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Novel Schema Classifies Allergy-related Safety Events in Healthcare Settings

Key findings

  • This study aimed to identify and classify safety failures at Mass General Brigham that led to allergy-related safety events over a five-year period, analyzing electronic health record (EHR) documentation of 744 such events
  • Of the 744 allergy-related safety events, 50% were attributable to incomplete or inaccurate EHR documentation; other human factors such as poor communication, purposeful allergy alert overrides, and inadequate training were responsible for 24% of events
  • Allergy alert limitations or malfunction of the EHR resulted in 17% of allergy-related safety events, while data exchange and interoperability failures resulted in 12%, and EHR system defaults resulted in 4% of such events
  • 72% of allergy-related safety events were related to drugs, but latex, foods, heparin, adhesives, and topical anesthetics were also responsible for many such events
  • It's hoped the novel classification schema developed for this study will help other institutions identify allergy-related safety failures and determine how quality improvement efforts should be focused to prevent similar failures moving forward

Every year in the U.S., patients with allergies have an estimated 7 million interactions with the healthcare system. Yet currently there's no national or international framework for classifying allergy-related safety failures.

Kimberly G. Blumenthal, MD, MSc, quality and safety officer for allergy at Massachusetts General Hospital and co-director of the Clinical Epidemiology Program in the Division of Rheumatology, Allergy and Immunology, Neelam A. Phadke, MD, MPH, faculty in that division, assistant chief quality officer for Mass General and assistant medical director for the Massachusetts General Physicians Organization, and colleagues have created such a classification schema. Described in The Journal of Allergy and Clinical Immunology: In Practice, they show how healthcare systems might use it to understand where to focus safety improvement efforts.


At Mass General Brigham, clinicians are trained to file reports for any safety issue, no matter how minor. A report can be completed in less than five minutes.

The researchers used a computer algorithm to search the free text of 299,031 safety reports filed in electronic health records (EHRs) between May 5, 2014, and January 1, 2019. The automated search was followed by a manual review to confirm allergy-related safety events.

Categories of Safety Events

The manual review identified 744 reports of allergy-related events. These were coded using the newly developed schema, which includes five primary categories with 22 subcategories. The reports were classified as follows (with some overlap):

  • Incomplete/inaccurate documentation in the EHR (n=375)—Failure to enter/update allergies in the Allergy Module (29% of all events); inadequately obtaining, confirming and recording allergy history; administering medications without EHR orders; making free-text allergy entries rather than using the drop-down menu in the Allergy Module; and failure to adequately confirm patient identity
  • Human factors (n=175)—Inadequate intra- and inter-team communication, overridden allergy alerts, and inadequate personnel training
  • Allergy alert limitation and/or malfunction (n=127)—Absence of allergy alerts for kit contents and devices, absence of allergy alerts for minor ingredients, alerts the receiving user could not act on, inadequate alert/problem list synchronization, absence of alerts for orders that were active before the allergy was entered, inappropriate allergy alerts firing and appropriate allergy alerts not firing
  • Data exchange and interoperability failures (n=91)—Inadequate interdepartmental EHR-to-EHR communication within a hospital, inadequate care pathway EHR-to-EHR communication, inadequate EHR-to-EHR communication at the time of transition to a new EHR system and inadequate communication between EHR systems at different hospitals within the healthcare system
  • EHR system default options (n=30)—Inappropriate alert filtering based on user settings, inadequate allergy dictionary defaults, and inadequate medication dictionary defaults

All told, EHR systems played a substantial role in the occurrence of allergy-related events. 573 safety failures (77%) were directly attributable to an EHR deficiency and several others could be attributed to EHR usability issues indirectly.

Common Culprits

As expected, drugs were the most common culprits in allergy-related events (n=537; 72%). Other potentially preventable events occurred when the care of patients with allergies required communication outside the primary EHR and thus bypassed safety checks, such as with these allergens:

  • Latex—15% of all events
  • Food—10%
  • Heparin—4%
  • Adhesives—3%
  • Topical analgesics such as lidocaine—1%

Laying the Groundwork

Ideally, the new classification will be the foundation for an allergy safety failure taxonomy approved by international consensus. Drugs should be the primary target of prevention efforts, but latex, food allergens, heparin, adhesives, and lidocaine also warrant close attention given that exposure to these allergens typically bypasses most EHR-based safety checkpoints. Both human and EHR factors allowed safety failures to occur, so prevention efforts should not exclude either or the complex interaction between the two.

of allergy-related safety events were attributable to incomplete or inaccurate documentation in the electronic health record

of allergy-related safety events were directly attributable to deficiencies in electronic health record systems

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Refer a patient to the Rheumatology Unit

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