Agencies
Services
Application and Information
Laboratory Certificate Application Process
Medicare CPT Codes
* CMS - Centers for Medicare & Medicaid Services
Resources
- 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
Forms
- Complaint Form and Instructions
- Example Letter of Release
- CMS 209 - Laboratory Personnel Report
- CLIA Payment Instructions
- Survey Checklist
- Post Clinical Laboratory Survey Questionnaire
- CMS-116 CLIA Application
- Disclosure or Change of Ownership and Tax ID
- Health Screening Event Requirements and Approval Request Form (for TESTING and COLLECTION of specimens)
- Tissue and Sperm Bank Registration
- Health Wellness Event Requirements and Approval Request Form (for collection of specimens ONLY)
- Laboratory Personnel Qualifications
- Laboratory Name, Address, and Email Change
- Laboratory Director Qualifications
Laws & Rules
Publications
- CLIA Regulations How do they Affect my Lab (CDC)
- Verifications of Performance Specifications (CDC)
- Calibration and Calibration Verification (CDC)
- Equivalent Quality Control Procedures (CDC)
- Proficiency Testing - DOs and DON'T's (CDC)
- How to Perform Lab Personnel Competency Assessments (CDC)
- Individualized Quality Control Plan - IQCP (CDC & CMS)
- Good Laboratory Practices (CDC)
- Ready? SetTest! Patient Testing is Important. Get the Right Results (CDC)
- Laboratory Record Retention Requirements
- To Test or Not to Test Booklet - Considerations for Waived Testing (CDC)
- Survey Operation Manual – Appendix C
- How to Obtain a CLIA Certificate (CMS)
- How to Obtain a CLIA Certificate of Waiver (CMS)
- Laboratory Director Responsibilities (CMS)