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CLINICAL AND LABORATORY STANDARDS INSTITUTE
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2014
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ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org 1
January 2014
This document provides updated tables for the Clinical and
Laboratory Standards Institute antimicrobial susceptibility
testing standards M02-A11, M07-A9, and M11-A8.
A standard for global application developed through the Clinical and Laboratory Standards Institute
consensus process.
M39-A4
Analysis and Presentationof Cumulative
Antimicrobial Susceptibility Test Data;
Approved GuidelineFourth Edition
950West Valley Road, Suite 2500, Wayne, PA19087 USA
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E: customerservice@clsi.org www.clsi.org
PRINT ISBN1-56238-897-5
ELECTRONIC ISBN1-56238-898-3
January 2014
M100-S24
Performance Standards for Antimicrobial
Susceptibility Testing; Twenty-Fourth
Informational Supplement
Laboratory Standards Institute antimicrobial susceptibility testing
standards M02-A11, M07-A9, and M11-A8.
An informational supplement for global application developed through the Clinical and Laboratory Standards Institute
consensus process.
M100_S24.indd All Pages 12/16/13 9:17 AM
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PRINT ISBN1-56238-893-2
November 2013
I/LA26-A2
Performance of Single Cell Immune Response
Assays; Approved GuidelineSecond Edition
This document contains methods of intracellular cytokine
evaluation, major histocompatibility complex multimer
quantitation, enzyme-linked immunospot technology, and
carboxyuorescein succinimidyl ester tracking dye staining for
the assessment of cellular proliferation. It also provides basic
aspects of specimen collection, transport, and preparation;
results interpretation; and quality assurance and test validation
approaches.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
I_LA26_A2.indd All Pages 11/11/13 8:44 AM
I/LA26-A2
Performance of Single Cell Immune
Response Assays; Approved Guideline
Second Edition
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Recently
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New and revised standards, published from August 2013
through April 2014, on timely clinical laboratory topics.
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more online at the CLSI Shop.
QMS15-A
Assessments: Laboratory Internal
Audit Program; Approved Guideline
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December 2013
QMS15-A
Assessments: Laboratory Internal Audit
Program; Approved Guideline
This document provides guidance for how a laboratory can establish
an internal audit program to enhance the quality of its services
through continual improvement. Whereas an audit program
denes the who, what, when, where, and how of meeting
requirements for internal auditing, the audit process describes the
details of how to conduct individual laboratory internal audits.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. PRINT ISBN1-56238-895-9
QMS15.indd All Pages 12/19/13 2:51 PM
M39-A4
Analysis and Presentation of
Cumulative Antimicrobial Susceptibility
Test Data; Approved Guideline
Fourth Edition
M100-S24
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PRINT ISBN1-56238-887-8
August 2013
EP09-A3
Measurement Procedure Comparisonand
Bias EstimationUsing Patient Samples;
Approved GuidelineThird Edition
This document addresses the design of measurement
procedure comparison experiments using patient samples
and subsequent data analysis techniques used to determine
the bias between two in vitro diagnostic measurement
procedures.
EP09_A3.indd All Pages 8/21/13 8:01 AM
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PRINT ISBN1-56238-887-8
September 2013
EP26-A
User Evaluationof Between-Reagent Lot
Variation; Approved Guideline
This document provides guidance for laboratories on the
evaluation of a new reagent lot, including a protocol using patient
samples to detect signicant changes from the current lot.
EP26_A.indd All Pages 10/17/13 1:49 PM
March 2014
A standard for global application developed through the Clinical and Laboratory Standards
Institute consensus process.
H52-A2
Red Blood Cell Diagnostic Testing Using
FlowCytometry; Approved Guideline
Second Edition
March 2014
H60-A
Laboratory Testing for the Lupus
Anticoagulant; Approved Guideline
EP09-A3
Measurement Procedure Comparison
and Bias Estimation Using Patient
Samples; Approved Guideline
Third Edition
EP26-A
User Evaluation of Between-Reagent Lot
H52-A2
Flow Cytometry; Approved Guideline
Second Edition
H60-A
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PRINT ISBN1-56238-891-6
October 2013
C40-A2
Measurement Procedures for the
Determinationof Lead Concentrations
inBlood and Urine; Approved
GuidelineSecond Edition
This document provides guidance for the measurement of
lead concentrations in blood and urine, including specimen
collection, measurement by graphite furnace atomic absorption
spectrometry, anodic stripping voltammetry, and inductively
coupled plasma mass spectrometry. It also includes guidelines
for quality assurance and quality control, and information on
prociency testing programs and laboratory certication.
C40-A2.indd All Pages 10/15/13 8:04 AM
C40-A2
Determination of Lead Concentrations
in Blood and Urine; Approved Guideline
Second Edition
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PRINT ISBN1-56238-885-1
ELECTRONIC ISBN1-56238-886-X
August 2013
MM07-A2
Fluorescence In SituHybridizationMethods
for Clinical Laboratories; Approved
This document addresses uorescence in situ hybridization
methods for medical genetic determinations, identication
of chromosomal abnormalities, and gene amplication.
Recommendations for probe and assay development,
manufacture, qualication, verication, and validation;
instrument requirements; quality assurance; and evaluation of
results are also included.
MM07-A2.indd All Pages 8/15/13 8:19 AM
February 2014
MM09-A2
Nucleic Acid Sequencing Methods in
Diagnostic Laboratory Medicine; Approved
February 2014
MM22-A
Microarrays for Diagnosis and Monitoring
of Infectious Diseases; Approved Guideline
MM07-A2
Fluorescence In Situ Hybridization
Methods for Clinical Laboratories;
Approved GuidelineSecond Edition
MM09-A2
Nucleic Acid Sequencing Methods
in Diagnostic Laboratory Medicine;
MM22-A
Microarrays for Diagnosis and
Monitoring of Infectious Diseases;
Approved Guideline
April 2014
EP14-A3
Evaluationof Commutability of Processed
Samples; Approved GuidelineThird
Edition
EP14-A3
Evaluation of Commutability of
Processed Samples; Approved Guideline
Third Edition
2014
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Table of Contents
Document Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Index of CLSI Standards, Guidelines, and Companion Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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
Former Document
Code
New Document
Code
Automation and Informatics
GP19-A2 AUTO13-A2
Clinical Chemistry and Toxicology
I/LA15-A C59-A
T/DM06-A C60-A
H17-A C61-A
General Laboratory
H01-A6 GP39-A6
C03-A4-AMD GP40-A4-AMD
H03-A6 GP41-A6
H04-A6 GP42-A6
H11-A4 GP43-A4
H18-A4 GP44-A4
HS06-A GP45-A
X04-R GP46-R
Method Evaluation
C28-A3c EP28-A3c
C51-A EP29-A
C53-A EP30-A
C54-A-IR EP31-A-IR

Former Document
Code
New Document
Code
Method Evaluation (continued)
X05-R EP32-R
Microbiology
X07-R M55-R
Newborn Screening
LA04-A5 NBS01-A6*
I/LA27-A NBS02-A2*
I/LA31-A NBS03-A
I/LA32-A NBS04-A
I/LA35-A NBS05-A
Point-of-Care Testing
AST04-A2 POCT13-A2
H49-A POCT14-A
Quality Management Systems
GP26-A4 QMS01-A4
GP02-A5 QMS02-A6*
GP21-A3 QMS03-A3
GP18-A2 QMS04-A2
GP09-A2 QMS05-A2
GP22-A3 QMS06-A3

Former Document
Code
New Document
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

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:
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.
* These documents replaced the respective standards noted in the Former Document Code column.
General Laboratory
Hematology
Immunology and Ligand Assay
Method Evaluation
Microbiology
Molecular Methods
Newborn Screening
Veterinary Medicine
There are more products online at the CLSI Shop.
Visit www.clsi.org to fnd our full library of resources.
Shop Online!
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Method Evaluation
Quality Management
Systems
Microbiology
Newborn Screening
Point-of-Care
Testing
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Document Code Document Title Location
AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Online
AUTO02-A2
Laboratory Automation: Bar Codes for Specimen Container Identifcation; Approved
StandardSecond Edition
Online
AUTO03-A2
Laboratory Automation: Communications With Automated Clinical Laboratory Systems,
Instruments, Devices, and Information Systems; Approved StandardSecond Edition
Pg. 18
AUTO04-A
Laboratory Automation: Systems Operational Requirements, Characteristics, and
Information Elements; Approved Standard
Online
AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard Online
AUTO07-A Laboratory Automation: Data Content for Specimen Identifcation; Approved Standard Online
AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline Online
AUTO09-A
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved
Standard
Online
AUTO10-A Autoverifcation of Clinical Laboratory Test Results; Approved Guideline Online
AUTO11* Information Technology Security of In Vitro Diagnostic Instruments and Software Systems Pg. 56
AUTO11-A IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard Online
AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard Pg. 18
AUTO13-A2
Laboratory Instruments and Data Management Systems: Design of Software User
Interfaces and End-User Software Systems Validation, Operation, and Monitoring;
Online
I/LA33-A
Validation of Automated Systems for Immunohematological Testing Before
Implementation; Approved Guideline
Pg. 23
I/LA33-A TK
ImplementationSample Templates and Test Cases Toolkit
Pg. 23
LIS01-A2
Specifcation for Low-Level Protocol to Transfer Messages Between Clinical Laboratory
Instruments and Computer Systems; Approved StandardSecond Edition
Online
LIS02-A2
Specifcation for Transferring Information Between Clinical Laboratory Instruments and
Information Systems; Approved StandardSecond Edition
Online
LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System Online
LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems Online
LIS05-A
Standard Specifcation for Transferring Clinical Observations Between Independent
Computer Systems
Online
LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems Online
LIS07-A Standard Specifcation for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory Online
LIS08-A
Standard Guide for Functional Requirements of Clinical Laboratory Information
Management Systems
Online
LIS09-A
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic
Health Record Environment and Networked Architectures
Online
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.
Index of CLSI Standards, Guidelines, and Companion Products
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C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and
Defnitions; Approved GuidelineThird Edition
Online
C29-A2
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame
Photometric Reference Method; Approved StandardSecond Edition
Online
C31-A2
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and
Handling; Approved GuidelineSecond Edition
Online
C34-A3
Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved
GuidelineThird Edition
Pg. 19
C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
Online
C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline Online
C39-A
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 GuidelineSecond Edition
Pg. 19
C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online
C43-A2
Gas Chromatography/Mass Spectrometry Confrmation of Drugs; Approved Guideline
Second Edition
Pg. 19
C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline Online
C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online
C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved GuidelineSecond
Edition
Pg. 19
C48-A
Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring
of Bone Diseases; Approved Guideline
Online
C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Online
C50-A
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved
Guideline
Online
C52-A2
Toxicology and Drug Testing in the Clinical Laboratory; Approved GuidelineSecond
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
C59-A
Apolipoprotein Immunoassays: Development and Recommended Performance
Characteristics; Approved Guideline
Online
C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline Online
C61-A
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
Pg. 26
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical
Approach; Approved Guideline
Pg. 26
EP07-A2 Interference Testing in Clinical Chemistry; Approved GuidelineSecond Edition Online
EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples;
Pg. 26
EP10-A3
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures;
Online
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EP12-A2
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline
Second Edition
Online
EP14-A3 Evaluation of Commutability of Processed Samples; Approved GuidelineThird Edition Pg. 26
EP15* User Verifcation of Precision and Estimation of Bias Pg. 56
EP15-A2
User Verifcation of Performance for Precision and Trueness; Approved GuidelineSecond
Edition
Online
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;
Pg. 26
EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved
Pg. 27
EP19-R A Framework for NCCLS Evaluation Protocols; A Report Online
EP21-A 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 GuidelineSecond 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;
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
EP32-R Metrological Traceability and Its Implementation; A Report Online
(continued)
General Laboratory
EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Pg. 27
GP05-A3 Clinical Laboratory Waste Management; Approved GuidelineThird Edition Pg. 20
GP05-A3 QG Waste Management ProgramAudit Checklist Pg. 20
GP11-A Basic Cost Accounting for Clinical Services; Approved Guideline Online
GP15-A3
Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline
Third Edition
Online
GP16-A3 Urinalysis; Approved GuidelineThird Edition Pg. 20
GP16-A3 WC Wall ChartIdentifable Microscopic Entities Seen in Urine Sediment Pg. 20
GP17-A3 Clinical Laboratory Safety; Approved GuidelineThird Edition Pg. 20
GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved GuidelineSecond Edition Online
GP23-A
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques;
Approved Guideline
Online
GP27-A2
Using Profciency Testing to Improve the Clinical Laboratory; Approved GuidelineSecond
Edition
Online
GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline Online
GP29-A2
Assessment of Laboratory Tests When Profciency Testing Is Not Available; Approved
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
General Laboratory
GP39-A6
Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved
StandardSixth Edition
Pg. 21
GP41-A6
Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Pg. 21
GP41-A6 QG Quality Venipuncture Quick Guide Pg. 21
GP42-A6
Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens;
Approved StandardSixth Edition
Online
GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Pg. 21
GP43-A4
Procedures for the Collection of Arterial Blood Specimens; Approved StandardFourth
Edition
Online
GP44-A4
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory
Tests; Approved GuidelineFourth Edition
Pg. 21
GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 21
GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline Online
GP46-R Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report Online
H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved StandardFifth Edition Pg. 22
I03-A
Standard for Relating Spectrophotometer Performance Characteristics to Analytical Goals;
Approved Standard
Online
I08-P Determining Performance of Volumetric Equipment; Proposed Guideline Online
I16-T Temperature Monitoring and Recording in Blood Banks; Tentative Guideline Online
M29* Protection of Laboratory Workers From Occupationally Acquired Infections Pg. 57
M29-A3
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Online
M29-A3 QG Personal Protection in the Laboratory Quick Guide Pg. 36
MM13-A
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 GuidelineSixth Edition
Pg. 52
(continued)
Hematology
H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved StandardFifth Edition Pg. 22
H07-A3
Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved
StandardThird Edition
Online
H15-A3
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in
Blood; Approved StandardThird Edition
Online
H20-A2
Reference Leukocyte (WBC) Dierential Count (Proportional) and Evaluation of
Instrumental Methods; Approved StandardSecond Edition
Online
H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based
Coagulation Assays and Molecular Hemostasis Assays; Approved GuidelineFifth 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 StandardSecond Edition
Pg. 22
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C59-A
Apolipoprotein Immunoassays: Development and Recommended Performance
Characteristics; Approved Guideline
Online
I/LA02-A2
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect
Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods;
Online
I/LA18-A2
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
Pg. 23
I/LA21-A2 Clinical Evaluation of Immunoassays; Approved GuidelineSecond Edition Online
I/LA23-A
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme,
Fluorescence, and Luminescence Immunoassays; Approved Guideline
Online
I/LA25-A2 Maternal Serum Screening; Approved StandardSecond Edition Online
I/LA26-A2
Performance of Single Cell Immune Response Assays; Approved GuidelineSecond
Edition
Pg. 23
Hematology
H30-A2
Procedure for the Determination of Fibrinogen in Plasma; Approved GuidelineSecond
Edition
Online
H42-A2
Enumeration of Immunologically Defned Cell Populations by Flow Cytometry; Approved
Online
H43-A2
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved
Online
H44-A2
Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and
Supravital Dyes); Approved GuidelineSecond Edition
Online
H47-A2
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)
Test; Approved GuidelineSecond Edition
Online
H48-A Determination of Factor Coagulant Activities; Approved Guideline Online
H51-A
Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved
Guideline
Online
H52-A2
Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved GuidelineSecond
Edition
Pg. 22
H54-A
Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved
Guideline
Online
H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline Online
H57-A
Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved
Guideline
Online
H58-A 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
POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online
(continued)
I/LA28-A2
Quality Assurance for Design Control and Implementation of Immunohistochemistry
Pg. 23
I/LA29-A
Detection of HLA-Specifc Alloantibody by Flow Cytometry and Solid Phase Assays;
Approved Guideline
Online
I/LA30-A Immunoassay Interference by Endogenous Antibodies; Approved Guideline Online
I/LA33-A
Pg. 23
I/LA33-A TK
ImplementationSample Templates and Test Cases Toolkit
Pg. 23
I/LA34-A
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
of T-cell Receptor Excision Circles; Approved Guideline
Pg. 41
Method Evaluation
C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and
Defnitions; Approved GuidelineThird Edition
Online
C29-A2
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame
Photometric Reference Method; Approved StandardSecond Edition
Online
C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
Online
C39-A
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum;
Approved Standard
Online
C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online
C43-A2
Gas Chromatography/Mass Spectrometry Confrmation of Drugs; Approved Guideline
Second Edition
Pg. 19
C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline Online
C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online
C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved GuidelineSecond
Edition
Pg. 19
C50-A
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
Pg. 26
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical
Pg. 26
EP07-A2 Interference Testing in Clinical Chemistry; Approved GuidelineSecond Edition Online
EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples;
Pg. 26
EP10-A3
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures;
Online
EP12-A2
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline
Second Edition
Online
EP14-A3 Evaluation of Commutability of Processed Samples; Approved GuidelineThird Edition Pg. 26
EP15* User Verifcation of Precision and Estimation of Bias Pg. 56
EP15-A2
User Verifcation of Performance for Precision and Trueness; Approved GuidelineSecond
Edition
Online
(continued)
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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
M06-A2
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved StandardSecond
Edition
Online
M07-A9
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically;
Approved StandardNinth Edition
Pg. 32
M11-A8
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved
StandardEighth Edition
Pg. 32
M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline Online
M21-A Methodology for the Serum Bactericidal Test; Approved Guideline Online
M22-A3
Quality Control for Commercially Prepared Microbiological Culture Media; Approved
Online
M23-A3
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters;
Online
M24-A2
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes;
Pg. 32
M26-A
Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved
Guideline
Online
Method Evaluation
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;
Pg. 26
EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved
Pg. 27
EP19-R A Framework for NCCLS Evaluation Protocols; A Report Online
EP21-A 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 GuidelineSecond 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;
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
Pg. 28
EP31-A-IR
Verifcation of Comparability of Patient Results Within One Health Care System; Approved
Guideline (Interim Revision)
Pg. 28
EP32-R Metrological Traceability and Its Implementation; A Report Online
H26-A2
Validation, Verifcation, and Quality Assurance of Automated Hematology Analyzers;
Pg. 22
MM17-A Verifcation and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Online
(continued)
Microbiology
M27-A3
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved
Online
M27-S4
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth
Pg. 32
M28-A2
Procedures for the Recovery and Identifcation of Parasites From the Intestinal Tract;
Online
M29* Protection of Laboratory Workers From Occupationally Acquired Infections Pg. 57
M29-A3
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Online
M29-A3 QG Personal Protection in the Laboratory Quick Guide Pg. 36
M32-P
Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility
Testing; Proposed Guideline
Online
M33-A
Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved
Standard
Online
M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline Online
M35-A2 Abbreviated Identifcation of Bacteria and Yeast; Approved GuidelineSecond Edition Online
M36-A
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved
Guideline
Online
M38-A2
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous
Fungi; Approved StandardSecond Edition
Online
M39-A4
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved
GuidelineFourth 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
M40-A Quality Control of Microbiological Transport Systems; Approved Standard Online
M41-A 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
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 GuidelineSecond Edition
Pg. 34
M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 34
M48-A 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 SpecimensDirect
Examination and Culture; Approved Guideline
Pg. 36
M55-R
Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and
Challenges; A Report
Pg. 36
(continued)
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Microbiology
M56* Principles and Procedures for Detection of Anaerobes in Clinical Specimens Pg. 57
M100-S24
Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth
Pg. 30
M100-S24 QG M100-S24 Tables 1A1C Quick Guide Pg. 31
M100-S24 WC
Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fourth
Pg. 31
MM03-A2
Molecular Diagnostic Methods for Infectious Diseases; Approved GuidelineSecond
Edition
Online
MM06-A2
Quantitative Molecular Methods for Infectious Diseases; Approved GuidelineSecond
Edition
Pg. 37
MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online
MM18-A
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
(continued)
Molecular Methods
I/LA28-A2
Quality Assurance for Design Control and Implementation of Immunohistochemistry
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
MM03-A2
Molecular Diagnostic Methods for Infectious Diseases; Approved GuidelineSecond
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 GuidelineSecond
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
Pg. 37
MM10-A
Genotyping for Infectious Diseases: Identifcation and Characterization; Approved
Guideline
Online
MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online
MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online
MM13-A
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
Pg. 37
MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline Online
MM17-A Verifcation and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Online
MM18-A
Interpretive Criteria for Identifcation of Bacteria and Fungi by DNA Target Sequencing;
Approved Guideline
Online
Molecular Methods
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
Pg. 41
(continued)
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 GuidelineSecond 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
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
POCT01-A2 Point-of-Care Connectivity; Approved StandardSecond Edition Online
POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline Online
POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved GuidelineSecond Edition Online
POCT05-A 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
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EP23-A Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 24
GP17-A3 Clinical Laboratory Safety; Approved GuidelineThird Edition Pg. 20
GP27-A2
Using Profciency Testing to Improve the Clinical Laboratory; Approved GuidelineSecond
Edition
Online
GP29-A2
Assessment of Laboratory Tests When Profciency Testing Is Not Available; Approved
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
POCT07-A
Quality Management: Approaches to Reducing Errors at the Point of Care; Approved
Guideline
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
QMS01-A4
Quality Management System: A Model for Laboratory Services; Approved Guideline
Fourth Edition
Pg. 52
QMS02-A6
Quality Management System: Development and Management of Laboratory Documents;
Approved GuidelineSixth Edition
Pg. 52
QMS03-A3 Training and Competence Assessment; Approved GuidelineThird Edition Pg. 52
QMS04-A2 Laboratory Design; Approved GuidelineSecond Edition Online
QMS05-A2
Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory;
Pg. 53
QMS06-A3
Quality Management System: Continual Improvement; Approved GuidelineThird
Edition
Pg. 53
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 Microscopic Components in Urine Sediment Wall Chart Pg. 47
POCT10-A2 WC2 Microscopic Components in Vaginal Fluid and KOH Preparations Wall Chart Pg. 47
POCT10-A2 WC3 Ectoparasites Wall Chart Pg. 47
POCT11-A2 Pulse Oximetry; Approved GuidelineSecond Edition Pg. 45
POCT12-A3
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved
Pg. 45
POCT13-A2
Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline
Second Edition
Online
POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online
(continued)
QMS07-A2
Application of a Quality Management System Model for Respiratory Services; Approved
Online
QMS08-A2
Application of a Quality Management System Model for Medical Imaging Services;
Online
QMS09-A2
Application of a Quality Management System Model for Inpatient Medication Use;
Online
QMS10-A
A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare
Organizations; Approved Guideline
Online
QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Online
QMS12-A
Development and Use of Quality Indicators for Process Improvement and Monitoring of
Laboratory Quality; Approved Guideline
Pg. 53
QMS13-A Quality Management System: Equipment; Approved Guideline Pg. 53
QMS14-A
Quality Management System: Leadership and Management Roles and Responsibilities;
Approved Guideline
Pg. 53
QMS14-AES
Executive Summary: Quality Management System: Leadership and Management Roles
and Responsibilities
Pg. 53
QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 53
QMS20* Understanding the Cost of Quality in the Laboratory Pg. 57
(continued)
Veterinary Medicine
VET01-A4
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for
Bacteria Isolated From Animals; Approved StandardFourth Edition
Pg. 54
VET01-S2
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for
Bacteria Isolated From Animals; Second Informational Supplement
Pg. 54
VET02-A3
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for
Veterinary Antimicrobial Agents; Approved GuidelineThird Edition
Online
VET03-A
Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic
Animals; Approved Guideline
Online
VET03/VET04-S1
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From
Aquatic Animals; First Informational Supplement
Pg. 54
VET04*
Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic
Animals
Pg. 57
VET05-R
Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for
Bacteria of Animal Origin; A Report
Pg. 54
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CLSI references in the College of American Pathologists (CAP) Accreditation
Program Checklists
Approved-level consensus standards recognized by the US Food and Drug
Administration (FDA) for use in satisfying a regulatory requirement
CLSI documents referenced in The Joint Commission Laboratory Accreditation
Standards chapters
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Approved Standard or Guideline:
Document has achieved consensus within the health care community.
*

Report:
Document that has not been subjected to consensus review and is released by the appropriate
consensus committee.
*
American National Standards have been approved by the American National Standards Institute (ANSI). CLSI
submits selected standards as candidate American National Standards when such status will enhance their national or
international usefulness.
NOTE: Any documents published before 2009 can be found online at www.clsi.org.
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DEFINITIONS:
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Objectives:
Describe the rationale for the standard in terms of
reducing human errors.
List the key elements (identifers) whose locations,
formats, and fonts are specifed on a
specimen label.
Identify the correct orientation of a specimen tube
as it is to be labeled.
WEBINAR: How to Lower the Mislabel Error Rate in Your Laboratory by
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CLSI Standards and Guidelines
CLSI standards are built on the expertise of and consensus achieved by government,
industry, and laboratory health care professionals to yield highly respected best
practices for continually improving quality, safety, and efficiency in laboratory
testing and reporting.
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September 2009
consensus process.
AUTO03-A2
Laboratory Automation: Communications
With Automated Clinical Laboratory
Systems, Instruments, Devices, and
Information Systems; Approved
Laboratory Automation:
Communications With Automated
Clinical Laboratory Systems,
Instruments, Devices, and
Information Systems; Approved
This document provides standards to facilitate accurate and timely
electronic exchange of data and information between the automated
laboratory elements.
Members LI: $39 LII: $52 LIII: $65
Nonmembers $130
SEPTEMBER 2009
AUTO03-A2
April 2011
consensus process.
AUTO12-A
SpecimenLabels: Content andLocation, Fonts,
andLabel Orientation; ApprovedStandard
Specimen Labels: Content and
Location, Fonts, and Label
Orientation; Approved Standard

The purpose of this standard is to reduce human errors currently
associated with the lack of standardization of labels on clinical
laboratory specimens. The standard identifes the required
human-readable elements to appear on specimen labels and specifes
the exact locations, fonts, and font sizes of these elements.
Nonmembers $130
APRIL 2011
AUTO12-A
now available on demand
Speakers: Charles D. Hawker, PhD, MBA, FACB
Salt Lake City, Utah, USA
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Ann Arbor, Michigan, USA
Related CLSI Document:
AUTO12-ASpecimen Labels: Content and
Location, Fonts, and Label Orientation;
Approved Standard
Download today at www.clsi.org/edu/on-demand.
CAP
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December 2009
consensus process.
C34-A3
Sweat Testing: Sample Collectionand
Quantitative Chloride Analysis; Approved
February 2009
consensus process.
C46-A2
Blood Gas and pHAnalysis and Related
Measurements; Approved Guideline
Second Edition
July 2012
consensus process.
C56-A
Hemolysis, Icterus, and Lipemia/Turbidity
Indices as Indicators of Interference inClinical
Laboratory Analysis; Approved Guideline
October 2013
consensus process.
C40-A2
Determinationof Lead Concentrations in
Blood and Urine; Approved Guideline
Second Edition

March 2010
consensus process.
C43-A2
Gas Chromatography/Mass Spectrometry
Conrmationof Drugs; Approved
November 2011
consensus process.
C58-A
Assessment of Fetal Lung Maturity by the
Lamellar Body Count; Approved Guideline
Sweat Testing: Sample Collection
and Quantitative Chloride
Analysis; Approved Guideline
Third Edition
This document addresses appropriate methods of collection
and analysis, quality control, and the evaluation and reporting of
test results.
Nonmembers $130
Blood Gas and pH Analysis and
Related Measurements; Approved
This document provides clear defnitions of the quantities in current use,
and provides a single source of information on appropriate specimen
collection, preanalytical variables, calibration, and quality control for
blood pH and gas analysis and related measurements.
Nonmembers $130
Hemolysis, Icterus, and Lipemia/
Turbidity Indices as Indicators of
Interference in Clinical Laboratory
Analysis; Approved Guideline
This document provides background information on mechanisms
of hemolysis, icterus, lipemia/turbidity (HIL) interference; intended
usefulness of HIL indices; establishment of HIL alert indices; availability
of automated HIL detection systems; and interpretation, strengths,
limitations, and verifcation of HIL indices in the clinical laboratory.
Nonmembers $130
Measurement Procedures for
the Determination of Lead
Concentrations in Blood and
Urine; Approved Guideline
Second Edition
This document provides guidance for the measurement of lead
concentrations in blood and urine, including specimen collection,
measurement by graphite furnace atomic absorption spectrometry,
anodic stripping voltammetry, and inductively coupled plasma mass
spectrometry. It also includes guidelines for quality assurance and
quality control, and information on profciency testing programs and
laboratory certifcation.
Nonmembers $130
Gas Chromatography/Mass
Spectrometry Confrmation of
Drugs; Approved Guideline
Second Edition
This document provides guidance on establishing uniform practices
necessary to produce quality data for quantitation and identifcation
of a drug or drug metabolite using the gas chromatography/
mass spectrometry method. Specifc quality assurance criteria for
maintaining and documenting optimal instrument performance are
also presented.
Nonmembers $130
Assessment of Fetal Lung Maturity
by the Lamellar Body Count;
Approved Guideline
This document provides guidelines for the use of automated cell
counting to enumerate lamellar bodies in amniotic fuid. It describes
the dierent counting technologies used in automated cell counters as
well as methods laboratorians can use to verify/validate the lamellar
body count test.
Nonmembers $130
DECEMBER 2009
FEBRUARY 2009
JULY 2012
OCTOBER 2013
MARCH 2010
NOVEMBER 2011
C34-A3
C46-A2
C56-A
C40-A2
C43-A2
C58-A
CAP JC
JC JC
FDA
CAP JC
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Waste Management ProgramAudit Checklist
Use this checklist for the regular assessment of a waste management
program as part of a continual improvement process.
Nonmembers $20
Wall ChartIdentifable Microscopic Entities Seen in
Urine Sediment
Handy reference with more than 30 images of elements
seen in urine.
Nonmembers $50
GP05-A3 QG
GP16-A3 WC
January 2011
consensus process.
GP05-A3
Clinical Laboratory Waste Management;
June 2012
consensus process.
GP17-A3
Clinical Laboratory Safety; Approved
April 2009
consensus process.
GP31-A
Laboratory Instrument Implementation,
Verication, and Maintenance; Approved
Guideline
February 2009
consensus process.
GP16-A3
Urinalysis; Approved Guideline
Third Edition
Clinical Laboratory Waste
Management; Approved

Based on US regulations, this document provides guidance on the
safe handling and disposal of chemical, infectious, radioactive, and
multihazardous wastes generated in the clinical laboratory. Although
this document is a valuable resource for a wider audience, it is intended
for use primarily in the United States.
Nonmembers $130
Clinical Laboratory Safety;
Approved Guideline
Third Edition

This document contains general recommendations for implementing
a high-quality laboratory safety program, which are provided in a
framework that is adaptable within any laboratory.
Nonmembers $130
Laboratory Instrument
Implementation, Verifcation, and
Maintenance; Approved Guideline
This guideline provides information about assessing instrument
performance and function from the time of instrument purchase to the
routine performance of clinical testing.
Nonmembers $130
Urinalysis; Approved Guideline
Third Edition

This document addresses procedures for testing urine, including
materials and equipment; macroscopic/physical evaluation; chemical
analysis; and microscopic analysis.
Nonmembers $130
JANUARY 2011
JUNE 2012 APRIL 2009
FEBRUARY 2009
GP05-A3
GP17-A3 GP31-A
March 2010
consensus process.
GP33-A
Accuracy inPatient and Sample
Identication; Approved Guideline
Accuracy in Patient and
Sample Identifcation;
Approved Guideline

This guideline describes the essential elements of systems and processes
required to ensure accurate patient identifcation. The principles in
this document may be applied to manual or electronic systems. Design
considerations covered include criteria for accuracy, dierences in inpatient
vs outpatient settings that impact patient identifcation, language and
cultural considerations, and standardization of processes across the health
care enterprise.
Nonmembers $130
MARCH 2010
GP33-A
GP16-A3
CAP FDA JC
CAP
CAP
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ADDITIONAL GENERAL LABORATORY COMPANION PRODUCTS
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Quality Venipuncture Quick Guide
This Quick Guide is available in a larger 11 x 17 inch size to provide
additional assistance in an accurate blood draw. The Quick Guide
lists all of the steps of the venipuncture procedure, as well as special
considerations, and the order of the tube draw. It also includes a
color photo of vein distribution on the right arm for guidance in the
venipuncture procedure.
Nonmembers $20
GP41-A6 QG
December 2010
consensus process.
GP34-A
Validationand Vericationof Tubes for
Venous and Capillary Blood Specimen
Collection; Approved Guideline
October 2007
consensus process.
GP41-A6
Procedures for the Collectionof Diagnostic
Blood Specimens by Venipuncture;
May 2010
consensus process.
GP44-A4
Procedures for the Handling and Processing
of Blood Specimens for CommonLaboratory
Tests; Approved GuidelineFourth Edition
December 2010
consensus process.
GP39-A6
Tubes and Additives for Venous and
Capillary Blood SpecimenCollection;
Validation and Verifcation of
Tubes for Venous and Capillary
Blood Specimen Collection;
Approved Guideline
This document provides guidance for conducting validation and
verifcation testing for venous and capillary blood collection tubes.
Nonmembers $130
Procedures for the Collection
of Diagnostic Blood Specimens
by Venipuncture; Approved
This document provides procedures for the collection of diagnostic
specimens by venipuncture, including line draws, blood culture
collection, and venipuncture in children.
Nonmembers $130
Procedures for the Handling and
Processing of Blood Specimens
for Common Laboratory Tests;
This document includes criteria for preparing an optimal serum or
plasma sample and for the devices used to process blood specimens.
Nonmembers $130
Tubes and Additives for Venous
and Capillary Blood Specimen
Collection; Approved Standard
Sixth Edition
This standard contains requirements for the materials, manufacturing,
and labeling of venous and capillary blood collection devices.
Nonmembers $130
DECEMBER 2010
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GP34-A
GP41-A6
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GP39-A6
Handling, Transport, and Storage of Specimens Quick Guide
Provides recommended conditions for proper handling, transport, and
storage of specimens for general chemistry and hematology analysis.
Nonmembers $40
Technique for Skin Puncture in Adults and Older Children Quick Guide
Includes every step in the skin puncture procedure from patient
preparation to specimen collection, and container labeling.
Nonmembers $20
Specimen Collection Quick Guides
Buy 10 Specimen Collection Quick Guides and Save Up to 25% O
the List Price!
Quick Guides included in this set:.

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C49-A/H56-A QG
GP41-A6 QG
GP42-A6 QG
GP44-A4 QG
H21-A5 QG
M29-A3 QG
M47-A QG
MM13-A QG
NBS01-A6 QG
NBS03-A QG
GP44-A4 QG
GP42-A6 QG QG 10
CAP
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Collection, Handling, Transport, and Storage for Hemostasis Quick Guide
Outlines best practice procedures for the proper collection,
transportation, and processing of blood specimens, as well as storage of
plasma for coagulation testing.
Nonmembers $20
H21-A5 QG
May 2011
consensus process.
H02-A5
Procedures for the Erythrocyte
SedimentationRate Test;
Approved StandardFifth Edition
June 2010
consensus process.
H26-A2
Validation, Verication, and Quality
Assurance of Automated Hematology
Analyzers; Approved Standard
Second Edition
March 2011
consensus process.
H59-A
Quantitative D-dimer for the
Exclusionof Venous Thromboembolic
Disease; Approved Guideline
January 2008
consensus process.
H21-A5
Collection, Transport, and Processing
of Blood Specimens for Testing
Plasma-Based CoagulationAssays
and Molecular Hemostasis Assays;
Approved GuidelineFifth Edition
Procedures for the Erythrocyte
Sedimentation Rate Test; Approved
StandardFifth Edition

This document provides a description of the principle, materials, and
procedure for a standardized erythrocyte sedimentation rate (ESR)
method; a selected routine method, as well as a procedure to
evaluate routine methods; and an outline of quality control programs
for the ESR test.
Nonmembers $130
Validation, Verifcation, and
Quality Assurance of Automated
Hematology Analyzers; Approved
This document provides guidance for the validation, verifcation,
calibration, quality assurance (QA), and quality control (QC) of
automated multichannel hematology analyzers for manufacturers,
end-user clinical laboratories, accrediting organizations, and regulatory
bodies. In addition, end-user clinical laboratories will fnd guidance
for establishment of clinically reportable intervals and for QA for
preexamination and examination aspects of their systems.
Nonmembers $130
Quantitative D-dimer for
the Exclusion of Venous
Thromboembolic Disease;
Approved Guideline
This document provides guidelines regarding the use of D-dimer in
exclusion of venous thromboembolism (VTE) including a description
of the value of clinical determination of the pretest probability of
VTE; the proper collection and handling of the specimen; assays used
for D-dimer analysis; determination of the threshold for exclusion
of VTE; interpretation of test results; and aspects of regulatory and
accreditation requirements.
Nonmembers $130
Collection, Transport, and Processing
of Blood Specimens for Testing
Plasma-Based Coagulation Assays
and Molecular Hemostasis Assays;
Approved GuidelineFifth Edition
This document provides procedures for collecting, transporting, and
storing blood; processing blood specimens; storing plasma for coagulation
testing; and general recommendations for performing the tests.
Nonmembers $130
MAY 2011
JUNE 2010
MARCH 2011
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H02-A5
H26-A2
H59-A
H21-A5
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March 2014
consensus process.
H60-A
Laboratory Testing for the
Lupus Anticoagulant; Approved
Guideline
This document provides guidance and recommendations regarding
the proper collection and handling of the specimen; descriptions
and limitations of screening and confrmatory assays, and mixing
tests used to identify the lupus anticoagulant (LA); determination of
cuto values and calculations associated with the various assays; and
interpretation of test results in an LA panel.
Nonmembers $130
MARCH 2014
H60-A
March 2014
consensus process.
H52-A2
FlowCytometry; Approved Guideline
Second Edition
Red Blood Cell Diagnostic Testing
Using Flow Cytometry; Approved
This guideline addresses the diagnostic red blood cell assays
performed as fuorescence-based assays on a fow cytometry platform;
including testing procedures for fetomaternal hemorrhage detection,
paroxysmal nocturnal hematuria screening, membrane defect anemia
testing for hereditary spherocytosis, and nucleated red blood cell
counting. Points of validation and quality control, and caveats of
interpretation are also discussed.
Nonmembers $130
MARCH 2014
H52-A2
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Validation of Automated Systems for Immunohematological
Testing Before ImplementationSample Templates and Test
Cases Toolkit
Provides 24 customizable templates from the appendixes of
I/LA33-A. Each simplifed template, test case, checklist, worksheet, and
schedule can be used by the laboratory for development of test cases
related to dierent aspects of installation qualifcation, operational
qualifcation, and performance qualifcation.
Nonmembers $100
Implementation; Approved Guideline (I/LA33-A) is not included on the CD-ROM.
I/LA33-A TK
March 2009
consensus process.
I/LA20-A2
Analytical Performance Characteristics
and Clinical Utility of Immunological
Assays for HumanImmunoglobulinE
(IgE) Antibodies and Dened Allergen
Specicities; Approved Guideline
Second Edition
November 2013
consensus process.
I/LA26-A2
Response Assays; Approved Guideline
Second Edition
December 2009
consensus process.
I/LA33-A
Validationof Automated Systems for
Immunohematological Testing Before
January 2011
consensus process.
I/LA28-A2
Quality Assurance for Design
Control and Implementation
of Immunohistochemistry Assays;
Approved Guideline
Second Edition
Analytical Performance
Characteristics and Clinical Utility of
Immunological Assays for Human
Immunoglobulin E (IgE) Antibodies
and Defned Allergen Specifcities;
This document provides guidance for the design, analytical
performance, standardization, quality assurance, and clinical
application of laboratory assays used in the measurement of human IgE
antibodies of defned allergen specifcity.
Nonmembers $130
Response Assays; Approved
This document contains methods of intracellular cytokine evaluation,
major histocompatibility complex multimer quantitation, enzyme-
linked immunospot technology, and carboxyfuorescein succinimidyl
ester tracking dye staining for the assessment of cellular proliferation.
It also provides basic aspects of specimen collection, transport, and
preparation; results interpretation; and quality assurance and test
validation approaches.
Nonmembers $130
Validation of Automated Systems
for Immunohematological Testing
Before Implementation;
Approved Guideline
This document provides guidance to the end user and laboratory for
validation of automated systems used in immunohematological testing
before implementation.
Nonmembers $130
Quality Assurance for Design
Control and Implementation of
Immunohistochemistry Assays;
This document provides guidelines for the development of validated
diagnostic, prognostic, and predictive immunohistochemical assays.
Nonmembers $130
MARCH 2009 NOVEMBER 2013
DECEMBER 2009
JANUARY 2011
I/LA20-A2 I/LA26-A2
I/LA33-A
I/LA28-A2
CAP JC
JC FDA
CAP JC FDA
October 2011
consensus process.
EP23-A
TM
Laboratory Quality Control Based on Risk
Management; Approved Guideline
EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements
Gain the tools to take on QC changes. Optimize the implementation of the EP23 guideline
while you hear about the latest QC changes.
Implement CLSI Document EP23
The EP23 Online Workshop is a distance learning program that imparts the knowledge
and skills necessary for the successful implementation of CLSI document EP23-A. The
program consists of self-paced lessons followed by a homework assignment, a live
classroom session, and a summary and evaluation section.
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Laboratory Quality Control Based on
Risk Management; Approved Guideline
This document provides guidance based on risk management for
laboratories to develop quality control (QC) plans tailored to the
particular combination of measuring system, laboratory setting, and
clinical application of the test.
EP23-A
TM
Use CLSIs approved guideline for laboratory QC based on risk management to:
Obtain guidance based on risk management for
laboratories.
Develop QC plans tailored to a combination of
measuring system, laboratory setting, and clinical
application of the test.
Members LI: $51 LII: $68 LIII: $85 | Nonmembers $170
Reduce risk through a comprehensive QC plan.
Find the help you need to implement
EP23THE RIGHT QC in your laboratory.
Why Use EP23?
The EP23 guideline is a powerful resource for laboratories
to use to customize their quality control plans to their own
specifc laboratory settings. It provides current research
and views of laboratory quality control.
Judith A. Yost, MA, MT(ASCP)
Director, Division Laboratory Services, Centers for Medicare &
Medicaid Services
JC FDA
Earn 5.0 P.A.C.E. Program
continuing education
credits for your
participation.
Register today at
www.clsi.org/edu/workshops.
Interact With Fellow Colleagues
During the live classroom session, all participants hear and see one anothers
QC plan (QCP) examples and learn from a CLSI instructor about how to
enhance the details of each QCP.
Study on Your Own Schedule
Self-paced lessons include the defnition of risk management, an example
explaining the concepts of EP23, a lesson showcasing new risk assessment
concepts not typically used by laboratorians, the EP23 Workbook, the
EP23 Worksheet, and CMS and individualized quality control plan (IQCP)
requirements.
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EP23-A Companion Products
*The worksheet and the workbook can only be purchased individually by previous purchasers of the EP23-A document.
Laboratory Quality Control Based on
Risk Management; Approved Guideline,
Workbook, and Worksheet Package
A Sample Form for Laboratory Quality
Control Based on Risk Management
A Practical Guide for Laboratory
Quality Control Based on
Risk Management
This EP23-A package includes:
Laboratory Quality Control Based
on Risk Management; Approved
Guideline (EP23-A)
A Practical Guide for Laboratory
Quality Control Based on Risk
Management; Workbook
(EP23-A WB)
A Sample Form for Laboratory
Quality Control Based on Risk
Management; Worksheet
(EP23-A WS)
The EP23-A worksheet contains a template and example that help
users identify potential failure modes at each stage of the test systems
process and consider what monitors are in place or could be used to
detect the problem. The worksheet does not represent a complete
or comprehensive evaluation of risk and laboratories are encouraged
to use other available resources to meet each institutions risk
management requirements.
Nonmembers $100
The EP23-A workbook provides an overview of each step necessary
to create a comprehensive quality control plan. It is tailored around a
specifc example that helps readers understand what information to
gather to help detect and assess risks.
Nonmembers $100
EP23-A PK
EP23-A WS*
EP23-A WB*
BUNDLE
AND SAVE!
Nonmembers $340
Why Enroll in the EP23 Online
Workshop?
This course design and execution allows for more
participant accountability through the use of a
virtual classroom opportunity. The on-screen
instructor works directly with participants on
their homework IQCP examplesa worthwhile,
added-value bonus feature to the online training.
Peggy Mann, MS, MT(ASCP)
Clinics Administration, Quality, Safety,
& Environment Program Manager
Ambulatory POC Coordinator
University of Texas Medical Branch
Galveston, Texas, USA
CAP FDA JC
August 2004
consensus process.
EP05-A2
Evaluationof PrecisionPerformance of
Quantitative Measurement Methods;
August 2013
consensus process.
EP09-A3
Measurement Procedure Comparisonand
Bias EstimationUsing Patient Samples;
April 2003
consensus process.
EP06-A
Evaluationof the Linearity of Quantitative
Measurement Procedures: AStatistical
June 2012
consensus process.
EP17-A2
Evaluationof DetectionCapability
for Clinical Laboratory Measurement
Procedures; Approved Guideline
Second Edition
Evaluation of Precision Performance
of Quantitative Measurement
Methods; Approved Guideline
Second Edition
This document provides guidance for designing an experiment to
evaluate the precision performance of quantitative measurement
methods; recommendations on comparing the resulting precision
estimates with manufacturers precision performance claims
and determining when such comparisons are valid; as well as
manufacturers guidelines for establishing claims.
Nonmembers $170
Measurement Procedure
Comparison and Bias Estimation
Using Patient Samples; Approved
This document addresses the design of measurement procedure
comparison experiments using patient samples and subsequent data
analysis techniques used to determine the bias between two in vitro
diagnostic measurement procedures.
Nonmembers $170
Evaluation of the Linearity of
Quantitative Measurement
Procedures: A Statistical Approach;
Approved Guideline
This document provides guidance for characterizing the linearity
of a method during a method evaluation; for checking linearity as
part of routine quality assurance; and for determining and stating a
manufacturers claim for linear range.
Nonmembers $170
Evaluation of Detection Capability
for Clinical Laboratory Measurement
Procedures; Approved Guideline
Second Edition
This document provides guidance for evaluation and documentation of
the detection capability of clinical laboratory measurement procedures
(ie, limits of blank, detection, and quantitation), for verifcation of
manufacturers detection capability claims, and for the proper use and
interpretation of dierent detection capability estimates.
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April 2014
consensus process.
EP14-A3
Evaluationof Commutability of
Processed Samples; Approved Guideline
Third Edition
Evaluation of Commutability
of Processed Samples; Approved
This document provides guidance for evaluating the commutability
of processed samples by determining if they behave dierently than
unprocessed patient samples when two quantitative measurement
procedures are compared.
Nonmembers $170
APRIL 2014
EP14-A3
CAP JC
JC FDA
November 2009
consensus process.
EP18-A2
Risk Management Techniques
to Identify and Control Laboratory
Error Sources; Approved Guideline
Second Edition
November 2011
consensus process.
EP24-A2
Assessment of the Diagnostic Accuracy
of Laboratory Tests Using Receiver
Operating Characteristic Curves;
ApprovedGuidelineSecondEdition
September 2012
consensus process.
EP27-A
Howto Construct and Interpret
anError Grid for Quantitative
Diagnostic Assays;
Approved Guideline
Risk Management Techniques to
Identify and Control Laboratory
Error Sources; Approved Guideline
Second Edition
This guideline describes risk management techniques that will aid in
identifying, understanding, and managing sources of failure (potential
failure modes) and help to ensure correct results. Although intended
primarily for in vitro diagnostics, this document will also serve as a
reference for clinical laboratory managers and supervisors who wish to
learn about risk management techniques and processes.
Nonmembers $170
Assessment of the Diagnostic
Accuracy of Laboratory Tests Using
Receiver Operating Characteristic
Curves; Approved Guideline
Second Edition
This document provides a protocol for evaluating the accuracy of a
test to discriminate between two subclasses of subjects when there
is some clinically relevant reason to separate them. In addition to the
use of receiver operating characteristic curves and the comparison
of two curves, the document emphasizes the importance of defning
the question, selecting the sample group, and determining the true
clinical state.
Nonmembers $170
How to Construct and Interpret an
Error Grid for Quantitative Diagnostic
Assays; Approved Guideline

This guideline describes what an error grid is, why it is useful, and how
to construct one and interpret the information. Guidance is provided
for manufacturers and for the clinical laboratory.
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EP27-A
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consensus process.
EP26-A
User Evaluationof Between-Reagent Lot
September 2009
consensus process.
EP25-A
Evaluationof Stability of In Vitro Diagnostic
Reagents; Approved Guideline
User Evaluation of Between-Reagent
Lot Variation; Approved Guideline

This document provides guidance for laboratories on the evaluation of
a new reagent lot, including a protocol using patient samples to detect
signifcant changes from the current lot.
Nonmembers $170
Evaluation of Stability of In Vitro
Diagnostic Reagents; Approved
Guideline

This document provides guidance for establishing shelf-life and in-use
stability claims for in vitro diagnostic reagents such as reagent kits,
calibrators, and control products.
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SEPTEMBER 2013
SEPTEMBER 2009
EP26-A
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October 2010
consensus process.
EP28-A3c
Dening, Establishing, and Verifying
Reference Intervals inthe Clinical
Laboratory; Approved Guideline
Third Edition
May 2010
consensus process.
EP30-A
Characterizationand Qualicationof
Commutable Reference Materials for
Laboratory Medicine; Approved Guideline
January 2012
consensus process.
EP29-A
Expressionof Measurement Uncertainty in
Laboratory Medicine; Approved Guideline
August 2012
consensus process.
EP31-A-IR
Vericationof Comparability
of Patient Results WithinOne
Health Care System; Approved
Guideline (InterimRevision)
Defning, Establishing, and Verifying
Reference Intervals in the Clinical
Laboratory; Approved Guideline
Third Edition
This document contains guidelines for determining reference values
and reference intervals for quantitative clinical laboratory tests.
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Characterization and Qualifcation
of Commutable Reference Materials
for Laboratory Medicine;
Approved Guideline
This document provides information to help material manufacturers
in the production and characterization of commutable reference
materials, as well as to assist assay manufacturers and laboratorians
in the appropriate use of these materials for calibration and trueness
assessment of in vitro diagnostic medical devices.
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Expression of Measurement
Uncertainty in Laboratory Medicine;
Approved Guideline

This guideline describes a practical approach to assist clinical
laboratories in developing and calculating useful estimates of
measurement uncertainty, and illustrates their application in
maintaining and improving the quality of measured values used in
patient care.
Nonmembers $170
Verifcation of Comparability of
Patient Results Within One Health
Care System; Approved Guideline
(Interim Revision)
This document provides guidance on how to verify comparability of
quantitative laboratory results for individual patients within a health
care system.
Nonmembers $170
OCTOBER 2010
MAY 2010
JANUARY 2012
AUGUST 2012
EP28-A3c
EP30-A
EP29-A
EP31-A-IR
JC
JC
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Revised cefepime disk diusion and minimal inhibitory
concentration (MIC) interpretive criteria along with
dosage regimens for using susceptible-dose dependent
(SDD) interpretive criteria
New cefazolin interpretive criteria and
recommendations for use as a surrogate test for
uncomplicated urinary tract infections to predict results
for oral cephalosporins
New doripenem disk diusion and MIC interpretive
criteria with dosage regimens on which the breakpoints
are based
Revised imipenem and meropenem disk diusion and
MIC interpretive criteria with dosage regimens on
which the breakpoints are based
Defnition for SDD with educational information
explaining the introduction of SDD interpretive criteria
An example and explanation for antimicrobial agents
having only susceptible interpretive criteria
Information for reporting frst- and second-generation
cephalosporins and cephamycins for Salmonella spp.
and Shigella spp.
Updated recommendations for the placement of disks
on a 100-mm plate
Aztreonam-avibactam
Biapenem
Ceftazidime-avibactam
Ceftolozane-tazobactam
Eravacycline
Surotomycin
Telavancin
M100-S24
This document provides updated tables for the CLSI
antimicrobial susceptibility testing standards M02-A11,
M07-A9, and M11-A8.
New or revised interpretive criteria are available for the following drugs:
Added:
Quality control ranges added and/or revised for:
consensus process.
M100-S24
This document provides updated tables for the Clinical
and Laboratory Standards Institute antimicrobial
susceptibility testing standards M02-A11, M07-A9,
and M11-A8.

January 2014
Objectives:
Identify the major changes found in CLSI document M100-S24.
Design a strategy for implementing the new practice guidelines
into your laboratory practices.
Develop a communication strategy for informing clinical sta of
signifcant AST and reporting changes.
CLSI/APHL Webinar: CLSI 2014 AST Update now available on demand
Speaker: Janet A. Hindler, MCLS, MT(ASCP)
Los Angeles, California, USA
M100-S24Performance Standards for Antimicrobial
Susceptibility Testing; Twenty-Fourth Informational Supplement
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M100-S24 Companion Products
M100-S24 QG
M100-S24 Tables 1A1C Quick Guide
Provides suggested groupings of antimicrobial agents that
should be considered for routine disk and broth dilution testing
and reporting by clinical laboratories. These guides serve as
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for profciency testing and accreditation. Printed on durable,
waterproof sheets and detachable for convenient, shared use in
the laboratory.
M100-S24 WC
Glossary of Antimicrobial Terms and
Abbreviations Wall Chart: Twenty-
Fourth Informational Supplement
Wall chart (based on M100-S24) features important terminology
(drug classes, subclasses, and dosage forms) for all antimicrobial
agents featured in M100-S24. Serves as a handy reference for
laboratorians in speaking the language when transmitting
important clinical susceptibility information to the clinician. The
chart also features a comprehensive listing of abbreviations
used around the world to identify antimicrobials in in vitro
diagnostic products such as automated susceptibility test
systems and antimicrobial agent disks.
AST QC QG
AST QC Flow Chart Quick Guides
The ultimate cheat sheet to quality control (QC) for
antimicrobial susceptibility testing. Easy-to-use fow charts
guide you through daily QC testing for both disk diusion and
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users can convert to weekly QC with a fip of a page. Also
included are guides to QC testing frequency and troubleshooting.
Formatted as 8 1/2 x 11 durable, waterproof sheets on a
convenient detachable ring. Based on the current editions of
M02, M07, and M100.
M02-A11/M07-A9 PK14
M100-S24 is available with the purchase of M02, M07, or both documents.
Collection includes:
M02-A11Performance Standards for Antimicrobial Disk Susceptibility Tests;
Approved StandardEleventh Edition
M07-A9Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That
Grow Aerobically; Approved StandardNinth Edition
M100-S24Performance Standards for Antimicrobial Susceptibility Testing; Twenty-
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January 2012
consensus process.
M02-A11
Disk Susceptibility Tests; Approved
StandardEleventh Edition
January 2012
consensus process.
M07-A9
Methods for DilutionAntimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically; Approved StandardNinth
Edition
March 2011
consensus process.
M24-A2
Susceptibility Testing of
Mycobacteria, Nocardiae, and Other
Aerobic Actinomycetes; Approved
February 2012
consensus process.
M11-A8
Methods for Antimicrobial Susceptibility
Testing of Anaerobic Bacteria; Approved
StandardEighth Edition
December 2012
consensus process.
M27-S4
Reference Method for Broth Dilution
Antifungal Susceptibility Testing of Yeasts;
Performance Standards for
Antimicrobial Disk Susceptibility
Tests; Approved Standard
Eleventh Edition
This document contains the current CLSI-recommended methods
for disk susceptibility testing, criteria for quality control testing, and
updated tables for interpretive zone diameters.
Nonmembers $340 Price includes M100-S24.
Methods for Dilution
Antimicrobial Susceptibility Tests
for Bacteria That Grow Aerobically;
Approved StandardNinth Edition
This document addresses reference methods for the determination
of minimal inhibitory concentrations of aerobic bacteria by broth
macrodilution, broth microdilution, and agar dilution.
Susceptibility Testing of
Mycobacteria, Nocardiae, and
Other Aerobic Actinomycetes;
Approved Standard
Second Edition
This standard provides protocols and related quality control parameters
and interpretive criteria for the susceptibility testing of mycobacteria,
Nocardia spp., and other aerobic actinomycetes.
Nonmembers $170
Methods for Antimicrobial
Susceptibility Testing of Anaerobic
Bacteria; Approved Standard
Eighth Edition

This standard provides reference methods for the determination
of minimal inhibitory concentrations of anaerobic bacteria by agar
dilution and broth microdilution.
Nonmembers $170
Reference Method for Broth
Dilution Antifungal Susceptibility
Testing of Yeasts; Fourth
This document provides updated tables for the CLSI antimicrobial
susceptibility testing standard M27-A3.
Members LI: $10.50 LII: $14.00 LIII: $17.50
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October 2011
consensus process.
M43-A
Methods for Antimicrobial Susceptibility
Testing for HumanMycoplasmas; Approved
Guideline
Susceptibility Testing for Human
Mycoplasmas; Approved Guideline

This document provides guidelines for the performance and quality
control of agar and broth microdilution antimicrobial susceptibility
tests on human mycoplasmas and ureaplasmas.
Nonmembers $170
OCTOBER 2011
M43-A
JC
January 2014
consensus process.
M39-A4
Analysis and Presentationof Cumulative
Antimicrobial Susceptibility Test Data;
August 2009
consensus process.
M44-A2
Method for Antifungal Disk Diffusion
Susceptibility Testing of Yeasts; Approved
Analysis and Presentation
of Cumulative Antimicrobial
Susceptibility Test Data; Approved
GuidelineFourth Edition
This document describes methods for recording and analysis of
antimicrobial susceptibility test data, consisting of cumulative
and ongoing summaries of susceptibility patterns of clinically
signifcant microorganisms.
Nonmembers $170
Method for Antifungal Disk
Diusion Susceptibility Testing
of Yeasts; Approved Guideline
Second Edition
This document provides newly established methodology for disk
diusion testing of Candida spp., criteria for quality control testing, and
interpretive criteria.
JANUARY 2014
AUGUST 2009
M39-A4
M44-A2
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
These supplemental tables provide new quality control limits for
CLSI document M44-A2Method for Antifungal Disk Diusion
Susceptibility Testing of Yeasts; Approved GuidelineSecond Edition.
It is available as a durable, waterproof chart for easy posting.

M44-S3
AUGUST 2009
CAP
Collection, Handling, Transport, and Storage for Hemostasis
Antibiograms: Developing Cumulative Reports for Your
Clinicians Quick Guide
Serves as a handy reference for laboratory personnel. It provides
recommendations for preparation of a cumulative antibiogram,
examples of selection criteria, and supplemental analyses. It also
shows how to prepare tables, include a description of limitations
of data, and provide examples of reports and graphs. Six durable,
waterproof sheets are on a convenient detachable ring. The Quick
Guide is based on M39-A4.
Nonmembers $60
M39-A4 QG
JC
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November 2013
I/LA26-A2
Performance of Single Cell Immune Response
This document contains methods of intracellular cytokine
evaluation, major histocompatibility complex multimer
quantitation, enzyme-linked immunospot technology, and
carboxyuorescein succinimidyl ester tracking dye staining for
the assessment of cellular proliferation. It also provides basic
aspects of specimen collection, transport, and preparation;
results interpretation; and quality assurance and test validation
approaches.
January 2014
M100-S24
Laboratory Standards Institute antimicrobial susceptibility testing
standards M02-A11, M07-A9, and M11-A8.
consensus process.
Our user-friendly, searchable CD-ROM includes all documents published through December 31, 2013.
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CAP FDA JC
CAP FDA JC
FDA JC
May 2007
M47-A
Principles and Procedures for
Blood Cultures; Approved Guideline
August 2010
M45-A2
Methods for Antimicrobial Dilutionand
Disk Susceptibility Testing of Infrequently
Isolated or Fastidious Bacteria; Approved
August 2008
M50-A
Quality Control for Commercial Microbial
IdenticationSystems; Approved Guideline
Principles and Procedures
for Blood Cultures;
Approved Guideline
This document provides
recommendations for the collection, transport, and processing of
blood cultures as well as guidance for the recovery of pathogens from
blood specimens taken from patients who are suspected of having
bacteremia or fungemia.
Nonmembers $170
Dilution and Disk Susceptibility
Testing of Infrequently Isolated
or Fastidious Bacteria; Approved
This document provides guidance to clinical microbiology laboratories
for standardized susceptibility testing of infrequently isolated or
fastidious bacteria that are not presently included in CLSI documents
M02 or M07. The tabular information in this document presents the
most current information for drug selection, interpretation, and quality
control for the infrequently isolated or fastidious bacterial pathogens
included in this guideline.
Nonmembers $170
Quality Control for Commercial
Microbial Identifcation Systems;
Approved Guideline

This document provides guidance for quality control of commercial
systems for microbial identifcation from culture, including information
that pertains to manufacturers, distributors, and laboratory users. The
intent is to ensure optimal performance of a microbial identifcation
system in an ecient (streamlined) manner.
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Personal Protection in the Laboratory Quick Guide
Serves as a handy resource in the laboratory for all you need to know
about hand hygiene and barrier protection. Formatted as an 8 1/2 x 11
durable, waterproof quick reference sheet.
Nonmembers $20
M29-A3 QG
June 2011
consensus process.
M53-A
Criteria for Laboratory
Testing and Diagnosis of Human
Immunodeciency Virus Infection;
Approved Guideline
February 2010
consensus process.
M55-R
Surveillance for Methicillin-Resistant
Staphylococcus aureus: Principles, Practices,
and Challenges; AReport
October 2012
consensus process.
M54-A
Principles and Procedures for Detection
of Fungi inClinical Specimens
Direct Examinationand Culture;
Approved Guideline
Criteria for Laboratory Testing
and Diagnosis of Human
Immunodefciency Virus Infection;
Approved Guideline
This document provides guidance for laboratorians performing human
immunodefciency virus testing and for the interpretation of results by
health care providers in advanced diagnostic laboratories.
Nonmembers $170
Surveillance for Methicillin-
Resistant Staphylococcus
aureus: Principles, Practices, and
Challenges; A Report
This document was developed to provide infection preventionists (infection
control practitioners), infectious disease specialists, and microbiologists with
the latest information regarding the development and implementation of a
successful MRSA surveillance program.
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Detection of Fungi in Clinical
SpecimensDirect Examination
and Culture; Approved Guideline
This guideline provides protocols, quality control parameters, and
interpretive criteria for performing fungal cultures and for the
detection and identifcation of fungi in direct examinations.
Nonmembers $170
JUNE 2011
FEBRUARY 2010
OCTOBER 2012
M53-A
M55-R
M54-A
JC
May 2010
consensus process.
M51-A
Method for Antifungal Disk Diffusion
Susceptibility Testing of Nondermatophyte
Filamentous Fungi; Approved Guideline
Method for Antifungal Disk
Diusion Susceptibility Testing of
Nondermatophyte Filamentous
Fungi; Approved Guideline
This document describes the guidelines for antifungal susceptibility
testing by the disk diusion method for nondermatophyte flamentous
fungi (moulds) that cause invasive disease.
MAY 2010
M51-A
Performance Standards for Antifungal Disk Diusion
Susceptibility Testing of Nondermatophyte Filamentous Fungi;
Supplemental tables that provide quality control limits and
epidemiological cuto values for M51-A.
M51-S1
MAY 2010
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CAP JC
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February 2014
consensus process.
MM09-A2
Nucleic Acid Sequencing Methods in
Diagnostic Laboratory Medicine; Approved
November 2010
consensus process.
MM06-A2
Quantitative Molecular Methods for
Infectious Diseases; Approved Guideline
Second Edition
August 2013
consensus process.
MM07-A2
Fluorescence In SituHybridizationMethods
for Clinical Laboratories; Approved
consensus process.
MM14-A2
Designof Molecular Prociency
Testing/External Quality Assessment;
May 2013
Nucleic Acid Sequencing Methods
in Diagnostic Laboratory
Second Edition
This document addresses diagnostic sequencing using both automated
capillary-based sequencers and massively parallel sequencing
instruments. Topics include specimen collection and handling; isolation
and extraction of nucleic acid; template preparation; sequence
generation, alignment, and assembly; validation and verifcation;
ongoing quality assurance; and reporting results.
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Quantitative Molecular Methods
for Infectious Diseases; Approved

This document provides guidance for the development and use of
quantitative molecular methods, such as nucleic acid probes and
nucleic acid amplifcation techniques of the target sequences specifc to
particular microorganisms. It also presents recommendations for quality
assurance, profciency testing, and interpretation of results.
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Fluorescence In Situ Hybridization
Methods for Clinical Laboratories;

This document addresses fuorescence in situ hybridization methods
for medical genetic determinations, identifcation of chromosomal
abnormalities, and gene amplifcation. Recommendations for probe
and assay development, manufacture, qualifcation, verifcation, and
validation; instrument requirements; quality assurance; and evaluation of
results are also included.
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Design of Molecular Profciency
Testing/External Quality
Assessment; Approved Guideline
Second Edition
This document provides guidelines for a quality profciency testing/
external quality assessment program, including reliable databases;
design control in the choice of materials and measurands; good
manufacturing processes; documentation procedures; complaint
handling; corrective and preventive action plans; and responsive timing
of reports.
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MAY 2013
MM09-A2
MM06-A2 MM07-A2
MM14-A2
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consensus process.
MM01-A3
Molecular Methods for Clinical
Genetics and Oncology Testing;
Approved Guideline
Third Edition
March 2012
consensus process.
MM05-A2
Nucleic Acid AmplicationAssays for
Molecular Hematopathology; Approved
Molecular Methods for Clinical
Genetics and Oncology Testing;

This document provides guidance for the use of molecular biological
techniques for detection of mutations associated with inherited medical
disorders, somatic or acquired diseases with genetic associations, and
pharmacogenetic response.
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Nucleic Acid Amplifcation Assays
for Molecular Hematopathology;
Approved Guideline
Second Edition
This guideline addresses the performance and application of assays
for gene rearrangement and translocations by both polymerase chain
reaction (PCR) and reverse-transcriptase PCR techniques, and includes
information on specimen collection, sample preparation, test reporting,
test validation, and quality assurance.
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Handling, Transport, and Storage of Specimens for Molecular
Methods Quick Guide
Describes the recommended methods for the collection of molecular
method samples, proper shipping conditions, and storage, addressing
issues including temperature, preservatives, and duration. Formatted as
an 8 1/2 x 11 durable, waterproof quick reference sheet.
Nonmembers $20
MM13-A QG
November 2011
consensus process.
MM19-A
Establishing Molecular Testing inClinical
Laboratory Environments; Approved
Guideline
November 2012
consensus process.
MM20-A
Quality Management for Molecular Genetic
Testing; Approved Guideline
February 2014
consensus process.
MM22-A
Microarrays for Diagnosis and Monitoring
of Infectious Diseases; Approved Guideline
Establishing Molecular Testing in
Clinical Laboratory Environments;
Approved Guideline

This guideline provides 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
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Quality Management for
Molecular Genetic Testing;
Approved Guideline

This document provides guidance for implementing international
quality management system standards in laboratories that perform
human molecular genetic testing for inherited or acquired conditions.
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Microarrays for Diagnosis and
Monitoring of Infectious Diseases;
Approved Guideline

This document provides guidance for the laboratory development and
use of qualitative nucleic acid microarray methods for the diagnosis and
monitoring of infectious diseases. It also presents recommendations for
validation and verifcation, quality control, and interpretation of results.
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CLSI References in the CAP
Accreditation Checklists
Numerous CLSI documents are
referenced in the College of American
Pathologists (CAP) Accreditation
Checklists and serve as key resources
in satisfying regulatory requirements.
CAP Accreditation Checklists are
updated regularly to include CLSI
standards, guidelines, and other
documents as references.
CLSI-FDARecognized
Consensus Standards
The US Food and Drug Administration
(FDA) maintains a database of
recognized consensus standards.
Included in the database are more
than 100 CLSI consensus standards
and guidelines, which can easily be
found using this reference.
CLSI Documents Referenced
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Use this crosswalk to identify CLSI
documents that are referenced to
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Accreditation Standards Chapters.
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CLSI Newborn Screening Standards
and Guidelines: Ensuring Good Health
From the Start
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consensus process.
NBS01-A6
Blood CollectiononFilter Paper for
NewbornScreening Programs; Approved
Blood Collection on Filter Paper
for Newborn Screening Programs;

This document highlights specimen collection methods, discusses
acceptable techniques for applying blood drops or aliquots to the flter paper
segment of the specimen collection device, and provides instructions on
proper specimen handling and transport to ensure quality specimens are
consistently obtained for newborn screening analysis.
Nonmembers $130
JULY 2013
NBS01-A6
May 2013
consensus process.
NBS02-A2
NewbornScreening Follow-up; Approved
Guideline Second Edition
Newborn Screening Follow-up;
Approved Guideline
Second Edition

This guideline describes the basic principles, scope, and range
of follow-up activities within the newborn screening system.
Nonmembers $130
MAY 2013
NBS02-A2
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FDA
Today, virtually all (>99%) of the more than 4 million infants born in the United
States each year are screened for conditions such as phenylketonuria, congenital
hypothyroidism, galactosemia, and hemoglobinopathies. CLSIs newborn screening
standards and guidelines provide the critical guidance needed to detect potentially life-
threatening and debilitating conditions for better outcomes and healthy, happy infants.
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consensus process.
NBS03-A
NewbornScreening for Preterm, LowBirth
Weight, and Sick Newborns; Approved
Guideline
Newborn Screening for Preterm,
Low Birth Weight, and Sick
Newborns; Approved Guideline

This guideline outlines the recommended protocols for screening preterm,
sick, or low birth weight infants for hearing loss and disorders detectable
through dried blood spot testing.
Nonmembers $130
OCTOBER 2009
NBS03-A
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
NBS05-A
NewbornScreening for Cystic Fibrosis;
Approved Guideline
This document describes
the use of newborn
screening laboratory tests
for detecting risk for cystic
fbrosis fromnewborn
dried blood spots (DBS)
and addresses both the
primary screening tests
and the refex tests
performed on DBS.
November 2011
Newborn Screening for
Cystic Fibrosis;
Approved Guideline

This document describes the use of newborn screening laboratory tests for
detecting risk for cystic fbrosis from newborn dried blood spots (DBS) and
addresses both the primary screening tests and the refex tests performed
on DBS.
Nonmembers $130
NOVEMBER 2011
NBS05-A
July 2010
consensus process.
NBS04 -A
NewbornScreening by TandemMass
Spectrometry; Approved Guideline
Newborn Screening by Tandem
Mass Spectrometry; Approved
Guideline

This guideline serves 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 beneft all newborns worldwide.
Nonmembers $130
JULY 2010
NBS04-A
November 2011
consensus process.
NBS06-A
NewbornBlood Spot Screening for
Severe Combined Immunodeciency
by Measurement of T-cell
Receptor ExcisionCircles;
Approved Guideline
Newborn Blood Spot Screening
for Severe Combined
Immunodefciency by Measurement
of T-cell Receptor Excision Circles;
Approved Guideline
This document addresses the detection of severe combined
immunodefciency (SCID) by population-based newborn screening using
dried blood spot specimens to measure T-cell receptor excision circles. SCID
is a lethal disorder of infancy that is not evident at birth, and eective
treatment requires presymptomatic detection.
Nonmembers $130
APRIL 2013
NBS06-A
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NEWBORN SCREENING COMPANION PRODUCTS
Making a Dierence Through Newborn Screening: Blood Collection
on Filter Paper
This video highlights specimen collection methods, discusses acceptable
techniques for applying blood drops or aliquots to the flter paper
segment of the specimen collection device, and provides instructions
on proper specimen handling and transport to ensure quality specimens
are consistently obtained for newborn screening analysis.
Nonmembers $300
Algorithm for Newborn Screening of Preterm, Low Birth Weight, and
Sick Newborns Quick Guide
Provides information on when to collect frst, second, and third
specimens for newborn screening and includes special care baby unit
screening algorithm for preterm, low birth weight, and sick newborns.
Nonmembers $20
Immunodefciency Disorders and T-cell Receptor Excision Circle
Values in the Newborn Screening Period
Wall chart that shows immunodefciency disorders and T-cell receptor
excision circle values in the newborn screening period.
Nonmembers $20
Specimen Collection and Sample Quality for Newborn Screening
Quick Guide
How to Collect an Acceptable Blood Spot Specimen
Simple Spot Check
Nonmembers $20
Newborn Screening Follow-up Process Quick Guide
Describes the newborn screening follow-up process.
Nonmembers $20
Generic Flow Chart for Assays to Measure T-cell Receptor Excision
Circles in Newborn Dried Blood Spot Specimens Quick Guide
Flow chart for assays to measure T-cell receptor excision circles in
newborn dried blood spot specimens.
Nonmembers $20
Schematic for Preparing Dried Blood Spot Reference Materials
Quick Guide
Provides a schematic for preparing dried blood spot reference materials.
Nonmembers $20
NBS01-A6 DVD
NBS03-A QG
NBS06-A WC
NBS01-A6 QG
NBS02-A2 QG
NBS06-A QG1 NBS06-A QG2
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2013 Clinical and Laboratory Standards Institute. All rights reserved. | www.clsi.org
quick guide
A2.13
A1
A2
A1.1
A1.2
A1.3
A2.2
A2.5
A2.3
A2.4
A2.1
Preparation
Sampling Technique
Wash hands vigorously.
Wear powder-free gloves and change
gloves between newborns.
Conrm identity of newborn and
ensure that all data elements on the
form are complete, accurate, and
consistent.
Position the newborns leg lower than
the heart to increase venous pressure.
The puncture should be made within
the shaded area as illustrated in the
gure above.
Allow blood specimen to air dry
thoroughly on a horizontally level,
nonabsorbent, open surface, such
as a drying rack or plastic-coated test
tube rack, for a minimum of three
hours at ambient temperature.
Keep specimen away from direct
sunlight. (Do not stack or heat.)
(See Appendix F of NBS01-A6.)
A3.1
A3.2
A3.4
A3.5
A3.6
A3.3
A2.14
A3
(See Appendix B of NBS01-A6.)
Failure to allow residual alcohol to
dry might dilute the specimen and
adversely affect test results.
Puncturing the heel on posterior
curvature will permit blood to ow
away from puncture, making proper
spotting difcult. Do not use previous
puncture sites.
Do not layer successive drops of blood on
the target spot. If blood ow diminishes
to incompletely ll circles, repeat
sampling technique A2.1 through A2.10.
Avoid touching the area within
the circle before and after blood
collection. Do not allow water,
feeding formulas, antiseptic solutions,
or powder from gloves or other
materials to come into contact with
the specimen card before or after use.
Do not place the specimens in the
transport container until thoroughly
dry. Insufcient drying adversely
affects test results. Use of sealed
plastic bags requires desiccation.
Ideally, transport specimens within 24
hours of collection. Include tracking
number and/or other identiers on the
envelope in case package is misplaced.
Milking or squeezing the puncture site
might cause hemolysis and admixture
of tissue uids with specimen.
After the specimen has dried, place in
an approved container for transport
(see local regulations).
Pitfalls
Wearing gloves, wipe newborns heel
with 70% isopropyl alcohol.
Allow heel to air dry.
*
Warm heel for puncture (incision/
stick) site. Use a commercially
available heel-warming device
containing an exothermic
thermochemical composition, or
warm the site with a soft cloth that
has been moistened with warm
water (less than 42C) for three to ve
minutes. In some situations, warming
the site may not be necessary to
increase blood ow and volume.
* Photos reprinted with permission from the New York State Department of Health, Wadsworth Center.
Photo reprinted with permission from the Newborn Screening Reference Center, National Institutes of Health, University of the Philippines Manila.
Photo reprinted with permission from Whatman, Inc.
Source Document: Blood Collection on Filter Paper for Newborn Screening Programs; Approved StandardSixth Edition (NBS01-A6)
*
*
A2.11
A2.6
A2.10
A2.7
A2.12
A2.9
A2.8
All used items should be disposed of in an
appropriate biohazard container.
Using a sterile lancet of recommended
length, perform puncture (depth
< 2.0 mm) as illustrated or use a
retractable incision device. A retractable
incision device may provide superior
blood ow by making a standardized
incision 1.0 mm deep by 2.5 mm long.
Gently touch the lter paper card to
the blood drop and ll each printed
circle with a SINGLE application of
blood. Do not touch the lter paper
to the heel. Apply blood to one
side only. Observe the saturation
of each printed circle as the blood
ows through the lter paper. After
collection, examine both sides of the
lter paper to ensure saturation.
Gently wipe off the rst drop of blood
with sterile gauze. (Initial drop contains
tissue uids, which might dilute
sample.)
After the specimen is collected, elevate
the newborns foot and, using sterile
gauze, briey apply gentle pressure to
the puncture site until the bleeding
stops. Do not apply adhesive bandages.
Apply gentle pressure with thumb
around the heel, but not near the
puncture site, and ease intermittently
as drops of blood form.
Wait for formation of large blood
droplet.
How to Collect an Acceptable Blood Spot Specimen

NBS01-A6 QG
Newborn Screening Follow-up Process
Source Document: Newborn Screening Follow-up; Approved GuidelineSecond Edition (NBS02-A2)
Screening Test
Results
Requires
Follow-up
Follow-up
Conrmation
Follow-up for
New Screening
Monitor
Biochemical/
Clinical
No Further
Tests Required
Facilitate
Counseling
Close Case
Lost
Lost
Close Case
Not Affected
Denitive Diagnosis
Lost to
Follow-up
Facilitate Intervention/Management
Facilitate Appropriate Services
Maintain in Case Registry
Results Appear Denitive
Facilitate Conrmatory Testing
Denitive Diagnosis
Not
Affected
Conrmatory
Testing
Carrier
Results Not Denitive
Invalid Screen
Negative
Is Not
Denitive
Facilitate Rescreening
(Including
No Specimen)
Screen Positive
(Including Borderline Results)
Periodically Monitor Care Coordination
Periodically Monitor Functional Outcomes
Evaluate Long-Term Data
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Lost to Follow-up Possible
Action or Outcome
Process End Point
Key
quick guide
NBS02-A2 QG
quick guide
Screen Positive
Low/Absent TREC
Normal Reference Gene
(Prepare Test DBS; Measure
TREC and Reference Gene)
Older Adult Blood
Screen Negative
Normal TREC
Normal Reference Gene
CB Units
Schematic for Preparing Dried Blood Spot
Reference Materials
Source Document: Newborn Blood Spot Screening for Severe Combined Immunodeciency by Measurement of T-cell Receptor Excision Circles;
Approved Guideline (NBS06-A)
NOTE: This owchart summarizes the preparation of dried blood spot reference materials for quality control in alignment with Section 7.4.1
of CLSI document NBS06-A.
Abbreviations: CB, cord blood; DBS, dried blood spot(s); QC, quality control; SCID, severe combined immunodeciency; TREC, T-cell receptor excision circle(s).
DBS QC Material for SCID
Screen Positive
QC Material for SCID
Screen Negative
DBS QC Material for
Failure to Amplify
Inconclusive
Low/Absent TREC
Low/Absent Reference Gene
Leukodepleted Adult Blood
Prepare and Evaluate DBS Reference Materials
Deplete Mononuclear Cells Prepare Higher, Lower, and
Lowest TREC CB Pools
CB 1 CB 2 CB n
Adjust Hematocrit
NBS06-A QG2
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NBS01-A6Blood Collection on Filter Paper for Newborn
Screening Programs; Approved StandardSixth Edition
NBS01-A6 DVDMaking a Dierence Through Newborn
Screening: Blood Collection on Filter Paper
NBS01-A6 QGSpecimen Collection and Sample Quality for
Newborn Screening Quick Guide
o How to Collect an Acceptable Blood Spot Specimen
o Simple Spot Check
NBS02-A2Newborn Screening Follow-up; Approved
NBS02-A2 QGNewborn Screening Follow-up Process
Quick Guide
NBS03-ANewborn Screening for Preterm, Low Birth
Weight, and Sick Newborns; Approved Guideline
NBS03-A QGAlgorithm for Newborn Screening of Preterm,
Low Birth Weight, and Sick Newborns Quick Guide
NBS04-ANewborn Screening by Tandem Mass
Spectrometry; Approved Guideline
NBS05-ANewborn Screening for Cystic Fibrosis;
Approved Guideline
NBS06-ANewborn Blood Spot Screening for Severe
Combined Immunodefciency by Measurement of T-cell
Receptor Excision Circles; Approved Guideline
NBS06-A QG1Generic Flow Chart for Assays to Measure
T-cell Receptor Excision Circles in Newborn Dried Blood Spot
Specimens Quick Guide
NBS06-A QG2Schematic for Preparing Dried Blood Spot
Reference Materials Quick Guide
NBS06-A WCImmunodefciency Disorders and T-cell
Receptor Excision Circle Values in the Newborn Screening
Period Wall Chart
Paper documents available in a three-ring binder.
NBSSC
Newborn Screening
Specialty Collection
bundle
and save!
Improve the health outcome and quality of
life of children by collecting the best possible
newborn screening blood specimens and
implementing eective follow-up services.
Objectives:
Defne the beginning and end of short-term
follow-up and long-term follow-up.
List the dierences between blood spot and
point-of-care screening follow-up.
List the six primary participants involved in
newborn screening follow-up.
WEBINAR: Enhancing the Quality of Follow-Up Services for Newborn Screening
Speaker:
Judith Tuerck, RN, MS
Oregon State Public Health Laboratory
Hillsboro, Oregon, USA
NBS02-A2Newborn Screening Follow-up; Approved
NOW AVAILABLE ON DEMAND
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October 2010
consensus process.
POCT07-A
Quality Management: Approaches
to Reducing Errors at the Point of Care;
Approved Guideline
December 2010
consensus process.
POCT08-A
Quality Practices inNoninstrumented
Point-of-Care Testing:
AnInstructional Manual and
Resources for Health Care Workers;
Approved Guideline
Quality Management: Approaches
to Reducing Errors at the Point of
Care; Approved Guideline

This document presents the core infrastructure for a standardized error
tracking system with the primary goals of reducing risk and increasing
quality of point-of-care testing, while accumulating standardized data
for benchmarking use.
Nonmembers $130
Quality Practices in
Noninstrumented Point-of-Care
Testing: An Instructional Manual
and Resources for Health Care
Workers; Approved Guideline
This instructional guideline delivers laboratory science concepts
and activities with the goal of increasing knowledge and quality of
laboratory testing for testing personnel with no laboratory background.
Nonmembers $130
OCTOBER 2010
DECEMBER 2010
POCT07-A
POCT08-A
Addressing Errors in Point-of-Care Testing Reference Guide
Includes preexamination considerations (patient preparation for the
test and sample collection and handling); examination considerations
(operator related, reagent related, sample related, and device related);
and postexamination considerations (communication related and
data management related).
Nonmembers $50
Quality Control Troubleshooting Flow Chart
Flow chart for noninstrumented quality control (QC) decision making
for QC out of range.
Nonmembers $20
Quality Control Log Sheet Quick Guide
Log sheet for noninstrumented point-of-care testing.
Nonmembers $20
POCT07-A RG
POCT08-A QG2
POCT08-A QG3
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Corrective Action Report Quick Guide
Report completed when any control falls outside the
acceptable range.
Nonmembers $20
POCT08-A QG1
Instrument Selection Worksheet
Clinical needs assessment comparison electronic worksheet, which
includes items to consider when comparing point-of-care testing
system specifcations.
Nonmembers $40
POCT08-A WS
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POCT PK
POCT Companion Products Package
Bundle and save! This package includes:
POCT07-A RGAddressing Errors in Point-of-Care Testing Reference Guide
POCT08-A QG1Corrective Action Report Quick Guide (Electronic Download)
POCT08-A QG2Quality Control Troubleshooting Flow Chart
POCT09-A WSInstrument Selection Worksheet (Electronic Download)
Nonmembers $130
bundle
and save!
JC
April 2010
consensus process.
POCT09-A
SelectionCriteria for Point-of-Care Testing
Devices; Approved Guideline
April 2011
consensus process.
POCT11-A2
Pulse Oximetry;
Approved Guideline
Second Edition
January 2013
consensus process.
POCT12-A3
Point-of-Care Blood Glucose Testing in
Acute and Chronic Care Facilities; Approved
Selection Criteria for
Point-of-Care Testing Devices;
Approved Guideline

This document provides guidance on selection of point-of-care testing
devices based on the patient care setting and clinical needs. It is
designed as an aid to laboratory and facility management to simplify
and facilitate the selection process, but also allows evaluation of
devices to identify those that are optimal to the patient care setting
and population served.
Nonmembers $130
Pulse Oximetry; Approved

Pulse oximetry is a widely used device for the clinical assessment of
arterial oxygenation and pulse rate. The clinical applications, quality
assessment, and limitations are discussed in this guideline.
Nonmembers $130
Point-of-Care Blood Glucose
Testing in Acute and Chronic Care
Facilities; Approved Guideline
Third Edition
This document contains guidelines for performance of point-of-care
blood glucose meter systems that stress quality control, training, and
administrative responsibility.
Nonmembers $130
APRIL 2010
APRIL 2011 JANUARY 2013
POCT09-A
POCT11-A2 POCT12-A3
Instrument Selection Worksheet
Clinical needs assessment comparison electronic worksheet, which
includes items to consider when comparing point-of-care testing
system specifcations.
Nonmembers $40
POCT09-A WS
JC
This guideline provides information on specimen
collection, test methodologies, procedural steps,
reporting of results, and the quality assurance
aspects of provider-performed microscopy.
Physician and Nonphysician Provider-Performed
Microscopy Testing; Approved GuidelineSecond Edition
POCT10-A2
DECEMBER 2011
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
POCT10-A2
Physician and Nonphysician Provider-
Performed Microscopy Testing;
This guideline provides information on specimen collection, test methodologies,
procedural steps, reporting of results, and the quality assurance aspects of
provider-performed microscopy.

December 2011
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Objectives:
List the CLIA regulations most frequently cited for manual test
defciencies.
Describe the inherent challenges of manual testing that have a
negative impact on patient care.
Recognize how to use the tools or avenues available to ensure
quality in point-of-care manual testing.
Objectives:
Defne terms related to risk assessment.
Identify CLSI document EP23 as a resource for developing a
laboratory quality control plan (QCP) based on risk management
and review a moderate complexity example.
Determine ways to create an optimal IQCP without the use of
equivalent quality control.
WEBINAR: Managing Manual Tests:
Challenges and Solutions
WEBINAR: EP23 and POCT: Tackling
Risk Management
Speakers: Patricia L. Kraft, MA, MT(ASCP)
Dayton, Ohio, USA
Karen W. Dyer, MT(ASCP) DLM
Baltimore, Maryland, USA
Speaker: James H. Nichols, PhD, DABCC, FACB
Nashville, Tennessee, USA
Related CLSI Documents:
POCT08-AQuality Practices in Noninstrumented Point-of-Care
Testing: An Instructional Manual and Resources for Health Care
Workers; Approved Guideline
POCT04-A2Point-of-Care In Vitro Diagnostic (IVD) Testing;
EP23-ALaboratory Quality Control Based on Risk
Management; Approved Guideline
Register today at www.clsi.org/edu/webinars.
Register today at www.clsi.org/edu/webinars.
Date/Time: May 14, 2014 1:002:00 PM Eastern (US) Time
Date/Time: July 16, 2014 1:002:00 PM Eastern (US) Time
CAP JC
POCT10-A2 COMPANION PRODUCTS
Fecal Leukocyte Examinations (Also Known as Stool White Blood
Cells) Quick Guide
Describes the testing procedure for fecal leukocyte examinations.
Nonmembers $20
Profciency Testing Exception Response Form (for Use for
Microscopic PT Only) Quick Guide
Used for profciency testing exception responses.
Nonmembers $20
Wet Mount Preparations and KOH Preparations Quick Guide
Provides the testing procedure for nonvaginal potassium hydroxide
(KOH) procedures, nonvaginal oil wet mount for ectoparasites (with or
without KOH), and vaginal procedures.
Nonmembers $20
Microscopic Components in Vaginal Fluid and KOH Preparations
Wall Chart
Shows images of cells, bacteria, microorganisms, fungus, yeast,
and ectoparasites found in vaginal fuid and potassium hydroxide
(KOH) preparations.
Nonmembers $20
Urine Sediment Examinations Quick Guide
Provides the testing procedure for urine sediment examinations.
Nonmembers $20
Microscopic Components in Urine Sediment Wall Chart
Shows images of cells, casts, noncellular material, parasites, and crystals
found in urine sediment.
Nonmembers $20
Ectoparasites Wall Chart
Shows images of ectoparasites.
Nonmembers $20
Nasal Smears for Infammatory Cells (Also Known as Nasal Smear
for Eosinophils, Nasal WBCs, and Nasal Smear for Granulocytes)
Quick Guide
Describes testing procedure for nasal smears for infammatory cells.
Nonmembers $20
POCT10-A2 QG1
POCT10-A2 QG3
POCT10-A2 QG5
POCT10-A2 WC2
POCT10-A2 QG4
POCT10-A2 WC1
POCT10-A2 WC3
POCT10-A2 QG2
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Provider-Performed Microscopy Training Checklist: Initial or Renewal
Competence/Validation Employee Training Checklist
Checklist to help observers assess if provider-performed microscopy
testing competence has been demonstrated by the employee.
Nonmembers $20
Microscope Maintenance Log
Log for documentation of daily maintenance of a microscope
for one year.
Nonmembers $20
POCT10-A2 CL POCT10-A2 LG
ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org 48 ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org 48
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The Fundamentals for
Implementing a Quality
Management System in
the Clinical Laboratory
Improved patient care
Reduced risk of medical errors
Streamlined laboratory
processes
Increased productivity and
eciency
Reduced costs
Enhanced employee abilities
Improved customer
satisfaction
Compliance with regulatory
and accreditation
requirements
WEBINAR: Laboratory Internal Audit Program: Tips for Developing and
Implementing an Internal Audit Process
The Key to Quality
TM
is designed to
provide a better understanding of how a
laboratorys quality management system
(QMS) can be developed.
from the Clinical and Laboratory
Standards Institute (CLSI)
This edition revises the previous version
published in 2007. By using the guidance
and tools in The Key to Quality, you can
establish or enhance the infrastructure for a
QMS or a methodology for continual quality
improvement with the following outcomes:
TM
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Objectives:
Distinguish between an internal audit program
and process.
Discuss how an internal audit program and process
will assist the laboratory in meeting quality and
compliance requirements.
Describe the dierent types of internal audits
and the value each provides to the laboratorys
quality program.
Speaker:
Jennifer Schigens, MBA, MT(ASCP), CLS
San Francisco, California, USA
QMS15-AAssessments: Laboratory Internal Audit
CLSIs NEW online, self-paced certifcate program
provides a systematic, process-oriented approach
to meeting quality objectives.
Learn How to Implement Your
QMS Most Eectively
Learn best practices for developing,
implementing, and sustaining policies,
processes, and procedures for each quality
system essential.
Study on your own schedulelog in from
any Internet-accessible device 24/7.
Earn 13 P.A.C.E. continuing education
credits and a certifcate of achievement upon
completion.
Laboratory Quality
Management System
(LQMS) Certifcate Program
Visit www.clsi.org for
details and to register.
Product Nonmember Price*
The Key to Quality $600
QSE PDF Document Package (includes 13 documents) $800
LQMS Certifcate Program $1,000
LQMS Certifcate Program + The Key to Quality $1,500
LQMS Certifcate Program + QSE PDF Document Package $1,600
LQMS Certifcate Program + The Key to Quality + QSE PDF Document Package $2,000
* Member pricing applies. Please see page 17 of the catalog for further details.
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The Key to Quality
The Fundamentals for Implementing a Quality
Management System in the Clinical Laboratory
The Key to Quality is designed to provide a better
understanding of how a laboratorys quality management
system can be developed.
fromthe Clinical and Laboratory
Standards Institute (CLSI)
The fundamentals for implementing
a quality management system in the
clinical laboratory.
TM
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June 2011
consensus process.
QMS01-A4
Quality Management System:
AModel for Laboratory Services;
Approved Guideline
Fourth Edition
consensus process.
QMS02-A6
Development and Management of
Laboratory Documents; Approved
GuidelineSixth Edition
February 2013
A Model for Laboratory Services;
Approved Guideline
Fourth Edition
This document provides a model for medical laboratories that will
assist with implementation and maintenance of an eective quality
management system.
Nonmembers $170
Development and Management of
Laboratory Documents; Approved
GuidelineSixth Edition
This document provides guidance on the processes needed for
document management, including creating, controlling, changing, and
retiring a laboratorys policy, process, procedure, and form documents
in both paper and electronic environments.
Nonmembers $170
JUNE 2011 FEBRUARY 2013
QMS01-A4 QMS02-A6
February 2009
consensus process.
QMS03-A3
Training and Competence Assessment;
Training and Competence
Assessment; Approved Guideline
Third Edition

This document provides background information and recommended
processes for the development of training and competence assessment
programs that meet quality and regulatory objectives.
Nonmembers $170
FEBRUARY 2009
QMS03-A3
CAP JC
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with newly published standards and other
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CAP JC
CAP JC FDA
JC
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September 2012
consensus process.
QMS05-A2
Quality Management System: Qualifying,
Selecting, and Evaluating a Referral
Laboratory; Approved GuidelineSecond
Edition
August 2011
consensus process.
QMS13-A
Quality Management System: Equipment;
Approved Guideline
December 2013
consensus process.
QMS15-A
Assessments: Laboratory Internal Audit
December 2010
consensus process.
QMS12-A
Development and Use of Quality Indicators
for Process Improvement and Monitoring of
Laboratory Quality; Approved Guideline
December 2012
consensus process.
QMS14-A
Leadership and Management
Roles and Responsibilities;
Approved Guideline
Qualifying, Selecting, and
Evaluating a Referral Laboratory;
Approved Guideline
Second Edition
This guideline provides recommended criteria and easily implemented
processes for qualifying, selecting, and evaluating a referral laboratory.
Nonmembers $170
Equipment; Approved Guideline

This guideline provides recommendations for establishing equipment
management processes from selection through decommission of
equipment used in the provision of laboratory services.
Nonmembers $170
Assessments: Laboratory Internal
Audit Program; Approved Guideline
This document provides guidance for how a laboratory can establish an
internal audit program to enhance the quality of its services through
continual improvement. Whereas an audit program defnes the who,
what, when, where, and how of meeting requirements for internal
auditing, the audit process describes the details of how to conduct
individual laboratory internal audits.
Nonmembers $170
Development and Use of
Quality Indicators for Process
Improvement and Monitoring of
Laboratory Quality;
Approved Guideline
This document provides guidance on development of quality indicators
and their use in the medical laboratory.
Nonmembers $170
Leadership and Management
Roles and Responsibilities;
Approved Guideline
This guideline presents concepts and information intended to assist
a laboratory in meeting leadership requirements for its quality
management system. Guidance is provided for leaders to eectively
design, implement, and maintain the cultural, structural, and functional
aspects of their laboratorys organization that are critical to managing
and sustaining quality.
Executive Summary (QMS14-AES) Included!
Nonmembers $170
SEPTEMBER 2012
AUGUST 2011
DECEMBER 2013
DECEMBER 2010
DECEMBER 2012
QMS05-A2
QMS13-A
QMS15-A
QMS12-A
QMS14-A
June 2011
consensus process.
QMS06-A3
Continual Improvement; Approved
Continual Improvement; Approved

This guideline considers continual improvement as an ongoing,
systematic eort that is an essential component of a quality
management system. A continual improvement program may consist of
fundamental processes and common supporting elements described in
this guideline.
Nonmembers $170
JUNE 2011
QMS06-A3
CAP
JC
JC
JC
CAP JC FDA
Available Through CLSI: International
Organization for Standardization
(ISO) Documents
Through an agreement with the American National
Standards Institute, CLSI is able to oer ISO Technical
Committee 212 approved and draft standards.
Customers from outside the United States may order
these ISO standards from their national standards
bodies.
For more information on ISO 15189, ISO 17511, and
ISO 19001, and to view the complete library of ISO
standards, visit www.clsi.org.
June 2010
consensus process.
VET03/VET04-S1
Susceptibility Testing of Bacteria Isolated
FromAquatic Animals; First Informational
Supplement
September 2011
consensus process.
VET05-R
Generation, Presentation, and Application
of Antimicrobial Susceptibility Test Data for
Bacteria of Animal Origin; AReport
Antimicrobial Susceptibility
Testing of Bacteria Isolated
From Aquatic Animals; First
This document provides updated tables for the Clinical and Laboratory
Standards Institute antimicrobial susceptibility testing guidelines
VET03-A and VET04-A.
Nonmembers $50
Generation, Presentation, and
Application of Antimicrobial
Susceptibility Test Data for
Bacteria of Animal Origin;
A Report
This report oers guidance on areas in which harmonization can be
achieved in veterinary antimicrobial surveillance programs with the
intent of facilitating comparison of data among surveillance programs.
Nonmembers $130
JUNE 2010
SEPTEMBER 2011
VET03/VET04-S1
VET05-R
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Antimicrobial Disk and Dilution
Susceptibility Tests for Bacteria
Isolated From Animals; Approved
StandardFourth Edition
This document provides the currently recommended techniques for
antimicrobial agent disk and dilution susceptibility testing, criteria for
quality control testing, and interpretive criteria for veterinary use.
Nonmembers $260 Price includes VET01-S2.
JULY 2013
VET01-A4
Performance Standards for Antimicrobial Disk and Dilution
Susceptibility Tests for Bacteria Isolated From Animals; Second
This document provides updated tables for the CLSI antimicrobial
susceptibility testing standard VET01.
VET01-S2
JULY 2013
July 2013
consensus process.
VET01-A4
Disk and DilutionSusceptibility Tests for
Bacteria Isolated FromAnimals; Approved
StandardFourth Edition
55
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consensus process.
EP15
User Vericationof Precisionand
Estimationof Bias
User Verifcation of Precision and
Estimation of Bias
This document describes the demonstration of precision, comparison of
measurement procedures, and estimation of bias for clinical laboratory
quantitative measurement procedures using a protocol designed to be
completed within fve working days or less.
Nonmembers $170
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CLSI Documents Scheduled for Publication
consensus process.
EP05
Evaluationof Precisionof Quantitative
Measurement Procedures
Evaluation of Precision of
Quantitative Measurement
Procedures
This document provides guidance for evaluating the precision
performance of quantitative measurement methods. It is intended
for manufacturers of quantitative measurement procedures and for
laboratories that develop or modify such methods.
Nonmembers $170
COMING SOON!
EP05
S
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4
consensus process.
AUTO11
InformationTechnologySecurityof InVitro
Diagnostic Instruments andSoftware
Systems

Information Technology Security
of In Vitro Diagnostic Instruments
and Software Systems

This document provides a framework for communication of
information technology security issues between the in vitro diagnostic
system vendor and the health care organization.
Nonmembers $130
COMING SOON!
AUTO11
consensus process.
C62
Liquid Chromatography-Mass
Spectrometry Methods
Liquid Chromatography-Mass
Spectrometry Methods
This document provides guidance to the clinical laboratorian for
the reduction of interlaboratory variance and the evaluation of
interferences, assay performance, and other pertinent characteristics
of clinical assays. This guideline emphasizes particular areas related to
assay development and presents a standardized approach for method
verifcation that is specifc to mass spectrometry technology.
Nonmembers $130
COMING SOON!
C62
consensus process.
M29
Protectionof Laboratory Workers From
Occupationally Acquired Infections
Protection of Laboratory
Workers From Occupationally
Acquired Infections
Based on US regulations, this document provides guidance on the
risk of transmission of infectious agents by aerosols, droplets, blood,
and body substances in a laboratory setting; specifc precautions for
preventing the laboratory transmission of microbial infection from
laboratory instruments and materials; and recommendations for the
management of exposure to infectious agents.
Nonmembers $170
COMING SOON!
M29
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consensus process.
M40
Quality Control of Microbiological
Transport Systems
consensus process.
M56
Principles and Procedures for Detectionof
Anaerobes inClinical Specimens
consensus process.
POCT06
Guidelines onthe Impact onGlucose
Measurements WhenDifferent Sample
Types are Used
Quality Control of Microbiological
Transport Systems
This document provides criteria to assist manufacturers and end users
of transport devices in providing and selecting dependable products for
the transport of microbiological clinical specimens.
Nonmembers $170
Detection of Anaerobes in Clinical
Specimens
This document presents standardized, cost-eective, and ecient
best practice processes for anaerobe bacteriology to assist clinical
laboratories in selecting those methods that lead to improved
patient care.
Nonmembers $170
Guidelines on the Impact on
Glucose Measurements When
Dierent Sample Types Are Used
This guideline provides information to assist the clinical and
point-of-care sta in result and measurement procedure comparisons
of glucose tests.
Nonmembers $130
COMING SOON!
COMING SOON! COMING SOON!
M40
M56 POCT06
consensus process.
QMS20
Understanding the Cost of Quality
inthe Laboratory
Understanding the Cost of Quality
in the Laboratory

This report provides guidance to a laboratory in understanding and
managing the dierent types of quality costs that aect processes,
services, and fnancial well-being.
Nonmembers $170
COMING SOON!
QMS20
consensus process.
VET04
Methods for Broth DilutionSusceptibility
Testing of Bacteria Isolated From
Aquatic Animals
Methods for Broth Dilution
Susceptibility Testing of Bacteria
Isolated From Aquatic Animals

This document provides the most up-to-date techniques for the
determination of minimal inhibitory concentrations of aquatic bacteria
by broth micro- and macrodilution, and criteria for data interpretation
and quality control testing.
Nonmembers $130
COMING SOON!
VET04
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