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 ?
Predictive Laboratories said it owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a "high complexity" molecular diagnostic laboratory operating under the Clinical Laboratory Improvement Act.
Under the Clinical Laboratory Improvement Act (CLIA), the Centers for Medicare & Medicaid Services (CMS) has regulated laboratories that develop LDTs.
I graduated AIT prior to the Clinical Laboratory Improvement Act so certification was not an issue and neither was degree completion.
Caption: Proposed creation of Certified Advanced Companion Diagnostics Facilities accredited by the College of American Pathologists under commission by the US Food and Drug Administration in accordance with the Clinical Laboratory Improvement Act.
In 1988, Congress passed the Clinical Laboratory Improvement Act, primarily in response to abuses found in physicians' office laboratories.
Since we were already Clinical Laboratory Improvement Act waived, there was no additional certification needed," he said in an interview.
Chembio anticipates receiving a CLIA (Clinical Laboratory Improvement Act) waiver from the FDA for these products soon, which will greatly expand the number of potential professional sites at which these tests could be performed.
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.
([section]) Clinical Laboratory Improvement Act of 1988; established quality standards for all laboratories to ensure accuracy, reliability, and timeliness of clinical tests.
OvaCheck and other lab-developed tests are regulated by the College of American Pathologists under the federal Clinical Laboratory Improvement Act.

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