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

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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 serious complications and accidental symptoms may promote mandatory national-level reporting of serious adverse events with high litigation risks.

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Most cited references 21

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Feedback from incident reporting: information and action to improve patient safety.

J Benn, M Koutantji, L. Wallace … (2009)

Effective feedback from incident reporting systems in healthcare is essential if organisations are to learn from failures in the delivery of care. Despite the wide-scale development and implementation of incident reporting in healthcare, studies in the UK suggest that information concerning system vulnerabilities could be better applied to improve operational safety within organisations. In this article, the findings and implications of research to identify forms of effective feedback from incident reporting are discussed, to promote best practices in this area. The research comprised a mixed methods review to investigate mechanisms of effective feedback for healthcare, drawing upon experience within established reporting programmes in high-risk industry and transport domains. Systematic searches of published literature were undertaken, and 23 case studies describing incident reporting programmes with feedback were identified for analysis from the international healthcare literature. Semistructured interviews were undertaken with 19 subject matter experts across a range of domains, including: civil aviation, maritime, energy, rail, offshore production and healthcare. In analysis, qualitative information from several sources was synthesised into practical requirements for developing effective feedback in healthcare. Both action and information feedback mechanisms were identified, serving safety awareness, improvement and motivational functions. The provision of actionable feedback that visibly improved systems was highlighted as important in promoting future reporting. Fifteen requirements for the design of effective feedback systems were identified, concerning: the role of leadership, the credibility and content of information, effective dissemination channels, the capacity for rapid action and the need for feedback at all levels of the organisation, among others. Above all, the safety-feedback cycle must be closed by ensuring that reporting, analysis and investigation result in timely corrective actions that effectively address vulnerabilities in existing work systems. Limited research evidence exists concerning the issue of effective forms of safety feedback within healthcare. Much valuable operational knowledge resides in safety management communities within high-risk industries. Multiple means of feeding back recommended actions and safety information may be usefully employed to promote safety awareness, improve clinical processes and promote future reporting. Further work is needed to establish best practices for feedback systems in healthcare that effectively close the safety loop.

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Evaluation of an intervention aimed at improving voluntary incident reporting in hospitals.

Sandy Muecke, Guy Maddern, P Selim … (2007)

To assess the effectiveness of an intervention package comprising intense education, a range of reporting options, changes in report management and enhanced feedback, in order to improve incident-reporting rates and change the types of incidents reported. Non-equivalent group controlled clinical trial involving medical and nursing staff working in 10 intervention and 10 control units in four major cities and two regional hospitals in South Australia. Comparison of reporting rates by type of unit, profession, location of hospital, type of incident reported and reporting mechanism between baseline and study periods in control and intervention units. The intervention resulted in significant improvement in reporting in inpatient areas (additional 60.3 reports/10,000 occupied bed days (OBDs); 95% CI 23.8 to 96.8, p<0.001) and in emergency departments (EDs) (additional 39.5 reports/10,000 ED attendances; 95% CI 17.0 to 62.0, p<0.001). More reports were generated (a) by doctors in EDs (additional 9.5 reports/10,000 ED attendances; 95% CI 2.2 to 16.8, p = 0.001); (b) by nurses in inpatient areas (additional 59.0 reports/10,000 OBDs; 95% CI 23.9 to 94.1, p<0.001) and (c) anonymously (additional 20.2 reports/10,000 OBDs and ED attendances combined; 95% CI 12.6 to 27.8, p<0.001). Compared with control units, the study resulted in more documentation, clinical management and aggression-related incidents in intervention units. In intervention units, more reports were submitted on one-page forms than via the call centre (1005 vs 264 reports, respectively). A greater variety and number of incidents were reported by the intervention units during the study, with improved reporting by doctors from a low baseline. However, there was considerable heterogeneity between reporting rates in different types of units.

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Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis

(2017)

Background A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. Methods The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Results Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes, and multiple mechanisms to provide feedback through routes to reporters and the wider community (local meetings, email alerts, bulletins, paper contributions, etc.). Conclusions The design of a patient safety learning system can be optimized by an awareness of the barriers to and facilitators of successful adoption and implementation identified by health care professionals. Evaluation of the effectiveness of a patient safety learning system is needed to refine its design.

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Author and article information

Contributors

Shigeru Fujita: Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ValidationRole: Writing – original draftRole: Writing – review & editing

Kanako Seto: Role: ConceptualizationRole: Data curationRole: InvestigationRole: Writing – review & editing

Yosuke Hatakeyama: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Ryo Onishi: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Kunichika Matsumoto: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Yoji Nagai: Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – review & editing

Shuhei Iida: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Tomohiro Hirao: Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: Writing – review & editing

Junko Ayuzawa: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Yoshiko Shimamori: Role: ConceptualizationRole: InvestigationRole: Writing – review & editing

Tomonori Hasegawa:

ORCID: https://orcid.org/0000-0002-1057-9867

Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: SupervisionRole: Writing – review & editing

Bernadette Watson: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS One

Journal ID (publisher-id): plos

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 28 July 2021

Publication date Collection: 2021

Volume: 16

Issue: 7

Electronic Location Identifier: e0255329

Affiliations

[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

Hong Kong Polytechnic University, HONG KONG

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: health@ 123456med.toho-u.ac.jp

Author information

Tomonori Hasegawa https://orcid.org/0000-0002-1057-9867

Article

Publisher ID: PONE-D-20-32116

DOI: 10.1371/journal.pone.0255329

PMC ID: 8318237

PubMed ID: 34320041

SO-VID: 02ebf4f2-25ed-49fe-a7dd-73d44347d6f6

License:

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.

History

Date received : 13 October 2020

Date accepted : 15 July 2021