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Improving Vaccine Administration Accountability Through Structured Risk Analysis

By ASHRM Forum posted 11 hours ago

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by Dr. Himanshu Tiwari, MBBS, MPH, MHA, CPHQ, CPHRM

How a Community Clinic Reduced Immunization Documentation Errors and Strengthened Compliance

Abstract
Increased regulatory scrutiny and workforce strain are challenging healthcare organizations to improve clinical safety without compromising workflow. This case study outlines a vaccine accountability improvement initiative at a community health clinic in Arizona. Using root cause analysis, data tracking, and targeted interventions, the team achieved a measurable and sustainable reduction in immunization documentation errors. The findings offer practical insights for risk management leaders seeking to build reliable, frontline-owned safety systems.

Introduction
Amid mounting regulatory expectations and limited clinical staffing, even routine healthcare procedures are susceptible to risk. At Sun Life Health’s Casa Grande Clinic, a surge in patient visits combined with medical assistant (MA) shortages revealed inconsistencies in vaccine documentation and dose accountability. These errors posed patient safety, compliance, and reputational risks.

This article presents a structured approach to identifying and addressing these vulnerabilities through a multidisciplinary quality improvement process. The outcome demonstrates the effectiveness of data-driven, frontline-engaged risk mitigation strategies.

The Problem: Documentation Lapses in a High-Pressure Environment
In early 2024, Sun Life Health identified a recurring pattern of errors in immunization records. Specific problems included missing vaccine lot numbers, incomplete verification documentation, and misclassification of eligibility status (e.g., Vaccines for Children [VFC] vs. Private).

The implications of these errors were significant: potential breaches of Health Resources & Services Administration (HRSA) and Vaccine for Children (VFC) program standards, inaccurate patient records, and increased liability exposure. A gap analysis revealed several contributing factors:
- Undefined task prioritization for MAs
- Inconsistent availability of second verifiers
- Electronic medical record (EMR) forms lacking required field validations
- Limited real-time supervisory support during high-volume hours

Team Identification: Assembling the Right Voices
Successful risk mitigation depends on involving the right stakeholders. For this project, we identified process owners, experts, end users, and “fresh eyes” from across the organization. Each team member played a defined role in ensuring comprehensive problem-solving.

Methodology
The project followed a structured quality improvement model, incorporating root cause analysis (RCA) using a Lean approach and Plan-Do-Study-Act (PDSA) cycles. Key steps included:
- Mapping of all vaccine administration workflows
- Identification of skipped or inconsistently performed steps
- Collaborative solution brainstorming
- Development of an action plan with clear responsibilities and timelines

This participatory approach facilitated buy-in from clinical staff and ensured practical, context-sensitive solutions.

Key Risk Insights
The risk assessment categorized process gaps based on severity and likelihood of recurrence. Two key risks emerged:
1. Documentation Gaps: Missing or incomplete entries for lot numbers, site of administration, and Vaccine Information Statements (VIS).
2. Verification Gaps: The absence of documented two-person verification to ensure all pieces of vaccine documentation and accountability forms is completed accurately, a standard safety measure. Below is an example of the Vaccine Documentation and Eligibility Form:

Additional identified gaps included:
- A: Undefined MA task priorities
- B: Inadequate availability of second verifiers
- C: Poorly defined documentation responsibilities
- D: EMR lacking hard stops to enforce data entry
- E: Rushed tasks due to overbooked schedules

Severity was rated as moderate to high, with a high likelihood of recurrence if left unaddressed.

Targeted Solutions
A summary of the targeted interventions is provided below:

We engaged our senior leadership team as part of regular rounding at the clinic in line with the Gemba walk. The expectation was that the leaders to be present to show their support, commitment, and guidance to help with the resources needed.

Vaccine Documentation and Eligibility Form with hard stops (red asterisk) in place

Line items marked with red asterisks were made mandatory.

Measuring Impact
PDSA cycles were used to assess intervention success. The most effective change was the assignment of two dedicated verifiers for all vaccine administrations. Implementation began in May 2024.

Counter Measures Implementation Table

Key Insights from Counter Measures

Iterative Approach to Process Improvement: The team piloted various countermeasures, such as the Buddy System for secondary verification, which, despite a four-week trial, was deemed unsuccessful. This willingness to test and abandon ineffective solutions demonstrates a commitment to finding what works empirically.
Emphasis on Feedback and Staff Engagement: The back-office team was actively involved in sharing feedback on effective ways to remember the second verification. Practical suggestions, such as printing extra labels with reminders, indicate a collaborative environment and attention to operational details.
Leveraging High Performers and Individual Accountability: High performers were consulted on error minimization, with their measures trialed across the team.
Designate Mandatory 2nd Vaccine Verification Experts(s): Subsequently, the designation of specific individuals (Vaccine Specialist (LPN) and a Chronic Disease State Specialist) for mandatory second verification roles helped ensure accountability and process adherence. Both vaccine experts to verify all vaccinations for 4 weeks starting 5/7/24 using Teams Group Chat and Messaging tool as a pilot project.
Targeted Training and Process Documentation: Vaccine Management training was restructured, with temporary task assignment and the introduction of a "See, Do, Teach" training model for new hires. Two leads were identified to guide training, underscoring the importance of practical and mentorship-based onboarding.
Continuous Monitoring and Visual Aids: The implementation includes posting colored graphs and cheat sheets for staff, creating visibility around performance and error rates. Leads are tasked with double-checking documentation, reinforcing a culture of consistency and vigilance.
Addressing Barriers and Challenges: The table candidly records increased errors during specific weeks, detailing barriers such as reliance on leads within pods and insufficient communication about available leads. This transparency supports targeted interventions.
Standard Operating Procedure (SOP) Refinement: Modifications to the SOP, with double-checking by leads and incorporation of new steps to address evolving challenges. The revision of reporting protocols, particularly for RLDatix, our Incident Reporting System, demonstrates adaptability in both documentation and data management.
Goal Setting and Data-Driven Adjustments: Performance targets have been actively revised—from an initial 8% error rate goal to a more ambitious 5%, with considerations for further reductions to 3%. These changes are supported by the maintenance of data tables and graphs, reflecting a commitment to measurable improvement.
Cross-Site Collaboration and Spread Events: There is evidence of process improvement initiatives being extended to other sites, with meetings and spread events involving multidisciplinary teams. This highlights scalability and the value of sharing best practices beyond the initial site.
Continuous Improvement Culture: Many initiatives are listed as "Continuous," showing the team's recognition that process improvement is not a one-time event but requires sustained attention and adaptation over time.

Vaccine Accountability Documentation Weekly Errors – Analysis

This chart illustrates weekly error rates in vaccine accountability documentation over time, with comparison against the organizational goal and medical assistant (MA) coverage rates.

Initial Period (Weeks 1–20): Early weeks show high variability, with error rates frequently exceeding 20%, peaking at 25.7%. Despite fluctuations in MA coverage, documentation errors remained consistently above the target threshold (8%).
Intervention Impact: Around Week 20, “Designated identifier(s)” were implemented. Following this intervention, there is a clear and sustained reduction in errors, with rates steadily declining toward zero in several consecutive weeks.
Recent Performance (Weeks 20–43): The average weekly error rate decreased to 5.79%, now below the goal and showing greater consistency. Several weeks achieved 0% error, suggesting process stabilization and improved documentation accuracy.
Overall Trend: The 2-period moving average (yellow line) confirms a strong downward trend post-intervention, demonstrating that corrective actions were effective and sustained over time.

Results from statistical process control (SPC) analysis were conclusive:
- Nine consecutive data points below the confirmed sustained process improvement per Nelson’s Rule 2
- Documentation error rates declined from 25% to near 0% over 12 weeks
This indicated not a temporary correction, but a systemic shift in practice.

Summary
Implementation of designated identifiers significantly improved vaccine documentation accuracy, reducing errors from an average of over 20% to under 6%. Continued adherence to these practices will help maintain compliance and reliability in vaccine accountability processes.

Lessons for Risk Leaders
1. Frontline Ownership Is Key: Inclusion fosters engagement and relevant insights.
2. Technology Alone Is Not Enough: EMRs should support, not replace, human accountability.
3. Use Data to Drive Change: Control charts increased staff awareness and motivation.
4. Assign Responsibility Clearly: Individual accountability outperforms shared responsibility in high-risk tasks.
5. Train Across Sites: Error rates rose when temporary MAs were assigned, highlighting the need for better cross-site training.

Looking Ahead
Future improvements will focus on automating vaccine verification through barcode scanning and enhancing EMR functionality with locked fields. However, the most valuable outcome remains cultural: a shared commitment to accuracy, accountability, and continuous improvement.

Author
Himanshu Tiwari, MBBS, MPH, MHA, CPHQ, CPHRM, is a physician by trade and serves as Director of Quality & Risk at Sun Life Health, Casa Grande- AZ. He leads enterprise-wide patient safety, regulatory compliance, and clinical risk initiatives. His work focuses on integrating frontline feedback with operational data to drive sustainable healthcare improvements.

References
• Agency for Healthcare Research and Quality. (2019). Root cause analysis toolkit. https://www.ahrq.gov/patient-safety/resources/index.html
• Centers for Disease Control and Prevention. (2022). Vaccine storage and handling toolkit. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

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