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Root-Cause Analysis and Evidence-Based Safety Improvement Plan for Healthcare-Associated Medication Errors in Acute Care Settings

πŸ“… October 3, 2025 ✍️ Bridge Essays ⏱ 9 min read

References

  • Kellogg, K. M., Hettinger, Z., Shah, M., Wears, R. L., Sellers, C. R., Squires, M., & Fairbanks, R. J. (2020). Our current approach to root cause analysis: Is it contributing to our failure to improve patient safety? BMJ Quality & Safety, 29(11), 1991-1998. https://doi.org/10.1136/bmjqs-2019-010186
  • Peerally, M. F., Carr, S., Waring, J., & Dixon-Woods, M. (2022). The problem with root cause analysis: A systematic review. BMJ Quality & Safety, 31(8), 589-598. https://doi.org/10.1136/bmjqs-2021-013726
  • Hibbert, P. D., Molloy, C. J., Hooper, T. D., Wiles, L. K., Runciman, W. B., Lachman, P., Muething, S. E., & Braithwaite, J. (2021). The application of the Global Trigger Tool: A systematic review. International Journal for Quality in Health Care, 33(1), 1-19. https://doi.org/10.1093/intqhc/mzaa115
  • Vincent, C., & Amalberti, R. (2023). Creating a culture of safety in healthcare: Current challenges and future opportunities. BMJ Quality & Safety, 32(1), 1-4. https://doi.org/10.1136/bmjqs-2022-015527
  • Rodziewicz, T. L., Houseman, B., & Hipskind, J. E. (2024). Medical error reduction and prevention. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK499956/

NURS4035: Improving Quality of Care and Patient Safety

Assessment 2: Root-Cause Analysis and Safety Improvement Plan

Course: NURS4035 – Improving Quality of Care and Patient Safety
Program: Bachelor of Science in Nursing (BSN)
School: School of Nursing and Health Sciences, Capella University
Assessment Type: Written Analysis and Safety Plan
Estimated Time to Complete: 10-15 hours


Assessment Overview

Patient safety incidents and sentinel events represent critical opportunities for healthcare organizations to learn, improve systems, and prevent future harm. This assessment challenges you to conduct a comprehensive root-cause analysis (RCA) of a safety concern or sentinel event within a healthcare setting and develop an evidence-based safety improvement plan to address the identified root causes.

You will demonstrate your understanding of systematic analysis techniques, evidence-based quality improvement strategies, and the development of actionable safety improvement plans. This assessment emphasizes the importance of moving beyond individual blame to identify systemic factors that contribute to patient safety events.


Assessment Instructions

Scenario

You are a nurse leader or quality improvement team member at a healthcare organization that has experienced a patient safety incident or sentinel event. Your leadership has tasked you with conducting a thorough root-cause analysis and developing a comprehensive safety improvement plan to prevent similar occurrences in the future.

Select ONE of the following safety concerns or sentinel events for your analysis:

  1. Medication Error – Wrong medication, wrong dose, wrong route, or wrong patient
  2. Healthcare-Associated Infection (HAI) – CAUTI, CLABSI, surgical site infection, or C. difficile
  3. Patient Fall with Injury – Fall resulting in fracture, head trauma, or other serious injury
  4. Pressure Injury Development – Stage III or IV pressure injury acquired during hospitalization
  5. Delayed or Missed Diagnosis – Failure to recognize or act on critical findings
  6. Surgical Error – Wrong-site surgery, retained foreign object, or procedural complication
  7. Communication Failure – Handoff error, critical test result not communicated, or care coordination breakdown

You may draw from your own clinical experience, use a hypothetical but realistic scenario, or research a published case study. However, do NOT use actual patient names or identifying information to maintain confidentiality and HIPAA compliance.


Part 1: Root-Cause Analysis (3-4 pages)

Conduct a systematic root-cause analysis of your selected safety concern or sentinel event. Your analysis should address the following:

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A. Event Description and Context (1 page)

  • Provide a detailed description of the safety incident or sentinel event
  • Describe the healthcare setting, patient population, and relevant clinical context
  • Outline the sequence of events leading up to and following the incident
  • Identify who was affected and the extent of harm or potential harm
  • Include the immediate response to the event

B. Systematic Analysis of Contributing Factors (2-3 pages)

Use a structured approach (such as the Five Whys, Fishbone Diagram, or Systems Analysis) to identify contributing factors across multiple categories:

Human Factors:

  • Communication breakdowns (handoffs, team communication, documentation)
  • Training and competency gaps
  • Fatigue, workload, or staffing issues
  • Individual knowledge or skill deficits

System Factors:

  • Workflow processes and procedures
  • Technology and equipment failures or limitations
  • Physical environment and facility design
  • Resource availability

Organizational Factors:

  • Policies, protocols, and procedures
  • Safety culture and leadership support
  • Quality monitoring and surveillance systems
  • Organizational priorities and resource allocation

External Factors:

  • Regulatory requirements
  • Industry standards and best practices
  • Patient and family factors
  • Sociocultural considerations

C. Root Cause Identification

Based on your analysis, explicitly identify 2-3 root causes that fundamentally contributed to the safety event. Categorize each root cause using the following framework:

  • HF-C: Human Factor – Communication
  • HF-T: Human Factor – Training/Competency
  • HF-F/S: Human Factor – Fatigue/Scheduling/Staffing
  • E: Environment/Equipment
  • R: Rules/Policies/Procedures
  • B: Barriers (to implementation or compliance)

Explain why these are root causes rather than simply contributing factors. Root causes represent the deepest systemic issues that, if addressed, would prevent or significantly reduce the likelihood of recurrence.

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Part 2: Evidence-Based Strategies (2-3 pages)

A. Literature Review and Best Practices

  • Identify and analyze evidence-based strategies from current nursing and healthcare literature that address the root causes you identified
  • Cite at least 4-5 peer-reviewed sources published within the last 5 years (2020-2025)
  • Discuss what the evidence reveals about effective interventions for similar safety concerns
  • Include relevant data, statistics, or outcomes that support the effectiveness of proposed strategies

B. Application to Your Scenario

  • Explain how the evidence-based strategies specifically apply to your identified safety concern
  • Discuss the feasibility and appropriateness of each strategy for your healthcare setting
  • Address potential barriers to implementation and how they might be overcome
  • Consider interdisciplinary collaboration and stakeholder engagement needs

Part 3: Safety Improvement Plan (3-4 pages)

Develop a comprehensive, actionable safety improvement plan that includes:

A. Intervention Strategies

For each root cause identified, propose specific interventions using the E-C-A framework:

  • E (Eliminate): Interventions that eliminate the hazard entirely (e.g., remove high-risk equipment, discontinue high-risk process)
  • C (Control): Interventions that add controls or safeguards (e.g., checklists, technology alerts, double-checks, education, process redesign)
  • A (Accept): Interventions that acknowledge but accept the risk (generally discouraged; use only when E or C is not feasible)

Note: Prioritize “Eliminate” and “Control” strategies. Minimize or avoid “Accept” interventions as they do not truly address safety concerns.

B. Implementation Plan

For each proposed intervention:

  • Describe specific action steps for implementation
  • Identify responsible parties and stakeholders
  • Provide a realistic timeline (short-term: 0-3 months, medium-term: 3-6 months, long-term: 6-12+ months)
  • Outline required resources (personnel, technology, financial, educational)

C. Goals and Expected Outcomes

  • Define measurable goals for the safety improvement plan using SMART criteria (Specific, Measurable, Achievable, Relevant, Time-bound)
  • Describe expected outcomes in terms of process measures, outcome measures, and balancing measures
  • Explain how success will be evaluated and monitored
  • Discuss plans for sustainability and continuous improvement

D. Resource Considerations

  • Identify existing organizational resources that can be leveraged (e.g., quality improvement teams, safety committees, electronic health record capabilities, staff expertise)
  • Describe any new or additional resources needed for successful implementation
  • Consider budget implications and potential cost-benefit analyses
  • Address potential resource constraints and alternative approaches

Assessment Requirements

Format and Length

  • Total Length: 8-11 pages (excluding title page and references)
  • Font: Times New Roman, 12-point
  • Spacing: Double-spaced
  • Margins: 1-inch on all sides
  • Format: APA 7th edition for all formatting, citations, and references

Required Components

  1. Title Page – Include your name, course number and title, instructor name, and date
  2. Introduction (1 page) – Introduce the safety concern, its significance to patient safety and quality care, and the purpose of your analysis
  3. Root-Cause Analysis (3-4 pages) – Complete systematic analysis as outlined in Part 1
  4. Evidence-Based Strategies (2-3 pages) – Literature review and application as outlined in Part 2
  5. Safety Improvement Plan (3-4 pages) – Comprehensive plan as outlined in Part 3
  6. Conclusion (1 page) – Summarize key findings, emphasize the importance of systems thinking in patient safety, and reflect on lessons learned
  7. References – Minimum of 5-7 current, peer-reviewed scholarly sources in APA format

Evaluation Criteria

Your assessment will be evaluated based on:

  • Analysis and Critical Thinking (30%): Depth and thoroughness of root-cause analysis; ability to identify systemic issues beyond surface-level causes; use of structured analytical tools
  • Evidence-Based Practice (25%): Quality and relevance of research sources; integration of current evidence; application of best practices to the specific scenario
  • Safety Improvement Plan (30%): Comprehensiveness and feasibility of proposed interventions; alignment with root causes; clarity of implementation steps; consideration of resources and sustainability
  • Professional Communication (15%): Organization and flow; clarity of writing; proper use of APA format; grammar and mechanics; professional tone

Resources and Support

Recommended Tools and Frameworks

  • Joint Commission Framework for Root Cause Analysis
  • CMS Guidance for Performing Root Cause Analysis with Performance Improvement Projects
  • Institute for Healthcare Improvement (IHI) tools and resources
  • Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network resources

Library Resources

Access the Capella University Library for scholarly databases including:

  • CINAHL (Cumulative Index to Nursing and Allied Health Literature)
  • PubMed/MEDLINE
  • Cochrane Library
  • Joanna Briggs Institute EBP Database

Writing Resources

  • Capella University Writing Center for APA formatting guidance
  • Grammarly or similar tools for grammar and mechanics review
  • SafeAssign for originality verification

Submission Guidelines

  • Submit your completed assessment as a Word document (.docx) or PDF
  • Use the assignment submission link in the courseroom
  • Ensure all required components are included
  • Verify that your document is properly formatted in APA 7th edition style
  • Review the scoring guide before submission to ensure all criteria are addressed

Academic Integrity

This assessment must reflect your own original work. Proper citation of all sources is required. Plagiarism, including self-plagiarism from previous courses, violates Capella University’s academic integrity policy and will result in serious consequences. When in doubt, cite your sources.


Additional Notes

  • This assessment aligns with BSN program outcomes related to quality improvement, evidence-based practice, patient safety, and professional communication
  • The skills you develop through this assessment are essential for nursing leadership roles and quality improvement initiatives in clinical practice
  • Consider how this experience prepares you for real-world root-cause analyses you may conduct as a professional nurse

Questions? Contact your instructor through the courseroom messaging system or attend virtual office hours for clarification and guidance.

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