CLSI MM19 P : 1ED 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
30-11-2011
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Safety
6 Strategic Planning
7 Patient Samples and Nucleic Acid Extraction
8 Implementation Plan
9 Quality
10 Developing a Quality Management System
11 Unique Consideration for Different Laboratory
Specialties
References
Appendix A - Regulatory Requirements
Appendix B - Technology Overview and Platforms
Appendix C - Examples of Technology Available to Detect
Infectious Diseases
The Quality Management System Approach
Related CLSI Reference Materials
Gives comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.
| DocumentType |
Proposed Guideline
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
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| CLSI HS1 A2 : 2ED 2004 | A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
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| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI MM2 A2 : 2ED 2002 | IMMUNOGLOBULIN AND T-CELL RECEPTOR GENE REARRANGEMENT ASSAYS |
| CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI MM3 A2 : 2ED 2006 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI MM5 A : 1ED 2003 | NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY |
| CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
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