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RECORD NUMBER: 282 OF 294

Main Title Verification and validation of procedures in the clinical microbiology laboratory /
Other Authors
Author Title of a Work
Clark, Richard B.
Sharp, Susan B.
Publisher American Society for Microbiology,
Year Published 2009
OCLC Number 549279151
ISBN 9781555815301; 1555815308
Subjects Clinical Laboratory Techniques--methods ; Microbiological Techniques ; Quality Control ; Microbiological laboratories--Management ; Diagnostic microbiology
Holdings
Library Call Number Additional Info Location Last
Modified
Checkout
Status
ELBM  RB37.V47 2009 AWBERC Library/Cincinnati,OH 10/11/2011
Collation 24 p. ; 28 cm.
Notes
Cover title. Includes bibliographical references (p. 22-24).
Contents Notes
Introduction -- Definitions -- Federal regulation -- Selection of a laboratory method -- Verification of common microbiology tests -- Validation of diagnostic tests used in clinical microbiology -- Summation -- Appendix A: Method selection and verification example -- References -- Appendix B: Process for selection of a test method "Focusing on the common qualitative and semi-quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use. Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance. The Cumitech begins with a review of federal regulations on test verification and validation, including the Clinical and Laboratory Improvement Amendments (CLIA). Next, the authors set forth the criteria for selecting a laboratory method and then verifying and validating a test, explaining all the key components of the process. Examples using both FDA-approved and laboratory-developed tests are provided, helping with the design of test verification studies that fully meet regulatory requirements."