Agencies
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Clinical Lab Improvement Amendments (CLIA)
Overview
Welcome to the Illinois Clinical Laboratory Improvement Amendments (CLIA) Program. The program's mission is to ensure the highest quality of laboratory testing is performed in the state through the use of education and enforcement of state and federal CLIA regulations.
Services
Under CLIA, a laboratory is defined as a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. This program certifies, inspects and monitors clinical laboratories for compliance of state and federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable. Feel free to contact the program for answers to technical and regulatory questions.
Resources
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