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 ?
Assessing targeted protein workflows with Thermo Scientific's new generation Triple Quadrupole mass spectrometers for large quantitation assays within a Clinical Laboratory Improvement Amendments (CLIA) environment.
Genomind's advanced lab has the highest level of accreditations, meeting Clinical Laboratory Improvement Amendments, College of American Pathologists, and New York State Department of Health standards.
This change took effect at the start of 2016 and requires laboratories to perform routine quality control in accordance with Clinical Laboratory Improvement Amendments (CLIA), or establish their own risk-based ICQP plan demonstrating QC performance intervals out to 3days if the manufacturer's instructions allow it.
The test is not Food and Drug Administration approved but has been validated in accordance with Clinical Laboratory Improvement Amendments.
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.
Let's eliminate the Clinical Laboratory Improvement Amendments (CLIA).
The fact that quality control and quality assurance activities for NGS must address both the wet-bench and dry-bench components of the analytic phase of testing raises several unique challenges for proficiency testing (PT) and external quality assessment as mandated by the Clinical Laboratory Improvement Amendments of 1988.
This waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
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 company is CLIA (Clinical Laboratory Improvement Amendments) certified for laboratory, Medicare and Medicaid certified, and has contracts with major health plans.
He noted that while clinical labs and some CDC labs are subject to the federal Clinical Laboratory Improvement Amendments of 1988, which address quality measures, research labs are not.

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