Healthcare organizations must identify the sources of failures and implement corrective actions to avoid future errors and, therefore, improve patient safety and quality of care. Organizations invest enormous resources in reporting systems in an effort to collect reports and data about errors. However, despite many imperatives to report—including goals to increase error reporting; the U.S. Patient Safety and Quality Improvement Act (PSQIA), which incentivizes voluntary reporting of patient safety information to patient safety organizations (PSOs); the European Commission's work on adverse event reporting across all member states; and introduction of other local initiatives mandating and/or facilitating event reporting throughout the world—underreporting of adverse events by staff members remains a problem. (Naveh and Katz-Navon)
As mainstays of efforts to detect problems with patient safety or with quality of care, patient safety event reporting systems are ubiquitous in healthcare organizations. Event reports* rely on those involved—frontline personnel such as nurses, pharmacists, and physicians—to provide detailed information about an event and the actions that led up to it. Such reporting is a passive form of surveillance for near misses or unsafe conditions, in contrast to active surveillance methods such as clinical observation or chart review with trigger tools. (AHRQ)
*The terms used to describe reportable events in healthcare organizations vary considerably and include "events," "incidents," "variances," "occurrences," "adverse events," "errors," "near misses," "close calls," and many others. In this guidance article, the term "event" is used to denote instances that typically warrant reporting, including near misses.
Prevalence of Medical Error
The universal prevalence of medical errors is a primary driver of the need for effective event reporting and response. Citing estimates that as many as one in 10 patients is harmed while receiving hospital care in developed countries, the World Health Organization (WHO) has designated patient safety as a serious global public health issue (WHO "10 Facts"). Estimates are even higher for certain populations. In the United States, for example, of nearly 1 million hospitalized Medicare beneficiaries discharged during a 1 month period, an estimated 13.5% experienced adverse events during their hospital stays (OIG "Adverse").
Such events often have deadly consequences; the number of premature deaths associated with preventable harm in hospitals is estimated at more than 400,000 patients per year, making medical errors the third leading cause of death in the United States, behind only heart disease and cancer (Hanlon et al.). The human and organizational costs of adverse events are staggering, with estimates of preventable errors in the United States ranging from $17 to $29 billion per year in healthcare expenses, lost worker productivity, and disability (Hoppes and Mitchell).
The United States is hardly alone in prevalence and impact of adverse events, which are acknowledged to be a significant concern worldwide. In Europe, healthcare-associated infections account for approximately 25% of adverse events, are directly responsible for 37,000 deaths per year, and are a contributing factor to an additional 110,000 deaths annually at a cost of over €5.4 billion to European hospitals (PSQCWG).
The First Step to Improve Patient Safety
Event reporting, a fundamental step in bringing adverse events and near misses into focus, is one component of an overall effort to collect information on patient safety. It is impossible to mitigate what has not been identified; only after identification can intervention and improvement begin. Reported incidents, and especially, near misses, have been called "nuggets of gold" that enable facilities to identify hazards, understand healthcare system complexities, and design interventions to reduce risks to future patients (Pham et al.). In addition to event reporting, risk managers must rely on other efforts in partnership with quality improvement professionals, such as chart review, safety rounds, and formal assessments, to identify safety and quality issues.
There is solid agreement among international patient safety experts that for patient safety to improve, organizations must learn from adverse events (Mitchell et al.). The European Commission Patient Safety and Quality of Care Working Group has articulated the critical importance of event reporting at the provider, organization, and system levels (PSQCWG):
Commonality and common causation only emerge with an analysis of aggregated data. Demonstrating the occurrence of serious events in respectable peer institutions helps counteract a typical response of "that could never happen here," which providers may genuinely feel when asked about a serious incident, such as wrong-site surgery.
With an effective reporting and feedback system, important patient events are more likely to be raised to the level where systematic improvements can be made, key adverse events are tracked, events are likely to be analyzed or used to prevent recurrence, and patients' risk of adverse events is reduced.
Efficacy of event reporting systems, or lack thereof, is also a barometer for regulatory compliance. In the United States, for example, effective event reporting systems are important for meeting Medicare compliance requirements aimed at increasing patient safety, representing a "foundational capability that can determine whether or not the hospital can maintain compliance with key Conditions of Participation." (CMS)
Benefits associated with adverse event reporting systems include increased provider and facility awareness of patient safety; increased identification of causal factors associated with adverse events; opportunities for patient safety improvement; increased trust within facilities, resulting in improved communication and willingness to disclose adverse events; facilitation of internal data tracking and trending; and increased transparency. (Hanlon et al.)
Worldwide, some event reporting systems are mandatory, but many are not. All reporting systems, whether voluntary or mandatory, have the capacity to yield critical information for patient safety. However, the information these systems generate has limitations. Event reports provide "snapshots" of safety issues, but cannot necessarily place reported problems into the appropriate institutional context. Limitations of voluntary event reporting include selection bias and limited capture, as well as failure to reliably identify serious events because physicians' use of voluntary event reporting systems is limited. With limited participation by physicians, voluntary event reporting systems can identify only the spectrum of events identified by those participating in error reporting. (AHRQ)
Despite the undisputed prevalence of events and near misses, underreporting is a significant concern. Compliance varies among different groups of reporters, especially physicians. Underreporting occurs for many reasons, including fear of liability and organizational and managerial barriers. Also, staff members are often apprehensive about punitive and adversarial approaches taken by employers. (Naveh and Katz-Navon)
Estimates vary, but there is definitive agreement that event reporting systems capture a minority of occurrences. For example, a study conducted by the U.S. Department of Health and Human Services' Office of Inspector General (OIG) revealed that in absence of clear event reporting requirements, hospital staff neglected to report 86% of events to incident reporting systems, in part because of staff misperceptions about what constitutes harm. (OIG "Hospital") Other research also indicates that voluntary incident reporting systems capture only a small portion of patient safety incidents, and that underreporting occurs even with mandatory systems. (Mansfield et al.)
In the United Kingdom, where reporting is mandatory, underreporting also appears significant given the estimated 10% rate of adverse events worldwide: 1.5 million reports are submitted annually to the National Reporting and Learning System in comparison to a reported 15.5 million hospital admissions in the 2013–2014 financial year (HSCIC; Mitchell et al.).
Although a variety of stakeholders, including physicians, nurses, pharmacists, support staff, patients, and families, are prospective reporters, there are notable differences in who actually reports, and at what frequency. Researchers have found that the majority of reports are submitted by nursing staff, who feel that safety reporting is one of their job responsibilities; pharmacists are also frequent reporters for medication-related events. However, physicians and medical residents, who are in the position to have intimate knowledge of events and their sequelae, tend to be less familiar with what and how to report, and may feel that reporting is not part of their job; therefore, they typically contribute a very small fraction of reports. (Heavner and Siner; Mansfield et al.)
Patients and families are also often well positioned to be aware of events; however, they may not have access to a formal event reporting system. Without access, patients and family members must rely on the assistance of someone who has access (e.g., a staff member) to report. Patients and families may also be fearful of reporting.
Such limitations on patients' and family members' ability to report vary according to location of the facility. Literature about event reporting in the United States does not indicate a uniformly strong focus on patients and families as reporters, while current systems and initiatives in Europe reflect an increasing commitment to including patients and families as reporters. See the discussion
Event Reporting in Action: Inclusion of Patients and Families for more information.
Barriers to Event Reporting
Numerous barriers to event reporting have been identified, with consistent themes noted worldwide. For example, an international panel of patient safety experts identified the following five key challenges limiting the full potential of incident reporting systems at the organizational level (Mitchell et al.):
- Inadequate engagement of clinicians
- Inadequate processing of reports
- Insufficient action in response to reports
- Inadequate funding and institutional support
- Insufficient leveraging of evolving health information technology developments
Individual perceptions and experiences often reflect factors cited at the system level. Adverse events are stressful for all involved—frontline staff, risk managers, leadership, and patients and families—and feelings such as guilt, shame, and doubt all negatively affect reporting. Barriers to effective event reporting for clinicians include the following (Evans et al.; Schectman and Plews-Ogen; Uribe et al.):
- Lack of
- Understanding of need to report near misses
- Sufficient time to report
- Clear reporting protocols
- Available computer and/or report forms
- Feedback on action taken following report of event
- Physician involvement in the system
- Belief that
- Reporting does not contribute to improvement
- An incident with low level of harm or no harm is not significant enough to report
- Fear of
- "Telling on" another healthcare worker
- Punishment and lawsuits
Such barriers are widespread. In both U.S. and Chinese studies, for example, nurses reported feeling that mistakes are held against them, and that event reports identify the problem as the person rather than the occurrence (i.e., the staff member involved will be personally blamed) (Kear, Ulrich; Wang et al.).
These barriers—and strategies for mitigation—are discussed in more detail in
Action Plan. See
Staff Perspectives on Underreporting of Events for candid quotations about barriers to event reporting from frontline staff.
Evolution of Event Reporting Systems
The type of system used varies widely according to locale and resources. Although some event reporting systems are still paper-based, increased use of health information technology allows reporting through web-based systems, and choice of system is sometimes constrained or driven by requirements of mandated reporting and/or by the characteristics or features of electronic medical records. For example, the U.S.-based National Academy for State Health Policy reports that as of 2014, 22 of 28 state event reporting systems were partially or fully electronic, compared with nine in 2007. Additionally, four state systems collect data manually, and seven accept both manual and electronic data. (Hanlon et al.)
The event reporting systems used by member states of the European Union are similarly variable, with a few collecting data only from paper reports, many collecting data electronically, and several accepting reports in both forms. However, the European Commission Patient Safety and Quality of Care Working Group has recommended transition to electronic data collection "as early as possible" to promote data accuracy, facilitate transmission and sharing of information, and simplify statistical analysis. (PSQCWG)
Increasingly, computerized risk management information systems (RMISs) and commercially available software are being used to identify, report, and track trends in events and claims for ease of data analysis. RMISs can facilitate timely and concise reporting, prioritization, and follow-up of events, as well as on-demand, customizable trend reports for management use. Many systems can identify sentinel events that require root-cause analysis and specified events that are reportable under local regulations.
An effective RMIS can also assist in prioritizing areas that should be targeted for improvement. In addition, performance information gained from RMIS data collection may allow comparison of internal historical performance with external performance information (e.g., performance of other organizations or with identified best practices), when available.
The United States has no national incident reporting system, and the path toward effective nationwide reporting of adverse events is very much in its infancy (NQF). However, other regulatory imperatives for event reporting are in place. For example, hospitals that receive reimbursement for patient care under a federal government program must track and analyze adverse events to comply with applicable program rules (e.g., Medicare Conditions of Participation) and to meet accreditation requirements, and event reporting systems are a common means used to meet these objectives. (OIG "Hospital") Furthermore, the need to provide legal protection for reports of events as well as for information derived from analyzing the reports has been recognized by the federal government with the passage of the Patient Safety and Quality Improvement Act of 2005 (PSQIA; Pub. L. No. 109-41) as a means of promoting the sharing of data that can improve patient safety throughout the healthcare system.
Through PSQIA, Congress authorized the creation of PSOs, establishing, for the first time, a protected legal environment in which providers in all states and U.S. territories may share information about patient safety events and quality (referred to as "patient safety work product," e.g., events, data, reports) without fear that the information will be used against them in litigation. By participating in a PSO, providers may voluntarily and confidentially report their patient safety and quality information to a PSO for aggregation and analysis and in return receive recommendations, protocols, best practices, expert assistance, and feedback from the PSO to improve the provider's patient safety activities. For more information, see
Patient Safety and Quality Improvement Act.
PSQIA does not, however, eliminate the need for healthcare organizations to submit state-mandated reports of events according to requirements of state reporting systems. Mandated reports, once submitted to a state reporting system, are not privileged under PSQIA.
U.S. State Laws
As large purchasers, regulators, and providers of healthcare services, states have unique opportunities and interest in improving patient safety and safeguarding the public (Hanlon et al.). In the absence of a national reporting system, just over half of states have instituted mandatory event reporting systems, which state authorities and accrediting organizations use as part of their safety oversight function and which are typically restricted to sentinel events (Naveh and Katz-Navon).
As identified by the National Academy for State Health Policy, to date, 27 states and the District of Columbia have adverse event reporting systems, all of which are mandatory with the exception of Oregon's system (Hanlon et al.). Many of those states incorporate at least a portion of the National Quality Forum's list of 28 serious reportable events to establish a more uniform set of criteria by which to report and act. Between 2007 and 2014, the number of states adopting or adapting the NQF list for their adverse event reporting system increased from 12 to 15, suggesting growing interest in standardization. (Hanlon et al.) See "Resource List" for more information.
U.S. State Adverse Event Reporting Systems for an interactive map illustrating which states maintain adverse event reporting systems and specific information about the systems of those that do.
The Joint Commission defines a sentinel event as a patient safety event, not primarily related to the natural course of the patient's illness or underlying condition, that reaches a patient and results in death, permanent harm, or severe temporary harm. Other events that are considered sentinel include, but are not limited to, patient suicide, patient elopement, wrong-site surgery, and surgery on the wrong patient. (Joint Commission)
The Joint Commission strongly encourages, but does not require, reporting to the organization of any patient safety events that meet the definition of sentinel event. However, the Joint Commission's hospital accreditation standards oblige accredited organizations to provide internal systems for reporting safety issues, near misses, hazardous conditions, and sentinel events as part of a hospital-wide patient safety program (Joint Commission):
- Leadership standard LD.04.04.05, EP 7, requires each accredited hospital to define patient safety for its own purposes and to communicate the definition, which must encompass sentinel events as defined by the Joint Commission, throughout the hospital. Accredited hospitals are encouraged to include in their definitions incidents in which no harm or only minor harm reached a patient and to determine how they will respond to such events.
- Medical staff standard MS.05.01.01, EP 10 and 11, requires sentinel event data, including patient safety data, to be included among information used for performance improvement activities.
Risk management information such as event report data assists in meeting these Joint Commission standards and is an important source of performance-monitoring data. See
Resource List for more information on the Joint Commission.
Det Norske Veritas (DNV) also requires adverse event reporting from accredited organizations. DNV reporting standard SR.1 states that hospitals "shall have documented procedures to define, record, analyze, and learn from incidents that impact safety." Such incidents include medical errors and adverse patient events. Interpretive guidance for this standard indicates the need for a hospital-wide document including, but not limited to, training requirements for adverse event reporting and a process to ensure that action plans are implemented to address deficiencies such as adverse events. (DNV)
Taking into account operational, political, and cultural contexts, outside of the United States legal requirements and regulatory schemes for event reporting vary significantly. Some member states in the European Union and some countries (e.g., England, Wales) mandate reporting and others have even enforced failure to comply with mandated reporting in courts of law (i.e., Australia) (PSQCWG; Starr). Other countries, such as Japan, utilize a combination of mandatory and voluntary reporting (Japan). In contrast, the concept of reporting harm from medical errors to improve patient safety is still emerging in other nations. In Saudi Arabia, for example, there is no mechanism in place for monitoring incidents that lead to medical errors (Mohammed).
For more information on reporting requirements for member states of the European Union, see Table 3 in
Reporting and Learning Systems for Patient Safety Incidents Across Europe; for additional detail on adverse event reporting systems in the Asia-Pacific region, see Table 20 in
Evaluating Quality Strategies in Asia-Pacific Countries: Survey Results.
Joint Commission International (JCI) maintains a "Sentinel Events Policy" to identify procedures for organizations involved in their accreditation or certification processes. JCI states that minimally, organizations "must include those events in [their] sentinel events polic[ies] that are subject to review described under the standard that addresses sentinel events from the accreditation program for which they are applying and the JCI Sentinel Event Policy"; furthermore, "accredited organizations and certified programs are expected to identify and respond appropriately to all sentinel events occurring in the organization or associated with services that the organization provides, or provides for." (Joint Commission International). See
Resource List for additional information.
Event Reporting Worldwide: Status and Strategies to learn more about the current state of event reporting, and strategies for improvement, in several regions of the world.
Develop Organizational Framework
Action Recommendation: Define events to be reported and identify roles of stakeholders.
Given widespread underreporting and acknowledged barriers, most organizations would likely benefit from defining, redefining, or affirming their established approach to event reporting—regardless of whether their system is new or well established, simple or sophisticated. Fundamental issues to be addressed include types of events to be reported, individual reporting responsibilities, and method(s) for event reporting.
To prevent duplication of time, effort, and resources, most facilities have merged their occurrence and event reporting systems and simply use the term "event reporting." Event reporting systems define, both on a facility-wide (e.g., medication error, fall) and on a department- or service-specific basis (e.g., emergency cesarean delivery, retention of an instrument or sponge), which occurrences must be reported. This is accomplished by providing facility staff with lists of events that must be reported by defining reportable events in policies and procedures. Examples of reportable occurrences of a clinical nature include administration of incompatible blood, missed diagnoses such as fractures or appendicitis, and allergic reactions to contrast media.
Typical event report forms (whether paper or electronic) contain demographic information on the individual involved in the event, a brief narrative description of the event, and checkboxes for classifying the event (or occurrence) by type and category. Forms are marked "confidential" and should contain other introductory language as required to meet applicable statutory protections from disclosure. Event reports are usually supplemented with a follow-up report that contains more detailed information, causative factors, and corrective actions. See
Confidential Event Report for a sample report form that lists common event types and categories.
Disparities in concepts, definitions, and classification systems of the types of events that should be reported, as well as different data capture methods, make measurement of preventable harm a challenge. Establishing consistent definitions, classifications, and measurement processes helps risk management and patient safety professionals support the primary goal of preventing harm and delivering safe care to patients by allowing accurate, consistent, and efficient identification of events as reportable.
Consistent definitions also lead to rapid responses, facilitate prevention by mitigating systems issues, and allow for standardized measurement of events and prevention strategies. They may additionally support regulatory requirements; for example, the U.S. PSQIA requires that event report data be collected and categorized by PSOs in a standardized manner with a common set of data elements to enable aggregation and analysis across all providers (Hoppes and Mitchell).
Common Formats. To standardize event reporting, the U.S. Agency for Healthcare Research and Quality (AHRQ) developed Common Formats, which can be used by providers and PSOs for reporting patient safety events that occur in acute care hospitals and nursing homes. The comprehensive and flexible Common Formats are one tool for decreasing variations in definitions and classifications. This no-cost, publicly available taxonomy has wide use and describes patient safety concerns as follows (CMS):
incident is a patient safety event that reaches the patient, whether or not the patient was harmed.
near miss (or close call) is a patient safety event that does not reach the patient.
unsafe condition is neither an incident nor a near miss but is a circumstance that makes the occurrence of such an event more likely.
Occurring more frequently than adverse events, close calls frequently go unreported. Experts estimate that for every serious event that occurs, there are 29 minor injuries and 300 near misses. In accordance with best practices for risk management, reporting of close calls—or near misses—is promoted as part of the Common Formats reporting tool. Near misses are an information-rich resource; the sheer volume of near misses means that systemic problems can be identified with far less than 100% reporting, and without any patient harm. (Marks et al.) See
Resource List for more information on the Common Formats.
The individual who witnesses or discovers the event should make the report; giving frontline staff responsibility and accountability for patient safety is empowering (Sankaranarayanan et al.). All employees, nonemployed professional staff, volunteers, visitors, and patients should be encouraged to report events and near misses. For healthcare organizations with multiple locations, reporting responsibilities extend to off-site facilities and treatment centers (e.g., system-owned physician offices, home health agencies, freestanding surgical centers).
Nursing departments are characteristically the most common source of event reports, but they should not be the only source. In fact, some of the best sources of patient safety and risk management information may be case management, patient relations, and the hospital chaplain's office. Security reports on risk- and safety-related issues are also very helpful. Additionally, the maintenance department should report any potential hazards to property or people and communicate hazard reduction measures taken.
Policies and Procedures
All organizations should have written policies and procedures on event reporting that are approved and endorsed by the governing board. Event reporting policies should address the specifics of what and how to report, specify timeframes for reporting and follow-up, and address responsibility for each. For examples of reporting policies, see
Occurrence Reports—Patient and Visitor and
Policy Regarding Reporting and Analysis of Sentinel Events, as well as
Resource List for a link to an event reporting policy template.
U.S. organizations should specifically review policies and procedures in light of PSQIA protection provisions for "patient safety work product"—qualifying information such as adverse events and near misses collected and analyzed for the purpose of reporting to the PSO in the context of a patient safety evaluation system. Those interested in participating with PSOs—- or those expecting to do so in the future—-may need to reconsider how event reports are submitted and create a patient safety evaluation system in which event reports are collected. See
Patient Safety and Quality Improvement Act for more information.
Retention of event reports. Absent any national standard recommending the time frame for event report retention, organizations may choose to tie their event report retention policies to their policies for retention of medical records. Others may tie their event report retention policies to those for purging policies and procedure manuals, since policy and procedure manuals are often needed for purposes of litigation and might be relevant to an event report. Hospitals typically retain their records for 10 years. The American Health Information Management Association recommends that unless otherwise mandated by state or federal law, patient medical records be retained for 10 years after the most recent patient encounter (AHIMA).
In developing a policy for event report retention, risk managers should also consider any relevant state statutes. Typically, state statutes require that medical records be retained for 7 to 10 years. Another issue to consider for a retention policy is whether an event report is or could be the subject of litigation. Also, if the event report involves a minor, the event report should be retained until the patient reaches the age of majority plus 10 years. In these cases, the policy should allow for exceptions to the recommended time frame for retention of event reports.
Event Reporting in Action: Inclusion of Patients and Families
Opportunities and systems to support event reporting by patients and families are inconsistent. However, finding that the quality of patient reports equals that of health professionals, and that such reports often provide a rich descriptive element that can be an important learning resource, the European Commission for Patient Safety and Quality Working Group advocates increased efforts to facilitate reporting by patients and families.
The Working Group has called for additional information on areas such as system requirements for adequate feedback, mechanisms needed to capture qualitative information provided by patients, and required changes to systems or culture. The Working Group advocates that data entry formats be designed with layperson use in mind (e.g., use of nonmedical terminology) and notes the importance of explicitly separating event reporting from formal complaint and litigation procedures as well as raising public awareness about the existence and purpose of the system.
Affirm Choice of System
Action Recommendation: Choose an event reporting system based on ease of use and results.
Organizations should ensure that they have identified an event reporting system that will be appropriate for the population served and will work within operational constraints. Successful adverse event reporting systems are nonpunitive, confidential, independent, timely, systems oriented, and responsive and include expert analysis (Leape).
There has been an explosion of both public and private adverse event reporting systems in healthcare worldwide, including national systems (e.g., the Australian Incident Management System, the National Reporting Learning System in England and Wales) and local systems (e.g., the Pennsylvania Patient Safety Reporting System); some systems broadly capture all types of events while others focus narrowly on a specific clinical area or specific types of events, such as medication errors (Pham et al.). Systems with narrow focus tend to require consistent efforts of champions to ensure that such specific issues are appropriately reported, analyzed, and resolved. One advantage of engaging with a PSO is that all types of events are reported in the same way and can then be analyzed by experts in the appropriate context of aggregated data for specific event types.
Choice of reporting system, and the framework for reporting, are highly individualized. Rather than searching for a universally applicable system or ideal solution, organizations must work to ensure that feasibility, data collected, and response actions are optimized for their individual facilities.
Evaluation of any event reporting system should determine not only how effective it is in capturing information on events and near misses but also, and even more importantly, how effective it is in improving systems and procedures (Cranfill). Organizations may want to meet with current users in focus groups or conduct individual interviews to learn what does and does not work with the reporting system. Risk managers should compile a list of challenges identified by staff and work through the list to see how the most common and pressing concerns can be addressed.
AHRQ has identified the following key components of an effective event reporting system, against which a current or prospective system could be evaluated (AHRQ):
- A supportive environment for event reporting that protects the privacy of staff who report occurrences
- The ability to receive reports from a broad range of personnel
- Timely dissemination of summaries of reported events
- A structured mechanism for reviewing reports and developing action plans
System Selection and Refinement
If the existing event reporting system is not providing the information needed to identify problem areas, analyze event trends, and make improvements, it is time to revamp or replace the system. One approach to accomplishing this is similar to other project management initiatives. A committee or task force comprising key clinical and management staff, including the risk manager, should be formed to establish objectives and criteria for the reporting system. A needs analysis and user surveys can reveal much about what type of event reporting system would work best.
Many steps can be taken to address identified shortcomings in an event reporting system. A multipronged approach to refine and maximize the efficacy of reporting systems includes the following strategies (Hanlon et al.):
- Updating online systems, including response options and reporting intake forms, to improve compliance
- Hiring additional staff members to help providers meet reporting requirements
- Shifting from a regional to a centralized process to provide a more standardized approach to program management
- Implementing programs to recognize leading reporters
- Moving away from an approach focused on sentinel events to a broader patient safety surveillance and improvement program
Selection of any event reporting system should align with the organization's goals and capabilities for using the data. Issues to consider include whether the data will be mapped or uploaded to a PSO or other external system, whether the system will be used to track multiple quality initiatives over time, how the system exports data, and whether the system helps identify sentinel events or those reportable under state statutes.
Systems should also be selected with the goal of making reporting easier, ensuring that providers have quick and ready access to systems that are simple enough to use with minimal or no training (Pham et al.).
Leaders can ensure that reports are linked to action by selecting reporting systems that code reports into specific areas such as medication errors or wrong-site surgery. Ensuring that reporting systems are visibly linked to effective action means that safety issues can be easily monitored and evaluated to provide the evidence that healthcare professionals need in order to engage. Additionally, this strategy promotes creation of an enduring interdisciplinary team to describe the ideal system, take responsibility for reviewing adverse events specific to the problem, develop interventions, and monitor improvements. (Mitchell et al.)
Once an electronic system is selected, it may be helpful to run simulations with the software, allowing the opportunity for a sampling of reporters who will be using the proposed system to give feedback on the system's usability and identify any trouble spots within the program.
Event Reporting in Action: System Redesign
The design and function of an event reporting system can make a significant impact on event reporting. For example, reengineering of a web-based error reporting system significantly increased voluntary error reporting at an urban academic multidisciplinary hospital in Rhode Island. The original system had a small number of entry fields and drop-down menu choices, which limited the quantity of event-specific information that could be entered. Reports were routed directly to risk managers; staff and clinical managers had limited access to the system. The updated system featured the following important differences (McKaig et al.):
- It contained a series of standardized screens, drop-down menu choices, and input fields designed to collect specific types of information regarding the nature and specific type of event.
- It enabled staff more complete access and input.
- It enabled reporters to identify stakeholders.
- It allowed clinical managers to perform an initial review to validate accuracy of the information in the report.
The reengineered system, in combination with hospital-wide training, a positive safety culture, and enhanced feedback to stakeholders, is credited with a sustained increase of approximately 50% in error reporting. (McKaig et al.).
Educate All Stakeholders
Action Recommendation: Ensure that all potential reporters understand why and how to report events.
Once a new or revised event reporting system is selected and leadership support is obtained, a great deal of education must be provided to clinicians, management, and staff. The risk manager should collaborate with quality improvement managers, information technology personnel, staff educators, and others when developing and providing educational programs. A train-the-trainer approach to education may be best for large, diverse, and geographically dispersed organizations. This educational style was identified as a key success factor in a case study on a systems approach to improving error reporting in one of the nation's largest not-for-profit integrated healthcare systems. (Joshi et al.)
Bearing in mind that both reports and follow-up are required for an effective event reporting system, training in the culture of safety and incident reporting should be required at the earliest possible point (PSQCWG). When initial training is complete, subsequently including training in error reporting systems in orientation of new hires is recommended (Mandavia et al.).
An effective event reporting education program will assist all staff in knowing what should be reported and provide staff with a basic understanding of the organization's definition of an event. Examples of reportable events to instruct staff on include the administration of the wrong medication to a patient or a near miss in which the nurse realized that the wrong medication was about to be given to a patient and stopped the administration. Both events require reporting so that an analysis of causative factors can be conducted and future occurrences can be prevented. An additional example is the failure of a backup generator during a power failure. The failure is reportable because it is not part of normal hospital operations and because it puts patients, staff, and visitors at risk. Yet another example is the unintentional retention of a sponge or instrument in a surgical wound postoperatively. Such an event should trigger an investigation of the event, an in-depth analysis of the cause, and an evaluation of the procedures used to account for surgical items. Finally, diagnostic errors are important reportable events. They are difficult to capture because, by their nature, they are not immediately obvious and may only be detected long after an actual event occurs (e.g., test results not reported). However, diagnostic errors are a significant and "largely unappreciated" problem, and the Institute of Medicine recommends voluntary reporting of diagnostic errors and near misses. (IOM)
Event Reporting in Action: Daily Safety Rounds
A combination of education and action modeled by clinical leadership was effective in overcoming barriers to event reporting by internal medicine residents at a Detroit, Michigan-area U.S. Department of Veterans Affairs Medical Center where resident physicians had collectively reported a total of just two incidents in the entire year prior to the intervention.
Strategies included initial education on event reporting; daily patient safety walking rounds with the chief resident for quality and safety; daily observation of rounding teams to aid in identifying errors and encourage a culture of reporting; provision of literature on the importance of event reporting; and provision of tools (e.g., diagrams, flowcharts) to assist in use of the electronic system. The chief resident for quality improvement and patient safety probed with questions such as "Have you come across any incident (adverse event or near miss) that you think needs to be reported?" and "What can I do to help you report this incident?" (Mandapakala and Levine)
Researchers began the intervention with education about event reporting ("talking"); however, they determined that "talking" alone was insufficient to increase reporting. However, subsequent daily safety rounds with the chief resident for quality and safety, in conjunction with reinforcement of education ("walking and talking"), facilitated an increase in error reporting. The intervention increased reports to 4, 13, 8, and 6, respectively, for each of 4 consecutive months measured. (Mandapakala and Levine) Although this intervention was designed to encourage reporting by physicians, it could facilitate reporting by nonphysician caregivers as well.
Foster Just Culture
Action Recommendation: Cultivate an atmosphere that encourages reporting without fear of blame and repercussions.
If an organization's culture is not conducive to event reporting, the system will not be successful and underreporting will be likely. Therefore, event reporting systems must allow ease of reporting for staff, must be viewed as a positive contribution, and must show evidence of resulting change and improvement.
To improve patient safety, adverse event reporting must be viewed as more than fulfilling regulatory requirements. In order for healthcare organizations to learn from adverse events and maximize patient safety, they must have a supportive, nonpunitive culture and a true accountability to deliver safe patient care. (Mitchell et al.) To embed such a culture requires true leadership commitment to build and maintain the trust of staff. This will not happen overnight, and may take many years (PSQCWG, Sankaranarayanan et al.).
The importance of culture in event reporting is universally acknowledged. Citing increasing evidence about the effectiveness of interventions for teamwork and professional engagement, combined with active error identification to reinforce patient safety culture and promote behavior change, WHO recommends a determined culture of safety and improvement including a positive attitude towards recognizing and sharing failures. WHO states that all those potentially involved in reporting, including clinicians, patients, and relatives, need to share a culture of safety and improvement in order to increase people's willingness to describe the circumstances and consequences that led to a harmful event. (Larizgoitia et al.)
A culture of safety in healthcare places great emphasis on the creation of a nonpunitive environment in which caregivers and other staff can report events, errors, and near misses because they are confident that the report will help staff learn from mistakes. The support of senior leaders and clinical providers is necessary to promote this "just culture"—a culture in which open communication prevails and which is conducive to reporting events without fear of reprisal. Empathy is also critical to ensure meaningful and effective event reporting, as is a deep awareness of components of effective communication such as method, response, and context (Pham et al.).
Risk managers, in conjunction with clinical leaders and organizational managers at all levels, must strive to create such an atmosphere in their organizations. See the guidance article
Culture of Safety for more information. AHRQ lists resources for understanding, implementing, and providing education about just culture on its patient safety website; see
Resource List for more information.
Culture is more than just a stated commitment; it runs deep through an organization's policies and practices and affects initiatives such as event reporting at the individual level. For example, it is theorized that healthcare personnel utilize a complex system of considerations when deciding whether to report or stay silent about an event, first seeking information and hints about the type of activities the organization expects, appreciates, and rewards. To reinforce just culture, both policy and practice for any reporting system should emphasize that valid feedback from staff on the organizational factors promoting errors is far more important and appreciated by management than any assignment of blame to individuals (Naveh and Katz-Navon).
Rewarding reporters is a meaningful way to demonstrate organizational commitment to reporting, and therefore, reinforce a just culture that values system improvement over individual blame. Rewards need not be elaborate or expensive, but to be most effective, they should be visible to all stakeholders. For example, Johns Hopkins Hospital utilizes a "Safety Star" program to recognize staff who have gone above and beyond to improve patient safety (Marks et al.).
Organizations that neglect to reward reporters in a visible manner, such as through an official facility-wide recognition system, leave a valuable method of education and reinforcement untapped (McKaig et al.). In addition to rewarding staff members who report errors, leadership should also consider rewarding managers who act to resolve the problem. This approach will enable and support such behaviors in the future. (Naveh and Katz-Navon)
Event Reporting in Action: Integration into Morbidity and Mortality Meetings
As reported in a combined analysis from North Cumberland University Hospital in the United Kingdom and Harvard Medical School in the United States, integration of a web-based, discipline-specific event reporting system into structured weekly morbidity and mortality meetings significantly affected the number of reported events in a general surgery department. Reports increased from zero in 2011 to more than 200 in 2013. Success of the initiative was attributed to a no-blame culture with emphasis on improving clinical outcomes, in combination with timely feedback. Other specialties subsequently adapted the process and experienced improved patient outcomes. (Kumar et al.)
Respond to Reports Accordingly
Action Recommendation: Analyze data and respond accordingly to improve clinical and operational processes.
A response system is more important than a reporting system; although it might seem obvious that collecting data and not reviewing it is of little value, requiring reporting in the absence of resources needed to review the reports has been cited as a major failure in government-run reporting systems (PSQCWG). Reporting of an event is just the beginning of a comprehensive response process; actions taken thereafter will determine the organization's ability to meet the ultimate objective of improved patient safety.
The following guiding principles of event response for risk managers and investigators have been identified (Hoppes et al.):
- Operate within appropriate legal authorities (state, organizational).
- Understand organizational culture and be sensitive to organizational ethics.
- Investigate with focus and purpose.
- Maintain the trust of colleagues, staff, patients, families, local authorities, and the media.
A successful review process must be expert, credible, and timely, with a balance of independent and appropriate content resources (PSQCWG). Leadership from the risk management department is critical to ensure that evaluation, prioritization, and action regarding events are carried out effectively (Mandavia et al.). This includes an immediate response addressing appropriate disclosure and the needs of the patient and their caregiver(s). For more information, see the guidance article
Disclosure of Unanticipated Outcomes. In addition to follow-up for individual events, aggregated data must also be assessed to track overall system performance over time. Similarly, Joint Commission International states that appropriate responses for accredited organizations and certified programs include the following activities (Joint Commission International):
- Conducting a timely, thorough, and credible root-cause analysis
- Developing an action plan designed to implement improvements aimed at risk reduction
- Implementing identified improvements
- Monitoring the effectiveness of the improvements
Given the prevalence of events and near misses, risk managers may not be able to address every occurrence—especially as increased awareness, educational efforts, system optimization, and cultural shifts result in more reports. Prioritization of characteristics such as level of harm, preventability, or regional/national priority has been suggested to ensure that the most meaningful reports are investigated and addressed thoroughly. Such focus might include events that occur most frequently, cause the most harm, or are of greatest concern, such as those on the National Quality Forum's list of serious reportable events. (Pham et al.)
Without analysis and follow-up, event reporting is of little or no value. However, many hospitals do not have robust processes for analyzing and acting upon aggregated event reports (AHRQ).
Such an examination should be a "comprehensive systematic analysis," such as root-cause analysis, focusing on systems and processes. Root-cause analysis is the most common form of comprehensive systematic analysis used for identifying the causal and contributory factors that underlie a sentinel event. (Joint Commission) Other tools and methodologies are also permissible. Events should be investigated by experienced professionals using a standardized approach to ensure that the review is thorough and the process and results are credible. The standardized investigation process should include a formal, written, competency-based plan for event identification, investigation and action, developed and agreed upon in advance. It should also balance the focus on and review of individual issues (e.g., error and contributing factors) with that of system issues (e.g., inadequate procedures, lack of available resources, and/or poor design). (Hoppes et al.)
The Joint Commission International states that root-cause analyses are considered acceptable if they do the following (Joint Commission International):
- Primarily focus on systems and processes, not individual performance
- Focus on specific causes in the clinical care process as well as on common causes in the organizational process
- Repeatedly dig deeper in pursuit of the root cause
- Identify changes that could be made in systems and processes that would reduce the risk of such events occurring in the future
Event Reporting in Action: Leaders Look for Near Misses
At the Hospital of the Medical University of South Carolina, which began intensive safety work around 2005, leaders examine not only the volume of safety reports received over time but also the percentage that are near misses. This analysis informs their evaluation of progress towards the ultimate goal of increasing patient safety. The hospital's chief quality officer has stated that "in a really good culture of safety, what you want is a high number of reports with a larger percentage of near misses and a smaller percentage of patient harm." (Putre)
Create an Action Plan
Born of the comprehensive systematic analysis, the action plan identifies the strategies that the organization intends to implement to reduce the risk of similar events occurring in the future. An effective action plan must address the following (Joint Commission):
- Actions to be taken
- Responsibility for implementation
- Timelines for implementation
- Strategies for evaluating the effectiveness of the actions taken, including metrics to measure the effectiveness of the action plans
- Strategies for sustaining the change
If designed and used correctly, an event report will indicate the level of follow-up needed and the speed at which it should be performed. Like the report itself, documents generated during follow-up should be treated as confidential in order to optimize legal protection. At the same time, fear of discovery should not override the organization's responsibility to disclose the occurrence of an event or error to the patient, investigate the cause, and implement preventive measures to avoid recurrence. A follow-up report should document management's process review and be designated as a patient safety, quality review, or peer-review document as indicated.
Event Reporting in Action: Immediate Action When Indicated
Despite the importance of methodical analysis, some events indicate such clear safety threats that it is equally important to have a strategy for immediate action.
Organizations with strong safety cultures have identified procedures for such situations. For example, at an urban academic hospital in Providence, Rhode Island, events identified by the reporter as resulting in patient harm are immediately routed by the system to senior hospital leadership and risk management for appropriate corrective action and for event reporting to appropriate outside agencies such as the applicable state department of health (McKaig et al.). Similarly, at Virginia Mason Hospital and Medical Center in Seattle, Washington, reports associated with a high risk for patient harm receive an immediate response; when necessary, processes or staff are taken "off line" until the safety threat is understood and addressed (Mansfield et al.).
Action Recommendation: Ensure that all stakeholders receive timely and comprehensive feedback on reported events.
Without feedback to reporters, all other recommendations for event reporting are meaningless. Feedback affirms reporters' actions and facilitates learning; lack thereof is a major barrier to reporting and response by both physicians and allied health professionals. (AHRQ) Feedback is also a motivator to report future incidents; there is a risk that reporters who do not receive feedback will eventually stop reporting, even when mandatory. (PSQCWG)
WHO states that providing reporters with timely feedback is a best practice to promote improvement through learning (Larizgoitia et al.). In addition to the individual who reports an event receiving timely feedback, managers should share reports with their staff. (Pham et al.)
In addition to direct feedback on specific situations, effective communication strategies (i.e., encourage additional reports from frontline staff) include the following (Marks et al.; McKaig et al.):
- Stories posted on the organizational intranet
- Annual patient safety fair events
- Periodic action reports from the patient safety committee
- Safety events showcased in monthly publications
- Sharing of lessons between departmental representatives and colleagues
- Provision of information to frontline staff by nursing and medical leadership
Event Reporting in Action: Sharing Findings with Stakeholders
Providing feedback is viewed as a critical component of the success of the patient safety reporting system at a nonprofit integrated health services organization. This is accomplished with tools including the following (Mansfield et al.):
- A quarterly newspaper
- A monthly "good catch" award
- Five-minute "pointer" videos that feature a healthcare provider, usually the individual who reported the issue, describing how the issue was identified and investigated and how an improvement strategy was implemented
The videos are seen as especially meaningful because they utilize frontline staff to emphasize the importance of safety.