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 ?
"Our territory has undergone a huge transformation in the use and occupation of the soil throughout the Central region, where there is a large percentage of the area occupied by the forest," said Clia Ramos, adding that "these territories must be always have an economic basis'.
CLIA Certifications cover everyone from students who want to learn about selling cruises, to new travel agents who can benefit from Accredited Cruise Counsellor, Master Cruise Counsellor and Elite Cruise Counsellor (ECC) and even cruise experts who want to specialise in a specific field such as meetings and events at sea or accessible travel, among others.
Off-label use under CLIA '88 requires providers to restrict the use of these devices to CLIA-waived operators.
In addition, many tests for analytes that were not originally included in the CLIA regulations are now in routine clinical use.
The betweenrun precision of the CLIA was performed using positive and negative controls, run once a day during the study period.
According to the company, the CLIA waived tests must meet stringent quality requirements to be used in non-laboratory POC settings.
Under the terms of the agreement, Orig3n's regenerative medicine research lab will remain in Boston's Innovation District and the genetic testing will be consolidated to Interleukin Genetics' CLIA laboratory.
Fluorescent Tre-ponemal Antibody - Absorption Test (FTA - ABS), T.pallidum haemagglutination assay (TPHA), enzyme immunoassay (EIA), and CLIA detect antibodies agai-nst T.pal-lidumantigens.4 The ICT uses T.pallidum specific antigens to detect antibodies against them in a card or strip format with visual read out.5
TheraLink is available now under CLIA and additional phospho-activation marker testing services are provided to the pharmaceutical industry.
Interestingly, the number of CLIA waivers varies by pharmacy format.
"With the globalization of CLIA, we have added new capabilities and expanded our resources in various parts of the world to support a growing cruise industry," said Christine Duffy, CLIA president and CEO.
CLIA standards relate to all clinical lab testing on specimens derived from humans in the U.S.