Clinical Laboratory (CLIA) Licensing and Certification Program
The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
A laboratory under CLIA is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 189,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.
The Indiana Department of Health (IDOH) inspects laboratories for compliance with the standards and specific requirements of CLIA. IDOH surveyors visit laboratories bi-annually for a certificate of compliance or more often if complaints are filed about a laboratory.
Contact the Program
Indiana Department of Health
Division of Acute Care
2 North Meridian Street, 4A
Indianapolis, IN 46204
(317) 233-7474 (Acute Care Receptionist)
(317) 233-1325 (IDOH Main Switchboard)
(317) 233-7495 (Secretary)
Report a Complaint or Incident to the IDOH
Report a complaint regarding a healthcare facility
Individuals can call or email to make complaints about care provided by any licensed or certified Indiana healthcare providers or suppliers.
Report an incident regarding a healthcare facility
The Incident Report Form is for healthcare facilities to notify the Indiana Department of Health of a reportable incident pursuant to the IDOH Reportable Unusual Occurrence Policy. The Incident Report Form is also for healthcare facility staff (nursing homes, intermediate care facilities, and hospice agencies) to report a reasonable suspicion of a crime against a resident pursuant to Federal regulations. This form is not to be used to file a complaint.
All forms (CMS 116 CLIA Application, Enclosure A Disclosure of Ownership and Enclosure I Methodology Test list) must be completed and signed and appropriate documentation attached for initial certificates and most changes of certificate type.
The CMS 116 CLIA Application and Enclosure A Disclosure of Ownership is completed for change of ownership and Tax ID.
The CMS 116 CLIA Applications may be completed for any changes.
Laws and Regulations
Federal Laws and Regulations
- 42 CFR 493 (Laboratory requirements)
- State Operations Manual Appendix C
- Code of Federal Regulations (CFR) Homepage
State Laws and Rules
- American Health Information Management Association
- Association of Professionals in Infection Control and Epidemiology
- Indiana Donor Network
- Clinical Laboratory Management Association
- American Society for Clinical Laboratory Science
- American Society for Clinical Pathologists
- Organ Procurement and Transportation Network
- Agency for Healthcare Research and Quality (AHRQ)
- Americans with Disabilities Act (ADA)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare and Medicaid Services (CMS)
- National Patient Safety Foundation
- Office of Civil Rights