Catalog2022 Web

CLSI CATALOG | Setting the standard in laboratory
medicine for a healthier world.
www.clsi.org | 2022
Global Laboratory Standards for a Healthier World
The Clinical and Laboratory Standards Institute (CLSI) is the global leader in the
standardization of medical laboratory best practices that can help you deliver more
accurate results and improved patient outcomes.
CLSI supports health care professionals, In this catalog, you’ll find our full listing of
laboratorians, IVD manufacturers, neutral consensus-based products that are
pharmaceutical companies, and government easy to access, use, and enable everyone
laboratories who need to meet the highest from medical technologists to quality control
expectations for quality, accreditation, and managers to improve the outcomes of their
regulatory compliance. We provide the best laboratory testing. CLSI documents and other
access to the most timely laboratory practices products are offered in PDF, print, and/or
and offer unsurpassed opportunities for our subscription format.
members.
2 CLSI Catalog 2022

What’s New?
C62 | Liquid Chromatography-Mass Spectrometry EP43 | Implementing a Laboratory Test Under Emergency
Methods, 2nd Edition Use Conditions, 1st Edition
EP27 | Constructing and Interpreting an Error Grid for H62 | Validation of Assays Performed by Flow Cytometry, 1st
Quantitative Measurement Procedures, 2nd Edition Edition
QMS15 | Laboratory Internal Audit Program, 2nd Edition MM24 | Molecular Methods for Genotyping and Strain Typing
of Infectious Organisms, 1st Edition
M47 | Principles and Procedures for Blood Cultures, 2nd
Edition NBS09 | Newborn Screening for X-Linked
Adrenoleukodystrophy, 1st Edition
EP26 | User Evaluation of Acceptability of a Reagent Lot
Change, 2nd Edition C64 | Quantitative Measurement of Proteins and Peptides by
Mass Spectrometry, 1st Edition
M100 | Performance Standards for Antimicrobial
Susceptibility Testing, 32nd Edition QMS26 | Managing Laboratory Records, 1st Edition
M39 | Analysis and Presentation of Cumulative NBS01 | Dried Blood Spot Specimen Collection for Newborn
Antimicrobial Susceptibility Test Data, 5th Edition Screening, 7th Edition
EP39 | A Hierarchical Approach to Selecting Surrogate VET02 | Development of Quality Control Ranges, Breakpoints,
Samples for the Evaluation of In Vitro Medical Laboratory and Interpretive Categories for Antimicrobial Agents Used in
Tests, 1st Edition Veterinary Medicine, 4th Edition
Coming Soon!
AUTO17 | Semantic Interoperability for In Vitro Diagnostic EP33 | Use of Delta Checks in the Medical Laboratory,
Systems, 1st Edition 2nd Edition
EP14 | Evaluation of Commutability of Processed Samples, For more details and up-to-date information
4th Edition visit clsi.org/projects-in-progress.
EP19 | A Framework for Using CLSI Documents to Evaluate
Clinical Laboratory Measurement Procedures, 3rd Edition
Free Online Course

Using M100: Performance Standards for
Antimicrobial Susceptibility Testing
Improve your lab’s antimicrobial susceptibility testing (AST) by using this

self-paced, online learning program. This interactive program will teach
you how to navigate the many tables found in CLSI’s document M100—
Performance Standards for Antimicrobial Susceptibility Testing, 32nd
Edition.
Learn more at clsi.org/using-m100.
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4 CLSI Catalog 2022

Membership Includes:
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Explore CLSI standards with eCLIPSE Ultimate Access™, our full online library.
• Comprehensive – Includes every current CLSI standard • Accessible – Download PDFs for offline use
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Visit clsi.org/eclipse to learn more.
6 CLSI Catalog 2022
Coming Soon!
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are subject to a myriad of regulatory requirements. Often, it is difficult to stay up-to-
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Learn to identify, understand, and meet requirements and gain guidance to help document
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7 |
Automation and Informatics
Document Pricing
Nonmembers Print: $200/PDF: $180 Level III Members Print: $100/PDF: $90
Level I Members Print: $60/PDF: $54 Individual Full Members Print: $150/PDF: $135
Level II Members Print: $80/PDF: $72 Individual Associate Members: Print: $170/PDF: $153
All documents are available as PDF downloads. Those marked with an asterisk Documents listed in gray are no longer being reviewed as part of our consensus
are available in print as well. process.
Access documents for free in eCLIPSE, included in some membership levels. Visit clsi.org/eclipse for more information.
Featured Documents
AUTO15 | Autoverification of Medical Laboratory Results for Specific Disciplines, 1st Edition
This guideline includes detailed information for design, testing, validation, implementation,
1st Edition
AUTO15
Autoverification of Medical Laboratory Results
for Specific Disciplines and ongoing support of an autoverification algorithm system for use in the medical
laboratory.
This guideline includes detailed information for design,

testing, validation, implementation, and ongoing support of
an autoverification algorithm system for use in the medical
laboratory.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
AUTO16 | Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition

Laboratories and IVD manufacturers need to understand the connectivity challenges facing
1st Edition
AUTO16
Next-Generation In Vitro Diagnostic
Instrument Interface medical laboratories today. AUTO16 can help you improve interoperability and reduce
connectivity installation cost and time.
This standard applies to the exchange of analytical testing

data between in vitro diagnostic instruments and health care
informatics systems.
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
AUTO01 | Laboratory Automation: Specimen AUTO04 | Laboratory Automation: Systems

Container/Specimen Carrier, 1st Edition Operational Requirements, Characteristics, and
Item Order Code: AUTO01AE Information Elements, 1st Edition
Item Order Code: AUTO04AE
AUTO02 | Laboratory Automation: Bar Codes for
Specimen Container Identification, 2nd Edition AUTO05 | Laboratory Automation:
Item Order Code: AUTO02A2E Electromechanical Interfaces, 1st Edition
AUTO03 | Laboratory Automation: Communications
With Automated Clinical Laboratory Systems, AUTO07 | Laboratory Automation: Data Content for
Instruments, Devices, and Information Systems, Specimen Identification, 1st Edition
2nd Edition Item Order Code: AUTO07AE
Item Order Code: AUTO03A2E
8 CLSI Catalog 2022

AUTO08 | Managing and Validating Laboratory AUTO15* | Autoverification of Medical Laboratory
Information Systems, 1st Edition Results for Specific Disciplines, 1st Edition
Item Order Code: AUTO08AE Item Order Code: AUTO15Ed1
AUTO09 | Remote Access to Clinical Laboratory AUTO16 | Next-Generation In Vitro Diagnostic
Diagnostic Devices via the Internet, 1st Edition Instrument Interface, 1st Edition
Item Order Code: AUTO09AE Item Order Code: AUTO16Ed1E
AUTO10 | Autoverification of Clinical Laboratory LIS01 | Specification for Low-Level Protocol to
Test Results, 1st Edition Transfer Messages Between Clinical Laboratory
Item Order Code: AUTO10AE Instruments and Computer Systems, 2nd Edition
Item Order Code: LIS01A2E
AUTO11 | Information Technology Security of In
Vitro Diagnostic Instruments and Software Systems, LIS02 | Specification for Transferring Information
2nd Edition Between Clinical Laboratory Instruments and
Item Order Code: AUTO11A2E Information Systems, 2nd Edition
Item Order Code: LIS02A2E
AUTO12 | Specimen Labels: Content and Location,
Fonts, and Label Orientation, 1st Edition
AUTO13 | Laboratory Instruments and Data
Management Systems: Design of Software
User Interfaces and End-User Software Systems
Validation, Operation, and Monitoring, 2nd Edition
Item Order Code: AUTO13A2E
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Clinical Chemistry and Toxicology
Document Pricing
Featured Documents
C34 | Sweat Testing: Sample Collection and Quantitative Chloride Analysis, 4th Edition
Ensuring your laboratory and clinical personnel are equipped to appropriately collect and
4th Edition
C34
Sweat Testing: Specimen Collection and
Quantitative Chloride Analysis
analyze chloride sweat samples is the best way to provide your patients with high quality
cystic fibrosis test results. Get your staff the resource they need with C34.
This guideline describes methods for all aspects of sweat testing,

including collection and analysis, results evaluation and reporting,
and quality control.
C64 | Quantitative Measurement of Proteins and Peptides by Mass Spectrometry, 1st Edition
This guideline describes the design, development, and validation of quantitative assays for
1st Edition
C64
Quantitative Measurement of Proteins and
Peptides by Mass Spectrometry proteins and peptides by mass spectrometry.
This guideline describes the design, development, and validation

of quantitative assays for proteins and peptides by mass
spectrometry.
C24 | Statistical Quality Control for Quantitative C34* | Sweat Testing: Sample Collection and
Measurement Procedures: Principles and Quantitative Chloride Analysis, 4th Edition
Definitions, 4th Edition Item Order Code: C34Ed4
Item Order Code: C24Ed4E
C37 | Preparation and Validation of Commutable
C29 | Standardization of Sodium and Potassium Frozen Human Serum Pools as Secondary Reference
Ion-Selective Electrode Systems to the Flame Materials for Cholesterol Measurement Procedures,
Photometric Reference Method, 2nd Edition 1st Edition
Item Order Code: C29A2E Item Order Code: C37AE
C31 | Ionized Calcium Determinations: Precollection C38 | Control of Preanalytical Variation in Trace
Variables, Specimen Choice, Collection, and Element Determinations, 1st Edition
Handling, 2nd Edition Item Order Code: C38AE
Item Order Code: C31A2E
10 CLSI Catalog 2022

C39 | A Designated Comparison Method for the C52* | Toxicology and Drug Testing in the Clinical
Measurement of Ionized Calcium in Serum, Laboratory, 3rd Edition
1st Edition Item Order Code: C52Ed3
Item Order Code: C39AE
C56 | Hemolysis, Icterus, and Lipemia/Turbidity
C40 | Measurement Procedures for the Indices as Indicators of Interference in Clinical
Determination of Lead Concentrations in Blood and Laboratory Analysis, 1st Edition
Urine, 2nd Edition Item Order Code: C56AE
Item Order Code: C40A2E
C56AQG | Examples of Hemolyzed, Icteric, and
C42 | Erythrocyte Protoporphyrin Testing, Lipemic/Turbid Samples Quick Guide
1st Edition Item Order Code: C56AEQGE
Item Order Code: C42AE Nonmember Rate: $20.00
C43 | Gas Chromatography/Mass Spectrometry C57 | Mass Spectrometry for Androgen and
Confirmation of Drugs, 2nd Edition Estrogen Measurements in Serum, 1st Edition
Item Order Code: C43A2E Item Order Code: C57Ed1E
C45 | Measurement of Free Thyroid Hormones, C58 | Assessment of Fetal Lung Maturity by the
1st Edition Lamellar Body Count, 1st Edition
Item Order Code: C45AE Item Order Code: C58AE
C46 | Blood Gas and pH Analysis and Related C61 | Determination of Serum Iron, Total Iron-
Measurements, 2nd Edition Binding Capacity and Percent Transferrin Saturation,
Item Order Code: C46A2E 1st Edition
Item Order Code: C61AE
C48 | Application of Biochemical Markers of Bone
Turnover in the Assessment and Monitoring of Bone C62* | Liquid Chromatography-Mass Spectrometry
Diseases, 1st Edition Methods, 2nd Edition
Item Order Code: C48AE Item Order Code: C62Ed2
C49* | Analysis of Body Fluids in Clinical Chemistry, C63* | Laboratory Support for Pain Management
2nd Edition Programs, 1st Edition
Item Order Code: C49Ed2 Item Order Code: C63Ed1
C50 | Mass Spectrometry in the Clinical Laboratory: C64* | Quantitative Measurement of Proteins and
General Principles and Guidance, 1st Edition Peptides by Mass Spectrometry, 1st Edition
Item Order Code: C50AE Item Order Code: C64Ed1

General Laboratory
Document Pricing
Featured Documents
GP33 | Accuracy in Patient and Sample Identification, 2nd Edition
The processes required by regulatory bodies for ensuring accurate patient and specimen
2nd Edition
GP33
Accuracy in Patient and Specimen
Identification
identification are covered in GP33. Invaluable guidance on bar-code system implementation
and user training is included.
This standard specifies the processes required to ensure accurate

patient and specimen identification in manual and electronic
systems across the health care organization. Processes include
system design considerations, differences in requirements for
patients with or without identification bands, and provisions for
patients with communication barriers.
GP42 | Collection of Capillary Blood Specimens, 7th Edition

This standard provides procedures for collection of capillary blood specimens. Specifications
7th Edition
GP42
Collection of Capillary Blood Specimens
for collection sites, puncture depth, and disposable devices used to collect, process, and
transfer capillary blood specimens are also included.
This standard provides procedures for collection of capillary blood

specimens. Specifications for collection sites, puncture depth, and
disposable devices used to collect, process, and transfer capillary
blood specimens are also included.
GP05 | Clinical Laboratory Waste Management, GP17* | Clinical Laboratory Safety, 3rd Edition
3rd Edition Item Order Code: GP17A3 COVID-19 Related
Item Order Code: GP05A3E
GP20 | Fine Needle Aspiration Biopsy (FNAB)
GP05A3CL | Waste Management Program – Audit Techniques, 2nd Edition
Checklist Item Order Code: GP20A2E
Item Order Code: GP05A3CLE
Nonmember Rate: $20.00 GP23 | Nongynecological Cytology Specimens:
Preexamination, Examination, and Postexamination
GP15 | Cervicovaginal Cytology Based on the Processes, 2nd Edition
Papanicolaou Technique, 3rd Edition Item Order Code: GP23A2E
Item Order Code: GP15A3E
GP33* | Accuracy in Patient and Sample
GP16 | Urinalysis, 3rd Edition Identification, 2nd Edition
Item Order Code: GP16A3E Item Order Code: GP33Ed2 COVID-19 Related

GP34 | Validation and Verification of Tubes for GP42A6QG | Technique for Skin Puncture in Adults
Venous and Capillary Blood Specimen Collection, and Older Children Quick Guide
1st Edition Item Order Code: GP42A6QGE
Item Order Code: GP34AE Nonmember Rate: $20.00
GP36 | Planning for Laboratory Operations During a GP44 | Procedures for the Handling and Processing
Disaster, 1st Edition of Blood Specimens for Common Laboratory Tests,
Item Order Code: GP36AE COVID-19 Related 4th Edition
Free for a limited time. Item Order Code: GP44A4E COVID-19 Related
GP39 | Tubes and Additives for Venous and Capillary GP45 | Studies to Evaluate Patient Outcomes,
Blood Specimen Collection, 6th Edition 1st Edition
Item Order Code: GP39A6E Item Order Code: GP45AE
GP40 | Preparation and Testing of Reagent Water in GP47 | Management of Critical- and Significant-Risk
the Clinical Laboratory, 4th Edition Results, 1st Edition
Item Order Code: GP40A4AMDE Item Order Code: GP47Ed1E
GP41* | Collection of Diagnostic Venous Blood GP48* | Essential Elements of a Phlebotomy Training
Specimens, 7th Edition Program, 1st Edition
Item Order Code: GP41Ed7 COVID-19 Related Item Order Code: GP48Ed1
GP41QG* | Quality Venipuncture Quick Guide GP49* | Developing and Managing a Medical
Item Order Code: GP41Ed7QG Laboratory (Test) Utilization Management Program,
Nonmember Rate: $20.00 1st Edition
Item Order Code: GP49Ed1
GP42* | Procedures and Devices for the Collection of
Diagnostic Capillary Blood Specimens, 7th Edition
Item Order Code: GP42Ed7
Did you know?

Through our Partnerships program, CLSI provides international outreach services
and hands-on support to laboratories throughout the world, helping them achieve
sustainable quality with systems to better diagnose and treat patients with
infectious diseases.
See where we work and how we can help your laboratory at clsi.org/global-training.

Hematology
Document Pricing
Featured Documents
H48 | Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2nd
2nd Edition
Edition
H48
Determination of Coagulation Factor
Activities Using the One-Stage Clotting Assay
Quantitative assays for measuring coagulant activity are important laboratory tools. Enhance
the precision and accuracy of patient clotting factor assay results with H48.
This guideline provides recommendations regarding the proper

collection and handling of specimens, reagents, controls,
calibrators, and materials needed to optimize factor assay testing.
It includes recommendations for good laboratory practices related
to analyzer and reagent performance, reference intervals, lot-to-
lot validation, and quality control. Assay limitations and sources of
errors and variability are also included.
H62 | Validation of Assays Performed by Flow Cytometry, 1st Edition

This guideline includes validation strategies for cell-based assays performed by flow
1st Edition
H62
Validation of Assays Performed by Flow
Cytometry cytometry. This guideline also includes recommendations for instrument qualification
and standardization and assay optimization. It also covers recommended practices for the
examination and postexamination phases.
This guideline includes validation strategies for cell-based
assays performed by flow cytometry. This guideline also
includes recommendations for instrument qualification
and standardization and assay optimization. It also
covers recommended practices for the examination and
postexamination phases.
H02 | Procedures for the Erythrocyte Sedimentation H20 | Reference Leukocyte (WBC) Differential Count
Rate Test, 5th Edition (Proportional) and Evaluation of Instrumental
Item Order Code: H02A5E Methods, 2nd Edition
Item Order Code: H20A2E
H07 | Procedure for Determining Packed Cell Volume
by the Microhematocrit Method, 3rd Edition H21 | Collection, Transport, and Processing of Blood
Item Order Code: H07A3E Specimens for Testing Plasma-Based Coagulation
Assays and Molecular Hemostasis Assays,
H15 | Reference and Selected Procedures for the 5th Edition
Quantitative Determination of Hemoglobin in Item Order Code: H21A5E
Blood, 3rd Edition
Item Order Code: H15A3E H21A5QG | H21-A5 Quick Guide
Item Order Code: H21A5QGE
Nonmember Rate: $20.00

H26 | Validation, Verification, and Quality Assurance H56 | Body Fluid Analysis for Cellular Composition,
of Automated Hematology Analyzers, 2nd Edition 1st Edition
Item Order Code: H26A2E Item Order Code: H56AE
H30 | Procedure for the Determination of Fibrinogen H57 | Protocol for the Evaluation, Validation, and
in Plasma, 2nd Edition Implementation of Coagulometers, 1st Edition
H42 | Enumeration of Immunologically Defined Cell H58 | Platelet Function Testing by Aggregometry,
Populations by Flow Cytometry, 2nd Edition 1st Edition
H43 | Clinical Flow Cytometric Analysis of Neoplastic H59 | Quantitative D-dimer for the Exclusion of
Hematolymphoid Cells, 2nd Edition Venous Thromboembolic Disease, 1st Edition
H44 | Methods for Reticulocyte Counting H60 | Laboratory Testing for the Lupus
(Automated Blood Cell Counters, Flow Cytometry Anticoagulant, 1st Edition
and Supravital Dyes), 2nd Edition Item Order Code: H60AE
H60AQG1 | Algorithmic Approach to Lupus
H47 | One-Stage Prothrombin Time (PT) Test and Anticoagulant Testing
Activated Partial Thromboplastin Time (APTT) Test, Item Order Code: H60AQG1E
2nd Edition Nonmember Rate: $20.00
H60AQG2 | Criteria for the Laboratory Diagnosis of
H48 | Determination of Coagulation Factor the Lupus Anticoagulant
Activities Using the One-Stage Clotting Assay, Item Order Code: H60AQG2E
2nd Edition Nonmember Rate: $20.00
Item Order Code: H48Ed2E
H62* | Validation of Assays Performed by Flow
H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry, 1st Edition
Cytometry, 2nd Edition Item Order Code: H62Ed1
H54 | Procedures for Validation of INR and Local
Calibration of PT/INR Systems, 1st Edition
Item Order Code: H54AE
Coming soon! If you develop laboratory

tests, you need Method Navigator!
CLSI’s new Method Navigator program pulls together specific guidance from CLSI documents that
will help your lab fulfill FDA, CLIA, ISO, and other requirements, all in one place. With checklists and
downloadable templates, easily navigate the guidance you need, all located conveniently in one place.
Learn more at clsi.org/method-nav.

Immunology and Ligand Assay
Document Pricing
Featured Documents
I/LA20 | Analytical Performance Characteristics, Quality Assurance, and Clinical Utility
3rd Edition
of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen
I/LA20
Analytical Performance Characteristics,
Specificities, 3rd Edition
Quality Assurance, and Clinical Utility
Give your laboratory staff the guidance they need for the clinical application of laboratory
of Immunological Assays for Human
Immunoglobulin E Antibodies of Defined
Allergen Specificities
assays used in the measurement of human IgE.

This report provides guidance for the design, analytical
performance, standardization, quality assurance, and clinical
application of laboratory assays used in the measurement
of human immunoglobulin E antibodies of defined allergen
specificity.
A CLSI report for global application.
I/LA26 | Performance of Single Cell Immune Response Assays, 2nd Edition

Learn about methods for intracellular cytokine evaluation, major histocompatibility complex
November 2013
I/LA26-A2
Performance of Single Cell Immune Response
Assays; Approved Guideline—Second Edition
multimer quantitation, and enzyme-linked immunospot technology for the assessment of
cellular proliferation with I/LA26.
This document contains methods of intracellular cytokine
evaluation, major histocompatibility complex multimer
quantitation, enzyme-linked immunospot technology, and
carboxyfluorescein 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.
I/LA02 | Quality Assurance of Laboratory Tests for I/LA20S (I/LA37) | Analytical Performance
Autoantibodies to Nuclear Antigens: (1) Indirect Characteristics and Clinical Utility of Immunological
Fluorescence Assay for Microscopy and (2) Microtiter Assays for Human Immunoglobulin E (IgE)
Enzyme Immunoassay Methods, 2nd Edition Antibodies and Defined Allergen Specificities,
Item Order Code: ILA02A2E 1st Edition
Item Order Code: ILA37Ed1E
I/LA20 | Analytical Performance Characteristics, Nonmember Rate: $80.00
Quality Assurance, and Clinical Utility of
Immunological Assays for Human Immunoglobulin I/LA21 | Clinical Evaluation of Immunoassays,
E Antibodies of Defined Allergen Specificities, 2nd Edition
3rd Edition Item Order Code: ILA21A2E
Item Order Code: ILA20Ed3E

I/LA23 | Assessing the Quality of Immunoassay I/LA30 | Immunoassay Interference by Endogenous
Systems: Radioimmunoassays and Enzyme, Antibodies, 1st Edition
Fluorescence, and Luminescence Immunoassays, Item Order Code: ILA30AE
1st Edition
Item Order Code: ILA23AE I/LA33 | Validation of Automated Systems
for Immunohematological Testing Before
I/LA25 | Maternal Serum Screening, 2nd Edition Implementation, 1st Edition
Item Order Code: ILA25A2E Item Order Code: ILA33AE
I/LA26 | Performance of Single Cell Immune I/LA34 | Design and Validation of Immunoassays
Response Assays, 2nd Edition for Assessment of Human Allergenicity of New
Item Order Code: ILA26A2E Biotherapeutic Drugs, 1st Edition
Item Order Code: ILA34AE
I/LA28 | Quality Assurance for Design Control and
Implementation of Immunohistochemistry Assays,
2nd Edition
Item Order Code: ILA28A2E
I/LA28A2QG | Comparison of the Characteristics

of Immunoassays Such as Enzyme-Linked
Immunosorbent Assay and Immunohistochemistry
Quick Guide
Item Order Code: ILA28A2QGE
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Method Evaluation
Document Pricing
Featured Documents
EP26 | User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition
This guideline includes recommendations for laboratories on evaluating a new reagent lot,
2nd Edition
EP26
User Evaluation of Acceptability of a Reagent
Lot Change based on a protocol that uses patient samples to detect clinically important changes from the
current lot.
This guideline includes recommendations for laboratories on

evaluating a new reagent lot, based on a protocol that uses
patient samples to detect clinically important changes from the
current lot.
EP39 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro
1st Edition
Medical Laboratory Tests, 1st Edition
EP39
A Hierarchical Approach to Selecting
Surrogate Samples for the Evaluation of
In Vitro Medical Laboratory Tests
This guideline establishes a definition of a surrogate sample, provides recommendations for
determining when to use surrogate samples, and describes a process for selecting the most
appropriate surrogate sample.
This guideline establishes a definition of a surrogate sample,
provides recommendations for determining when to use
surrogate samples, and describes a process for selecting the most
appropriate surrogate sample.
EP05 | Evaluation of Precision of Quantitative EP07S (EP37) | Supplemental Tables for Interference
Measurement Procedures, 3rd Edition Testing in Clinical Chemistry, 1st Edition
Item Order Code: EP05A3E COVID-19 Related Item Order Code: EP37Ed1E
EP06* | Evaluation of the Linearity of Quantitative
Measurement Procedures: A Statistical Approach, EP09 | Measurement Procedure Comparison and
2nd Edition Bias Estimation Using Patient Samples, 3rd Edition
Item Order Code: EP06Ed2 COVID-19 Related Item Order Code: EP09Ed3cE
EP07* | Interference Testing in Clinical Chemistry, EP10 | Preliminary Evaluation of Quantitative Clinical
3rd Edition Laboratory Measurement Procedures, 3rd Edition
Item Order Code: EP10A3AMDE
Item Order Code: EP07Ed3 COVID-19 Related

EP12 | User Protocol for Evaluation of Qualitative EP24 | Assessment of the Diagnostic Accuracy
Test Performance, 2nd Edition of Laboratory Tests Using Receiver Operating
Item Order Code: EP12A2E COVID-19 Related Characteristic Curves, 2nd Edition
Item Order Code: EP24A2E
EP14* | Evaluation of Commutability of Processed
Samples, 3rd Edition EP25 | Evaluation of Stability of In Vitro Diagnostic
Item Order Code: EP14A3 Reagents, 1st Edition
Item Order Code: EP25AE COVID-19 Related
EP15 | User Verification of Precision and Estimation
of Bias, 3rd Edition EP26* | User Evaluation of Between-Reagent Lot
Item Order Code: EP15A3E Variation, 2nd Edition
Item Order Code: EP26Ed2
EP17 | Evaluation of Detection Capability for Clinical
Laboratory Measurement Procedures, 2nd Edition EP27 | Constructing and Interpreting an Error Grid
Item Order Code: EP17A2E COVID-19 Related for Quantitative Measurement Procedures, 2nd
Edition
EP18 | Risk Management Techniques to Identify and Item Order Code: EP27Ed2E
Control Laboratory Error Sources, 2nd Edition
Item Order Code: EP18A2E COVID-19 Related EP28 | Defining, Establishing, and Verifying
Reference Intervals in the Clinical Laboratory,
EP18A2EP23AWS | Laboratory Quality Control Based 3rd Edition
on Risk Management; Worksheet Template Item Order Code: EP28A3CE
Item Order Code: EP18A2EP23AWSE
Free document EP29 | Expression of Measurement Uncertainty in
Laboratory Medicine, 1st Edition
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User Verification of Precision Implementation Guide
Implementation Guide
EP15-Ed3-IG1
User Verification of Bias (Trueness) Implementation Evaluation of Detection Capability Implementation
Guide Introduction Guide
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify
Implementation Guide Implementation Guide
a manufacturer’s or laboratory-developed test’s precision claims. For additional information on verifying
EP15-Ed3-IG2 precision, see CLSI document EP15.1 EP17-Ed2-IG
NOTE: The study described in this implementation guide for verifying precision can also be used to
Introduction estimate bias (trueness). See CLSI document EP15-Ed3-IG2.2 Introduction
IMPORTANT NOTE: The This implementation guide describes the minimum procedures necessary for a medical laboratory to verify
This implementation guide describes the minimum procedures necessary for a medical laboratory tostudy described in CLSI document EP151 is not intended for use by a test developer
that a measurement procedure’s detection capability is consistent with the claims established by the
to establish
estimate bias (trueness) of a laboratory measurement procedure. For additional precision
information for a new commercial or laboratory-developed test. Instead,
on estimating test developers should
developer. Detection capability includes (as shown in the figure below):
bias, see CLSI document EP15.1 use CLSI document EP053 for guidance on establishing or validating precision. Laboratories and commercial
manufacturers are collectively referred to as “developers” in this implementation•guide. Upper boundary on blank sample measurements (ie, limit of blank [LoB])
Evaluation of Total Analytical Error for Quantitative Medical
NOTE: The study described in this implementation guide uses the data and statistics generated from Risk Management Techniques to Identify and Control
• “Yes/no” detection of measurand presence (ie, limit of detection [LoD])
the precision study
Laboratory Measurement Procedures Implementation described in CLSI document EP15.1 The instructions provided in CLSI document
Guide
EP15-Ed3-IG12 should be used for running the precision study.
Accuracy: A Combination of Precision and Bias • Minimum amount of measurand that can be quantitated reliably with Laboratory Error
respect to a defined Sources Implementation Guide
accuracy
It is important
for use by that
a testmeasurement procedures provide accurate results. In order to dogoal
so, (ie,
they limit of quantitation
must both be [LoQ])
Implementation Guide IMPORTANT NOTE: The study described in CLSI document EP151 is not intended developer Implementation Guide
These values are especially critical to detecting extremely small amounts of a measurand. It is always
precisetest.
to establish or validate bias claims for a new commercial or laboratory-developed andInstead,
have low bias as shown in the figure below.
test
EP21-Ed2-IG the case that LoB < LoD ≤ LoQ. Knowledge of the detection capability helps EP18-Ed2-IG
determine the lower limit of
developers should use CLSI document EP093 for guidance on establishing bias claims. Laboratories and
the measuring interval, which is the lowest measurand concentration at which all defined performance
commercial manufacturers are collectively referred to as “developers” in this implementation guide.
characteristics of the measurement procedure are met (eg, acceptable bias, imprecision, linearity).
Introduction Accuracy: A Combination of Precision and Bias Introduction
Each measurement procedure also has an upper limit of quantitation, but determining this value is not
This implementation guide describes the minimum procedures necessary for a medical laboratory to within the scope of CLSI document EP17.1 This implementation guide describes the minimum procedures necessary for a medical laboratory to
It is important that measurement procedures provide accurate results. In order to do so, they must both be
determine total analytical error (TAE) for quantitative measurement procedures. For additional information identify and control laboratory error sources using risk management techniques. These instructions focus
precise and have low bias as shown in the figure below.
on evaluating TAE, see CLSI document EP21.1 on the failure modes and effects analysis (FMEA) technique. Other options are included in CLSI documents
Concentration EP181 and EP23™.2
0 N
Several terms and abbreviations used in this implementation guide—and other CLSI documents—deserve IMPORTANT NOTE: This implementation guide is not intended for use by a test developer to determine
careful attention and understanding because of their similarity and the way in which they are represented error sources for a new commercial or laboratory-developed test. Instead, test developers should use CLSI
in other sources. They include: Reportable Interval document EP181 for guidance on determining error sources. Laboratories and commercial manufacturers
• Total analytical error (TAE): a measured and calculated quantity that includes errors associated are collectively referred to as “developers” in this implementation guide.
with the examination (analytical) phase of testing. Less bias, More bias, Less bias, Analytical Measuring Interval
• Allowable total error (ATE): an error goal set by the laboratory. In other publications, ATE might be more precise more precise less precise Overview of the Risk Management Process
abbreviated as TEa (ie, total error allowable). Diagnostic devices are extremely diverse in their technology, design, and function. Every test system is
LoB LoD LoQ ULoQ
• Total error (TE): includes errors from preexamination, examination, and postexamination sources. subject to hazards or hazardous situations during the preexamination, examination, and postexamination
testing stages. The relative importance and likelihood of these failures vary with the device, the sample,
While CLSI document EP151 contains instructions for studying both precision and bias, this
Abbreviations: implementation
LoB, limit of blank; LoD, limit of detection; LoQ, limit of quantitation; ULoQ, upper limit of quantitation.
the user, and the environment. In addition, a high level of variability exists in terms of skill and knowledge
NOTE: Laboratories and commercial manufacturers are collectively referred
Lessto as “developers” in this
bias, More bias, guide focuses only on precision. CLSI document EP15-Ed3-IG22 focuses on bias.NOTE: For additional information, see CLSI document EP17.1
Less bias, level among end users. The number of potential and observed failures can be large, making it important
implementation guide. more precise more precise less precise to prioritize efforts to reduce risk. Some failures are almost certain to cause patient harm, whereas a
High precision (low coefficient of variation expressed as a percentage [% CV]) means
IMPORTANTthat when
NOTE: aThe
sample
study outlined in this implementation guide is not intended for use by a test
What Is Total Analytical Error? result that must be repeated but is not time sensitive only raises cost. With the classification of severity
is run repeatedly, the results are very close to each other. Precision can be broken into various
developer components.
to establish or validate detection capability for a new commercial or laboratory-developed
of harm and probability (or frequency) of occurrence, the importance of failures can be prioritized. The
test.“Repeatability”
When the precision of a single run is considered, it is called “within-run precision.” Instead, test developers
is should use CLSI document EP171 for guidance on establishing or validating
TAE is an estimate of error in the results for patient samples, including imprecision, bias, nonlinearity, risk management process can help identify possible failures, their severity, and the likelihood they will
While CLSI document EP15 detection capability. Laboratories and commercial manufacturers are collectively referred to as “developers”
can contains instructions for studying both precision and bias,when
this implementation
1
interferences, matrix differences, and other sources of analytical testing error. TAE be measured over measured all components are held essentially the same (single run, operator, lot, calibration, etc.). occur. With this information, their importance can be prioritized, and measures to reduce the risk can be
New: CLSI’s Implementation Guides

guide focuses only on bias. CLSI document EP15-Ed3-IG12 focuses on precision.
“Reproducibility” is measured when all components are varied (multiple runs, days, in this implementation
operators, guide.
lots, etc.).
the entire analytical measuring interval (AMI) or at specific subintervals. The TAE calculation is compared implemented.
with user-selected limits based on clinical need. Knowledge of the TAE is important when the laboratory is
Having low or no bias means that when a sample is run, its results are very close to the true value (actual
deciding whether differences in results for a patient are meaningful, as well as in answering the questions The risk management process asks the following questions:
concentration or activity) for the sample.
“How accurate are these results?” or “Does the measurement procedure meet clinical performance needs?”
© Clinical and Laboratory Standards Institute. All rights reserved. | .org Page 1 of 11
Accuracy: A Combination of Precision, Bias, and Other Sources of Error
© Clinical and Laboratory Standards Institute. All rights reserved. | .org Page 1 of 9
It is important that measurement procedures provide accurate results. In order to do so, they must both be
precise and have low bias as shown in the figure below.
© Clinical and Laboratory Standards Institute. All rights reserved. | .org Page 1 of 7 What can be
Help your laboratory scientists learn to use CLSI’s Evaluation Protocol Standards. Properly implementing our EP
done to
What can go How often
How bad is it? mitigate or
wrong? will it occur?
reduce the
standards ensures quality test results, regulatory requirement readiness, and preparedness for accreditation.
risk?
Nonmember Price: $50.00

© Clinical and Laboratory Standards Institute. All rights reserved. | .org Page 1 of 10 © Clinical and Laboratory Standards Institute. All rights reserved. | .org Page 1 of 10
EP Implementation Guides are available in electronic format only.
EP06IG | User Verification of Linearity EP21IG | Evaluation of Total Analytical Error for
Implementation Guide, 1st Edition Quantitative Medical Laboratory Measurement
Procedures Implementation Guide, 1st Edition
EP10IG | Preliminary Evaluation of Quantitative
Medical Laboratory Measurement Procedures EP26IG | User Evaluation of Acceptability of a
Implementation Guide, 1st Edition Reagent Lot Change Implementation Guide, 2nd
Edition
EP15IG1 | User Verification of Precision
Implementation Guide, 1st Edition EP28IG | Verification of Reference Intervals in the
Medical Laboratory Implementation Guide, 1st
Edition
EP15IG2 | User Verification of Bias (Trueness)
Implementation Guide, 1st Edition
EP34IG | Verification of an Extended Measuring
Interval Implementation Guide, 1st Edition
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EP18IG | Risk Management Techniques to

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NBS01* | Blood Collection on Filter Paper for NBS03* | Newborn Screening for Preterm, Low Birth
Newborn Screening Programs, 7th Edition Weight, and Sick Newborns, 2nd Edition
Item Order Code: NBS01Ed7 Item Order Code: NBS03Ed2
NBS01Ed7QG* | Specimen Collection and Specimen NBS04* | Newborn Screening by Tandem Mass
Quality for Newborn Screening Quick Guide, 7th Spectrometry, 2nd Edition
Edition Item Order Code: NBS04Ed2
Item Order Code: NBS01Ed7QG
Nonmember Rate: $30.00 NBS05* | Newborn Screening for Cystic Fibrosis,
2nd Edition
NBS02 | Newborn Screening Follow-up, 2nd Edition Item Order Code: NBS05Ed2
Item Order Code: NBS02A2E
NBS06 | Newborn Blood Spot Screening for Severe
NBS02A2QG | Newborn Screening Follow-up Combined Immunodeficiency by Measurement of
Process Quick Guide T-cell Receptor Excision Circles, 1st Edition
Item Order Code: NBS02A2QGE Item Order Code: NBS06AE

NBS06AQG1 | Generic Flow Chart for Assays NBS08* | Newborn Screening for
to Measure T-cell Receptor Excision Circles in Hemoglobinopathies, 1st Edition
Newborn Dried Blood Spot Specimens Item Order Code: NBS08Ed1
Item Order Code: NBS06AQG1E
Nonmember Rate: $20.00 NBS09* | Newborn Screening for X-Linked
Adrenoleukodystrophy, 1st Edition
NBS06AQG2 | Schematic for Preparing Dried Blood Item Order Code: NBS09Ed1
Spot Reference Materials Quick Guide
Item Order Code: NBS06AQG2E
NBS07* | Newborn Blood Spot Screening for
Pompe Disease by Lysosomal Acid α-Glucosidase
Activity Assays, 1st Edition
Item Order Code: NBS07Ed1
Online Course: Making a Difference Through Newborn

FRONT INSERT
Bleed
Screening: Blood Collection on Filter Paper
Trim Trim
Bleed
Lines 4.75” (+.031) Lines
120.65mm (±.8mm)
This video demonstrates how to:

Based on CLSI Standard NBS01-Ed7
• Prepare for specimen collection.
License Agreement: The content contained in this DVD is copyrighted by CLSI. You may not copy, reproduce,
• Collect blood specimens using the recommended

alter, store, or transmit in any form (including electronic, mechanical, recording, or otherwise) any portion
of this DVD without prior written permission from CLSI. Interested parties may send permission requests
to permissions@clsi.org.
heelstick technique.
Restrictions: You may not, and you may not permit others to (a) disassemble, decompile, or otherwise
derive source code from the DVD; (b) reverse engineer any such code; (c) publish any aspect of the DVD, or
any derivative works that you have created therefrom; (d) copy any aspect of the DVD, except as specifically
• Handle specimens properly and maintain appropriate

provided above; (e) sell, rent, lease, or otherwise transfer any portion thereof; (f) use any portion of the
DVD in an online system; or (g) use any portion of the DVD in any manner that infringes on the intellectual
property or other rights of another party.
records.
Limited Warranty and Limitations of Liability: For a period of 60 days from the date you acquire the
DVD, CLSI warrants that the DVD will be free of defects that prevent you from viewing this video.
CLSI’s sole obligation under this warranty is to replace any defective DVD, provided that you give
• Transfer specimens to the screening lab in a timely

CLSI written notice of the defect within such 60-day period. The DVD is licensed to you on an “as
is” basis without any warranty of any nature. CLSI disclaims all other warranties express or implied,
including the implied warranties of merchantability and fitness for a particular purpose. CLSI shall not
manner.
be liable for damage or loss of any kind arising out of, or resulting from, your possession or use of the
newborn
DVD (including data loss or corruption), regardless of whether such liability is based in tort, contract, or
otherwise. If the foregoing limitation is held to be unenforceable, CLSI’s maximum liability to you shall not
exceed the amount of your payment for the DVD.
• Prevent testing problems that can delay the newborn’s

screening diagnosis and treatment.
Making a Difference Through Newborn Screening:
Blood Collection on Filter Paper
Nonmembers: $100
This panel is the front of your jewelcase.

Member discounts apply.
Bleed
Bleed Lines
Lines
Trim Trim
Point-of-Care Testing
Document Pricing
Featured Documents
POCT14 | Point-of-Care Coagulation Testing and Anticoagulation Monitoring, 2nd Edition
This guideline provides recommendations to users and manufacturers of point-of-care coagulation
2nd Edition
POCT14
Point-of-Care Coagulation Testing and
Anticoagulation Monitoring testing devices for monitoring heparin and vitamin K antagonist therapy and for the evaluation
of hemostasis, as well as to ensure reliable results comparable with those obtained by routine
medical laboratory testing.
This guideline provides recommendations to users and
manufacturers of point-of-care coagulation testing devices
for monitoring heparin and vitamin K antagonist therapy and
for the evaluation of hemostasis, as well as to ensure reliable
results comparable with those obtained by routine medical
laboratory testing.
POCT15 | Point-of-Care Testing for Infectious Diseases, 1st Edition

This report summarizes current knowledge of rapid and point-of-care testing practices used
1st Edition
POCT15
Point-of-Care Testing for Infectious Diseases
worldwide for infectious diseases.
This report summarizes current knowledge of rapid and point-of-care

testing practices used worldwide for infectious diseases.
A CLSI report for global application.
POCT01 | Point-of-Care Connectivity, 2nd Edition POCT05* | Performance Metrics for Continuous
Item Order Code: POCT01A2E Interstitial Glucose Monitoring, 2nd Edition
Item Order Code: POCT05Ed2
POCT01QG | CLSI Vendor Code Registry, 1st Edition
Item Order Code: POCT01QGEd1E POCT06 | Effects of Different Sample Types on
Free document Glucose Measurements, 1st Edition
Item Order Code: POCT06Ed1E
POCT02 | Implementation Guide of POCT01 for
Healthcare Providers, 1st Edition POCT07 | Quality Management: Approaches to
Item Order Code: POCT02AE Reducing Errors at the Point of Care, 1st Edition
Item Order Code: POCT07AE COVID-19 Related
POCT04 | Essential Tools for Implementation and
Management of a Point-of-Care Testing Program, Free for a limited time.
3rd Edition
Item Order Code: POCT04Ed3E COVID-19 Related

POCT08 | Quality Practices in Noninstrumented POCT10 | Physician and Nonphysician Provider-
Point-of-Care Testing: An Instructional Manual and Performed Microscopy Testing, 2nd Edition
Resources for Health Care Workers, 1st Edition Item Order Code: POCT10A2E
Item Order Code: POCT08AE
POCT12 | Point-of-Care Blood Glucose Testing in
POCT08AQG1 | Corrective Action Quick Guide Acute and Chronic Care Facilities, 3rd Edition
Item Order Code: POCT08AQG1E Item Order Code: POCT12A3E
POCT13 | Glucose Monitoring in Settings Without
POCT08AQG2 | Quality Control Troubleshooting Laboratory Support, 3rd Edition
Flow Chart Item Order Code: POCT13Ed3cE
Item Order Code: POCT08AQG2E
Nonmember Rate: $20.00 POCT14* | Point-of-Care Monitoring of
Anticoagulation Therapy, 2nd Edition
POCT08AQG3 | Quality Control Log Sheet Quick Item Order Code: POCT14Ed2
Guide
Item Order Code: POCT08AQG3E POCT15* | POCT for Infectious Diseases, 1st Edition
Nonmember Rate: $20.00 Item Order Code: POCT15Ed1 COVID-19 Related
POCT09 | Selection Criteria for Point-of-Care Testing POCT17 | Use of Glucose Meters for Critically Ill
Devices, 1st Edition Patients, 1st Edition
Item Order Code: POCT09AE Item Order Code: POCT17Ed1E
Free document
POCT09AWS | Instrument Selection Worksheet
Item Order Code: POCT09AWSE
New Ways to Access Standards

With an eCLIPSE subscription, you’ll get online access to our full library, with over
200 documents in 12 different subject areas. Now with added functionality, eCLIPSE
provides you with fast, easy data searching in an electronic format.
You can access the latest in AST with the M100 Plus subscription. New
subscriptions for Newborn Screening, Quality Management Systems, and Point-of-
Care Testing are coming soon.
Learn more and sign up to be the first to hear about these new offerings
at clsi.org/subscriptions.
Quality Management Systems
Document Pricing
Featured Documents
QMS05 | Qualifying, Selecting, and Evaluating a Referral Laboratory, 3rd Edition

This guideline provides recommended criteria and easily implemented processes to qualify,
3rd Edition
QMS05
Qualifying, Selecting, and Evaluating a
Referral Laboratory select, and evaluate a referral laboratory.
This guideline provides recommended criteria and easily

implemented processes to qualify, select, and evaluate a referral
laboratory.
QMS15 | Laboratory Internal Audit Program, 2nd Edition

This guideline provides recommendations for establishing a laboratory internal audit program
2nd Edition
QMS15
Laboratory Internal Audit Program
to enhance the quality of laboratory services through continual improvement. An audit
program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements
for internal auditing, and the audit process describes the details of conducting individual
This guideline provides recommendations for establishing a
laboratory internal audit program to enhance the quality of
laboratory services through continual improvement. An audit
program defines the “who,” “what,” “when,” “where,” and “how”
laboratory internal audits.
of meeting requirements for internal auditing, and the audit
process describes the details of conducting individual laboratory
internal audits.
QMS01* | Quality Management System: A Model for QMS02QG | Ten Rules for Laboratory Document
Laboratory Services, 5th Edition Management Quick Guide
Item Order Code: QMS01Ed5 Item Order Code: QMS02A6QGE
QMS01CL | Gap Analysis Checklists, 1st Edition
Item Order Code: QMS01CLE QMS03 | Training and Competence Assessment,
Nonmember Rate: $30.00 4th Edition
Item Order Code: QMS03Ed4E COVID-19 Related
QMS02 | Quality Management System:
Development and Management of Laboratory QMS04 | Laboratory Design, 3rd Edition
Documents, 6th Edition Item Order Code: QMS04Ed3E
Item Order Code: QMS02A6E

QMS05* | Quality Management System: Qualifying, QMS18 | Process Management, 1st Edition
Selecting, and Evaluating a Referral Laboratory, Item Order Code: QMS18Ed1E
3rd Edition
Item Order Code: QMS05Ed3 QMS19* | Customer Focus in a Quality Management
System, 1st Edition
QMS06 | Quality Management System: Continual Item Order Code: QMS19Ed1
Improvement, 3rd Edition
Item Order Code: QMS06A3E QMS20* | Understanding the Cost of Quality in the
Laboratory, 2nd Edition
QMS11 | Nonconforming Event Management, Item Order Code: QMS20REd2
2nd Edition
Item Order Code: QMS11Ed2E QMS21 | Purchasing and Inventory Management,
1st Edition
QMS12* | Development and Use of Quality Item Order Code: QMS21Ed1E
Indicators for Process Improvement and Monitoring
of Laboratory Quality, 2nd Edition QMS22* | Management of Paper-based and
Item Order Code: QMS12Ed2 Electronic Laboratory Information, 1st Edition
Item Order Code: QMS22Ed1
QMS13 | Quality Management System: Equipment,
1st Edition QMS23* | General Laboratory Equipment
Item Order Code: QMS13AE Performance, Qualification, Use, and Maintenance,
2nd Edition
QMS14* | Quality Management System: Leadership Item Order Code: QMS23Ed2
and Management Roles and Responsibilities, 1st
Edition QMS24 | Using Proficiency Testing and Alternative
Item Order Code: QMS14A Assessment to Improve Medical Laboratory Quality,
QMS14 Executive Summary included with purchase 3rd Edition
Item Order Code: QMS24Ed3E
QMS15* | Assessments: Laboratory Internal Audit
Program, 2nd Edition QMS25 | Handbook for Developing a Laboratory
Item Order Code: QMS15Ed2 Quality Manual, 1st Edition
Item Order Code: QMS25Ed1E
QMS16 | Laboratory Personnel Management, 1st
Edition QMS26* | Managing Laboratory Records, 1st Edition
Item Order Code: QMS16Ed1E Item Order Code: QMS26Ed1
QMS17* | External Assessments, Audits, and

Inspections of the Laboratory, 1st Edition
Item Order Code: QMS17Ed1

Global Health Partnerships
Our Partnerships Program
Since 2005, CLSI has worked with over 70+ district, regional, and national labs training and educating staff throughout
the world to strengthen core competencies and practices. Our team has successfully assisted labs throughout Ethiopia,
Kazakhstan, Kenya, Namibia, Mali, Tanzania, Vietnam, and Zambia achieve accreditation aligned with international
standards.
We provide: Achieving Results

• Assessment services We assist labs by raising their practices to international
• In-person training standards in the shortest possible time. We have
helped many countries improve the diagnosis of
• Webinars and online learning infectious diseases such as HIV/AIDS, malaria, and
• Technical assistance and mentoring tuberculosis—allowing patients to receive the life-
• Quality Management Systems implementation saving treatment and monitoring they need.
• Continual improvement support
Partnering With Us
If you or your organization is interested in a partnership opportunity, CLSI is ready to work with you on a site-specific
plan. Simply e-mail us at ghp@clsi.org to get started.
Looking for more details? View the Case Studies on our website for more site-specific information
at clsi.org/partnerships.
New: Gap Analysis Tool

Understand your lab’s current practices and how closely
they align with minimum QMS requirements.
Performing a gap analysis of laboratory quality CLSI’s new Gap Analysis Tool can help personnel
activities helps your laboratory: quickly and easily assess whether their laboratory is
• Recognize existing quality activities compared in compliance with QMS requirements and can track
with minimum QMS requirements. progress toward achieving complete compliance.
• Analyze your laboratory’s unique situation and Help your laboratory monitor and track your
provide a defined starting point for improvement laboratory’s progress in QMS compliance by visiting
activities. clsi.org/gap-analysis.
• Provide information for creating a customized
implementation plan and determining necessary
resources.
CLSI Catalog 2022

Veterinary Medicine
Document Pricing
Featured Document
VET02 | Development of Quality Control Ranges, Breakpoints, and Interpretive Categories for
4th Edition
Antimicrobial Agents Used in Veterinary Medicine, 4th Edition
VET02
Development of Quality Control Ranges,
Breakpoints, and Interpretive Categories
for Antimicrobial Agents Used in Veterinary
This guideline discusses the necessary and recommended data for selecting appropriate
Medicine
quality control ranges, breakpoints, and interpretive categories for antimicrobial agents for
veterinary use.
This guideline discusses the necessary and recommended data
for selecting appropriate quality control ranges, breakpoints, and
interpretive categories for antimicrobial agents for veterinary use.
VET01* | Performance Standards for Antimicrobial VET03S (VET04)* | Methods for Broth Dilution
Disk and Dilution Susceptibility Tests for Bacteria Susceptibility Testing of Bacteria Isolated From
Isolated From Animals, 5th Edition Aquatic Animals, 3rd Edition
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VET01S* | Performance Standards for Antimicrobial
Disk and Dilution Susceptibility Tests for Bacteria VET05 | Generation, Presentation, and Application
Isolated From Animals, 5th Edition of Antimicrobial Susceptibility Test Data for Bacteria
Item Order Code: VET01SEd5 of Animal Origin, 1st Edition
Nonmember Rate: $80.00 Item Order Code: VET05RE
VET02* | Development of In Vitro Susceptibility VET06 | Methods for Antimicrobial Susceptibility
Testing Criteria and Quality Control Parameters for Testing of Infrequently Isolated or Fastidious
Veterinary Antimicrobial Agents, 4th Edition Bacteria Isolated From Animals, 1st Edition
Item Order Code: VET02Ed4 Item Order Code: VET06Ed1E
VET03* | Methods for Antimicrobial Disk VET09* | Understanding Susceptibility Test Data
Susceptibility Testing of Bacteria Isolated From as a Component of Antimicrobial Stewardship in
Aquatic Animals, 2nd Edition Veterinary Settings, 1st Edition
Item Order Code: VET03Ed2 Item Order Code: VET09Ed1

The products found in this catalog were developed by our 2,000+ Volunteers.
Join them today to make a difference in your laboratory tomorrow.
Better Standards. Better Results. Better Care.

Using our unique Our standards are championed CLSI supports the
consensus-based process, CLSI by our 1,800+ members and implementation of these
volunteers help create our used by countless laboratory standards around the world,
neutral standards. professionals around the globe. through our Partnerships
program.
Learn more about volunteering with CLSI at clsi.org/volunteer-today.
Contact CLSI:
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CLSI CATALOG | Setting the standard in laboratory

medicine for a healthier world.

2 CLSI Catalog 2022

Free Online Course

Improve your lab’s antimicrobial susceptibility testing (AST) by using this

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Give Superpower to Your Clinical Practices—

How can CLSI membership help you and your organization?

Health Systems Laboratories Industry Government Individuals

4 CLSI Catalog 2022

Standards Development Opportunities

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Multiple Search Functions Annotations

If you develop laboratory tests, you need Method

Learn more at clsi.org/method-nav.

This guideline includes detailed information for design,

AUTO16 | Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition

This standard applies to the exchange of analytical testing

AUTO01 | Laboratory Automation: Specimen AUTO04 | Laboratory Automation: Systems

8 CLSI Catalog 2022

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This guideline describes methods for all aspects of sweat testing,

This guideline describes the design, development, and validation

10 CLSI Catalog 2022

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This standard specifies the processes required to ensure accurate

GP42 | Collection of Capillary Blood Specimens, 7th Edition

This standard provides procedures for collection of capillary blood

12 CLSI Catalog 2022

Did you know?

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This guideline provides recommendations regarding the proper

H62 | Validation of Assays Performed by Flow Cytometry, 1st Edition

14 CLSI Catalog 2022

Coming soon! If you develop laboratory

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assays used in the measurement of human IgE.

A CLSI report for global application.

I/LA26 | Performance of Single Cell Immune Response Assays, 2nd Edition

16 CLSI Catalog 2022

I/LA28A2QG | Comparison of the Characteristics

Calling All Volunteers

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This guideline includes recommendations for laboratories on

18 CLSI Catalog 2022

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EP35* | Assessment of Equivalence or Suitability EP43 | Implementing a Laboratory Test Under

EP39* | A Hierarchical Approach to Selecting

Project Proposals Needed

20 CLSI Catalog 2022

New: CLSI’s Implementation Guides

Nonmember Price: $50.00

EP Implementation Guides are available in electronic format only.

EP18IG | Risk Management Techniques to

Shop now at clsi.org/implementation-guides.

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This guideline includes recommendations for collecting,

M100 | Performance Standards for Antimicrobial Susceptibility Testing, 32nd Edition

This document includes updated tables for the Clinical and