Standardizing patient safety information for CT and MRI examinations: development of standard candidate items with...

For the safe performance of CT and MRI examinations, it is essential to confirm patient information, including any contrast agent allergies and implanted metallic devices. However, the data items collected and their management methods vary among facilities, and the extent of this variation remains unclear. This study aimed to identify commonly used patient safety data items in CT and MRI examinations, propose standard candidate items, and evaluate their conceptual resource-level mapping to HL7 FHIR resources to promote interoperability. A nationwide questionnaire survey was conducted in April 2024, targeting 4,274 medical institutions in Japan equipped with radiology examination ordering systems. The survey investigated the management status of data items-including examination ordering, contrast agent safety, MRI safety, and general safety management-across different systems (EMR/CPOE and RIS). Items with a usage rate of 80% or higher were extracted as standard candidate items. Responses were received from 782 facilities (18.3%). Ten items were identified as standard candidate items: purpose of examination (95.4%), disease name (87.5%), examination site (99.9%), contrast agent allergy (84.5%), creatinine (88.2%), eGFR (87.1%), infection (92.3%), and drug allergy (86.0%), along with pacemakers/ICDs (87.0%) and implanted metals (82.4%) among MRI-equipped facilities (n = 638). All 10 items could be mapped to HL7 FHIR R4 resources, and 6 of them had dedicated profiles in the JP Core FHIR Implementation Guide v1.1.2. This study identified data items commonly used for patient safety in CT and MRI examinations, confirmed the conceptual resource-level mapping to FHIR, and provided a foundation for standardization and interoperability.