NDLI: Is CLIA 2003 the quality alliance envisioned between manufacturers, laboratory professionals, and regulatory agencies?

Content Provider	Springer Nature Link
Author	Ehrmeyer, Sharon S. Laessig, Ronald H.
Copyright Year	2004
Abstract	The Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) had a groundbreaking effect on laboratory professionals, instrument and reagent manufacturers, and regulators in the United States, and by association, worldwide. CLIA’88 defined new levels of responsibility for all three of these stakeholders in modern laboratory testing. As a result, we envisioned a CLIA-driven approach to regulations, which in effect, created a three-member “quality alliance.” In 2003, the long awaited CLIA updates to the quality control and quality assurance requirements were published. The revisions in CLIA 2003 will herald an era in which manufactures take responsibility for meeting new standards of quality (improved accuracy and precision or reduced total allowable error) in the clinical laboratory and, especially, at point of care where testing is performed by non-laboratorians. The European (Bureau International des Poids ed Mesures) efforts at traceability, the National Committee of Clinical Laboratory Standards efforts at estimating total allowable error, and the new CLIA 2003 quality systems approach for quality requirements return to the fundamental concepts of accuracy to assess the efficacy of clinical laboratory testing.
Starting Page	145
Ending Page	147
Page Count	3
File Format	PDF
ISSN	09491775
Journal	Accreditation and Quality Assurance
Volume Number	9
Issue Number	3
e-ISSN	14320517
Language	English
Publisher	Springer-Verlag
Publisher Date	2003-12-18
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Quality alliance Assured quality CLIA’88 CLIA 2003
Content Type	Text
Resource Type	Article
Subject	Chemistry Instrumentation Chemical Engineering Safety, Risk, Reliability and Quality

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
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Accreditation and Quality Assurance : Volume 8, Issue 9, September 2003

Accreditation and Quality Assurance : Volume 8, Issue 10, October 2003

Is CLIA 2003 the quality alliance envisioned between manufacturers, laboratory professionals, and regulatory agencies?

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