CLIA

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CLIA

Abbreviation for Clinical Laboratory Improvement Amendments. Federal legislation and the personnel and procedures established by it under the aegis of the Health Care Financing Administration (HCFA) for the surveillance and regulation of all clinical laboratory procedures in the United States.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) were passed by Congress in response to public concerns about the quality of laboratory testing, particularly in physician's office laboratories and in Papanicoloau smear interpretation. This legislation brought all 150,000 U.S. clinical laboratories, including physician's office laboratories, under uniform regulations. A clinical laboratory is defined as any facility where materials derived from the human body are examined for the purpose of providing information for the diagnosis, prevention, or treatment of disease or the assessment of health. Standards applied to laboratory personnel and procedures are based on test complexity and potential harm to the patient. The regulations establish application procedures and fees for CLIA registration, enforcement and surveillance methods, and sanctions applicable when laboratories fail to meet standards. CLIA regulations define three categories of testing complexity: waived, moderate, and high. For tests of moderate or high complexity, the laboratory must participate in a continuing program of proficiency testing whereby an independent laboratory periodically submits specimens of known composition for testing.

CLIA

Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a response to a test result. See HCFA, POLs, Waived tests.

CLIA

Abbreviation for Clinical Laboratory Improvement Act.

CLIA

(klē′ă)
Clinical Laboratory Improvement Amendments (the U.S. legal amendments regulating and overseeing privately run medical laboratories).
References in periodicals archive ?
Molecular diagnostics company Cepheid revealed on Tuesday the receipt of US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert Xpress Flu test for the detection of multiple segments of RNA.
Global genomics company, BGI, today announced that it has obtained Clinical Laboratory Improvement Amendments (CLIA) certificate of registration for its Hong Kong based laboratory.
Other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements.
The agency also said other laboratory-developed tests will need in-house validations to adequately characterize the performance of the assay and meet Clinical Laboratory Improvement Amendments requirements.
The relevant requirement from the Clinical Laboratory Improvement Amendments of 1988 is: "The laboratory must immediately alert the individual .
AlloMap test has been available since January 2005 as a Laboratory Developed Test (LDT) performed in the XDx Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, and has been ordered at more than 50 US transplant centers.
The report calls for the development of enforcement methods against labs performing genetic tests for clinical purposes without Clinical Laboratory Improvement Amendments certification or making false or misleading claims about genetic tests.
and Baylor College of Medicine today announced that Baylor has obtained a non-exclusive worldwide license to a number of Affymetrix patents covering comparative genomic hybridization (CGH) microarray services in Clinical Laboratory Improvement Amendments (CLIA) environments.
All clinical lab services are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Clinical Laboratory Improvement Act of 1988, currently Clinical Laboratory Improvement Amendments.
In the US these include the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (2), Genetic Testing Under the Clinical Laboratory Improvement Amendments (3), New York State Department of Health Laboratory Standards (4), the College of American Pathologists (CAP) checklist for molecular pathology laboratories (5), the American College of Medical Genetics (ACMG) Standards and Guidelines for Clinical Genetics Laboratories (6), and a NCCLS guideline (7).
Rapid strep antigen tests now on the market fall into two categories based on the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

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