Clsi Catalog 2021 Web

2021 CATALOG
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 2021

What’s New?
EP06 | Evaluation of Linearity of Quantitative Measurement POCT05 | Performance Metrics for Continuous Interstitial
Procedure, 2nd Edition Glucose Monitoring, 2nd Edition
EP43 | Implementing a Laboratory Test Under Emergency Use POCT14 | Point-of-Care Coagulation Testing and
Conditions, 1st Edition Anticoagulation Monitoring, 2nd Edition
C64 | Quantitative Measurement of Proteins and Peptides by POCT15 | Point-of-Care Testing for Infectious Diseases, 1st
Mass Spectrometry, 1st Edition Edition
GP42 | Collection of Capillary Blood Specimens, 7th Edition QMS05 | Qualifying, Selecting, and Evaluating a Referral
Laboratory, 3rd Edition
LQMS Certificate Program | Updated
QMS20 | The Cost of Quality in the Medical Laboratory, 2nd
M23S | Development of In Vitro Susceptibility Testing Criteria Edition
and Quality Control Parameters, 1st Edition
QMS26 | Managing Laboratory Records, 1st Edition
M54 | Principles and Procedures for Detection and Culture of
Fungi in Clinical Specimens, 2nd Edition VET01S | Performance Standards for Antimicrobial Disk and
Dilution Susceptibility Tests for Bacteria Isolated From Animals,
M59 | Epidemiological Cutoff Values for Antifungal 5th Edition
Susceptibility Testing, 3rd Edition VET02 | Development of Quality Control Ranges, Breakpoints,
M60 | Performance Standards for Antifungal Susceptibility and Interpretive Categories for Antimicrobial Agents Used in
Testing of Yeasts, 2nd Edition Veterinary Medicine, 4th Edition
M61 | Performance Standards for Antifungal Susceptibility VET03 | Methods for Antimicrobial Broth Dilution and Disk
Testing of Filamentous Fungi, 2nd Edition Diffusion Susceptibility Testing of Bacteria Isolated From
M100 | Performance Standards for Antimicrobial Aquatic Animals, 2nd Edition
Susceptibility Testing, 31st Edition VET03S (VET04) | Performance Standards for Antimicrobial
MM13 | Collection, Transport, Preparation, and Storage of Susceptibility Testing of Bacteria Isolated From Aquatic
Specimens for Molecular Methods, 2nd Edition Animals, 3rd Edition
NBS01 | Dried Blood Spot Specimen Collection for Newborn VET09 | Understanding Susceptibility Test Data as a
Screening, 7th Edition Component of Antimicrobial Stewardship in Veterinary
Settings, 1st Edition
NBS09 | Newborn Screening for X-Linked
Adrenoleukodystrophy, 1st Edition
Coming Soon!
MM24 | Molecular Methods for Genotyping and Strain Typing of H62 | Validation of Assays Performed by Flow Cytometry,
Infectious Organisms, 2nd Edition 1st Edition
AUTO17 | Semantic Interoperability for In Vitro Diagnostic Systems, 1st For more details and up-to-date information
Edition
visit clsi.org/projects-in-progress.
EP39 | Surrogate Sample Framework, 1st Edition
CLSI Documents Helpful for COVID-19 Testing

Throughout the catalog you’ll see documents with a note in red that says “COVID-19 Related.” These
documents have been identified as helpful for the laboratory community’s use during the COVID-19
pandemic. To learn more about how they can help with COVID-19 testing, visit clsi.org/covid-19.
3 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

Automation and Informatics
Document Pricing
Nonmembers: $180 Level III Members: $90
Level I Members: $54 Individual Full Members: $135
Level II Members: $72 Individual Associate Members: $153
* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus 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
Item Order Code: AUTO05AE
AUTO03* | Laboratory Automation:
Communications With Automated Clinical AUTO07* | Laboratory Automation: Data Content
Laboratory Systems, Instruments, Devices, and for Specimen Identification, 1st Edition
Information Systems, 2nd Edition Item Order Code: AUTO07AE
Item Order Code: AUTO03A2E

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: AUTO16Ed1
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
Item Order Code: AUTO12A
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
Reminder
Join our e-mail list to be the first to learn about new documents and volunteer
opportunities. Sign up today at clsi.org/email.

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.
C49 | Analysis of Body Fluids in Clinical Chemistry, 2nd Edition

Regulatory requirements for laboratories performing body fluid testing have changed.
2nd Edition
C49
Analysis of Body Fluids in Clinical Chemistry
Medical laboratories need to determine appropriate fluid types for testing and understand
performance limitations of testing methods.
This guideline provides information for the medical laboratory

for evaluating measurement procedures, as well as a strategy
to characterize assay performance, when applied to body
fluid matrixes. Key concepts that apply to the entire test cycle,
including preexamination, examination, and postexamination
phases of body fluid testing, are discussed.
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

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: C56AEQG
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: C57Ed1D
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: C46A2 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, 1st Edition
Item Order Code: C48AE Item Order Code: C62AE
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.
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.
GP49 | Developing and Managing a Medical Laboratory (Test) Utilization Management

1st Edition
Program, 1st Edition
GP49
Developing and Managing a Medical
Laboratory (Test) Utilization Management
Eliminate unnecessary testing and focus on performing appropriate tests that improve quality
and outcomes. Learn about implementing a test utilization management program in your lab
Program
with GP49.
This report provides guidance for initiating, developing, and

maintaining an effective test utilization program.
A CLSI report for US application.
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: GP16A3 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: GP34A 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: GP44A4 COVID-19 Related
GP39* | Tubes and Additives for Venous and GP45* | Studies to Evaluate Patient Outcomes,
Capillary 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: GP40A4AMD Item Order Code: GP47Ed1
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, 6th Edition
Item Order Code: GP42A6
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.
H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry, 2nd Edition
This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-
March 2014
H52-A2
Red Blood Cell Diagnostic Testing
Using Flow Cytometry; Approved
Guideline—Second Edition
based assays on a flow cytometry platform. Points of validation and quality control, and
caveats of interpretation are also discussed.
This guideline addresses the diagnostic red blood cell (RBC) assays
performed as fluorescence-based assays on a flow cytometry
platform; including testing procedures for fetomaternal hemorrhage
detection, paroxysmal nocturnal hematuria screening, membrane
defect anemia testing for hereditary spherocytosis, and nucleated
RBC counting. Points of validation and quality control, and caveats of
interpretation are also discussed.
H02* | Procedures for the Erythrocyte H20* | Reference Leukocyte (WBC) Differential
Sedimentation Rate Test, 5th Edition Count (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: H21A5
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 H54* | Procedures for Validation of INR and Local
Assurance of Automated Hematology Analyzers, Calibration of PT/INR Systems, 1st Edition
2nd Edition Item Order Code: H54AE
Item Order Code: H26A2
H56* | Body Fluid Analysis for Cellular Composition,
H30* | Procedure for the Determination of 1st Edition
Fibrinogen in Plasma, 2nd Edition Item Order Code: H56AE
H57* | Protocol for the Evaluation, Validation, and
H42* | Enumeration of Immunologically Defined Cell Implementation of Coagulometers, 1st Edition
Populations by Flow Cytometry, 2nd Edition Item Order Code: H57AE
H58* | Platelet Function Testing by Aggregometry,
H43* | Clinical Flow Cytometric Analysis of 1st Edition
Neoplastic Hematolymphoid Cells, 2nd Edition Item Order Code: H58AE
H59* | Quantitative D-dimer for the Exclusion of
H44* | Methods for Reticulocyte Counting Venous Thromboembolic Disease, 1st Edition
(Automated Blood Cell Counters, Flow Cytometry Item Order Code: H59AE
and Supravital Dyes), 2nd Edition
Item Order Code: H44A2E H60 | Laboratory Testing for the Lupus
Anticoagulant, 1st Edition
H47* | One-Stage Prothrombin Time (PT) Test and Item Order Code: H60A
Activated Partial Thromboplastin Time (APTT) Test,
2nd Edition H60AQG1* | Algorithmic Approach to Lupus
Item Order Code: H47A2E Anticoagulant Testing
Item Order Code: H60AQG1E
H48 | Determination of Coagulation Factor Nonmember Rate: $20.00
Activities Using the One-Stage Clotting Assay,
2nd Edition H60AQG2* | Criteria for the Laboratory Diagnosis of
Item Order Code: H48Ed2 the Lupus Anticoagulant
Item Order Code: H60AQG2E
H52 | Red Blood Cell Diagnostic Testing Using Flow Nonmember Rate: $20.00
Cytometry, 2nd Edition
Item Order Code: H52A2
Did you know you can create a custom solution package

for your lab?
Custom 5-Document Package Custom 10-Document Package
Select Any 5 Documents Select Any 10 Documents
Nonmembers: $800 Nonmembers: $1,530
Simply fill out our online form for a custom quote request or contact customer
service to order your custom document package today. Member rates apply.

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
Calling All Volunteers

CLSI offers unmatched opportunity to maximize your voice in the global laboratory
and health care community. Work alongside colleagues and experts from diverse
sectors to improve patient care worldwide.
Visit clsi.org/volunteer-today for more information.

Method Evaluation
Document Pricing
Featured Documents
EP34 | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution
1st Edition
and Spiking, 1st Edition
EP34
Establishing and Verifying an Extended
Measuring Interval Through Specimen
Establish, validate, or verify a dilution scheme that will provide an extended measuring
interval for specimens with concentrations above the analytical measuring interval of an in
Dilution and Spiking
vitro diagnostic measurement procedure.

It is often medically necessary to provide results for specimens
with concentrations above the analytical measuring interval of
an in vitro diagnostic measurement procedure. This guideline
helps manufacturers and laboratory scientists with establishing,
validating, or verifying a dilution scheme that will provide an
extended measuring interval for such specimens.
EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory

1st Edition
Measurement Procedures, 1st Edition
EP35
Assessment of Equivalence or Suitability
of Specimen Types for Medical Laboratory
Measurement Procedures
This guideline provides recommendations for assessing clinically equivalent performance
for additional similar-matrix specimen types and suitable performance for dissimilar-matrix
specimen types, such that the laboratory does not necessarily need to repeat the full
measurement procedure validation for each specimen type. The recommendations in this
This guideline provides recommendations for assessing clinically
equivalent performance for additional similar-matrix specimen
types and suitable performance for dissimilar-matrix specimen
types, such that the laboratory does not necessarily need to
guideline apply to both quantitative measurement procedures and qualitative examinations.

repeat the full measurement procedure validation for each
specimen type. The recommendations in this guideline apply
to both quantitative measurement procedures and qualitative
examinations.
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: EP05A3 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: EP06Ed2E COVID-19 Related Item Order Code: EP09Ed3c
EP07 | Interference Testing in Clinical Chemistry, EP10 | Preliminary Evaluation of Quantitative Clinical
3rd Edition Laboratory Measurement Procedures, 3rd Edition
Item Order Code: EP10A3AMD
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: EP25A COVID-19 Related
EP15 | User Verification of Precision and Estimation
of Bias, 3rd Edition EP26 | User Evaluation of Between-Reagent Lot
Item Order Code: EP15A3 Variation, 1st Edition
Item Order Code: EP26A
EP17* | Evaluation of Detection Capability for Clinical
Laboratory Measurement Procedures, 2nd Edition EP27* | How to Construct and Interpret an Error Grid
Item Order Code: EP17A2E COVID-19 Related for Quantitative Diagnostic Assays, 1st Edition
Item Order Code: EP27AE
EP18 | Risk Management Techniques to Identify and
Control Laboratory Error Sources, 2nd Edition EP28 | Defining, Establishing, and Verifying
Item Order Code: EP18A2 COVID-19 Related Reference Intervals in the Clinical Laboratory,
3rd Edition
EP18A2EP23AWS* | Laboratory Quality Control Item Order Code: EP28A3C
Based on Risk Management; Worksheet Template
Item Order Code: EP18A2EP23AWSE EP29* | Expression of Measurement Uncertainty in
Free document Laboratory Medicine, 1st Edition
Item Order Code: EP29AE
EP19* | A Framework for Using CLSI Documents
to Evaluate Clinical Laboratory Measurement EP30* | Characterization and Qualification of
Commutable Reference Materials for Laboratory
Procedures, 2nd Edition
Medicine, 1st Edition
Item Order Code: EP19Ed2E COVID-19 Related Item Order Code: EP30AE
Free report
EP31* | Verification of Comparability of Patient
EP21 | Evaluation of Total Analytical Error for Results Within One Health Care System, 1st Edition
Quantitative Medical Laboratory Measurement (Interim Revision)
Procedures, 2nd Edition Item Order Code: EP31AIRE
Item Order Code: EP21Ed2
EP32* | Metrological Traceability and Its
EP23™ | Laboratory Quality Control Based on Risk Implementation, 1st Edition
Management, 1st Edition Item Order Code: EP32RE
Item Order Code: EP23A COVID-19 Related
EP33 | Use of Delta Checks in the Medical
EP23AQG* | EP23 Quick Reference Guide Laboratory, 1st Edition
Item Order Code: EP23AQGE Item Order Code: EP33Ed1
EP34 | Establishing and Verifying an Extended
E23AWB* | Laboratory Quality Control Based on Risk Measuring Interval Through Specimen Dilution and
Management; Electronic Workbook Spiking, 1st Edition
Item Order Code: EP23AWBE Item Order Code: EP34Ed1

Method Evaluation
Document Pricing
EP35 | Assessment of Equivalence or Suitability QSR LDT* | Quality System Regulations for
of Specimen Types for Medical Laboratory Laboratory Developed Tests: A Practical Guide for
Measurement Procedures, 1st Edition the Laboratory
Item Order Code: EP35Ed1 COVID-19 Related Item Order Code: QSRLDTE COVID-19 Related
Free for a limited time.
EP36* | Harmonization of Symbology and Equations,
1st Edition
Item Order Code: EP36Ed1E
Free report
EP43* | Implementing a Laboratory Test Under
Emergency Use Conditions, 1st Edition
Item Order Code: EP36Ed1E
Project Proposals Needed

Interested in proposing a new CLSI project? Use our online form to submit your
project idea.
Propose your project today at clsi.org/standards-development/propose-a-project.

Microbiology
Document Pricing
Featured Documents
M60 | Performance Standards for Antifungal Susceptibility Testing of Yeasts, 2nd Edition
This document provides updated minimal inhibitory concentration, zone diameter, and quality
2nd Edition
M60
Performance Standards for Antifungal
Susceptibility Testing of Yeasts control tables for the Clinical and Laboratory Standards Institute antifungal susceptibility
testing documents M27 and M44.
This document provides updated minimal inhibitory

concentration, zone diameter, and quality control tables for
the Clinical and Laboratory Standards Institute antifungal
susceptibility testing documents M27 and M44.
A CLSI supplement for global application.
M61 | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi,

2nd Edition
2nd Edition
M61
Performance Standards for Antifungal
Susceptibility Testing of Filamentous Fungi This document provides minimal inhibitory concentration breakpoints and quality control
tables for the Clinical and Laboratory Standards Institute antifungal susceptibility testing
documents M38 and M51.
This document provides minimal inhibitory concentration
breakpoints and quality control tables for the Clinical and
Laboratory Standards Institute antifungal susceptibility testing
documents M38 and M51.
A CLSI supplement for global application.
M02 | Performance Standards for Antimicrobial Disk M11 | Methods for Antimicrobial Susceptibility
Susceptibility Tests, 13th Edition Testing of Anaerobic Bacteria, 9th Edition
Item Order Code: M02Ed13 Item Order Code: M11Ed9
M02QG | Disk Diffusion Reading Guide, 1st Edition M15* | Laboratory Diagnosis of Blood-borne Parasitic
Item Order Code: M02QG Diseases, 1st Edition
Nonmember Rate: $20.00 Item Order Code: M15AE
M07 | Methods for Dilution Antimicrobial M22 | Quality Control for Commercially Prepared
Susceptibility Tests for Bacteria That Grow Microbiological Culture Media, 3rd Edition
Aerobically, 11th Edition Item Order Code: M22A3
Item Order Code: M07Ed11

M23* | Development of In Vitro Susceptibility M34* | Western Blot Assay for Antibodies to Borrelia
Testing Criteria and Quality Control Parameters, 5th burgdorferi, 1st Edition
Edition Item Order Code: M34AE
Item Order Code: M23Ed5E
Free document M35* | Abbreviated Identification of Bacteria and
Yeast, 2nd Edition
M23S* | Procedure for Optimizing Disk Contents Item Order Code: M35A2E
(Potencies) for Disk Diffusion Testing of
Antimicrobial Agents Using Harmonized CLSI and M36* | Clinical Use and Interpretation of Serologic
EUCAST Criteria, 1st Edition Tests for Toxoplasma gondii, 1st Edition
Item Order Code: M23SEd1E Item Order Code: M36AE
Free document M38 | Reference Method for Broth Dilution
Antifungal Susceptibility Testing of Filamentous
M23S2* | Process to Submit Disk Content (Potency)
Data for Joint CLSI-EUCAST Working Group Review Fungi, 3rd Edition
and Approval, 1st Edition Item Order Code: M38Ed3
Item Order Code: M23S2Ed1E M39 | Analysis and Presentation of Cumulative
Free document Antimicrobial Susceptibility Test Data, 4th Edition
Item Order Code: M39A4
M24 | Susceptibility Testing of Mycobacteria,
Nocardiae, and Other Aerobic Actinomycetes, M39 QG* | Antibiograms: Developing Cumulative
3rd Edition Reports for Your Clinicians
Item Order Code: M24Ed3 Item Order Code: M39A4QGE
M24S (M62) | Performance Standards for
Susceptibility Testing of Mycobacteria, Nocardia spp., M40 | Quality Control of Microbiological Transport
and Other Aerobic Actinomycetes, 1st Edition Systems, 2nd Edition
Item Order Code: M62Ed1 Item Order Code: M40A2 COVID-19 Related
M41* | Viral Culture, 1st Edition
M26* | Methods for Determining Bactericidal Item Order Code: M41AE
Activity of Antimicrobial Agents, 1st Edition
Item Order Code: M26AE M43* | Methods for Antimicrobial Susceptibility
Testing for Human Mycoplasmas, 1st Edition
M27* | Reference Method for Broth Dilution Item Order Code: M43AE
Antifungal Susceptibility Testing of Yeasts,
4th Edition M44 | Method for Antifungal Disk Diffusion
Item Order Code: M27Ed4E Susceptibility Testing of Yeasts, 3rd Edition
M28* | Procedures for the Recovery and
Identification of Parasites From the Intestinal Tract, M45 | Methods for Antimicrobial Dilution and Disk
2nd Edition Susceptibility Testing of Infrequently Isolated or
Item Order Code: M28A2E Fastidious Bacteria, 3rd Edition
M29 | Protection of Laboratory Workers From
Occupationally Acquired Infections, 4th Edition M47 | Principles and Procedures for Blood Cultures,
Item Order Code: M29A4 COVID-19 Related 1st Edition
Item Order Code: M47A

Microbiology
Document Pricing
M48 | Laboratory Detection and Identification of M58 | Methods for the Identification of Cultured
Mycobacteria, 2nd Edition Microorganisms Using Matrix-Assisted Laser
Item Order Code: M48Ed2 Desorption/Ionization Time-of-Flight Mass
Spectrometry, 1st Edition
M50* | Quality Control for Commercial Microbial Item Order Code: M58Ed1
Identification Systems, 1st Edition
Item Order Code: M50AE M59 | Epidemiological Cutoff Values for Antifungal
Susceptibility Testing, 2nd Edition
M51* | Method for Antifungal Disk Diffusion Item Order Code: M59Ed3
Susceptibility Testing of Nondermatophyte Nonmember Rate: $80.00
Filamentous Fungi, 1st Edition
Item Order Code: M51AE M60 | Performance Standards for Antifungal
Susceptibility Testing of Yeasts, 2nd Edition
M52 | Verification of Commercial Microbial Item Order Code: M60Ed2
Identification and Antimicrobial Susceptibility Nonmember Rate: $80.00
Testing Systems, 1st Edition
Item Order Code: M52Ed1 M61 | Performance Standards for Antifungal
Susceptibility Testing of Filamentous Fungi,
M53* | Criteria for Laboratory Testing and Diagnosis 2nd Edition
of Human Immunodeficiency Virus Infection, Item Order Code: M61Ed2
1st Edition Nonmember Rate: $80.00
Item Order Code: M53AE
M100 | Performance Standards for Antimicrobial
M54 | Principles and Procedures for Detection of Susceptibility Testing, 31st Edition
Fungi in Clinical Specimens—Direct Examination and Item Order Code: M100Ed31
Culture, 2nd Edition
M56 | Principles and Procedures for Detection of

Anaerobes in Clinical Specimens, 1st Edition
Item Order Code: M56A
M57 | Principles and Procedures for the

Development of Epidemiological Cutoff Values for
Antifungal Susceptibility Testing, 1st Edition

AST Resources
Strengthen Your Antimicrobial Susceptibility Testing (AST) Results
For over 30 years, the microbiology community has relied upon our annually updated M100 document for the latest, most
trusted AST breakpoint data. Now the reference you reach for is more easily accessible in a variety of new formats to help
you identify and update AST breakpoints with confidence.
M100 Document M100 PLUS M100, M23, and M60 FREE

The 31st edition of this document provides Get full online access to M100, M02, M07, You can now quickly reference the most
updated tables for the CLSI AST standards and M11 with added functionality and trusted AST breakpoints from anywhere
M02, M07, and M11, and fast, easy data searching in an electronic with an Internet connection. M100, M60,
is available as a downloadable PDF or format. Plus, you’ll have the added and M23 are available online as convenient
printed document. benefit of quick access to related companions to the documents.
materials via an AST Resource Center. Access today at clsi.org/freeresources.
Learn more at clsi.org/m100-plus.
Free Rationale Documents

Using the CLSI voluntary consensus process, the Subcommittee on AST develops standards that promote accurate AST
and appropriate reporting.
To meet this need, CLSI has published free rationale documents that provide the scientific reasons behind the
subcommittee’s decisions, along with documentation of the standardized data and methods used to determine
breakpoints. Access all Rationale Documents at clsi.org/rationale.
Polymyxin
nas aerugi
ts for Ent
erobactera
Breakpoin a, and Acinetobac
nos
les,
ter spp. MR01 | Polymyxin Breakpoints for MR05 | Ceftaroline Breakpoints for
Enterobacterales, Pseudomonas Staphylococcus aureus, 1st Edition
Pseudomo
1
ment MR0 Fluoroqui
nale docu nol
CLSI ratio Pseudomo one Breakpoints
April 2020 nas aerugi for Entero
nosa bacteriace
aeruginosa, and Acinetobacter spp., Item Order Code: MR05Ed1E

MS
Michael n Hosp Satlin, MD, ital ae and
Presbyteria
CLSI ratio
MM) New York nale docu
s, PhD, D(AB February ment MR0
M. Humphries, Inc. USA
2019FASM, FRCPA in 2
Romney BS, FRACP,
Diagnostic dge, MD, and Qual
ity
Accelerate John D. Turni on Safety
USA Commission
FIDSA Australian
PharmD,
2nd Edition
h Care
James S.
Lewis II,
ce Unive rsity Healt
ter spp . Chris tina Chan
h and Scien
Acinetobac Aust
ralia tell
Oregon Healt Accelerate
ts for Diagnostic
m Bre
USA akpoin USA s, Inc.
MeropenePatel, PhD, D(ABMM)
MR06 | Daptomycin Breakpoints for

Romney
Jean B. M.
Coulter Accelerateg Humphries, PhD,
Beckman ptibility Testin Diagnostic D(ABMM)
icrobial Susce
Item Order Code: MR01Ed2E

USA s, Inc.
USA 3 on Antim
docu ment MR0 ommittee Azithromybrings together theexcelle varied
nale of the CLSI Subc James S.organization that cin Bre nce
CLSI ratio
On behalf ership Lewis II,comm akpoin
: to foster
er 2019 t memb
Oregon on cause
t of a PharmD, FIDSA laboratories t for Neisser
fulfill
Septemb te (CLSI) is
a not-for-profi the advan Healt
cemen h and ines that help iaUSA ards and guidel Science Unive gonorrhoea
1 Foreword
for
Enterococci, 1st Edition

ards Institu community
l and Labora
tory Stand
worldwide
laboratory
medical labora .
tory stand rsity
that e
The Clinica
and exper
tise of the implementing ability1 Forew CLSI ps standards s
perspectives D(ABping MM)and global applic ord ratiotynale Testing develo variou
medic
toryphrie s,inePhD, by develo
ncy, effect
iveness, and l Susceptibili
May docusmen
review data from
in M. Hum
labora with efficie
Theicrobia
tee on Antim ing. lThe
Clinica
Laboratory to establish antim MR04
2019 mmittee ticrobial
Romney responostic sibilitis,esInc.
Subcommit perspe
andsubco
theirDiagn process, the appropriatein
reportctives l studies) Standards Institu
Accelerate consensus testing and labora ], and clinica
and exper
tise of the te (CLSI) is
voluntary l susceptibility odynamic
[PK-PD tory medic worldwide a not-for-profi
data are
USA Using the CLSI antimicrobia etic-pharmac theirs.respon
range
ine by develo
and how labora
the tory
community
t membership
te acokin ping s,
sibiliti for the advan organization that
MR02 | Fluoroquinolone Breakpoints Item Order Code: MR06Ed1E

accura l (QC) QC range and implem documents
promote d, PhD s (eg, in vitro, pharm and quality contro es with and
aureus ed in CLSI enting medical labora
efficie
Woo Romn breakpoints ncy, effect cement of brings togeth
Elizabeth studies, Inc.
hylococcus
s and ostic oints, Usingpriate ey provid iveness, and
source ds, breakp ing appro the CLSI volunt g M. Hum oints are tory stand a common er the varied
Diagn metho select Testin breakp phrie global applic ards and cause: to
teAccel
ts for Stap
test ed data for ary conse
Accelerate susceptibility
promo lity cterial erate Diagn nsuss, PhD, D(ABMM) guidelines foster excelle
M23. ptibi
1 CLSI antiba accura ability.
recommend icrobial entSusce
Breakpoin sary and sources and USA te antimicrobia ostics,proces Inc. s, the Subcoy that help
laboratories
nce
USA of the neces on in CLSI docum
Antim l suscep clinical efficac mmit
Ceftaroline
itteebed studies (eg, in a lacktogeth oftibility varied may tee on Antim fulfill
The details omm are descri er the g ished
CLSI evalua Subction, susceptibility
test se,
result in ingvitro,
that brings pharmacokin aretestin
establ andnceappro icrobial Susce
lf of ted thefor may Ellen decrea metho
ization breakpoints : to foster etic-ph excelle ation
es inform priate reporting. ptibility Testin
On beha presen
M45.
3
icrobia l agent ership N.
organ
mann Kersh er in ds,
which
, PhD
breakp
on cause
oints, ors and updatarmac fulfill odyna time, The subco g develops
M100 and
2
to an antimr-profitThe memb
eters,details
and Cente the
of a comm
t ofcontin ually monit help labora
and qualit toriesble at the mic [PK-PD
y control ], and clinica mmittee reviews
standards
that
susceptibility is a not-fo param the
cemen rsnecesfor Disea
CLSI that availa
(CLSI) ds, QCunity presen
the of advan es, sary ines t information (QC)
ctionranges. l studies) data from
for Enterobacteriaceae and

ord organism’s Institu teical methocomm for ted chang
USA and guidel se Cont
and
curren recom in conjun to establ various
1 ForewOver time, a micro
tory Stand
ards5 wide laboras.tory
biolog these types
2 stand
forards
evalua the most
using tion, are descri
rol
mend
alway edPreveand
s be used ish
Labora
l andr safety men
. In additit MR0 on, micro of
Because al labora
medicines are develo
M100 tory and pedM45. Daptomycin
guidelines
should bed in CLSI
data for
ent.ntion
thatFor more
select
antimicrobia
l
The Clinica
nale docu the world
tise ofmore accurate
result enting .
3
pststand
treatm
docum ards ing appro
ratio
CLSI perspectives
and/o
and exper
d to ensure ping and
gh CLSI stand
implem ards and guidelapplicability
s, and global
ore,
Over stand 1 ards and
Forew ordresultBreakpoin s to
Testin
guide
g
patien
develo ent M23.
variou s 1
CLSI
priate breakp
oints
be refine ine by develo
er 2019tory medic ents. efficie Althouncy, ivenes
always chang
ing; theref time, a micro
labora ltory
The Clinicaorganism’s
test
Susceptibili
ty
ts for Ent s data from antibacterial
breakpoints
and QC range
s, and how
Novemb in laborain its docum with e and medicine
esscienc
effectis
edge, andmmit
clinica
or safety
releva
teellyon Antim . Ining.
nticrobia
additiTheon, lsubco
and mmitsuscep erococci
tee review
tibilityicrobia l susceptibility are provid the data
are
MR07 | Cefazolin Breakpoints

sibilitiof micro Laboratory antim to an antim ed in CLSI
their respon t knowl s, the Subco refinereport perspectives biologish
s) to establ icalStandards Institu documents
the field curren
ent,nsus proces appropriate d toclinica ensure l studie
more and expertise metho
icrobia
te (CLSI) isl agent may decrea
clinical judgm ary conse g. testing and inmic, andin laboratory accura
its docum te of the world ds, QC param
a not-for-profi se, result
Using the
with CLSI volunt visit wwwl.clsi.or susceptibility armacodyna ents.CLSI Althou medicine results. Becausehow widethe eters,
data areand ing in a lack
ation, antimicrobia MM) acokinetic-ph the field their respon ratio
gh CLSIby
nale developing and of these labora tory comm mann
the 1 t memb
Pseudomonas aeruginosa, 1st Edition

ardss,andand implem er ership organ of clinica
accurate PhD, D(AB
inform
ranges. with
of scienc sibiliti stand
docu
range types
ents of unity for in which breakp ization that l efficacy and/
promote phries, in vitro, pharm e andoints
Sept medic esandwith QC
menCLSI docum
guidel chang
M. Hum studies,s (eg, Inc. and quality
control (QC) clinical judgm breakp emb ine isefficie
erare alway
2019 ncy, edeffectin tines
MR0
iveness, and6
enting medic
are
es, CLSI the advan
developedal labora continually
oints
cemen of are establ brings
Romneysources and ostic selectinform ing appro
priate
Using the CLSI ent, curren oints
provid s chang ing; therefore, global using the tory stand monitt ors a common ished togeth may er the varied
Diagnds, breakpoints, ed data for
ation, visit
promocterial
breakp
volunt t knowledge,
www.clsi.or ary conse applicability most curren ards and and updat cause: to be
Accelerate test metho recommend ent M23.
d.
1 CLSI antiba te accura
te g. nsusand proces clinically y
releva
standards
and guidel . t informguidelines es inform
ation that
foster excelle
ation nce
and reserve antim s, the nt labora ines availa help
USA of the neces
sary in CLSI docum
e. All rights This CLSIsources
rationale and studie icrobial suscep clinical efficac Subcommit be tory test should alway ble atlabora tories fulfill
the time,
Standards bedInstitut a lack of tibility testin ished may tee on Antim results to s be used
ory descri Group. test methodocum ins,in
for Enterobacterales (Systemic

The details tion, are ent
se, result
s (eg,
ising vitro, pharm are establ g and appro icrobial Susce guide patien in conjun
for evalua
z© Clinical and Laborat
may decrea ds,hairh breakp older based on CLSI oints the acokinetic-ph ation priate t treatment.
ptibility Testin ction
Mintted Groupthe Co-C
Romn breakp andand agend es inform
Cliffordpresen les icrobial agent eyer M.in MD,oints,MS,
which and qualit updat a items armacodyna reporting. g develo For more
erobactera
3
2 and M45. an antimWorking Theand mann
ael Satlin , Hum
ually monit phrie ors y contro submi
at thetted time, mic, The subco ps standards
USA M100 tibility to Ad Hoc parameters,
details
Mich Accel s, PhD, availa l (QC) blerange by the and mmittee
ts for Ent
and of erate CLSI-E clinical studie reviews data that
Breakpoint D, FIDSA, of es, CLSIthe contin

ism’s suscep ds, QC presen neces Diagnsary and t information D(AB
ostic inMM)conjunction
s. UCAST Joints) to from variou
Breakpoin
organroline ical metho chang ted USA for the most curren s, Inc.be used
recom Fluoro establish
Lewis II, Pharm
time, aCLSImicroCefta
on, micro
biolog
se of these types g M100ped usingevalua tion, are alwaysmend ed data For quinolone antimicrobia s
lf ofr the
Over
JamesteS.results. Becau ent. for more
Cefazolin
. In additi Testin
lity ines are develo and and
2
ines should descri selecting Ad Hoc Worki l susceptibility
On beha , MD, ptibi M45.guidel bed in treatm ng
Infections)
safety
and/oEliopoulos more accura Susce © 3 t CLSI appro
M. d to ensureon Antimicrobstand ial ards and guidel Clinical and
stand
Laborat ards Cliffo s to guide
patien
er docum
the varied ent M23.1 priate breakp
Georgerefine
(Systemic
gh CLSI therefore,Over time, ory Standa rd Mint
test result brings togeth CLSI antiba oints
ommittee ents. Althou s changing; nt labora USA
tory
a micro rds z that
Institut
ization e. All rights excellence cterial breakp and QC ranges, and
CLSI Subc ine is alway lly releva and/o ership. organ
organ ism’s suscep : tod.foster oints are how the
in its docum
reserve
r safety on cause
Infections), 1st Edition

e and medic and clinica oints. fulfill data
the field
of scienc
curren knowledge, is a not-for-profirefinedadvan
7 tinstitu
t memb
for the to
In additi
cemen Cefazolin
t ofon, a comm
ngmicroGroup on AST
that
tibility
help Breakpto an tories
labora antimicrobia
provided
in CLSI docum are
(Uncom Breakpoints for

MR0 te (CLSI) ensure more inesbiolog ents
1 Forewwith ordclinical judgm
umetory ntent, ards g. community insubmi On bybehathe Worki
ards lfand
guidel
of accura
ical metho
ds, QC param
l agent may
decrease,
lel and
onainform docLabora wwwStand .clsi.or laboratory
itstory tted
docum stand ents. Althou the Ad te results.
Hoc Work eters, and resulting
a items
al laborathe field. Co-Chairs plicated Because
CLSI rati ation, visit of the worldwide on CLSI
Urinary Enterobactera
agend
medic gh CLSI stand ofards that the mann in a lack of
of scienc , Jame psing
The Clinica Grou these clinical efficac 1
0 and expertise ent andis basedimplementing applic ability Antim e and medic s Jorgegnsen ards and
develo
stand p to types of chang
s Reass
er in which
Marchperspe 202ctives docum ping s, and global
with clinica icrob ine is alway , PhD,
ty Testin guidelvariou
are develoess Dapt
es, CLSI contin breakpoints y
toryCLSI
This medic ine by
ration aledevelo
effectivenes information,
l judgm
icrobial Susce ent,
ial Susce
ptibili
curren Tract Inf
ptibi
tee review les
lityssTestin
data from
chang and ines Mich
ing; theref l ael Satlin ped usingomycin Break ually monit are establ
ished may
in labora
sibilities with efficiency,
mmit tee on Antim
1 Forew visit
ing. ordThe www subco
CLS.clsi.or
mmit t knowl
I ratig.s) to establ
ections)
edge, ish andantimgicrobia
clinically
ore, stand , MD, MS,
ards and
the most
and
guidelinesthe CLSI
curren
point ors and updat
s
t informationfor Enterococces information
be
s, the Subco priate report
their respon
nsus proces approThis clinical studieonale doc relevant
laboratory 1 test result should always be
Subcomm available i
ary conse MM) tibility testing and CLSIThe ration ], and Ma um ittee on at the time,
MR03 | Meropenem Breakpoints for Item Order Code: MR07Ed1E

volunt D(AB mic [PK-PD ale docum
Clinica rch ent 202 ent used
how theMR08
CLSI odyna l and are s
Using the phrie PhD,icrobial suscep
s,antim etic-pharmac s.
perspe Labora is tory
based 0Stand on CLSI s, and
data to guide patien
t treatment.
in conjunction
M. Hum accurate Inc. vitro, pharmacokin (QC) range ctives and QC rangeardsagend
Romneypromote nost ics,s (eg, in y control 2 Introin labora exper and Instituate items ents
docum For more
and qualit duct iontory
breakp oints tise of the world ed in CLSI (CLSI)submi is a not-fo
tted by
e Diag s and studie breakpoints, priate medic oints are provid wide labora the tWorki
r-profi
Accelerat source methods, select ing appro
d.Treatm their respon breakpine by develo
ping and tory comm memb ngership
Group on
tibility test mende.ed
rightsfor
Alldata
reserve ent of Neisse
1 CLSI antiba
cterialsibilities
ria gonor with efficie ey, PharmD, implementing unity for organ Azithr
ization omyci
USA suscep oryand recomrds Institut ent option
M23. Currently,Romney
s. Using rhoea ncy, y medical labora
the advan
cement of that n.brings
of theand neces sary
Laborat
Standa
bed in CLSI
docum
therapy with the the Cente
CLSI er, Mich M.for aele Dudlinfections effectivenes
lack of clinica
l efficac
is a signifi s,ished may be
and global tory stand a common together
the varied
The details z © Clinical are descri rhold
Acce volunt rsaryingHum in aphri cant challe ards and cause: to
Clifford Mint ted for evaluation, p Chai
promo ceftria lera result Diseas
conse es, are establ applic guidelines foster excelle
Grou tedecrea xone se, temg, nsuse Contro PhD nge becauability.
Workicrobiaing
regim
l en may accura
USA ng te(250 antim Diag breakpoints
nost proces s,,the
l and D(AB
Preveninform ation se resista that help nce
sTesti
presen agentisility
hoped er in which intram esSubco MM laboratories
Ad Hoc source icrobia ics,andr) updat
Acinetobacter spp., 1st Edition

uscula tion ) (CDC) nce has emerg
monitors Inc.
3
to l suscep mmit
USA
M100 and
M45.
teriaceae an antimSusceptib and
and the mann
preser
studieve and testin
tibility at the time, tee on andAntim
the World ed to nearly fulfill
tibility toicrobial
2
the
s (eg, ineffect
ually azithr ble
Enterobac suscep on Antim ds, QC param
eters,
suscep tibility
es, CLSI testcontin
vitro,ivenes
t pharm ation
s acokin
availa gomyci
varied and appro
n (1 g,priate icrobia
AudHealth
lrey
SusceOrgan all therap
lf oftime, theaCLSImicroorgan
ism’s
ommmicro itteebiolog ical metho types of chang Clifford
methods,
most curren
inform
toget
of ceftria thexone
heretic-ph in conjunbecau
ction oral) for treatm
reporting.ent N.ptibili
Schuty ization
Testinrecom eutic
On beha Subc se of these using theizatio Min breakpoints,
n that brings always and be usedexcell armac
enceodyna se a strain Mayo Theofsubco etz, MD, g develo mend dual
Over the CLSI. In addition,
© Clinical
TheLaborat
and pedUSA
details tz
ines should : tot foster qualit For more mic [PK-PD
is unlike Clinuncom
ic mmit plicate MPHps standards
FIDSA, and results. Becau are develo oryofStanda
organ
theguidel ent.y contro ], andly to be resista tee d gonor
review , D(AB that
tories fulfill l (QC) ranges. USA clinica
and/or safety on cause treatm
accurate guidelines tpresen membership ards and nt neces
rds Institut
of asary comm patienlabora l studie nts)totoboth srhea.
data 4
ThisMM
from )
ensure more ards and r-profi ore, standted for ceme evaluaresults to
guide
e.and
All recom
rights help establceftria variou s
refined to CLSI stand (CLSI) is a not-fo mend
MR08 | Cefazolin Breakpoints for

theref 2advan tory test tion, that reserve d. ed data ish antim
xoneicrobia
word ents. Although Institu is te s changing; unity for
alway
M100 thelabora
nt and On M45.beha
ards 3 and
guide are lines
described for select rt and
l
1 Fore in its docum atorye Stand ards ine commlly releva lf in CLSI docum to suppo appropriate ing
of scienc
and medic wide labora and clinica laboratory stand
tory
t knowledge, ing medical Over time,
Antimicr of the CLSI Hoc ng Groupent that M23.uce1 new
breakpoints
al and fieldLabor the world . obia oint Ad develo
OralWorki Cepps stand
ardsintrod CLSI antiba
cterial breakp and QC ranges, and
The Clinicthe tise ofent, curren ment ability a microorgan l Susc halo s and

experl judgm imple l applic oline Breakp epti g us aureu spor s
s and
clinica ping and g. and globa or safety Ceftar ty Testin
ism’s suscep bilitsydata
lococc from variou in Ad Hoc oints are how the
perspective with www.clsi.or
by develo iveness, by the CLSI 1. InForeadditi ptibili for Staphy tibility Test provided
in CLSI docum are
data
1
inevisit compiled onrefine al Suscewor on,oints tee review to aning icrobial
Working
tory medic ation, ncy, effect
in laborainform ties with efficie ent is based on data mmit tee ntratio Antim icrobi
nd(MIC)
to ensure breakp
The more
dmicro
subco mmitbiolog ical metho lish antim
antim icrobial agent Group and ents
ting. s) to estab ds, QC param
Subcoory conce priate se, result the CLSI Sub
nsibili docum in its repor The Clinical laccura may decrea
their respo CLSI rationale ss, the al inhibit docum and studie te results. Becau eters, and
nsus proce
oline minim g and appro oints.[PK-PD ], ents.
and clinicaAlthou Labo the mann ing in a lack com
This
estaryto theconse
ceftar ty testin(SDD) breakp the field persp
of scienc ectives gh CLSI rator y Stand
stand
se of these
areof er in which of clinica mittee on
CLSI volun
chang al susce ose dependent harmacodynamic
ptibili e and and expertise ardss,ards and the data types changes,1 breakpoints l efficacy
Enterobacterales (Uncomplicated
Using the the icrobitible-d
acokinetic-p
with clinica in
s. laboratory medic ine is alway andinstithowute
guidel ines CLSI contin are establ and/
accurate nt and antim suscep l (QC) range l judgm med and
s byQC
of
rangethesworld (CLSIare
ents develo
) is ually monit ished may
promoteresista in vitro, pharm s, and quality contro information, their respo ent, curren
point icine changwide
ed in CLSI ing;docum a not-f ped using ors and updat be
studies (eg, point priate visitbreak
www nsibilities t sknowl aredeveprovidlopin
edge, and
theref
laboratory ore, stand or-profit the mem most curren es inform
sources and ods, break ing appro point
.clsi.or with g and clinica
imple comm ards and guidelbership organ t inform ation
ty test meth data for
select This CLSIUsing
antiba cterial break g. efficiency, effec llymenreleva tingntmed
unity
laboratory for the adva ines should izatioation available
susceptibili recom mended M23.
d.
ent Breakp prom
1 CLSI
rationthe ale CLSI volun
documenttary tiven ess, cy ical test
labor result ncem always n
ent of a be that bring at the time,
used in conjun
sary and rights reserve
e. Alldocum l effica and globabe atory stand s to guide s together
in CLSI oints for ote accu is basedconsaensu of clinica patiencomm
s of the neces are describedrds Institut
sources Enterorate antim ing in on lack s proce established may l applicability.
CLSI ards and t treatm on caus ctionthe varie
d
cocci icrobeial pointagend e: to foste
Standa
The detail Laboratory
andation,
susceptible-d ase, result
to chang s aress, athe items guidelines ent. For
for evalu
© Clinical oseand
test may depen
decre studi es in minim
break suscealptibi Subcsubmi
es inform omm ation
tted that help more r excellence
presented 3 icrobial agent meth ods,mann
dent
er (eg,which
(SDD) in vitro,
breakp ors and updat
inhibit
lity orytestin conce
itteeby the Ad
the time,on Antim Hoc laboratori
M45. to an antim eters, and
the breakpoint ually monit oints
phar maco ble g at
and ntratio icrobWorki
ial ng Group to Reasse
es fulfil
M100 and approprian (MIC) breakp
2
suppo
MR04 | Azithromycin Breakpoint for Urinary Tract Infections), 1st Edition

ptibility kinetavaila l
ism’s susce QC param The deta es, CLSI contin s, andtquali inform ation rted
ic-ph byarma
highernction te repo ointsSusce ptibility
methods, of changils of thethe most curren ty contrused in conju cody dosage treatm rting. The and introd Testing ss Daptomycin
a microorgan microbiological typesprese necessary s be ol (QC) rang morenamic, ent regimsubcomm uce develops
new resista
Over time, on, se of these develonted ped using should alway treatment. Fores. and clinic stand
. In additi results. Becau guidelines are M10 for evalu guidelines and recom t al studien optionsittee
es) to estabfor dapto reviews nt and ards that
and/or safety e more accurate ards and ation, sare guide patien
© Clinical men data from
02 and ded data mycin
ards and
and
ensur CLSI stand therefore,
stand
Laborat M45
ory Standa. 3 rds
test result todescribed for selec lish antim . various
refined to Although s changing; nt laboratory Institute.
All rights
in CLSI
docu ss
ting appr icrobial
susceptibi
ents. ine is alway relevaOver men opria
clinically lity
reserve
in its docum time, a d. to reasse t M23. 1 te break
e and medic ledge, and or safet microorgan ing Group CLSI
uce new antibacterial
points and
the field
of scienc current know y. In addit ism’s e Ad susceHoc Work and introd breakpoint QC ranges, and
ent, refin ion,
bacte riacea ptibi ions
l judgm ed to Entero microbiolo ic infectlity to an s are provi how
with clinica .clsi.org. by the CLSI ensubacte for system lin.antimicrob ded in CLSI the data are
Neisseria gonorrhoeae, 1st Edition Item Order Code: MR08Ed1E

re more gical meth
visit www compiled in its docu
rales accuregim ens for cefazo ods, ial agen documen
information, on data s for Enteroments. ent rate results. Beca QC parameters t may decre 1 ts
document
is based breakpoint the field
r dosage
Although
treatm use of these , and the ase, resul
on (MIC) of
by highe science and
CLSI stand
rationale concentrati with ards and types of manner ting in a
This CLSI inhibitory s supported clinical medicine guidelines changes, in whic
h break
lack of
clinical
minimal breakpoint informati judgment, curre is always CLSI points are efficacy
cefazolin ant MIC on, visit nt changing; are deve
loped using continually mon and/
and resist www.clsi.o knowledge, and therefore, establishe
intermediate This CLSI rg. clinically standards 1 the most curre itors and
updates
d may be
relevant and nt infor informati
cefazolin
rationale
documen laboratory guidelines shou mation
available on
minimal t is base test resul ld alwa at the time
ys be

(UTIs) and inhib d on data comp ts to guide patie used ,
introduce itory conc in conju
iled by nt treat nction
cefaz
reserve d.
olin. new inter entration (MIC the ment. For
e. All rights mediate ) breakpoint CLSI Oral Ceph more
rds Institut and resist s for Enter alosporin
tory Standa ant MIC Ad Hoc
© Clinica
l and Labora breakpoint obacterales for Working
s supported uncomplic Grou
by highe ated urina p to reassess
r dosage ry tract
treatmen infections
© Clinica t regim
l and Labora ens for
tory Stand
ards Institu
te. All rights
reserved.

Molecular Methods
Document Pricing
Featured Documents
MM17 | Validation and Verification of Multiplex Nucleic Acid Assays, 2nd Edition
Nucleic acid testing is one of the fastest growing fields in laboratory medicine. This guideline
2nd Edition
MM17
Validation and Verification of Multiplex
Nucleic Acid Assays
includes recommendations for analytical validation and verification of multiplex assays, with a
review of biological and synthetic reference materials.
This guideline includes recommendations for analytical validation

and verification of multiplex assays, as well as a review of
different types of biological and synthetic reference materials.
MM18 | Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA
2nd Edition
Sequencing, 2nd Edition
MM18
Interpretive Criteria for Identification
of Bacteria and Fungi by Targeted DNA
This guideline includes the most current information for microbial classification by targeted
DNA sequencing, with particular emphasis on interpreting and reporting results.
Sequencing
This guideline includes information on sequencing DNA

targets of cultured isolates, provides a quantitative metric for
perceiving microbial diversity, and can serve as the basis to
identify microorganisms. By establishing interpretive criteria
for microorganism identification by targeted DNA sequencing,
this guideline provides structure to laboratories that identify
microorganisms for medical use.
MM01* | Molecular Methods for Clinical Genetics and MM07* | Fluorescence In Situ Hybridization Methods
Oncology Testing, 3rd Edition for Clinical Laboratories, 2nd Edition
Item Order Code: MM01A3E Item Order Code: MM07A2E
MM03* | Molecular Diagnostic Methods for MM09 | Nucleic Acid Sequencing Methods in
Infectious Diseases, 3rd Edition Diagnostic Laboratory Medicine, 2nd Edition
Item Order Code: MM03Ed3E COVID-19 Related Item Order Code: MM09A2 COVID-19 Related
MM05* | Nucleic Acid Amplification Assays for MM11* | Molecular Methods for Bacterial Strain
Molecular Hematopathology, 2nd Edition Typing, 1st Edition
Item Order Code: MM05A2E Item Order Code: MM11AE
MM06 | Quantitative Molecular Methods for MM12* | Diagnostic Nucleic Acid Microarrays,
Infectious Diseases, 2nd Edition 1st Edition
Item Order Code: MM06A2 COVID-19 Related Item Order Code: MM12AE

MM13* | Collection, Transport, Preparation, and MM20* | Quality Management for Molecular Genetic
Storage of Specimens for Molecular Methods, Testing, 1st Edition
2nd Edition Item Order Code: MM20AE
Item Order Code: MM13Ed2E COVID-19 Related
MM21* | Genomic Copy Number Microarrays for
MM14* | Design of Molecular Proficiency Testing/ Constitutional Genetic and Oncology Applications,
External Quality Assessment, 2nd Edition 1st Edition
Item Order Code: MM14A2E COVID-19 Related Item Order Code: MM21Ed1*
Free for a limited time. MM22* | Microarrays for Diagnosis and Monitoring of
MM17 | Validation and Verification of Multiplex Infectious Diseases, 1st Edition
Nucleic Acid Assays, 2nd Edition Item Order Code: MM22AE COVID-19 Related
Item Order Code: MM17Ed2 COVID-19 Related Free for a limited time.
MM18 | Interpretive Criteria for Identification of MM23* | Molecular Diagnostic Methods for Solid
Bacteria and Fungi by Targeted DNA Sequencing, Tumors (Nonhematological Neoplasms), 1st Edition
2nd Edition Item Order Code: MM23Ed1E
Item Order Code: MM18Ed2
MM19* | Establishing Molecular Testing in Clinical

Laboratory Environments, 1st Edition
Item Order Code: MM19AE COVID-19 Related
Learning Opportunities
Our online learning programs and webinars provide a variety of easy-to-use
educational resources that ensure accreditation readiness, support professional
development, and give your staff the resources they need to provide the best test
results for patients.
Visit clsi.org/elearning to view our offerings.
Newborn Screening
Document Pricing
Featured Documents
NBS05 | Newborn Screening for Cystic Fibrosis, 2nd Edition
NBS05 provides essential information about newborn screening laboratory tests for detecting
2nd Edition
NBS05
Newborn Screening for Cystic Fibrosis
analytes and genetic markers associated with cystic fibrosis.
This guideline describes newborn screening laboratory

tests for detecting analytes and genetic markers associated
with cystic fibrosis (CF). It includes both the first-tier and
second-tier screening tests performed on newborn dried blood
spot specimens, as well as the screening strategies for
identifying newborns at increased risk for developing CF.
NBS08 | Newborn Screening for Hemoglobinopathies, 1st Edition

NBS08 describes the recommended protocols for detecting hemoglobinopathies and
1st Edition
NBS08
Newborn Screening for Hemoglobinopathies
thalassemias. Early, presymptomatic detection to identify newborns with abnormal
hemoglobins is critical.
This guideline describes the recommended protocols for

detecting hemoglobinopathies and thalassemias by population-
based newborn screening using dried blood spot specimens.
Early, presymptomatic detection to identify newborns with
abnormal hemoglobins is critical because it improves treatment
effectiveness.
NBS01 | Blood Collection on Filter Paper for NBS04 | Newborn Screening by Tandem Mass
Newborn Screening Programs, 7th Edition Spectrometry, 2nd Edition
Item Order Code: NBS01Ed7 Item Order Code: NBS04Ed2
NBS02* | Newborn Screening Follow-up, 2nd Edition NBS05 | Newborn Screening for Cystic Fibrosis,
Item Order Code: NBS02A2E 2nd Edition
Item Order Code: NBS05Ed2
NBS02A2QG* | Newborn Screening Follow-up
Process Quick Guide NBS06* | Newborn Blood Spot Screening for Severe
Item Order Code: NBS02A2QGE Combined Immunodeficiency by Measurement of
Nonmember Rate: $20.00 T-cell Receptor Excision Circles, 1st Edition
Item Order Code: NBS06AE
NBS03 | Newborn Screening for Preterm, Low Birth
Weight, and Sick Newborns, 2nd Edition

NBS06AQG1* | Generic Flow Chart for Assays NBS07 | Newborn Blood Spot Screening for Pompe
to Measure T-cell Receptor Excision Circles in Disease by Lysosomal Acid α-Glucosidase Activity
Newborn Dried Blood Spot Specimens Assays, 1st Edition
Item Order Code: NBS06AQG1E Item Order Code: NBS07Ed1
NBS08 | Newborn Screening for
NBS06AQG2* | Schematic for Preparing Dried Hemoglobinopathies, 1st Edition
Blood Spot Reference Materials Quick Guide Item Order Code: NBS08Ed1
Item Order Code: NBS06AQG2E
NBS09 | Newborn Screening for X-Linked
Adrenoleukodystrophy, 1st Edition
Did you know?
CLSI has a new, updated Laboratory Quality Management System Certificate Program.
This online learning program provides the knowledge and skills necessary for successful
implementation and sustainment of a quality management system in your laboratory. You
can earn 13 P.A.C.E.® CE credits while learning from content experts.
Learn more at clsi.org/lqmsolpkg.

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

Item Order Code: POCT01A2E
POCT05* | Performance Metrics for Continuous
POCT01QG* | CLSI Vendor Code Registry, 1st Edition Interstitial Glucose Monitoring, 2nd Edition
Item Order Code: POCT01QGEd1E Item Order Code: POCT05Ed2E
Free document POCT06* | Effects of Different Sample Types on
Glucose Measurements, 1st Edition
POCT02* | Implementation Guide of POCT01 for
Healthcare Providers, 1st Edition Item Order Code: POCT06Ed1E
Item Order Code: POCT02AE POCT07* | Quality Management: Approaches to
Reducing Errors at the Point of Care, 1st Edition
POCT04 | Essential Tools for Implementation and
Management of a Point-of-Care Testing Program, Item Order Code: POCT07AE COVID-19 Related
3rd Edition Free for a limited time.
Item Order Code: POCT04Ed3 COVID-19 Related

POCT07RG | Addressing Errors in Point-of-Care POCT09AWS* | Instrument Selection Worksheet
Testing, 1st Edition Item Order Code: POCT09AWSE
Item Order Code: POCT07RDEd1 Nonmember Rate: $40.00
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: POCT12A3
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: POCT15Ed1E COVID-19 Related
POCT09* | Selection Criteria for Point-of-Care POCT17* | Use of Glucose Meters for Critically Ill
Testing Devices, 1st Edition Patients, 1st Edition
Item Order Code: POCT09AE Item Order Code: POCT17Ed1E
Free document
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
QMS01 | Quality Management System: A Model for Laboratory Services, 5th Edition
Reduce nonconformances and help your lab pass and maintain accreditation with QMS01.
5th Edition
QMS01
A Quality Management System Model for
Laboratory Services This document will show you how to develop and implement a quality management system
that fits your lab’s unique needs.
This guideline provides a model for medical laboratories to

organize the implementation and maintenance of an effective
quality management system.
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.
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: QMS02A6
QMS01CL* | Gap Analysis Checklists, 1st Edition
Item Order Code: QMS01CLE QMS03 | Training and Competence Assessment,
Nonmember Rate: $30.00 4th Edition
Item Order Code: QMS03Ed4 COVID-19 Related
QMS02 | Quality Management System:
Development and Management of Laboratory QMS04 | Laboratory Design, 3rd Edition
Documents, 6th Edition Item Order Code: QMS04Ed3
Item Order Code: QMS02A6

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: QMS06A3 QMS20 | Understanding the Cost of Quality in the
Laboratory, 2nd Edition
QMS11 | Nonconforming Event Management, Item Order Code: QMS20REd2
2nd Edition
Item Order Code: QMS11Ed2 QMS21 | Purchasing and Inventory Management,
1st Edition
QMS12 | Development and Use of Quality Indicators Item Order Code: QMS21Ed1
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
QMS15 | Assessments: Laboratory Internal Audit
Program, 1st Edition QMS25 | Handbook for Developing a Laboratory
Item Order Code: QMS15A Quality Manual, 1st Edition
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

Veterinary Medicine
Document Pricing
Featured Document
VET03 | Methods for Antimicrobial Broth Dilution and Disk Diffusion Susceptibility Testing of
2nd Edition
Bacteria Isolated From Aquatic Animals, 2nd Edition
VET03
Methods for Antimicrobial Broth Dilution
and Disk Diffusion Susceptibility Testing of
Bacteria Isolated From Aquatic Animals
This guideline provides the most up-to-date techniques for the determination of minimal
inhibitory concentrations and zones of inhibition of aquatic bacteria and criteria for data
interpretation and quality control testing.
This guideline provides the most up-to-date techniques for the
determination of minimal inhibitory concentrations and zones of
inhibition of aquatic bacteria and criteria for data interpretation
and quality control testing.
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
Item Order Code: VET01Ed5 Item Order Code: VET04Ed3
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: VET01SEd5E 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

Explore CLSI standards with eCLIPSE Ultimate Access™, our full online library.
• Comprehensive – Includes every current CLSI standard • Accessible – Download PDFs for offline use
• Searchable – Keyword, title, or full text search • Interactive – Add bookmarks and comments
Multiple Search Functions Annotations

Search by document number, keyword, full text, or by Users can add comments, importance markers, tags,
using filters. and bookmarks at the document, page, section, or
Link Peek paragraph level.
Displays a sample of a referenced document, an Custom Collections
individual page, or another section without leaving Allows users to select and group together document
the current view. content to create a new, custom document.
Page-by-Page Online PDF View Advanced Print Options
Documents are displayed in an interactive page-by- Customize printing options for selected pages,
page view rather than as a continuous stream of sections, or paragraphs, which includes the ability to
pages. print associated annotations.
Table of Contents Share
The table of contents is displayed alongside the Share comments, importance markers, tags, and
document for convenience. messages with other users within your organization.
Linking Bulletin Board
The linking feature allows users to easily access This feature provides access to messages from CLSI
related CLSI document references within a document. and account administrators.
Messaging
Send e-mail messages to other users, account
administrators, and CLSI.
Access is included for all employees at organizations Access is included for two concurrent users with the
with the following memberships: following memberships:
• Health System • Level I Health Care
• Level I Industry • Level I Government
• Level II Industry
Is your membership level not included? Contact us at membership@clsi.org to learn about how to get access
to eCLIPSE.
Visit clsi.org/eclipse to learn more.
CLSI Membership
Elevate Your Career—

Become a Member Today
What will CLSI membership offer you and your organization?

CLSI is the meeting place for the world’s savviest medical laboratory experts. To stay on the
leading edge of industry knowledge and shape the future of laboratory medicine, sign up now.
Health Systems Laboratories Industry Government Individuals

Save big on a Raise the Develop Agencies An option for
per-site basis by standards for innovative Have a seat at anyone interested
extending CLSI quality in your products by the table and in being part of
benefits to every laboratory using globally participate in CLSI.
site in your health environment. recognized our standards
system under one standards. development
umbrella. process.
See the unique offerings and benefits for your organization at clsi.org/membership.

Membership Includes:
Standards Access
• Discounts for organizations ranging from 50–70%
• Discounts for individuals ranging from 15–25%
• Many membership levels include access to CLSI’s entire library of standards. Some options
also include multi-site access.
Members-only Access
• Access our searchable online member directory.
Ensure your company is listed among the top labs.
• Use our online member resource center.
Includes accreditation resources to help you meet requirements and more.
• Receive our monthly Membership E-newsletter.
Standards Development Opportunities

• Propose new projects.
• Volunteer on or nominate candidates for standards committees.
• Review, comment, and vote on documents.
• Vote on governance officer elections and CLSI bylaws.
Membership Levels:
We offer various membership levels based on your organization’s size
and needs. Visit clsi.org/join to learn more about membership options.

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 consensus- Our standards are CLSI supports the
based process, CLSI championed by our 1,800+ implementation of these
volunteers help create our members and used by standards around the world,
neutral standards. countless laboratory through our Partnerships
professionals around program.
the globe.
Volunteering With CLSI

Learn more about volunteering with CLSI at clsi.org/vol.

Bill to: (Please print.) Ship to (if different than billing address): (Please print.)
Name: Name:
Organization: Organization:
Address: Address:
City: State/Province: City: State/Province:

Zip/Postal Code: Zip/Postal Code:
Country: Country:
Telephone: Telephone:
E-mail: E-mail:
Qty Item Code Title PDF/Print Promo Code Price Total
Subtotal
CLSI Membership Discounts
Shipping/Handling (See info below)
Type of Membership Percentage
Express Shipping
Level I or Health System Organization 70%
Level II Organization 60% Sales Tax (PA Shipments add 6%)
Level III Organization 50% Total

Individual Full 25%
Individual Student 25% Membership Account # (if nonmember, answer N/A):
Individual Associate 15%
Shipping and Handling Method of Payment

Within the USA Add 10% (min $10) Payment enclosed in full MasterCard
International Express
All other locations 1–3 day delivery Visa American Express Discover
Add 35% (min $40)
Card Number
Express Shipping (North America Only)*
Early
2-Day Overnight Expiration Date (MM/YY): CSV:
Morning
1–3 Documents $11 $16 $23 Name (as it appears on credit card)
4–6 Documents $14 $19 $26
Purchase order MUST be faxed or mailed.
7–10
$16 $21 $28 Payment due in full upon receipt of invoice.
Documents
Federal Tax ID #23-7089361
Specialty Mail to:
$16 $21 $28
Collections
Clinical and Laboratory Standards Institute
*Express charges are in addition to the regular shipping PO Box 645766
and handling charges. PITTSBURGH, PA 15264 USA
Thank you for your order. Please photocopy this form for Wire Transfer
multiple orders. Contact customerservice@clsi.org.

Clsi Catalog 2021 Web

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Clsi Catalog 2021 Web

Uploaded by

Copyright:

Available Formats

2021 CATALOG

Global Laboratory Standards for a Healthier World

2 | CLSI Catalog 2021

CLSI Documents Helpful for COVID-19 Testing

3 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

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

4 | CLSI Catalog 2021

5 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

This guideline describes methods for all aspects of sweat testing,

C49 | Analysis of Body Fluids in Clinical Chemistry, 2nd Edition

This guideline provides information for the medical laboratory

6 | CLSI Catalog 2021

7 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

This standard specifies the processes required to ensure accurate

GP49 | Developing and Managing a Medical Laboratory (Test) Utilization Management

This report provides guidance for initiating, developing, and

A CLSI report for US application.

8 | CLSI Catalog 2021

Did you know?

9 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

This guideline provides recommendations regarding the proper

10 | CLSI Catalog 2021

Did you know you can create a custom solution package

11 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

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

12 | CLSI Catalog 2021

I/LA28A2QG* | Comparison of the Characteristics

Calling All Volunteers

13 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

vitro diagnostic measurement procedure.

EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory

guideline apply to both quantitative measurement procedures and qualitative examinations.

14 | CLSI Catalog 2021

15 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

Project Proposals Needed

16 | CLSI Catalog 2021

This document provides updated minimal inhibitory

A CLSI supplement for global application.

M61 | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi,

A CLSI supplement for global application.

17 | CLSI Catalog 2021

18 | ORDER TODAY: Toll Free (US): 877.447.1888 | +1.610.688.0100 | www.clsi.org | customerservice@clsi.org

M56 | Principles and Procedures for Detection of

M57 | Principles and Procedures for the

19 | CLSI Catalog 2021

M100 Document M100 PLUS M100, M23, and M60 FREE

Free Rationale Documents

aeruginosa, and Acinetobacter spp., Item Order Code: MR05Ed1E

MR06 | Daptomycin Breakpoints for

Item Order Code: MR01Ed2E

Enterococci, 1st Edition

MR02 | Fluoroquinolone Breakpoints Item Order Code: MR06Ed1E

for Enterobacteriaceae and

MR07 | Cefazolin Breakpoints

Pseudomonas aeruginosa, 1st Edition

for Enterobacterales (Systemic

Item Order Code: MR02Ed1E

Infections), 1st Edition

(Uncom Breakpoints for