Rates and Factors Associated With Serious Outcomes of Patient Safety Incidents in Malaysia: An Observational Study.

Introduction: This study aimed to examine the reporting rate and the factors associated with serious outcomes of patient safety incidents at public hospitals in Malaysia. Methods: All patient safety incidents reported in the e-Incident-Reporting System from January to December 2019 were included in the study. A descriptive study was used to describe the characteristics of incidents, and logistic models were used to identify factors associated with low reporting rates and severe harm or death outcomes of incidents. Results: There were 9431 patient safety incidents reported in the system in 2019. The mean reporting rate was 2.1/1000 patient bed-days or 1.5% of hospital admissions. The major category of incidents was drug-related incidents (32.4%). No-harm incidents contributed to 56.1% of all the incidents, while 1.1% resulted in death. More hospitals in the eastern (odds ratio [OR], 12.1) and southern regions (OR, 6.1) had low reporting rates compared to the central region. Incidents with severe harm or death outcomes were associated with more males (OR, 1.4) than females and with the emergency department (OR, 10.6), internal medicine (OR, 5.7), obstetrics and gynecology (OR, 2.4), and surgical department (OR, 5.0) more than the pharmacy department. Compared to drug-related incidents, operation-related (OR, 3.0), procedure-related (OR, 3.5), and therapeutic-related (OR, 4.8) incidents had significantly more severe harm or death outcomes, and patient falls (OR, 0.4) had less severe harm or death outcomes. Conclusion: The mean reporting rate was 2.1/1000 patient bed-days or 1.5% of hospital admissions. More hospitals in the eastern and southern regions had low reporting rates. Certain categories of incidents had significantly more severe outcomes.