Patient safety is a top priority in healthcare services. Moreover, it is also a critical policy issue as about 10% of hospitalized patients experience adverse events. ¹ In low- and middle-income countries, an estimated 134 million adverse incidents occur among hospitalized patients every year; these incidents account for an estimated 2.6 million deaths each year. Understanding the causes of incidents provides a foundation for patient safety improvement; therefore, reporting and analysis of patient safety incidents is a key imperative. Lessons learned from the reported safety incidents can help inform interventions to prevent recurrence of similar incidents. However, this can happen only if the hospitals take responsibility for instituting safety measures and share their data at the national level. ²

Patient safety incident reporting systems have adopted various formats; a majority of these systems require reporting of incidents by health workers. The types of incidents that need to be reported vary in each country; these range from potential events to sentinel events such as incident that result in the death or disability of a patient. The World Health Organization (WHO) has developed a framework for reporting adverse events. ³ Subsequently, WHO developed a minimal information model for incident reporting systems ⁴ suitable for adoption by low-income, middle-income, and developed countries. However, the reporting rates show wide variability among countries, with some countries still struggling to implement the system. ⁵

The United Kingdom is one of the countries that have successfully implemented incident reporting. English NHS organisations reported 2,246,622 incidents or 10.3% increase on the incidents reported from April 2019 to March 2020 compared to from April 2018 to March 2019. Another example is the Taiwan Patient Safety Reporting System which by 2019, the number of participating institutions has reached 12,491, and the cumulative number of notified cases reported from 2005 has reached 714,896. In contrast, the number of incidents reported to the Malaysian Incident Reporting and Learning system over the past 18 years of its operation has been quite low; the number of incidents reported in the year 2016 was 2,769. However, after the implementation of national online reporting system in 2017, the number of reports showed a 105.5% increase from the preceding year.

Indonesia is the world’s fourth most populated country, with an estimated 270 million people. The Commission for Hospital Accreditation (CHA) accredited only half of the country’s 2,925 hospitals. In 2005, the national patient safety incident reporting system was established and the national guidelines for reporting was revised on 2015. ⁶ There were two reporting levels: hospital-level (internal reporting) and national-level (external reporting). Internal reporting required written reports of all incidents that occurred within the hospital, from near misses to sentinel events; these incidences were to be reported within 48 hours. External reporting referred to incident reports that have been reviewed, investigated, and forwarded to the National Committee via electronic means.

Incident reporting is a mandatory requirement for hospital accreditation; however, the performance of the reporting system is far from satisfactory. The national level data is not publicly accessible. Moreover, our previous study revealed very low rates of reporting. The total number of incidents reported in 2019 was 7,465; these incidents were reported from 334 out of the 2,877 hospitals (12%) in Indonesia. ⁷ Evaluation of the system also revealed some weaknesses such as the existence of punitive system, lack of confidentiality, poor timeliness of reporting, and lack of responsiveness. ⁸ The existing policies, guidelines, and regulations in Indonesia, to a large extent, do not satisfy the WHO-recommended requirements for incident reporting systems. Furthermore, there is a lack of awareness and understanding of the reporting system among officials at almost all levels. Several studies have identified the barriers that contribute to low incident reporting rates in Indonesian hospitals, for example lack of knowledge about how and what to report, fear of being blame, lack of feedback after reporting, lack of commitment, lack of rewards for reporting, the avoidance of conflict, timeliness of reporting, lack of socialization and training. ^{9 – 11}

The high prevalence of under-reporting severely undermines the capacity of incident reporting systems to promote learning and improve patient safety. We used London protocol framework in identifying the factors that lead to patient safety incident reporting that consisted of patient factors, task and technology factors, individual factor, team factor and work environment. In-depth characterization of factors that contribute to under-reporting is a key imperative to improve patient safety incident reporting systems. However, despite its importance, this form of study has never been conducted in Indonesia. Therefore, we aimed to analyze the factors that contribute to under-reporting of patient safety incidents in Indonesian public hospitals based on the perspectives of leaders of hospitals, government departments, and independent institutions.

A total of 26 participants were approached all but one agreed to be interviewed, with a total of 25 participants from nine organizations were enrolled. The details of the participants were presented in Table 1.

We categorized the responses according to the emerging themes.

Reporting of patient safety incidents in Indonesia continues to face many challenges. Most of the causes of under-reporting identified in this study have been reported in previous studies conducted in Indonesia ^{9 , 15 , 16} and globally, ^{5 , 17} either as barriers to reporting of incidents or as factors that affect patient safety incident reporting. After almost two decades, the implementation of the reporting system has not reached its potential and some classical problems have continued to persist. ⁹

This study found a divergence between government departments and independent organizations on the one hand and hospitals on the other hand about the perceived causes of under-reporting. Respondents from government departments and independent organizations reported about the lack of feedback for the hospital and lack of awareness of the benefits of reporting as the causes of under-reporting; hospitals, on other hand, did not refer to the same problem. Conversely, respondents from hospitals referred to the burden of reporting which was not reported by other organizations. This discrepancy could be attributed to the fact that the sampled hospitals had never reported the incidents to the National Committee; therefore, they were not aware about the issue of lack of feedback or did not perceive the benefits of incident reporting.

Reporting of incidents is an essential first step to learn from the experience. Failure to learn from incidents refers to the inability to obtain, retain, and apply the appropriate lessons from previous experiences in order to avoid future occurrences of the same or similar events. ¹⁸ Inability to learn might mean lessons from past incidents were either not learnt or were not successfully implemented, monitored, and maintained. ¹⁸

In Indonesia, very little work has been done to document the lessons learned from the national patient safety incident reporting and how it can improve the processes of care or patient outcomes. There has been a lack of institutional feedback mechanism ever since the inception of the reporting system. ⁸ As of April 2021, no annual reports, comprehensive information, or sharing of lessons learned from the reported incidents have been published on the website of the National Committee. This is unfortunate because lessons learned from the incidents can help save lives. Thus, many lives may have been lost just because the national system failed to learn from the incidents.

The root causes of under-reporting, either the hospital- or government-related, may reflect the lack of government support and the political will to improve patient safety incident reporting. Political will refers to the willingness of political leaders to take action to achieve a set of goals and to sustain the costs of these actions over time with some components include public commitment and resource allocation, enforcement of credible sanctions, continuity of effort, and institutionalization of learning and adaptation. ¹⁹ For example, lack of funding for incident reporting in Indonesia was found to constrain the usefulness of reporting. ⁹ Additionally, the role of government in upgrading knowledge and skills of health workers, either through socialization or training in incident reporting, was found to be inadequate; ⁹ this contributed to the lack of knowledge about the reporting procedure among health workers, lack of understanding of the benefits of reporting, and the absence of institutional reporting culture. ¹¹ The clear message about the importance of reporting in the national policy has not been translated into daily practice at the hospital level. As a consequence, there is a lack of reporting culture.

Additionally, there is weak enforcement of the credible sanctions regarding the implementation of internal and external reporting system by hospitals as mentioned in Standard 9 of Patient Safety and Quality Improvement. ²⁰ The consequences for hospitals that fail to report or meet the quality standards and accreditation requirements have not been clearly stated; consequently, only 12% of Indonesian hospitals reported incidents in 2019. ⁷ To improve reporting, policymakers must set specific and achievable goals for the incident reporting system; for example, application of credible sanctions for hospitals that do not report their incidents, although it is one of the mandatory requirements for accreditation.

There is poor continuity of efforts for assessing, monitoring, and evaluating the incident reporting system. ⁵ The hospital incident reporting systems are fragmented and isolated; in addition, establishment of best practices for implementation requires data analysis and sharing at the national level. This also reflects the failure of government to learn and adapt to the emerging circumstances through the fifteen years of the incident reporting implementation.

Reforms in patient safety incident reporting are required to help overcome the government or independent agency-related causes of under-reporting in Indonesia. These reforms should include developing a national patient safety strategic plan, establishing priorities, developing a timetable, implementing the plan, monitoring and evaluating policy implementation, and revising and updating the policy. ²¹ A good example has been shown by the Malaysian Ministry of Health. In Malaysia, patient safety incident reporting is included as one of the patient safety goals; the incident reports are compiled regularly and analyzed every three months by the healthcare facilities and submitted to the National system by 31st January of the subsequent year. ⁵ A clear, unambiguous and firm policy is required to develop a successful system. To address the confidentiality issue, Indonesia should adopt the NHS policy where the identity of the reporter, patient, health worker, and other individuals involved in the incident is not reported. The system is programmed to remove any personal identifiers in the report. This inculcates a sense of safety among the reporting health workers and hospitals and helps increase the number of reports. Further, the reporting also needs to be categorized into mandatory reporting for adverse events and sentinel events and voluntary reporting for any other incidents. The primary focus of reporting should be to draw lessons. Reporting needs to be made compulsory and no incident should be reported as zero incident, so that there is no excuse for not reporting the incident. Lastly, good patient safety leadership at the national, local, and hospital level is crucial to foster institutional changes and improve patient safety.

A key limitation of this study is the potential lack of representativeness of the study sample. Moreover, the opinions of individuals may not be a true reflection of the organization. Thus, due diligence should be exercised while interpreting our results. However, this study addresses several critical issues related to the reporting of patient safety incidents and identifies several areas for improvement.

Our study identified several causes of underreporting of patient safety incidents in Indonesia from the perspectives of government departments, independent agencies, and hospitals, which were classified as hospital-related factors and government or independent agency-related factors. The hospital-related contributing factors include a lack of understanding of the benefits of reporting, a lack of knowledge about reporting, the responsibility to report the incident, a lack of hospital-level leadership, a lack of reporting culture, and reporting as an additional burden for health workers. Meanwhile, government or independent agency-related factors included a lack of policy, a lack of government leadership, a lack of feedback and socialization provided to hospitals by related agencies, and system confidentiality.

There was disagreement among hospital and government or independent agency leaders about the perceived causes of under-reporting. The root causes of under-reporting may reflect a lack of government support and political will to improve patient safety incident reporting. As a result of our findings, we recommend that government agencies, independent agencies, hospitals, and other stakeholders work together to implement comprehensive reforms in patient safety incident reporting.

ID: conceptualization, data curation, analysis, methodology, project administration, resources, writing original draft and preparation.

SL and SB: conceptualization, supervision, validation, review and editing.

TR: data analysis, validation, review and editing.