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. 2022 Jul;10(7):1844-1855.e3.
doi: 10.1016/j.jaip.2022.03.026. Epub 2022 Apr 8.

Allergy Safety Events in Health Care: Development and Application of a Classification Schema Based on Retrospective Review

Neelam A Phadke  1 , Paige Wickner  2 , Liqin Wang  3 , Li Zhou  3 , Elizabeth Mort  4 , David W Bates  5 , Claire Seguin  6 , Xiaoqing Fu  7 , Kimberly G Blumenthal  8
Affiliations

Allergy Safety Events in Health Care: Development and Application of a Classification Schema Based on Retrospective Review

Neelam A Phadke et al. J Allergy Clin Immunol Pract. 2022 Jul.

Abstract

Background: Allergy safety requires understanding the operational processes that expose patients to their known allergens, including how and when such processes fail.

Objective: To improve health care safety for patients with allergies, we developed and assessed an allergy safety event classification schema to describe failures resulting in allergy-related safety events.

Methods: Using keyword searches followed by expert manual review of 299,031 voluntarily-filed safety event reports at 2 large academic medical centers, we identified and classified allergy-related safety events from 5 years of safety reports. We used driver diagrams to elucidate root causes for commonly observed allergy safety events in health care settings.

Results: From 299,031 safety reports, 1922 (0.6%) were extracted with keywords and 744 (0.2%) were manually confirmed as allergy-related safety events. Safety failures were due to incomplete/inaccurate electronic health record documentation (n = 375, 50.4%), human factors (n = 175, 23.5%), allergy alert limitation and/or malfunction (n = 127, 17.1%), data exchange and interoperability failures (n = 92, 12.4%), and electronic health record system default options (n = 30, 4.0%). Safety failures resulted in known allergen exposures to drugs (n = 537), including heparin (n = 27) and topical anesthetics such as lidocaine (n = 8); latex (n = 114); food allergens (n = 73); and adhesive (n = 23).

Conclusions: We identified 744 allergy-related safety events to inform a novel safety failure classification schema as an important step toward a safer health care environment for patients with allergies. Improved systems are required to address safety issues with certain food and drug allergens.

Keywords: Allergy safety hazard/failure; Drug allergy; Food allergy; Patient safety.

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Conflict of interest statement

Conflicts of interest: N. A. Phadke reports spousal employment by Chiesi Farmaceutici, L. Zhou reports grants from CRICO during the conduct of this study, and K. G. Blumenthal reports grants from the National Institutes of Health, Massachusetts General Hospital, and the American Academy of Allergy, Asthma, and Immunology during the conduct of this study as well as a copyright for a decision support tool for β-lactam allergy licensed to Persistent Systems. The rest of the authors declare that they have no relevant conflicts of interest.

Figures

FIGURE 1.
FIGURE 1.
Allergy safety hazards. This “Swiss cheese” schematic provides an overview of the clinical allergy pathway at the system level; each step is a safety hazard that, if not carried out correctly, could expose patients to a known allergen. The timeline demonstrates both the events and the interactions that occur at each step of the process. EHR, Electronic health record.
FIGURE 2.
FIGURE 2.
Allergen exposure driver diagrams. These prototypical diagrams demonstrate the allergy safety hazards perfectly aligned in a real-world setting to allow the occurrence of a safety event due to (A) latex, (B) food allergens, (C) heparin, (D) adhesive, and (E) lidocaine. Steps that are duplicative within and across figures may warrant the most attention to reduce allergy safety events. EHR, Electronic health record.
FIGURE 2.
FIGURE 2.
Allergen exposure driver diagrams. These prototypical diagrams demonstrate the allergy safety hazards perfectly aligned in a real-world setting to allow the occurrence of a safety event due to (A) latex, (B) food allergens, (C) heparin, (D) adhesive, and (E) lidocaine. Steps that are duplicative within and across figures may warrant the most attention to reduce allergy safety events. EHR, Electronic health record.
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