Alphabetical Listing of CLSI Books0309

These documents are protected by copyright

1

LOCATION Abbreviation Vol No Replaces Status Date

STATUS TITLE

VOL 7 EP19-R 22 10 EP19-P JUNE 2002

Approved by Board of Directors – MAY 2002 Report Published – JUNE 2002

A Framework for NCCLS evaluation protocols

VOL 13 HS11-A 25 30 HS11-P Dec 2005

Approved Guideline A Model for Managing Medical Device Alerts

(Hazards and Recalls) for Healthcare Organizations

VOL 2 HS1-A2 24 37 HS1-A Nov 2004

Approved Guideline – 2

nd Edition

A Quality Management System Model for Health Care

VOL 4 M35-A 22 18 M35-P SEP 2002

Approved Guideline Abbreviated Identification of Bacteria and Yeast

VOL 7 D13-A 13 15 1993 Approved Guideline Agglutination analyses; antibody characterists,

methodology, limitation and clinical validation

VOL 7 M39-A2 25 28 M39-A Nov 2005

Approved Guideline 2

nd Edition

Analysis and Presentation of Cumulative

Antimicrobial Susceptibility Test Data

VOL 16 C49-A 27 14 C49-P April

2007 Approved Guideline Analysis of Body Fluids in Clinical Chemistry

VOL 17 I/LA20-A2 29 9 I/LA20-A Mar 2009


nd Edition

Analytical Performance Characteristics and Clinical Utility of

Immunological Assays for Human Immunoglobulin E (IgE)Antibodies and Defined Allergen Specificities

VOL 6 C40-A 21 9 C40-P Jun 2001 Approved Guideline Analytical Procedures for the Determination of Lead

in Blood and Urine

VOL 10 M33-A 24 7 M33-P FEB 2004

Approved Guideline Antiviral Susceptibility Testing Herpes Simplex Virus

by Plaque Reduction Assay

VOL 8 GP26-A3 24 36 GP26-A2 Nov 2004


rd Edition

Application of a Quality Management System Model

for Laboratory Services- Third Edition

VOL 11 HS10-A2 26 17 HS10-A May 2006


nd Edition


for Inpatient Medication Use

VOL 8 HS5-A2 26 16 HS5-A May 2006


nd Edition


for Medical Imaging Services

CLSI UPDATED MARCH 2009 Alphabetical Listing


2

LOCATION Abbreviation Vol No Replaces Status

Date

STATUS TITLE

VOL 5

HS4-A2 26 15 HS4-A May 2006


nd Edition


for Respiratory Services

VOL 11 C48-A 24 22 C48-P JUL 2004

Approved Guideline Application of Biochemical Markers of Bone Turnover

in the Assessment and Monitoring of Bone Diseases

VOL 10 I/LA23-A 24 16 I/L23-P 5/04 Approved Guideline Assessing the Quality of Immunoassay System:

Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline

VOL 8 LA1-A2 14 17 LA1-A Dec 1994

Approved Guideline Assessing the Quality of Radioimmunoassay Systems

– Second Edition

VOL 5 GP-10A 15 19 GP10-T DEC 1995

Approved Guideline Assessment of the Clinical Accuracy of Laboratory

Tests Using Receiver Operating Characteristic (ROC)Plots

VOL 7 GP29-A 22 26 GPA29-P Dec 2002

Approved Guideline Assessment of Laboratory Tests When Proficiency

Testing is not Available

VOL 3 GP11-A 18 14 GP11-T Nov-98 Approved Guideline Basic cost accounting for clinical services

VOL 13 T/DM6-A 17 14 T/DM6-P Sep 97 Approved Guideline Blood Alcohol Testing in the Clinical Laboratory

VOL 9 LA4-A4 23 21 LA3-A4 Jul 2003 Approved Standard – 4

th Edition

Blood Collection on Filter Paper for Newborn

Screening Programs

VOL 4 C46-A2 29 8 C46-A Feb 2009

Approved Guideline-2

nd Edition

Blood gas and pH analysis & related measurements

VOL 13 H56-A 26 20 H56-P June 2006

Approved Guideline Body Fluid Analysis for Cellular Composition

VOL 3 H38-P 19 7 Apr-99 Proposed Standard Calibration and quality control of automated

hematology analyzers


3


Date

STATUS TITLE

VOL 9 H42-A 17 18 42-T Dec 1998 Approved Guideline Clinical Applications of Flow Cytometry: Quality

Assurance and Immunophenotyping of Lymphocytes

VOL 9 H43-A 17 18 43-P June 1998

Approved Guideline Clinical Applications of Flow Cytometry:

Immunophenotyping of Leukemic Cells

VOL 2 I/LA 21-A 22 9 I/LA21-P June 2002

Approved Guideline

Clinical evaluation of immunoassays

VOL 5 GP17-A2 24 13 GP17-A APRIL 2004


ND Edition

Clinical Laboratory Safety

VOL 7 GP5-A2 22 3 GP5-A March 2002

Approved Guideline Second Edition

Clinical laboratory waste management

VOL 10 M36-A 24 6 M36-P FEB 2004

Approved Guideline Clinical Use and Interpretation of Serologic Tests for

Toxoplasma gondii

VOL 7 H21-A4 23 35 H21-A3 DEC 2003


th Edition

Collection, transport, and processing of blood specimens for

coagulation testing plasma – based coagulation assays

VOL 12 MM13-A 25 31 MM13-P Dec 2005

Approved Guideline Collection, Transport, Preparation, and Storage of

Specimens for Molecular Methods

VOL 4 GP22-A2 24 35 GP22-A Nov 2004


nd Edition

Continuous quality improvement; Integrating Five Key

Quality System Components

VOL 2 C 39-A 18 23 C39-P Oct-99 Approved Standard

Designated comparison method for the measurement

of ionized calcium in serum

VOL 5 I/LA22-P 20 10 2000 Proposed Guideline Detection of Anticardiolipin Antibodies by ELISA


4


Date

STATUS TITLE

VOL 8 H17-A 18 19 H17-P DEC 1998

Approved Standard Determination of Serum Ion, Total Iron-Binding

Capacity and Percent Transferrin Saturation

VOL 17 M23-A3 28 27 M23-A2 Oct 2008


rd Edition

Development of In Vitro Susceptibility Testing Criteria and

Quality Control Parameters

VOL 1 M37-A3 28 7 M37-A2 Feb 2008


nd Edition

Development of in vitro susceptibility testing criteria &

QC parameters for vet antimicrobial agents

VOL 14 MM12-A 26 20 MM12-P May 2006

Approved Guideline Diagnostic Nucleic Acid Microarrays

VOL 9 EP21-A 23 20 EP21-P April 2003

Approved Guideline

Estimation of Total Analytical Error for Clinical

Methods

VOL 5 EP14-A2 25 1 EP14-A January 2005


nd Edition

Evaluation of Matrix Effects

VOL 1 EP5-A2 24 25 EP5-A Aug 2004


nd

Edition

Evaluation of Precision Performance of Quantitative

Measurement Methods

VOL 6 EP6-A 23 16 EP6-P2 April 2003

Approved Guideline

Evaluation of the Linearity of Quantitative Analytical

Methods

VOL 5 H52-A 21 26 H52-P Dec 2001

Approved Guideline Fetal Red Cell Detection


5

LOCATION

Abbreviation

Vol No Replaces Status Date

STATUS TITLE

VOL 10 GP20-A2 23 27 GP20-A Oct 2003 Approved Guideline 2

nd Edition

Fine Needle Aspiration Biopsy (FNAB) Techniques

VOL 11 I/LA24-A 24 26 I/LA24-P Aug 2004

Approved Guideline Fluorescence Calibration and Quantitative

Measurement of Fluorescence Intensity

VOL 9 MM7-A 24 5 MM7-P JAN 2004

Approved Guideline Fluorescence In Situ Hybridization (FISH) Methods for

Medical Genetics

VOL 6 C25-A 17 3 C25-T JAN 1997

Approved Guideline Fractional Oxyhemoglobin, Oxygen Content and

Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting

VOL 5

C43-A 22 22 C43-P Nov 2002

Approved Guideline Gas Chromatography/Mass Spectometry (GC/MS)

Confirmation of Drugs

VOL 14 MM10-A 26 9 MM10-P Feb 2006

Approved Guideline Genotyping for Infectious Diseases: Identification and

Characterization

VOL 1 AST4-A2 25 12 AST4-A May 2005

Approved Guideline

Glucose Monitoring in Settings Without Laboratory

Support

VOL 8 C44-A 22 25 C44-P Dec 2002

Approved Guideline Harmonization of Glycohemoglobin Measurements

VOL 4 C28-A2 20 13 C28-A Jun 00 Approved Guideline 2

nd Edition

How to define and determine reference intervals in

the clinical lab approved guideline.


6

LOCATION Abbreviation Vol No Replaces Status Date STATUS TITLE

VOL 9 MM2-A2 22 12 MM2-A Aug 2002 Approved Guideline -2

nd

Edition

Immunoglobulin and T-Cell receptor gene

rearrangement assays

VOL 7 D12-A2 13 14 1993 Approved Guideline

Immunoprecipitin analyses; Procedures for evaluating

the performance of materials

VOL 17 X3-R 22 4 Mar 2002 Published Report

Implementing a Needlestick and Sharps Injury Prevention

Program in the Clinical Laboratory

VOL 8 EP7-A2 25 27 EP7-A2 Nov 2005


nd

edition

Interference Testing in Clinical Chemistry

VOL 16 MM18-A 28 12 MM18-P April 2008 Approved Guideline

Interpretive Criteria for Identification of Bacteria and

Fungi by DNA Target Sequencing

VOL 4 C31-A2 15 20 C31-A Jun 2001 Approved Guideline 2

nd

edition

Ionized calcium determinations: Precollection

variables, specimen choice, collection, & handling.

VOL 1 AUTO2-A2 25 29 AUTO2-A Dec 2005

Approved Standard 2

nd

edition

Lab automation: Barcodes for specimen container

identification

VOL 2 AUTO3-P 18 18 Dec-98 Lab automation: Communication with automated clinical

laboratory systems instrument devices and information systems

VOL 2 AUTO5-P 19 23 Oct-99 Proposed Standard

Lab automation electromechanical interfaces

VOL 2 AUTO4-P 19 22 Oct-99 Proposed Standard

Lab automation: Systems operational requirements,

characteristics, & information elements

VOL 4 M15-A 20 12 M15-T Jun 00 Approved Guideline

Lab diagnosis of bloodborne parasitic diseases


7


Date

STATUS TITLE

VOL 10 AUTO7-A 24 20 AUTO7-P June 2004

Approved Standard Laboratory Automation: Data Content for Specimen

Identification

VOL 8 GP18-A 18 3 GP18-P APR 98 Approved Guideline

Laboratory Design

VOL 15 M48-A 28 17 M48-P May 2008

Approved Guideline

Laboratory Detection and Identification of

Mycobacteria VOL 4 GP2-A5 22 5 GP2-A4 March

2006 Approved Guideline 5

th

Edition

Laboratory Documents: Development and Control

VOL 5 GP19-A2 23 4 GP19-A Feb 2003

Approved Guideline

Laboratory Instruments and Data Management

Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation and Monitoring

VOL 16 GP31-P 27 12 June

2007 Proposed Guideline

Laboratory Instrument Implementation, Verification, and

Maintenance VOL 13 EP13-R 15 8 Aug

1995 Report Laboratory Statistics

VOL 16

GP32-A 27 27 GP32-P May 2007

Approved Guideline

Management of Nonconforming Laboratory Events

VOL 16

C50-A 27 24 C50-P Oct 2007

Approved Guideline

Mass Spectrometry in the Clinical Laboratory:

General Principles and Guidance VOL 12 I/LA25-A 24 39 I/LA25-P Dec

2004 Approved Standard Maternal serum screening

VOL 11 C45-A 24 31 C45-P Oct 2004 Approved Guideline

Measurement of Free Thyroid Hormones


8


Date

STATUS TITLE

VOL 10 ISO 15189 Jul 2003 Corrected Version Medical Laboratories – Particular requirements for

quality and competence

VOL 6 EP9-A2 22 19 EP9-A Sept 2002


nd

Edition

Method comparison and bias estimation using patient

samples

VOL 14 M45-A 26 19 M45-P May 2006 Approved Guideline Methods for Antimicrobial Dilution and Disk Susceptibility

Testing of Infrequently Isolated of Fastidious Bacteria VOL 10 M44-A 24 15 M44-P 5/04 Approved Guideline Method for Antifungal Disk Diffusion Susceptibility

Testing of Yeasts; Approved Guideline VOL 3 M21-A 19 17 M21-T Sep-99 Approved Guideline Methodology for the serum bactericidal test

VOL 9 M42-A 26 23 M42-R June 2006

Approved Guideline

Methods for Antimicrobial Disk Susceptibility Testing

of Bacteria Isolated from Aquatic Animals. VOL 6 M11-A6 24 2 M11-A5 Jan 2004 Approved Standard

6th Edition

Methods for Antimicrobial Susceptibility Testing of

Anaerobic Bacteria

VOL 3 M7-A8 29 2 M7-A7 Jan 2009

Approved Standard 8

th Edition

Methods for Dilution Antimicrobial Susceptibility Tests

for Bacteria That Grow Aerobically

VOL 14 M49-A 26 24 M49-P June 2006

Approved Guideline Methods for Broth Dilution Susceptibility Testing of

Bacteria Isolated from Aquatic Animals

VOL 3 M26-A 19 18 M26-T Sep-99 Approved Guideline Methods for determining bactericidal activity of

antimicrobial agents

VOL 8 H44-A2 24 8 H44-A FEB 2004

Approved Guideline – 2ND Edition

Methods for Reticulocyte Counting ( Automated

Blood Cell Counters, Flow Cytometry and Supravital Dyes)


9


Date

STATUS TITLE

VOL 10 GP28-A 25 7 GP28-P Feb 2005 Approved Guideline Microwave Device Used in the Clinical Laboratory

VOL 5 MM1-A2 26 27 MM1-A June 2006


nd

Edition

Molecular diagnostic methods for genetic diseases

VOL 8 MM3-A2 26 8 MM3-A Feb 2006 Approved Guideline – 2nd Edition

Molecular Diagnostic Methods for Infectious Diseases

VOL 14 I/LA27-A 26 18 I/LA27-P May 2006 Approved Guideline Newborn Screen Follow-up

VOL 17 I/LA31-P 28 34 Dec 2008 Proposed Guideline Newborn Screening Guidelines for Premature and/or Sick

Newborns

VOL 3 GP23-A 19 14 GP23-P Aug-99 Approved Guideline Non gynecologic cytologic. specimens collection &

cytoprepatory techniques

VOL 12 MM9-A 24 40 MM9-P Dec 2004 Approved Guideline

Nucleic Acid Sequencing Methods in Diagnostic

Laboratory Medicine

VOL 9 MM5-A 23 17 MM5-P April 2003 Approved Guideline

Nucleic Acid Amplification Assays for Molecular

Hematopathology

VOL 7 H47-A 16 3 H28T &H29T JUN 96 Approved Guideline

One stage prothrombin time (PT) test and activated

partial thromboplastin time (APTT)

VOL 7 GP15-A2 21 17 GP15-A Nov 2001 Approved Guideline – 2

nd

Edition

Papincolaou technique

VOL 5 H26-A 16 12 H26-P DEC 96 Approved Standard

Performance Goals for the Internal Quality Control of

Multichannel Hematology Analyzers

VOL 11 I/LA26-A 24 29 I/LA26-P Oct 2004 Approved Guideline

Performance of Single Cell Immune Response Assays

VOL 12 H45-A2 25 15 H45-A June 2005 Approved Guideline – 2nd Edition

Performance of the Bleeding Time Test


10


Date

STATUS TITLE

VOL 17 POCT5-A 28 33 POCT05-P Dec 2008 Approved Standard

Performance Metrics for Continuous Interstitial Glucose

Monitoring

VOL 3 M31-A2 22 6 M31-A May 2002 Approved Standard 2

nd Edition

Performance standards for antimicrobial disk & dilution

susceptibility tests for bacteria isolated from animals

VOL 5 M2-A10 29 1 M2-A9 Jan 2009

Approved Standard 10

th Edition

Performance Standards of Antimicrobial Disk

Susceptibility Tests

VOL 3 M100-S12 22 1 M100-S11 Jan 2002 12th INFORMATIONAL SUPPLEMENT

Performance standards for antimicrobial susceptibility

testing

VOL 6 M100-S6 15 14 M100-S5 Dec 1995 6th Informational

Supplement Performance Standards for Antimicrobial Susceptibility

Testing

VOL 10 M100-S15 25 1 M100-S14 JAN 2005 15th Informational


Testing – 15th Informational Supplement

VOL 13 M100-S16 26 3 M100-S15 Jan 2006

16th Informational


Testing –16th Informational Supplement

VOL 18 M100-S19 29 3 M100-S18 Jan 2009 19th Informational


Testing

CD Case I POCT1-A2 POCT1-A Approved Standard – 2

nd

Edition

Point of care connectivity – On CD-ROM

VOL 8 C30-A2 22 17 C30-A Aug 2002


nd

Edition

Point-of-Care Blood Glucose Testing in Acute and

Chronic Care Facilities

VOL 1 POCT4-A2 26 30 AST2-A Aug 2006


nd

Edition

Point of care invitro diagnostic (IVD) testing

VOL 11 H49-A 24 23 H49-P JUL 2004

Approved Guideline

Point-of-Care Monitoring of Anticoagulation Therapy


11


Date

STATUS TITLE

VOL 6 EP10-A2 18 6 EP10-A Dec 2002


nd

Edition

Preliminary Evaluation of Quantitative Clinical

Laboratory Methods

VOL 5 C3-A4 26 22 C3-P4 June 2006


th

Edition

Preparation & testing of Reagent Water in the Clinical

Laboratory

VOL 3 C37-A 19 25 C37-P Nov-99 Approved Guideline Preparation & validation of commutable frozen human

serum pools as secondary reference materials for cholesterol measurement

VOL 16 M47-A 27 17 M47-P May

2007 Approved Guideline

Principles and Procedures for Blood Cultures

VOL 5 H7-A3 20 18 H7-A2 Approved Standard Procedure for Determining Packed Cell Volume by the

Microhematocrit Method

VOL 7 * H3-A5 23 32 H3-A4 DEC 2003

Approved Standard – 5

th Edition

Procedure for the Collection of Diagnostic Blood

Specimens by Venipuncture.

VOL 7 H30-A2 21 18 H30-A Nov 2001 Approved Guideline – 2nd Edition

Procedure for the determination of fibrinogen in

plasma

VOL 3 * H4-A4 19 16 Consolidates H4-A3 & H14-A2

Sep-99 Approved Standard Procedures and devices for collection of diagnostic

blood specimens by skin puncture

VOL 13 H54-A 25 23 H54-P Aug 2005 Approved Guideline Procedures for Validation of INR and Local Calibration of

PT/INR Systems


12


Date

STATUS TITLE

VOL 3 H11-A4 24 28 H11-A3 Sept 2004

Approved Standard – 4th Edition

Procedures for the collection of arterial blood

specimens

VOL 2 H 18-A3 24 38 H18-A2 Nov 2004 Approved Guideline – 2

nd

Edition

Procedures for the handling and processing of blood

specimens

VOL 12 M28-A2 25 16 M28-A June 2005


nd

Edition

Procedures for the Recovery and Identification of

Parasites from the Intestinal Tract

VOL 14 X6-R 25 14 June 2005

Approved Proceedings From the QC for the Future Workshop; A

Report

VOL 11 MM14-A 25 24 MM14-P Aug 2005

Approved Guideline

Proficiency Testing (External Quality Assessment) for

Molecular Methods

VOL 6 M29-A3 25 10 M29-A2 March 2005

Approved Guideline - 3rd Edition

Protection of laboratory workers from occupationally

acquired infections

VOL 11 EP17-A 24 34 EP17-P Oct 2004 Approved Guideline

Protocols for Determination of Limits of Detection and

Limits of Quantitation

VOL 13 M6-A2 26 6 M6-A Jan 2006

Approved Standard -2

nd Edition

Protocols for Evaluating Dehydrated Mueller-Hinton

Agar

VOL 6 HS2-A 23 5 HS2-P Feb 2003

Approved Guideline

Provider-Performed Microscopy Testing

VOL 12 HS3-A 25 5 HS3-P Jan 2005 Approved Guideline

Pulse Oximetry


13


Date

STATUS TITLE

VOL 10 M22-A3 24 19 M22-A2 June 2004

Approved Standard-3

rd

Edition

Quality Assurance for commercially prepared

microbiological culture media

VOL 4 I/LA2-A2 16 11 I/LA2-A Mar 2006

Approved Guideline- 2

nd

Edition

Quality assurance of Laboratory Tests for

Autoantibodies to Nuclear Antigens (1)Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods

VOL 10 M40-A 23 34 M40-P Dec 2003

Approved Standard Quality Control of Microbiological Transport Systems

VOL 18 M50-A 28 23 M50-P Aug 2008

Approved Guideline

Quality Control for Commercial Microbial Identification

Systems

VOL 7 M24-SI Informational Supplement

Quality Control MIC Limits for Mycobacterium peregrinum and

Staphylococcus aureus(When Testing Rapidly Growing Mycobacteria)

VOL 8 M38-A 22 16 M38-P AUG 2002

Approved Standard Reference Method for Broth Dilution Antifungal

Susceptibility Testing of Filamentous Fungi VOL 3 MM4-P 17 10 Dec 99 Approved Guideline Quality for immunocytochemistry

VOL 4 EP18-A 22 28 EP18-P Dec 2002

Approved Guideline

Quality management for unit-use testing

VOL 10 MM6-A 23 28 MM6-P Oct 2003 Approved Guideline

Quantitative Molecular Methods for Infectious Diseases

VOL 8 M27-A2 22 15 M27-A AUG 2002

Approved Standard – 2nd Edition

Reference Method for Broth Dilution Antifungal Susceptibility

Testing of Yeasts VOL 4 H2-A4 20 27 H2-A3 Dec00 Approved Standard

– 4th Edition Reference & selected procedure for the erythrocyte

sedimentation rate (ESR) test VOL 4 H15-A3 20 28 H15-A2 Dec00 Approved Standard

– 3rd Edition Reference & selected procedures for the quantitative

determination of hemoglobin in blood Vol 14 AUTO9-A 26 11 AUTO9-p March

2006 Approved Standard Remote Access to Clinical Laboratory Diagnostic

Devices via the Internet VOL 4 EP18-P2 27 23 EP18-A Aug

2007 Proposed Guideline – 2

nd

Edition

Risk Management Techniques to Identify and Control

Laboratory Error Sources


14

LOCATION Abbreviation Vol No Replaces Status Date

STATUS TITLE

VOL 3 GP9-A 18 15 GP9-T Nov-98 Approved Guideline

Selecting and evaluating a referral laboratory

VOL 16 LIS01-A2 28 13 LIS1-A April 2008

Approved Standard 2

nd Edition

Specification for Low-Level Protocol to Transfer

Messages Between Clinical Laboratory Instruments and Computer Systems.

VOL 11 LIS2-A 24 33 LIS2-A Oct 2004 Approved Standard – 2nd Edition

Specification for Transferring Information Between

Clinical Laboratory Instruments and Information Systems

VOL 6 I/LA18-A2 21 15 I/LA18-A Sep 2001

Approved Guideline

Specifications for Immunological Testing for Infectious

Diseases VOL 18 LIS3-A 23 9 Formerly

ASTM E792-02

Publish Apr 2003

Standard Guide for Selection of a Clinical Laboratory

Information Management System

VOL 5 C29-A2 20 17 C29-A Approved Standard Standardization of Sodium & Potassium Ion-Selective

Electrode Systems to the Flame Photometric Reference Method

VOL 1 C24-A3 26 25 C24-A2 June 2006

Approved Guideline- 3

rd

Edition

Statistical Quality Control for quantitative

measurement procedures: principles & definitions

VOL 11 HS6-A 24 32 HS6-P Oct 2004 Approved Guideline

Studies to Evaluate Patient Outcomes

VOL 4 C34-A2 20 14 C34-A Jun 00 Approved Guideline 2nd Edition

Sweat testing sample collection & quantitative analysis

VOL 7 M24-A 23 18 M24-T2 April 2003

Approved Standard Susceptibility Testing of Mycobacteria, Nocardia, and

Other Aerobic Actinomycetes

VOL 5 NRSCL13-A 20 21 NRSCL 13-P Approved Guideline

The Reference System for the Clinical Laboratory: Criteria

for Development and Credentialing of Methods and Materials for Harmonization of Results

VOL 5 GP21-A2 24 14 GP21-A APR 2004

Approved Guideline-2nd

Edition

Training and Competence Assessment


15


Date

STATUS TITLE

VOL 10 H1-A5 23 33 H1-A4 Dec 2003

Approved Standard – 5

th Edition

Tubes and Additives for Venous Blood Specimen

Collection

VOL 5 GP16-A2 15 15 GP16-A NOV 2001


ND

EDITION

Urinalysis and Collection, Transportation, and

Preservation of Urine Specimens

VOL 1 T/DMB-A 19 6 T/DMB-P Feb 99 Approved Guideline

Urine drug testing in the clinical lab

VOL 14 MM16-A 26 29 MM16-P Aug 2006

Approved Guideline

Use of External RNA Controls in Gene Expression

Assays

VOL 7 EP12-A 22 14 EP12-P Aug 2002

Approved Guideline

User protocol for evaluation of qualitative test

performance

VOL 7 EP15-A2 25 17 EP15-A April 2006


nd

Edition – 2nd

Printing

User verification of Performance for Precision and

Trueness

VOL 1 GP27-A2 27 8 GP22-A Feb 2007


nd

Edition

Using proficiency test (PT) to improve the clinical

laboratory

VOL 5

M34-A 20 20 M34-P Approved Guideline

Western Blot Assay for Antibodies to Borrelia

burgdorferi

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