[Comparison of document-based and on-site inspections of hospitals based on medical law: A case report from Osaka City during the COVID-19 pandemic].

Objectives　On-site inspections of hospitals were conducted in Osaka City during fiscal years 2018 and 2019, whereas document-based inspections were performed during the COVID-19 pandemic in fiscal year 2021. This case report aimed to compare the outcomes of these two methods and provide a good indication of the method that should be selected in case of a pandemic.Methods　For on-site inspections, documents, including checklists, were sent to 351 hospitals from the Osaka City Public Health Office, and responses from each hospital were returned. On-site inspections were conducted, and the written instructions that indicated inadequate aspects and guidance were mailed to hospitals.For document-based inspections, documents were sent to 176 hospitals, and responses were returned. For hospitals that answered "incomplete" regarding the categories of medical safety management systems and hospital-acquired infection control, public health physicians called to confirm and instruct their inadequate responses, and the same step as the on-site inspection was executed. We compared and examined the outcomes of the on-site and document-based inspections.Results　In the on-site inspections, 12 of the 351 hospitals (3.4%) were recognized as inadequate because of a shortage of healthcare workers. In the document-based inspections, eight out of 176 hospitals (4.5%) were identified, and there was no significant difference.Regarding the medical safety management system, 95 of the 351 hospitals (27.1%) on on-site inspection and 21 of the 176 hospitals (11.9%) on document-based inspection received written instructions. The proportion of hospitals that received written instructions was significantly higher for on-site inspections than for document-based inspections (P < 0.001).For hospital-acquired infection control, 65 of 351 hospitals (18.6%) on on-site inspection and 17 of 176 hospitals (9.7%) on document-based inspection got written instructions. The proportion of hospitals that received written instructions was significantly higher for on-site inspections than document-based inspections (P = 0.007).Conclusion　Document-based inspection can easily unify the guiding criteria with fewer public health physicians. However, because of the limited amount of information available without checking the documents retained in hospitals, it is difficult to monitor the matters that need instructions. Thus, on-site inspection is preferable. However, if onsite inspection is difficult, inspection combined with online methods should be considered.