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Root Cause Analysis in Healthcare: The Full Guide

09 Feb 2026 9 min read
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Yoanna Stefanova Technical Copywriter at XTATIC HEALTH

In 2021, a Norwegian hospital experienced a sentinel event when a baby died unexpectedly during labor. Rather than issuing a superficial report, the hospital carried out a formal root cause analysis (RCA)  a structured investigation aimed at uncovering system-level factors that contributed to the tragedy. A 2025 qualitative study of this event, based on interviews with nine hospital managers and a review of the RCA documentation, illustrates how RCA is actually conducted today and highlights the complexity leaders face when translating adverse events into meaningful system change.

This case sets the tone for understanding how RCA should work in healthcare: not as a blame assignment exercise or regulatory formality, but as a disciplined method to understand why harm happened and what must change to prevent it.

What is root cause analysis (RCA)?

Root cause analysis (RCA) is a structured, retrospective method used to investigate adverse events and medical errors in healthcare. Superficial reviews often stop at the immediate mistake. In contrast, RCA goes deeper to uncover underlying system weaknesses — commonly referred to as latent causes. These may include communication failures, impractical protocols, staffing constraints, or poorly designed workflows and technologies.

RCA asks “Why did this happen?” repeatedly until the investigation reaches the core system condition that allowed the event to occur. In healthcare, the goal is not simply explanation, but prevention — identifying process failures so institutions can introduce corrective measures with lasting impact.

The approach originated in high-risk industries such as aviation and nuclear energy, where understanding system failure is essential to safety. Over time, it evolved into a cornerstone of patient safety practice. Today, hospitals, pharmaceutical manufacturers, and clinical trial organizations conduct RCA following serious events such as wrong-site surgeries or fatal diagnostic errors.

Regulatory bodies, including the Joint Commission and the Agency for Healthcare Research and Quality (AHRQ), encourage or mandate RCA for serious incidents. According to AHRQ, the goal is not only to identify root causes but also to implement system-based interventions that reduce the likelihood of recurrence [1].

Many RCA frameworks categorize causes into two broad types:

  • Active errors – committed by frontline healthcare professionals during care delivery

  • Latent conditions  embedded in workflows, organizational culture, policies, or system design

This distinction matters. Active errors explain what happened. Latent conditions explain why it was possible. Sustainable improvement comes from addressing the latter [1,2].

The importance of RCA in patient safety and quality improvement

When applied rigorously, root cause analysis improves patient safety by shifting the focus from individual fault to systemic vulnerability. This shift reduces repeated medical errors and supports a stronger culture of safety. Institutions that adopt RCA consistently tend to see fewer sentinel events and improved staff confidence in reporting problems.

Every adverse event whether a diagnostic error or a surgical site infection  holds valuable information. RCA gives healthcare teams a structured way to extract those insights. According to AHRQ, institutions that conduct thorough RCA after serious events uncover patterns that standard incident reports often miss. These insights frequently lead to interventions such as redesigned verification steps, clearer communication protocols, or technology-enabled safeguards [1].

When healthcare professionals see that reporting errors leads to meaningful corrective action rather than punishment, they are more likely to speak up again. Over time, this helps dismantle the “wall of silence” that has historically surrounded preventable harm.

Hospitals accredited by the Joint Commission are expected to carry out RCA for serious reportable events. However, the process offers value beyond compliance. For leadership teams, RCA provides a diagnostic map of system weaknesses that must be addressed to deliver safe, high-quality care.

RCA also benefits patients indirectly. Fewer repeated errors and clearer communication result in more reliable care pathways. Both patients and professionals benefit most when healthcare organizations prioritize learning over blame[1,2].

Key steps in conducting a root cause analysis

The RCA process begins after an adverse event or near miss. However, effective analysis does not happen automatically. It requires structure, discipline, and time. In practice, many RCAs fall short not because the steps are unknown, but because they are applied inconsistently or under significant operational pressure.

Most healthcare organizations follow a systematic path that moves from data gathering to solution planning. The first step is assembling an RCA team. This team should include individuals directly involved in patient care, such as nurses or physicians, as well as those with authority to implement corrective actions. No single role sees the entire system, making diverse perspectives essential.

Next, the team reconstructs the timeline of events. This often involves creating a flow diagram or detailed event narrative based on medical records, internal communication, and eyewitness accounts. From this reconstruction, contributing factors are identified across domains such as environment, communication, training, decision-making, and organizational processes.

After data collection, the team applies cause-and-effect thinking. The “Five Whys” method is commonly used to push analysis beyond surface explanations:

Problem: A patient received the wrong medication.

Why? The nurse selected the wrong vial.

Why? The shelf labels were switched.

Why? A technician reorganized storage without notice.

Why? No protocol existed for labeling updates.

Why? The hospital lacked a standardized medication storage review process.

Root cause: Absence of a system to manage medication organization safely.

The final step focuses on corrective measures and action planning. Effective RCA assigns responsibility, sets deadlines, and monitors outcomes. When similar events recur, it often indicates that a key latent condition was missed or that corrective actions were never fully embedded into daily practice [3].

Common tools and techniques used in RCA

Healthcare teams use a variety of tools to support root cause analysis, each offering a different lens on system failure.

Fishbone (Ishikawa) diagrams help teams explore contributing factors across categories such as people, processes, equipment, environment, and policies. Pareto charts help prioritize the “vital few” causes responsible for most harm. Process mapping and SIPOC diagrams expose gaps between formal workflows and real-world practice.

Other techniques extend RCA thinking further. Failure Mode and Effects Analysis (FMEA) helps anticipate failures before incidents occur, while fault tree analysis models how multiple system breakdowns combine into adverse outcomes. These tools do not compete with each other; used together, they help teams move from broad exploration to targeted intervention [4,5].

OCR (Optical Character Recognition) enables these unstructured documents to be digitized, indexed, and made searchable. When integrated into RCA workflows, OCR allows investigators to extract relevant data directly from scanned records, link documentation to specific events or causes, and reduce reliance on manual transcription. This improves investigation completeness, shortens analysis time, and ensures that important signals are not missed due to document silos.

Use Case: Real-world applications of RCA in healthcare

The effectiveness of RCA becomes clear when examined in real clinical settings.

Investigations into wrong-site surgery consistently showed that the issue was not surgical competence, but inconsistent verification and communication failures. System-level interventions such as standardized site marking and mandatory timeouts led to sharp reductions in recurrence [1].

In neonatal transport cases, RCA revealed that complications initially attributed to equipment failure were actually driven by missing preparation checklists. Addressing this latent system gap through simulation training and process redesign improved outcomes [6].

Diagnostic errors also benefit from RCA. In one academic hospital, delayed cancer treatment was traced to ambiguous handoffs and assumptions about prior test results. Corrective actions focused on documentation redesign and structured read-back communication during care transitions [2].

Across these cases, the lesson is consistent: RCA works when it targets system design, not individual behavior.

Challenges and limitations of RCA in healthcare settings

If RCA is so effective, why do errors persist? The answer lies in execution.

One of the most common challenges is superficial analysis. Teams may stop after identifying training gaps or policy violations without questioning whether the system itself makes safe behavior difficult. Another challenge is inconsistency. RCA quality varies widely depending on team composition, analytical depth, and follow-through.

Time pressure further complicates the process. Clinicians balancing patient care and documentation may struggle to engage in deep analysis, resulting in rushed or fragmented investigations. Even well-reasoned recommendations often fail when they require workflow redesign or sustained leadership oversight.

Operational burden is another major barrier. RCA investigations frequently rely on fragmented documentation spread across emails, scanned forms, PDFs, and shared folders. Critical evidence remains locked in unstructured documents.

Digitally supported RCA workflows reduce this burden. Automated prompts, predefined templates, and centralized documentation shorten investigation time while improving analytical depth. OCR-based document digitization converts scanned records and legacy documents into searchable, structured data that can be directly linked to RCA workflows.

Equally important is closing the loop between analysis and action. Digitally enabled RCA links causes directly to corrective and preventive actions, assigns ownership, sets deadlines, and tracks effectiveness over time. This transforms RCA from a reporting exercise into a continuous improvement mechanism [1,2].

Best Practices for Effective RCA Implementation

Effective RCA requires intention. Diverse, interprofessional teams are more likely to identify meaningful system changes. Linear thinking should be avoided, as complex failures rarely have a single cause.

RCA must lead to action. Linking recommendations to an action hierarchy prioritizes high-leverage system redesign over weaker fixes such as additional training alone. Measurement is essential. Organizations should define clear metrics to assess whether interventions reduce harm over time.

Most importantly, the entire RCA process must be blame-free. A just culture that encourages transparency and learning creates the conditions for honest reporting and sustained improvement [1].

RCA vs. other problem-solving approaches in healthcare

Not every healthcare problem requires a full RCA. Lower-risk issues may be addressed with simpler methods.

RCA functions best as the investigative approach for complex, high-impact events where system failure is suspected. It complements other methodologies rather than replacing them. FMEA anticipates failure proactively. Morbidity and mortality conferences support clinical learning. Lean and Six Sigma improve efficiency. RCA explains why harm occurred and what must change to prevent it [7].

Healthcare is moving toward more integrated and timely RCA practices. Artificial intelligence is beginning to support pattern detection in adverse events, while real-time RCA enables faster and more accurate investigations.

Embedding RCA workflows into clinical, quality, and operational systems allows earlier detection of safety signals, faster initiation of investigations, and better alignment between analysis and day-to-day care delivery. In this model, RCA becomes part of how healthcare systems learn — not something performed only after harm occurs.

Root cause analysis offers a clear path toward safer healthcare systems — but only when it moves beyond documentation and drives real system change. Technology alone will not prevent the next adverse event. However, when combined with disciplined analysis, reliable data, and a culture that values learning over blame, RCA significantly increases the effectiveness of patient safety efforts.

At BGO Software, we support this shift by working at the intersection of healthcare and technology. By understanding both the clinical realities of patient care and the technical demands of building reliable digital systems, we help organizations translate safety insights into practical, scalable solutions — contributing to safer processes, more effective RCA, and better healthcare outcomes overall.

Frequently Asked Questions (FAQ)

What are the 5 Whys of root cause analysis?

The 5 Whys is a simple technique that asks “Why?” five times to trace a problem back to its root cause. It works well for straightforward issues but can miss deeper system flaws in complex cases.

What is a root cause analysis in the NHS?

The NHS uses RCA to investigate serious incidents and sentinel events. It’s a structured process focused on learning and preventing future harm, not assigning blame.

What are the 5 P’s of root cause analysis?

The 5 P’s refer to People, Processes, Policies, Procedures, and Place. These categories help identify contributing factors behind medical errors or system failures.

What are the 5 steps of root cause analysis?

Common steps include defining the problem, collecting data, identifying causes, developing corrective measures, and tracking outcomes. The exact steps may vary depending on the setting.

How does RCA improve patient safety?

RCA helps healthcare teams uncover not just what went wrong but why. Addressing the root causes reduces repeat errors and builds safer care environments.

Sources:

[1] Gupta, K., & Lyndon, A. (2016). Rethinking root cause analysis. PSNet. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. https://psnet.ahrq.gov/perspective/rethinking-root-cause-analysis

[2] Singh, G., Patel, R. H., Vaqar, S., & Bodor, G. S. (2024). Root cause analysis and medical error prevention. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK570638/

[3] Martin-Delgado, J., Martínez-García, A., Aranaz, J. M., Valencia-Martín, J. L., & Mira, J. J. (2020). How Much of Root Cause Analysis Translates into Improved Patient Safety: A Systematic Review. Medical Principles and Practice, 29(6), 524. https://doi.org/10.1159/000508677

[4] Kumah, A., Nwogu, C. N., Issah, A.-R., Obot, E., Kanamitie, D. T., Sifa, J. S., & Aidoo, L. A. (2024). Cause-and-effect (fishbone) diagram: A tool for generating and organizing quality improvement ideas. Global Journal on Quality and Safety in Healthcare, 7(2), 85–87. https://doi.org/10.36401/JQSH-23-42 

[5] Tagaram SD, Chen C. Quality Tools and Techniques (Fishbone Diagram, Pareto Chart, Process Map) [Updated 2024 Sep 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/sites/books/NBK607994/

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Yoanna Stefanova

Yoanna is a Technical Copywriter with a keen interest in healthcare innovations and medicine. She is dedicated to crafting clear and engaging content that highlights the latest advancements and trends in the medical field.

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