Regulations and Quality Assurance in Laboratory Medicine: USA Experience

In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, per...

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Autor principal:	Sharon S. Ehrmeyer
Formato:	article
Lenguaje:	EN
Publicado:	De Gruyter 2006
Materias:	Clinical Laboratory Improvement Amendments (CLIA) laboratory quality regulations medical errors quality quality control quality assessment Biochemistry QD415-436
Acceso en línea:	https://doaj.org/article/d1e746365dcc413a9c37ee94aef83a10
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id	oai:doaj.org-article:d1e746365dcc413a9c37ee94aef83a10
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spelling	oai:doaj.org-article:d1e746365dcc413a9c37ee94aef83a102021-12-02T12:47:57ZRegulations and Quality Assurance in Laboratory Medicine: USA Experience0250-46851303-829Xhttps://doaj.org/article/d1e746365dcc413a9c37ee94aef83a102006-12-01T00:00:00Zhttp://www.turkjbiochem.com/2006/161.pdfhttps://doaj.org/toc/0250-4685https://doaj.org/toc/1303-829XIn the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, performance requirements or safeguards are designed to prevent testing errors. The U.S. Institute of Medicine found that testing processes fail as a result of human error, lack of documentation and lack of test management. To ensure quality, we must focus on all three phases of the testing process – pre-analytical, analytical, post-analytical. We can no longer just hope that quality will happen as a result of following a series of prescribed protocols – rules, regulations, good laboratory practices, etc. Quality laboratory test results requires planning, leadership and oversight.Sharon S. EhrmeyerDe GruyterarticleClinical Laboratory Improvement Amendments (CLIA)laboratory qualityregulationsmedical errorsqualityquality controlquality assessmentBiochemistryQD415-436ENTürk Biyokimya Dergisi, Vol 31, Iss 4, Pp 161-163 (2006)
institution	DOAJ
collection	DOAJ
language	EN
topic	Clinical Laboratory Improvement Amendments (CLIA) laboratory quality regulations medical errors quality quality control quality assessment Biochemistry QD415-436
spellingShingle	Clinical Laboratory Improvement Amendments (CLIA) laboratory quality regulations medical errors quality quality control quality assessment Biochemistry QD415-436 Sharon S. Ehrmeyer Regulations and Quality Assurance in Laboratory Medicine: USA Experience
description	In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, performance requirements or safeguards are designed to prevent testing errors. The U.S. Institute of Medicine found that testing processes fail as a result of human error, lack of documentation and lack of test management. To ensure quality, we must focus on all three phases of the testing process – pre-analytical, analytical, post-analytical. We can no longer just hope that quality will happen as a result of following a series of prescribed protocols – rules, regulations, good laboratory practices, etc. Quality laboratory test results requires planning, leadership and oversight.
format	article
author	Sharon S. Ehrmeyer
author_facet	Sharon S. Ehrmeyer
author_sort	Sharon S. Ehrmeyer
title	Regulations and Quality Assurance in Laboratory Medicine: USA Experience
title_short	Regulations and Quality Assurance in Laboratory Medicine: USA Experience
title_full	Regulations and Quality Assurance in Laboratory Medicine: USA Experience
title_fullStr	Regulations and Quality Assurance in Laboratory Medicine: USA Experience
title_full_unstemmed	Regulations and Quality Assurance in Laboratory Medicine: USA Experience
title_sort	regulations and quality assurance in laboratory medicine: usa experience
publisher	De Gruyter
publishDate	2006
url	https://doaj.org/article/d1e746365dcc413a9c37ee94aef83a10
work_keys_str_mv	AT sharonsehrmeyer regulationsandqualityassuranceinlaboratorymedicineusaexperience
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Regulations and Quality Assurance in Laboratory Medicine: USA Experience

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