Clinical Laboratory Improvement Amendments
Encyclopedia
Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States
federal regulatory standards
that apply to all clinical laboratory
testing performed on humans in the United States, except clinical trials and basic research.
as any facility which performs laboratory
testing on specimens derived from humans for the purpose of providing information (1) for the diagnosis
, prevention
, or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
Centers for Medicare and Medicaid Services
(CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, Division of Laboratory Services.
The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
federal regulatory standards
Standardization
Standardization is the process of developing and implementing technical standards.The goals of standardization can be to help with independence of single suppliers , compatibility, interoperability, safety, repeatability, or quality....
that apply to all clinical laboratory
Medical laboratory
A medical laboratory or clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.-Departments:...
testing performed on humans in the United States, except clinical trials and basic research.
CLIA Program
In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratoryMedical laboratory
A medical laboratory or clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.-Departments:...
as any facility which performs laboratory
Laboratory
A laboratory is a facility that provides controlled conditions in which scientific research, experiments, and measurement may be performed. The title of laboratory is also used for certain other facilities where the processes or equipment used are similar to those in scientific laboratories...
testing on specimens derived from humans for the purpose of providing information (1) for the diagnosis
Diagnosis
Diagnosis is the identification of the nature and cause of anything. Diagnosis is used in many different disciplines with variations in the use of logics, analytics, and experience to determine the cause and effect relationships...
, prevention
Preventive medicine
Preventive medicine or preventive care refers to measures taken to prevent diseases, rather than curing them or treating their symptoms...
, or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
Centers for Medicare and Medicaid Services
Centers for Medicare and Medicaid Services
The Centers for Medicare & Medicaid Services , previously known as the Health Care Financing Administration , is a federal agency within the United States Department of Health and Human Services that administers the Medicare program and works in partnership with state governments to administer...
(CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, Division of Laboratory Services.
The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.