How do hospitals report adverse events? Understanding the patient safety process

October 2, 2025 •

5 min read

Patient safety event reporting systems are a ubiquitous and essential component of modern healthcare, used by facilities to capture and analyze adverse events, near misses, and other incidents that compromise safety. This multi-layered approach to how hospitals report adverse events combines internal tracking with both mandatory and voluntary external reporting to improve care.

Quick Summary

Hospitals report adverse events through a tiered system including internal incident reports, mandatory state disclosures for specific incidents, and confidential submissions to Patient Safety Organizations (PSOs) for broader analysis. The goal is to identify systemic issues and implement improvements rather than assign blame.

Key Points

Internal Reporting: Hospitals use internal incident reporting systems, often digital, for frontline staff to report adverse events and 'near misses' anonymously and without fear of punishment.
Just Culture: A non-punitive approach, known as 'Just Culture', is promoted to encourage staff to report errors and near misses by focusing on systemic failures rather than individual blame.
Mandatory State Reporting: Many states require hospitals to mandatorily report specific, serious 'Sentinel Events' (e.g., wrong-site surgery, infant abduction) to state health departments for regulatory oversight.
Voluntary PSO Submissions: The Patient Safety and Quality Improvement Act of 2005 enables confidential reporting of data to Patient Safety Organizations (PSOs) for national-level aggregation and analysis, with legal protections for the information.
Automated Surveillance: Modern EHR systems use automated triggers and surveillance rules to proactively detect potential adverse events by monitoring for specific medical occurrences or lab value combinations.
Data-Driven Improvement: The primary purpose of reporting is not punishment but to gather data for root cause analysis, identify systemic issues, and implement preventative measures to improve overall patient safety.

Multiple Layers of Reporting: Internal, State, and National

To effectively improve patient care, hospitals rely on a multi-layered approach to reporting adverse events. This involves collecting data internally, submitting specific events to state health departments, and sharing information confidentially with national Patient Safety Organizations (PSOs). This system helps identify both local procedural failures and broader, systemic issues within the healthcare industry.

Internal Reporting Systems

At the foundational level, hospitals use internal incident reporting systems. These platforms, which are often digital, are used by frontline staff such as nurses, doctors, and pharmacists to document any unexpected occurrences. Reports are filed for adverse events that cause harm, as well as 'near misses' or 'close calls'—incidents that could have caused harm but didn't. The goal is to provide a detailed, objective account of the event, including the who, what, where, and when, and the actions taken. A critical component is fostering a “Just Culture,” which encourages reporting without fear of undue punishment. This non-punitive approach helps ensure valuable information is not hidden due to fear of retribution.

Mandatory State Reporting

Many states have laws requiring healthcare facilities to report specific, serious adverse events to a state-run health department. These are often referred to as 'Serious Reportable Events' or 'Sentinel Events' and may include incidents like:

Death or major permanent loss of function unrelated to the patient's illness.
Wrong-site, wrong-procedure, or wrong-patient surgery.
Infection from contaminated tissues or blood products.
Infant abduction or a patient rape.

These systems create a centralized database for regulators to monitor trends and enforce standards. A hospital is typically required to investigate the root cause of the event and provide a plan of action to prevent recurrence within a specific timeframe.

Voluntary Reporting to Patient Safety Organizations (PSOs)

Patient Safety Organizations (PSOs) are external, third-party groups that create a secure environment for healthcare providers to voluntarily report and analyze patient safety event data. Established by the Patient Safety and Quality Improvement Act of 2005, PSOs collect information, called "Patient Safety Work Product," with federal protections for privilege and confidentiality. This encourages providers to share data without fear of legal liability, promoting a culture of learning. PSOs aggregate data from many institutions, allowing them to identify the underlying causes of rare but tragic adverse events and disseminate best practices to the wider healthcare community. For example, the FDA's MedWatch program and the Vaccine Adverse Event Reporting System (VAERS) are national systems where healthcare professionals and consumers can report voluntarily.

Methods for Detecting Adverse Events

Hospitals don't just wait for voluntary reports. They also use more proactive methods to detect adverse events. A comparison of these methods is shown below.


Method	Description	Advantages	Limitations
Voluntary Reporting	Healthcare staff submit incident reports based on firsthand knowledge or observation.	Captures near misses; highlights frontline concerns; low cost per submission.	Prone to significant underreporting; relies on human memory; can be perceived as punitive.
Automated Surveillance	Uses electronic health records (EHRs) and IT systems to automatically flag specific event triggers.	Detects high volume of events not captured by other methods; efficient for routine checks.	Requires advanced technology; may produce many false positives; less effective for complex or rare events.
Manual Chart Review	Trained personnel systematically review patient records using predefined 'trigger tools' to identify potential events.	Systematic and thorough; can identify events missed by other methods.	Labor-intensive and time-consuming; high cost per event detected.

Automated Trigger Systems

With the widespread adoption of electronic health records (EHRs), many hospitals are using automated surveillance systems. These systems are programmed with rules to identify specific combinations of medical events that suggest an adverse event may have occurred. For example, a rule might trigger an alert if a patient receives a medication and subsequently has an abnormal lab value that indicates a potential reaction. This proactive approach is becoming increasingly important for identifying events in real-time.

Manual Chart Review with Trigger Tools

Even with automated systems, manual chart review remains a key method for identifying adverse events. Healthcare providers and risk management staff can review patient records using established 'trigger tools' developed by organizations like the Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality (AHRQ). These tools identify potential adverse events by searching for specific indicators, or 'triggers,' within patient documentation.

Challenges and the Drive for Improvement

Despite the importance of adverse event reporting, several challenges persist. The primary issue is persistent underreporting, often due to a fear of retribution, a lack of time, or the perceived futility of the process. A study found that while most resident physicians recognized the importance of reporting, many had not filed a report, citing lack of time and knowing the process as key barriers.

To overcome this, healthcare organizations are focusing on:

Creating a Just Culture: Shifting the focus from individual blame to system-wide failures and learning from mistakes.
Simplifying Reporting: Designing user-friendly digital systems that reduce the burden on staff.
Improving Feedback Loops: Ensuring that staff who report events see how their contributions lead to meaningful changes.

Ultimately, the data collected from adverse event reports is used to conduct root cause analyses and implement preventative strategies. The sole objective is the prevention of future adverse events by fixing the underlying system problems, rather than focusing on individual performance. Reporting is a critical feedback mechanism that enables hospitals to become safer, more resilient institutions. For more information on how healthcare organizations are promoting a culture of safety, visit the Agency for Healthcare Research and Quality.

Conclusion

Hospitals employ a sophisticated, multi-pronged strategy to report adverse events, combining internal incident reports, mandatory state-level filings for serious events, and confidential submissions to PSOs. This process is supported by both voluntary reporting from staff and proactive detection methods like automated EHR surveillance. While challenges like underreporting exist, a growing emphasis on creating a just culture and learning from systemic failures is enhancing the effectiveness of these reporting systems. By identifying and addressing the root causes of errors, hospitals can drive continuous improvement and significantly enhance patient safety and healthcare quality.

Frequently Asked Questions

An adverse event is an unintended injury or complication arising from healthcare management, rather than from the patient's underlying condition. It includes everything from medication errors and falls to healthcare-acquired infections.

Reporting is a mix of mandatory and voluntary efforts. Many states mandate reporting of specific, serious 'sentinel events' to health departments, while internal and PSO reporting for less severe incidents or near misses is largely voluntary.

A PSO is a federally listed, external organization that collects and analyzes patient safety data voluntarily reported by healthcare providers. The data is protected by confidentiality and privilege, encouraging providers to share information openly to promote learning and improvement.

A 'Just Culture' moves the focus of an error away from blaming an individual and toward identifying the systemic factors that contributed to the error. This creates a psychologically safe environment where staff feel comfortable reporting mistakes, leading to more data and more effective system improvements.

Information submitted to PSOs is considered 'Patient Safety Work Product' and is granted federal protection for confidentiality. Internal reports are also typically separated from a patient’s health record to protect privacy and support a non-punitive reporting environment.

Hospitals use automated surveillance systems within their electronic health records (EHRs) that are programmed to identify specific event triggers. These rules can automatically flag patterns or combinations of clinical data, such as medication orders and lab results, that indicate a potential adverse event.

'Trigger tools' are systematic methods for reviewing patient medical charts to identify potential adverse events. They consist of a predefined list of clues or 'triggers' that indicate an event may have occurred, such as specific medication changes or abnormal lab results.