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Indiana State Department of Health

ISDH Home > Health Care Quality & Regulatory > Acute Care/Hospitals > Clinical Laboratory (CLIA) Licensing and Certification Program 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.

Frequently Asked Questions

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
Lorraine Switzer
lswitzer@isdh.in.gov
(317) 233-7502
(317) 233-7495  [Secretary]

Report a Complaint or Incident to the ISDH

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 Report Form is for health care facilities to notify the Indiana State Department of Health of a reportable incident pursuant to the ISDH Reportable Unusual Occurrence Policy.  The Incident Report Form is also for health care 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.

Consumer Information

Centers for Medicare and Medicaid Services/CLIA

Advance Directives Resource Center

Directories

Directory of CLIA Laboratories

Employment Opportunities

Learn more about Employment Opportunities with the Indiana State Department of Health

Forms

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 are completed for change of ownership and Tax ID. 

The CMS 116 CLIA Applications may be completed for any changes. 

CMS 116 CLIA Application

Enclosure A Disclosure of Ownership

Enclosure I Methodology Test List

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 Code 16-41-12

Indiana Law and Rules Homepage

Indiana Register

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 Foundation

Office of Civil Rights

Program Information and Policies

State Operations Manual