dedicated to implementing HAC-related best-practice prevention bundles and culture of safety interventions designed to increase the use of high-reliability organization practices resulted in significant HAC and SSE reductions. Structured collaboration and rapid sharing of evidence-based practices and tools are effective approaches to decreasing hospital-acquired harm.

The Well-Defined Pediatric ICU: Active Surveillance Using Nonmedical Personnel to Capture Less Serious Safety Events

Adverse events, diverse and often costly, commonly occur in pediatric intensive care units (PICUs). Serious safety events (SSEs) are captured through well-developed systems, typically by voluntary reporting. Less serious safety events (LSSEs), including close calls, however, occur at a higher frequency than those that result in immediate harm or death but are underestimated by standard reporting systems. LSSEs can reveal system defects and precede serious events resulting in patient or provider harm. A unique active surveillance program was created at Children's Hospitals and Clinics of Minnesota to quantify and categorize, and, ultimately reduce, LSSEs, in PICUs. Premedical college graduates without formal health care training daily canvassed the PICUs and facilitated reporting of LSSEs at the point of care. Events were recorded on a Web application and stored in a relational database management system. Events were enumerated and categorized according to distinctive characteristics (Theme Index) and real or potential harm (Harm Index). Some 1,980 PICU patients, representing 10,766 PICU patient-days in a 15-month period (June 1, 2013- August 31, 2014) experienced 2,465 LSSEs-5.4 LSSEs/ day or 0.23 LSSEs/patient-day. Such events resulted in a patient intervention 38% of the time. Some 158 quality/safety improvement projects were initiated during the observation period, 74 of which have been completed. Quality/safety information was broadcasted to providers, local leadership, and hospital management. LSSEs occur frequently in our PICUs. Non-health care providers can cost-effectively facilitate reporting by actively canvassing PICU providers on a daily basis and can contribute to quality/safety improvement projects and local safety culture. Reported events can serve as a focus for quality/safety improvement projects. A Web application and mobile tablet interfaces are efficient tools to record events.

Improving Situation Awareness to Reduce Unrecognized Clinical Deterioration and Serious Safety Events

Failure to recognize and treat clinical deterioration remains a source of serious preventable harm for hospitalized patients. We designed a system to identify, mitigate, and escalate patient risk by using principles of high-reliability organizations. We hypothesized that our novel care system would decrease transfers determined to be unrecognized situation awareness failures events (UNSAFE). These were defined as any transfer from an acute care floor to an ICU where the patient received intubation, inotropes, or ≥ 3 fluid boluses in first hour after arrival or before transfer. The setting for our observational time series study was a quaternary care children's hospital. Before initiating tests of change, 2 investigators reviewed recent serious safety events (SSEs) and floor-to-ICU transfers. Collectively, 5 risk factors were associated with each event: family concerns, high-risk therapies, presence of an elevated early warning score, watcher/clinician gut feeling, and communication concerns. Using the model for improvement, an intervention was developed and tested to reliably and proactively identify patient risk and mitigate that risk through unit-based huddles. A 3-times daily inpatient huddle was added to ensure risks were escalated and addressed. Later, a "robust" and explicit plan for at-risk patients was developed and spread. The rate of UNSAFE transfers per 10,000 non-ICU inpatient days was significantly reduced from 4.4 to 2.4 over the study period. The days between inpatient SSEs also increased significantly. A reliable system to identify, mitigate, and escalate risk was associated with a near 50% reduction in UNSAFE transfers and SSEs.

Quality Improvement Initiative to Reduce Serious Safety Events and Improve Patient Safety Culture

Many thousands of patients die every year in the United States as a result of serious and largely preventable safety events or medical errors. Safety events are common in hospitalized children. We conducted a quality improvement initiative to implement cultural and system changes with the goal of reducing serious safety events (SSEs) by 80% within 4 years at our large, urban pediatric hospital. A multidisciplinary SSE reduction team reviewed the safety literature, examined recent SSEs, interviewed internal leaders, and visited other leading organizations. Senior hospital leaders provided oversight, monitored progress, and helped to overcome barriers. Interventions focused on: (1) error prevention; (2) restructuring patient safety governance; (3) a new root cause analysis process and a common cause database; (4) a highly visible lessons learned program; and (5) specific tactical interventions for high-risk areas. Our outcome measures were the rate of SSEs and the change in patient safety culture. SSEs per 10000 adjusted patient-days decreased from a mean of 0.9 at baseline to 0.3 (P < .0001). The days between SSEs increased from a mean of 19.4 at baseline to 55.2 (P < .0001). After a worsening of patient safety culture outcomes in the first year of intervention, significant improvements were observed between 2007 and 2009. Our multifaceted approach was associated with a significant and sustained reduction of SSEs and improvements in patient safety culture. Multisite studies are needed to better understand contextual factors and the significance of specific interventions.