CLSI AUTO10 P : 1ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
31-10-2006
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Design of Algorithms
4.1 Data Elements
4.2 Algorithm-Based Decisions
4.3 Reporting of Results
4.4 Selective Suppression of Auto verification
5 Regulatory Compliance
5.1 Statutory Obligation
6 Validation of Algorithms
6.1 Logic
6.2 Independent Data Observations/Collection
(monitoring of data in/data out)
6.3 Algorithm Updates
6.4 Software Updates
6.5 Validation Tools
6.6 Periodic Revalidation
References
Additional References
The Quality System Approach
Describes recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results.
| DocumentType |
Proposed Guideline
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CFR 42(PTS430-END) : OCT 2010 | PUBLIC HEALTH - HEALTH CARE FINANCING ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
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