A Checklist for FTCA Risk Assessment Compliance

For many health centers, the FTCA deeming process has become more demanding over the past few years. HRSA has tightened expectations, the FTCA Division has issued more warning notices, and more grantees are discovering—often too late—that their quarterly risk assessments were not as complete or defensible as they believed. A growing number of sites have faced rejection letters for issues ranging from missing methodology to vague analysis to incomplete action plans, putting their medical malpractice protections at risk.

Yet at their core, Quarterly FTCA Risk Assessments are not simply a compliance exercise. They are a safety mechanism. When done well, they help health centers step back every quarter, examine a clinical process with a critical lens, identify where patients may be exposed to harm, and take measurable steps to reduce malpractice risk. A strong, documented assessment becomes evidence of a health center’s commitment to safe, effective, and reliable patient care.

The problem is that many assessments fall short because they are treated as a form to fill out—not a process. HRSA has been exceptionally clear: a checklist alone is not a risk assessment. A narrative alone is not a risk assessment. A tool with “yes/no” answers and no explanation is not a risk assessment. To be compliant, the assessment must demonstrate a structured, clinical, and systematic approach to identifying, analyzing, prioritizing, and mitigating risks.

This is the heart of FTCA’s quarterly requirement: prove that your organization is actively reducing the likelihood of medical malpractice through a defensible, documented process.

To help leadership teams evaluate whether their own assessments truly meet FTCA expectations, we’ve created a comprehensive checklist that breaks down the essential elements reviewers look for. Rather than recreating every detail here, the list focuses on the major themes that every compliant assessment must include:

• A clearly defined clinical or patient-safety–focused topic.

• A systematic methodology describing how the assessment was conducted.

• Specific risks identified through data, observation, or analysis.

• A meaningful analysis that explains trends, severity, and contributing factors.

• A prioritization process demonstrating why certain risks rise to the top.

• A focused action plan that directly responds to the findings, not generic improvements.

• SMART goals that reflect the center’s intended outcomes.

• Measurable results that demonstrate whether the actions were effective.

• Documentation that is clear enough to be shared with governing boards and reviewers.

These components are not simply recommended—they reflect what HRSA and FTCA reviewers consistently expect to see. They are the elements that distinguish a well-executed risk assessment from one that triggers corrective action, warning notices, or jeopardizes deeming renewal.

When health centers use the quarterly rhythm to truly understand their risks, document their reasoning, and implement targeted mitigation strategies, they build a safer system for patient care. The operational benefit is clear: fewer preventable errors, more reliable processes, and a stronger culture of safety. The compliance benefit is equally important: an FTCA application that can stand up to scrutiny, supported by clear and complete documentation.

If your health center wants to strengthen its FTCA readiness, improve risk documentation, or simply ensure your assessments meet the current expectations, we encourage you to review the full Quarterly FTCA Risk Assessment Compliance Checklist. It offers a practical, detailed guide to help your team evaluate each assessment objectively and confidently. For more detailed reading on FTCA Quarterly Risk Assessments, check out our earlier blog post, “FTCA Quarterly Risk Management Assessments: A Crucial Tool for Community Health Centers”.

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Disclaimer: This blog post and checklist were created by RegLantern LLC as a general informational and educational resource. It is not reviewed, endorsed, or approved by HRSA, Acentra, ECRI, or any other governmental or private entity. RegLantern is an independent company and does not speak for, represent, or act on behalf of HRSA, Acentra, ECRI, or any other agency or organization. Nothing in this document should be construed as legal advice, risk-management advice, or a guarantee of FTCA coverage or compliance. Health centers and other users should consult directly with HRSA, their legal counsel, insurance carriers, and other qualified advisors for questions related to FTCA coverage, applications, denials, or other regulatory requirements, and should rely on official HRSA guidance and communications as the definitive source of requirements.