Video Abstract

Video Abstract

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BACKGROUND AND OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

What’s Known on This Subject:

Serious safety events (SSEs) continue to cause significant harm to pediatric patients, requiring a multitude of resources to investigate and develop mitigation strategies. Shared learning of events can assist in less resource-intense system improvements to mitigate patient harm.

What This Study Adds:

Although individual hospitals investigate their SSEs, it can be difficult to assess trends because of their infrequent occurrence. Membership in a patient safety organization provides an opportunity for shared learning on SSEs.

Highly reliable organizations are those in which complex environments exist, consequences of errors are high, and occurrence of errors are low. The principles of high reliability, including deference to expertise, sensitivity to operations, preoccupation with failure, reluctance to simplify, and commitment to resilience, are directly applicable to health care settings.14  However, even when hospitals fully support high-reliability principles, the implementation of reliable and sustainable patient care processes in all circumstances is challenging. Many hospitals have started this work by intensely investigating their serious patient-harm events.5,6 

In general, serious safety events (SSEs) rarely occur in individual hospitals; however, the harm incurred is significant for both patients and health care providers. Given the infrequency of SSEs at individual hospitals, identifying trends and designing strategies to mitigate risk can be challenging. In the Patient Safety and Quality Improvement Act of 2005,7  these limitations were addressed by allowing hospitals to learn from safety events from other institutions while asserting privilege and confidentiality. After the passage of Patient Safety and Quality Improvement Act, patient safety organizations (PSOs) were formed to collect and analyze data and share experiences surrounding safety events to improve patient care. Although sharing within PSOs has resulted in greater safety for adult patients,8,9  the strategies that work for adults are often not directly applicable to children, and safety priorities may differ. The Child Health Patient Safety Organization (CHILDPSO), a federally registered PSO dedicated to children’s hospitals, was formed specifically to collect data on patient-harm events and produce shared learning opportunities for pediatric hospitals.

The CHILDPSO uses a standard reporting structure, the Agency for Healthcare Research and Quality Common Format,10  and a standard system of analysis to classify safety events submitted by hospitals. The CHILDPSO communicates summarized safety data to participating hospitals in diverse ways (eg, weekly collaborative safety huddles, safe table webinars, and annual meetings). In addition, the CHILDPSO provides immediate notification of patient safety trends (eg, Patient Safety Action Alerts)11  that are released publicly. The broad dissemination of CHILDPSO Patient Safety Action Alerts provides an opportunity for hospitals to collaboratively address and move to eliminate serious, preventable pediatric patient harm (eg, zero harm).12 

The CHILDPSO equips children’s hospitals to identify and address weaknesses in their systems that may contribute to patient harm. The association of membership within the CHILDPSO and safety events has not been previously described. In this study, we aimed to (1) describe the trend in SSEs among CHILDPSO hospitals, (2) describe types of events reported to the CHILDPSO, and (3) identify contributing factors of SSEs in children’s hospitals. We hypothesize that the shared learning offered through membership in the CHILDPSO will lead to a decrease in the SSEs of pediatric member hospitals.

This was a retrospective cohort study of safety events from 44 tertiary and quaternary care children’s hospitals consistently participating in the CHILDPSO from January 1, 2015, to December 31, 2018. Although participating member hospitals can submit any events to the CHILDPSO by using the Agency for Healthcare Research and Quality Common Formats,10  the CHILDPSO suggests that hospitals submit SSEs at a minimum and include the harm level and descriptive fields aligned with highly reliable organization event analysis. To address our study aims, we included only SSEs identified by using a previously defined system developed by the CHILDPSO based on analysis of historical events and methodology from the Healthcare Performance Improvement (HPI) Taxonomy of Safety Events in Healthcare general event types.13  Other lesser-harm events (precursor safety events, near-miss events, etc)13  submitted to the CHILDPSO during the time frame of the study were excluded.

Hospitals report a level of severity for each SSE, and the CHILDPSO assigns a main group, subgroup, and up to 3 contributing factors for each SSE. First, hospitals define severity on a scale of 1 (most severe) to 5 (least severe), and the CHILDPSO sorts SSEs by severity into 2 groups: SSEs 1–3 (death, severe permanent harm, and moderate permanent harm) or SSEs 4–5 (severe temporary harm and moderate temporary harm). Next, each SSE is assigned a main group and subgroup by the CHILDPSO by using the CHILDPSO taxonomy, which uses historical case reviews and the HPI Taxonomy of Safety Events in Healthcare general event types.13  Lastly, contributing factors of each SSE are reviewed and assigned by the CHILDPSO system described above.

In accordance with patient safety work product14  nonidentification standards, SSEs were examined in aggregate, and subcategories with <5 events were excluded. Rates of SSEs per 10 000 adjusted patient days were calculated and plotted over time on the basis of monthly numerator and denominator submissions. We assessed the trend in the rate by using Poisson regression. We summarized the event data with frequencies and percentages.

All statistical analyses were performed by using SAS version 9.4 (SAS Institute, Inc, Cary, NC), and P values <.05 were considered statistically significant. The Office of Research Integrity at Children’s Mercy Kansas City deemed this study exempt from institutional board review and approved this study.

During the study, 44 pediatric hospitals participating in CHILDPSO reported 830 SSEs for 22.5 million adjusted patient days. The 12-month moving average rate of SSEs decreased from 0.71 to 0.41 per 10 000 adjusted patient days (P < .001) (Fig 1).

FIGURE 1

SSE rate of the CHILDPSO-participating hospitals: SSE rate (12-month rolling average) of the 44 consistently reporting CHILDPSO member hospitals (total number of patient days = 22 493 678).

FIGURE 1

SSE rate of the CHILDPSO-participating hospitals: SSE rate (12-month rolling average) of the 44 consistently reporting CHILDPSO member hospitals (total number of patient days = 22 493 678).

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The median hospital volume of SSEs was 12 events (interquartile range: 6–23), or ∼3 reported SSEs per year. A plurality of SSEs was classified as causing temporary severe harm (SSEs 4–5, n = 656, 79%), with fewer classified as causing permanent severe harm or death (SSEs 1–3, n = 174, 21%).

SSEs occurred most frequently within the main group of patient care management (n = 610, 67.0%). Within the patient care management group, the most frequent subgroups included missed, delayed, or wrong diagnosis or treatment (n = 190, 31.1%); medication errors (n =187, 30.7%); and suboptimal care coordination (n = 137, 22.5%) (Table 1). The second most common main group for serious harm events to occur was within the procedural domain (n = 130, 14.3%). Serious harm events in the procedural domain could include the subgroups of unintended retained foreign objects, other procedural, and wrong procedure. Following care management and procedural groups, serious harm also occurred in the product or device (n = 52, 5.7%) group.

TABLE 1

CHILDPSO SSEs Classified by Using HPI Safety Events in Healthcare General Event Types: Main Groups and CHILDPSO-Developed Event Subgroups

HPI Event Main GroupsCHILDPSO Event SubgroupsEvents, n (%)
Care management  610 (67.0) 
 Missed, delayed, or wrong diagnosis or treatment 190 (31.1) 
 Medication error 187 (30.7) 
 Suboptimal care coordination 137 (22.5) 
Procedural  130 (14.3) 
 Unintended retained foreign object 52 (40) 
 Other procedural 49 (37.7) 
 Wrong procedure 16 (12.3) 
Product and/or device  52 (5.7) 
 Device malfunction or use not as intended 31 (59.6) 
 Contaminated drugs, devices, or biologics 18 (34.6) 
 Intravascular air embolism ++a 
Patient protection  23 (2.5) 
 Suicide and/or attempted suicide 12 (52.2) 
 Inappropriate discharge ++a 
 Inadequate clinician supervision and/or competency ++a 
Environmental  15 (1.7) 
 Burn 9 (60) 
 Other environmental ++a 
 Information system ++a 
HPI Event Main GroupsCHILDPSO Event SubgroupsEvents, n (%)
Care management  610 (67.0) 
 Missed, delayed, or wrong diagnosis or treatment 190 (31.1) 
 Medication error 187 (30.7) 
 Suboptimal care coordination 137 (22.5) 
Procedural  130 (14.3) 
 Unintended retained foreign object 52 (40) 
 Other procedural 49 (37.7) 
 Wrong procedure 16 (12.3) 
Product and/or device  52 (5.7) 
 Device malfunction or use not as intended 31 (59.6) 
 Contaminated drugs, devices, or biologics 18 (34.6) 
 Intravascular air embolism ++a 
Patient protection  23 (2.5) 
 Suicide and/or attempted suicide 12 (52.2) 
 Inappropriate discharge ++a 
 Inadequate clinician supervision and/or competency ++a 
Environmental  15 (1.7) 
 Burn 9 (60) 
 Other environmental ++a 
 Information system ++a 

HPI Taxonomy of Safety Events in Healthcare was modified by CHILDPSO to include the subgroups of suboptimal care coordination, inadequate clinician supervision and/or competency, and information system on the basis of analyses of events. ++, CHILDPSO subgroups with <5 events were excluded.

a

CHILDPSO event subgroups with <5 events were excluded.

The most common contributing factor across all levels of harm events was failure to recognize or lack of situational awareness (SA), occurring in 17.9% (n = 382) of events (Table 2). The contributing factor of SA was defined as the ability to understand what is occurring with a patient and why it is occurring and to anticipate what could happen next. When events were divided on the basis of severity of harm, failure to recognize or lack of SA occurred in 22.2% (n = 100) for SSEs 1–3 and in 16.7% (n = 282) for SSEs 4–5.

TABLE 2

CHILDPSO Contributing Factors by Level of Harm

Contributing FactorsOverallSSE 1–3SSE 4–5
No. events 830 174 656 
No. contributing factors 2139 451 1688 
Failure to recognize or lack of SA, n (%) 382 (17.9) 100 (22.2) 282 (16.7) 
Process failures, n (%) 274 (12.8) 32 (7.1) 242 (14.3) 
Failure to communicate effectively, n (%) 270 (12.6) 65 (14.4) 205 (12.1) 
Error in medical decision-making, n (%) 168 (7.9) 60 (13.3) 108 (6.4) 
No rule or standard in place, n (%) 168 (7.9) 17 (3.8) 151 (8.9) 
Failure to escalate or insufficient access to experts, n (%) 153 (7.2) 57 (12.6) 96 (5.7) 
Insufficient coordination of care, n (%) 147 (6.9) 32 (7.1) 115 (6.8) 
Error in technique, n (%) 117 (5.5) 9 (2) 108 (6.4) 
Team culture, n (%) 101 (4.7) 17 (3.8) 84 (5) 
Issues in environment, n (%) 71 (3.3) 6 (1.3) 65 (3.9) 
Inability to access information, n (%) 66 (3.1) 11 (2.4) 55 (3.3) 
Insufficient monitoring, n (%) 60 (2.8) 16 (3.5) 44 (2.6) 
Technology troubles, n (%) 52 (2.4) 7 (1.6) 45 (2.7) 
Equipment or device failure, n (%) 41 (1.9) 4 (0.9) 37 (2.2) 
Insufficient supervision, n (%) 31 (1.4) 8 (1.8) 23 (1.4) 
Insufficient staffing, n (%) 26 (1.2) 8 (1.8) 18 (1.1) 
Conditions adverse to quality, n (%) 9 (0.4) 2 (0.4) 7 (0.4) 
Fatigue, n (%) 3 (0.1) 0 (0.0) 3 (0.2) 
Contributing FactorsOverallSSE 1–3SSE 4–5
No. events 830 174 656 
No. contributing factors 2139 451 1688 
Failure to recognize or lack of SA, n (%) 382 (17.9) 100 (22.2) 282 (16.7) 
Process failures, n (%) 274 (12.8) 32 (7.1) 242 (14.3) 
Failure to communicate effectively, n (%) 270 (12.6) 65 (14.4) 205 (12.1) 
Error in medical decision-making, n (%) 168 (7.9) 60 (13.3) 108 (6.4) 
No rule or standard in place, n (%) 168 (7.9) 17 (3.8) 151 (8.9) 
Failure to escalate or insufficient access to experts, n (%) 153 (7.2) 57 (12.6) 96 (5.7) 
Insufficient coordination of care, n (%) 147 (6.9) 32 (7.1) 115 (6.8) 
Error in technique, n (%) 117 (5.5) 9 (2) 108 (6.4) 
Team culture, n (%) 101 (4.7) 17 (3.8) 84 (5) 
Issues in environment, n (%) 71 (3.3) 6 (1.3) 65 (3.9) 
Inability to access information, n (%) 66 (3.1) 11 (2.4) 55 (3.3) 
Insufficient monitoring, n (%) 60 (2.8) 16 (3.5) 44 (2.6) 
Technology troubles, n (%) 52 (2.4) 7 (1.6) 45 (2.7) 
Equipment or device failure, n (%) 41 (1.9) 4 (0.9) 37 (2.2) 
Insufficient supervision, n (%) 31 (1.4) 8 (1.8) 23 (1.4) 
Insufficient staffing, n (%) 26 (1.2) 8 (1.8) 18 (1.1) 
Conditions adverse to quality, n (%) 9 (0.4) 2 (0.4) 7 (0.4) 
Fatigue, n (%) 3 (0.1) 0 (0.0) 3 (0.2) 

SSEs were defined by using HPI Safety Event Classification: SSE1 (death), SSE2 (severe permanent harm), SSE3 (moderate permanent harm), SSE4 (severe temporary harm), and SSE5 (moderate temporary harm). Of the 830 SSEs reported, failure to recognize or lack of SA was the most common contributing factor across all harm events, with 22.2% (n = 100) for SSEs categorized as 1–3 and 16.7% (n = 282) for SSEs categorized as 4–5.

Contributing factors for SSEs causing temporary harm (SSEs 4–5) included lack of SA (n = 282, 16.7%), process failures (n = 247, 14.3%), and failure to communicate effectively (n = 205, 12.1%). Among SSEs resulting in permanent harm or death (SSEs 1–3), contributing factors included lack of SA (n = 100, 22.2%), failure to communicate effectively (n = 65, 14.4%), error in medical decision-making (n = 60, 13.3%), and failure to escalate or insufficient access to experts (n = 57, 12.6%) (Fig 2).

FIGURE 2

SSE contributing factors and associated level of harm. SSEs were defined by using HPI Safety Event Classification: SSE1 (death), SSE2 (severe permanent harm), SSE3 (moderate permanent harm), SSE4 (severe temporary harm), and SSE5 (moderate temporary harm). Of the 830 SSEs reported, 174 were categorized as SSE 1–3 and 656 were SSE 4–5. The most common contributing factor across all SSE harm levels was failure to recognize or lack of SA being identified in 22.2% (n = 100) for SSEs 1–3 and in 16.7% (n = 282) for SSEs 4–5.

FIGURE 2

SSE contributing factors and associated level of harm. SSEs were defined by using HPI Safety Event Classification: SSE1 (death), SSE2 (severe permanent harm), SSE3 (moderate permanent harm), SSE4 (severe temporary harm), and SSE5 (moderate temporary harm). Of the 830 SSEs reported, 174 were categorized as SSE 1–3 and 656 were SSE 4–5. The most common contributing factor across all SSE harm levels was failure to recognize or lack of SA being identified in 22.2% (n = 100) for SSEs 1–3 and in 16.7% (n = 282) for SSEs 4–5.

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In this study, we describe the severity, types, and contributing factors of the SSEs submitted from our tertiary and quaternary pediatric member hospitals to the CHILDPSO. Although many of the SSEs occurred within the patient care management domain, lack of SA and failure to communicate effectively were common contributing factors among all types and all levels of harm SSEs.

The dynamic, reactive, social, and technical aspects of health care all influence accurate recognition of high-acuity situations. To aid in standardizing the social component of health care systems, several tools have been developed to aid health care workers in recognizing situations that may lead to patient harm, such as rapid responses,15,16  patient monitoring systems, and clinical decision support tools.17,18  Additional interventions developed to assist with recognition of potentially harmful patient situations are SA19  or high-acuity huddles, which use early warning systems to convene a team.20  SA huddles focus on collaborative thinking among disciplines and encourage closed-loop communication in planning next steps in the patient’s plan of care.

Effective communication of information among care providers is also essential to reduce the occurrence of SSEs.20,21  In previous work, researchers describe ineffective communication as a key factor leading to errors and delays in diagnosis or treatment.22,23  Although failures are often complex, there are effective strategies to mitigate ineffective communication. One strategy to assist with streamlining communication is the use of standardized communication tools or templates.24  For instance, I-PASS25  is a standardized communication tool aimed to decrease variation during physician handoffs. Nursing handoffs similar to I-PASS have also been successfully deployed.2628  It is likely that processes that aim to decrease variation may decrease patient-harm risk but may not be sufficient to eliminate risk.

As pediatric hospitals continue to work toward a goal of zero harm,11  the learning and collaboration provided through the CHILDPSO detects weaknesses that exist in pediatric health care systems that place patients at risk. The CHILDPSO is an important data-gathering and codification organization, and the reported safety data in the CHILDPSO enable a collaborative learning environment, allow for focused improvement efforts, and provide the ability to communicate safety concerns in real time. In this way, the CHILDPSO promotes proactive, institutional-level strategies to mitigate risk. For members of the CHILDPSO, the granular information from other member hospitals’ individual events may provide insight into the complexity of SSEs and give other hospitals the ability to proactively identify and address their own risks. In addition, patient safety trends communicated by the Patient Safety Action Alerts are publicly available to anyone and are meant to be a resource for all institutions that care for children, regardless of member status within the CHILDPSO. With these dissemination strategies, the CHILDPSO aids hospitals to approach zero harm.12 

In addition to communication of real-time harm events, the CHILDPSO also analyzes trends and provides tools to make risk assessments more robust. The most recent safety tool provided by the CHILDPSO was the development of a diagnostic toolkit to identify high-risk conditions leading to communication and diagnostic errors.29  The diagnostic toolkit includes a template for hospitals to assess their own internal risk for diagnostic errors and assists with developing strategies to help with mitigating harm. The toolkit also includes a summary within a patient safety alert, a gap analysis, and case-based learning resources all related to diagnostics.

Although it is helpful to use information from shared learning systems, such as the CHILDPSO, to provide optimal and safe care to patients, it is imperative that the information learned from investigation of the few individual institutions’ SSEs be shared widely within their own institutions. If this key important step is not well defined, many organizations will continue to miss the mark in learning from their own harm events and taking the steps needed to mitigate them from happening again. Standardizing this organizational sharing can be difficult, although there are already numerous resources to guide organizations in developing their investigation and sharing processes.30 

The findings in this study should be interpreted with the following limitations in mind. First, although the CHILDPSO has a robust process for analysis of events, it relies on member hospitals to assign their own level of harm to their events. This initial level of harm is therefore open to the member hospital’s interpretation of the HPI harm scale. Second, although the CHILDPSO does have a standard reporting format required for submission, the safety events submitted by member hospitals are voluntarily reported and may contain limited information. Therefore, the application of contributing factors can be somewhat challenging and may not allow for accurate assessment and application. Third, the CHILDPSO does not have a deadline for submission of events. Adverse events discovered at member hospitals could have occurred months before the actual submission date. Fourth, the subgroup of missed, delayed, or wrong diagnosis is broad and could be further separated out to obtain more granular information. Additionally, if separated, each label could lead to specific and detailed recommendations on these diagnostic errors.22,31,32  Finally, the primary purpose of the CHILDPSO is to gather, organize, code, and distribute SSE data to member hospitals, aiming to create a shared dialogue of safety events. Although a decrease in reported SSEs was noted over time, a causal relationship between membership in a PSO has not been established.

SSEs decreased across children’s hospitals reporting to the CHILDPSO. SSEs occurred most often in the care management group, with missed, delayed, or wrong diagnosis or treatment being the most common subgroup. Our findings suggest that tools aimed to improve communication and SA may be the most effective in preventing patient harm. Although previous recommendations have been made directing hospitals to focus on improving recognition of a deteriorating patient, in further studies, researchers should focus on mitigating diagnostic errors.

Dr Burrus proposed the study idea, participated in the study design and analysis and interpretation of the data, was the primary author of the manuscript, and provided critical intellectual content in the revision of the manuscript; Drs Hall, Bettenhausen, and Kemper, Ms Tooley, and Ms Conrad participated in the study design and analysis and interpretation of the data, were authors of the manuscript, and have provided critical intellectual content in the revision of the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

FUNDING: No external funding.

COMPANION PAPER: A companion to this article can be found online at www.pediatrics.org/cgi/doi/10.1542/peds.2021-051017.

CHILDPSO

Child Health Patient Safety Organization

HPI

Healthcare Performance Improvement

PSO

patient safety organization

SA

situational awareness

SSE

serious safety event

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.