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Home » Topics & Services » Health Care Regulation » Clinical Lab Improvement Amendments (CLIA) » Application and Information

Application and Information


Laboratory Certificate Application Process

  • How to obtain a CLIA Certificate (CMS*) 
  • How to obtain a CLIA Certificate of Waiver (CMS) 
  • CLIA License Application CMS-116 and instructions (CMS) 
  • Making Changes to your CLIA Certificate
  • Laboratory Personnel Qualifications 
  • Laboratory Director Responsibilities (CMS) 

Medicare CPT Codes

  • List of CPT Codes Waived Tests (CMS) 
  • List of CPT Codes PPM Tests (CMS) 
  • List of CPT-4 and HCPCS Codes Non-waived Tests subject to edits (CMS) 

* CMS - Centers for Medicare & Medicaid Services

  • Health Care Facilities
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    • Free Standing Emergency Centers
    • Health Maintenance Organizations (HMOs)
    • Home Health Agencies
    • Home Nursing Agencies
    • Home Services Agencies
    • Home Services/Home Nursing Placement
    • Hospice
    • Hospitals
    • Out-Patient Physical Therapy/Speech Pathology
    • Portable X-Ray
    • Pregnancy Termination Facilities
    • Rural Health Centers
  • Health Care Worker Registry
    • CNA Facts
    • Disqualifying Convictions
  • Nursing Homes
    • Advance Directives
    • How to Select a Nursing Home
    • Quarterly Reports of Nursing Home Violators
    • Who Regulates Nursing Homes?
    • Veterans' Homes
  • Assisted Living
  • Clinical Lab Improvement Amendments (CLIA)
    • Application and Information
    • Forms
    • Frequently Asked Questions
    • Making Changes to your CLIA Certificate & CLIA Payment Instructions
  • File a Complaint
  • ICF/IID & SMHRF
  • Life Safety & Construction
    • ASTC Licensure
    • Frequently Asked Questions (FAQs)
    • Hospital Licensure
    • Nursing Home Licensure
    • Policies and Procedures
  • Life Care Facilities Program

Resources

Resources - Clinical Lab Improvement Amendments

CMS: CLIA
CMS: Individualized Quality Control Plan (IQCP)
CMS: Individualized Quality Control Plan (IQCP) Workbook
CMS: IQCP Frequently Asked Questions
CMS: List of CPT Codes Waived Tests
CMS: List of CPT Codes PPM Tests
CMS: List of CPT-4 and HCPCS Codes Non-waived Tests subject to edits (CMS)
Definitions
FDA: CLIA - Currently Waived Analytes
FDA: CLIA - Test Complexity Determination
IL Secretary of State Corporation/LLC Search
IRS: Not-for-profit (federal 501(c)(3) tax determination letter
OSHA Publications
OSHA State Plans
Pay for your CLIA Certificate On-Line
Medicaid Provider Enrollment
Medicare Provider Enrollment and Certification
Moderate Complexity Lab Director Course
  • Read more about Resources - Clinical Lab Improvement Amendments

Forms

Forms - Clinical Lab Improvement Amendments

PDF icon CMS-116 CLIA Application
PDF icon Complaint Form and Instructions
PDF icon Tissue and Sperm Bank Registration
PDF icon Clia Certificate Type Change
PDF icon Laboratory Name, Address, and Director Change
PDF icon Disclosure or Change of Ownership and Tax ID
PDF icon Example Letter of Release
PDF icon Health Wellness Event Requirements and Approval Request Form (for collection of specimens ONLY)
PDF icon Health Screening Event Requirements and Approval Request Form (for TESTING and COLLECTION of specimens)
PDF icon Laboratory Personnel Qualifications
PDF icon CMS 209 - Laboratory Personnel Report
PDF icon CLIA Payment Instructions
PDF icon Survey Checklist
PDF icon Post Clinical Laboratory Survey Questionnaire
  • Read more about Forms - Clinical Lab Improvement Amendments

Laws & Rules

Survey Operation Manual - Appendix C
Laboratory Record Retention Requirements
Illinois Clinical Laboratories Code
Illinois Sperm Bank and Tissue Bank Code

Publications

Publications - Clinical Lab Improvement Amendments

PDF icon CLIA Regulations How do they Affect my Lab (CDC)
PDF icon Verifications of Performance Specifications (CDC)
PDF icon Calibration and Calibration Verification (CDC)
PDF icon Equivalent Quality Control Procedures (CDC)
PDF icon Proficiency Testing - DOs and DON'T's (CDC)
PDF icon How to Perform Lab Personnel Competency Assessments (CDC)
PDF icon Individualized Quality Control Plan - IQCP (CDC & CMS)
PDF icon Good Laboratory Practices (CDC)
PDF icon Ready? SetTest! Patient Testing is Important. Get the Right Results (CDC)
PDF icon Laboratory Record Retention Requirements
PDF icon To Test or Not to Test Booklet - Considerations for Waived Testing (CDC)
PDF icon Survey Operation Manual – Appendix C
PDF icon How to Obtain a CLIA Certificate (CMS)
PDF icon How to Obtain a CLIA Certificate of Waiver (CMS)
PDF icon Laboratory Director Responsibilities (CMS)
  • Read more about Publications - Clinical Lab Improvement Amendments
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