Clinical Chemistry Siemens Point of Care - Urinalysis
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 43: 893-896, 1997;
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via ISI Web of Science (1)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Phillips, D. L.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Phillips, D. L.
Related Collections
Right arrow Drug Monitoring and Toxicology
Right arrow Endocrinology and Metabolism
(Clinical Chemistry. 1997;43:893-896.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

Quality systems for unit-use testing devices

David L. Phillips
Unit-use testing or single-test-system analysis has existed for many years. Quality-control and quality-assurance procedures have generally used conventional methods and lyophilized or aqueous control materials. Because these materials were readily available and generally accepted, they became part of the quality-assurance program for many early unit-use test systems such as the DuPont aca®. Over the years, these control products became standard and are now required as part of good laboratory practice. Technically speaking, however, conventional quality-control methods and materials cannot completely control the test system when used in a unit-use or single-test-system device. When conventional control material is run on a unit-use single-test system, only that testing unit is checked. One cannot test every unit with control material because by definition these are single-test systems: Once the control has been run, the patient's sample cannot be run. Conventional quality-assurance and quality-control methods do not, of themselves, assure quality. A one-size-fits-all, or "two levels per day of use" as outlined in the CLIA '88 regulations, is not appropriate. The divergence between HCFA-approved practices and those of the deemed agencies, coupled with the financial aspects of this quality-control method, led to the formation of the Subcommittee on Unit Use Testing of the National Committee on Clinical Laboratory Standards to develop guidelines for manufacturers, users, and regulators to use in developing new quality systems.


Key Words: indexing terms: quality control • point of care testing






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 1997 by the American Association for Clinical Chemistry.