Prevalence of Adverse Events
Although ambulatory care is the most-often used care setting for health services, determining the prevalence of adverse events in this setting is much more nuanced and challenging than hospital, surgical, or even long-term care settings. Unlike inpatient or residential care settings, medical errors in ambulatory care tend to:
- Be subtle in nature
- Not result in immediate harm, or may even take years for results of harm to appear
- Involve actions or inaction and patient adherence issues, which can be difficult to monitor
- Occur after the patient has left the facility, making the adverse event difficult to track
Additionally, ambulatory care settings often lack the level of resources afforded to hospital settings, such as onsite diagnostic testing services and clinical specialists, which can create gaps in care if test-tracking and follow-up is not optimized. Research suggests that outpatient diagnostic errors effect approximately 12 million U.S. adults every year—a 5.08% error rate—about half of which are estimated to be potentially harmful. (Singh et al.)
This setting also often lacks automated technology that supports patient safety. For example, bar-code administration systems are critical to medication safety in hospitals, but they are not commonly used in physician practices. In fact, previous research has shown that medication errors are among the most common errors in ambulatory care facilities: approximately 4.5 million ambulatory visits related to adverse drug events occur each year in the U.S. (Sarkar et al.); another study conducted in two states found that 28% of prescriptions contained one or more nonillegibility errors (Abramson et al.).
In addition to diagnostic testing errors and medication safety events, ECRI and the ISMP PSO also identified falls, health information privacy issues, and safety/security incidents as key risks in this care setting as reported in Deep Dive: Safe Ambulatory Care, published in 2019. Of the 4,355 events that occurred in ambulatory care settings reported to the patient safety organization (PSO) between December 2017 and November 2018 (ECRI and the ISMP PSO):
- 47% involved diagnostic testing errors
- 27% involved medication safety issues
- 14% involved falls
- 8% involved the Health Insurance Portability and Accountability Act or privacy issues
- 5% involved security or safety issues
Underreporting
Despite the undisputed prevalence of adverse events and near misses, underreporting is a significant concern and compliance varies among different groups of reporters. Although a variety of stakeholders are prospective reporters (including physicians, nurses, pharmacists, support staff, patients, and families) there are notable differences in who actually reports, and at what frequency. Researchers have found that most reports are submitted by nursing staff, who believe 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 believe that reporting is not part of their job; therefore, they typically contribute a very small fraction of reports. (Heavner and Siner; Mansfield et al.)
Research has also shown that fear of liability and organizational and managerial barriers exist, and staff members are often apprehensive about punitive and adversarial approaches taken by employers. (Naveh and Katz-Navon)
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. Barriers to effective event reporting for clinicians include the following (Evans et al.; Schectman and Plews-Ogen; Uribe et al.):
- Lack of:
- Anonymity
- 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 believing that mistakes are held against them, and that event reports identify the person as the problem 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 the Action Plan. See Staff Perspectives on Underreporting of Events for candid quotations about barriers to event reporting from frontline staff.
Develop Organizational Framework
Action Recommendation: Define events to be reported and identify roles of stakeholders.
Defining Events
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. However, establishing consistent definitions, classifications, and measurement processes allows for accurate, consistent, and efficient identification of events as reportable. Consistent definitions also lead to rapid responses, facilitate prevention by mitigating systems issues, allow for standardized measurement of events and prevention strategies, and help support regulatory requirements for collection and categorization.
To standardize event reporting, the U.S. Agency for Healthcare Research and Quality (AHRQ) developed
Common Formats, a no-cost, publicly available taxonomy that can be used by providers and PSOs for reporting safety events. It describes patient safety concerns as follows (CMS):
- An incident is a patient safety event that reaches the patient, regardless of if the patient was harmed.
- A near miss (or close call) is a patient safety event that does not reach the patient.
- An 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 or resident harm. (Marks et al.)
See
ECRI Resources for Reportable Events for a list of serious reportable events that are paired with related resources for mitigation.
Defining Roles and Responsibilities
The role of stakeholders is quite clear: anyone who witnesses or discovers an event should make or contribute to the report. This means an event that involves multiple stakeholders should allow input from all involved, including patients, family members, patient relations, frontline staff, case management, and the surgical team. Such "participants" should be listed on the event form, their roles described in the event narrative, and contact information provided for follow-up, if needed.
Event Forms
Typical event report forms (whether paper or electronic) contain demographic information on the individual involved in the event (see
Racial and Ethnic Disparities in Event Reporting for specific guidance), 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
Event Report Template for sample content that should be addressed or adapt ECRI's
Event Summary Tool.
Reporting Policies and Procedures
As of this writing, there is no consistent format for reporting race or ethnicity of individuals involved in events, often rendering such information underreported and therefore even harder to track disparities. However, research suggests that such disparities are generally widespread in healthcare, many of which were exacerbated or brought to light during the COVID-19 pandemic. See the following ECRI coverage of recent research concerning disparities: To combat disparities in event reporting, ECRI recommends that all healthcare organizations examine the racial demographics of reported patient and resident safety events and root cause analyses performed by the organization for serious events and determine whether racial or ethnic disparities exist in the types of events reported and analyzed. Organizations can use this information to design policies that work to eliminate racism and discrimination from within the organization. Additional strategies can be found inJoint Commission's Sentinel Event Alert #64, which recommends organizations address healthcare disparities through improving patient quality and safety. See Bias and Racism in Addressing Patient Safety in ECRI's
2022 Top 10 Patient Safety Concerns and Culturally and Linguistically Competent Care for more information.
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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 what and how to report; specify timeframes for reporting, follow-up, and report retention; and staff responsibilities for each.
U.S. organizations should review policies and procedures in light of the U.S. Patient Safety Quality Improvement Act (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 (42 U.S.C. §§ 299b-21 to b-26). Those interested in participating with PSOs—-or those anticipating doing 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 ECRI's
Patient Safety and Quality Improvement Act for more information).
Affirm Choice of System
Action Recommendation: Choose an event reporting system based on ease of use and optimization features (e.g., interoperability with existing electronic health record system, dissemination of event report summaries).
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, responsive, and include expert analysis (Leape).
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
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. Organizations may want to meet with current users in focus groups or conduct individual interviews to learn what does and does not work within 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 may be addressed.
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 and resident safety surveillance and improvement program
For organizations accredited by Joint Commission, sentinel events prompt immediate investigation and response and organizations are urged—though not required—to report them to Joint Commission. As such, Joint Commission has published sentinel event policy and procedures for the following ambulatory care settings:
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Selection of any event reporting system should align with the organization's goals and capabilities for using the data, such as 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.
Ultimately, systems should be selected and updated 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. Leaders can also 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, so that safety issues can be easily monitored and evaluated to provide the evidence needed to address them.
Once an electronic system is implemented or updated, 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.
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, subsequent training in error reporting systems during orientation of new hires is recommended (Mandavia et al.).
ECRI's
Event Reporting Training Program can be used as a model for educating frontline staff.
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. Risk managers, in conjunction with clinical leaders and organizational managers at all levels, must strive to create such an atmosphere in their organizations. See
Culture of Safety: An Overview for more information.
Respond to Event Reports Accordingly
Action Recommendation: Analyze data and respond accordingly to improve clinical and operational processes.
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 and resident safety.
Figure Event Reporting Process Map provides a full overview of the process. 
It should be noted that each organization's response plan will look and behave differently from others depending on a variety of factors. These may include whether the facility is independently owned, part of an accountable care organization, or part of a larger health or hospital system; what the organizational design is like—including positions and assigned responsibilities; and how the chain of command is structured, among other factors. But generally speaking, the following guiding principles of event response for risk managers and investigators have been identified (Hoppes et al.):
- Operate within appropriate legal authorities (e.g., federal, state).
- 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. Leadership from risk management is critical to ensure that evaluation, prioritization, and action regarding events are carried out effectively, including an immediate response addressing appropriate disclosure and the needs of the patient and their caregiver(s) (seeCommunicating with Patients after an Event: Do's and Don'ts andCommunicating with Patients after an Event: Handling Reactions for more information). Ambulatory care facilities can use ECRI'sRespectful Management of Serious Adverse Events Checklist to track their event response.
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 (JCI) states that appropriate responses for accredited organizations and certified programs include the following activities (JCI):
- 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 may 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.)
Analysis
Without analysis and follow-up, event reporting is of little or no value. However, many facilities 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 (RCA), focusing on systems and processes. RCA is one of the most common forms of comprehensive systematic analysis used for identifying the causal and contributory factors that underlie sentinel events, if they do the following (JCI):
- 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 investigate 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.
For more information on RCA, see the following ECRI resources:
Another common methodology—one that is possibly underutilized or confused for RCAs—is apparent cause analysis, which is often used for medium- or low-risk safety events and does not require the same level of resources as RCAs. SeeComparison: Root Cause and Apparent Cause Analyses for more information.
Other tools and methodologies are also permissible, such as:
- Human factors analysis and classification system
- After action reviews
- Debriefs and huddles
- SWARMing
- Concise incident analysis
Regardless of the analysis method, 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.)
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 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 and resident safety, quality review, or peer-review document as indicated.
Provide Feedback
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 reporter actions and facilitates learning; lack thereof is a major barrier to reporting and response. (AHRQ) Feedback also motivates reporting future incidents; there is a risk that reporters who do not receive feedback will eventually stop reporting, even when mandatory. (PSQCWG)
The World Health Organization states that providing reporters with timely feedback is a best practice to promote improvement through learning (Larizgoitia et al.). In addition to a reporter receiving timely feedback, managers should share reports with their staff. (Pham et al.) Effective communication strategies to help encourage additional reports from frontline staff include the following (Marks et al.; McKaig et al.; Mansfield et al.):
- Stories posted on the organizational intranet
- Annual patient and resident safety fair events
- Periodic action reports from the patient and resident safety committee
- Safety events highlighted in monthly publications or quarterly newsletters
- Sharing of lessons among departmental representatives and colleagues
- This could be achieved by making 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.
- Provision of information to frontline staff by nursing and medical leadership
- Monthly "good catch" awards to reporters
Centers for Medicare and Medicaid Services
42 CFR §416.43(a)(2). Ambulatory surgical centers (ASCs) must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC as part of its quality assurance and performance improvement program.
42 CFR §416.43(c)(2)(3). Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time. The ASC must also implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies.
42 CFR §416.48(a)(1). Adverse drug reactions must be reported to the physician responsible for the patient and must be documented in the patient's medical record.
Patient Safety and Quality Improvement Act
Through PSQIA, federally designated PSOs offer a protected legal environment in which providers in all states and U.S. territories may share information about patient and resident 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 and resident 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 and resident safety activities. For more information, see ECRI's
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. (42 USC §§ 299b-21 to b-26)
U.S. State Law
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's 2015 report, 27 states and the District of Columbia have adverse event reporting systems, all of which are mandatory, with the exception of Oregon. Many of these 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. (Hanlon et al.)
See
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.
Joint Commission
In its
Sentinel Event Policy and Procedures, 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, wrong-site or wrong-patient surgery, severe maternal morbidity, sexual and physical abuse/assault, and infant abduction or wrongful discharge. (Joint Commission "Sentinel")
The Joint Commission strongly encourages, but does not require, reporting to the organization of any safety events that meet the definition of sentinel event. However, the Joint Commission's accreditation standards oblige accredited organizations to provide internal systems for reporting safety issues, near misses, hazardous conditions, and sentinel events as part of a system-wide safety program (Joint Commission "Comprehensive"):
- Leadership standard LD.03.09.01, addresses the responsibility of leaders to establish an organization-wide safety program; to proactively explore potential system failures; to analyze and take action on problems that have occurred; and to encourage the reporting of adverse events and close calls ("near misses"), both internally and externally.
- Medication management standard MM.07.01.03 requires the organization to respond to actual or potential adverse drug events, significant adverse drug reactions, and medication errors.
Accreditation Association for Ambulatory Health Care
The Accreditation Association for Ambulatory Health Care addresses event reporting through several standards from peer review, medical emergency, administrative, medication safety, and behavioral health perspectives. Accreditation coordinators can work with risk managers and medical staff to maintain compliance, especially as standards are updated, and offer strategies for quality improvement, as needed.
Standard 2.III.C.4. All clinical incidents are reviewed in accordance with the organization's peer review policies and procedures.
Standard 3.E.e. Orientation and training, according to position description, are provided to all staff, including the reporting of adverse incidents under the risk management program.
Standard 4.G. One of the following is in place in the event of an emergency or unplanned outcome for which hospitalization is indicated to evaluate and stabilize the patient:
- A written transfer agreement for transferring patients to a nearby hospital
- A written policy of credentialing and privileging physicians and dentists who have admitting and similar privileges at a nearby hospital
- A written agreement with a physician or provider group with admitting privileges at a nearby hospital
- A detailed written procedural plan for medical emergencies
Standard 5.II.D. The organization's risk management program and/or policies define incidents and adverse incidents.
Standard 5.II.E. Incidents and adverse incidents are reviewed and corrective actions are taken as needed.
Standard 11.F. Procedures are in place to prevent errors from look-alike, sound-alike, and high-alert medications, if present.
Standard 17.S.2. The behavioral health service has a system is in place for documenting and reporting incidents and adverse incidents consistent with organizational policies and AAAHC Standards.
