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
Format: Artikel
Sprache:eng
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Zusammenfassung: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.
ISSN:0036-5513
1502-7686
DOI:10.1080/00365519950185364