NURS FPX 4035 Assignment 2 Root-Cause Analysis and Safety Improvement Plan

Name

Capella university

NURS-FPX4035 Enhancing Patient Safety and Quality of Care

Prof. Name

Date

Root-Cause Analysis and Safety Improvement Plan

This template is provided as a guide to 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 study. However, all possibilities and questions should be fully considered in your quest for the “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?

● A patient received the wrong medication due to inadequate medication safety measures. Contributing factors included poor interprofessional communication, incomplete medication histories, lack of standardized procedures, and high workload pressures.
● The patient experienced adverse effects, resulting in delayed recovery and increased healthcare expenses. Healthcare staff faced challenges maintaining medication safety, and the hospital incurred additional costs due to prolonged treatment and corrective interventions.

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, a lack of safety culture, or inadequate leadership support.
Society/Culture: What role might cultural assumptions or backgrounds play?

Human Factors
● Communication Breakdowns: Incomplete or unclear communication among healthcare team members led to incorrect medication administration.
● Staff Fatigue: High workload and reliance on memory increased the likelihood of dosing and prescribing errors.
● Lack of Training: Staff lacked up-to-date training on new medications, drug interactions, and safe administration practices.

System Factors
● Workflow Processes: The absence of standardized medication reconciliation and verification procedures increased the risk of errors.
● Technology Gaps: Inadequate use or absence of electronic prescribing alerts and barcode scanning led to missed errors.
● Documentation Issues: Incomplete or outdated patient medication records contributed to harmful drug interactions.

Organizational Culture:
● Safety Culture: The institution lacked a strong culture of medication safety, leading to inconsistent adherence to best practices.
● Leadership Support: Limited leadership engagement in implementing clinical decision support systems and ongoing medication safety education.

Society/Culture:
● Cultural Assumptions: Patients with language or health literacy barriers were not fully educated about their medications or side effects, which reduced their ability to advocate for their own safety.

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.

Procedures and Policies:
● The hospital did not consistently implement validated tools such as Medication Decision Support Systems (MDSS) or electronic prescribing safeguards.

Were any steps that were not taken or did not happen as intended?
● Critical medication history and allergy information were not reviewed or communicated accurately during shift handovers.

Documentation:
● A review of medical records revealed missing medication reconciliation forms and inadequate documentation of administered drugs and adverse reactions.

Who was involved?:

Staff: Identify the roles of individuals directly involved in the event.
Supervisors and Managers: Investigate

Staff:

Nurses and pharmacists are responsible for administering medications accurately and providing patient education.

Supervisors and Managers:

Unit supervisors oversee medication safety protocols and ensure compliance with administration and documentation standards.

Was there a communication breakdown?:

Interdisciplinary Communication: Assess how well different teams communicated.
Patient-Provider Communication: Explore whether patients were informed and understood their care.

Interdisciplinary Communication:
● Lack of structured communication led to failures in conveying critical medication details, including dosage changes and potential drug interactions.

Patient-Provider Communication:
● Patients were not adequately informed about their prescribed medications, possible side effects, or the importance of adherence.

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.

Physical Environment:
● Lack of barcode scanners, unclear medication labeling, and disorganized medication storage areas contributed to administration errors.
Staffing Levels:
● Understaffing resulted in rushed medication rounds and reduced time for proper verification.
Training and Competency:
● Staff lacked adequate training in pharmacology, high-alert medications, and the use of electronic prescribing tools.

Did organizational policies or procedures play a role?:

Policy Compliance: Investigate if policies were followed.
Policy Clarity: Assess if policies are clear and accessible.

Policy Compliance:
● Medication safety protocols were not consistently followed, leading to procedural gaps.
Policy Clarity:
● Existing medication administration policies were vague and not fully integrated into the daily workflow.

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.

Vital Signs Monitoring:
● Patients receiving high-risk medications were not routinely monitored for early signs of adverse drug reactions.

Alarm Fatigue:
● Staff overlooked or delayed responding to medication alert systems due to frequent or non-specific warnings.

What can be learned to prevent recurrence?:

Lessons Learned: Identify systemic changes, training needs, and improvement opportunities.
Quality Improvement: Consider implementing preventive measures.

Lessons Learned:
● Structured training, standardized medication protocols, and clear interdisciplinary communication are critical for preventing medication errors.

Quality Improvement:
● Implement evidence-based strategies, such as Medication Decision Support Systems (MDSS), which significantly reduce prescribing and administration errors (Syrowatka et al., 2024).

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.

Risk Mitigation:
● Standardized medication reconciliation at admission, transfer, and discharge.
● Use of electronic prescribing, barcode scanning, and real-time alert systems to prevent errors.

Education and Training:
● Ongoing training programs on drug interactions, safe administration practices, and updates on high-risk medications.

Reporting and Feedback:
● Encourage non-punitive reporting of medication errors and near-misses to enhance learning and refine safety protocols.

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 made a situation turn out less than ideal

HFC

HF T

F/S

Incomplete Medication Reconciliation

Inadequate Communication During Shift Handover

Failure to use standardized reconciliation tools led to incorrect or missing medication data.

(Human Factor – Communication)

Human Factor-fatigue/scheduling

Poor interdisciplinary communication resulted in missed allergy information and dosage errors.

(Human Factor – Communication

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.

Medication errors (MEs) remain a significant risk to patient safety and usually lead to adverse drug events, prolonged hospitalizations, and extra healthcare expenditures. Research indicates that millions of patients are impacted by medication mistakes each year globally, and the costs associated with them are avoidable (up to £98.5 million in the UK) (Elliott et al., 2024). Among the contributing factors are failure to perform medication reconciliation, poor interdisciplinary communication, and lack of staff education about high-alert medications. Azadi and García-Peñalvo (2025) also found that Medication Decision Support Systems (MDSS) embedded in Electronic Health Records (EHRs) substantially decrease prescribing and administration errors, providing real-time alerts on drug interactions, allergies, and duplicate therapies. MDSS led to an observable reduction in adverse drug events and an increase in prescribing guideline compliance at facilities that implemented it.

The risk of MEs is further increased by communication failures that can occur during shift reports. Alizadeh-risani et al. (2024) stated that the introduction of structured communication tools (SBAR) leads to an increase in the accuracy of information transfer about medications. They found that nurses who received SBAR training demonstrated better medication documentation for patients and more prompt reporting of discrepancies compared to their non-trained peers. Additionally, continuous employee training is crucial in preventing mistakes. Ahmed and Rahman (2025) emphasized that ongoing professional education in pharmacology and safe medication practices enhanced staff competency and patient safety. Nurses who received frequent medication safety education were more likely to notice dosage mistakes and promote patient-based modifications. Last but not least, Ravi et al. (2022) emphasized the significance of the nurse-pharmacist collaboration in medication safety. Their results demonstrated that multidisciplinary rounds and shared decision-making resulted in a 32% decrease in medication discrepancies. The strategies crucial for reducing medication errors and enhancing healthcare quality include promoting teamwork, utilizing technology, and fostering a culture of safety.

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

The strategies identified—such as implementing Medication Decision Support Systems (MDSS), structured communication tools like SBAR, and continuous staff training—can directly address the safety issues and sentinel events related to medication errors in this scenario.

1. MDSS Integration: Embedding MDSS into Electronic Health Records (EHRs) can help prevent errors by flagging potential drug interactions, incorrect dosages, or duplicate prescriptions in real time. This is especially critical where incomplete documentation or rushed prescribing leads to high-risk mistakes.

2. Structured Handoffs (SBAR): Applying SBAR during shift changes ensures that all medication-related information, including allergies, previous adverse reactions, and current medications, is accurately communicated and documented. This addresses the root issue of poor interdisciplinary communication, helping to avoid missed or duplicated doses.

3. Staff Education and Training: Routine training on safe medication administration, updates on new drugs, and the use of assistive technologies equips healthcare providers with the knowledge needed to make informed decisions. This strategy directly counters the issue of insufficient staff preparation and reduces reliance on memory or outdated practices.

4. Team Collaboration: Encouraging nurse-pharmacist collaboration helps identify and resolve prescription issues before they reach the patient, thereby improving patient care. This proactive approach minimizes errors stemming from unclear prescriptions or dosage questions.

By systematically applying these evidence-based strategies, healthcare settings can significantly reduce medication-related sentinel events, enhance patient safety, and lower associated care costs.

Safety Improvement Plan

To address the root causes of patient falls, a structured action plan will be implemented using elimination (E), control (C), or acceptance (A) strategies.

List any future actions needed to prevent reoccurrence.

Action Plan

One for each Root Cause/Contributing Factor from above

E / C /

Choose one

Incomplete Medication Reconciliation

Implement Comprehensive Medication Reconciliation Protocols:
Ensure all medications are accurately documented at admission, transfer, and discharge using a standardized checklist to avoid omissions or duplications.

EHR Integration with Alerts:
Utilize Electronic Health Records with built-in alerts for missing or conflicting medication information during transitions of care.

Inadequate Communication During Shift Handover

Adopt Structured Handover Tools (e.g., SBAR):
Mandate the use of standardized communication frameworks during shift changes to ensure critical medication details are consistently transferred between care providers.

Interdisciplinary Collaboration:
Strengthen communication between nurses, pharmacists, and physicians during rounds and handovers to ensure shared accountability for medication accuracy.

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).

● Standardized Medication Reconciliation Policy:
A new hospital-wide policy will require complete medication reconciliation at every transition point—admission, transfer, and discharge—using a validated checklist to ensure accuracy.

● Mandatory Use of SBAR for Shift Handover:
Structured communication using SBAR will be implemented as a required component of all nursing shift reports to enhance clarity and consistency in the sharing of medication-related information.

● Ongoing Professional Development:
Staff will participate in quarterly training sessions focused on safe medication practices, reconciliation procedures, and the use of clinical decision support tools.

● EHR Enhancements:
Electronic Health Records will be upgraded to include medication reconciliation prompts, allergy alerts, and drug interaction warnings to support real-time error prevention.

● Interdisciplinary Case Review Meetings:
Monthly meetings involving nurses, pharmacists, and physicians will review medication error trends and evaluate adherence to new policies, encouraging continuous improvement.

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.

Goal

Desired Outcome

Timeline

Standardize medication reconciliation

100% accuracy in documenting patient medications at admission, transfer, and discharge

Months 1-2

Improve shift-to-shift communication

100% adherence to SBAR during handovers involving medication details

Months 3-4

Enhance staff competency in medication safety

≥90% of clinical staff trained in safe medication practices

Months 5-7

Reduce medication errors

30% reduction in medication errors related to reconciliation and handover

Analysis during 12th Month

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.

● Electronic Health Record (EHR) Enhancements:
Upgrade existing EHR systems to include prompts for medication reconciliation, allergy checks, and drug interaction alerts.

● Staff Training Modules:
Develop or procure evidence-based e-learning modules and workshops focused on medication safety, reconciliation procedures, and SBAR handoff communication.

● SBAR Tools and Templates:
Implement standardized SBAR templates (digital or print) to support consistent handovers across departments.

● Pharmacy Collaboration:
Leverage existing pharmacy staff for medication reconciliation support and cross-verification, particularly during high-risk transitions.

● Quality Improvement Team Support:
Engage the hospital’s QI team to monitor compliance, track medication error trends, and provide feedback for continuous improvement.

● Clinical Decision Support Systems (CDSS):
Incorporate or enhance current CDSS features within the EHR to assist with real-time medication verification.

● Leadership and Administrative Backing:
Ensure commitment from hospital leadership to allocate funding, adjust workflows, and support policy implementation efforts.

References:

Ahmed, R., & Rahman, T. (2025). Enhancing medication safety: The role of community and hospital pharmacists in modern healthcare systems. Deleted Journal, 2(3), 328–355. https://doi.org/10.56778/rjhs.v2i3.418

Alizadeh-risani, A., Mohammadkhah, F., Pourhabib, A., Fotokian, Z., & Khatooni, M. (2024). Comparison of the SBAR method and modified handover model on handover quality and nurse perception in the emergency department: A quasi-experimental study. BMC Nursing, 23(1). https://doi.org/10.1186/s12912-024-02266-4

Azadi, A., & García-Peñalvo, F. J. (2025). A synergistic bridge between human–computer interaction and data management within CDSS. Data, 10(5), 60. https://doi.org/10.3390/data10050060