Clsi 2015-catalog

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2015
2016
CATALOG

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Quality System Regulation for
Laboratory-Developed Tests
A Practical Guide for the Laboratory
January 2015
M100-S25
Performance Standards for Antimicrobial
Susceptibility Testing; Twenty-Fifth
Informational Supplement
January 2015
M07-A10
Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically; Approved Standard —Tenth
Edition
January 2015
M02-A12
Performance Standards for Antimicrobial
Disk Susceptibility Tests; Approved
Standard—Twelfth Edition
Recently
Published
From CLSI
New and revised standards on timely clinical laboratory topics.
M100-S25*
Performance Standards for
Antimicrobial Susceptibility Testing;
Twenty-Fifth Informational Supplement
M07-A10*
Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That
Grow Aerobically; Approved Standard—
Tenth Edition
M02-A12*
Performance Standards for
Antimicrobial Disk Susceptibility Tests;
Approved Standard—Twelfth Edition
This document provides updated tables for the Clinical and
Laboratory Standards Institute antimicrobial susceptibility
testing standards M02-A11, M07-A9, and M11-A8.
A standard for global application developed through the Clinical and Laboratory Standards
Institute consensus process.
EP15-A3
User Verification of Precision and
Estimation of Bias; Approved Guideline—
Third Edition
September 2014
GP23-A2
Nongynecological Cytology Specimens:
Preexamination, Examination, and
Postexamination Processes; Approved
Guideline—Second Edition
November 2014
GP36-A
Planning for Laboratory Operations During
a Disaster; Approved Guideline
December 2014
EP15-A3
User Verification of Precision and
Estimation of Bias; Approved Guideline—
Third Edition
GP23-A2
Nongynecological Cytology Specimens:
Preexamination, Examination, and
Postexamination Processes; Approved
GP36-A
Planning for Laboratory Operations
During a Disaster; Approved Guideline
POCT06
Effects of Different Sample Types on Glucose
Measurements
1st Edition
C57
Mass Spectrometry for Androgen and
Estrogen Measurements in Serum
1st Edition
POCT13
Glucose Monitoring in Settings Without
Laboratory Support
3rd Edition
POCT06-Ed1
Effects of Different Sample Types on
Glucose Measurements, 1st Edition
C57-Ed1
Mass Spectrometry for Androgen and
Estrogen Measurements in Serum,
1st Edition
POCT13-Ed3
Glucose Monitoring in Settings Without
Laboratory Support, 3rd Edition
3rd Edition
MM03
Molecular Diagnostic Methods for
Infectious Diseases
1st Edition
QMS18
Process Management
MM03-Ed3
Molecular Diagnostic Methods for
Infectious Diseases, 3rd Edition
QMS18-Ed1
Process Management, 1st Edition
QSR LDT
Laboratory-Developed Tests: A Practical
Guide for the Laboratory
*These documents are sold only in packages of M02 and M100; M07 and M100;
and M02, M07, and M100.
April 2015
MM23
Molecular Diagnostic Methods for Solid
Tumors (Nonhematological Neoplasms)
MM23-Ed1
Molecular Diagnostic Methods for Solid
Tumors (Nonhematological Neoplasms),
1st Edition
EP05-A3
Evaluation of Precision of Quantitative
Measurement Procedures; Approved
Guideline—Third Edition
October 2014
EP05-A3
Evaluation of Precision of Quantitative
Measurement Procedures; Approved

2015/2016
Table of Contents
Document Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Index of CLSI Standards and Companion Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Catalog Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Document and Product Listings by Category
Accreditation Preparedness – Essentials for Verifying Test Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Accreditation Preparedness – Laboratory Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Automation and Informatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Clinical Chemistry and Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Hematology and Coagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Immunology and Ligand Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Microbiology Methodologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Molecular Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Newborn Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Phlebotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Point-of-Care Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Quality Management Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Reducing Risk.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Specimen Handling and Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Susceptibility Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Veterinary Medicine.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Coming Soon.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Featured Products
Quality System Regulation for Laboratory-Developed Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
eM100.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
CLSI Communities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
The Key to Quality™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Online Learning Programs.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
eCLIPSE™ Ultimate Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Infobase™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
CLSI Course Offerings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Order Form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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Former Document
Code
New Document
Code
Automation and Informatics
GP19-A2 AUTO13-A2
Clinical Chemistry and Toxicology
H17-A C61-A
General Laboratory
H01-A6 GP39-A6
C03-A4-AMD GP40-A4-AMD
H03-A6 GP41-A6
H04-A6 GP42-A6
H11-A4 GP43-A4
H18-A4 GP44-A4
HS06-A GP45-A
Method Evaluation
C28-A3c EP28-A3c
C51-A EP29-A
C53-A EP30-A
C54-A-IR EP31-A-IR
X05-R EP32-R
Former Document
Code
New Document
Code
Microbiology
X07-R M55-R
Newborn Screening
LA04-A5 NBS01-A6*
I/LA27-A NBS02-A2*
I/LA31-A NBS03-A
I/LA32-A NBS04-A
I/LA35-A NBS05-A
Point-of-Care Testing
AST04-A2 POCT13-A2
H49-A POCT14-A
Quality Management Systems
GP26-A4 QMS01-A4
GP02-A5 QMS02-A6*
GP21-A3 QMS03-A3
GP18-A2 QMS04-A2
GP09-A2 QMS05-A2
GP22-A3 QMS06-A3
Former Document
Code
New Document
Code
Quality Management Systems (continued)
HS04-A2 QMS07-A2
HS11-A QMS10-A
GP32-A QMS11-A
GP35-A QMS12-A
GP37-A QMS13-A
GP38-A QMS14-A
GP38-AES QMS14-AES
Veterinary Medicine
M31-A3 VET01-A4
M37-A3 VET02-A3
M42/M49-S1 VET03/VET04-S2
M42-A VET03-A
M49-A VET04-A2
X08-R VET05-R
In order to better classify our library of documents, CLSI expanded and color coded
its document categories. The assigned colors are prominently displayed on each CLSI
document cover.
The document categories are:
As part of this initiative, some CLSI documents were assigned new codes to reflect their categories. See below for the
complete list of affected documents, or visit www.clsi.org.
* These documents replaced the respective standards noted in the “Former Document Code” column.
General Laboratory
Hematology
Immunology and Ligand Assay
Method Evaluation
Microbiology
Molecular Methods
Newborn Screening
Veterinary Medicine
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DOCUMENTCATEGORIES

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Be Prepared to Comply Using CLSI. Let CLSI Guide You
Through the FDA Proposed Requirements for LDTs!
Labs that perform LDTs will be held accountable to the same
standards as IVD manufacturers.
CLSI has the resources you need to
prepare for the FDA’s proposed guidance!
You can find essential information in our practical guide, Quality
System Regulation for Laboratory-Developed Tests (QSR LDT).
HOW
WHERE
THEY AFFECT
YOUR ORGANIZATION
YOU CAN FIND
INFORMATION
Order the QSR LDT Practical Guide Today! Visit www.clsi.org/LDTs.
Through FDA’s proposed phased-in implementation, after 12
months, enforcement of premarket review requirements for the
highest-risk LDTs begins.
WHEN THEY WILL
GO INTO EFFECT
EP19—A Framework for
Using CLSI Documents to
Evaluate Clinical Laboratory
Measurement Procedures
QSR LDT—Quality System
Regulation for Laboratory-
DevelopedTests: A Practical
Guide for the Laboratory
Learn how to validate LDTs to
establish product performance
claims as part of your submission
packets to the FDA.
Learn how the proposed changes
for the FDA QSReg for LDTs differs
from current CLIA requirements,
and what your lab should do to
prepare.
Members LI: $90 LII: $120 LIII: $150 Nonmembers: $300FREE!
Laboratory-Developed Tests
A Practical Guide for the Laboratory
JUNE 2015 January 2015
This report uses the “measurement procedure lifecycle”
framework to aid users of CLSI evaluation protocols
documents during establishment and implementation of
measurement procedures developed by both commercial
manufacturers and clinical laboratories, ie, for laboratory-
developed tests.
A CLSI report for global application
EP19
A Framework for Using CLSI Documents
to Evaluate Clinical Laboratory
Measurement Procedures
2nd Edition
1
2
3

Document Code Document Title Location Format
AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Online PDF
AUTO02-A2
Laboratory Automation: Bar Codes for Specimen Container Identification; Approved
Standard—Second Edition
Online PDF
AUTO03-A2
Laboratory Automation: Communications With Automated Clinical Laboratory Systems,
Instruments, Devices, and Information Systems; Approved Standard—Second Edition
Online PDF
AUTO04-A
Laboratory Automation: Systems Operational Requirements, Characteristics, and
Information Elements; Approved Standard
Online PDF
AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard Online PDF
AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard Online PDF
AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline Online PDF and Print
AUTO09-A
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved
Standard
Online PDF
AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline Online PDF
AUTO11-A2
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems;
Approved Standard—Second Edition
Pg. 22 PDF and Print
AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard Pg. 22 PDF and Print
AUTO13-A2
Laboratory Instruments and Data Management Systems: Design of Software User
Interfaces and End-User Software Systems Validation, Operation, and Monitoring;
Approved Guideline—Second Edition
Online PDF
I/LA33-A
Validation of Automated Systems for Immunohematological Testing Before
Implementation; Approved Guideline
Pg. 28 PDF
I/LA33-A TK
Implementation—Sample Templates and Test Cases Toolkit
Pg. 28 CD
LIS01-A2
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory
Instruments and Computer Systems; Approved Standard—Second Edition
Online PDF
LIS02-A2
Specification for Transferring Information Between Clinical Laboratory Instruments and
Information Systems; Approved Standard—Second Edition
Online PDF
LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System Online PDF
LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems Online PDF
LIS05-A
Standard Specification for Transferring Clinical Observations Between Independent
Computer Systems
Online PDF
LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems Online PDF
LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory Online PDF
LIS08-A
Standard Guide for Functional Requirements of Clinical Laboratory Information
Management Systems
Online PDF
LIS09-A
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic
Health Record Environment and Networked Architectures
Online PDF
All CLSI standards, guidelines, and companion products are listed in the index below. Various
documents are located in the catalog, and a corresponding page number is indicated in the “Location”
column. All other documents are available on the CLSI website at www.clsi.org, and are indicated with
“Online” in the “Location” column below.
Index of CLSI Standards and Companion Products

INDEX
C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and
Definitions; Approved Guideline—Third Edition
Pg. 18, 24 PDF and Print
C29-A2
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame
Photometric Reference Method; Approved Standard—Second Edition
Online PDF
C31-A2
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and
Handling; Approved Guideline—Second Edition
Online PDF
C34-A3
Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved
Pg. 24 PDF
C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
Online PDF
C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline Online PDF and Print
C39-A
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum;
Approved Standard
Online PDF
C40-A2
Measurement Procedures for the Determination of Lead Concentrations in Blood and
Urine; Approved Guideline—Second Edition
C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF
C43-A2
Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—
Second Edition
Online PDF
C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF
C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second
Edition
C48-A
Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring
of Bone Diseases; Approved Guideline
Online PDF
C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Pg. 24 PDF and Print
C49-A/H56-A QG Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Pg. 24 Print
C50-A
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved
Guideline
Online PDF
C52-A2
Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second
Edition
Online PDF and Print
C56-A
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical
Laboratory Analysis; Approved Guideline
C56-A QG Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Pg. 25 PDF and Print
C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition Pg. 25 PDF and Print
C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline Online PDF
C61-A
Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin
Saturation; Approved Standard
Online PDF
C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline Pg. 25 PDF and Print
EP05-A3
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—
Third Edition
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical
Approach; Approved Guideline
EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print
EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples;
Approved Guideline—Third Edition
EP10-A3-AMD
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures;
EP12-A2
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—
Second Edition
Online PDF
EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print

INDEX
EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;
EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved
EP19-Ed2
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement
Procedures, 2nd Edition
Pg. 4, 57 PDF
EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print
EP24-A2
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating
Characteristic Curves; Approved Guideline—Second Edition
EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF
EP28-A3c
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory;
EP30-A
Characterization and Qualification of Commutable Reference Materials for Laboratory
Medicine; Approved Guideline
Online PDF
EP31-A-IR
Verification of Comparability of Patient Results Within One Health Care System; Approved
Guideline (Interim Revision)
EP32-R Metrological Traceability and Its Implementation; A Report Online PDF
GP40-A4-AMD
Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—
Fourth Edition
(continued)
General Laboratory
EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print
GP05-A3 Clinical Laboratory Waste Management; Approved Guideline—Third Edition Pg. 46 PDF and Print
GP05-A3 CL Waste Management Program—Audit Checklist Pg. 46 PDF and Print
GP15-A3
Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline—
Third Edition
Online PDF
GP16-A3 Urinalysis; Approved Guideline—Third Edition Pg. 48 PDF and Print
GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print
GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition Online PDF
GP23-A2
Nongynecological Cytology Specimens: Preexamination, Examination, and
Postexamination Processes; Approved Guideline—Second Edition
GP27-A2
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second
Edition
GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline Online PDF
GP29-A2
Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved
GP31-A
Laboratory Instrument Implementation, Verification, and Maintenance; Approved
Guideline
GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print
GP34-A
Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection;
Approved Guideline
GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline Pg. 47 PDF and Print
GP39-A6
Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved
Standard—Sixth Edition
GP40-A4-AMD
Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—
Fourth Edition
GP41-A6
Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard—Sixth Edition

General Laboratory
GP41-A6 QG Quality Venipuncture Quick Guide Pg. 36 PDF and Print
GP42-A6
Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens;
Approved Standard—Sixth Edition
Online PDF
GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Online PDF and Print
GP43-A4
Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth
Edition
Online PDF
GP44-A4
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory
Tests; Approved Guideline—Fourth Edition
GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 48 Print
GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline Online PDF
H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print
I08-P Determining Performance of Volumetric Equipment; Proposed Guideline Online PDF
I16-T Temperature Monitoring and Recording in Blood Banks; Tentative Guideline Online PDF
M29-A4
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline—Fourth Edition
MM13-A
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods;
Approved Guideline
MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print
POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print
QG 10 Specimen Collection Quick Guides Online Print
QMS02-A6
Quality Management System: Development and Management of Laboratory Documents;
Approved Guideline—Sixth Edition
(continued)
Hematology
H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print
H07-A3
Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard—Third Edition
Online PDF
H15-A3
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in
Blood; Approved Standard—Third Edition
Online PDF
H20-A2
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of
Instrumental Methods; Approved Standard—Second Edition
H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based
Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition
H21-A5 QG Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Pg. 26, 49 Print
H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers;
H30-A2
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second
Edition
Online PDF
H42-A2
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved
Online PDF
H43-A2
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved
Online PDF
H47-A2
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)
Test; Approved Guideline—Second Edition
Online PDF
H48-A Determination of Factor Coagulant Activities; Approved Guideline Online PDF
H51-A
Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved
Guideline
Online PDF

INDEX
I/LA02-A2
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect
Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods;
Online PDF
I/LA20-A2
Analytical Performance Characteristics and Clinical Utility of Immunological Assays for
Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved
Pg. 28 PDF
I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition Online PDF
I/LA23-A
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme,
Fluorescence, and Luminescence Immunoassays; Approved Guideline
Online PDF
I/LA25-A2 Maternal Serum Screening; Approved Standard—Second Edition Online PDF
I/LA26-A2
Performance of Single Cell Immune Response Assays; Approved Guideline—Second
Edition
I/LA28-A2
Quality Assurance for Design Control and Implementation of Immunohistochemistry
Assays; Approved Guideline—Second Edition
I/LA28-A2 QG
Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked
Immunosorbent Assay and Immunohistochemistry Quick Guide
Pg. 28 Print
I/LA30-A Immunoassay Interference by Endogenous Antibodies; Approved Guideline Online PDF
I/LA33-A
Implementation; Approved Guideline
Pg. 28 PDF
I/LA33-A TK
Implementation—Sample Templates and Test Cases Toolkit
Pg. 28 CD
I/LA34-A
Design and Validation of Immunoassays for Assessment of Human Allergenicity of New
Biotherapeutic Drugs; Approved Guideline
Online Print
NBS06-A
Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement
of T-cell Receptor Excision Circles; Approved Guideline
NBS06-A QG1
Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn
Dried Blood Spot Specimens Quick Guide
Pg. 35 Print
NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print
NBS06-A WC
Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn
Screening Period
Pg. 35 Print
Hematology
H52-A2
Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second
Edition
H54-A
Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved
Guideline
H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline Online PDF and Print
H57-A
Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved
Guideline
Online PDF
H58-A Platelet Function Testing by Aggregometry; Approved Guideline Online PDF and Print
H59-A
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved
Guideline
H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline Pg. 27 PDF and Print
H60-A QG1 Algorithmic Approach to Lupus Anticoagulant Testing Pg. 27 PDF and Print
H60-A QG2 Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Pg. 27 PDF and Print
MM05-A2
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—
Second Edition
Online PDF
POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print
(continued)

Method Evaluation
C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and
Definitions; Approved Guideline—Third Edition
C29-A2
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame
Photometric Reference Method; Approved Standard—Second Edition
Online PDF
C37-A
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary
Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
Online PDF
C39-A
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum;
Approved Standard
Online PDF
C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF
C43-A2
Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—
Second Edition
Online PDF
C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF
C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second
Edition
C50-A
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved
Guideline
Online PDF
EP05-A3
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—
Third Edition
EP06-A
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical
Approach; Approved Guideline
EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print
EP09-A3
Measurement Procedure Comparison and Bias Estimation Using Patient Samples;
EP10-A3-AMD
Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures;
EP12-A2
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—
Second Edition
Online PDF
EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Online PDF and Print
EP15-A3 User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition Pg. 18 PDF and Print
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;
EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved
EP18-A2/EP23-A
WS
EP18/EP23 Sources of Failure Template Pg. 44 Word
EP19-Ed2
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement
Procedures, 2nd Edition
Pg. 4, 57 PDF
EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print
EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print
EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print
EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print
EP23-AWS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word
EP24-A2
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating
Characteristic Curves; Approved Guideline—Second Edition
EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF
EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print
EP27-A
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays;
Approved Guideline
Online PDF

Method Evaluation
EP28-A3c
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory;
EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline Online PDF and Print
EP30-A
Characterization and Qualification of Commutable Reference Materials for Laboratory
Medicine; Approved Guideline
Online PDF
EP31-A-IR
Verification of Comparability of Patient Results Within One Health Care System; Approved
Guideline (Interim Revision)
EP32-R Metrological Traceability and Its Implementation; A Report Online PDF
EP36-Ed1 Harmonization of Symbology and Equations, 1st Edition Pg. 57 PDF
H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers;
MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print
(continued)
Microbiology
AST QC QG AST QC Flow Chart Quick Guides Pg. 29, 50 PDF and Print
M02-A12
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—
Twelfth Edition
M06-A2
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second
Edition
Online PDF
M07-A10
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically;
Approved Standard—Tenth Edition
M11-A8
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved
Standard—Eighth Edition
M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline Online PDF
M21-A Methodology for the Serum Bactericidal Test; Approved Guideline Online PDF
M22-A3
Quality Control for Commercially Prepared Microbiological Culture Media; Approved
M23-A3
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters;
M24-A2
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes;
M26-A
Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved
Guideline
Online PDF
M27-A3
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved
M27-S4
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth
M28-A2
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract;
M29-A4
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
M32-P
Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility
Testing; Proposed Guideline
Online PDF
M33-A
Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved
Standard
M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline Online PDF
M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition Pg. 30 PDF and Print
M36-A
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved
Guideline
Online PDF

Microbiology
M38-A2
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous
Fungi; Approved Standard—Second Edition
M39-A4
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved
M39-A4 QG Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Pg. 52 Print
M40-A2
Quality Control of Microbiological Transport Systems; Approved Standard—Second
Edition
M41-A Viral Culture; Approved Guideline Online PDF
M43-A
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved
Guideline
Online PDF
M44-A2
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved
M44-S3
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration
(MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion
Susceptibility Testing of Yeasts; Third Informational Supplement
M45-A2
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated
or Fastidious Bacteria; Approved Guideline—Second Edition
M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 31, 36 PDF and Print
M47-A QG Collection, Handling, and Transport for Blood Cultures Quick Guide Pg. 31, 36 Print
M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline Online PDF
M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline Online PDF and Print
M51-A
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte
Filamentous Fungi; Approved Guideline
Online PDF
M51-S1
Performance Standards for Antifungal Disk Diffusion Susceptibility Testing of
Nondermatophyte Filamentous Fungi; Informational Supplement
Online PDF
M52-Ed1
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility
Testing Systems, 1st Edition
M53-A
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection;
Approved Guideline
Online PDF
M54-A
Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct
Examination and Culture; Approved Guideline
M55-R
Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and
Challenges; A Report
M56-A
Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved
Guideline
M100-S25
Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth
M100-S25 QG M100-S25 Tables 1A–1C Quick Guide Pg. 29, 50 PDF and Print
M100-S25 WC
Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fifth
Online Print
MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print
MM06-A2
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second
Edition
MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF
MM18-A
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing;
Approved Guideline
MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print
(continued)

Molecular Methods
I/LA28-A2
Quality Assurance for Design Control and Implementation of Immunohistochemistry
Assays; Approved Guideline—Second Edition
M53-A
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection;
Approved Guideline
Online PDF
MM01-A3
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—
Third Edition
Online PDF
MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print
MM05-A2
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—
Second Edition
Online PDF
MM06-A2
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second
Edition
MM07-A2
Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—
Second Edition
MM09-A2
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved
MM10-A
Genotyping for Infectious Diseases: Identification and Characterization; Approved
Guideline
Online PDF
MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF
MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online PDF
MM13-A
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods;
Approved Guideline
MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print
MM14-A2
Design of Molecular Proficiency Testing/External Quality Assessment; Approved
MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline Online PDF
MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print
MM18-A
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing;
Approved Guideline
MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline Pg. 33 PDF and Print
MM20-A Quality Management for Molecular Genetic Testing; Approved Guideline Pg. 33 PDF and Print
MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print
MM23-Ed1
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st
Edition
NBS06-A
NBS06-A QG1
Pg. 35 Print
NBS06-A WC
Screening Period
Pg. 35 Print
Newborn Screening
NBS01-A6
Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—
Sixth Edition
NBS01-A6 DVD Making a Difference Through Newborn Screening: Blood Collection on Filter Paper Pg. 34, 36 DVD
NBS01-A6 QG Specimen Collection and Sample Quality for Newborn Screening Quick Guide Pg. 34, 36 PDF and Print
NBS02-A2 Newborn Screening Follow-up; Approved Guideline—Second Edition Pg. 34 PDF and Print
NBS02-A2 QG Newborn Screening Follow-up Process Quick Guide Pg. 34 Print

Newborn Screening
NBS03-A
Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved
Guideline
NBS03-A QG
Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns
Quick Guide
Pg. 34 Print
NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline Pg. 35 PDF and Print
NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline Pg. 35 PDF and Print
NBS06-A
NBS06-A QG1
Pg. 35 Print
NBS06-A WC
Screening Period Wall Chart
Pg. 35 Print
(continued)
POCT01-A2 Point-of-Care Connectivity; Approved Standard—Second Edition Online PDF
POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline Online PDF
POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition Pg. 38 PDF
POCT05-A Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline Online PDF
POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition Pg. 38 PDF and Print
POCT07-A
Quality Management: Approaches to Reducing Errors at the Point of Care; Approved
Guideline
POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print
POCT08-A
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and
Resources for Health Care Workers; Approved Guideline
POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print
POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print
POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print
POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline Pg. 39 PDF
POCT09-A WS Instrument Selection Worksheet Pg. 39 PDF
POCT10-A2
Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline—
Second Edition
POCT10-A2 CL1
Provider-Performed Microscopy Training Checklist: Competence/Validation Cumulative
Record
POCT10-A2 CL2
Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/
Validation Employee Training Checklist
POCT10-A2 LG Microscope Maintenance Log Online PDF and Print
POCT10-A2 QG1 Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide Online PDF and Print
POCT10-A2 QG2
Nasal Smears for Inflammatory Cells (Also Known as “Nasal Smear for Eosinophils,”
“Nasal WBCs,” and “Nasal Smear for Granulocytes”) Quick Guide
POCT10-A2 QG3 Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide Online PDF and Print
POCT10-A2 QG4 Urine Sediment Examinations Quick Guide Online PDF and Print
POCT10-A2 QG5 Wet Mount Preparations and KOH Preparations Quick Guide Online PDF and Print

EP18-A2/EP23-A
WS
Sources of Failure Template Pg. 44 Word
EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print
EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print
EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print
EP23-A WS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word
GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print
GP27-A2
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second
Edition
GP29-A2
Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved
GP31-A
Laboratory Instrument Implementation, Verification, and Maintenance; Approved
Guideline
GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print
K2Q The Key to Quality Pg. 40 PDF and Print
POCT07-A
Quality Management: Approaches to Reducing Errors at the Point of Care; Approved
Guideline
POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print
POCT08-A
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and
Resources for Health Care Workers; Approved Guideline
POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print
POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print
POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print
QMS01-A4
Quality Management System: A Model for Laboratory Services; Approved Guideline—
Fourth Edition
QMS02-A6
Quality Management System: Development and Management of Laboratory Documents;
Approved Guideline—Sixth Edition
QMS03-A3 Training and Competence Assessment; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print
QMS04-A2 Laboratory Design; Approved Guideline—Second Edition Online PDF and Print
QMS05-A2
Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory;
QMS06-A3
Quality Management System: Continual Improvement; Approved Guideline—Third
Edition
QMS07-A2
Application of a Quality Management System Model for Respiratory Services; Approved
Online PDF
QMS10-A
A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare
Organizations; Approved Guideline
Online PDF
POCT10-A2 WC3 Ectoparasites Wall Chart Online PDF and Print
POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print
POCT11-A2 Pulse Oximetry; Approved Guideline—Second Edition Online PDF
POCT12-A3
Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved
POCT13-Ed3 Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition Pg. 57 PDF and Print
POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print
(continued)

QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Pg. 21, 47 PDF and Print
QMS11-Ed2 Nonconforming Event Management, 2nd Edition Pg. 57 PDF and Print
QMS12-A
Development and Use of Quality Indicators for Process Improvement and Monitoring of
Laboratory Quality; Approved Guideline
QMS13-A Quality Management System: Equipment; Approved Guideline Online PDF and Print
QMS14-A
Quality Management System: Leadership and Management Roles and Responsibilities;
Approved Guideline
QMS14-AES
Executive Summary: Quality Management System: Leadership and Management Roles
and Responsibilities
QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 41 PDF and Print
QMS16-Ed1 Laboratory Personnel Management, 1st Edition Pg. 57 PDF and Print
QMS18-Ed1 Process Management, 1st Edition Pg. 41 PDF and Print
QMS20-R Understanding the Cost of Quality in the Laboratory; A Report Pg. 41 PDF and Print
(continued)
Veterinary Medicine
VET01-A4
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for
Bacteria Isolated From Animals; Approved Standard—Fourth Edition
VET01S-Ed3
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for
Bacteria Isolated From Animals; Third Informational Supplement
VET02-A3
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for
Veterinary Antimicrobial Agents; Approved Guideline—Third Edition
VET03-A
Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic
Animals; Approved Guideline
VET03/VET04-S2
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From
Aquatic Animals; Second Informational Supplement
VET04-A2
Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic
Animals; Approved Guideline—Second Edition
VET05-R
Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for
Bacteria of Animal Origin; A Report

CLSI references in the College of American Pathologists (CAP) Accreditation
Program Checklists
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Administration (FDA) for use in satisfying a regulatory requirement
CLSI documents referenced in The Joint Commission Laboratory Accreditation
Standards chapters
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submits selected standards as candidate American National Standards when such status will enhance their national or
international usefulness.
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FDA
JC

EP06 | Evaluation of the Linearity of
Quantitative Measurement Procedures: A
Statistical Approach
This guideline provides information for
characterizing the linearity of a method
during a method evaluation; for checking
linearity as part of routine quality
assurance; and for determining and stating
a manufacturer’s claim for linear range.
Item Order Code: EP06-A
Nonmember Price: $180
EP07 | Interference Testing in Clinical
Chemistry
This guideline provides background
information, guidance, and experimental
procedures for investigating, identifying,
and characterizing the effects of interfering
substances on clinical chemistry test results.
Item Order Code: EP07-A2
EP09 | Measurement Procedure Comparison
and Bias Estimation Using Patient Samples
This guideline addresses the design of
measurement procedure comparison
experiments using patient samples and
subsequent data analysis techniques used
to determine the bias between two in vitro
diagnostic measurement procedures.
EP15 | User Verification of Precision and
Estimation of Bias
This guideline describes the estimation
of imprecision and of bias for clinical
laboratory quantitative measurement
procedures using a protocol that can be
completed within as few as five days.
Formatted in an enhanced,
full-color layout!
C24 | Statistical Quality Control for
Quantitative Measurement Procedures:
Principles and Definitions
This guideline provides definitions of
analytical intervals, planning of quality
control procedures, and guidance for quality
control applications.
Item Order Code: C24-A3
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
Accreditation Preparedness – Essentials for Verifying
Test Performance
JUNE 2006
FDA | JC
CAP | FDA | JC CAP | FDA | JC
CAP | FDA
CAP | FDA | JC
APRIL 2003
NOVEMBER 2005 AUGUST 2013
SEPTEMBER 2014

EP17 | Evaluation of Detection Capability for
Clinical Laboratory Measurement Procedures
evaluation and documentation of the
detection capability of clinical laboratory
measurement procedures (ie, limits of
blank, detection, and quantitation), for
verification of manufacturers’ detection
capability claims, and for the proper use
and interpretation of different detection
capability estimates.
EP21 | Estimation of Total Analytical Error
for Clinical Laboratory Methods
This guideline provides manufacturers
and end users with a means to estimate
total analytical error for an assay. A data
collection protocol and an analysis method,
which can be used to judge the clinical
acceptability of new methods using patient
specimens, are included. These tools can
also monitor an assay’s total analytical error
by using quality control samples.
Item Order Code: EP21-A
EP28 | Defining, Establishing, and Verifying
Reference Intervals in the Clinical Laboratory
This guideline contains information for
determining reference values and reference
intervals for quantitative clinical laboratory
tests. A CLSI-IFCC joint project.
Item Order Code: EP28-A3c
GP31 | Laboratory Instrument
Implementation, Verification, and
Maintenance
This guideline provides information about
assessing instrument performance and
function from the time of instrument
purchase to the routine performance of
clinical testing.
Item Order Code: GP31-A
EP31 | Verification of Comparability of
Patient Results Within One Health Care
System
This guideline provides information on
how to verify comparability of quantitative
laboratory results for individual patients
within a health care system.
Item Order Code: EP31-A-IR
Accreditation Preparedness – Essentials for Verifying
Test Performance
CAP | FDA | JC FDA | JC
CAP | FDA | JC
CAP | JC
CAP | JC
JUNE 2012 APRIL 2003
OCTOBER 2010 AUGUST 2012
APRIL 2009

GENERALLABORATORY
QMS01 | Quality Management System: A
Model for Laboratory Services
This guideline provides a model for
medical laboratories that will assist with
implementation and maintenance of an
effective quality management system.
Item Order Code: QMS01-A4
New enhanced, full-color version!
QMS02 | Quality Management System:
Development and Management of
Laboratory Documents
This guideline provides information on
the processes needed for document
management, including creating, controlling,
changing, and retiring a laboratory’s policy,
process, procedure, and form documents in
both paper and electronic environments.
Related ISO Quality Document
Accreditation Preparedness – Laboratory Practices
CAP | FDA | JC CAP | JC
GP27 | Using Proficiency Testing to Improve
the Clinical Laboratory
This guideline provides assistance to
laboratories in using proficiency testing as a
quality improvement tool.
Item Order Code: GP27-A2
ISO 15189:2012
Medical laboratories – Requirements for quality and competence
This International Standard specifies requirements for quality and competence in medical laboratories.
Item Order Code: ISO 15189:2012
Price: $180*
*CLSI membership rates do not apply for ISO documents.
Want to learn more about ISO quality documents?
Visit www.clsi.org/accreditation to view our crosswalk that shows how CLSI quality system essentials (QSEs) correspond
with clauses in ISO quality documents. The ISO quality documents are listed along with the related CLSI documents under
each QSE.
CAP | FDA | JC
FEBRUARY 2007
GP29 | Assessment of Laboratory Tests
When Proficiency Testing Is Not Available
This guideline offers methods to assess test
performance when proficiency testing is not
available; these methods include examples
with statistical analyses. This document is
intended for use by laboratory managers
and testing personnel in traditional clinical
laboratories as well as in point-of-care and
bedside testing environments.
Item Order Code: GP29-A2
CAP | JC
AUGUST 2008
JUNE 2011 FEBRUARY 2013

@CLSI_LabNews
Clinical and Laboratory
Standards Institute
(Company Page and Group)
QMS03 | Training and Competence
Assessment
information and recommended processes
for the development of training and
competence assessment programs that
meet quality and regulatory objectives.
New enhanced, full-color version!
QMS06 | Quality Management System:
Continual Improvement
This guideline considers continual
improvement as an ongoing, systematic
effort that is an essential component of a
quality management system. A continual
improvement program may consist of
fundamental processes and common
supporting elements described in this
guideline.
QMS11 | Management of Nonconforming
Laboratory Events
This guideline provides an outline and
the content for developing a program
to manage a health care service’s
nonconforming events that is based on
the principles of quality management and
patient safety.
Item Order Code: QMS11-A
New enhanced, full-color version
coming July 2015!
Accreditation Preparedness – Laboratory Practices
CAP | JC CAP | FDA | JC
CAP | JC
FEBRUARY 2009 JUNE 2011
NOVEMBER 2007
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OCTOBER 2014 APRIL 2011
AUTO11 | Information Technology Security
of In Vitro Diagnostic Instruments and
Software Systems
This standard provides a framework for
communication of information technology
security issues between the in vitro
diagnostic system vendor and the health
care organization.
Item Order Code: AUTO11-A2
FDA
AUTO12 | Specimen Labels: Content and
Location, Fonts, and Label Orientation
The purpose of this standard is to reduce
human errors currently associated with
the lack of standardization of labels on
clinical laboratory specimens. The standard
identifies the required human-readable
elements to appear on specimen labels and
specifies the exact locations, fonts, and font
sizes of these elements.
Item Order Code: AUTO12-A
CAP | FDA | JC
Free On-Demand Webinar | Introduction to CLSI Document AUTO11—Information Technology
Security of In Vitro Diagnostic Instruments and Software Systems
This informative webinar introduces CLSI document AUTO11.
It addresses items such as the document’s scope, an outline of
the document, why the document was created, and how the
document is beneficial to the laboratory.
Item Order Code: AUTO11-A2 WR
Nonmember Price: FREE
Visit www.clsi.org/webinars to learn more.
Speaker:
Ed Heierman III, PhD
Software Architect, Abbott,
Irving, Texas, USA

Don’t Get Cited for Common Deficiencies!
CLSI crosswalks help you ensure your lab is prepared for accreditation and inspections.
Numerous CLSI documents are referenced in these crosswalks. They serve as key resources
in satisfying regulatory requirements and avoiding compliance issues.
Be ready for inspection at any time!
Download these free CLSI crosswalks at www.clsi.org/accreditation.
The
Joint Commission

C24 | Statistical Quality Control for
Quantitative Measurement Procedures:
Principles and Definitions
This guideline provides definitions of
analytical intervals, planning of quality
control procedures, and guidance for quality
control applications.
C40 | Measurement Procedures for the
Determination of Lead Concentrations in
Blood and Urine
the measurement of lead concentrations
in blood and urine, including specimen
collection, measurement by graphite
furnace atomic absorption spectrometry,
anodic stripping voltammetry, and inductively coupled
plasma mass spectrometry. It also includes guidelines for
quality assurance and quality control, and information on
proficiency testing programs and laboratory certification.
C49 | Analysis of Body Fluids in Clinical
Chemistry
This guideline provides information for the
application of widely available measurement
procedures for testing body fluids and for
reporting and interpreting those results. It
emphasizes defining the common clinical
situations for this use; acceptable practice for
measuring analytes without extended method verification
for abnormal body fluid; influence of biologic and analytic
variation on interpretation of results; and variability
in comparing results between different instrument
manufacturers. This document does not consider serum,
plasma, whole blood, or fluids for which assays typically
have performance claims in the measurement procedure
documentation. A CLSI-IFCC joint project.
Item Order Code: C49-A
CAP | FDA | JC
JC
CAP | JC
C34 | Sweat Testing: Sample Collection and
Quantitative Chloride Analysis
This guideline addresses appropriate
methods of collection and analysis, quality
control, and the evaluation and reporting of
test results.
C46 | Blood Gas and pH Analysis and Related
Measurements
This guideline provides clear definitions of
the quantities in current use, and provides a
single source of information on appropriate
specimen collection, preanalytical variables,
calibration, and quality control for blood pH
and gas analysis and related measurements.
Related Companion Product (Bench Aid)
C49/H56 QG | Collection, Handling,
Transport, and Storage for Body Fluids Quick
Guide
Describes recommended methods for the
collection, handling, transport, and storage
of various types of body fluids. Formatted
as durable, waterproof sheets for quick
reference.
Item Order Code: C49-A/H56-A QG
CAP | FDA | JC
CAP | JC
DECEMBER 2009JUNE 2006
FEBRUARY 2009OCTOBER 2013
APRIL 2007 JANUARY 2015

C56 | Hemolysis, Icterus, and Lipemia/
Turbidity Indices as Indicators of Interference
in Clinical Laboratory Analysis
information on mechanisms of hemolysis,
icterus, lipemia/turbidity (HIL) interference;
intended usefulness of HIL indices;
establishment of HIL alert indices;
availability of automated HIL detection systems; and
interpretation, strengths, limitations, and verification of
HIL indices in the clinical laboratory.
C56 QG | Examples of Hemolyzed, Icteric,
and Lipemic/Turbid Samples Quick Guide
Shows examples of hemolyzed, icteric,
and lipemic/turbid samples. Formatted
as a durable, waterproof sheet for quick
reference.
Item Order Code: C56-A QG
C57 | Mass Spectrometry for Androgen and
Estrogen Measurements in Serum
This guideline is intended to aid the
laboratorian in developing appropriate
procedures for the use of mass
spectrometry in the measurement of
androgens and estrogens.
Item Order Code: C57-Ed1
C62 | Liquid Chromatography-Mass
Spectrometry Methods
This guideline provides information to the
clinical laboratorian for the reduction of
interlaboratory variance and the evaluation
of interferences, assay performance, and
other pertinent characteristics of clinical
assays. This guideline emphasizes particular
areas related to assay development and
presents a standardized approach for
method verification that is specific to mass
spectrometry technology.
FDA | JC
JC
JULY 2012 OCTOBER 2014
FEBRUARY 2015 OCTOBER 2014
Free On-Demand Webinar | Introduction to CLSI Document C62—Liquid Chromatography-
Mass Spectrometry Methods
This informative webinar introduces CLSI document C62. It
addresses items such as the document’s scope, an outline of
the document, why the document was created, and how the
document is beneficial to the laboratory.
Item Order Code: C62-A WR
Nonmember Price: FREE
Visit www.clsi.org/webinars to learn more.
Speaker:
William Clarke, PhD, MBA, DABCC
Associate Professor of Pathology, Johns
Hopkins Medical Institutions, Baltimore,
Maryland, USA

Hematology and Coagulation
H02 | Procedures for the Erythrocyte
Sedimentation Rate Test
This standard provides a description of the
principle, materials, and procedure for a
standardized erythrocyte sedimentation
rate (ESR) method; a selected routine
method, as well as a procedure to evaluate
routine methods; and an outline of quality
control programs for the ESR test.
Item Order Code: H02-A5
H52 | Red Blood Cell Diagnostic Testing Using
Flow Cytometry
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.
JC
CAP | JC
H21 | Collection, Transport, and Processing
of Blood Specimens for Testing
Plasma-Based Coagulation Assays and
Molecular Hemostasis Assays
This guideline provides procedures for
collecting, transporting, and storing blood;
processing blood specimens; storing
plasma for coagulation testing; and general
recommendations for performing the tests.
H26 | Validation, Verification, and Quality
Assurance of Automated Hematology
Analyzers
This standard provides guidance for the
validation, verification, calibration, quality
assurance (QA), and quality control (QC)
of automated multichannel hematology
analyzers for manufacturers, end-user
clinical laboratories, accrediting organizations, and
regulatory bodies. In addition, end-user clinical laboratories
will find guidance for establishment of clinically reportable
intervals and for QA for preexamination and examination
aspects of their systems.
CAP | FDA | JC
CAP | FDA | JC
JANUARY 2008MAY 2011
JUNE 2010
MARCH 2014
H21 QG | Collection, Handling, Transport,
and Storage for Hemostasis Quick Guide
Outlines best practice procedures for the
proper collection, transportation, and
processing of blood specimens as well as
storage of plasma for coagulation testing.
Formatted as durable, waterproof sheets for
quick reference.
Item Order Code: H21-A5 QG
JANUARY 2008

H60 QG1 | Algorithmic Approach to Lupus
Anticoagulant Testing Quick Guide
Describes the algorithmic approach to lupus
anticoagulant testing for independent,
paired, and integrated test systems.
Formatted as durable, waterproof sheets for
quick reference.
Item Order Code: H60-A QG1
H60 QG2 | Criteria for the Laboratory
Diagnosis of the Lupus Anticoagulant Quick
Guide
Includes sample identification criteria
and recommendations specific to each
criterion for the laboratory diagnosis of the
lupus anticoagulant. Formatted as durable,
waterproof sheets for quick reference.
Item Order Code: H60-A QG2
Hematology and Coagulation
JC
DECEMBER 2014 DECEMBER 2014
H59 | Quantitative D-dimer for the Exclusion
of Venous Thromboembolic Disease
This guideline provides information
regarding the use of D-dimer in exclusion of
venous thromboembolism (VTE) including
a description of the value of clinical
determination of the pretest probability
of VTE; the proper collection and handling
of the specimen; assays used for D-dimer analysis;
determination of the threshold for exclusion of VTE;
interpretation of test results; and aspects of regulatory and
accreditation requirements.
Item Order Code: H59-A
CAP | FDA | JC
MARCH 2011
H60 | Laboratory Testing for the Lupus
Anticoagulant
This guideline provides information and
recommendations regarding the proper
collection and handling of the specimen;
descriptions and limitations of screening
and confirmatory assays, and mixing tests
used to identify lupus anticoagulant (LA);
determination of cutoff values and calculations associated
with the various assays; and interpretation of test results in
an LA panel.
Item Order Code: H60-A
JC
APRIL 2014

I/LA20 | Analytical Performance
Characteristics and Clinical Utility of
Immunological Assays for Human
Immunoglobulin E (IgE) Antibodies and
Defined Allergen Specificities
for the design, analytical performance,
standardization, quality assurance, and
clinical application of laboratory assays
used in the measurement of human IgE
antibodies of defined allergen specificity.
Item Order Code: I/LA20-A2
I/LA28 | Quality Assurance for
Design Control and Implementation of
Immunohistochemistry Assays
for the development of validated
diagnostic, prognostic, and predictive
immunohistochemical assays.
I/LA33 | Validation of Automated Systems
for Immunohematological Testing Before
Implementation
to the end user and laboratory for
validation of automated systems used
in immunohematological testing before
implementation.
Item Order Code: I/LA33-A
FDA | JC
CAP | FDA | JC
JC
I/LA26 | Performance of Single Cell Immune
Response Assays
This guideline 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.
JC
NOVEMBER 2013MARCH 2009
JANUARY 2011
DECEMBER 2009
Related Companion Product (Toolkit)
I/LA33 TK | Validation of Automated
Systems for Immunohematological Testing
Before Implementation—Sample Templates
and Test Cases Toolkit
Provides 24 customizable templates from
the appendixes of I/LA33. Each simplified
template, test case, checklist, worksheet, and
schedule can be used by the laboratory for development
of test cases related to different aspects of installation
qualification, operational qualification, and performance
qualification.
Item Order Code: I/LA33-A TK
I/LA28 QG | Comparison of the
Characteristics of Immunoassays Such as
Enzyme-Linked Immunosorbent Assay and
Immunohistochemistry Quick Guide
Shows a comparison of the characteristics
of immunoassays. Formatted as four
durable, waterproof sheets on a convenient
detachable ring for quick reference.
Item Order Code: I/LA28-A2 QG
DECEMBER 2009
SEPTEMBER 2014

Microbiology Methodologies
M02* | Performance Standards for
Antimicrobial Disk Susceptibility Tests
This standard contains the current
CLSI-recommended methods for disk
susceptibility testing, criteria for quality
control testing, and updated tables for
interpretive zone diameters.
An Interactive Searchable Database for Drug
Selection, Interpretation, and Quality Control
Procedures!
eM100 is built to work the way you do—efficiently and in the laboratory.
This online implementation of CLSI’s most widely recognized antimicrobial susceptibility testing document provides
information for drug selection, interpretation, and quality control as well as the latest recommendations for detecting
resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format.
M07* | Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically
This standard addresses reference methods
for the determination of minimal inhibitory
concentrations of aerobic bacteria by broth
macrodilution, broth microdilution, and agar
dilution.
M100* | Performance Standards for Antimicrobial Susceptibility Testing
This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A12,
M07-A10, and M11-A8. The tabular information presented in M100 represents the most current information
for drug selection, interpretation, and quality control using the procedures standardized in the most current
editions of M02, M07, and M11.
M100 is updated every January, so please check shop.clsi.org for the 2016 version.
JANUARY 2015 JANUARY 2015
JANUARY 2015
AST QC QG | AST QC Flow Chart Quick Guide
The ultimate “cheat sheet” to quality control
(QC) for antimicrobial susceptibility testing.
Based on M02, M07, and M100, these
easy-to-use flow charts guide you through daily QC testing
for both disk diffusion and aerobic dilution. Once required
daily QC has been documented, users can convert to
weekly QC with a flip of a page. Formatted as durable,
waterproof sheets on a convenient detachable ring for
convenient, shared use in the laboratory.
Item Order Code: AST QC QG
M100 QG | M100-S25 Tables 1A–1C
Quick Guide
Provides suggested groupings of
antimicrobial agents that should be
considered for routine disk and broth dilution testing and
reporting by clinical laboratories. Formatted as durable,
waterproof sheets on a convenient detachable ring for
convenient, shared use in the laboratory.
Item Order Code: M100-S25 QG
*Note that in 2015, M100 must be purchased with one of the following M02 or M07 packages.
Item Order Code: M02-A12/M07-A10 PK15 (includes M02-A12, M07-A10, and M100-S25) | Nonmember Price: $500
Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340
Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340
JANUARY 2015 JANUARY 2015
Visit www.clsi.org/eM100 to learn more.

M22 | Quality Control for Commercially
Prepared Microbiological Culture Media
This standard contains quality assurance
procedures for manufacturers and users
of prepared, ready-to-use microbiological
culture media.
Item Order Code: M22-A3
M35 | Abbreviated Identification of Bacteria
and Yeast
This guideline provides the minimum
identification criteria that can be used
to rapidly identify organisms commonly
isolated from clinical specimens.
M28 | Procedures for the Recovery and
Identification of Parasites From the
Intestinal Tract
This guideline addresses the collection,
processing, and examination of intestinal
tract specimens for the identification of
parasites.
JUNE 2005JUNE 2004
NOVEMBER 2008
M40 | Quality Control of Microbiological
Transport Systems
This standard provides criteria to assist
manufacturers and end users of transport
devices in providing and selecting
dependable products for the transport of
microbiological clinical specimens.
JUNE 2014

M47 | Principles and Procedures for Blood
Cultures
This guideline provides recommendations
for the collection, transport, and processing
of blood cultures as well as guidance for
the recovery of pathogens from blood
specimens taken from patients who
are suspected of having bacteremia or
fungemia.
Item Order Code: M47-A
M54 | Principles and Procedures for
Detection of Fungi in Clinical Specimens—
Direct Examination and Culture
This guideline provides protocols, quality
control parameters, and interpretive criteria
for performing fungal cultures and for the
detection and identification of fungi in
direct examinations.
CAP | FDA | JC
M56 | Principles and Procedures for Detection
of Anaerobes in Clinical Specimens
This guideline presents standardized,
cost-effective, and efficient best practice
processes for anaerobe bacteriology to
assist clinical laboratories in selecting those
methods that lead to improved patient care.
JULY 2014
MAY 2007
OCTOBER 2012
M47 QG | Collection, Handling, and
Transport for Blood Cultures Quick Guide
Provides a quick reference for nursing,
emergency room staff, phlebotomists, and
laboratorians on the timing and collection,
transport and set-up, as well as procedures
for processing blood cultures.
Item Order Code: M47-A QG
MARCH 2015

Molecular Methods
MM03 | Molecular Diagnostic Methods for
Infectious Diseases, 3rd Edition
This report addresses topics relating
to clinical applications, amplified and
nonamplified nucleic acid methods,
selection and qualification of nucleic acid
sequences, establishment and evaluation of
test performance characteristics, inhibitors,
and interfering substances, controlling false-positive
reactions, reporting and interpretation of results, quality
assurance, regulatory issues, and recommendations for
manufacturers and clinical laboratories.
Item Order Code: MM03-Ed3
MM07 | Fluorescence In Situ Hybridization
Methods for Clinical Laboratories
This guideline addresses fluorescence in
situ hybridization methods for medical
genetic determinations, identification of
chromosomal abnormalities, and gene
amplification. Recommendations for probe
and assay development, manufacture,
qualification, verification, and validation;
instrument requirements; quality assurance;
and evaluation of results are also included.
Item Order Code: MM07-A2
MM13 | Collection, Transport, Preparation,
and Storage of Specimens for Molecular
Methods
This guideline provides information related
to proper and safe biological specimen
collection and nucleic acid isolation and
purification. These topics include methods
of collection, recommended storage and
transport conditions, and available nucleic
acid purification technologies for each
specimen/nucleic acid type. A CLSI-IFCC
joint project.
Item Order Code: MM13-A
FDA | JC
CAP | JC
CAP | FDA | JC
MM06 | Quantitative Molecular Methods
for Infectious Diseases
the development and use of quantitative
molecular methods, such as nucleic acid
probes and nucleic acid amplification
techniques of the target sequences
specific to particular microorganisms.
It also presents recommendations for
quality assurance, proficiency testing, and
interpretation of results.
FDA | JC
NOVEMBER 2010FEBRUARY 2015
AUGUST 2013
DECEMBER 2005
MM09 | Nucleic Acid Sequencing Methods
in Diagnostic Laboratory Medicine
This guideline addresses diagnostic
sequencing using both automated
capillary-based sequencers and massively
parallel sequencing instruments. Topics
include specimen collection and handling;
isolation and extraction of nucleic acid;
template preparation; sequence generation,
alignment, and assembly; validation and
verification; ongoing quality assurance; and
reporting results.
CAP | FDA | JC
FEBRUARY 2014
MM13 QG | Handling, Transport, and
Storage of Specimens for Molecular Methods
Quick Guide
Describes the recommended methods for
the collection of molecular method samples,
proper shipping conditions, and storage
addressing issues including temperature,
preservatives, and duration.
Item Order Code: MM13-A QG
MARCH 2015

Molecular Methods
MM14 | Design of Molecular Proficiency
Testing/External Quality Assessment
a quality proficiency testing/external
quality assessment program, including
reliable databases; design control in the
choice of materials and measurands; good
manufacturing processes; documentation
procedures; complaint handling; corrective
and preventive action plans; and responsive
timing of reports.
MM19 | Establishing Molecular Testing in
Clinical Laboratory Environments
This guideline provides comprehensive
information for planning and
implementation of molecular diagnostic
testing, including strategic planning,
regulatory requirements, implementation,
quality management, and special
considerations for the subspecialties of
molecular genetics, infectious diseases,
oncology, and pharmacogenetics.
MM22 | Microarrays for Diagnosis and
Monitoring of Infectious Diseases
the laboratory development and use
of qualitative nucleic acid microarray
methods for the diagnosis and monitoring
of infectious diseases. It also presents
recommendations for validation
and verification, quality control, and
interpretation of results.
JC
CAP | JC
JC
MM20 | Quality Management for Molecular
Genetic Testing
for implementing international quality
management system standards in
laboratories that perform human molecular
genetic testing for inherited or acquired
conditions.
JC
NOVEMBER 2012
MAY 2013
NOVEMBER 2011
FEBRUARY 2014
MM17 | Verification and Validation of
Multiplex Nucleic Acid Assays
This guideline provides recommendations
for analytic verification and validation of
multiplex assays, as well as a review of
different types of biologic and synthetic
reference materials.
JC
MARCH 2008

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