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 ?
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.
Anastassiadis said: I feel honoured and humbled by the General Assemblys trust in me as CLIA Europe chair and I look forward to continuing the work and effectiveness of CLIA Europe in representing all of its members and ensuring the future success of the cruise industry.
Interestingly, the number of CLIA waivers varies by pharmacy format.
To better serve our Members, CLIA will bring all functions under one roof in Washington, DC," Duffy said.
Our CLIA certification is an important milestone in realizing our vision to build an open-access technology and capability platform that enables anyone and any company to discover and develop therapeutic products to benefit patients.
Little information is available in the literature on the frequency or types of sanctions for PT sample referral or result communication that are imposed under the CLIA regulations.
The outcome of those validation inspections, performed by CMS or our agents, the State survey agencies, will be our principal means for verifying that the laboratories accredited by ASHI remain in compliance with CLIA requirements.
And more Americans than ever are crazy for short cruises, making quick getaways another hot segment for the industry, according to CLIA.
Of all physician office labs that are registered with CLIA, 42% perform only waived tests.
A survey requesting information about tests performed before and after the implementation of CLIA was developed and mailed to all members of the rural practice section of the Washington Academy of Family Physicians.
One intent of CLIA was the regulation of smaller, provider-based laboratories, such as those operated by health-care providers in the Child Health and Disability Prevention (CHDP) program.
But, they argue, although CLIA standards may have started as a good idea, they quickly have become unnecessarily nit-picky.