CATALOG

2017/2018
Set the Standard for Quality
in Your Laboratory With CLSI

2017/2018 www.clsi.org
Recently Published Documents
NBS04 | Newborn Screening by Tandem Mass Spectrometry, GP48 | Essential Elements of a Phlebotomy Training Program, 1st Edition
2nd Edition This guideline is a resource for health care professionals and educators
This guideline serves as a reference for the multiple activities related to for development and implementation of curricula for phlebotomy
operating a tandem mass spectrometry laboratory as part of public and training programs and courses.
private newborn screening programs. Published: April 2017 Item Order Code: GP48-ED1
Published: May 2017 Item Order Code: NBS04-ED2

M58 | Methods for the Identification of Cultured Microorganisms NBS07 | Newborn Blood Spot Screening for Pompe Disease by Lysosomal
Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Acid α-Glucosidase Activity Assays, 1st Edition
Spectrometry, 1st Edition This report discusses the detection of Pompe disease (PD) by
This guideline includes performance, reporting, and quality assurance population-based newborn screening using dried blood spot specimens
recommendations for the identification of cultured microorganisms by to measure acid α-glucosidase enzyme activity. Classic infantile-
medical laboratory professionals using matrix-assisted laser desorption/ onset PD is a lethal disorder that is not evident at birth, and therapy
ionization time-of-flight mass spectrometry. Recommendations for effectiveness is improved by presymptomatic detection.
end-user verification and workflow integration are also included. Published: March 2017 Item Order Code: NBS07-ED1
Published: April 2017 Item Order Code: M58-ED1

GP41 | Collection of Diagnostic Venous Blood Specimens, 7th Edition C52 | Toxicology and Drug Testing in the Medical Laboratory, 3rd Edition
This standard provides procedures for the collection of diagnostic This guideline provides an overview of drug testing by medical
venous blood specimens, including line draws, blood culture collection, laboratories, including testing for drugs of abuse. It discusses the
and venipuncture in children. preexamination, examination, and postexamination considerations
Published: April 2017 Item Order Code: GP41-ED7 for specimen collection, methods of analysis, and the reporting and
interpretation of results.
Published: January 2017 Item Order Code: C52-ED3

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M100 | Performance Standards for Antimicrobial Susceptibility Testing, QMS21 | Purchasing and Inventory Management, 1st Edition
27th Edition This guideline describes effective purchasing and inventory
This document provides updated tables for the Clinical and Laboratory management processes, which ensure availability of the appropriate
Standards Institute antimicrobial susceptibility testing standards equipment, instruments, reagents, consumable materials, other
M02-A12, M07-A10, and M11-A8. products, and services procured from external sources needed for
Published: January 2017 Item Order Code: M100-S27 providing quality laboratory services.
Published: November 2016 Item Order Code: QMS21-ED1

VET06 | Methods for Antimicrobial Susceptibility Testing of Infrequently I/LA20 | Analytical Performance Characteristics, Quality Assurance, and
Isolated or Fastidious Bacteria Isolated From Animals, 1st Edition Clinical Utility of Immunological Assays for Human Immunoglobulin E
This document provides guidance for antimicrobial agent disk and Antibodies of Defined Allergen Specificities, 3rd Edition
dilution susceptibility testing, criteria for quality control testing, and This report provides guidance for the design, analytical performance,
breakpoints for fastidious and infrequently tested bacteria for standardization, quality assurance, and clinical application of laboratory
veterinary use. assays used in the measurement of human immunoglobulin E
Published: January 2017 Item Order Code: VET06-ED1 antibodies of defined allergen specificity.
Published: October 2016 Item Order Code: I/LA20-ED3

QMS25 | Handbook for Developing a Laboratory Quality Manual, I/LA37 | Supplemental Data for Allergen Specificity for IgE Antibody
1st Edition Autoanalyzers
This handbook assists laboratories in developing a quality manual— This database provides a harmonized listing of the allergen codes
a vital component of implementing and maintaining a complete currently used by immunoglobulin E antibody assay manufacturers,
laboratory quality management system. along with their common name, Latin name, and allergen grouping.
Published: January 2017 Item Order Code: QMS25-ED1 Published: October 2016 Item Order Code: I/LA37

QMS03 | Training and Competence Assessment, 4th Edition QMS24 | Using Proficiency Testing and Alternative Assessment to Improve
This guideline provides a structured approach for developing effective Medical Laboratory Quality, 3rd Edition
laboratory personnel training and competence assessment programs. This guideline describes a complete proficiency testing (PT) process to
Published: December 2016 Item Order Code: QMS03-ED4 assist laboratories in using PT as a quality improvement tool.
Published: September 2016 Item Order Code: QMS24-ED3

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New M100 Resources
The Go-to Gold Standard in Antimicrobial Susceptibility Testing (AST)
For over 30 years, the microbiology community has relied on 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

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

Why Make CLSI’S M100 Your Reference of Choice?

Not only has CLSI long been the world-leading provider of AST breakpoints, methods, and quality control standards, but we are
also the only organization in the world designated as a World Health Organization collaborating center for creation of medical
laboratory standards. CLSI is also the only organization of its kind with an inclusive, transparent standards development process.
Through equal balance of input among industry, government, and health care professionals, we protect against the threat of
opaque decision-making and conflicted data.
CLSI Upcoming Publications
GP49 | Developing and Managing a Medical Laboratory (Test) Utilization C49 | Analysis of Body Fluids in Clinical Chemistry, 2nd Edition
Management Program, 1st Edition This guideline provides information for the medical laboratory for evaluating
This report provides guidance for initiating, developing, and maintaining an measurement procedures, as well as a strategy to characterize assay
effective test utilization program. 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.
QMS17 | External Assessments, Audits, and Inspections of the Laboratory,
1st Edition
This guideline provides recommendations for establishing and maintaining a QMS19 | Customer Focus in a Quality Management System, 1st Edition
process to assist the laboratory in achieving a continuous state of readiness This guideline provides useful information for how laboratories can develop
for assessment by an external organization. This includes selecting and and maintain a customer focus and meet the regulatory and accreditation
evaluating an external assessment organization, preparing and undergoing a requirements for managing external and internal customers.
successful assessment, and sustaining ongoing readiness for assessment.

2018 AST Package

M100 | Performance Standards for Antimicrobial Susceptibility Testing, 28th Edition
This document includes updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02, M07,
and M11.

M02 | Performance Standards for Antimicrobial Disk Susceptibility M07 | Methods for Dilution Antimicrobial Susceptibility Tests for
Tests, 13th Edition Bacteria That Grow Aerobically, 11th Edition
This standard contains the currently recommended methods for This standard contains reference methods for the determination
disk susceptibility testing and criteria for quality control testing. of minimal inhibitory concentrations of aerobic bacteria by broth
macrodilution, broth microdilution, and agar dilution.

Visit clsi.org/standards for our latest publications.

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EP23 enables laboratories to perform “The Right QC” based on unique risks identified
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Method Validation and Verification Method Correlation Proficiency Testing Adverse and Nonconforming Events Controls: Mean and Standard
Deviation

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 Buy Now and Get a Free Membership
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Specimen and Reagent Storage Personnel Records, Responsibilities, Lab Director Responsibilities Waived and Quantitative QC Patient and Specimen Identification
and Competence
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Automation and Informatics
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. Documents listed in gray are no longer being reviewed as part of our consensus process.

AUTO01* | Laboratory Automation: Specimen Container/Specimen AUTO10* | Autoverification of Clinical Laboratory Test Results,
Carrier, 1st Edition 1st Edition
Item Order Code: AUTO01-A Item Order Code: AUTO10-A
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: AUTO02-A2 Item Order Code: AUTO11-A2
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: AUTO12-A
Item Order Code: AUTO03-A2
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: AUTO04-A Item Order Code: AUTO13-A2
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: AUTO05-A 2nd Edition
Item Order Code: LIS01-A2
AUTO07* | Laboratory Automation: Data Content for Specimen
Identification, 1st Edition LIS02* | Specification for Transferring Information Between Clinical
Item Order Code: AUTO07-A Instruments and Computer Systems, 2nd Edition
Item Order Code: LIS02-A2
AUTO08 | Managing and Validating Laboratory Information Systems,
1st Edition LIS04* | Standard Guide for Documentation of Clinical Laboratory
Item Order Code: AUTO08-A Computer Systems, 1st Edition
Item Order Code: LIS04-A
AUTO09* | Remote Access to Clinical Laboratory Diagnostic Devices
via the Internet, 1st Edition
Item Order Code: AUTO09-A
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 Clinical Chemistry and Toxicology
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. Documents listed in gray are no longer being reviewed as part of our consensus process.

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: C24-ED4 Item Order Code: C40-A2
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: C42-A
Second Edition
Item Order Code: C29-A2 C43* | Gas Chromatography/Mass Spectrometry Confirmation of
Drugs, 2nd Edition
C31* | Ionized Calcium Determinations: Precollection Variables, Item Order Code: C43-A2
Specimen Choice, Collection, and Handling, 2nd Edition
Item Order Code: C31-A2 C45* | Measurement of Free Thyroid Hormones, 1st Edition
Item Order Code: C45-A
C34* | Sweat Testing: Sample Collection and Quantitative Chloride
Analysis, 3rd Edition C46 | Blood Gas and pH Analysis and Related Measurements,
Item Order Code: C34-A3 2nd Edition
Item Order Code: C46-A2
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: C37-A Item Order Code: C48-A

C38* | Control of Preanalytical Variation in Trace Element C49 | Analysis of Body Fluids in Clinical Chemistry, 1st Edition
Determinations, 1st Edition Item Order Code: C49-A
Item Order Code: C38-A 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: C50-A
Item Order Code: C39-A

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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: C52-ED3 Item Order Code: C58-A
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: C56-A Item Order Code: C61-A
C57 | Mass Spectrometry for Androgen and Estrogen Measurements in C62* | Liquid Chromatography-Mass Spectrometry Methods,
Serum, 1st Edition 1st Edition
Item Order Code: C57-ED1 Item Order Code: C62-A

Quality System Regulation for

Laboratory-Developed Tests

1 4

Management Responsibility
Chapter 1:
A Practical Guide for the Laboratory

11
Management Design

Be Fully Prepared
Labeling andResponsibility
Packaging Controls
Controls
15 Servicing

for Compliance With LDT Development

Servicing
Chapter 15:
Packaging Controls
Chapter 11: Labeling and

Design Controls
Chapter 4:
Order CLSI QSR LDT practical guide today. Visit clsi.org/standards for more information.
 General Laboratory
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. Documents listed in gray are no longer being reviewed as part of our consensus process.

GP05* | Clinical Laboratory Waste Management, 3rd Edition GP39* | Tubes and Additives for Venous and Capillary Blood Specimen
Item Order Code: GP05-A3 Collection, 6th Edition
Item Order Code: GP39-A6
GP15* | Cervicovaginal Cytology Based on the Papanicolaou Technique,
3rd Edition GP40 | Preparation and Testing of Reagent Water in the Clinical
Item Order Code GP15-A3 Laboratory, 4th Edition
Item Order Code: GP40-A4-AMD
GP16 | Urinalysis, 3rd Edition
Item Order Code: GP16-A3 GP41 | Collection of Diagnostic Venous Blood Specimens, 7th Edition
Item Order Code: GP41-ED7
GP17 | Clinical Laboratory Safety, 3rd Edition
Item Order Code: GP17-A3 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: GP42-A6
Item Order Code: GP20-A2
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: GP44-A4
Item Order Code: GP23-A2
GP45* | Studies to Evaluate Patient Outcomes, 1st Edition
GP31 | Laboratory Instrument Implementation, Verification, and Item Order Code: GP45-A
Maintenance, 1st Edition
Item Order Code: GP31-A GP47 | Management of Critical- and Significant-Risk Results, 1st Edition
Item Order Code: GP47-ED1
GP33* | Accuracy in Patient and Sample Identification, 1st Edition
Item Order Code: GP33-A GP48 | Essential Elements of a Phlebotomy Training Program, 1st Edition
Item Order Code: GP48-ED1
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: GP34-A Management Program, 1st Edition
Item Order Code: GP49-ED1
GP36 | Planning for Laboratory Operations During a Disaster, 1st Edition
Item Order Code: GP36-A
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 CLSI Partnerships
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The results of GHP’s efforts are readily seen throughout the world. By enabling laboratories to bring their practices up
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Learn more or get involved with our team at clsi.org/partnerships.
 Hematology
Document Pricing
Nonmembers: $140 Level II Members: $56 Individual Full Members: $105
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* Available as PDF download only. Documents listed in gray are no longer being reviewed as part of our consensus process.

H02* | Procedures for the Erythrocyte Sedimentation Rate Test, H43* | Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid
5th Edition Cells, 2nd Edition
Item Order Code: H02-A5 Item Order Code: H43-A2
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: H07-A3 Item Order Code: H47-A2
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: H15-A3 Item Order Code: H48-ED2
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: H20-A2 Item Order Code: H52-A2
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: H54-A
Item Order Code: H21-A5
H56 | Body Fluid Analysis for Cellular Composition, 1st Edition
H26 | Validation, Verification, and Quality Assurance of Automated Item Order Code: H56-A
Hematology Analyzers, 2nd Edition
Item Order Code: H26-A2 H57* | Protocol for the Evaluation, Validation, and Implementation of
Coagulometers, 1st Edition
H30* | Procedure for the Determination of Fibrinogen in Plasma, Item Order Code: H57-A
2nd Edition
Item Order Code: H30-A2 H58* | Platelet Function Testing by Aggregometry, 1st Edition
Item Order Code: H58-A
H42* | Enumeration of Immunologically Defined Cell Populations by
Flow Cytometry, 2nd Edition
Item Order Code: H42-A2
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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: H60-A
Item Order Code: H59-A

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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
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Making a Difference Through Newborn Screening: Blood Collection on Filter Paper (NBS01-A6 DVD)
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Collect blood specimens using the recommended heelstick technique.

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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
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