Clinical Laboratory (CLIA) Licensing and Certification Program
Program Overview
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 State Department of Health (ISDH) inspects laboratories for compliance with the standards and specific requirements with CLIA. ISDH surveyors visit laboratories bi-annually for certificate of compliance or more often if complaints are filed about a laboratory.
Contact the Program
Indiana State Department of Health
Division of Acute Care
2 North Meridian Street, 4A
Indianapolis, IN 46204
(317) 233-7474 (Acute Care Receptionist)
(317) 233-1325 (ISDH Main Switchboard)
Map
Program Manager
Wanda Proffitt
wproffit@isdh.in.gov
(317) 233-7502
(317) 233-7495 [Secretary]
Report a complaint regarding a health care facility
Individuals can call or email to make complaints about care provided at any licensed or certified Indiana health care providers or suppliers.
Report an incident regarding a health care facility
The Incident Reporting Form is only for facilities to notify the Indiana State Department of Health of an unusual occurence. This form is not to be used to file a complaint.
Consumer Information
Centers for Medicare and Medicaid Services/CLIA
Directories
Directory of CLIA Laboratories
Employment Opportunities
Learn more about Employment Opportunities with the Indiana State Department of Health
Forms
Centers of Medicare and Medicaid Services Forms
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
Indiana Law and Rules Homepage
Limited Criminal History Search
Links
Professional Organizations
American Health Information Management Association
Association of Professionals in Infection Control and Epidemiology
Indiana Organ Procurement Organization
Clinical Laboratory Management Association
American Society for Clinical Laboratory Science
American Medical Technologists
American Society for Clinical Pathologists
State Government
Indiana Public Access Counselor
Federal Government
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)
Health Care Excel (HCE)
National Patient Safety Organization
Program Information and Policies
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