Every day, healthcare systems face the critical challenge of ensuring patient safety. Adverse events, unfortunately, are a reality, leading to injuries for thousands annually. While often associated with hospital settings, home care environments are also susceptible. Unique factors in home care, such as limited staff supervision, communication complexities, and reliance on patient and family involvement, can increase the risk of serious incidents. Some of these incidents may even be classified as sentinel events, as defined by The Joint Commission. Understanding and effectively utilizing Root Cause Analysis In Health Care Tools And Technique 2010 principles remains crucial for preventing recurrence and improving patient outcomes.
Understanding Sentinel Events in Healthcare
The Joint Commission, a leading healthcare accreditation organization, defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof” (The Joint Commission, 2012). This definition encompasses events where recurrence carries a significant risk of serious adverse outcomes. Reviewable sentinel events, specifically, are defined as incidents resulting in “an unanticipated death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition” (The Joint Commission, 2012). Permanent loss of function can include impairments in sensory, motor, physiological, or intellectual abilities that necessitate ongoing treatment or lifestyle adjustments that were not present at the start of care.
The Joint Commission’s sentinel event policy extends beyond patient incidents. It includes a subset of events that are reviewable regardless of death or serious injury, even encompassing certain “harm events” to staff, visitors, or vendors within the healthcare organization’s premises (The Joint Commission, 2012). This broad scope highlights the importance of a robust system for identifying and responding to potential safety risks across the entire healthcare ecosystem.
The Power of Root Cause Analysis (RCA) in Healthcare Settings
Sentinel events, by their very nature, demand immediate attention and thorough investigation. The Joint Commission mandates that accredited organizations respond to these events with a “thorough and credible root cause analysis [RCA] and action plan” (The Joint Commission, 2013a). Root cause analysis is a systematic approach to uncovering the fundamental factors that contribute to performance variations and adverse events (Anderson et al., 2010). It’s a powerful methodology for enhancing systems, minimizing harm, and proactively preventing the recurrence of adverse events, all while avoiding individual blame. The core objectives of RCA are to answer three critical questions:
- What happened? – Clearly define the event and its immediate consequences.
- Why did it happen? – Identify the contributing and root causes through in-depth investigation.
- What can be done to prevent it from happening again? – Develop and implement effective action plans to mitigate risks and improve systems.
Assembling an Effective RCA Team
Prompt action is essential when a sentinel event occurs. The Joint Commission provides a 45-day timeframe for completing the RCA and developing an action plan. Delaying the process can create unnecessary pressure to meet this deadline. The initial and crucial step in RCA is forming the right team.
An effective RCA team should be multidisciplinary, comprising staff members with direct knowledge of the relevant processes and systems. Leadership involvement is vital to ensure decision-making authority and facilitate the implementation of necessary changes. While input from staff directly involved in the sentinel event can be valuable, decisions on their inclusion should be made carefully, considering potential emotional distress.
The most effective teams are built on voluntary participation and cooperation. Strong listening and communication skills among team members are paramount (Anderson et al., 2010). Members should be motivated, have adequate time for meetings and assignments, and can participate as needed or throughout the entire process.
Every team requires a designated leader and facilitator. Ideal leaders possess organizational authority, event knowledge, and consensus-building skills. The facilitator should have experience in conducting RCAs and managing group dynamics. For optimal efficiency, smaller teams are generally recommended (Croteau, 2010).
Gathering Comprehensive Information for RCA
Collecting relevant information is crucial for the RCA team to accurately define the problem and understand the sequence of events. Witness accounts should be gathered promptly, before memories fade. Reassuring staff about the confidentiality of the RCA process and its non-punitive nature is essential to encourage open and honest participation. Individual interviews can provide unbiased information, and clinicians may feel more comfortable sharing details in private. Group interviews can foster idea exchange and collaborative problem-solving. Utilizing open-ended questions effectively encourages staff to share, clarify, and elaborate on their perspectives.
Beyond interviews, gathering pertinent documentation is vital. This includes medical records, photographs, notes, and communication logs. Relevant policies, procedures, training records, schedules, and staffing information should also be collected. A literature review related to the process under investigation can be beneficial early in the RCA, helping to identify potential root causes, effective strategies, and relevant actions.
If equipment or devices are involved, secure them for examination and gather manufacturer guidelines, usage instructions, and maintenance logs. It’s also important to determine if reporting is required under the Safe Medical Devices Act (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance).
Structuring Information for Effective Analysis
RCAs often involve managing substantial amounts of information. Organizing this information effectively is critical for a successful analysis and ensuring easy access for the team. Tools like team charters, agendas, and project plans can help define objectives, set timelines, assign responsibilities, and keep the team focused. A concise, factual summary of the event, prepared early in the process, will maintain team focus. Timelines and flowcharts enhance understanding and clarify interdependencies between different disciplines.
Visual tools such as flow charts, affinity charts, or fishbone diagrams can effectively organize information. Flow charts illustrate processes as designed versus how they are actually implemented, revealing potential process deviations. Fishbone diagrams (also known as Ishikawa diagrams or cause-and-effect diagrams) highlight contributing factors and their potential causes. Affinity charts help categorize potential causes into logical groupings. The Joint Commission provides valuable tools, including an RCA framework and action plan templates, to ensure a comprehensive event review and organized findings. These resources are accessible at http://www.jointcommission.org/sentinel_event.aspx.
Identifying Contributing Factors in Healthcare Incidents
Once information is collected and structured, the RCA team begins identifying contributing factors – system failures that lead to negative consequences (Croteau, 2010). These are underlying causes of the event, though not necessarily the primary root cause. The key question in discovering contributing factors is “Why?”
Discussions should focus on system processes and outcomes, not individual behaviors. Examine processes to determine if inherent flaws exist or if process variations contributed to the event. Consider all possible contributing factors. Examples include:
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Human Factors: Consider human limitations and capabilities such as fatigue, distraction, or inattentional blindness. (See Box 1)
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Patient Assessment: Evaluate timeliness, accuracy, connection to the care plan, documentation, and communication.
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Equipment: Assess availability, functionality, condition, and appropriateness of maintenance and calibration.
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Environment: Consider lighting, accessibility, privacy, and overall safety.
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Information: Evaluate accessibility, accuracy, and completeness of relevant information.
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Communication: Analyze technology used, documentation practices, timing, and handoff procedures.
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Training/Competency: Review education, scope of practice, competency assessments, qualifications, and training effectiveness.
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Procedural Compliance: Evaluate adherence to procedures, availability of policies and procedures, and any barriers to compliance.
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Care Planning: Assess individualization and effectiveness of care plans.
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Organizational Culture: Examine the organization’s response to risk and safety issues, communication of safety priorities, and adverse outcome prevention efforts.
The Joint Commission’s “Minimum Scope of Root Cause Analysis for Specific Types of sentinel events” can guide teams in thoroughly examining contributing factors (The Joint Commission, n.d.). Encourage open discussion and idea sharing without criticism. Whiteboards or flip charts can be used to visually group ideas and ensure all team members can see and contribute to the process. Once all potential contributing factors are identified, the team can focus on pinpointing the root cause.
Determining the Root Cause: The “5 Whys” Technique and Beyond
To identify the root cause, the team must delve deeper into the contributing factors until the most fundamental causal factor is revealed. Success hinges on maintaining focus on system issues rather than solely on human error. When human error is involved, the underlying cause of the error must be identified and addressed. It’s the system failures that enable errors, not the errors themselves, that need correction to prevent recurrence.
Various tools can aid in this process. The “Five Whys” technique is a simple yet effective method (Anderson et al., 2010). Start by listing a contributing factor and then ask “Why?” The answer becomes the next factor, and the question “Why?” is asked again. This iterative process continues until no new answers emerge, revealing the root cause.
Consider the example of a wound infection linked to a retained dressing.
- Contributing Factor: A retained dressing was present. Why?
- Answer 1: The dressing count was not reconciled. Why?
- Answer 2: Clinician A was unable to reconcile the count. Why?
- Answer 3: Clinician B had not documented the count. Why?
- Answer 4: Clinician B forgot to document. Why?
- Answer 5: Clinician B did not have her laptop during the visit and could not document immediately.
In this case, several “Whys” were needed to uncover the root cause: a delay in documentation due to lack of immediate access to necessary tools.
To further validate the identified root cause, consider these questions (Croteau, 2010):
- If the cause were absent, would the problem likely have occurred?
- If the cause is corrected, is the problem likely to recur due to the same factor?
- If the cause is corrected, is a similar condition likely to recur?
If the answer to each question is “No,” then the root cause has likely been identified. In the dressing example, if the clinician had immediate documentation access, forgetting to document would be less likely, and similar issues would be less probable.
It’s crucial to avoid stopping the “Why” questioning prematurely to ensure the true root cause is found. The team should also evaluate if the identified cause is actionable to prevent recurrence (Croteau, 2010). If it is, it might be acceptable to conclude the questioning. Recognize that multiple root causes can exist, and interactions between them can be the actual triggers for events (The Joint Commission, 2013b). Correcting only one cause may not prevent recurrence; all root causes must be addressed.
The root cause statement should be concise and clear. The Veteran’s Health Administration (n.d.) suggests these guidelines for developing root cause statements:
- Clearly demonstrate cause and effect.
- Avoid negative or blaming language.
- Recognize that every human error has a preceding cause.
- Procedure violations are not root causes but have underlying causes.
- Failure to act is only a root cause if a pre-existing duty to act existed.
Developing Effective Action Plans for Prevention
After determining the root cause(s), the team focuses on developing strategies to minimize the risk of recurrence. While the goal is to prevent event repetition, it’s important to acknowledge that failures and errors can still occur. Strategies should aim to minimize the chance of process failures reaching patients and to mitigate the impact if they do (The Joint Commission, 2010). Actions focused on system and process improvements, rather than individual performance, are most effective in preventing recurrence.
Action plans should be concrete, easily understood, and directly linked to the root cause or contributing factors. Make the safest option the easiest option to reduce workarounds. The plan must clearly define responsibilities for implementing each action and establish a timeline for completion. Pilot testing may be included in action plans. Strategies for measuring the effectiveness of each action should also be determined.
Actions vary in their effectiveness. The National Center for Patient Safety (n.d.) provides a Hierarchy of Actions, categorizing actions by strength:
Stronger Actions:
- Physical changes to the work environment
- Forcing functions (making it impossible to make an error)
- Process simplification
- Standardization
Intermediate Actions:
- Increased staffing
- Software modifications
- Reduced distractions
- Checklists and cognitive aids
- Read-back procedures
- Elimination of look-alike/sound-alike medications
- Enhanced documentation or communication
- Redundancy
Weaker Actions:
- Double checks
- New procedures
- Training
- Warnings
Once actions are proposed, consider cost, resources, long-term sustainability, and implementation barriers. Buy-in from leadership and frontline staff is crucial. Individuals assigned action items must take ownership.
Reporting and Sharing RCA Findings
Sharing RCA results with leadership is essential. Reports should include a concise event description, the analysis process, identified root causes and contributing factors, and the action plan. Sharing lessons learned with all staff demonstrates that RCAs are not punitive but a mechanism for process improvement and enhanced patient safety. Transparency fosters a culture of safety and continuous learning.
RCA is a valuable tool for identifying the systemic causes of sentinel events and adverse outcomes. The shift from blaming individuals to focusing on systems represents a significant improvement in healthcare safety practices. RCA can be applied whenever a home care agency experiences a serious adverse event. (See Figure 1) It can also be used proactively to analyze near misses – asking “what might have happened?” Whether reactive or proactive, RCA empowers healthcare organizations to improve systems, refine processes, and ultimately, ensure safer patient care.
RCA Case Study: Preventing Retained Foreign Objects
A 75-year-old woman was readmitted to the hospital with a wound infection after abdominal surgery. Negative pressure wound therapy (NPWT) was initiated and later transitioned to wet-to-dry dressings before hospital discharge. Upon admission to home care, NPWT was restarted by Nurse 1. Crucially, information about the initial packing count was not communicated to the home care agency.
Later that day, the patient reported NPWT malfunction. Nurse 1 identified a device defect and temporarily packed the wound with wet-to-dry dressings, documenting nine gauze pads in the electronic record. On January 9th, Nurse 2 removed seven gauze pieces, repacked with foam, and initiated a new NPWT system, but did not reconcile the count discrepancy. This missed reconciliation went unnoticed during subsequent visits.
On January 11th, Nurse 1 removed the NPWT dressing and discovered an additional gauze pad within the wound bed. The patient reported increased pain and a low-grade fever. The nurse promptly reported these findings, and the patient was seen by the surgeon. A wound culture confirmed infection, and antibiotics were started.
This case triggered an RCA due to the retained foreign object, a sentinel event. A timeline was created, and records were reviewed, revealing the lack of packing count communication from the hospital as a critical initial point of failure. The inability to pinpoint exactly when the gauze was retained highlighted systemic weaknesses in communication and reconciliation processes.
The RCA team, comprising leadership, medical advisors, risk management, and nursing staff, investigated the event. An immediate alert was sent to staff emphasizing adherence to packing reconciliation procedures. The team used an affinity chart to identify potential causes and contributing factors. (See Figure 2)
Contributing factors included:
- Lack of standardized wound packing and cover dressing documentation.
- Limited availability of single-length packing materials.
- Increased risk with multi-piece dressings.
- Inconsistent wound assessment practices.
- Large, draining wound making dressing saturation and retention more likely.
- Inconsistent packing count reconciliation due to a new process still being integrated.
The team determined the root cause: Cover dressings were not included in the count and reconciliation process, increasing the risk of cover dressings being mistaken for packing in large, draining wounds, leading to retained foreign bodies. This statement clearly establishes a cause-and-effect relationship, focusing on a system issue, not individual error.
Risk reduction actions implemented included:
- Policy Change: Mandating packing counts on referrals involving packed wounds.
- Procedure Revision: Standardizing wound packing processes to include counting both packing and cover dressings, limiting multi-piece packing, documenting dressing materials externally, and requiring immediate supervisor notification for count discrepancies.
- Equipment Availability: Providing dressing kits with single-length Kerlix for NPWT cases and upgrading wound exploration flashlights.
- Communication Enhancements: Developing patient/family dressing change logs, standardizing documentation, and exploring software alerts. Adherence is monitored through record reviews.
- Training and Competency: Educating staff on the rationale for counting all dressing materials and utilizing simulation training for NPWT dressings and new documentation.
These actions incorporated stronger measures like simplification, forcing functions (software alerts), and simulation training. Lessons learned were shared across the organization, emphasizing the importance of standardized handoff procedures between care settings to enhance patient safety.
This case study underscores the critical role of RCA in healthcare risk management. Healthcare professionals skilled in RCA offer invaluable expertise, driving improvements in patient safety and fostering a culture of continuous quality improvement.
REFERENCES
Anderson, J. E., Kodner, C., Schulman, K. A., & Shortell, S. M. (2010). Improving patient care: The implementation of change in health care. Jossey-Bass.
Croteau, R. J. (2010). Root cause analysis in health care: Tools and techniques. Joint Commission Resources.
Institute of Medicine. (1999). To err is human: Building a safer health system. National Academies Press.
The Joint Commission. (2010). Sentinel event policy and procedures.
The Joint Commission. (2012). Comprehensive accreditation manual for hospitals.
The Joint Commission. (2013a). Accreditation process guide.
The Joint Commission. (2013b). Sentinel event statistics: Cumulative root cause analysis data.
The Joint Commission. (n.d.). Minimum scope of root cause analysis for specific types of sentinel events. Retrieved from http://www.jointcommission.org/sentinel_event.aspx
Veteran’s Health Administration. (n.d.). Root cause analysis tools.
