Regulations and Quality Assurance in Laboratory Medicine: USA Experience

Autor: Sharon S. Ehrmeyer
Jazyk: angličtina
Rok vydání: 2006
Předmět:
Zdroj: Türk Biyokimya Dergisi, Vol 31, Iss 4, Pp 161-163 (2006)
Druh dokumentu: article
ISSN: 0250-4685
1303-829X
Popis: 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.
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