Tessa Quinn
Adverse events in hospitals refer to instances where patients experience harm as a result of their medical treatment, which is contrary to what is expected of healthcare services. While there is no standardized national reporting system for adverse events, some states and organizations have implemented mandatory reporting requirements for hospitals. Additionally, voluntary reporting systems are prevalent in hospitals, with frontline personnel playing a crucial role in identifying and reporting safety hazards. These reporting systems are designed to improve patient safety, identify risks, and develop strategies to prevent future adverse events. The effectiveness of reporting programs is influenced by factors such as ease of use, timely feedback, and confidentiality protections. While underreporting remains an issue, organizations like the Institute of Medicine (IOM) and the National Quality Forum (NQF) have advocated for systematic and standardized reporting of adverse events to facilitate consistent data collection and improve patient outcomes.
| Characteristics | Values |
|---|---|
| Reporting adverse events | Required in some states, but no national reporting |
| Classification systems | International Classification of Diseases (ICD), Current Procedural Terminology (CPT) |
| ICD use case | Classifying morbidity data, medical records indexing, medical care review, health statistics, billing for hospital services |
| CPT use case | Uniform language to describe medical, surgical, and diagnostic services, nationwide communication |
| CPT use cases (continued) | Used in Medicare and Medicaid for billing |
| Adverse events | Lapses in patient safety, unintended consequences of a complex healthcare system |
| Adverse events causes | Errors, substandard care, known side effects, unexpected complications |
| Adverse events consequences | Long-term and serious implications for patient health |
| Sentinel events | Serious adverse events that require immediate investigation and response |
| Sentinel Event Policy | Adopted by The Joint Commission in 1996 to help hospitals improve safety and learn from adverse events |
| Root cause analysis (RCA) | Required by The Joint Commission under certain circumstances, such as sentinel events |
| Risk assessment | Prospective risk assessment every 18 months, typically through Failure Mode and Effects Analysis (FEMA) |
| Patient Safety Quality Improvement Act (PSQIA) | Established in 2005 to collect, aggregate, and analyze adverse event information |
| PSO program | Collects and aggregates large amounts of data for de-identified analysis to educate healthcare providers |
| Patient Safety Primer Detection of Safety Hazards | Provides a detailed discussion of methods to identify errors and latent safety problems |
| Voluntary event reporting systems | Generally confidential, with legal protection unless professional misconduct or criminal acts occurred |
| Incident reports | Critical to identifying risks, investigating circumstances, and developing risk mitigation strategies |
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What You'll Learn
Adverse event reporting systems: voluntary vs mandatory
While patients admitted to the hospital expect that the medical care they receive will improve their health, adverse events in hospitals are not uncommon. Adverse events refer to instances where patients are harmed as a result of their medical treatment or care. These events can be caused by errors, substandard care, known side effects, or unexpected complications.
Despite nationwide efforts to improve patient safety, reducing patient harm remains a challenge. Lapses in patient safety are a significant healthcare quality issue, causing tens of thousands of preventable deaths each year in the United States. To address this, several states and entities have mandated the reporting of serious adverse events, also known as "never events." However, there is no standardized national reporting system, and even in states with mandatory reporting, these events are often underreported due to ambiguity and uncertainty about what constitutes a reportable incident.
To promote consistent reporting, it is desirable to link adverse events with a national, standardized coding system such as the International Classification of Diseases (ICD) or the Current Procedural Terminology (CPT). The Institute of Medicine (IOM) and the Federal Government's Quality Interagency Coordination Committee have recommended systematic reporting of adverse events. The National Quality Forum (NQF) has also developed a consensus list of 27 serious reportable events to facilitate standardized reporting.
Additionally, voluntary reporting systems play a crucial role in adverse event reporting. The Joint Commission, for example, adopted a Sentinel Event Policy in 1996 to assist healthcare organizations in improving safety and learning from serious adverse events. Organizations are strongly encouraged to report sentinel events, which signal the need for immediate investigation and response. Voluntary reporting raises transparency, promotes a culture of safety, and contributes to the general knowledge base for preventing future incidents.
In conclusion, both voluntary and mandatory reporting systems are essential for addressing adverse events in healthcare. While mandatory reporting provides a framework for consistent and comprehensive data collection, voluntary reporting encourages proactive collaboration, learning, and improvement within the healthcare community. By combining these approaches, healthcare organizations can enhance patient safety, reduce harm, and continuously improve the quality of care they provide.
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Patient harm: adverse and temporary harm events
Patients admitted to the hospital expect their health to improve, but unfortunately, that is not always the case. In some instances, patients are harmed as a result of their medical treatment. Patient harm refers collectively to adverse events and temporary harm events. Adverse events are undesirable clinical outcomes that prolong the patient's stay, cause permanent harm, require life-saving intervention, or contribute to death. Temporary harm events, on the other hand, require medical intervention but do not prolong the patient's stay, cause lasting harm, or require life-sustaining intervention.
Every year, millions of patients experience adverse and temporary harm events as a result of medical care or in a healthcare setting. These events can be caused by errors, substandard care, known side effects, or unexpected complications, and they may or may not be preventable. While most harm events resolve quickly, some have long-term and serious implications for patient health. Common adverse events that may result in avoidable patient harm include medication errors, unsafe surgical procedures, healthcare-associated infections, diagnostic errors, patient falls, pressure ulcers, patient misidentification, unsafe blood transfusions, and venous thromboembolism (blood clots).
Despite nationwide efforts to improve patient safety, reducing patient harm remains a challenge. The Department of Health and Human Services (HHS) is committed to helping its agencies determine the impact of harm events in Federal programs and supports new and existing efforts to improve patient safety. In 2010, OIG reported the first national incidence rate of patient harm events in hospitals, finding that 27% of hospitalized Medicare patients experienced harm in October 2008. More recently, in October 2018, a quarter of Medicare patients experienced adverse events and temporary harm events during their hospital stays. Of these harm events, 43% were deemed preventable and linked to substandard or inadequate care.
To improve patient safety and reduce the occurrence of adverse events, reliable data is needed to identify where and when mishaps occur in the care process. However, there is currently no standardized national reporting system for adverse events, and even in states where reporting is mandatory, these events are often underreported due to ambiguity and uncertainty about what needs to be reported. To address this issue, the Institute of Medicine (IOM) has recommended systematic reporting of healthcare errors and adverse events, and the National Quality Forum (NQF) has been tasked with identifying a standardized list of preventable, serious adverse events to facilitate consistent reporting.
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Sentinel events: immediate investigation and response
Sentinel events are patient safety events that result in death, permanent harm, or severe temporary harm. They are called "sentinel" because they signal the need for immediate investigation and response. Sentinel events are not primarily related to the natural course of a patient's illness or underlying condition. They are usually wrong-site surgery, foreign body retention, and falls, followed by suicide, delay in treatment, and medication errors.
The Joint Commission adopted a formal Sentinel Event Policy in 1996 to help hospitals that experience serious adverse events improve safety and learn from those sentinel events. The Joint Commission partners with hospitals that have experienced a sentinel event in the investigation, analysis, and development of corrective action plans. The Sentinel Event Policy has the following goals: protect the patient, improve systems, and prevent further harm.
Each accredited organization is strongly encouraged, but not required, to report sentinel events to The Joint Commission. The Joint Commission can provide support and expertise during the review of a sentinel event. Reporting raises the level of transparency in the organization and promotes a culture of safety. The reporting organization should prepare and submit a thorough root cause analysis and action plan within 45 days of the sentinel event. The process should commence within 72 hours of the event. The steps in an RCA include identifying the team, information gathering, organizing information, identifying contributing factors, and drilling down to the root cause.
The Joint Commission provides a framework for the RCA. The hospital can utilize this template, consisting of multiple analysis questions and prompts, or utilize a similar framework for identifying the causal factors. The RCA involves repeatedly asking a series of “why” questions until the root systemic causal factor(s) that culminated in the sentinel event is identified. The RCA should focus on vulnerabilities in systems and processes, not on the individual(s). It identifies the risk points and their potential contributions.
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Preventable adverse events: reliable data and standardised reporting
Preventable adverse events are a major healthcare quality problem, causing tens of thousands of deaths each year in the United States alone. These events are unintended consequences of a complex and imperfect healthcare system, where minor mishaps can combine to cause harmful or disastrous results. While most adverse events are resolved quickly, some have long-term and serious implications for patient health.
Despite nationwide efforts to improve patient safety, reducing patient harm remains a challenge. To address this, researchers and healthcare providers need reliable data on adverse events to identify trends and compare various approaches to patient safety. However, there is currently no standardised national reporting system for adverse events, and the existing data suffers from inconsistencies in quality and reporting rates. This lack of standardisation makes it challenging to aggregate data and draw meaningful conclusions.
To improve data consistency and facilitate accurate measurement and monitoring of adverse events, standardised, valid, and reliable definitions and reporting formats are essential. The Institute of Medicine (IOM) and the Federal Government's Quality Interagency Coordination Committee have recommended systematic reporting of healthcare errors and adverse events. The National Quality Forum (NQF) has also developed a list of serious reportable events to facilitate standardised reporting. Additionally, classification systems such as the International Classification of Diseases (ICD) and the Current Procedural Terminology (CPT) can be used to provide uniform language for describing medical services and procedures.
To further enhance data reliability and consistency, factors such as employing dedicated personnel, using simple and structured prompts, and implementing automated data capture and transfer can be utilised. These measures will contribute to accurate data collection and enable more effective prevention and management of preventable adverse events in healthcare settings.
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Incident reports: risk mitigation and patient safety
Incident reporting in healthcare is a critical aspect of patient safety and risk mitigation. It involves collecting data on adverse events and near misses to identify trends, safety hazards, and areas for improvement. While incident reporting systems (IRS) are ubiquitous in hospitals, under-reporting of adverse events is common, with public health researchers estimating that only 10-20% of errors are reported. This under-reporting may be due to several factors, including ambiguity about what constitutes a reportable incident and fear of penalties or retribution.
To address this issue, hospitals should foster a "just culture" that prioritizes patient safety and encourages open and transparent reporting without fear of blame. Leadership, commitment, policies, and practical steps are essential to creating this supportive environment. Healthcare organizations should also provide ongoing training in safety and risk mitigation to help staff identify and report incidents effectively.
Incident reports can be used to initiate investigations and analyses of adverse events, identifying systemic issues and contributing factors. By understanding the root causes of incidents, hospitals can develop interventions and improve processes to mitigate risks and enhance patient safety. This continuous improvement approach aligns with the goal of providing patient-centered care and reducing patient harm.
Additionally, incident reporting can help hospitals reduce costs associated with gaps in staff scheduling, fines for non-compliance, legal suits, and negative publicity resulting from incidents. By encouraging a culture of reporting and learning from incidents, hospitals can identify and address issues proactively, preventing future adverse events and improving the overall quality of care.
In conclusion, incident reports are a vital tool for risk mitigation and enhancing patient safety in healthcare settings. By encouraging a transparent and supportive reporting culture, hospitals can identify trends, implement interventions, and improve processes to mitigate risks and ultimately enhance patient outcomes.
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Frequently asked questions
While adverse event reporting is a staple of the risk management plan in hospitals, there is no standardized national reporting system. A number of states require the reporting of at least some types of adverse events. The Joint Commission mandates that all hospitals employ a voluntary error reporting system.
Adverse events are events in which care results in undesirable clinical outcomes—outcomes not caused by underlying disease—that prolong the patient's stay, cause permanent patient harm, require life-saving intervention, or contribute to death.
Reporting adverse events helps hospitals improve patient safety and learn from past events to prevent further harm. It also helps identify where and when mishaps occur in the care process, allowing hospitals to change processes and reduce the chance of harm.
