CATALOG 2018

Set the Standard for Quality

in Your Laboratory With CLSI
New Documents

M23 | Development of In Vitro M27 | Reference Method for M38 | Reference Method for M59 | Epidemiological
Susceptibility Testing Criteria and Broth Dilution Antifungal Broth Dilution Antifungal Cutoff Values for Antifungal
Quality Control Parameters, 5th Susceptibility Testing of Yeasts, Susceptibility Testing of Susceptibility Testing, 2nd Edition
Edition 4th Edition Filamentous Fungi, 3rd Edition January 2018
January 2018 November 2017 November 2017 This document includes
This guideline discusses the This standard covers antifungal This standard includes antifungal epidemiological cutoff values
necessary and recommended agent selection and preparation, agent selection, preparation and quality control tables
data for selecting appropriate test procedure implementation of antifungal stock solutions developed according to criteria
breakpoints and quality control and interpretation, and quality and dilutions for testing, test provided in the Clinical and
ranges for antimicrobial agents. control requirements for procedure implementation and Laboratory Standards Institute
susceptibility testing of yeasts interpretation, and quality control guideline M57. The tables in M59
that cause invasive fungal requirements for susceptibility are intended for use with CLSI
infections. Supplemental tables testing of filamentous fungi document M57.
for M27 are published in CLSI (moulds) that cause invasive and
document M60. cutaneous fungal infections.
Supplemental tables for M38 are
published in CLSI document M61.

CLSI Catalog 2018

M60 | Performance Standards M61 | Performance Standards QMS17 | External Assessments, QMS19 | Customer Focus in a
for Antifungal Susceptibility for Antifungal Susceptibility Audits, and Inspections of the Quality Management System,
Testing of Yeasts, 1st Edition Testing of Filamentous Fungi, 1st Laboratory, 1st Edition 1st Edition
November 2017 Edition August 2017 September 2017
This document includes updated November 2017 This guideline provides This guideline provides useful
minimal inhibitory concentration, This document provides recommendations for information for how laboratories
zone diameter, and quality updated quality control tables establishing and maintaining a can develop and maintain a
control tables for the Clinical and for the Clinical and Laboratory process to assist the laboratory customer focus and meet the
Laboratory Standards Institute Standards Institute antifungal in achieving a continuous state regulatory and accreditation
antifungal susceptibility testing susceptibility testing documents of readiness for assessment requirements for managing
documents M27 and M44. The M38 and M51. The tables in M61 by an external organization. external and internal customers.
tables in M60 are intended for are intended for use with CLSI This includes selecting and
use with CLSI documents M27 documents M38 and M51. evaluating an external
and M44. assessment organization,
preparing for and undergoing
a successful assessment, and
sustaining ongoing readiness for
assessment.

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AST Resources
The Go-to Gold Standard in Antimicrobial Susceptibility Testing (AST)
For over 30 years, the microbiology community has relied upon our annually updated M100 document as the gold standard for the latest, most trusted
AST breakpoint data. Now the reference you reach for is more easily accessible in a variety of new formats.

M100 Document M100 PLUS M100 FREE

The 28th edition of this document provides updated Get full online access to M100, M02, M07, and You can now quickly reference the most trusted
tables for the CLSI AST standards M02, M07, and M11, M11 with added functionality and fast, easy data AST breakpoints from anywhere with an Internet
and is available as a downloadable PDF or printed searching in an electronic format. Plus, you’ll have the connection. M100 is available online as a convenient
document. added benefit of quick access to related materials via companion to the M100 document.
an AST Resource Center.

New January 2018 AST Documents*

M100 | Performance Standards for Antimicrobial M100 | Performance Standards for Antimicrobial M100 | Performance Standards for Antimicrobial
Susceptibility Testing, 28th Edition Susceptibility Testing, 28th Edition Susceptibility Testing, 28th Edition
M02 | Performance Standards for Antimicrobial Disk M02 | Performance Standards for Antimicrobial Disk M07 | Methods for Dilution Antimicrobial Susceptibility
Susceptibility Tests, 13th Edition Susceptibility Tests, 13th Edition Tests for Bacteria That Grow Aerobically, 11th Edition
M07 | Methods for Dilution Antimicrobial Susceptibility Nonmember: $342 Nonmember: $342
Tests for Bacteria That Grow Aerobically, 11th Edition Order Code: M02Ed13PK18 Order Code: M07Ed11PK18
Nonmember: $504
Order Code: M02Ed13M07Ed11PK18

* Only sold in packages.

CLSI Catalog 2018

Automation and Informatics
Document Pricing
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AUTO01* | Laboratory Automation: Specimen Container/Specimen AUTO10* | Autoverification of Clinical Laboratory Test Results,
Carrier, 1st Edition 1st Edition
Item Order Code: AUTO01AE Item Order Code: AUTO10AE
AUTO02* | Laboratory Automation: Bar Codes for Specimen Container AUTO11 | Information Technology Security of In Vitro Diagnostic
Identification, 2nd Edition Instruments and Software Systems, 2nd Edition
Item Order Code: AUTO02A2E Item Order Code: AUTO11A2
AUTO03* | Laboratory Automation: Communications With AUTO12 | Specimen Labels: Content and Location, Fonts, and Label
Automated Clinical Laboratory Systems, Instruments, Devices, and Orientation, 1st Edition
Information Systems, 2nd Edition Item Order Code: AUTO12A
Item Order Code: AUTO03A2E
AUTO13* | Laboratory Instruments and Data Management Systems:
AUTO04* | Laboratory Automation: Systems Operational Design of Software User Interfaces and End-User Software Systems
Requirements, Characteristics, and Information Elements, 1st Edition Validation, Operation, and Monitoring, 2nd Edition
Item Order Code: AUTO04AE Item Order Code: AUTO13A2E
AUTO05* | Laboratory Automation: Electromechanical Interfaces, LIS01* | Specification for Low-Level Protocol to Transfer Messages
1st Edition Between Clinical Laboratory Instruments and Computer Systems,
Item Order Code: AUTO05AE 2nd Edition
Item Order Code: LIS01A2E
AUTO07* | Laboratory Automation: Data Content for Specimen
Identification, 1st Edition LIS02* | Specification for Transferring Information Between Clinical
Item Order Code: AUTO07AE Laboratory Instruments and Information Systems, 2nd Edition
Item Order Code: LIS02A2E
AUTO08 | Managing and Validating Laboratory Information Systems,
1st Edition LIS04* | Standard Guide for Documentation of Clinical Laboratory
Item Order Code: AUTO08A Computer Systems, 1st Edition
Item Order Code: LIS04AE
AUTO09* | Remote Access to Clinical Laboratory Diagnostic Devices
via the Internet, 1st Edition
Item Order Code: AUTO09AE

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Clinical Chemistry and Toxicology
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C24 | Statistical Quality Control for Quantitative Measurement C40 | Measurement Procedures for the Determination of Lead
Procedures: Principles and Definitions, 4th Edition Concentrations in Blood and Urine, 2nd Edition
Item Order Code: C24Ed4 Item Order Code: C40A2
C29* | Standardization of Sodium and Potassium Ion-Selective C42* | Erythrocyte Protoporphyrin Testing, 1st Edition
Electrode Systems to the Flame Photometric Reference Method, Item Order Code: C42AE
2nd Edition
Item Order Code: C29A2E C43* | Gas Chromatography/Mass Spectrometry Confirmation of
Drugs, 2nd Edition
C31* | Ionized Calcium Determinations: Precollection Variables, Item Order Code: C43A2E
Specimen Choice, Collection, and Handling, 2nd Edition
Item Order Code: C31A2E C45* | Measurement of Free Thyroid Hormones, 1st Edition
Item Order Code: C45AE
C34* | Sweat Testing: Sample Collection and Quantitative Chloride
Analysis, 3rd Edition C46 | Blood Gas and pH Analysis and Related Measurements,
Item Order Code: C34A3E 2nd Edition
Item Order Code: C46A2
C37* | Preparation and Validation of Commutable Frozen Human
Serum Pools as Secondary Reference Materials for Cholesterol C48* | Application of Biochemical Markers of Bone Turnover in the
Measurement Procedures, 1st Edition Assessment and Monitoring of Bone Diseases, 1st Edition
Item Order Code: C37AE Item Order Code: C48AE

C38* | Control of Preanalytical Variation in Trace Element C49* | Analysis of Body Fluids in Clinical Chemistry, 1st Edition
Determinations, 1st Edition Item Order Code: C49AE
Item Order Code: C38AE C50* | Mass Spectrometry in the Clinical Laboratory: General Principles
C39* | A Designated Comparison Method for the Measurement of and Guidance, 1st Edition
Ionized Calcium in Serum, 1st Edition Item Order Code: C50AE
Item Order Code: C39AE

CLSI Catalog 2018

C52 | Toxicology and Drug Testing in the Clinical Laboratory, C58* | Assessment of Fetal Lung Maturity by the Lamellar Body Count,
3rd Edition 1st Edition
Item Order Code: C52Ed3 Item Order Code: C58AE
C56 | Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of C61* | Determination of Serum Iron, Total Iron-Binding Capacity and
Interference in Clinical Laboratory Analysis, 1st Edition Percent Transferrin Saturation, 1st Edition
Item Order Code: C56A Item Order Code: C61AE
C57 | Mass Spectrometry for Androgen and Estrogen Measurements in C62* | Liquid Chromatography-Mass Spectrometry Methods,
Serum, 1st Edition 1st Edition
Item Order Code: C57Ed1 Item Order Code: C62AE

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General Laboratory
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GP05* | Clinical Laboratory Waste Management, 3rd Edition GP39* | Tubes and Additives for Venous and Capillary Blood Specimen
Item Order Code: GP05A3E Collection, 6th Edition
Item Order Code: GP39A6E
GP15* | Cervicovaginal Cytology Based on the Papanicolaou Technique,
3rd Edition GP40 | Preparation and Testing of Reagent Water in the Clinical
Item Order Code: GP15A3E Laboratory, 4th Edition
Item Order Code: GP40A4AMD
GP16 | Urinalysis, 3rd Edition
Item Order Code: GP16A3 GP41 | Collection of Diagnostic Venous Blood Specimens, 7th Edition
Item Order Code: GP41Ed7
GP17 | Clinical Laboratory Safety, 3rd Edition
Item Order Code: GP17A3 GP42* | Procedures and Devices for the Collection of Diagnostic Capillary
Blood Specimens, 6th Edition
GP20* | Fine Needle Aspiration Biopsy (FNAB) Techniques, 2nd Edition Item Order Code: GP42A6E
Item Order Code: GP20A2E
GP44 | Procedures for the Handling and Processing of Blood Specimens
GP23* | Nongynecological Cytology Specimens: Preexamination, for Common Laboratory Tests, 4th Edition
Examination, and Postexamination Processes, 2nd Edition Item Order Code: GP44A4
Item Order Code: GP23A2E
GP45* | Studies to Evaluate Patient Outcomes, 1st Edition
GP31 | Laboratory Instrument Implementation, Verification, and Item Order Code: GP45AE
Maintenance, 1st Edition
Item Order Code: GP31A GP47 | Management of Critical- and Significant-Risk Results, 1st Edition
Item Order Code: GP47Ed1
GP33* | Accuracy in Patient and Sample Identification, 1st Edition
Item Order Code: GP33AE GP48 | Essential Elements of a Phlebotomy Training Program, 1st Edition
Item Order Code: GP48Ed1
GP34 | Validation and Verification of Tubes for Venous and Capillary
Blood Specimen Collection, 1st Edition GP49 | Developing and Managing a Medical Laboratory (Test) Utilization
Item Order Code: GP34A Management Program, 1st Edition
Item Order Code: GP49Ed1
GP36 | Planning for Laboratory Operations During a Disaster, 1st Edition
Item Order Code: GP36A

CLSI Catalog 2018

Are you struggling with deficiencies
from your latest inspection?
CLSI has the resources you need. We’ve identified the top 10 most commonly cited
deficiencies by major accreditation organizations and created document lists to
address each area. Each document list is designed to provide you with tools to help
you prepare for accreditation inspection, improve areas of concern, and resolve
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Hematology
Document Pricing
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H02* | Procedures for the Erythrocyte Sedimentation Rate Test, H43* | Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid
5th Edition Cells, 2nd Edition
Item Order Code: H02A5E Item Order Code: H43A2E
H07* | Procedure for Determining Packed Cell Volume by the H47* | One-Stage Prothrombin Time (PT) Test and Activated Partial
Microhematocrit Method, 3rd Edition Thromboplastin Time (APTT) Test, 2nd Edition
Item Order Code: H07A3E Item Order Code: H47A2E
H15* | Reference and Selected Procedures for the Quantitative H48 | Determination of Coagulation Factor Activities Using the
Determination of Hemoglobin in Blood, 3rd Edition One-Stage Clotting Assay, 2nd Edition
Item Order Code: H15A3E Item Order Code: H48Ed2
H20* | Reference Leukocyte (WBC) Differential Count (Proportional) and H52 | Red Blood Cell Diagnostic Testing Using Flow Cytometry,
Evaluation of Instrumental Methods, 2nd Edition 2nd Edition
Item Order Code: H20A2E Item Order Code: H52A2
H21 | Collection, Transport, and Processing of Blood Specimens for H54* | Procedures for Validation of INR and Local Calibration of PT/INR
Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Systems, 1st Edition
Assays, 5th Edition Item Order Code: H54AE
Item Order Code: H21A5
H56 | Body Fluid Analysis for Cellular Composition, 1st Edition
H26 | Validation, Verification, and Quality Assurance of Automated Item Order Code: H56A
Hematology Analyzers, 2nd Edition
Item Order Code: H26A2 H57* | Protocol for the Evaluation, Validation, and Implementation of
Coagulometers, 1st Edition
H30* | Procedure for the Determination of Fibrinogen in Plasma, Item Order Code: H57AE
2nd Edition
Item Order Code: H30A2E H58* | Platelet Function Testing by Aggregometry, 1st Edition
Item Order Code: H58AE
H42* | Enumeration of Immunologically Defined Cell Populations by
Flow Cytometry, 2nd Edition
Item Order Code: H42A2E

CLSI Catalog 2018

H59 | Quantitative D-dimer for the Exclusion of Venous H60 | Laboratory Testing for the Lupus Anticoagulant, 1st Edition
Thromboembolic Disease, 1st Edition Item Order Code: H60A
Item Order Code: H59A

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Immunology and Ligand Assay
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I/LA02* | Quality Assurance of Laboratory Tests for Autoantibodies to I/LA28* | Quality Assurance for Design Control and Implementation of
Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Immunohistochemistry Assays, 2nd Edition
Microtiter Enzyme Immunoassay Methods, 2nd Edition Item Order Code: ILA28A2E
Item Order Code: ILA02A2E
I/LA30* | Immunoassay Interference by Endogenous Antibodies,
I/LA20 | Analytical Performance Characteristics, Quality Assurance, and 1st Edition
Clinical Utility of Immunological Assays for Human Immunoglobulin E Item Order Code: ILA30AE
Antibodies of Defined Allergen Specificities, 3rd Edition
Item Order Code: ILA20Ed3 I/LA33* | Validation of Automated Systems for Immunohematological
Testing Before Implementation, 1st Edition
I/LA21* | Clinical Evaluation of Immunoassays, 2nd Edition Item Order Code: ILA33AE
Item Order Code: ILA21A2E
I/LA34* | Design and Validation of Immunoassays for Assessment of
I/LA23* | Assessing the Quality of Immunoassay Systems: Human Allergenicity of New Biotherapeutic Drugs, 1st Edition
Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Item Order Code: ILA34AE
Immunoassays, 1st Edition
Item Order Code: ILA23AE I/LA37* | Analytical Performance Characteristics and Clinical Utility of
Immunological Assays for Human Immunoglobulin E (IgE) Antibodies
I/LA25* | Maternal Serum Screening, 2nd Edition and Defined Allergen Specificities, 1st Edition
Item Order Code: ILA25A2E Item Order Code: ILA37Ed1E
I/LA26 | Performance of Single Cell Immune Response Assays,
2nd Edition
Item Order Code: ILA26A2

CLSI Catalog 2018

Help shape the standards that impact your day-to-day work.
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Method Evaluation
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EP05 | Evaluation of Precision of Quantitative Measurement Procedures, EP18* | Risk Management Techniques to Identify and Control Laboratory
3rd Edition Error Sources, 2nd Edition
Item Order Code: EP05A3 Item Order Code: EP18A2E
EP06* | Evaluation of the Linearity of Quantitative Measurement EP19* | A Framework for Using CLSI Documents to Evaluate Clinical
Procedures: A Statistical Approach, 1st Edition Laboratory Measurement Procedures, 2nd Edition
Item Order Code: EP06AE Item Order Code: EP19Ed2E
EP07* | Interference Testing in Clinical Chemistry, 2nd Edition EP21 | Evaluation of Total Analytical Error for Quantitative Medical
Item Order Code: EP07A2E Laboratory Measurement Procedures, 2nd Edition
Item Order Code: EP21Ed2
EP10* | Preliminary Evaluation of Quantitative Clinical Laboratory
Measurement Procedures, 3rd Edition EP23™ | Laboratory Quality Control Based on Risk Management,
Item Order Code: EP10A3AMDE 1st Edition
Item Order Code: EP23A
EP12* | User Protocol for Evaluation of Qualitative Test Performance,
2nd Edition EP24* | Assessment of the Diagnostic Accuracy of Laboratory Tests Using
Item Order Code: EP12A2E Receiver Operating Characteristic Curves, 2nd Edition
Item Order Code: EP24A2E
EP14 | Evaluation of Commutability of Processed Samples, 3rd Edition
Item Order Code: EP14A3 EP25* | Evaluation of Stability of In Vitro Diagnostic Reagents,
1st Edition
EP15 | User Verification of Precision and Estimation of Bias, Item Order Code: EP25AE
3rd Edition
Item Order Code: EP15A3 EP26 | User Evaluation of Between-Reagent Lot 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 for Quantitative
Item Order Code: EP17A2 Diagnostic Assays, 1st Edition
Item Order Code: EP27AE

CLSI Catalog 2018

EP28 | Defining, Establishing, and Verifying Reference Intervals in the EP32* | Metrological Traceability and Its Implementation, 1st Edition
Clinical Laboratory, 3rd Edition Item Order Code: EP32Ed1E
Item Order Code: EP28A3C
EP33 | Use of Delta Checks in the Medical Laboratory, 1st Edition
EP29* | Expression of Measurement Uncertainty in Laboratory Medicine, Item Order Code: EP33Ed1
1st Edition
Item Order Code: EP29AE EP36* | Harmonization of Symbology and Equations, 1st Edition
Item Order Code: EP36Ed1E
EP30* | Characterization and Qualification of Commutable Reference Free report!
Materials for Laboratory Medicine, 1st Edition
Item Order Code: EP30AE
EP31* | Verification of Comparability of Patient Results Within One
Health Care System, 1st Edition (Interim Revision)
Item Order Code: EP31AIRE

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Microbiology
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M02 | Performance Standards for Antimicrobial Disk Susceptibility Tests, M27 | Reference Method for Broth Dilution Antifungal Susceptibility
13th Edition Testing of Yeasts, 4th Edition
Item Order Code: M02Ed13 Item Order Code: M27Ed4
M07 | Methods for Dilution Antimicrobial Susceptibility Tests for M28 | Procedures for the Recovery and Identification of Parasites From
Bacteria That Grow Aerobically, 11th Edition the Intestinal Tract, 2nd Edition
Item Order Code: M07Ed11 Item Order Code: M28A2
M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic M29 | Protection of Laboratory Workers From Occupationally Acquired
Bacteria, 8th Edition Infections, 4th Edition
Item Order Code: M11A8 Item Order Code: M29A4
M15* | Laboratory Diagnosis of Blood-borne Parasitic Diseases, M34* | Western Blot Assay for Antibodies to Borrelia burgdorferi,
1st Edition 1st Edition
Item Order Code: M15AE Item Order Code: M34AE
M22 | Quality Control for Commercially Prepared Microbiological Culture M35 | Abbreviated Identification of Bacteria and Yeast, 2nd Edition
Media, 3rd Edition Item Order Code: M35A2
Item Order Code: M22A3
M36* | Clinical Use and Interpretation of Serologic Tests for Toxoplasma
M23 | Development of In Vitro Susceptibility Testing Criteria and Quality gondii, 1st Edition
Control Parameters, 5th Edition Item Order Code: M36AE
Item Order Code: M23Ed5
M38 | Reference Method for Broth Dilution Antifungal Susceptibility
M24 | Susceptibility Testing of Mycobacteria, Nocardiae, and Other Testing of Filamentous Fungi, 3rd Edition
Aerobic Actinomycetes, 2nd Edition Item Order Code: M38Ed3
Item Order Code: M24A2
M39 | Analysis and Presentation of Cumulative Antimicrobial
M26* | Methods for Determining Bactericidal Activity of Antimicrobial Susceptibility Test Data, 4th Edition
Agents, 1st Edition Item Order Code: M39A4
Item Order Code: M26AE

CLSI Catalog 2018

M40 | Quality Control of Microbiological Transport M53* | Criteria for Laboratory Testing and Diagnosis of Human
Systems, 2nd Edition Immunodeficiency Virus Infection, 1st Edition
Item Order Code: M40A2 Item Order Code: M53AE
M41* | Viral Culture, 1st Edition M54 | Principles and Procedures for Detection of Fungi in Clinical
Item Order Code: M41AE Specimens—Direct Examination and Culture, 1st Edition
Item Order Code: M54A
M43* | Methods for Antimicrobial Susceptibility Testing for Human
Mycoplasmas, 1st Edition M56 | Principles and Procedures for Detection of Anaerobes in Clinical
Item Order Code: M43AE Specimens, 1st Edition
Item Order Code: M56A
M44 | Method for Antifungal Disk Diffusion Susceptibility Testing of
Yeasts, 2nd Edition M57 | Principles and Procedures for the Development of Epidemiological
Item Order Code: M44A2 Cutoff Values for Antifungal Susceptibility Testing, 1st Edition
Item Order Code: M57Ed1
M45 | Methods for Antimicrobial Dilution and Disk Susceptibility Testing
of Infrequently Isolated or Fastidious Bacteria, 3rd Edition M58 | Methods for the Identification of Cultured Microorganisms
Item Order Code: M45Ed3 Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass
Spectrometry, 1st Edition
M47 | Principles and Procedures for Blood Cultures, 1st Edition Item Order Code: M58Ed1
Item Order Code: M47A
M59 | Epidemiological Cutoff Values for Antifungal Susceptibility Testing,
M48* | Laboratory Detection and Identification of Mycobacteria, 2nd Edition
1st Edition Item Order Code: M59Ed2
Item Order Code: M48AE
M60 | Performance Standards for Antifungal Susceptibility Testing of
M50 | Quality Control for Commercial Microbial Identification Systems, Yeasts, 1st Edition
1st Edition Item Order Code: M60Ed1
Item Order Code: M50A
M61 | Performance Standards for Antifungal Susceptibility Testing of
M51* | Method for Antifungal Disk Diffusion Susceptibility Testing of Filamentous Fungi, 1st Edition
Nondermatophyte Filamentous Fungi, 1st Edition Item Order Code: M61Ed1
Item Order Code: M51AE
M100 | Performance Standards for Antimicrobial Susceptibility Testing,
M52 | Verification of Commercial Microbial Identification and 28th Edition
Antimicrobial Susceptibility Testing Systems, 1st Edition Item Order Code: M100Ed28
Item Order Code: M52Ed1

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Molecular Methods
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MM01* | Molecular Methods for Clinical Genetics and Oncology Testing, MM14 | Design of Molecular Proficiency Testing/External Quality
3rd Edition Assessment, 2nd Edition
Item Order Code: MM01A3E Item Order Code: MM14A2
MM03 | Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition MM17* | Verification and Validation of Multiplex Nucleic Acid Assays,
Item Order Code: MM03Ed3 1st Edition
Item Order Code: MM17AE
MM05* | Nucleic Acid Amplification Assays for Molecular
Hematopathology, 2nd Edition MM18* | Interpretive Criteria for Identification of Bacteria and Fungi by
Item Order Code: MM05A2E DNA Target Sequencing, 1st Edition
Item Order Code: MM18AE
MM06* | Quantitative Molecular Methods for Infectious Diseases,
2nd Edition MM19 | Establishing Molecular Testing in Clinical Laboratory
Item Order Code: MM06A2E Environments, 1st Edition
Item Order Code: MM19A
MM07 | Fluorescence In Situ Hybridization Methods for Clinical
Laboratories, 2nd Edition MM20 | Quality Management for Molecular Genetic Testing,
Item Order Code: MM07A2 1st Edition
Item Order Code: MM20A
MM09 | Nucleic Acid Sequencing Methods in Diagnostic Laboratory
Medicine, 2nd Edition MM21 | Genomic Copy Number Microarrays for Constitutional Genetic
Item Order Code: MM09A2 and Oncology Applications, 1st Edition
Item Order Code: MM21Ed1
MM11* | Molecular Methods for Bacterial Strain Typing, 1st Edition
Item Order Code: MM11AE MM22 | Microarrays for Diagnosis and Monitoring of Infectious Diseases,
1st Edition
MM12* | Diagnostic Nucleic Acid Microarrays, 1st Edition Item Order Code: MM22A
Item Order Code: MM12AE
MM23 | Molecular Diagnostic Methods for Solid Tumors
MM13* | Collection, Transport, Preparation, and Storage of Specimens for (Nonhematological Neoplasms), 1st Edition
Molecular Methods, 1st Edition Item Order Code: MM23Ed1
Item Order Code: MM13AE

CLSI Catalog 2018

 Newborn Screening
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NBS01 | Blood Collection on Filter Paper for Newborn Screening NBS05 | Newborn Screening for Cystic Fibrosis, 1st Edition
Programs, 6th Edition Item Order Code: NBS05A
Item Order Code: NBS01A6
NBS06 | Newborn Blood Spot Screening for Severe Combined
NBS02 | Newborn Screening Follow-up, 2nd Edition Immunodeficiency by Measurement of T-cell Receptor Excision Circles,
Item Order Code: NBS02A2 1st Edition
Item Order Code: NBS06A
NBS03 | Newborn Screening for Preterm, Low Birth Weight, and
Sick Newborns, 1st Edition NBS07 | Newborn Blood Spot Screening for Pompe Disease by Lysosomal
Item Order Code: NBS03A Acid α-Glucosidase Activity Assays, 1st Edition
Item Order Code: NBS07Ed1
NBS04 | Newborn Screening by Tandem Mass Spectrometry, 2nd Edition
Item Order Code: NBS04Ed2

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Making a Difference Through Newborn Screening: Blood Collection on Filter Paper (NBS01A6 DVD)
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This video demonstrates how to:

Based on CLSI Standard NBS01-A6
Prepare for specimen collection.
License Agreement: The content contained in this DVD is copyrighted by CLSI. You may not copy, reproduce,
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

Collect blood specimens using the recommended heelstick technique.

to [email protected].
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property or other rights of another party.

Handle specimens properly and maintain appropriate records.
DVD in an online system; or (g) use any portion of the DVD in any manner that infringes on the intellectual

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.

Transfer specimens to the screening lab in a timely manner.

CLSI’s sole obligation under this warranty is to replace any defective DVD, provided that you give
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newborn
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Prevent testing problems that can delay the newborn’s diagnosis and treatment.
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.

screening Making a Difference Through Newborn Screening:

Blood Collection on Filter Paper
Making a Difference Through Newborn Screening:
Blood Collection on Filter Paper
Based on CLSI Standard NBS01-A6
Members Level I: $90 Level II: $120 Level III: $150
Nonmembers: $300
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2010
Point-of-Care Testing
Document Pricing
Nonmembers: $140 Level II Members: $56 Individual Full Members: $105
Level I Members: $42 Level III Members: $70 Individual Associate Members: $119
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POCT01* | Point-of-Care Connectivity, 2nd Edition POCT09* | Selection Criteria for Point-of-Care Testing Devices,
Item Order Code: POCT01A2E 1st Edition
Item Order Code: POCT09AE
POCT02* | Implementation Guide of POCT01 for Healthcare Providers,
1st Edition POCT10* | Physician and Nonphysician Provider-Performed Microscopy
Item Order Code: POCT02AE Testing, 2nd Edition
Item Order Code: POCT10A2E
POCT04 | Essential Tools for Implementation and Management of a
Point-of-Care Testing Program, 3rd Edition POCT12 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care
Item Order Code: POCT04Ed3 Facilities, 3rd Edition
Item Order Code: POCT12A3
POCT05* | Performance Metrics for Continuous Interstitial Glucose
Monitoring, 1st Edition POCT13 | Glucose Monitoring in Settings Without Laboratory Support,
Item Order Code: POCT05AE 3rd Edition
Item Order Code: POCT13Ed3
POCT06 | Effects of Different Sample Types on Glucose Measurements,
1st Edition POCT14* | Point-of-Care Monitoring of Anticoagulation Therapy,
Item Order Code: POCT06Ed1 1st Edition
Item Order Code: POCT14AE
POCT07* | Quality Management: Approaches to Reducing Errors at the
Point of Care, 1st Edition POCT17* | Use of Glucose Meters for Critically Ill Patients, 1st Edition
Item Order Code: POCT07AE Item Order Code: POCT17Ed1E
POCT08 | Quality Practices in Noninstrumented Point-of-Care Testing:
An Instructional Manual and Resources for Health Care Workers,
1st Edition
Item Order Code: POCT08A

CLSI Catalog 2018

 This year, CLSI proudly celebrates 50 years of service as a voluntary consensus
standards organization for medical laboratory testing. Originally formed as
the National Committee for Clinical Laboratory Standards (NCCLS), the idea for
the committee arose from the technological revolution in clinical laboratory
products in the 1960s. Learn more about the history of CLSI and ways to celebrate with us this year at clsi.org/50years.

AST Standards

International

Partnerships
CLSI Begins

Accredited

50 Years
CLSI was organized In 1977, CLSI was CLSI began CLSI celebrated its CLSI’s Global Health CLSI celebrates 50
in 1968 by accredited by the publishing its most 25th anniversary Partnerships years of service in
representatives American National well-recognized with more than program began the field of public
of the laboratory Standards Institute document, M100, 300 standards providing health as a voluntary
profession, the (ANSI) as a voluntary Performance and guidelines assessment consensus standards
industries that consensus standards Standards for published. CLSI also services, training, organization.
supply and organization. Antimicrobial began working with and technical
support them, Susceptibility the International assistance to
and governmental Testing. Organization for resource-constrained
agencies. Standardization (ISO). laboratories.
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Quality Management Systems
Document Pricing
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Level I Members: $54 Level III Members: $90 Individual Associate Members: $153
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K2Q | The Key to Quality™ Includes fundamental information for QMS12 | Development and Use of Quality Indicators for Process
implementing and sustaining a quality management system. Improvement and Monitoring of Laboratory Quality, 1st Edition
Nonmember Price: $600 Item Order Code: QMS12A
Item Order Code: K2Q
QMS13 | Quality Management System: Equipment, 1st Edition
QMS01 | Quality Management System: A Model for Laboratory Services, Item Order Code: QMS13A
4th Edition
Item Order Code: QMS01A4 QMS14 | Quality Management System: Leadership and Management
Roles and Responsibilities, 1st Edition
QMS02 | Quality Management System: Development and Management QMS14 Executive Summary included with purchase
of Laboratory Documents, 6th Edition Item Order Code: QMS14A
Item Order Code: QMS02A6
QMS15 | Assessments: Laboratory Internal Audit Program, 1st Edition
QMS03 | Training and Competence Assessment, 4th Edition Item Order Code: QMS15A
Item Order Code: QMS03Ed4
QMS16 | Laboratory Personnel Management, 1st Edition
QMS04 | Laboratory Design, 3rd Edition Item Order Code: QMS16Ed1
Item Order Code: QMS04Ed3
QMS17 | External Assessments, Audits, and Inspections of the
QMS05 | Quality Management System: Qualifying, Selecting, and Laboratory, 1st Edition
Evaluating a Referral Laboratory, 2nd Edition Item Order Code: QMS17Ed1
Item Order Code: QMS05A2
QMS18 | Process Management, 1st Edition
QMS06 | Quality Management System: Continual Improvement, Item Order Code: QMS18Ed1
3rd Edition
Item Order Code: QMS06A3 QMS19 | Customer Focus in a Quality Management System, 1st Edition
Item Order Code: QMS19Ed1
QMS11 | Nonconforming Event Management, 2nd Edition
Item Order Code: QMS11Ed2 QMS20 | Understanding the Cost of Quality in the Laboratory, 1st Edition
Item Order Code: QMS20Ed1

CLSI Catalog 2018

QMS21 | Purchasing and Inventory Management, 1st Edition QMS25 | Handbook for Developing a Laboratory Quality Manual,
Item Order Code: QMS21Ed1 1st Edition
Item Order Code: QMS25Ed1
QMS24 | Using Proficiency Testing and Alternative Assessment to
Improve Medical Laboratory Quality, 3rd Edition QSR LDT | Quality System Regulations for Laboratory Developed Tests:
Item Order Code: QMS24Ed3 A Practical Guide for the Laboratory
Item Order Code: QSRLDT

Make Quality a Standard Practice With CLSI Products and Programs

The Key to Quality™ Laboratory Quality Management System

Find the guidance you need to develop a QMS (LQMS) Certificate Program
infrastructure with these fundamental resources for Learn the fundamentals for implementing and
implementing a QMS in your lab. sustaining a QMS based on The Key to Quality™ in our
Includes: online 12-part certificate program.

• Resources for each of the 12 quality system Features:

essentials (QSEs) for building a QMS • In-depth learning focused on each of the 12 QSEs
• The policies, processes, and procedures requirements • Ways to meet accreditation quality requirements
for each QSE
• A certificate and 13 P.A.C.E.® CE credits after
• Examples for how to apply the 12 QSEs in your completion of the program
unique laboratory environment
Nonmember Price: $500. Member discounts apply.
Nonmember Price: $600. Member discounts apply.
Visit clsi.org/LQMS for more information.
Visit clsi.org/K2Q to learn more.

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Veterinary Medicine
Document Pricing
Nonmembers: $140 Level II Members: $56 Individual Full Members: $105
Level I Members: $42 Level III Members: $70 Individual Associate Members: $119
* Available as PDF download only.

VET01 | Performance Standards for Antimicrobial Disk and Dilution VET04 | Methods for Broth Dilution Susceptibility Testing of Bacteria
Susceptibility Tests for Bacteria Isolated From Animals, 4th Edition Isolated From Aquatic Animals, 2nd Edition
Item Order Code: VET01A4 Item Order Code: VET04A2
VET01S | Performance Standards for Antimicrobial Disk and Dilution VET03/VET04S* | Performance Standards for Antimicrobial Susceptibility
Susceptibility Tests for Bacteria Isolated From Animals, 3rd Edition Testing of Bacteria Isolated From Aquatic Animals, 2nd Edition
Item Order Code: VET01SEd3 Item Order Code: VET03VET04S2E
VET02 | Development of In Vitro Susceptibility Testing Criteria and VET05* | Generation, Presentation, and Application of Antimicrobial
Quality Control Parameters for Veterinary Antimicrobial Agents, Susceptibility Test Data for Bacteria of Animal Origin, 1st Edition
3rd Edition Item Order Code: VET05Ed1E
Item Order Code: VET02A3
VET06 | Methods for Antimicrobial Susceptibility Testing of Infrequently
VET03* | Methods for Antimicrobial Disk Susceptibility Testing of Isolated or Fastidious Bacteria Isolated From Animals, 1st Edition
Bacteria Isolated From Aquatic Animals, 1st Edition Item Order Code: VET06Ed1
Item Order Code: VET03AE

CLSI Is Now Offering VET01S Free Online!

CLSI is offering new ways to access the VET01S supplement data you need, when
and where you need it.
Free VET01S Data: Quickly reference the most trusted antimicrobial
susceptibility testing (AST) veterinary breakpoint tables as a convenient,
complimentary supplement to the AST standard VET01.
Visit clsi.org/education/microbiology for access.

CLSI Catalog 2018

 Explore CLSI standards with eCLIPSE Ultimate Access™, an enhanced, premium platform with advanced features.
• Unlimited – 24/7 online access • Accessible – Download PDFs for offline use
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CLSI Membership
Advance laboratory quality
in your own organization
—and worldwide.

What will CLSI membership offer you and your organization?

CLSI membership lets you directly impact best practice standards used to improve patient care worldwide—standards you use every day. It’s your way to
stay up-to-date on the latest laboratory quality improvements. It’s your opportunity to connect with colleagues across the globe.

Standards Development Opportunities Members-only Access

• Propose new projects that are needed by • Access and be listed in our searchable online
your organization and the global laboratory member directory.

The Benefits community.

• Volunteer or nominate candidates to help
Ensure your company is listed among the top labs.
• Use our online member resource center.
develop our consensus-based standards. Includes accreditation resources to help you meet
of Membership • Vote on documents to ensure they meet the
needs of the laboratory community.
requirements and more.
• Receive our monthly Membership Newsletter.
• Serve as a voting member in governance officer Get updates about new publications, volunteer
elections and CLSI Bylaws. and voting opportunities, and other members-
only events.

CLSI Catalog 2018

Select the membership option that is right for you and your organization.
Level I–Gold Level II–Silver
Premium-level access for all High-level access for one site
sites in your organization. Gold in your organization. Silver
Membership allows all users Membership lets companies stay
to access the full library of CLSI up-to-date on the latest standards.
standards online in our searchable A good option for members who
platform, eCLIPSE. Empower your have been CLSI subscribers for
staff with the documents they many years and have a small staff.
need, when they need them.

Level III–Bronze Individuals

Starter access for one site in your Individuals may apply for CLSI
organization. Bronze Membership membership if their organization
allows small organizations to or place of employment is not a
stay on budget and still select the member of CLSI. Our Individual
resources they need to attain the Membership provides an affordable
highest levels of quality. All Bronze option for anyone who is interested
Members receive a 50% discount in supporting or volunteering for
on products so they can build a CLSI.
standards library customized to
their needs.

Visit clsi.org/membership to learn more and join.

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