Effect of legislation (CLIA'88) on setting quality specifications for US laboratories

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandated, in response to concern over the perceived quality of clinical laboratory testing, universal regulation for all testing sites in the USA, including previously unregulated sites in physician offices. The intent of CLIA...

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Veröffentlicht in:Scandinavian journal of clinical & laboratory investigation 1999, Vol.59 (7), p.563-567
Hauptverfasser: EHRMEYER, S. S, LAESSIG, R. H
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container_title Scandinavian journal of clinical & laboratory investigation
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creator EHRMEYER, S. S
LAESSIG, R. H
description The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandated, in response to concern over the perceived quality of clinical laboratory testing, universal regulation for all testing sites in the USA, including previously unregulated sites in physician offices. The intent of CLIA'88 is to ensure quality of testing through a combination of total quality management and mandated minimum quality practices. CLIA also defines, intentionally or unintentionally, through its proficiency testing requirements, intralaboratory performance standards. Meeting these requirements has been a prime motivator in improving laboratory performance. Seven years after the implementation of CLIA'88, the percentage of laboratories passing proficiency testing has increased and most laboratories have implemented quality practices.
doi_str_mv 10.1080/00365519950185364
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source MEDLINE; Taylor & Francis Medical Library - CRKN; Access via Taylor & Francis
subjects Analytical biochemistry: general aspects, technics, instrumentation
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Clinical Laboratory Techniques - standards
Fundamental and applied biological sciences. Psychology
Humans
Investigative techniques, diagnostic techniques (general aspects)
Laboratories - legislation & jurisprudence
Laboratories - standards
Medical sciences
Miscellaneous. Technology
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Quality Control
United States
title Effect of legislation (CLIA'88) on setting quality specifications for US laboratories
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