Clinical Laboratory CLIA Audit
This Clinical Laboratory CLIA Audit ensures thorough verification and compliance with CLIA, CMS, State Lab Licensure requirements. Designed for Lab Directors, this checklist provides 27+ detailed inspection points across 6 sections. Applicable across US markets.
- Industry: Healthcare
- Frequency: Monthly
- Estimated Time: 30-60 minutes
- Role: Lab Director
- Total Items: 32
- Compliance: CLIA, CMS, State Lab Licensure
Pre-Audit Preparation
Initial setup and documentation review.
- Audit scope defined?
- Previous findings reviewed?
- Required documentation available?
- Personnel notified?
- Audit tools prepared?
Documentation Review
Verify documentation completeness and accuracy.
- Policies current?
- Records complete?
- Retention requirements met?
- Training records current?
- Licenses valid?
Process Observation
Direct observation of operations.
- Procedures followed?
- Equipment maintained?
- Safety protocols followed?
- Environment controlled?
- Controls effective?
- Housekeeping adequate?
Compliance Verification
Verify regulatory compliance.
- Regulatory requirements met?
- Compliance monitoring in place?
- Corrective action process effective?
- Updates communicated?
- External findings addressed?
Risk Assessment
Evaluate risk management.
- Risks identified?
- Risk controls working?
- Monitoring adequate?
- Incidents reviewed?
Findings and Actions
Document findings and corrective actions.
- Findings documented?
- Severity classified?
- Root cause initiated?
- Actions assigned?
- Follow-up scheduled?
- Overall Rating
- Summary Notes
Related Healthcare Checklists
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Why Use This Clinical Laboratory CLIA Audit?
This clinical laboratory clia audit helps healthcare teams maintain compliance and operational excellence. Designed for lab director professionals, this checklist covers 32 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with CLIA, CMS, State Lab Licensure. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Clinical Laboratory CLIA Audit cover?
This checklist covers 32 inspection items across 6 sections: Pre-Audit Preparation, Documentation Review, Process Observation, Compliance Verification, Risk Assessment, Findings and Actions. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-60 minutes.
Who should use this Clinical Laboratory CLIA Audit?
This checklist is designed for Lab Director professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.