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Guidance for Clinical Laboratory Improvement Amendments of 1988 (Clia) Criteria for Waiver; Draft Guidance for Industry and Fda

By Department of Health and Human Services

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Book Id: WPLBN0000062192
Format Type: PDF eBook
File Size: 0.1 MB
Reproduction Date: 2005
Full Text

Title: Guidance for Clinical Laboratory Improvement Amendments of 1988 (Clia) Criteria for Waiver; Draft Guidance for Industry and Fda  
Author: Department of Health and Human Services
Volume:
Language: English
Subject: Health., Medical research, Medical reports
Collections: Medical Library Collection
Historic
Publication Date:
Publisher: Centers for Disease Control and Prevention

Citation

APA MLA Chicago

Health And Human Services, D. O. (n.d.). Guidance for Clinical Laboratory Improvement Amendments of 1988 (Clia) Criteria for Waiver; Draft Guidance for Industry and Fda. Retrieved from http://hawaiilibrary.net/


Excerpt
For 90 days following the date of publication in the Federal Register of the notice announcing the availability of this guidance, comments and suggestions regarding this document should be submitted to the Docket No. assigned to that notice, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.

Table of Contents
Table of Contents I. INTRODUCTION............................................................................................................. 1 II. DEMONSTRATING “SIMPLE”.................................................................................. 4 III. DEMONSTRATING “INSIGNIFICANT RISK OF ERRONEOUS RESULT”........ 5 Developing QC Procedures .................................................................................................... 6 Validating QC Procedures ..................................................................................................... 7 General Recommendations for Designing QC ........................................................................ 8 QC Materials .......................................................................................................................... 9 Other QC Concerns ................................................................................................................ 9 IV. DEMONSTRATING “ACCURATE” ......................................................................... 10 Universal Precautions ........................................................................................................... 10 Financial Disclosure ............................................................................................................. 10 Instructions for Use .............................................................................................................. 10 Demographic Data................................................................................................................ 10 Study Reports ....................................................................................................................... 11 Untrained/Professional Precision Study for Quantitative Tests ............................................ 11 Precision Target for Quantitative Tests.................................................................................................................. 13 Untrained/Professional Agreement Study for Quantitative Tests ......................................... 13 Performance Target for Quantitative Tests ........................................................................................................... 14 Untrained/Professional Agreement Study for Qualitative Tests ........................................... 15 Performance Target for Qualitative Tests.............................................................................................................. 16 Untrained/Professional Agreement Studies for Highly Sensitive or Specific Qualitative Tests ............................................................................................................................................ 16 Performance Target for Highly Sensitive Qualitative Tests............................................................................... 17 V. WAIVER LABELING..................................................................................................... 17 Quick Reference Instructions ............................................................................................... 17 Quality Control Labeling Recommendations ....................................................................... 18 VI. VOLUNTARY SAFEGUARDS FOR WAIVED TESTS............................................ 20 VII. REFERENCES............................................................................................................ 21 APPENDIX A - Waiver Checklist ......................................................................................... 22 APPENDIX B - Waiver Labeling Checklist ......................................................................... 24

 

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