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CLSI I/LA32 P : 1ED 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY

Superseded date

27-07-2010

Superseded by

CLSI NBS04 A : 1ED 2010

Published date

12-01-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 General Considerations
5 Disorders Detected by Tandem Mass Spectrometry
6 Reagents, Internal Standards, Plate and Plate Covers,
   and Specimen Preparation
7 Mass Spectrometer Calibration and Verification
8 Instrument Operation
9 Method Validation
10 Establishing and Validating Cutoffs
11 Quality Assurance
12 Proficiency Testing
13 Result (Run) Acceptance Criteria
14 Result Reporting and Interpretation
15 External Factors Affecting Results
16 Follow-Up (Short-Term) Activities
17 Additional assays
References
Appendix A - In-House Control Preparation
Appendix B - Scan Speed Considerations
Appendix C - Maintenance
Appendix D - Tubing Considerations
Appendix E - Flow Path Blockages
Appendix F - Troubleshooting Guides
Appendix G - Ion Comparison
Appendix H - Chemical Structures
The Quality Management System Approach
Related ClSI Reference Materials

Describes as a reference source for the numerous activities related to operating a tandem mass spectrometry laboratory as part of public and private newborn screening programs with the goal of creating greater test accuracy, performance, and consistency among laboratories, thereby ensuring data quality that will ultimately benefit all newborns worldwide.

DocumentType
Proposed Guideline
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI NBS01 A5 : 5ED 2007 BLOOD COLLECTION ON FILTER PAPER FOR NEWBORN SCREENING PROGRAMS
CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI EP19 R : 1ED 2002 A FRAMEWORK FOR NCCLS EVALUATION PROTOCOLS
CLSI GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
CLSI I/LA27 A : 1ED 2006 NEWBORN SCREENING FOLLOW-UP
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE

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