The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, or severe temporary harm. Sentinel events are debilitating to both patients and health care providers involved in the event. The term sentinel refers to a system issue that may result in similar events in the future. The National Quality Forum defined the term serious reportable events as “preventable, serious, and unambiguous adverse events that should never occur.” These events are also termed as never events. Previously, sentinel events included events that occurred only to patients. In 2013, the concept was expanded to include “harm events” to the staff, visitors, and vendors on the organization’s premises.
Serious reportable events can be classified into the following categories:
- Care management
- Patient protection
- Radiologic event
- Criminal events
Hospitals vary in their definitions, investigations, and reporting of sentinel events. Examples of sentinel events from the Joint Commission include the following:
- Suicide during treatment or within 72 hours of discharge
- Unanticipated death during the care of an infant
- Abduction while receiving care
- Discharge of an infant to the wrong family
- Hemolytic transfusion reaction due to blood transfusion with major blood group incompatibilities
- Surgery on the wrong individual or wrong body part
- Retained foreign body after surgery
- Severe neonatal jaundice (bilirubin >30 mg/dl)
- Prolonged fluoroscopy with very high or inappropriate dose or to the wrong site
- Fire during direct patient care caused by hospital equipment
- Intrapartum maternal death
- Unanticipated severe maternal morbidity resulting in permanent or severe temporary harm
- Delay in treatment
- Medication error
- Criminal event
Response to a Sentinel Event
The hospital must review all sentinel events. All accredited hospitals are encouraged but not obligated to report to the Joint Commission every sentinel event. Since 2007, about 800 sentinel events are reported to the Joint Commission every year according to their summary data of sentinel events. Sentinel events occur in every healthcare setting. The great majority occur in a medical/surgical hospital setting, followed by psychiatric hospitals (including psychiatric units and clinics) and emergency departments. More than three-fourths of them are voluntarily reported to the agency. The most common sentinel events are wrong-site surgery, foreign body retention, and falls. They are followed by suicide, delay in treatment, and medication errors. The risk of suicide is the highest immediately following hospitalization, during the inpatient stay, or immediately post-discharge. Fortunately, infant discharge to the wrong family has been reduced to zero. Hemolytic transfusion reactions due to major blood group incompatibilities are still reported with an incidence of 7-9 per year.
An appropriate response to a sentinel event may include the following:
- Stabilize the patient
- Disclose the event to the patient and family
- Provide support for the family and staff involved
- Notification to the hospital leadership
- Immediate investigation
- Comprehensive systematic review
- Root cause analysis (RCA) for identifying the causal and contributory factors
- Strong corrective actions to eliminate the root cause and prevent similar future events
- Establish a timeline for the implementation of corrective actions
- System improvement
Issues of Concern
Sentinel Event Policy
All healthcare organizations should have a policy for responding to a sentinel event. In 1996, the Joint Commission instituted a formal sentinel event policy. It partners with hospitals that have experienced a sentinel event in the investigation, analysis, and development of corrective action plans. The policy has the following goals:
- Improve patient care and prevent such safety events in the future
- Analyze the root causes that contributed to the sentinel event (cultural, latent, and active failures), and develop strong, actionable plans
- Enhance general awareness and disseminate the learnings about patient sentinel events, root factors, and mitigation strategies
- Maintain the trust of the public, staff, and hospitals that patient safety is a topmost priority
Sentinel Event Database
The Joint Commission collects and analyzes the data from the sentinel events reviewed and reported by the organizations. The de-identified data helps in general awareness and dissemination of error prevention strategies to all hospitals. The Joint Commission’s website provides resources on sentinel events, statistics, webinars, and quick safety tips.
Reporting a Sentinel Event to the Joint Commission
Reporting a sentinel event to the Joint Commission is voluntary. The advantages of reporting the sentinel event include:
- The lessons learned from the sentinel event increase the awareness of the potential sentinel events, root causes, and strategies for prevention. Other hospitals and organizations can learn from the Joint Commission’s sentinel event database.
- Self-reporting allows consultation with Joint Commission staff for the systematic review and root cause analysis of the sentinel event and the development of an action plan.
- It reinforces the hospital’s message to the public and staff regarding its culture of safety.
Required Response to a Reviewable Sentinel Event
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. Various root causes can be related to communication, equipment, environmental, human, process, staff, supervisory, team, and culture. Several attempts to improve the RCA process have been developed to formulate effective solutions. However, a recent study showed that most of the proposed solutions were weaker actions that were unlikely to reduce the event recurrence.
The National Patient Safety Foundation developed guidelines to standardize the RCA process and direct organizations for improvement efforts. They emphasized that action steps are needed after the analysis is completed and renamed them as root cause analysis and action (RCA2). After the cause is identified, solutions to the problem or error should be recognized and implemented. RCA2 differs from other patient safety tools like the failure mode effect analysis (FMEA) and the situation background assessment recommendation (SBAR). FMEA is a systematic, proactive method for identifying potential risks and assessing their impact before harm has occurred. SBAR is a framework for communication between team members about a patient's condition.
An RCA2 must be thorough and credible. The sequential steps in an RCA2 are:
- Identifying multidisciplinary team members for RCA2
- Gathering all the relevant information
- Organizing the collected information
- Identifying the root cause
- Developing a strong action plan
An interprofessional team requires individuals with leadership involved in the process under review, helping for an effective analysis. It should also include patients or family representatives when appropriate. All the critical information is collected by individual and group interviews, medical records, and literature review. Various tools like flow charts, Pareto charts, affinity diagrams, and fishbone diagrams are used to visualize and organize information. The Pareto principle is based on the 80-20 rule, that 80% of problems are due to 20% of the contributing causes. A Pareto chart helps in prioritizing quality improvement efforts by identifying the areas with maximal potential impact. A Pareto chart is like a frequency plot to understand the variability of continuous measures. The flowchart breaks down the sequential steps of a complicated process and potential steps to make improvements. For instance, a flowchart can help improve the workflow, eliminate waste, and improve throughput. A fishbone diagram (also known as the Ishikawa diagram or cause and effect diagram) is a quality improvement tool that helps organize the different potential root causes that contribute to an outcome. It can be used in categorizing the various causes (e.g., process, people, policies, equipment, materials). It does not identify the frequency of the occurrences. Affinity diagrams help organize brainstormed ideas into groups. Specific safety solutions categories (training, policy, counseling, compliance check, institutional, information technology, physical environment, form/paperwork) can be developed to prevent future adverse events.
The action hierarchy of RCA2 helps in identifying the corrective actions that will have the strongest effect on an effective and sustained system change. More strong actions require less reliance on human factors and memory. Action strengths are known to be based on the principles of human factors. The most effective actions accommodate or control the limitations of human behavior. It also involves how people interact with systems, tasks, tools, and the environment through using design and standardization. Stronger actions should be prioritized to sustain the system change. Things like forcing functions, barcodes for medication administration, process or equipment standardization, pre-procedural timeout with all members, and simplification of the process are examples of stronger actions. Checklists serve to force improved function and utilize the principles of human factor engineering.
The mental health environment of the care checklist was developed by Veteran Affairs of the USA in 2007. It is comprised of environmental modification strategies in psychiatric rooms and restrooms to reduce inpatient suicide rates. Some of the checklist components include reducing pointed objects, minimizing anchoring points, and decreasing fixtures. The checklist has been found to have a sustained effect in decreasing inpatient suicide. Using a whiteboard in the operating room and using a red marker for the surgical site are intermediate corrective action examples. Two independent nurses checking the dose of a medication is another example of intermediate corrective action. Simulation training and education is an example of weak corrective action. The action plan should be specific. It should identify the person responsible, timelines, oversight, pilot testing (if applicable), and strategies to measure the actions' effectiveness. The action plan is submitted online to the Joint Commission and may include an onsite visit by the surveyor. The Joint Commission determines the acceptability and follow-up plan. The hospital has the freedom to reexamine and challenge any ruling that may not improve patient care.
One of the most critical surgical safety measures is the timeout process, which involves a pause before the surgery commences involving all team members. This process occurs before surgery begins with the patient inside the operating room to ensure that the correct patient, the correct procedure, and the correct site are verified to minimize mistakes. This is part of the Universal Protocol that the joint commission established in 2004. Implementing pre-procedural time-out with all team members is an example of strong corrective action. Spinal surgery poses an additional problem as the correct level identification is beyond the Universal Protocol's limits. It is recommended that the surgeon develops and implements a patient-specific protocol by which he can correctly identify the level to be operated on. Most of the techniques used are learned at the resident and fellow level; however, deficiencies during the training have been noted. Specific training sessions on clinical guidelines and review of wrong-site surgery cases may help reduce its occurrence.
Sentinel Event Measure of Success (SEMOS)
SEMOS is a quantifiable measure to evaluate if the action plan was effective and sustained. It has a numerator and denominator. The organization follows up on the data via chart audit and observation to measure compliance. Every organization should have a clear framework for reporting and responding to a sentinel event that is non-punitive, fosters teamwork, and promotes a just culture.
Enhancing Healthcare Team Outcomes
Every healthcare organization should have a stepwise crisis management plan for the effective and respectful management of a sentinel event. The proper disclosure of adverse events to patients with the involvement of risk management is required. Several states mandate full disclosure of errors. The goal of RCA2 is to identify and mitigate system errors and prevent future occurrences. A collaborative interprofessional team approach is needed for a successful and timely implementation. Strong actions help in standardizing and simplifying the workflow process. The process aims at continuous improvement and promotion of patient and family-centered care. It is a step towards enhancing the organizational culture of safety and promoting a just, non-punitive, and fair culture.
Effective second victim programs help in providing support and education to the staff. Patient safety organizations can provide guidance and actionable recommendations to improve patient safety in the hospital environment. They provide a toolkit for optimal communication and resolution. They can also help to disseminate the lessons learned from the sentinel events.