• Home
  • >
  • Blog
  • >
  • RCA is a Patient Safety Initiative and a Compliance Imperative

October 2, 2025

RCA is a Patient Safety Initiative and a Compliance Imperative

The Ripple Effect: Applying Root Cause Analysis and Other Tools to Strengthen Patient Safey and Compliance 

Written by: Dr. Stacey R. Atkins, PhD, MSW, LSW, CPC, CIGE 

Improving patient safety and maintaining regulatory compliance requires more than addressing isolated incidents, it demands systemic methods that reveal and correct underlying issues. Root Cause Analysis (RCA) and related tools such as the Fishbone Diagram, Five Whys, Failure Modes and Effects Analysis (FMEA), and Human Factors engineering provide structured approaches to uncover systemic weaknesses. When applied effectively the methods recreate ripple effects that extend beyond resolving individual events to strengthening organizational culture, reducing liability, and promoting continuous learning. This article examines the processes and tools available for healthcare organizations, highlights evidence-based outcomes, and provides best practices for healthcare leaders seeking to transform patient safety and compliance through actionable, system-level improvements. 

Introduction

Healthcare organizations continually face pressure to provide safe, high-quality care while meeting regulatory and accreditation requirements. Despite advances in technology and clinical practice, medical errors and adverse events remain persistent challenges. The Joint Commission, the Centers for Medicare & Medicaid Services (CMS), and patient safety organizations consistently highlight the importance of systematic approaches to error prevention.  Root Cause Analysis (RCA) is one such approach.

RCA is defined as a structured method used to identify the underlying factors that contribute to errors or adverse events, with the goal of preventing recurrence. Unlike surface-level corrective actions that may only address symptoms, RCA examines deeper causes—whether they stem from human factors, organizational systems, or external pressures.

For healthcare compliance leaders, RCA provides not only a mechanism to resolve immediate issues but also a pathway to improve overall governance, reduce liability, and build a culture of safety.

Understanding Root Cause Analysis

RCA is widely recognized as a post-event analysis method designed to uncover systemic flaws. In healthcare, RCA is typically conducted after sentinel events, near misses, or other significant incidents. The Agency for Healthcare Research and Quality (AHRQ) emphasizes that RCA should shift focus from individual blame to systemic improvement, acknowledging that most errors are products of multiple contributing factors rather than a single failure.

While Failure Modes and Effects Analysis (FMEA) is proactive, RCA is reactive.

  • FMEA anticipates potential points of failure before they occur, while RCA investigates why an error has already happened. RCA is also distinct from corrective and preventive action (CAPA) systems because it emphasizes systemic causes rather than isolated fixes.

Healthcare organizations are required or strongly encouraged to use RCA following sentinel events. The Joint Commission mandates RCA for accredited facilities in these situations, underscoring its role as a compliance and accreditation tool.

Effective Root Cause Analysis relies not only on process but also on the right tools to guide deeper understanding. Several proven techniques help healthcare teams systematically uncover contributing and root causes:

  • Fishbone Diagram (Ishikawa) – A visual mapping tool that categorizes potential causes into 'bones' of a fish (such as people, processes, equipment, environment, and policies). This diagram helps teams recognize how multiple factors intersect, making it especially useful for complex events.
  • Five Whys Method – A simple but powerful questioning approach where the team repeatedly asks 'Why?'—typically at least five times—until underlying systemic causes emerge. This prevents premature conclusions and ensures that deeper issues are explored.
  • Flowcharts and Timelines – Reconstruct the sequence of events, allowing investigators to pinpoint where processes failed or communication broke down. These tools are particularly valuable in analyzing delays or patient handoff errors.
  • Failure Modes and Effects Analysis (FMEA) – Although technically proactive, FMEA complements RCA by anticipating points of failure before they occur. Together, RCA and FMEA create a cycle of learning that looks backward to prevent recurrence and forward to prevent potential risks.
  • Human Factors Engineering – Examines issues such as fatigue, workload, communication gaps, and environmental pressures. By incorporating human factors, RCA recommendations move beyond blaming individuals and instead focus on systemic redesign to support safer performance.

Integrating these tools ensures that RCA findings are not only comprehensive but also actionable, bridging the gap between analysis, compliance, and patient safety outcomes.

Tools and Techniques that Strengthen RCA

The RCA Process: Step by Step

A well-structured RCA typically follows these stages:

  1. Problem Identification – Define the event clearly and establish the scope of the investigation.
  2. Data Collection – Gather all available information, including medical records, staff interviews, policies, and timelines.
  3. Event Mapping – Use tools such as flowcharts or timelines to reconstruct the sequence of events.
  4. Identify Contributing Factors – Determine what conditions, decisions, or gaps led to the event.
  5. Determine Root Causes – Apply methods like the “Five Whys” or fishbone (Ishikawa) diagrams to move beyond symptoms.
  6. Develop Action Plans – Create corrective measures that are specific, measurable, achievable, relevant, and time-bound.
  7. Implementation – Assign accountability and resources to ensure recommended changes are put into practice.
  8. Follow-Up and Evaluation – Monitor whether interventions are effective and adjust as needed.

Benefits of RCA for Healthcare Organizations

  • Improved Patient Safety – RCA reduces the likelihood of repeat adverse events by targeting systemic issues.
  • Compliance and Accreditation – RCA aligns directly with regulatory and accreditation standards.
  • Financial Savings – RCA can reduce malpractice claims, settlements, and costs of rework.
  • Staff Engagement and Safety Culture – RCA fosters trust and encourages open reporting of near misses.
  • System Efficiency – RCA highlights inefficiencies and improves workflow.

Challenges and Limitations

  • Despite its benefits, RCA is not without obstacles:
  • Data Gaps: Missing or incomplete data can compromise findings.
  • Blame Culture: Without leadership support, staff may fear participating honestly.
  • Resource Constraints: RCA can be time- and labor-intensive.
  • Implementation Failures: Recommendations may not be acted upon or sustained.
  • Measuring Effectiveness: Many organizations fail to evaluate outcomes.

Best Practices for Effective RCA

Healthcare leaders can adopt best practices to strengthen RCA:

  • Leadership Commitment
  • Multidisciplinary Teams
  • Human Factors Perspective
  • Actionable Recommendations
  • Ongoing Monitoring
  • Learning from Success as well as Failures

Case Example

  • A community hospital reported repeated medication errors involving insulin administration.
  • An RCA team discovered that the electronic health record (EHR) system defaulted to 'units' without clarifying subcutaneous versus intravenous administration.
  • By redesigning the order entry screen and adding a double-check requirement, the hospital eliminated the error pathway.

This example demonstrates how RCA identifies systemic flaws and produces targeted solutions that protect patients while strengthening compliance.

Implications for Compliance and Risk Management

RCA is not just a patient safety initiative—it is also a compliance imperative. Documented RCA processes demonstrate adherence to regulatory expectations, mitigate liability risks, and strengthen audits. RCA outputs also inform staff training, policy revisions, and quality reporting, making it central to governance. In today’s environment, RCA bridges clinical safety and administrative accountability.

Several empirical studies confirm that Root Cause Analysis (RCA) can yield measurable improvements in patient safety and compliance when properly implemented:

These studies highlight that RCA effectiveness depends not only on identifying root causes, but also on implementing strong, system-level corrective actions and maintaining leadership accountability.

Conclusion

Root Cause Analysis is more than a checklist—it is a philosophy of continuous improvement. By uncovering underlying causes, implementing systemic solutions, and monitoring outcomes, healthcare providers can prevent recurrence, enhance compliance, and foster a culture of safety. The ripple effect of RCA begins with asking 'why' but extends across every level of the organization.

About the Author

Dr. Stacey R. Atkins, PhD, MSW, LMSW, CPC, CIGE

Dr. Adkins is a Compliance Specialist working as a team member in the Education Department of the American Institute of Healthcare Compliance. Her career spans leadership roles with the Office of the State Inspector General, Department of Behavioral Health and Developmental Services, and HRSA, among others.

References

Copyright © 2025 American Institute of Healthcare Compliance All Rights Reserved

Share 0
Post 0
Share 0

TAGS

Agency for Healthcare Research and Quality, Compliance, Patient Safety, quality