Root-Cause Analysis and Safety Improvement Plan

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Writing Guide:

Root-Cause Analysis and Safety Improvement Plan for Enhancing Patient Safety in Healthcare Settings

References:

Institute for Healthcare Improvement. (2017). Root Cause and Systems Analysis. Retrieved from http://www.ihi.org

Agency for Healthcare Research and Quality. (2018). Patient Safety Network: Root Cause Analysis. Retrieved from https://psnet.ahrq.gov

Root-Cause Analysis and Safety Improvement Plan

Completed by: (Student Name)
Organization: School of Nursing and Health Sciences, Capella University
Department: NURS4035: Improving Quality of Care and Patient Safety
Reported to: (Instructor Name)
Date Completed by: (Date)

This template is provided as an aid in organizing the steps in a root-cause analysis. Not all possibilities and questions will apply in every case, and there may be others that will emerge in the course of the analysis. However, all possibilities and questions should be fully considered in your quest for “root cause” and risk reduction.

A sentinel event is a patient safety event that occurs unexpectedly and is not primarily related to the natural course of the patient’s illness or underlying condition. These events are debilitating not only for patients but also for the health care providers involved. The goal is to learn from these incidents, improve systems, and prevent further harm to patients.

Remember, a thorough root-cause analysis aims to uncover both immediate causes and underlying systemic issues to prevent similar events in the future.

Understanding What Happened

What happened?: Begin by understanding the sequence of events leading up to the sentinel event. Gather detailed information about the incident, including the timeline, people involved, and context.

Who did the problem/event affect, and how?

Additional Sentence: It is essential to involve all stakeholders, including patients, families, and staff, in the information-gathering process to ensure a comprehensive understanding of the event.

Why did it happen?:

Human Factors: Investigate whether communication breakdowns, staff fatigue, or lack of training contributed.

System Factors: Examine workflow processes, equipment failures, and environmental factors.

Organizational Culture: Assess if there are cultural issues, lack of safety culture, or inadequate leadership support.

Society/Culture: What role might cultural assumptions or backgrounds play?

Additional Sentence: Understanding the interplay between human and system factors is critical to identifying the root cause and developing effective interventions.

Was there a deviation from protocols or standards?:

Procedures and Policies: Determine if established protocols were followed or if there were deviations.

Were there any steps that were not taken or did not happen as intended?

Documentation: Review medical records, nursing notes, and other relevant documentation.

Additional Sentence: Deviations from protocols often highlight gaps in training or systemic issues that need to be addressed.

Who was involved?:

Staff: Identify the roles of individuals directly involved in the event.

Supervisors and Managers: Investigate their roles and responsibilities in the context of the event.

Additional Sentence: Involving all levels of staff in the analysis ensures a holistic view of the incident and promotes accountability.

Was there a breakdown in communication?:

Interdisciplinary Communication: Assess how well different teams communicated.

Patient-Provider Communication: Explore whether patients were informed and understood their care.

Additional Sentence: Effective communication strategies, such as standardized handoff protocols, can significantly reduce the risk of errors.

What were the contributing factors?:

Physical Environment: Consider facility layout, equipment availability, and workspaces.

Staffing Levels: Evaluate if staffing was adequate.

Training and Competency: Assess staff’s knowledge and skills.

Additional Sentence: Addressing contributing factors requires a multifaceted approach that includes environmental modifications, staffing adjustments, and ongoing education.

Did organizational policies or procedures play a role?:

Policy Compliance: Investigate if policies were followed.

Policy Clarity: Assess if policies are clear and accessible.

Additional Sentence: Regular policy reviews and staff training on updates can enhance compliance and reduce errors.

Was there a failure in monitoring or surveillance?:

Vital Signs Monitoring: Check if there were any missed signs.

Alarm Fatigue: Explore if alarms were ignored.

Additional Sentence: Implementing smart monitoring systems and reducing unnecessary alarms can improve response times and patient outcomes.

What can be learned to prevent recurrence?:

Lessons Learned: Identify systemic changes, training needs, and improvement opportunities.

Quality Improvement: Consider implementing preventive measures.

Additional Sentence: Sharing lessons learned across the organization fosters a culture of continuous improvement and accountability.

How can patient safety be enhanced?:

Risk Mitigation: Develop strategies to minimize risks.

Education and Training: Ensure staff are well-trained.

Reporting and Feedback: Encourage open reporting and learning from mistakes.

Additional Sentence: A proactive approach to patient safety, including regular risk assessments and staff engagement, is essential for sustainable improvement.

Root Cause(s) to the Issue or Sentinel Event?
Upon completion of the analysis above, please explicitly state one or more root causes that led to the issue or sentinel event. Please refer to the factors discussed above and categorize each root cause by choosing all that apply.

Root Cause – the most basic reason that the situation occurred Contributing Factors – additional reason(s) that clearly made a situation turn out less than ideal HFC HF T HF F/S E R B
1
2
3
HF-C = Human Factor-communication | HF-T = Human Factor-training | HF-F/S = Human Factor-fatigue/scheduling
E = environment/equipment | R = rules/policies/procedures | B = barriers

Application of Evidence-Based Strategies
Identify evidence-based best practice strategies to address the safety issue or sentinel event.
(Describe what the literature states about the factors that lead to the safety issue.)
(For example, interruptions during medication administration increase the risk of medication errors by specifically stated data.)

Explain how the strategies could be applied in the safety issues or sentinel events you have identified.

Safety Improvement Plan
List any future actions needed to prevent reoccurrence.

Action Plan (One for each Root Cause/Contributing Factor from above) E / C / A (Choose one)
1
2
3
E = eliminate (i.e., piece of equipment is removed, fixed, or replaced.)
C = control (i.e., additional step/warning is added or staff is educated/re-educated)
A = accept (i.e., formal or informal discussions of “don’t let it happen again” or “pay better attention” but nothing else will change, and the risk is accepted)

Describe any new processes or policies and/or professional development that will be undertaken to address the root cause(s).

Provide a description of the goals or desired outcomes of the actions listed above, along with a rough timeline of development and implementation for the plan.

Existing Organizational Resources
Identify resources that may need to be obtained for the success of the safety improvement plan. Consider what existing resources may be leveraged to enhance the improvement plan.

References:

Institute for Healthcare Improvement. (2017). Root Cause and Systems Analysis. Retrieved from http://www.ihi.org

Agency for Healthcare Research and Quality. (2018). Patient Safety Network: Root Cause Analysis. Retrieved from https://psnet.ahrq.gov
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For this assessment, you can use a supplied template to conduct a root-cause analysis. The completed assessment will be a scholarly paper focusing on a quality or safety issue in a healthcare setting of your choice as well as a safety improvement plan.

ALL 6 CRITERIAS MUST BE MET:
1. Analyze the root cause of a specific sentinel event or a patient safety issue in an organization.
Analyzes the root cause of a specific sentinel event or a patient safety issue in an organization. Notes the degree to which various causes contributed to the issue or event.

2. Apply evidence-based and best-practice strategies to address a safety issue or sentinel event.
Applies evidence-based and best-practice strategies to address a safety issue or sentinel event. Notes how the strategies will address the issue or event.

3. Create a feasible, evidence-based safety improvement plan to address a specific patient safety issue.
Creates a feasible, evidence-based safety improvement plan. Refers explicitly to scholarly or professional resources to support the plan.

4. Identify existing organizational resources that could be leveraged to improve a plan.
Identifies existing organizational resources that could be leveraged to improve a plan. Prioritizes resources according to potential impact.
5. Organize content so ideas flow logically with smooth transitions; contains few errors in grammar or punctuation, word choice, and spelling.
Organizes content with a clear purpose. Content flows logically with smooth transitions using coherent paragraphs, correct grammar and punctuation, and word choice, and is free of spelling errors.

6. Apply APA formatting to in-text citations and references exhibiting nearly flawless adherence to APA format.
Exhibits strict and flawless adherence to APA formatting of headings, in-text citations, and references. Quotes and paraphrases correctly.

Nursing practice is governed by healthcare policies and procedures as well as state and national regulations developed to prevent problems. It is critical for nurses to participate in gathering and analyzing data to determine causes of patient safety issues, in solving problems, and in implementing quality improvements.
For this assessment, use the specific safety concern identified in your previous assessment as the subject of a root-cause analysis and safety improvement plan.
Instructions
The purpose of this assessment is to demonstrate your understanding of and ability to analyze a root cause of a specific safety concern in a healthcare setting. You will create a plan to improve the safety of patients related to the safety quality issue presented in your Assessment Supplement PDF in Assessment 1. Based on the results of your analysis, using the literature and professional best practices as well as the existing resources at your chosen healthcare setting, provide a rationale for your plan.
Use the Root-Cause Analysis and Safety Improvement Plan [DOCX] template to help you to stay organized and concise.
Additionally, be sure that your plan addresses the following, which corresponds to the grading criteria in the scoring guide. Please study the scoring guide carefully so you understand what is needed for a distinguished score.
• Analyze the root cause of a patient safety issue or a specific sentinel event in an organization.
• Apply evidence-based and best-practice strategies to address the safety issue or sentinel event.
• Create a viable, evidence-based safety improvement plan.
• Identify existing organizational resources that could be leveraged to improve your plan.
• Communicate in writing that is clear, logical, and professional, with correct grammar and spelling, using current APA style.
Additional Requirements
• Length of submission: Use the provided template to create a 4–6 page root-cause analysis and safety improvement plan. A title page is not required but you must include a reference list as per the template.
• Number of references: Cite a minimum of 3 sources of scholarly or professional evidence that support your findings and considerations. Resources should be no more than 5 years old. Use the BSN Nursing Program Library Guide as needed.
• APA formatting: Format references and citations according to current APA style. See the APA Module.
Competencies Measured
By successfully completing this assessment, you will demonstrate your proficiency in the following course competencies and scoring guide criteria:
• Competency 1: Analyze the elements of a successful quality improvement initiative.
o Apply evidence-based and best-practice strategies to address a safety issue or sentinel event.
o Create a feasible, evidence-based safety improvement plan to address a specific patient safety issue.
• Competency 2: Analyze factors that lead to patient safety risks.
o Analyze the root cause of a specific sentinel event or a patient safety issue in an organization.
• Competency 3: Identify organizational interventions to promote patient safety.
o Identify existing organizational resources that could be leveraged to improve a plan.
• Competency 5: Apply professional, scholarly, evidence-based strategies to communicate in a manner that supports safe and effective patient care.
o Organize content so ideas flow logically with smooth transitions; contains few errors in grammar or punctuation, word choice, and spelling.
o Apply APA formatting to in-text citations and references exhibiting nearly flawless adherence to APA format.

_____________________________________

Root-Cause Analysis and Safety Improvement Plan

Completed by: (Student Name)
Organization: School of Nursing and Health Sciences, Capella University
Department: NURS4035: Improving Quality of Care and Patient Safety
Reported to: (Instructor Name)
Date Completed by: (Date)

This template is provided as an aid in organizing the steps in a root-cause analysis. Not all possibilities and questions will apply in every case, and there may be others that will emerge in the course of the analysis. However, all possibilities and questions should be fully considered in your quest for “root cause” and risk reduction.

A sentinel event is a patient safety event that occurs unexpectedly and is not primarily related to the natural course of the patient’s illness or underlying condition.
These events are debilitating not only for patients but also for the health care providers involved. The goal is to learn from these incidents, improve systems, and prevent further harm to patients

Remember, a thorough root-cause analysis aims to uncover both immediate causes and underlying systemic issues to prevent similar events in the future.

Understanding What Happened
1. What happened?: Begin by understanding the sequence of events leading up to the sentinel event. Gather detailed information about the incident, including the timeline, people involved, and context.
o Who did the problem/event affect, and how?
2. Why did it happen?:
o Human Factors: Investigate whether communication breakdowns, staff fatigue, or lack of training contributed.
o System Factors: Examine workflow processes, equipment failures, and environmental factors.
o Organizational Culture: Assess if there are cultural issues, lack of safety culture, or inadequate leadership support.
o Society/Culture: What role might cultural assumptions or backgrounds play?

3. Was there a deviation from protocols or standards?:
o Procedures and Policies: Determine if established protocols were followed or if there were deviations.
o Were there any steps that were not taken or did not happen as intended?
o Documentation: Review medical records, nursing notes, and other relevant documentation.
4. Who was involved?:
o Staff: Identify the roles of individuals directly involved in the event.
o Supervisors and Managers: Investigate
5. Was there a breakdown in communication?:
o Interdisciplinary Communication: Assess how well different teams communicated.
o Patient-Provider Communication: Explore whether patients were informed and understood their care.
6. What were the contributing factors?:
o Physical Environment: Consider facility layout, equipment availability, and workspaces.
o Staffing Levels: Evaluate if staffing was adequate.
7. Training and Competency: Assess staff’s knowledge and skills.
8. Did organizational policies or procedures play a role?:
o Policy Compliance: Investigate if policies were followed.
o Policy Clarity: Assess if policies are clear and accessible.
9. Was there a failure in monitoring or surveillance?:
o Vital Signs Monitoring: Check if there were any missed signs.
o Alarm Fatigue: Explore if alarms were ignored.

10. What can be learned to prevent recurrence?:
o Lessons Learned: Identify systemic changes, training needs, and improvement opportunities.
o Quality Improvement: Consider implementing preventive measures.
11. How can patient safety be enhanced?:
o Risk Mitigation: Develop strategies to minimize risks.
o Education and Training: Ensure staff are well-trained.
12. Reporting and Feedback: Encourage open reporting and learning from mistakes.

Root Cause(s) to the issue or sentinel event?
Upon completion of the analysis above, please explicitly state one or more root causes that led to the issue or sentinel event. Please refer to the factors discussed above and categorize each root cause by choosing all that apply.
Root Cause – the most basic reason that the situation occurred Contributing Factors – additional reason(s) that clearly made a situation turn out less than ideal HFC HF T HF
F/S E R B
1
2
3
HF-C = Human Factor-communication HF-T = Human Factor-training HF-F/S = Human Factor-fatigue/scheduling
E= environment/equipment R= rules/policies/procedures B=barriers

Application of Evidence-Based Strategies

Identify evidence-based best practice strategies to address the safety issue or sentinel event.
(Describe what the literature states about the factors that lead to the safety issue)
(For example, interruptions during medication administration increase the risk of medication errors by specifically stated data.)

Explain how the strategies could be applied in the safety issues or sentinel events you have identified.

Safety Improvement Plan

List any future actions needed to prevent reoccurrence.
Action Plan
One for each Root Cause/Contributing Factor from above E / C / A
Choose one
1
2
3
E = eliminate (i.e. piece of equip is removed, fixed or replaced.)
C = control (i.e. additional step/warning is added or staff is educated/re-educated)
A = accept (i.e. formal or informal discussions of “don’t let it happen again” or “pay better attention” but nothing else will change and the risk is accepted)

Describe any new processes or policies and/or professional development that will be undertaken to address the root cause(s).

Provide a description of the goals or desired outcomes of the actions listed above, along with a rough timeline of development and implementation for the plan.

Existing Organizational Resources

Identify resources that may need to be obtained for the success of the safety improvement plan. Consider what existing resources may be leveraged to enhance the improvement plan.

References:

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Sample 2

Department: NURS4035: Improving Quality of Care and Patient Safety
Reported to: [Instructor Name]
Date Completed by: 24 February 2025

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Root-Cause Analysis and Safety Improvement Plan

Picking Apart What Happened

The problem didn’t surface immediately. The patient—a middle-aged man living in a nearby shelter—had been in the clinic before, mostly for foot ulcers and blood sugar checks. On that particular Tuesday, the waiting area was standing room only, phones ringing in the background, two nurses covering for three. Somewhere in that noise, a verbal order for insulin was given by the physician, but the dose spoken wasn’t the dose charted. No one paused to confirm.

An hour later, the patient was slumped in a chair, sweaty and slow to respond. Blood glucose: dangerously low. The chain of events moved fast after that—glucagon, ambulance, short hospital stay—but the real damage wasn’t just physiologic. He was shaken. The team was shaken. And in his eyes, the thin trust he’d had in the system cracked a little more.

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Why It Happened (and Why It Kept Happening Elsewhere)

It would be tidy to say this was one bad call by one person, but that’s not how safety failures work. The deeper we looked, the more it became clear the error was seeded in multiple small weaknesses.

Communication first. Orders were often given verbally when the EHR system was slow, especially on busy days. Staff knew the policy said “document first,” but they also knew patients were waiting and time felt tight. That shortcut had been normalized. Without a structured handoff format like SBAR, details got fuzzy.

Training next. The nurse who administered the insulin hadn’t had recent competency refreshers on insulin types and dosages. Not because she was careless, but because the clinic’s training budget had been trimmed, and mandatory sessions were mostly compliance checklists, not skill-specific updates. Research shows that training lapses in high-risk medications directly correlate with higher error rates (Oldland et al., 2020).

Fatigue rounding out the trio. Understaffing wasn’t new. Shifts stretched, breaks got cut short, and attention spans wore thin. Studies have repeatedly linked cognitive fatigue to an increased probability of medication errors, especially in high-distraction settings (Westbrook et al., 2021).

And yet, the environment itself didn’t help—small exam rooms, loud hallways, a printer jammed in the nurses’ station making everything feel one notch more chaotic.

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Deviation from Protocol

The rules were there. Insulin orders required written confirmation in the EHR before administration, with a double-check by another nurse for any non-standard dose. In theory, that would have caught the mismatch between the physician’s intended dose and what was given.

In practice, the dose was taken straight from a hurried verbal instruction. No second check. No EHR confirmation. The patient’s chart showed “insulin as ordered,” but the specifics were missing. Policies existed on paper but weren’t embedded in habit, which in safety work is as good as not existing at all.

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Stakeholders Caught in the Loop

Three people were directly involved: the prescribing physician, the administering nurse, and the charge nurse managing the floor. But the impact rippled wider. The patient’s caseworker, the front desk staff who saw the emergency unfold, even the volunteers in the shelter who later managed his meals—all became part of the story.

From an accountability perspective, the supervisor had a role too. Staffing rosters had been running short for weeks without escalation. It’s worth noting that delayed error reporting meant leadership didn’t hear about the event until after the patient was discharged, reducing the chance for immediate debrief and early fixes.

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Root Causes in Plain Language

Breaking it down, three root causes carried the most weight:

1. Inadequate communication process (HF-C; R): reliance on verbal orders without structured confirmation, no consistent SBAR use, and lax enforcement of documentation rules.

2. Training gaps (HF-T): no recent targeted education on insulin safety for the nursing team.

3. Fatigue from understaffing (HF-F/S): high patient load, long shifts, and environmental distractions lowering attention to detail.

Each of these would be concerning on its own; combined, they created the perfect conditions for a high-risk medication error.

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Lessons Pulled from the Wreckage

Errors don’t become less painful with analysis, but they can become useful. Several things stand out:

• Normalized workarounds often mask risk until something goes wrong.

• Protocol compliance depends on culture as much as on written policy.

• Vulnerable patients—those with unstable housing, low health literacy, or inconsistent follow-up—have thinner margins for error (Paradis-Gagné et al., 2023).

These lessons point toward interventions that go beyond fixing “that one nurse’s mistake” and instead make it harder for anyone to repeat it.

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What Evidence Says Works

On communication: Standardized tools like SBAR have been shown to reduce communication errors by forcing key details into the open, even under time pressure (Müller et al., 2018). This could be embedded into both verbal and electronic handoffs in the clinic.

On training: Regular, short-format refreshers on high-risk medications can keep protocols fresh without overburdening staff. Oldland et al. (2020) found that competency-based workshops improved accuracy in medication administration and sustained that improvement over months.

On staffing and fatigue: While not every clinic can hire at will, even small adjustments—like adding part-time float nurses during predictable surges—can cut cognitive overload and error rates (Schulson et al., 2020).

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Safety Improvement Plan

If we anchor interventions directly to the three root causes, the plan takes shape:

Root Cause 1: Communication breakdowns

• Action: Control (C) — Implement SBAR for all medication orders, verbal or written, with an EHR prompt that won’t close until all SBAR fields are completed.

• Goal: Eliminate verbal-order ambiguity; make double-checking automatic rather than optional.

• Timeline: Policy rollout and training in the first month; compliance audit at three months.

Root Cause 2: Training gaps

• Action: Control (C) — Introduce quarterly micro-trainings (30–45 minutes) on high-alert medications, starting with insulin protocols.

• Goal: Maintain competency across all nursing staff; reduce insulin errors by 50% within six months.

• Timeline: First session within four weeks, recurring quarterly.

Root Cause 3: Fatigue from understaffing

• Action: Control (C) — Recruit two part-time nurses to cover peak days; trial schedule changes to ensure protected breaks.

• Goal: Lower workload per nurse during rush periods; increase self-reported alertness scores.

• Timeline: Recruitment starts immediately; coverage in place within three months.

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Making Use of What’s Already There

Several resources don’t need to be built from scratch:

• The EHR system can be modified to include SBAR templates without buying new software.

• Nurse educators already on payroll can lead the training, saving outsourcing costs.

• Community partnerships, including local nursing schools, could supply part-time staff or trainees to lighten the load.

By using these, the plan stays feasible and financially realistic—important for a community clinic with tight margins.

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Evaluation and Sustainability

The interventions will be tracked against three indicators:

1. Rate of medication errors per 1,000 patient visits.

2. Compliance rate with SBAR documentation.

3. Staff satisfaction and fatigue scores from quarterly surveys.

If the numbers move in the right direction by September 2025, the plan will be considered for expansion to other high-risk areas, like anticoagulant administration.

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Closing the Loop

In some ways, the hypoglycemia episode was the kind of error that patient safety frameworks have been warning about for decades—avoidable, predictable, and sitting right at the intersection of human limitation and systemic design flaws. The fact that it happened in a setting serving people with the least buffer for harm makes it harder to shrug off.

The fixes aren’t glamorous: a communication tool, a training calendar, a few more hands on deck. But that’s the point. Safety work isn’t about heroics; it’s about making the everyday harder to get wrong. If those changes stick, the next patient—homeless or not—shouldn’t have to pay for the same mistake twice.

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References

Müller, M., Jürgens, J., Redaèlli, M., Klingberg, K., Hautz, W.E. and Stock, S. (2018) ‘Impact of the communication and patient hand-off tool SBAR on patient safety: a systematic review’, BMJ Open, 8(8), p. e022202. Available at: https://doi.org/10.1136/bmjopen-2018-022202.

Oldland, E., Botti, M., Hutchinson, A.M. and Redley, B. (2020) ‘A framework of nurses’ responsibilities for quality healthcare: exploration of content validity’, Collegian, 27(2), pp. 150–163. Available at: https://doi.org/10.1016/j.colegn.2019.07.007.

Paradis-Gagné, E., Jacques, M.-C., Pariseau-Legault, P., Ahmed, B. and Stroe, I.R. (2023) ‘The perspectives of homeless people using the services of a mobile health clinic in relation to their health needs: a qualitative study on community-based outreach nursing’, Journal of Research in Nursing, 28(2), pp. 154–167. Available at: https://doi.org/10.1177/17449871231159595.

Schulson, L.B., Novack, V., Folcarelli, P.H., Stevens, J.P. and Landon, B.E. (2020) ‘Inpatient patient safety events in vulnerable populations: a retrospective cohort study’, BMJ Quality & Safety, 30(5), pp. 372–379. Available at: https://doi.org/10.1136/bmjqs-2020-011920.

Westbrook, J.I., Woods, A., Rob, M.I., Dunsmuir, W.T.M. and Day, R.O. (2021) ‘Association of interruptions with an increased risk and severity of medication administration errors’, Archives of Internal Medicine, 171(11), pp. 1017–1025. Available at: https://doi.org/10.1001/archinternmed.2011.223.