Published online October 2, 2006
PEDIATRICS Vol. 118 No. 4 October 2006, pp. 1332-1340 (doi:10.1542/peds.2006-0565)

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ARTICLE

Adverse Events in the Neonatal Intensive Care Unit: Development, Testing, and Findings of an NICU-Focused Trigger Tool to Identify Harm in North American NICUs

Paul J. Sharek, MD, MPH^a, Jeffrey D. Horbar, MD^b,c, Wilbert Mason, MD, MPH^d, Hema Bisarya, MHSA^e, Cary W. Thurm, PhD^e, Gautham Suresh, MD, DM, MS^f, James E. Gray, MD^g, William H. Edwards, MD^h, Donald Goldmann, MD, MPH^i,j and David Classen, MD, MS^k

^a Division of General Pediatrics, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California
^b Vermont Oxford Network, Burlington, Vermont
^c Department of Pediatrics, University of Vermont College of Medicine, Burlington, Vermont
^d Division of Infectious Diseases and Quality Management Program, Childrens Hospital Los Angeles, Los Angeles, California
^e Division of Performance Improvement, Child Health Corporation of America, Shawnee Mission, Kansas
^f Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina
^g Division of Neonatology, Department of Pediatrics, Harvard University School of Medicine, Boston, Massachusetts
^h Division of Neonatology, Department of Pediatrics, Dartmouth Medical School, Lebanon, New Hampshire
ⁱ Institute for Healthcare Improvement, Cambridge, Massachusetts
^j Department of Pediatrics, Children's Hospital, Harvard University School of Medicine, Boston, Massachusetts
^k Division of Infectious Diseases, Department of Medicine, University of Utah School of Medicine, Salt Lake City, Utah

OBJECTIVES. Currently there are few practical methods to identify and measure harm to hospitalized children. Patients in NICUs are at high risk and warrant a detailed assessment of harm to guide patient safety efforts. The purpose of this work was to develop a NICU-focused tool for adverse event detection and to describe the incidence of adverse events in NICUs identified by this tool.

METHODS. A NICU-focused trigger tool for adverse event detection was developed and tested. Fifty patients from each site with a minimum 2-day NICU stay were randomly selected. All adverse events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger, and the entire tool, was evaluated for positive predictive value. Study chart reviewers, in aggregate, identified 88.0% of all potential triggers and 92.4% of all potential adverse events.

RESULTS. Review of 749 randomly selected charts from 15 NICUs revealed 2218 triggers or 2.96 per patient, and 554 unique adverse events or 0.74 per patient. The positive predictive value of the trigger tool was 0.38. Adverse event rates were higher for patients <28 weeks' gestation and <1500 g birth weight. Fifty-six percent of all adverse events were deemed preventable; 16% could have been identified earlier, and 6% could have been mitigated more effectively. Only 8% of adverse events were identified in existing hospital-based occurrence reports. The most common adverse events identified were nosocomial infections, catheter infiltrates, and abnormal cranial imaging.

CONCLUSIONS. Adverse event rates in the NICU setting are substantially higher than previously described. Many adverse events resulted in permanent harm and the majority were classified as preventable. Only 8% were identified using traditional voluntary reporting methods. Our NICU-focused trigger tool appears efficient and effective at identifying adverse events.

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Key Words: trigger • adverse event • harm • NICU • patient safety

Abbreviations: AE—adverse event • ADE—adverse drug event • CHCA—Child Health Corporation of America • IRB—institutional review board • PPV—positive predictive value • ECMO—extracorporeal membrane oxygenation

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Accepted Jun 1, 2006.

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