This report provides a comprehensive and detailed overview of Strategic Objective 6: Information, research and risk management, a crucial area aimed at ensuring a constant flow of information and knowledge to drive the mitigation of risk, a reduction in levels of avoidable harm, and improvements in the safety of care. It offers insights derived from Member State survey responses, highlighting the maturity of information systems, and initiatives promoting research and technology for patient safety enhancement globally.
The report is systematically structured around five key strategies [i]:
- Strategy 6.1: Patient safety incident reporting and learning systems (PSIRLSs).
- Strategy 6.2: Patient safety information systems.
- Strategy 6.3: Patient safety surveillance systems.
- Strategy 6.4: Patient safety research programmes.
- Strategy 6.5: Digital technology for patient safety.
Key Findings and Challenges:
Despite global efforts, the report reveals a persistent lack of high-quality, comprehensive, and integrated information systems for patient safety, noting that current data sources often provide only a fragmented view. The overall global performance score for Strategic Objective 6 is 44 out of 100, with only 22% of related criteria fully met and 38% partially met, indicating a significant need for improvement.
Here’s a more detailed breakdown of the findings across the strategies:
- Patient Safety Incident Reporting and Learning Systems (PSIRLSs):
- While introduced in 70% of countries, their effectiveness remains limited, with only one-third of countries reporting active engagement from most healthcare facilities.
- Interoperability and international collaboration for data sharing are limited, with only about one-third of countries aligning their reporting formats with the WHO minimum information model.
- Only 29% of countries reported developing definitions and classifications of patient safety incidents aligned with WHO’s International Classification for Patient Safety (ICPS).
- Globally, 52% of countries use dedicated software or Internet-based systems for reporting, while 32% use email, reflecting a shift towards digital but also continued use of traditional methods.
- Reporting mandates vary: 22% of countries have voluntary systems, 29% mandatory, and 41% a hybrid approach, balancing learning and accountability. High-income countries (HICs) generally lead in adopting mixed strategies (54%).
- Most countries include adverse events (69% preventable, 67% non-preventable) in their reporting systems, and about half include near misses (48%) and non-harmful incidents (46%).
- Only 27% of countries regularly distribute safety alerts derived from incident analysis, with many alerts limited to medical products or specific programs.
- Patient Safety Information Systems:
- While three-quarters of countries have identified patient safety indicators, only a minority integrate these into health information systems or publish annual safety reports, highlighting a significant gap in data utilization. Only 25% of countries have identified and disseminated specific indicators for monitoring.
- Only a quarter of countries have incorporated patient safety indicators into national or subnational standard reporting formats and Health Information Systems (HISs).
- Only 18% of countries issue an annual public report detailing patient safety performance, primarily concentrated in Upper Middle-Income Countries (UMCs) and HICs.
- Challenges include data quality and availability issues, lack of standardized metrics, and underreporting due to fear of retribution.
- Patient Safety Surveillance Systems:
- 41% of countries are integrating existing safety surveillance programs (e.g., pharmacovigilance, haemovigilance) as a preliminary step, but only 11% have established comprehensive channels for sharing information between these programs and PSIRLSs.
- Only 23% of global respondents report the existence of a robust and independent system to investigate severe harm and sentinel events, with no Low-Income Countries (LICs) or Lower Middle-Income Countries (LMCs) reporting such mechanisms.
- Only 13% of countries conduct regular burden of harm studies, and there’s a complete absence of such studies in LMCs and the African Region.
- Patient Safety Research Programmes:
- Research on patient safety remains a low priority, considered so by only 11% of countries.
- Only 6% of countries allocate sufficient resources for patient safety research, and 84% of LICs and LMCs have not commenced allocating necessary resources.
- Only 11% of countries support translational and implementation research in patient safety.
- Less than 10% of countries in the African and South-East Asia Regions, and LMICs, utilize international and national research evidence in policy and practice decisions.
- Digital Technology for Patient Safety:
- Nearly 90% of countries report adopting Electronic Health Records (EHRs), but full integration of EHRs with healthcare processes is reported by only one-quarter of countries.
- Only 26% of surveyed countries indicated that EHRs are fully integrated into their health care processes (ambulatory, inpatient, diagnostic services), while 65% report partial usage.
- Only 23% of countries have a functional digital health strategy with a strong focus on patient safety considerations, and only 21% conduct thorough safety evaluations before and after deploying these technologies.
- Only 22% of countries have surveillance mechanisms for monitoring the safety of digital health products.
Regional and Income-Based Disparities:
Performance varies significantly by region and income level:
- The African Region presents a substantial opportunity for improvement across all strategies.
- The Western Pacific Region shows strong performance in incident reporting and learning systems.
- The European Region leans towards using digital technology in patient safety.
- There is a positive correlation between a country’s income level and its median scores across all patient safety strategies, with High-Income Countries (HICs) generally reporting higher scores due to more established infrastructures. However, some lower-income countries show successful initiatives.
Importance of Data and Standardization:
The report underscores the crucial importance of robust and reliable data in patient safety for identifying problems, setting benchmarks, and monitoring performance. It advocates for comprehensive and integrated information systems that incorporate patient and family experiences to inform care process redesign and measure risk reduction effectiveness. WHO’s role in standardizing concepts and classifications, such as the International Classification for Patient Safety (ICPS) and the International Classification of Diseases (ICD-11), is highlighted as essential for enhancing data quality, interoperability, and analytical insights into healthcare-associated harm. ICD-11’s new three-element model, for instance, allows for flexible and in-depth capture of data on healthcare-associated harm, including diagnostic safety incidents, which are often underreported.
Country Examples and Initiatives:
The report provides various country examples demonstrating different approaches and progress:
- Thailand has successfully launched a National Reporting and Learning System (NRLS) with voluntary participation from 67% of hospitals, focusing on encouraging reporting and building trust.
- South Africa adopted the WHO International Classification for Patient Safety to structure its national system, which saw compliance rise from 37% to 69%, though data quality and reporting culture challenges persist.
- The National Reporting and Learning System (NRLS) in England and Wales (now transitioning to Learn From Patient Safety Events (LFPSE) service) has been integral in promoting a fair-blame reporting culture and is leveraging AI and machine learning to extract insights from incident reports.
- Ireland is developing a “Quality and Safety Signals” program to aggregate and analyze data from multiple sources to optimize patient safety surveillance.
- Germany recognizes patient safety in its annual healthcare funding and provides specific funding for practical patient safety research.
- Singapore has stringent guidelines for IT security and governance in deploying IT solutions, with thorough evaluations and monitoring of EHR incidents. Independent investigation mechanisms exist in countries like Ecuador, Sweden, the UK (HSSIB), Namibia, and South Africa (Ombud), though not universally adopted.
In conclusion, the report emphasizes that while there has been progress in certain areas, particularly in patient safety incident reporting and digital technology adoption, there remains a critical need for comprehensive, integrated, and well-resourced information systems and research programs to drive meaningful improvements in patient safety globally, especially in lower-income settings.
Reference: Global patient safety report 2024. Geneva: World Health Organization; 2024.
