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CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory
CLINICAL AND LABORATORY STANDARDS INSTITUTE 2014 CATALOG Set the Standard for Quality in Your Laboratory

CLINICAL AND LABORATORY STANDARDS INSTITUTE

2014

CATALOG

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Recently Published From CLSI I

New and revised standards, published from August 2013 through April 2014, on timely clinical laboratory topics.

October 2013 C40-A2 Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine;
October 2013
C40-A2
Measurement Procedures for the
Determination of Lead Concentrations
in Blood and Urine; Approved
Guideline—Second Edition
August 2013 EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved
August 2013
EP09-A3
Measurement Procedure Comparison and
Bias Estimation Using Patient Samples;
Approved Guideline—Third Edition
April 2014 EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition
April 2014
EP14-A3
Evaluation of Commutability of Processed
Samples; Approved Guideline—Third
Edition

September 2013of Processed Samples; Approved Guideline—Third Edition EP26-A User Evaluation of Between-Reagent Lot Variation;

EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline March 2014 H52-A2 Red Blood Cell
EP26-A
User Evaluation of Between-Reagent Lot
Variation; Approved Guideline
March 2014
H52-A2
Red Blood Cell Diagnostic Testing Using
Flow Cytometry; Approved Guideline—
Second Edition

March 2014Using Flow Cytometry; Approved Guideline— Second Edition H60-A Laboratory Testing for the Lupus Anticoagulant;

H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline November 2013 I/LA26-A2 Performance of
H60-A
Laboratory Testing for the Lupus
Anticoagulant; Approved Guideline
November 2013
I/LA26-A2
Performance of Single Cell Immune Response
Assays; Approved Guideline—Second Edition

C40-A2

Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline— Second Edition

EP09-A3

Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline— Third Edition

EP14-A3

Evaluation of Commutability of Processed Samples; Approved Guideline— Third Edition

EP26-A

User Evaluation of Between-Reagent Lot Variation; Approved Guideline

H52-A2

Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline— Second Edition

H60-A

Laboratory Testing for the Lupus Anticoagulant; Approved Guideline

I/LA26-A2

Performance of Single Cell Immune Response Assays; Approved Guideline— Second Edition

January 2014 M39-A4 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved
January 2014
M39-A4
Analysis and Presentation of Cumulative
Antimicrobial Susceptibility Test Data;
Approved Guideline—Fourth Edition

January 2014Test Data; Approved Guideline—Fourth Edition M100-S24 Performance Standards for Antimicrobial

M100-S24 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement
M100-S24
Performance Standards for Antimicrobial
Susceptibility Testing; Twenty-Fourth
Informational Supplement
August 2013
MM07-A2
Fluorescence In Situ Hybridization Methods
for Clinical Laboratories; Approved
Guideline—Second Edition
February 2014 MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second
February 2014
MM09-A2
Nucleic Acid Sequencing Methods in
Diagnostic Laboratory Medicine; Approved
Guideline—Second Edition

M39-A4

Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline— Fourth Edition

M100-S24

Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement

MM07-A2

Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition

MM09-A2

Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition

February 2014 MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline
February 2014
MM22-A
Microarrays for Diagnosis and Monitoring
of Infectious Diseases; Approved Guideline
December 2013 QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline
December 2013
QMS15-A
Assessments: Laboratory Internal Audit
Program; Approved Guideline

MM22-A

Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline

QMS15-A

Assessments: Laboratory Internal Audit Program; Approved Guideline

Shop Online!

Find these newly published standards and more online at the CLSI Shop.

TABLE OF CONTENTS

TABLE OF CONTENTS 3 5 2014 Table of Contents Document Categories Index of CLSI Standards, Guidelines,
TABLE OF CONTENTS 3 5 2014 Table of Contents Document Categories Index of CLSI Standards, Guidelines,
TABLE OF CONTENTS 3 5 2014 Table of Contents Document Categories Index of CLSI Standards, Guidelines,
TABLE OF CONTENTS 3 5 2014 Table of Contents Document Categories Index of CLSI Standards, Guidelines,
TABLE OF CONTENTS 3 5 2014 Table of Contents Document Categories Index of CLSI Standards, Guidelines,
3
3

5

2014

Table of Contents

Document Categories

Index of CLSI Standards, Guidelines, and Companion Products

Catalog Key

17

Document and Product Listings by Specialty Area

Automation and Informatics

18

Clinical Chemistry and Toxicology

19

General Laboratory

20

Hematology

22

Immunology and Ligand Assay

23

Method Evaluation

24

Microbiology

30

Molecular Methods

37

Newborn Screening

40

Point-of-Care Testing

44

Quality Management Systems

50

Veterinary Medicine

54

Featured Products

EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements

24

StatisPro™

29

Infobase™ 2014

34

eM100

35

eCLIPSE™ Ultimate Access

49

The Key to Quality™

50

LQMS Certifcate Program

51

Order Form

58

DOCUMENT CATEGORIES

In order to better classify our library of documents, CLSI expanded and color coded its document categories. The assigned colors are prominently displayed on each CLSI document cover.

The new document categories are:

Automation and Informaticseach CLSI document cover. The new document categories are: Clinical Chemistry and Toxicology General Laboratory

Clinical Chemistry and ToxicologyThe new document categories are: Automation and Informatics General Laboratory Hematology Immunology and Ligand Assay

General LaboratoryAutomation and Informatics Clinical Chemistry and Toxicology Hematology Immunology and Ligand Assay Method Evaluation

HematologyClinical Chemistry and Toxicology General Laboratory Immunology and Ligand Assay Method Evaluation Microbiology

Immunology and Ligand AssayChemistry and Toxicology General Laboratory Hematology Method Evaluation Microbiology Molecular Methods Newborn

Method EvaluationGeneral Laboratory Hematology Immunology and Ligand Assay Microbiology Molecular Methods Newborn Screening

MicrobiologyHematology Immunology and Ligand Assay Method Evaluation Molecular Methods Newborn Screening Point-of-Care Testing

Molecular MethodsImmunology and Ligand Assay Method Evaluation Microbiology Newborn Screening Point-of-Care Testing Quality Management

Newborn ScreeningAssay Method Evaluation Microbiology Molecular Methods Point-of-Care Testing Quality Management Systems Veterinary

Point-of-Care TestingEvaluation Microbiology Molecular Methods Newborn Screening Quality Management Systems Veterinary Medicine As part of

Quality Management SystemsMolecular Methods Newborn Screening Point-of-Care Testing Veterinary Medicine As part of this initiative, some CLSI

Veterinary MedicineScreening Point-of-Care Testing Quality Management Systems As part of this initiative, some CLSI documents were

As part of this initiative, some CLSI documents were assigned new codes to refect their categories. See below for the complete list of aected documents, or visit www.clsi.org.

Former Document

New Document

Former Document

New Document

Code

Code

Code

Code

Automation and Informatics

Method Evaluation (continued)

GP19-A2

AUTO13-A2

X05-R

EP32-R

Clinical Chemistry and Toxicology

Microbiology

I/LA15-A

C59-A

X07-R

M55-R

T/DM06-A

C60-A

Newborn Screening

H17-A

C61-A

LA04-A5

NBS01-A6*

General Laboratory

I/LA27-A

NBS02-A2*

H01-A6

GP39-A6

I/LA31-A

NBS03-A

C03-A4-AMD

GP40-A4-AMD

I/LA32-A

NBS04-A

H03-A6

GP41-A6

I/LA35-A

NBS05-A

H04-A6

GP42-A6

Point-of-Care Testing

H11-A4

GP43-A4

AST04-A2

POCT13-A2

H18-A4

GP44-A4

H49-A

POCT14-A

HS06-A

GP45-A

Quality Management Systems

X04-R

GP46-R

GP26-A4

QMS01-A4

Method Evaluation

GP02-A5

QMS02-A6*

C28-A3c

EP28-A3c

GP21-A3

QMS03-A3

C51-A

EP29-A

GP18-A2

QMS04-A2

C53-A

EP30-A

GP09-A2

QMS05-A2

C54-A-IR

EP31-A-IR

GP22-A3

QMS06-A3

Former Document

New Document

Code

Code

Quality Management Systems (continued)

HS04-A2

QMS07-A2

HS05-A2

QMS08-A2

HS10-A2

QMS09-A2

HS11-A

QMS10-A

GP32-A

QMS11-A

GP35-A

QMS12-A

GP37-A

QMS13-A

GP38-A

QMS14-A

GP38-AES

QMS14-AES

Veterinary Medicine

M31-A3

VET01-A3

M37-A3

VET02-A3

M42/M49-S1

VET03/VET04-S1

M42-A

VET03-A

M49-A

VET04-A

X08-R

VET05-R

* These documents replaced the respective standards noted in the “Former Document Code” column.

CLSI COMMUNITIES

CLSI COMMUNITIES Quality Management Systems Method Evaluation Newborn Screening Microbiology Point-of-Care Testing

Quality Management Systems

Method Evaluation

CLSI COMMUNITIES Quality Management Systems Method Evaluation Newborn Screening Microbiology Point-of-Care Testing
Newborn Screening Microbiology Point-of-Care Testing
Newborn Screening
Microbiology
Point-of-Care
Testing
Communities
Communities
Communities
Communities
Communities
Communities
Communities
Communities

Communities

Participate in CLSI’s online Communities to collaborate with fellow professionals!

Share your knowledge and disseminate information.online Communities to collaborate with fellow professionals! Explore ideas and participate in group or private

Explore ideas and participate in group or private discussions.Share your knowledge and disseminate information. Access experience-based solutions from professional

Access experience-based solutions from professional colleagues.ideas and participate in group or private discussions. Find resources to do your job better, shorten

Find resources to do your job better, shorten decision times, and decrease risk.experience-based solutions from professional colleagues. Network to find individuals who share similar goals and

Network to find individuals who share similar goals and interests.your job better, shorten decision times, and decrease risk. Join today at community.clsi.org. If you are

Join today at community.clsi.org.

If you are interested in submitting content such as case studies or featured articles for the Communities, please e-mail communities@clsi.org.

INDEX

Index of CLSI Standards, Guidelines, and Companion Products

All CLSI standards, guidelines, and companion products are listed in the index below. Documents published from 2009 to present are located in the catalog, and a corresponding page number is indicated in the “Location” column. Documents published before 2009 are available on the CLSI website at www.clsi.org, and are indicated with “online” in the “Location” column below.

Documents marked with an asterisk are documents that are expected to publish by June 2014.

Automation and Informatics

Automation and Informatics Document Code AUTO01-A AUTO02-A2 AUTO03-A2 AUTO04-A AUTO05-A AUTO07-A

Document Code

AUTO03-A2

Document Title

Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

Laboratory Automation: Bar Codes for Specimen Container Identifcation; Approved Standard—Second Edition

Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition

Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard

Laboratory Automation: Electromechanical Interfaces; Approved Standard

Laboratory Automation: Data Content for Specimen Identifcation; Approved Standard

Managing and Validating Laboratory Information Systems; Approved Guideline

Laboratory Information Systems; Approved Guideline Location Online Online Pg. 18 Online Online

Location

Online

Online

Pg. 18

Online

Online

Online

Online

Online AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard AUTO10-A
Online AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard AUTO10-A
Online AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard AUTO10-A

Online

Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard

AUTO11*

AUTO12-A

I/LA33-A

I/LA33-A TK

Autoverifcation of Clinical Laboratory Test Results; Approved Guideline

Information Technology Security of In Vitro Diagnostic Instruments and Software Systems

IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard

Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition

Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit

Specifcation for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition

Specifcation for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition

Standard Guide for Selection of a Clinical Laboratory Information Management System

Standard Guide for Documentation of Clinical Laboratory Computer Systems

Standard Specifcation for Transferring Clinical Observations Between Independent Computer Systems

Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems

Standard Specifcation for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

INDEX

Clinical Chemistry and Toxicology

Document Code

Document Title

Location

Statistical Quality Control for Quantitative Measurement Procedures: Principles and Defnitions; Approved Guideline—Third Edition

Online

Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition

Online

Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition

Online

C34-A3

Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition

Pg. 19

Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline

Online

Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline

Online

A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard

Online

C40-A2

Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition

Pg. 19

Erythrocyte Protoporphyrin Testing; Approved Guideline

Online

C43-A2

Gas Chromatography/Mass Spectrometry Confrmation of Drugs; Approved Guideline— Second Edition

Pg. 19

Harmonization of Glycohemoglobin Measurements; Approved Guideline

Online

Measurement of Free Thyroid Hormones; Approved Guideline

Online

C46-A2

Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition

Pg. 19

Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline

Online

Analysis of Body Fluids in Clinical Chemistry; Approved Guideline

Online

Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline

Online

Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition

Online

C56-A

Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline

Pg. 19

C58-A

Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline

Pg. 19

Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline

Online

Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline

Online

Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard

Online

C62*

Liquid Chromatography-Mass Spectrometry Methods

Pg. 56

EP05*

Evaluation of Precision of Quantitative Measurement Procedures

Pg. 56

EP05-A2

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

Pg. 26

EP06-A

Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

Pg. 26

Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition

Online

EP09-A3

Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Pg. 26

Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition

Online

INDEX

Clinical Chemistry and Toxicology (continued)

 

Document Code

Document Title

Location

User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition

Online

EP14-A3

Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition

Pg. 26

EP15*

User Verifcation of Precision and Estimation of Bias

Pg. 56

User Verifcation of Performance for Precision and Trueness; Approved Guideline—Second Edition

Online

EP17-A2

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition

Pg. 26

EP18-A2

Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition

Pg. 27

A Framework for NCCLS Evaluation Protocols; A Report

Online

Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline

Online

EP24-A2

Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition

Pg. 27

EP25-A

Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

Pg. 27

EP28-A3c

Defning, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition

Pg. 28

EP30-A

Characterization and Qualifcation of Commutable Reference Materials for Laboratory Medicine; Approved Guideline

Pg. 28

EP31-A-IR

Verifcation of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision)

Pg. 28

Metrological Traceability and Its Implementation; A Report

Online

General Laboratory

EP26-A

User Evaluation of Between-Reagent Lot Variation; Approved Guideline

Pg. 27

GP05-A3

Clinical Laboratory Waste Management; Approved Guideline—Third Edition

Pg. 20

GP05-A3 QG

Waste Management Program—Audit Checklist

Pg. 20

Basic Cost Accounting for Clinical Services; Approved Guideline

Online

Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline— Third Edition

Online

GP16-A3

Urinalysis; Approved Guideline—Third Edition

Pg. 20

GP16-A3 WC

Wall Chart—Identifable Microscopic Entities Seen in Urine Sediment

Pg. 20

GP17-A3

Clinical Laboratory Safety; Approved Guideline—Third Edition

Pg. 20

Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition

Online

Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline

Online

Using Profciency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition

Online

Microwave Device Use in the Histology Laboratory; Approved Guideline

Online

Assessment of Laboratory Tests When Profciency Testing Is Not Available; Approved Guideline—Second Edition

Online

GP31-A

Laboratory Instrument Implementation, Verifcation, and Maintenance; Approved Guideline

Pg. 20

GP33-A

Accuracy in Patient and Sample Identifcation; Approved Guideline

Pg. 20

GP34-A

Validation and Verifcation of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline

Pg. 21

INDEX

General Laboratory

(continued)

Document Code

Document Title

Location

GP39-A6

Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition

Pg. 21

GP41-A6

Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition

Pg. 21

GP41-A6 QG

Quality Venipuncture Quick Guide

Pg. 21

Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition

Online

GP42-A6 QG

Technique for Skin Puncture in Adults and Older Children Quick Guide

Pg. 21

Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition

Online

GP44-A4

Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition

Pg. 21

GP44-A4 QG

Handling, Transport, and Storage of Specimens Quick Guide

Pg. 21

Studies to Evaluate Patient Outcomes; Approved Guideline

Online

Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report

Online

H02-A5

Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition

Pg. 22

Standard for Relating Spectrophotometer Performance Characteristics to Analytical Goals; Approved Standard

Online

Determining Performance of Volumetric Equipment; Proposed Guideline

Online

Temperature Monitoring and Recording in Blood Banks; Tentative Guideline

Online

M29*

Protection of Laboratory Workers From Occupationally Acquired Infections

Pg. 57

Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third Edition

Online

M29-A3 QG

Personal Protection in the Laboratory Quick Guide

Pg. 36

Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

Online

MM13-A QG

Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide

Pg. 38

QG 10

Specimen Collection Quick Guides

Pg. 21

QMS02-A6

Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition

Pg. 52

Hematology

H02-A5

Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition

Pg. 22

Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third Edition

Online

Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition

Online

Reference Leukocyte (WBC) Dierential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition

Online

H21-A5

Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition

Pg. 22

H21-A5 QG

Collection, Handling, Transport, and Storage for Hemostasis Quick Guide

Pg. 22

H26-A2

Validation, Verifcation, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition

Pg. 22

INDEX

Hematology

(continued)

Document Code

Document Title

Location

Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition

Online

Enumeration of Immunologically Defned Cell Populations by Flow Cytometry; Approved Guideline—Second Edition

Online

Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition

Online

Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline—Second Edition

Online

One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition

Online

Determination of Factor Coagulant Activities; Approved Guideline

Online

Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline

Online

H52-A2

Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition

Pg. 22

Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline

Online

Body Fluid Analysis for Cellular Composition; Approved Guideline

Online

Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline

Online

Platelet Function Testing by Aggregometry; Approved Guideline

Online

H59-A

Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline

Pg. 22

H60-A

Laboratory Testing for the Lupus Anticoagulant; Approved Guideline

Pg. 22

MM05-A2

Nucleic Acid Amplifcation Assays for Molecular Hematopathology; Approved Guideline— Second Edition

Pg. 37

Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

Online

Immunology and Ligand Assay

 

Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline

Online

Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition

Online

Specifcations for Immunological Testing for Infectious Diseases; Approved Guideline— Second Edition

Online

I/LA20-A2

Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defned Allergen Specifcities; Approved Guideline—Second Edition

Pg. 23

Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition

Online

Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline

Online

Maternal Serum Screening; Approved Standard—Second Edition

Online

I/LA26-A2

Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition

Pg. 23

INDEX

Immunology and Ligand Assay (continued)

 

Document Code

 

Document Title

Location

I/LA28-A2

Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition

Pg. 23

Detection of HLA-Specifc Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline

Online

Immunoassay Interference by Endogenous Antibodies; Approved Guideline

Online

I/LA33-A

Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

Pg. 23

I/LA33-A TK

Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit

Pg. 23

Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline

Online

NBS06-A

Newborn Blood Spot Screening for Severe Combined Immunodefciency by Measurement

Pg. 41

of

T-cell Receptor Excision Circles; Approved Guideline

Method Evaluation

Statistical Quality Control for Quantitative Measurement Procedures: Principles and Defnitions; Approved Guideline—Third Edition

Online

Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition

Online

Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline

Online

A

Designated Comparison Method for the Measurement of Ionized Calcium in Serum;

 

Approved Standard

Online

Erythrocyte Protoporphyrin Testing; Approved Guideline

Online

C43-A2

Gas Chromatography/Mass Spectrometry Confrmation of Drugs; Approved Guideline— Second Edition

Pg. 19

Harmonization of Glycohemoglobin Measurements; Approved Guideline

Online

Measurement of Free Thyroid Hormones; Approved Guideline

Online

C46-A2

Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition

Pg. 19

Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline

Online

EP05*

Evaluation of Precision of Quantitative Measurement Procedures

Pg. 56

EP05-A2

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

Pg. 26

EP06-A

Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

Pg. 26

Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition

Online

EP09-A3

Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Pg. 26

Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition

Online

User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline— Second Edition

Online

EP14-A3

Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition

Pg. 26

EP15*

User Verifcation of Precision and Estimation of Bias

Pg. 56

User Verifcation of Performance for Precision and Trueness; Approved Guideline—Second Edition

Online

INDEX

Method Evaluation (continued)

 

Document Code

 

Document Title

Location

EP17-A2

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition

Pg. 26

EP18-A2

Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition

Pg. 27

A

Framework for NCCLS Evaluation Protocols; A Report

Online

Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline

Online

EP23-A™

Laboratory Quality Control Based on Risk Management; Approved Guideline

Pg. 24

EP23-A WB

A Practical Guide for Laboratory Quality Control Based on Risk Management

Pg. 25

EP23-A WS

A Sample Form for Laboratory Quality Control Based on Risk Management

Pg. 25

EP24-A2

Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition

Pg. 27

EP25-A

Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

Pg. 27

EP26-A

User Evaluation of Between-Reagent Lot Variation; Approved Guideline

Pg. 27

EP27-A

How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

Pg. 27

EP28-A3c

Defning, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition

Pg. 28

EP29-A

Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline

Pg. 28

EP30-A

Characterization and Qualifcation of Commutable Reference Materials for Laboratory Medicine; Approved Guideline

Pg. 28

EP31-A-IR

Verifcation of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision)

Pg. 28

Metrological Traceability and Its Implementation; A Report

Online

H26-A2

Validation, Verifcation, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition

Pg. 22

Verifcation and Validation of Multiplex Nucleic Acid Assays; Approved Guideline

Online

Microbiology

AST QC QG

AST QC Flow Chart Quick Guides

Pg. 31

M02-A11

Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard— Eleventh Edition

Pg. 32

Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second

 
 

Edition

Online

M07-A9

Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition

Pg. 32

M11-A8

Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition

Pg. 32

Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline

Online

Methodology for the Serum Bactericidal Test; Approved Guideline

Online

Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition

Online

Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition

Online

M24-A2

Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition

Pg. 32

Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved

 
 

Guideline

Online

INDEX

Microbiology (continued)

Document Code

Document Title

Location

Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition

Online

M27-S4

Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement

Pg. 32

Procedures for the Recovery and Identifcation of Parasites From the Intestinal Tract; Approved Guideline—Second Edition

Online

M29*

Protection of Laboratory Workers From Occupationally Acquired Infections

Pg. 57

Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third Edition

Online

M29-A3 QG

Personal Protection in the Laboratory Quick Guide

Pg. 36

Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline

Online

Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard

Online

Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline

Online

Abbreviated Identifcation of Bacteria and Yeast; Approved Guideline—Second Edition

Online

Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline

Online

Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition

Online

M39-A4

Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition

Pg. 33

M39-A4 QG

Collection, Handling, Transport, and Storage for Hemostasis Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide

Pg. 33

M40*

Quality Control of Microbiological Transport Systems

Pg. 57

Quality Control of Microbiological Transport Systems; Approved Standard

Online

Viral Culture; Approved Guideline

Online

M43-A

Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline

Pg. 33

M44-A2

Method for Antifungal Disk Diusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition

Pg. 33

M44-S3

Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diusion Susceptibility Testing of Yeasts; Third Informational Supplement

Pg. 33

M45-A2

Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition

Pg. 34

M47-A

Principles and Procedures for Blood Cultures; Approved Guideline

Pg. 34

Laboratory Detection and Identifcation of Mycobacteria; Approved Guideline

Online

M50-A

Quality Control for Commercial Microbial Identifcation Systems; Approved Guideline

Pg. 34

M51-A

Method for Antifungal Disk Diusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline

Pg. 36

M51-S1

Performance Standards for Antifungal Disk Diusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Informational Supplement

Pg. 36

M53-A

Criteria for Laboratory Testing and Diagnosis of Human Immunodefciency Virus Infection; Approved Guideline

Pg. 36

M54-A

Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline

Pg. 36

M55-R

Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report

Pg. 36

INDEX

Microbiology (continued)

Document Code

Document Title

Location

M56*

Principles and Procedures for Detection of Anaerobes in Clinical Specimens

Pg. 57

M100-S24

Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement

Pg. 30

M100-S24 QG

M100-S24 Tables 1A–1C Quick Guide

Pg. 31

M100-S24 WC

Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fourth Informational Supplement

Pg. 31

Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition

Online

MM06-A2

Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition

Pg. 37

Molecular Methods for Bacterial Strain Typing; Approved Guideline

Online

Interpretive Criteria for Identifcation of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline

Online

MM22-A

Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline

Pg. 38

Molecular Methods

I/LA28-A2

Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition

Pg. 23

M53-A

Criteria for Laboratory Testing and Diagnosis of Human Immunodefciency Virus Infection; Approved Guideline

Pg. 36

MM01-A3

Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline— Third Edition

Pg. 37

Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition

Online

MM05-A2

Nucleic Acid Amplifcation Assays for Molecular Hematopathology; Approved Guideline— Second Edition

Pg. 37

MM06-A2

Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition

Pg. 37

MM07-A2

Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline— Second Edition

Pg. 37

MM09-A2

Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition

Pg. 37

Genotyping for Infectious Diseases: Identifcation and Characterization; Approved Guideline

Online

Molecular Methods for Bacterial Strain Typing; Approved Guideline

Online

Diagnostic Nucleic Acid Microarrays; Approved Guideline

Online

Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

Online

MM13-A QG

Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide

Pg. 38

MM14-A2

Design of Molecular Profciency Testing/External Quality Assessment; Approved Guideline—Second Edition

Pg. 37

Use of External RNA Controls in Gene Expression Assays; Approved Guideline

Online

Verifcation and Validation of Multiplex Nucleic Acid Assays; Approved Guideline

Online

Interpretive Criteria for Identifcation of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline

Online

INDEX

Molecular Methods

(continued)

Document Code

Document Title

Location

MM19-A

Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline

Pg. 38

MM20-A

Quality Management for Molecular Genetic Testing; Approved Guideline

Pg. 38

MM22-A

Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline

Pg. 38

NBS06-A

Newborn Blood Spot Screening for Severe Combined Immunodefciency by Measurement of T-cell Receptor Excision Circles; Approved Guideline

Pg. 41

Newborn Screening

NBS01-A6

Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard— Sixth Edition

Pg. 40

NBS01-A6 DVD

Making a Dierence Through Newborn Screening: Blood Collection on Filter Paper

Pg. 42

NBS01-A6 QG

Specimen Collection and Sample Quality for Newborn Screening Quick Guide

Pg. 42

NBS02-A2

Newborn Screening Follow-up; Approved Guideline—Second Edition

Pg. 40

NBS02-A2 QG

Newborn Screening Follow-up Process Quick Guide

Pg. 42

NBS03-A

Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline

Pg. 41

NBS03-A QG

Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide

Pg. 42

NBS04-A

Newborn Screening by Tandem Mass Spectrometry; Approved Guideline

Pg. 41

NBS05-A

Newborn Screening for Cystic Fibrosis; Approved Guideline

Pg. 41

NBS06-A

Newborn Blood Spot Screening for Severe Combined Immunodefciency by Measurement of T-cell Receptor Excision Circles; Approved Guideline

Pg. 41

NBS06-A QG1

Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide

Pg. 42

NBS06-A QG2

Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide

Pg. 42

NBS06-A WC

Immunodefciency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart

Pg. 42

Point-of-Care Testing

Point-of-Care Connectivity; Approved Standard—Second Edition

Online

Implementation Guide of POCT01 for Health Care Providers; Approved Guideline

Online

Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition

Online

Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline

Online

POCT06*

Guidelines on the Impact on Glucose Measurements When Dierent Sample Types Are Used

Pg. 57

POCT07-A

Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline

Pg. 44

POCT07-A RG

Addressing Errors in Point-of-Care Testing Reference Guide

Pg. 44

POCT08-A

Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline

Pg. 44

POCT08-A QG1

Corrective Action Report Quick Guide

Pg. 44

POCT08-A QG2

Quality Control Troubleshooting Flow Chart

Pg. 44

POCT08-A QG3

Quality Control Log Sheet Quick Guide

Pg. 44

POCT08-A WS

Instrument Selection Worksheet

Pg. 44

POCT09-A

Selection Criteria for Point-of-Care Testing Devices; Approved Guideline

Pg. 45

INDEX

Point-of-Care Testing

(continued)

Document Code

Document Title

Location

POCT09-A WS

Instrument Selection Worksheet

Pg. 45

POCT10-A2

Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline— Second Edition

Pg. 46

POCT10-A2 CL

Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/ Validation Employee Training Checklist

Pg. 47

POCT10-A2 LG

Microscope Maintenance Log

Pg. 47

POCT10-A2 QG1

Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide

Pg. 47

POCT10-A2 QG2

Nasal Smears for Infammatory Cells (Also Known as “Nasal Smear for Eosinophils,” “Nasal WBCs,” and “Nasal Smear for Granulocytes”) Quick Guide

Pg. 47

POCT10-A2 QG3

Profciency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide

Pg. 47

POCT10-A2 QG4

Urine Sediment Examinations Quick Guide

Pg. 47

POCT10-A2 QG5

Wet Mount Preparations and KOH Preparations Quick Guide

Pg. 47

POCT10-A2 WC1