Kahlenberg L, Harsey L, Patterson M, et al. Implementation of a Modified WHO Pediatric Procedural Sedation Safety Checklist and Its Impact on Risk Reduction. Hosp Pediatr. 2017 Apr;7(4):225-231.

BACKGROUND AND OBJECTIVES: Major adverse events (AEs) related to pediatric deep sedation occur at a low frequency but can be of high acuity. The high volume of deep sedations performed by 3 departments at our institution provided an opportunity to reduce variability and increase safety through implementation of a procedural sedation safety checklist. We hypothesized that implementation of a checklist would improve compliance of critical safety elements (CSEs) (primary outcome variable) and reduce the sedation-related AE rate (secondary outcome variable).

METHODS: This process improvement project was divided into 5 phases: a retrospective analysis to assess variability in capture of CSE within 3 departments that perform deep sedation and the association between noncapture of CSE and AE occurrence (phase 1), design of the checklist and trial in simulation (phase 2), provider education (phase 3), implementation and interim analysis of checklist completion (phase 4), and final analysis of completion and impact on outcome (phase 5).

RESULTS: We demonstrated interdepartmental variability in compliance with CSE completion prechecklist implementation, and we identified elements associated with AEs. Completion of provider education was 100% in all 3 departments. Final analysis showed a checklist completion rate of 75%, and its use significantly improved capture of several critical safety elements. Its use did not significantly reduce AEs (P = .105).

CONCLUSIONS: This study demonstrates that the implementation of a sedation checklist improved process adherence and capture of critical safety elements; however, it failed to show a significant reduction in sedation-related AEs.

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Commentary: 

Adverse events in pediatric procedural sedation are infrequent but often significant.  There are several methods to improve quality outcomes, including time-out forms, organized protocols and procedure checklists.  Checklists have been used across a number of industries outside of the medical field with the overall goals of improving communication, improving adherence to processes and policies, and possibly reduce errors.

Kahlenberg et al described an in-depth quality improvement project where a Procedural Sedation Safety Checklist was implemented across multiple hospital areas performing deep sedations (sedation services, emergency department, ICU).  With this design, 19 “critical safety elements (CSE)” were incorporated into a modification of the World Health Organization (WHO) surgical checklist.  Critical safety elements include items such as medication double check, bag and mask check, time-out, American Society of Anesthesiologists (ASA) physical score documentation, documentation of nil per os (NPO) time and a calculated body mass index (BMI).  The authors’ hypothesis was that the implementation of an organized and standard checklist would improve compliance and adherence of these critical safety elements as well as decrease incidence of deep sedation related adverse events across all departments.  Data was collected over 5 separate phases.  These phases included an analysis of the association between the non-capture of CSE and adverse events via a retrospective chart review, design of the checklist and trial in simulation, provider education, interim analysis of checklist completion and lastly, overall impact after 5 months of use. The primary endpoint was overall adverse event reduction.  Data obtained from sedation services were compiled from submissions from the Pediatric Sedation Research Consortium (PSRC) while data from intensive care units (ICU) and emergency departments were obtained from an institutional database.

Results showed that, prior to the implementation of the checklist, there was great variability in compliance of CSE and documentation.  Compliance with institutional dosing guidelines and weight associated elements were not documented by any department. Additionally, a case control analysis compared CSE documentation to patients with adverse events (cases) and those without (controls).  In every instance, dosing medications above documented institutional standards was associated with an adverse event.  Additionally, completing a medication double check was associated with a three-fold increase in the odds of an adverse event.  An audit of checklist completion was also performed six weeks after checklist implementation.  This showed a compliance rate, with all CSE checked, of 67%.  A second audit 5 months after implementation showed the overall compliance rate had increased to 75%, after reeducation and interdepartmental feedback.  The adverse event rate after 5 months with the checklist completed, was 3.39% and with the checklist incomplete was 4.22%.  The overall adverse event rate was 54/1033 (5.3%) which decreased to 28/773 (3.6%) after the 5-month observation period.

The major limitation of this study is that the majority of the results are reliant on check list compliance, rather than direct observation.   Additionally, the chosen post-checklist observation period of 5 months may have been a bit too short to observe a statistically decrease in adverse events.  Lastly, the authors admit to issues with compliance with provider education, specifically with the required simulation training.

So, will you add a check list to the start of your next sedation?

A key point that the authors raise is that, while the overall rate of compliance with the checklist increased over the 5-month study period, the overall rate adverse events was not statistically significant.  This could be in fact due to the relatively small number of total adverse events recorded, both at the beginning of the observation period and at the end.  Compliance with 5 specific CSE was associated with decreased AE: equipment check, time out documented, NPO status documented, formalized risk stratification and discharge details provided.  Of these elements, interestingly, the medication double check was notably higher in those that had an adverse event.  This may be due to this fact medications may have been double checked after an event, not before.  A study by Cravero, et al (Pediatrics. 2006 Sep;118(3):1087-96) as early as 2006 has shown that adverse events in sedation are overall rare, and likely related to the underlying condition of the patient.

References:

1. Kahlenberg L, Harsey L, Patterson M, Wachsberger D, Gothard D, Holder M, Forbes M, and Tirodker U. “Implementation of a Modified WHO Pediatric Procedural Sedation Safety Checklist and Its Impact on Risk Reduction.” Hospital Pediatrics.4 (2017): 225-31.
2. Cravero, Joseph, Blike G, Beach M, Gallagher S, Hertzog J, Havidich J, and Gelman B. “Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room: Report from the Pediatric Sedation Research Consortium.” Pediatrics. American Academy of Pediatrics, 01 Sept. 2006.

Reviewed by:

Carmen D Sulton, MD

Assistant Professor of Pediatrics and Emergency Medicine

Emory University School of Medicine

Atlanta, GA

Laurie Burton, MD

Assistant Professor of Pediatrics and Emergency Medicine

Emory University School of Medicine

Atlanta, GA

Pradip Kamat, MD, MBA, FCCM

Associate Professor of Pediatrics

Emory University School of Medicine

Director Children’s Sedation services at Egleston

Atlanta, GA

Jason Reynolds, MD

Assistant Professor of Pediatrics

Section of Pediatric Sedation

Baylor College of Medicine

San Antonio, TX

Patricia Scherrer, MD

Associate Professor of Pediatrics

Section of Pediatric Sedation

Baylor College of Medicine

San Antonio, TX