Clinical Laboratory CLIA Compliance Inspection Checklist [FREE PDF]
This clinical laboratory CLIA compliance inspection checklist ensures clinical labs operating under CLIA certificates comply with 42 CFR Part 493 and CAP accreditation requirements. Laboratory directors and quality managers use this to prepare for biennial CLIA inspections and maintain ongoing compliance.
- Industry: Laboratory
- Frequency: Semi-Annually
- Estimated Time: 45-60 minutes
- Role: Laboratory Director / Quality Manager
- Total Items: 9
- Compliance: CLIA 88 (42 CFR Part 493), CAP (College of American Pathologists) accreditation standards, CMS Survey and Certification for CLIA, COLA accreditation requirements
Quality Control
Verify quality control practices meet CLIA requirements.
- QC performed each day of patient testing per manufacturer requirements?
- All QC results documented with acceptance criteria applied?
- Proficiency testing (PT) enrolled for all regulated analytes?
- PT results reviewed and passing grade maintained?
Personnel & Equipment
Verify personnel qualifications and equipment maintenance.
- Laboratory director meets CLIA qualification requirements for lab complexity?
- All testing personnel meet CLIA education and training requirements?
- Equipment maintenance logs current per manufacturer schedule?
- Reference ranges verified for patient population?
- CLIA compliance notes
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Why Use This Clinical Laboratory CLIA Compliance Inspection Checklist [FREE PDF]?
This clinical laboratory clia compliance inspection checklist [free pdf] helps laboratory teams maintain compliance and operational excellence. Designed for laboratory director / quality manager professionals, this checklist covers 9 critical inspection points across 2 sections. Recommended frequency: semi-annually.
Ensures compliance with CLIA 88 (42 CFR Part 493), CAP (College of American Pathologists) accreditation standards, CMS Survey and Certification for CLIA, COLA accreditation requirements. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Clinical Laboratory CLIA Compliance Inspection Checklist [FREE PDF] cover?
This checklist covers 9 inspection items across 2 sections: Quality Control, Personnel & Equipment. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed semi-annually. Each completion takes approximately 45-60 minutes.
Who should use this Clinical Laboratory CLIA Compliance Inspection Checklist [FREE PDF]?
This checklist is designed for Laboratory Director / Quality Manager professionals in the laboratory 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.