JMIR Publications

ABSTRACT

Background:

It is assumed that the implementation of health information technology introduces new vulnerabilities within a complex sociotechnical healthcare system, but no international consensus exists on a standardized format to enhance collection, analysis, and interpretation of technology-induced errors.

Objective:

The study’s first aim was to develop a classification for patient safety incident reporting associated with the use of mature electronic health records (EHRs). The second aim was to validate the classification by using a data set of incidents during a six-month period immediately after the implementation of a new EHR system.

Methods:

The starting point of the classification development was the FIN-TIERA tool, based on research on commonly recognized error types. A multi-professional research team used iterative tests on consensus building to develop a classification. The final classification, with preliminary descriptions of classes, was validated by applying it to analyze EHR-related error incidents (n=428) during the implementation phase of a new EHR system to evaluate its characteristics and applicability for purposes of incident reporting. Interrater agreement was applied.

Results:

The number of EHR-related patient safety incidents during the implementation period (n=501) was fivefold when compared with the pre-implementation period (n=82). The literature identified new error types that were added to the emerging classification. Error types were adapted iteratively after several test rounds to develop a classification for purposes of patient safety incident reporting in the clinical use of a high-maturity EHR system. Of the 427 classified patient safety incidents, interface problems accounted for 96 incident reports; usability problems, 73; documentation problems, 60; and clinical workflow problems, 33. Altogether, 89 reports were related to medication section problems, and downtime problems were rare (n=8). During the classification work, 74 of the original sample (501) were rejected due to insufficient information, even though the reports were deemed EHR-related. Interrater agreement during the blinded review was 98%.

Conclusions:

A new classification for EHR-related patient safety incidents applicable to mature EHRs is presented. The number of EHR-related patient safety incidents during the implementation period possibly reflects patient safety challenges during the implementation of a new type of high-maturity EHR system. The results indicate that the types of errors previously identified in the literature change with EHRs’ development cycle. Clinical Trial: N.a.