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Quality System Regulation for Laboratory-Developed Tests
A Practical Guide for the Laboratory
January 2015
M100-S25Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement
January 2015
M07-A10Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard —Tenth Edition
January 2015
M02-A12Performance 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-A3User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition
September 2014
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.
GP23-A2Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition
November 2014
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.
GP36-APlanning for Laboratory Operations During a Disaster; Approved Guideline
December 2014
EP15-A3User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition
GP23-A2Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition
GP36-APlanning for Laboratory Operations During a Disaster; Approved Guideline
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.
POCT06Effects of Different Sample Types on Glucose Measurements
1st 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.
C57Mass Spectrometry for Androgen and Estrogen Measurements in Serum
1st 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.
POCT13Glucose Monitoring in Settings Without Laboratory Support
3rd Edition
POCT06-Ed1Effects of Different Sample Types on Glucose Measurements, 1st Edition
C57-Ed1Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition
POCT13-Ed3Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition
3rd 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.
MM03Molecular Diagnostic Methods for Infectious Diseases
1st 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.
QMS18Process Management
MM03-Ed3Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition
QMS18-Ed1Process Management, 1st Edition
QSR LDTQuality System Regulation for 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
MM23Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
MM23-Ed1Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st 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.
EP05-A3Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
October 2014
EP05-A3Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
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2015/2016 Table of ContentsDocument 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.
Automation and Informatics
Clinical Chemistry and Toxicology
General Laboratory
Hematology
Immunology and Ligand Assay
Method Evaluation
Microbiology
Molecular Methods
Newborn Screening
Point-of-Care Testing
Quality Management Systems
Veterinary Medicine
There are more products online at the CLSI Shop. Visit shop.clsi.org to find our full library of resources.Shop Online!
DO
CUM
ENT
CATE
GO
RIES
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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-Developed Tests: 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!
Quality System Regulation for 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
EP19A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
2nd Edition
1
2
3
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Automation and Informatics
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-A2Laboratory 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 Validation of Automated Systems for Immunohematological Testing Before 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
YOU CAN FIND INFORMATION
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Clinical Chemistry and Toxicology
Document Code Document Title Location Format
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 Guideline—Third Edition
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
Pg. 24 PDF and Print
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
Pg. 24 PDF and Print
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
Pg. 25 PDF and Print
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
Online PDF and Print
EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
Pg. 18 PDF and Print
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
Pg. 18 PDF and Print
EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition
Online PDF and Print
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
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IND
EXClinical Chemistry and Toxicology
Document Code Document Title Location Format
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; Approved Guideline—Second Edition
Pg. 19 PDF and Print
EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition
Pg. 44 PDF and Print
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
Online PDF and Print
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; Approved Guideline—Third Edition
Pg. 19 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)
Pg. 19 PDF and Print
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
Online PDF and Print
(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
Online PDF and Print
GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition
Pg. 20 PDF and Print
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 Guideline—Second Edition
Pg. 20 PDF and Print
GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline
Pg. 19 PDF and Print
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
Online PDF and Print
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
Online PDF and Print
GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition
Online PDF and Print
GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition
Pg. 36 PDF and Print
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General Laboratory
Document Code Document Title Location Format
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
Pg. 48 PDF and Print
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
Pg. 47 PDF and Print
MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline
Pg. 32, 49 PDF and Print
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
Pg. 20, 40 PDF and Print
(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
Online PDF and Print
H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition
Pg. 26, 49 PDF and Print
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; Approved Standard—Second Edition
Pg. 26 PDF and Print
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 Guideline—Second Edition
Online PDF
H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition
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
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Immunology and Ligand Assay
I/LA02-A2Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline—Second Edition
Online PDF
I/LA20-A2Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition
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
Pg. 28 PDF and Print
I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition
Pg. 28 PDF and Print
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 Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline
Pg. 28 PDF
I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before 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
Pg. 35 PDF and Print
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
Document Code Document Title Location Format
H52-A2 Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition
Pg. 26 PDF and Print
H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline
Online PDF and Print
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
Pg. 27 PDF and Print
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)
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Method Evaluation
Document Code Document Title Location Format
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
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
Pg. 24 PDF and Print
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
Online PDF and Print
EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
Pg. 18 PDF and Print
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
Pg. 18 PDF and Print
EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition
Online PDF and Print
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; Approved Guideline—Second Edition
Pg. 19 PDF and Print
EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition
Pg. 44 PDF and Print
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-A WS 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
Online PDF and Print
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
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Method Evaluation
Document Code Document Title Location Format
EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition
Pg. 19 PDF and Print
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)
Pg. 19 PDF and Print
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; Approved Standard—Second Edition
Pg. 26 PDF and Print
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
Pg. 29, 50 PDF and Print
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
Pg. 29, 50 PDF and Print
M11-A8 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition
Pg. 51 PDF and Print
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 Standard—Third Edition
Pg. 30 PDF and Print
M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition
Online PDF and Print
M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition
Pg. 51 PDF and Print
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 Standard—Third Edition
Pg. 51 PDF and Print
M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement
Pg. 51 PDF and Print
M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition
Pg. 30 PDF and Print
M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition
Pg. 47 PDF and Print
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
Online PDF and Print
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
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Microbiology
Document Code Document Title Location Format
M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition
Pg. 51 PDF and Print
M39-A4 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition
Pg. 51 PDF and Print
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
Pg. 30 PDF and Print
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 Guideline—Second Edition
Pg. 52 PDF and Print
M44-S3Zone 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
Pg. 52 PDF and Print
M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition
Pg. 52 PDF and Print
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
Pg. 57 PDF and Print
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
Pg. 31 PDF and Print
M55-R Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report
Online PDF and Print
M56-A Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
Pg. 31 PDF and Print
M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement
Pg. 29, 50 PDF and Print
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 Informational Supplement
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
Pg. 32 PDF and Print
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
Online PDF and Print
MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print
(continued)
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Molecular Methods
Document Code Document Title Location Format
I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition
Pg. 28 PDF and Print
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
Pg. 32 PDF and Print
MM07-A2 Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition
Pg. 32 PDF and Print
MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition
Pg. 32 PDF and Print
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
Pg. 32, 49 PDF and Print
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 Guideline—Second Edition
Pg. 33 PDF and Print
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
Online PDF and Print
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
Online PDF and Print
NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline
Pg. 35 PDF and Print
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
Newborn Screening
NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition
Pg. 34, 36 PDF and Print
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
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Newborn Screening
Document Code Document Title Location Format
NBS03-A Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline
Pg. 34 PDF and Print
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 Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline
Pg. 35 PDF and Print
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 Wall Chart
Pg. 35 Print
(continued)
Point-of-Care Testing
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
Pg. 38, 44 PDF and Print
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
Pg. 38 PDF and Print
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
Online PDF and Print
POCT10-A2 CL1 Provider-Performed Microscopy Training Checklist: Competence/Validation Cumulative Record
Online PDF and Print
POCT10-A2 CL2 Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/Validation Employee Training Checklist
Online PDF and Print
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
Online PDF and Print
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
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Quality Management Systems
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
Pg. 20 PDF and Print
GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition
Pg. 20 PDF and Print
GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline
Pg. 19 PDF and Print
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
Pg. 38, 44 PDF and Print
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
Pg. 38 PDF and Print
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
Pg. 20, 40 PDF and Print
QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition
Pg. 20, 40 PDF and Print
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; Approved Guideline—Second Edition
Online PDF and Print
QMS06-A3 Quality Management System: Continual Improvement; Approved Guideline—Third Edition
Pg. 21, 40 PDF and Print
QMS07-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guideline—Second Edition
Online PDF
QMS10-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline
Online PDF
Point-of-Care Testing
Document Code Document Title Location Format
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 Guideline—Third Edition
Pg. 39 PDF and Print
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)
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Quality Management Systems
Document Code Document Title Location Format
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
Pg. 41 PDF and Print
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
Pg. 41 PDF and Print
QMS14-AES Executive Summary: Quality Management System: Leadership and Management Roles and Responsibilities
Pg. 41 PDF and Print
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
Pg. 54 PDF and Print
VET01S-Ed3 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement
Pg. 54, 57 PDF and Print
VET02-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline—Third Edition
Pg. 54 PDF and Print
VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline
Pg. 54 PDF and Print
VET03/VET04-S2 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement
Pg. 54 PDF and Print
VET04-A2 Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline—Second Edition
Pg. 55 PDF and Print
VET05-R Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin; A Report
Pg. 55 PDF and Print
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CLSI references in the College of American Pathologists (CAP) Accreditation Program Checklists
Approved-level consensus standards recognized by the US Food and Drug Administration (FDA) for use in satisfying a regulatory requirement
CLSI documents referenced in The Joint Commission Laboratory Accreditation Standards chapters
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Level II Organization: 60%
Level III Organization: 50%
Individual Full: 25%
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Individual Student: 10%
Standard or Guideline: Document has achieved consensus within the health care community.* Report: Document that has not been subjected to consensus review and is released by the appropriate consensus committee.
*American National Standards have been approved by the American National Standards Institute (ANSI). CLSI submits selected standards as candidate American National Standards when such status will enhance their national or international usefulness.
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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 Nonmember Price: $180
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.
Item Order Code: EP09-A3 Nonmember Price: $180
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.
Item Order Code: EP15-A3 Nonmember Price: $180
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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.
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EP17 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
This guideline provides information for 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.
Item Order Code: EP17-A2Nonmember Price: $180
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-ANonmember Price: $180
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-A3cNonmember Price: $180
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-ANonmember Price: $140
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-IRNonmember Price: $180
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OCTOBER 2010 AUGUST 2012
APRIL 2009
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GEN
ERAL LABORATO
RY
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 Nonmember Price: $180
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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.
Item Order Code: QMS02-A6 Nonmember Price: $180
Related ISO Quality Document
Accreditation Preparedness – Laboratory Practices
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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-A2Nonmember Price: $140
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 15189:2012Price: $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-A2Nonmember Price: $140
CAP | JC
AUGUST 2008
JUNE 2011 FEBRUARY 2013
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QMS03 | Training and Competence Assessment
This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives.
Item Order Code: QMS03-A3Nonmember Price: $180
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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.
Item Order Code: QMS06-A3Nonmember Price: $180
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-ANonmember Price: $180
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Accreditation Preparedness – Laboratory Practices
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OCTOBER 2014 APRIL 2011
Automation and Informatics
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-A2Nonmember Price: $140
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-ANonmember Price: $140
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Free On-Demand Webinar | Introduction to CLSI Document AUTO11—Information Technology Security of In Vitro Diagnostic Instruments and Software SystemsThis 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
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Speaker: Ed Heierman III, PhD Software Architect, Abbott, Irving, Texas, USA
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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
Speaker: Ed Heierman III, PhD Software Architect, Abbott, Irving, Texas, USA
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Clinical Chemistry and Toxicology
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-A3Nonmember Price: $140
C40 | Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine
This guideline provides information for 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.
Item Order Code: C40-A2Nonmember Price: $140
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-ANonmember Price: $140
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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.
Item Order Code: C34-A3Nonmember Price: $140
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.
Item Order Code: C46-A2Nonmember Price: $140
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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.
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C56 | Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis
This guideline provides background 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.
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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.
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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-Ed1Nonmember Price: $140
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.
Item Order Code: C62-ANonmember Price: $140
Clinical Chemistry and Toxicology
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JULY 2012 OCTOBER 2014
FEBRUARY 2015 OCTOBER 2014
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Free On-Demand Webinar | Introduction to CLSI Document C62—Liquid Chromatography-Mass Spectrometry MethodsThis 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
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Speaker: William Clarke, PhD, MBA, DABCCAssociate Professor of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
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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-A5Nonmember Price: $140
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.
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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.
Item Order Code: H21-A5Nonmember Price: $140
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.
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JANUARY 2008
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Related Companion Product (Bench Aid)
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 QG1Nonmember Price: $20
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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 QG2Nonmember Price: $20
Hematology and Coagulation
JCDECEMBER 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-ANonmember Price: $140
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-ANonmember Price: $140
JC
APRIL 2014
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Immunology and Ligand Assay
I/LA20 | Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities
This guideline provides information 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-A2Nonmember Price: $140
I/LA28 | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays
This guideline provides information for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays.
Item Order Code: I/LA28-A2Nonmember Price: $140
I/LA33 | Validation of Automated Systems for Immunohematological Testing Before Implementation
This guideline provides information to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation.
Item Order Code: I/LA33-ANonmember Price: $140
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.
Item Order Code: I/LA26-A2Nonmember Price: $140
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 TKNonmember Price: $100
Related Companion Product (Bench Aid)
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 QGNonmember Price: $40
DECEMBER 2009
SEPTEMBER 2014
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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
Related Companion Product (Bench Aid)
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 QGNonmember Price: $120
Related Companion Product (Bench Aid)
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 QGNonmember Price: $100
*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: $500Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340
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Microbiology Methodologies
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-A3Nonmember Price: $180
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.
Item Order Code: M35-A2Nonmember Price: $180
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.
Item Order Code: M28-A2Nonmember Price: $180
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.
Item Order Code: M40-A2Nonmember Price: $180
JUNE 2014
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Microbiology Methodologies
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-ANonmember Price: $180
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.
Item Order Code: M54-ANonmember Price: $180
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.
Item Order Code: M56-A Nonmember Price: $180
JULY 2014
MAY 2007
OCTOBER 2012
Related Companion Product (Bench Aid)
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 Nonmember Price: $20
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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-Ed3Nonmember Price: $140
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-A2Nonmember Price: $140
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-ANonmember Price: $140
FDA | JC
CAP | JC
CAP | FDA | JC
MM06 | Quantitative Molecular Methods for Infectious Diseases
This guideline provides information for 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.
Item Order Code: MM06-A2Nonmember Price: $140
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.
Item Order Code: MM09-A2Nonmember Price: $140
CAP | FDA | JCFEBRUARY 2014
Related Companion Product (Bench Aid)
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 QGNonmember Price: $20
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Molecular Methods
MM14 | Design of Molecular Proficiency Testing/External Quality Assessment
This guideline provides information for 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.
Item Order Code: MM14-A2Nonmember Price: $140
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.
Item Order Code: MM19-ANonmember Price: $140
MM22 | Microarrays for Diagnosis and Monitoring of Infectious Diseases
This guideline provides information for 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.
Item Order Code: MM22-ANonmember Price: $140
JC
CAP | JC
JC
MM20 | Quality Management for Molecular Genetic Testing
This guideline provides information for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions.
Item Order Code: MM20-A Nonmember Price: $140
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.
Item Order Code: MM17-A Nonmember Price: $140
JCMARCH 2008
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Newborn Screening
NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs
This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
Item Order Code: NBS01-A6Nonmember Price: $140
NBS03 | Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns
This guideline outlines the recommended protocols for screening preterm, sick, or low birth weight infants for hearing loss and disorders detectable through dried blood spot testing.
Item Order Code: NBS03-ANonmember Price: $140
CAP | FDA | JC
JC
JULY 2013
OCTOBER 2009
NBS02 | Newborn Screening Follow-up
This guideline describes the basic principles, scope, and range of follow-up activities within the newborn screening system.
Item Order Code: NBS02-A2Nonmember Price: $140 CAP | JC
MAY 2013
Related Video
NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD
This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique;
handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment.
Item Order Code: NBS01-A6 DVDNonmember Price: $300
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NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide
How to Collect an Acceptable Blood Spot Specimen
Simple Spot Check
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NBS02 QG | Newborn Screening Follow-up Process Quick Guide
Describes the newborn screening follow-up process.
Item Order Code: NBS02-A2 QGNonmember Price: $20
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NBS03 QG | Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide
Provides information on when to collect first, second, and third specimens for newborn screening and includes special care baby unit screening algorithm for preterm, low birth weight, and sick newborns.
Item Order Code: NBS03-A QGNonmember Price: $20
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Newborn Screening
NBS04 | Newborn Screening by Tandem Mass Spectrometry
This guideline serves as a reference source for the numerous activities related to operating a tandem mass spectrometry laboratory as part of public and private newborn screening programs with the goal of creating greater test accuracy, performance, and consistency among laboratories, thereby ensuring data quality that will ultimately benefit all newborns worldwide.
Item Order Code: NBS04-ANonmember Price: $140
NBS06 | Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles
This guideline addresses the detection of severe combined immunodeficiency (SCID) by population-based newborn screening using dried blood spot specimens to measure T-cell receptor excision circles. SCID is a lethal disorder of infancy that is not evident at birth, and effective treatment requires presymptomatic detection.
Item Order Code: NBS06-ANonmember Price: $140
Newborn Screening Specialty CollectionCollection includes all 6 Newborn Screening documents, the NBS01 DVD, and 6 companion products (bench aids).
Item Order Code: NBSSCNonmember Price: $800
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JC
JULY 2010
APRIL 2013
NBS05 | Newborn Screening for Cystic Fibrosis
This guideline describes the use of newborn screening laboratory tests for detecting risk for cystic fibrosis from newborn dried blood spots (DBS) and addresses both the primary screening tests and the reflex tests performed on DBS.
Item Order Code: NBS05-A Nonmember Price: $140
JCNOVEMBER 2011
Related Companion Product (Bench Aid)
NBS06 QG1 | Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide
Flow chart for assays to measure T-cell receptor excision circles in newborn dried blood spot specimens. Formatted as a durable, waterproof sheet for quick reference.
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Related Companion Product (Bench Aid)
NBS06 QG2 | Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide
Provides a schematic for preparing dried blood spot reference materials. Formatted as a durable, waterproof sheet for quick reference.
Item Order Code: NBS06-A QG2Nonmember Price: $20
Related Companion Product (Wall Chart)
NBS06 WC | Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period Wall Chart
Shows immunodeficiency disorders and T-cell receptor excision circle values in the newborn screening period.
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JULY 2013
JULY 2013 JULY 2013
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Phlebotomy
Related Companion Product (Bench Aid)
GP41 QG | Quality Venipuncture Quick Guide
Lists all of the steps of the venipuncture procedure, as well as special considerations, and the order of the tube draw. It also
includes a color photo of vein distribution on the right arm for guidance in the venipuncture procedure. Formatted as an 11x17-inch chart.
Item Order Code: GP41-A6 QGNonmember Price: $20
JANUARY 2008
GP41 | Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture
This standard provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children.
Item Order Code: GP41-A6Nonmember Price: $140
CAP | FDA | JC
OCTOBER 2007
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-ANonmember Price: $180
CAP | FDA | JC
MAY 2007
Related Companion Product (Bench Aid)
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 Nonmember Price: $20
MARCH 2015
NBS01 | Blood Collection on Filter Paper for Newborn Screening Programs
This standard highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
Item Order Code: NBS01-A6Nonmember Price: $140
CAP | FDA | JC
JULY 2013
Related Video
NBS01 DVD | Making a Difference Through Newborn Screening: Blood Collection on Filter Paper DVD
This video shows how to prepare for specimen collection; collect blood specimens using the recommended heelstick technique;
handle specimens properly; maintain appropriate records; and prevent testing problems that can delay the newborn’s diagnosis and treatment.
Item Order Code: NBS01-A6 DVDNonmember Price: $300
Related Companion Product (Bench Aid)
NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide
How to Collect an Acceptable Blood Spot Specimen
Simple Spot Check
Item Order Code: NBS01-A6 QGNonmember Price: $20
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Point-of-Care Testing
POCT04 | Point-of-Care In Vitro Diagnostic (IVD) Testing
This guideline provides information to users of in vitro diagnostic devices outside the clinical laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory.
Item Order Code: POCT04-A2Nonmember Price: $140
Related Companion Product (Bench Aid)
POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide
Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent
related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory.
Item Order Code: POCT07-A RGNonmember Price: $50
POCT08 | Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers
This instructional guideline delivers laboratory science concepts and activities with the goal of increasing knowledge and quality of laboratory testing for testing personnel with no laboratory background.
Item Order Code: POCT08-ANonmember Price: $140
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POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care
This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.
Item Order Code: POCT07-ANonmember Price: $140
A Document Competency Quiz is available for this document! Visit www.clsi.org/edu for more information.
JC
OCTOBER 2010
AUGUST 2006
JANUARY 2015
DECEMBER 2010
Related Companion Product (Bench Aid)
POCT08 QG1 | Corrective Action Report Quick Guide
Report completed when any control falls outside the acceptable range. Formatted as a durable, waterproof sheet for convenient use in the laboratory.
Item Order Code: POCT08-A QG1Nonmember Price: $20
SEPTEMBER 2011
POCT Companion Product PackageThis package includes:
POCT07-A RG—Addressing Errors in Point-of-Care Testing Reference Guide
POCT08-A QG1—Corrective Action Report Quick Guide (Electronic Download)
Item Order Code: POCT PK
POCT08-A QG2—Quality Control Troubleshooting Flow Chart
POCT09-A WS—Instrument Selection Worksheet (Electronic Download)
Nonmember Price: $140
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POCT06 | Effects of Different Sample Types on Glucose Measurements
This report provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests.
Item Order Code: POCT06-Ed1Nonmember Price: $140
MAY 2015
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Point-of-Care Testing
POCT09 | Selection Criteria for Point-of-Care Testing Devices
This guideline provides information on selection of point-of-care testing devices based on the patient care setting and clinical needs. It is designed as an aid to laboratory and facility management to simplify and
facilitate the selection process, but also allows evaluation of devices to identify those that are optimal to the patient care setting and population served.
Item Order Code: POCT09-ANonmember Price: $140
POCT12 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
This guideline contains information for performance of point-of-care blood glucose meter systems that stress quality control, training, and administrative responsibility.
Item Order Code: POCT12-A3Nonmember Price: $140
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CAP | JC
APRIL 2010
JANUARY 2013
Related Companion Product (Bench Aid)
POCT08 QG2 | Quality Control Troubleshooting Flow Chart
Flow chart for noninstrumented quality control (QC) decision making for QC out of range. Formatted as a durable, waterproof sheet for convenient use in the laboratory.
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Related Companion Product (Bench Aid)
POCT08 QG3 | Quality Control Log Sheet Quick Guide
Log sheet for noninstrumented point-of-care testing. Formatted as a durable, waterproof sheet for convenient use in the laboratory.
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Related Companion Product (Worksheet)
POCT09 WS | Instrument Selection Worksheet
Clinical needs assessment comparison electronic worksheet, which includes items to consider when comparing point-of-care testing system specifications.
Item Order Code: POCT09-A WSNonmember Price: $40
JULY 2013 SEPTEMBER 2011
SEPTEMBER 2011
Related On-Demand POCT08 Webinar | Managing Manual Tests: Challenges and SolutionsObjectives:
List the CLIA regulations most frequently cited for manual test deficiencies.
Describe the inherent challenges of manual testing that have a negative impact on patient care.
Recognize how to use the tools or avenues available to ensure quality in point-of-care manual testing.
Item Order Code: POCT08 WRNonmember Price: $99
Visit www.clsi.org/webinars to learn more.
Speakers: Karen W. Dyer, MT(ASCP), DLM Survey and Certification Group, Centers for Medicare & Medicaid Services (CMS), Baltimore, Maryland, USAPatricia L. Kraft, MA, MT(ASCP) Laboratory POCT/Safety/Education Coordinator, Good Samaritan Hospital, Dayton, Ohio, USA
Related Companion Product (Wall Chart)
POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts
Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and KOH preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory.
Item Order Code: POCT10/GP16 WCNonmember Price: $60
MARCH 2015
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Quality Management Systems
The Key to Quality™This workbook includes fundamental information for implementing and sustaining a quality management system (QMS). You will learn:
The 12 quality system essentials (QSEs) for building a QMS The policies, processes, and procedures requirements for each QSE How to apply the 12 QSEs in your unique laboratory environment
The Key to Quality includes ready-to-use templates and examples of completed forms and QMS tools to assist users in fulfilling the required elements in each QSE.
Item Order Code: K2QNonmember Price: $600
QMS03 | Training and Competence Assessment
This guideline provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives.
Item Order Code: QMS03-A3Nonmember Price: $180
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.
Item Order Code: QMS06-A3Nonmember Price: $180
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-A4Nonmember Price: $180
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.
Item Order Code: QMS02-A6Nonmember Price: $180
CAP | JC CAP | FDA | JC
CAP | FDA | JC CAP | JC
SEPTEMBER 2013
FEBRUARY 2009 JUNE 2011
JUNE 2011 FEBRUARY 2013
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Quality Management Systems
QMS15 | Assessments: Laboratory Internal Audit Program
This guideline provides information for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement.
Whereas an audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, the audit process describes the details of how to conduct individual laboratory internal audits.
Item Order Code: QMS15-ANonmember Price: $180
Formatted in an enhanced, full-color layout!
QMS18 | Process Management
This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and
contributing to patient safety and positive outcomes.
Item Order Code: QMS18-Ed1Nonmember Price: $180
Formatted in an enhanced, full-color layout!
QMS20 | Understanding the Cost of Quality in the Laboratory
This report provides guidance to a laboratory in understanding and managing the different types of quality costs that affect processes, services, and financial well-being.
Item Order Code: QMS20-RNonmember Price: $180
Formatted in an enhanced, full-color layout!
QMS12 | Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality
This guideline provides information on development of quality indicators and their use in the medical laboratory.
Item Order Code: QMS12-ANonmember Price: $180
QMS14 | Quality Management System: Leadership and Management Roles and Responsibilities
This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is
provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory’s organization that are critical to managing and sustaining quality.
Executive Summary also included. This companion product provides an executive summary of QMS14-A.
Item Order Code: QMS14-ANonmember Price: $180
JC JC
DECEMBER 2013
MARCH 2015 MAY 2014
DECEMBER 2010 DECEMBER 2012
Related On-Demand Webinar QMS20 Webinar | Impact of Quality Costs on Your Laboratory’s Operating BudgetObjectives:
List, describe, and provide laboratory examples of the types of quality costs.
Distinguish between costs that support good quality and those that result from poor quality.
Use basic tools to quantify laboratory failure quality costs.
Item Order Code: QMS20-R NOVWR Nonmember Price: $99
Speakers: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USAAnne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ)CSSBBSenior Consultant, Chi Solutions, Inc., Ann Arbor, Michigan, USA
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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On-Demand QMS03 Webinar | Providing POCT Training and Competency for Health Care ProfessionalsObjectives:
Define the key elements of developing a sound competency and training program.
Articulate the principles and the systematic approach required to assess and maintain competency standards for POCT device operators.
Item Order Code: QMS03 WR Nonmember Price: $99
On-Demand QMS04 Webinar | Abandon the Past and Prepare for the Future: Laboratory Design Updates Objectives:
Understand the overall design process. Incorporate Lean and flexibility into laboratory design. Recognize the utilities, safety issues, codes, and other aspects affecting the layout of the laboratory.
Item Order Code: QMS04-A3 WR Nonmember Price: $99
On-Demand QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive? Objectives:
Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program.
Identify gaps in your organization’s NCE management program. Understand potential resources available within QMS11 to assist in improving your program.
Item Order Code: QMS11-A2 WR Nonmember Price: $99
Speakers: Marcia L. Zucker, PhD President, ZIVD LLC, Metuchen, New Jersey, USAMark D. S. Shephard, PhD, MAACB, OAMProfessor, Flinders University International Centre for Point-of-Care Testing, Adelaide, Australia
Speaker: Karen K. Mortland, RA, MT(ASCP) Mortland Planning & Design, Inc., Chicora, Pennsylvania, USA
Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ)CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA
Quality Management Systems
On-Demand QMS18 Webinar | How to Meet Requirements for Managing Any Laboratory Process Objectives:
Describe the four regulatory and accreditation requirements for laboratory process management.
Use two types of process flow charts for meeting the requirements for every new or changed laboratory process.
Explain how the CLSI quality system essentials form a valuable tool for laboratory process management.
Item Order Code: QMS18-A WR Nonmember Price: $99
Speaker: Lucia M. Berte, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE President, Laboratories Made Better! P.C., Broomfield, Colorado, USA
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
Visit www.clsi.org/webinars to learn more.
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Do you know how much your lab spends on: Supporting good quality?
Resolving problems and errors?
Preventing poor quality from occurring?
Find out by enrolling in the only program that truly implements the steps needed to determine the existing cost of quality in your lab!
Implementing the Cost of Quality in the Laboratory Certificate ProgramEarn 4.0 P.A.C.E. CE credits through this online self-paced program.
Enroll today at www.clsi.org/COQ.
EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements
Learn how to implement a successful IQCP program!
Gain knowledge and skills to implement CLSI document EP23-A™.
Simplify QC based on risk management.
Create an IQCP for an analyte and learn from a CLSI instructor about how to enhance your IQCP.
Enroll today! Visit www.clsi.org/EP23Workshop for more information.
Laboratory Quality Management System (LQMS) Certificate Program
Do you know how to ensure that your lab:
Meets accreditation quality requirements?
Runs with the highest efficiency and productivity?
Provides the highest quality test results for your patient population?
Learn the skills needed for successful implementation with the Laboratory Quality Management System (LQMS) Certificate Program. This program focuses on providing an approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective lab services through implementation of a QMS.
Enroll today! Visit www.clsi.org/lqms for more information.
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Reducing Risk
POCT07 | Quality Management: Approaches to Reducing Errors at the Point of Care
This guideline presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.
Item Order Code: POCT07-ANonmember Price: $140
EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources
This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics,
this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes.
Item Order Code: EP18-A2Nonmember Price: $180
JC
CAP | FDA | JC
OCTOBER 2010
NOVEMBER 2009
Related Companion Product (Worksheet)
EP18/EP23 WS | Sources of Failure Template Worksheet
A failure modes and effects analysis table may be used as a checklist or as a tool to help identify potential failures in a testing system. These potential failures are then addressed by an appropriate quality assurance program. Use this electronic template to easily identify these possible failures.
Item Order Code: EP18-A2/EP23-A WSNonmember Price: FREE
Related Companion Product (Bench Aid)
POCT07 RG | Addressing Errors in Point-of-Care Testing Reference Guide
Includes preexamination considerations (patient preparation for the test and sample collection and handling); examination considerations (operator related, reagent related, sample related, and device related); and postexamination considerations (communication related and data management related). Formatted as a spiral-bound reference guide for convenient use in the laboratory.
Item Order Code: POCT07-A RGNonmember Price: $50
Related Educational Product
Quiz for Document Competency: POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care
Document competency quiz designed to test your comprehension of the concepts in CLSI guideline POCT07. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits!
Item Order Code: Quiz POCT07-ANonmember Price: $50
NOVEMBER 2013
JANUARY 2015
JULY 2013
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Reducing Risk
EP23 | Laboratory Quality Control Based on Risk Management
This guideline provides information based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
Item Order Code: EP23-ANonmember Price: $180
Formatted in an enhanced, full-color layout!
JC
OCTOBER 2011
Related Companion Product (Bench Aid)
EP23 QG | EP23 Quick Reference Guide
Includes the steps needed to create a laboratory’s individualized quality control plan (IQCP) as well as a process flow chart that lists the steps for creating an IQCP. Formatted as an 11x17-inch chart for posting in the laboratory.
Item Order Code: EP23-A QGNonmember Price: $50
Related Companion Product (Worksheet)
EP23-A WS | A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet
This EP23 worksheet contains a template and example that help users identify potential failure modes at each stage of the test system’s process and consider what monitors are in place or could be used to detect the problem. The worksheet does not represent a complete or comprehensive evaluation of risk and laboratories are encouraged to use other available resources to meet each institution’s risk management requirements.
Item Order Code: EP23-A WSNonmember Price: $100
Related Companion Product (Workbook)
EP23 WB | A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook
This workbook provides an overview of each step necessary to create a comprehensive quality control plan. It is tailored around a specific example that helps readers understand what information to gather to help detect and assess risks.
Item Order Code: EP23-A WBNonmember Price: $100
AUGUST 2013
SEPTEMBER 2013AUGUST 2013
This package includes:
EP23—Laboratory Quality Control Based on Risk Management
EP23 Implementation Workbook—A Practical Guide for Laboratory Quality Control Based on Risk Management
Item Order Code: EP23-A PK
EP23 Worksheet—A Sample Form for Laboratory Quality Control Based on Risk Management
Nonmember Price: $340
bundle and save!
EP23 Package | Laboratory Quality Control Based on Risk Management; Approved Guideline, Workbook, and Worksheet Package
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Related On-Demand Webinar GP17 Webinar | The Latest in Laboratory Safety: What You Need to Know to Maintain Compliance
Objectives: Understand the major changes in CLSI document GP17—Clinical Laboratory Safety.
Discuss the effects of Globally Harmonized System of Classification and Labelling of Chemicals on the guideline and what role it plays in 2015.
Explain how to use the document to maintain safety regulation compliance and improve the laboratory safety culture.
Item Order Code: GP17-A3 WR Nonmember Price: $99
Speaker: Daniel J. Scungio, MT(ASCP), SLS Sentara Healthcare, Norfolk, Virginia, USA
Safety
GP17 | Clinical Laboratory Safety
This guideline contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory.
Item Order Code: GP17-A3Nonmember Price: $140
GP05 | Clinical Laboratory Waste Management
Based on US regulations, this guideline provides information on the safe handling and disposal of chemical, infectious, radioactive, and multihazardous wastes generated in the clinical laboratory. Although this document is a valuable resource for a wider audience, it is intended for use primarily in the United States.
Item Order Code: GP05-A3Nonmember Price: $140
GP33 | Accuracy in Patient and Sample Identification
This guideline describes the essential elements of systems and processes required to ensure accurate patient identification. The principles in this document may be applied to manual or electronic systems. Design considerations covered include
criteria for accuracy, differences in inpatient vs outpatient settings that impact patient identification, language and cultural considerations, and standardization of processes across the health care enterprise.
Item Order Code: GP33-ANonmember Price: $140
CAP | JC
CAP | JC
CAP | JCJUNE 2012
JANUARY 2011
MARCH 2010
Related Companion Product (Bench Aid)
GP05 CL | Waste Management Program– Audit Checklist
Checklist that includes the elements of a waste management program. Formatted on a durable, waterproof sheet for quick reference in the laboratory.
Item Order Code: GP05-A3 CLNonmember Price: $20
MARCH 2015
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Related On-Demand Webinar QMS11 Webinar | Nonconforming Event Management: Is Your Program Comprehensive?
Objectives: Describe the four key processes and associated activities for an effective nonconforming event (NCE) management program.
Identify gaps in your organization’s NCE management program.
Understand potential resources available within QMS11 to assist in improving your program.
Item Order Code: QMS11-A2 WR Nonmember Price: $99
Speaker: Anne T. Daley, MS, MT(ASCP)DLM, CMQOE(ASQ)CSSBB President, Daley Consulting, LLC, Mesa, Arizona, USA
Safety
GP36 | Planning for Laboratory Operations During a Disaster
This guideline provides information for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.
Item Order Code: GP36-ANonmember Price: $140
M29 | Protection of Laboratory Workers From Occupationally Acquired Infections
Based on US regulations, this guideline provides information on the risk of transmission of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for preventing the laboratory
transmission of microbial infection from laboratory instruments and materials; and recommendations for the management of exposure to infectious agents.
Item Order Code: M29-A4Nonmember Price: $180
CAP | JC
CAP | JC
DECEMBER 2014
NOVEMBER 2007
MAY 2014
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-ANonmember Price: $180
New enhanced, full-color version coming July 2015!
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
Visit www.clsi.org/webinars to learn more.
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Specimen Handling and Processing
GP44 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
This guideline includes criteria for preparing an optimal serum or plasma sample and for the devices used to process blood specimens.
Item Order Code: GP44-A4 Nonmember Price: $140
GP16 | Urinalysis
This guideline addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis.
Item Order Code: GP16-A3Nonmember Price: $140
FDA | JC
CAP | FDA | JC
MAY 2010
FEBRUARY 2009
Related Companion Product (Wall Charts)
POCT10/GP16 WC | Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts
Provides images of microscopic components in urine sediment and vaginal fluid, including bacteria and parasites, casts, cells, crystals, noncellular material, and vaginal fluid and potassium hydroxide preparations. Formatted as two 17x22-inch wall charts for posting in the laboratory.
Item Order Code: POCT10/GP16 WCNonmember Price: $60
Related Companion Product (Bench Aid)
GP44 QG | Handling, Transport, and Storage of Specimens Quick Guide
Provides recommended conditions for proper handling, transport, and storage of specimens for general chemistry and hematology analysis. Formatted as durable, waterproof sheets for quick reference in the laboratory.
Item Order Code: GP44-A4 QGNonmember Price: $40
Related Educational Product
Quiz for Document Competency: GP44—Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
Document competency quiz designed to test your comprehension of the concepts in CLSI guideline GP44. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits!
Item Order Code: Quiz GP44-A4Nonmember Price: $50
MARCH 2015
AUGUST 2014
JULY 2013
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Specimen Handling and Processing
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-ANonmember Price: $140
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.
Item Order Code: H21-A5Nonmember Price: $140
CAP | FDA | JC
CAP | FDA | JC
DECEMBER 2005
JANUARY 2008
Related Companion Product (Bench Aid)
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 in the laboratory.
Item Order Code: H21-A5 QGNonmember Price: $20
Related Educational Product
Quiz for Document Competency: H21—Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
Document competency quiz designed to test your comprehension of the concepts in CLSI guideline H21. Read the document that you have previously purchased and take a quiz to validate reading comprehension. Earn a score of 75% or higher (three attempts allowed) on the 12-question quiz, and print out a certificate for 2.0 P.A.C.E.® continuing education credits!
Item Order Code: Quiz H21-A5Nonmember Price: $50
JULY 2008
JULY 2013
This collection provides information on:
Handling and processing of blood and urine specimens Collecting samples for coagulation testing Collecting, transporting, and storing specimens for molecular methods
It contains the following documents:
GP16 – Urinalysis GP44 – Procedures for the Handling and Processing of Blood Specimens
GP44 QG – Handling, Transport, and Storage of Specimens Quick Guide
H21 – Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
H21-A5 QG – Collection, Handling, Transport, and Storage for Hemostasis Quick Guide
MM13 – Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
Item Order Code: SCH03Nonmember Price: $420
bundle and save! Specimen Handling and Processing Package
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Susceptibility Testing
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.
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
*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: $500Item Order Code: M02-A12 PK15 (includes M02-A12 and M100-S25) | Nonmember Price: $340Item Order Code: M07-A10 PK15 (includes M07-A10 and M100-S25) | Nonmember Price: $340
Related Companion Product (Bench Aid)
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 QGNonmember Price: $120
Related Companion Product (Bench Aid)
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. Serves as a useful reference for laboratories seeking to meet requirements for proficiency testing and accreditation. Formatted as durable, waterproof sheets on a convenient detachable ring for convenient, shared use in the laboratory.
Item Order Code: M100-S25 QGNonmember Price: $100
JANUARY 2015 JANUARY 2015
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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.
Visit www.clsi.org/eM100 to learn more.
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Susceptibility Testing
Related On-Demand Webinar CLSI 2015 Antimicrobial Susceptibility Testing UpdateObjectives:
Identify the major changes found in M100-S25. Design a strategy for implementing the new practice guidelines into your laboratory practices.
Develop a communication strategy for informing clinical staff of significant antimicrobial susceptibility testing and reporting changes.
Speaker: Janet A. Hindler, MCLS, MT(ASCP) Sr. Specialist, Clinical Microbiology, UCLA Health System, Los Angeles, California, USA
Item Order Code: CLSI 2015 Antimicrobial Susceptibility Testing Update Nonmember Price: $125
M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
This standard provides reference methods for the determination of minimal inhibitory concentrations of anaerobic bacteria by agar dilution and broth microdilution.
Item Order Code: M11-A8Nonmember Price: $180
M27 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
This standard addresses the selection and preparation of antifungal agents; implementation and interpretation of test procedures; and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections.
Item Order Code: M27-A3Nonmember Price: $180
M24 | Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
This standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardia spp., and other aerobic actinomycetes.
Item Order Code: M24-A2Nonmember Price: $180
MARCH 2011FEBRUARY 2012
APRIL 2008
M27 Supplement | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard M27-A3.
Item Order Code: M27-S4Nonmember Price: $35
DECEMBER 2012
M38 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
This standard addresses the selection of antifungal agents, preparation of antifungal stock solutions and dilutions for testing
implementation and interpretation of test procedures, and quality control requirements for susceptibility testing of filamentous fungi (moulds) that cause invasive and cutaneous fungal infections.
Item Order Code: M38-A2Nonmember Price: $180
M39 | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
This guideline describes methods for recording and analysis of antimicrobial susceptibility test data, consisting of cumulative and ongoing summaries of susceptibility patterns of clinically significant microorganisms.
Item Order Code: M39-A4Nonmember Price: $180
JANUARY 2014APRIL 2008
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Susceptibility Testing
M45 | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
This guideline provides information to clinical microbiology laboratories for standardized susceptibility testing of
infrequently isolated or fastidious bacteria that are not presently included in CLSI documents M02 or M07. The tabular information in this document presents the most current information for drug selection, interpretation, and quality control for the infrequently isolated or fastidious bacterial pathogens included in this guideline.
Item Order Code: M45-A2Nonmember Price: $180
AUGUST 2010
M44 and Third Informational Supplement | Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
This guideline provides newly established methodology for disk diffusion testing of Candida spp., criteria for quality control
testing, and interpretive criteria.
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
These supplemental tables provide new quality control limits for CLSI document M44. It is available as a laminated chart for easy posting.
Item Order Code: M44-A2 and M44-S3Nonmember Price: $180
AUGUST 2009
Related Companion Product (Bench Aid)
M39 QG | Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide
Serves as a handy reference for laboratory personnel. It provides recommendations for preparation of a cumulative antibiogram, examples of selection criteria, and supplemental analyses. It also shows how to prepare tables, includes a description of limitations of data, and provides examples of reports and graphs. Formatted as seven durable, waterproof sheets on a convenient detachable ring.
Item Order Code: M39-A4 QGNonmember Price: $60
JANUARY 2015
This collection provides guidance for microbiologists performing routine susceptibility testing. Information covered includes:
Disk and dilution testing procedures Interpretive tables for antimicrobial susceptibility tests Safety precautions
It contains the following documents:
M02 – Performance Standards for Antimicrobial Disk Susceptibility Tests
M07 – Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
M39 – Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
M45 – Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
M100 – Performance Standards for Antimicrobial Susceptibility Testing
AST QC QG – AST Quality Control Quick Guide M100 QG – M100 Tables 1A–1C Quick Guide M100 WC – Glossary of Antimicrobial Terms and Abbreviations Wall Chart
Item Order Code: SCM03Nonmember Price: $950
bundle and save! General Susceptibility Testing Package
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General Susceptibility Testing Package
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Related On-Demand Webinar VET01 Webinar | Updates to the CLSI Veterinary AST Supplement
Objectives: Discuss CLSI document VET01-A4 and its supplement, VET01S, and how they impact veterinary antimicrobial susceptibility testing (AST).
Identify the procedures and applications of the various methods recommended by CLSI for AST.
Describe the changes made to the supplement and the importance of interpreting results, based on drug selection, for better animal care.
Item Order Code: VET01-A4 WR Nonmember Price: $99
Speaker: Michael T. Sweeney, MT Principal Scientist, Zoetis, Kalamazoo, Michigan, USA
Veterinary Medicine
VET01 and Third Informational Supplement | Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
This standard provides the currently recommended techniques for antimicrobial
agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use.
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement
This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01.
Item Order Code: VET01-A4Nonmember Price: $230
VET02 | Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents
This guideline addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.
Item Order Code: VET02-A3Nonmember Price: $140
VET03/VET04 Supplement Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement
This supplement provides updated tables for the CLSI antimicrobial susceptibility testing guidelines VET03-A and VET04-A2.
Item Order Code: VET03/VET04-S2Nonmember Price: $100
VET03 | Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals
This guideline provides the most up-to-date techniques for disk diffusion susceptibility testing of aquatic species isolates, and criteria for quality control testing.
Item Order Code: VET03-ANonmember Price: $140
JULY 2013 FEBRUARY 2008
SEPTEMBER 2014JUNE 2006
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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Veterinary Medicine
VET04 and Second Informational Supplement* | Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals
This guideline provides the most up-to-date techniques for the determination of minimal inhibitory concentrations of aquatic bacteria by broth micro- and macrodilution, and criteria for data interpretation and quality control testing. The VET04 supplement provides updated tables for VET03-A and VET04-A2.
VET05 | Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin
This report offers guidance on areas in which harmonization can be achieved in veterinary antimicrobial surveillance programs with the intent of facilitating comparison of data among surveillance programs.
Item Order Code: VET05-RNonmember Price: $140
SEPTEMBER 2014 SEPTEMBER 2011
*Note that VET04 must be purchased in a package with the VET03/VET04 Supplement. Item Order Code: VET04-A2 PK | Nonmember Price: $180
Infobase 2015 is a user-friendly, searchable CD-ROM of over 200 CLSI standards for best practices in medical testing.
Infobase 2015 includes: All standards in the CLSI document library published through December 31, 2014 A feature that allows searching across and within all standards to locate relevant information The ability to access documents without a Web connection
Please contact customerservice@clsi.org to learn more.
Members save up to 70% on CLSI products! See page 17 for discount pricing structure.
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CLSI Course OfferingsCLSI offers numerous educational and training programs and services, including seminars, workshops, on-site assessments, in-lab mentoring, webinars, and online education programs.
Offerings include: On-site assessment to evaluate existing lab
operations against the accreditation model health officials have selected, identifying and analyzing gaps between existing practices and best practices
Assistance with the development of national strategic plans for labs
Customized and interactive training and educational programs for lab staff, management, and quality officers, focusing on the development and strengthening of quality management systems
Assistance with the development of continuous quality improvement strategies
Measurable and scalable programs for all labs seeking international accreditation
Visit www.clsi.org/training for more information.
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JUNE 2015
Be on the lookout for these new and revised standards, which are scheduled to be published through August 2015 to address the timely issues most relevant to our members and customers. The projected publication dates are listed below.
CLSI Documents Scheduled for Publication
EP36 | Harmonization of Symbology and Equations
This report provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit
to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general.
Item Order Code: EP36-Ed1FREE!
M52 | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
This guideline includes recommendations for verification of commercial US Food and Drug Administration–cleared microbial
identification and antimicrobial susceptibility testing systems by clinical laboratory professionals to fulfill regulatory or quality assurance requirements for the use of these systems for diagnostic testing.
Item Order Code: M52-Ed1Nonmember Price: $180
VET01 Supplement Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals
This supplement provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01.
Item Order Code: VET01S-Ed3Nonmember Price: $100
EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
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.
Item Order Code: EP19-Ed2FREE!
POCT13 | Glucose Monitoring in Settings Without Laboratory Support
This guideline focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control, training, and administrative responsibility.
Item Order Code: POCT13-Ed3Nonmember Price: $140
Formatted in an enhanced, full-color layout!
QMS11 | Nonconforming Event Management
Grounded in the principles of quality management, risk management, and patient safety, this guideline provides an outline and content for developing a program to manage
a laboratory’s nonconforming events.
Item Order Code: QMS11-Ed2Nonmember Price: $180
New enhanced, full-color version!
QMS16 | Laboratory Personnel Management
This guideline provides a roadmap for meeting the regulatory and accreditation requirements of personnel management in the laboratory environment. This guideline
offers suggestions and examples on managing the processes required for laboratory personnel to fully achieve laboratory management’s operational and quality goals.
Item Order Code: QMS16-Ed1Nonmember Price: $180
Formatted in an enhanced, full-color layout!
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