| Main Title |
Verification and validation of procedures in the clinical microbiology laboratory / |
| Other Authors |
|
| 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." |
| Place Published |
Washington, DC |
| Corporate Au Added Ent |
American Society for Microbiology. |
| Title Ser Add Ent |
Cumitech ; 31A. |
| PUB Date Free Form |
c2009 |
| Series Title Untraced |
Cumitech ; 31A |
| BIB Level |
m |
| Cataloging Source |
OCLC/T |
| Merged OCLC records |
502030035 |
| OCLC Time Stamp |
20111006145550 |
| Language |
eng |
| Origin |
OCLC |
| Type |
CAT |
| OCLC Rec Leader |
02500cam 2200385Ka 45020 |
