Patient safety management systems and activities related to promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues: A cross-sectional study

PLOS ONE RESEARCH ARTICLE Patient safety management systems and activities related to promoting voluntary inhospital reporting and mandatory nationallevel reporting for patient safety issues: A cross-sectional study a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 Shigeru Fujita1, Kanako Seto1, Yosuke Hatakeyama1, Ryo Onishi1, Kunichika Matsumoto1, Yoji Nagai2, Shuhei Iida3,4, Tomohiro Hirao5, Junko Ayuzawa6, Yoshiko Shimamori7, Tomonori Hasegawa ID1* 1 Toho University School of Medicine, Tokyo, Japan, 2 Hitachinaka General Hospital, Ibaraki, Japan, 3 Nerima General Hospital, Tokyo, Japan, 4 Institute for Healthcare Quality Improvement, Tokyo, Japan, 5 Faculty of Medicine, Kagawa University, Kagawa, Japan, 6 Faculty of Medical Science, Kyushu University, Fukuoka, Japan, 7 Iwate Medical University School of Nursing, Iwate, Japan * OPEN ACCESS Citation: Fujita S, Seto K, Hatakeyama Y, Onishi R, Matsumoto K, Nagai Y, et al. (2021) Patient safety management systems and activities related to promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues: A cross-sectional study. PLoS ONE 16(7): e0255329. https://doi.org/10.1371/journal. pone.0255329 Editor: Bernadette Watson, Hong Kong Polytechnic University, HONG KONG Received: October 13, 2020 Accepted: July 15, 2021 Published: July 28, 2021 Copyright: © 2021 Fujita et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: Data cannot be shared publicly. The external researchers can contact the Ethics Committee of Toho University regarding the use of the data but the committee does not accept applications other than Japanese language (, +81-3-37624151). If an external researcher contacts the research team directly ( (personal address of corresponding author), (first author), Abstract Both voluntary in-hospital reporting and mandatory national-level reporting systems for patient safety issues need to work well to develop a patient safety learning system that is effective in preventing the recurrence of adverse events. Some of the hospital systems and activities may increase voluntary in-hospital reporting and mandatory national-level reporting. This study aimed to identify the hospital systems and activities that increase voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues. An anonymous mail survey of hospitals in Japan was conducted in 2017. The hospitals were selected by stratified random sampling according to number of beds. The survey examined the annual number of reported events in the voluntary in-hospital reporting system for patient safety and experience of reporting unexpected patient deaths possibly due to medical interventions to the mandatory national-level reporting system in the last 2 years. The relationship of the answer to the questions with the patient safety management systems and activities at each hospital was analyzed. The response rate was 18.8% (603/3,215). The number of in-hospital reports per bed was positively related to identifying events by referring complaints or questions of patients or family members, using root cause analysis for analyzing reported events, and developing manuals or case studies based on reported events, and negatively related to the unification and standardization of medical devices and equipment. The experience with mandatory national-level reporting of serious adverse events was positively related to identifying problematic cases by a person in charge of patient safety management from the in-hospital reporting system of complications and accidental symptoms. Enhanced feedback for reporters may promote voluntary in-hospital reporting of minor cases with low litigation risks. Developing an in-hospital mechanism that examines all PLOS ONE | https://doi.org/10.1371/journal.pone.0255329 July 28, 2021 1 / 10 PLOS ONE (Department of Social Medicine, Toho University School of Medicine), the research team members will submit reviews of external provision of data to the Ethics Committee on behalf of external researchers. For data usage applications, the Ethics Committee of Toho University will examine whether the data requester can handle the data appropriately before sharing the data. Although the authors cannot make their study’s data publicly available at the time of publication, all authors commit to make the data underlying the findings described in this study fully available without restriction to those who request the data, in compliance with the PLOS Data Availability policy. For data sets involving personally identifiable information or other sensitive data, data sharing is contingent on the data being handled appropriately by the data requester and in accordance with all applicable local requirements. Funding: SF, YN, SI, TH, JA, YS and TH have received a Health Labor Sciences Research Grant from the Ministry of Health Labor and Welfare in Japan (H29-iryo-ippan-004). The funder played no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. For the remaining authors none were declared. Competing interests: The authors have declared that no competing interests exist. Promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues serious complications and accidental symptoms may promote mandatory national-level reporting of serious adverse events with high litigation risks. Introduction A reporting culture is one of the significant components of patient safety culture [1]. Although patient safety learning systems may not function well due to underreporting, they have been constructed at hospital and national levels in several countries [1–6]. The patient safety learning system consists of adverse event and near miss reporting, investigation, analysis, and feedback; the proactive reporting by a person involved in the error is a significant foundation of the system [4]. In the patient safety learning system, healthcare workers are encouraged to report near misses, adverse events or sentinel events to in-hospital reporting system and sometimes to a national-level reporting system [2, 5, 6]. Several studies have reported barriers to inhospital reporting, including fear of blame, insufficient feedback to reporters, lack of organizational support, and the perception that reporting does not result in improvement to patient safety [3–8]. Conversely, previous studies have reported the drivers, including a shorter time to report, a trigger list to help healthcare workers understand what to report, providing enhanced feedback on errors and hazards, anonymous reporting, assignment of full-time patient safety managers, education, and training [4–9]. As for the fee (...truncated)