Clinical Laboratory Improvement Act

Clin·i·cal Lab·o·ra·to·ry Im·prove·ment Act

(CLIA) (klin'i-kăl lab'ră-tōr-ē im-prūv'mĕnt akt)
U.S. federal legislation, and the personnel and procedures established by it under the aegis of the Commission on Medicare and Medicaid Services (CMS), for the surveillance and regulation of all clinical laboratory procedures in the U.S.
References in periodicals archive ?
ISO 15189 and Clinical Laboratory Improvement Act (CLIA) laboratory accreditations.
In 1988, Congress passed the Clinical Laboratory Improvement Act, primarily in response to abuses found in physicians' office laboratories.
ResearchDx provides services including assay development, validation, and optimization for a clinical setting; study management and regulatory submissions; validation of laboratory-developed tests; test deployment in its Clinical Laboratory Improvement Act (CLIA) and College of American Pathologists (CAP) accredited laboratory; and in vitro diagnostic (IVD) kit manufacturing in its good manufacturing practice (GMP) facility.
Since we were already Clinical Laboratory Improvement Act waived, there was no additional certification needed," he said in an interview.
In the case of the laboratory, where it is customary for the test beverage to be given by a phlebotomist or technologist, we should be guided by provisions of CLIA'88 (the Clinical Laboratory Improvement Act of 1988).
Since the introduction of the Clinical Laboratory Improvement Act of 1988 every laboratory has faced new regulatory compliance challenges including Clinical Laboratory Improvement Amendments/Centers for Medicare and Medicaid Services (CLIA/CMS) pre-use verifications of the manufacturer's performance claims of each new instrument and method used in the laboratory.
The FDA, however, has approved the test for use only in labs that meet the requirements of the Clinical Laboratory Improvement Act.
Finally, quality management deals exclusively with US laboratories regulated under the Clinical Laboratory Improvement Act and Amendments.
Food and Drug Administration that its new ImmunoDip(R) microalbumin urine dipstick test has received waived status under the Clinical Laboratory Improvement Act of 1988 (CLIA).
However, decreasing staffing levels in clinical laboratories, increasingly strict performance standards based on the Clinical Laboratory Improvement Act, and the round-the-clock nature of labor and delivery services may represent the ultimate challenge to the rapid detection of group B streptococcus in hospital-based laboratories," noted Dr.
The Clinical Laboratory Improvement Act of 1988 (CLIA) limits how far health care facilities can go to reduce staffing costs while maintaining quality patient care.
In 1988, the federal government mandated, through the Clinical Laboratory Improvement Act (CLIA), a 10 percent random rescreening rate.

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