Clsi 2015-catalog

Set the Standard for Quality in Your Laboratory With CLSI

20152016 CATALOG

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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






GP23-A2Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition

November 2014






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






POCT06Effects of Different Sample Types on Glucose Measurements

1st Edition






C57Mass Spectrometry for Androgen and Estrogen Measurements in Serum

1st Edition






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






MM03Molecular Diagnostic Methods for Infectious Diseases

1st Edition






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






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


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


New Document Code

Quality Management Systems (continued)

HS04-A2 QMS07-A2

HS11-A QMS10-A

GP32-A QMS11-A

GP35-A QMS12-A

GP37-A QMS13-A

GP38-A QMS14-A

GP38-AES QMS14-AES

Veterinary Medicine

M31-A3 VET01-A4

M37-A3 VET02-A3

M42/M49-S1 VET03/VET04-S2

M42-A VET03-A

M49-A VET04-A2

X08-R VET05-R

In order to better classify our library of documents, CLSI expanded and color coded its document categories. The assigned colors are prominently displayed on each CLSI document cover.

The document categories are:

As part of this initiative, some CLSI documents were assigned new codes to reflect their categories. See below for the complete list of affected documents, or visit www.clsi.org.

* These documents replaced the respective standards noted in the “Former Document Code” column.



General Laboratory

Hematology

Immunology and Ligand Assay

Method Evaluation

Microbiology

Molecular Methods

Newborn Screening



Veterinary Medicine

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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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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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IND

EX



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


C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF

C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition

Online PDF

C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF

C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition


C48-A Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline

Online PDF

C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Pg. 24 PDF and Print

C49-A/H56-A QG Collection, Handling, Transport, and Storage for Body Fluids Quick Guide Pg. 24 Print

C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline

Online PDF

C52-A2 Toxicology and Drug Testing in the Clinical Laboratory; Approved Guideline—Second Edition

Online PDF and Print

C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline


C56-A QG Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide Pg. 25 PDF and Print

C57-Ed1 Mass Spectrometry for Androgen and Estrogen Measurements in Serum, 1st Edition Pg. 25 PDF and Print

C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline Online PDF

C61-A Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard

Online PDF

C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline Pg. 25 PDF and Print

EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition


EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline


EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print

EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition


EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition


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


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


EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition


EP19-Ed2 A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition

Pg. 4, 57 PDF

EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Pg. 19 PDF and Print

EP24-A2 Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition


EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Online PDF

EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition


EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline

Online PDF

EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision)


EP32-R Metrological Traceability and Its Implementation; A Report Online PDF

GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition


(continued)

General Laboratory

EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Online PDF and Print

GP05-A3 Clinical Laboratory Waste Management; Approved Guideline—Third Edition Pg. 46 PDF and Print

GP05-A3 CL Waste Management Program—Audit Checklist Pg. 46 PDF and Print

GP15-A3 Cervicovaginal Cytology Based on the Papanicolaou Technique; Approved Guideline—Third Edition

Online PDF

GP16-A3 Urinalysis; Approved Guideline—Third Edition Pg. 48 PDF and Print

GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print

GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition Online PDF

GP23-A2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition


GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition


GP28-A Microwave Device Use in the Histology Laboratory; Approved Guideline Online PDF

GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition


GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline


GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print

GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline


GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline Pg. 47 PDF and Print

GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition


GP40-A4-AMD Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition


GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition


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General Laboratory


GP41-A6 QG Quality Venipuncture Quick Guide Pg. 36 PDF and Print

GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition

Online PDF

GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Online PDF and Print

GP43-A4 Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition

Online PDF

GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition


GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 48 Print

GP45-A Studies to Evaluate Patient Outcomes; Approved Guideline Online PDF

H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print

I08-P Determining Performance of Volumetric Equipment; Proposed Guideline Online PDF

I16-T Temperature Monitoring and Recording in Blood Banks; Tentative Guideline Online PDF

M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition


MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline


MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print

POCT10/GP16 WC Microscopic Components in Urine Sediment and Vaginal Fluid Wall Charts Pg. 39, 48 PDF and Print

QG 10 Specimen Collection Quick Guides Online Print

QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition


(continued)

Hematology

H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 26 PDF and Print

H07-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—Third Edition

Online PDF

H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition

Online PDF

H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition


H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition


H21-A5 QG Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Pg. 26, 49 Print

H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition


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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IND

EX


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


I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition


I/LA28-A2 QG Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked Immunosorbent Assay and Immunohistochemistry Quick Guide

Pg. 28 Print

I/LA30-A Immunoassay Interference by Endogenous Antibodies; Approved Guideline Online PDF

I/LA33-A 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


NBS06-A QG1 Generic Flow Chart for Assays to Measure T-cell Receptor Excision Circles in Newborn Dried Blood Spot Specimens Quick Guide

Pg. 35 Print

NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 35 Print

NBS06-A WC Immunodeficiency Disorders and T-cell Receptor Excision Circle Values in the Newborn Screening Period

Pg. 35 Print

Hematology


H52-A2 Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition


H54-A Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline


H56-A Body Fluid Analysis for Cellular Composition; Approved Guideline Online PDF and Print

H57-A Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline

Online PDF

H58-A Platelet Function Testing by Aggregometry; Approved Guideline Online PDF and Print

H59-A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline


H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline Pg. 27 PDF and Print

H60-A QG1 Algorithmic Approach to Lupus Anticoagulant Testing Pg. 27 PDF and Print

H60-A QG2 Criteria for the Laboratory Diagnosis of the Lupus Anticoagulant Pg. 27 PDF and Print

MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition

Online PDF

POCT14-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline Online PDF and Print

(continued)

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Method Evaluation


C24-A3 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition


C29-A2 Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard—Second Edition

Online PDF

C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline

Online PDF

C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard

Online PDF

C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online PDF

C43-A2 Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition

Online PDF

C45-A Measurement of Free Thyroid Hormones; Approved Guideline Online PDF

C46-A2 Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition


C50-A Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline

Online PDF

EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition


EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline


EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Pg. 18 PDF and Print

EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition


EP10-A3-AMD Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline—Third Edition


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


EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition


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


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


EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition


EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline Online PDF and Print

EP30-A Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline

Online PDF

EP31-A-IR Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (Interim Revision)


EP32-R Metrological Traceability and Its Implementation; A Report Online PDF

EP36-Ed1 Harmonization of Symbology and Equations, 1st Edition Pg. 57 PDF

H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition


MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print

(continued)

Microbiology

AST QC QG AST QC Flow Chart Quick Guides Pg. 29, 50 PDF and Print

M02-A12 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Twelfth Edition


M06-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition

Online PDF

M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Tenth Edition


M11-A8 Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition


M15-A Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline Online PDF

M21-A Methodology for the Serum Bactericidal Test; Approved Guideline Online PDF

M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition


M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Third Edition


M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition


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


M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement


M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition


M29-A4 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition


M32-P Evaluation of Lots of Dehydrated Mueller-Hinton Broth for Antimicrobial Susceptibility Testing; Proposed Guideline

Online PDF

M33-A Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard


M34-A Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline Online PDF

M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition Pg. 30 PDF and Print

M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline

Online PDF

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Microbiology


M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition


M39-A4 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition


M39-A4 QG Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide Pg. 52 Print

M40-A2 Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition


M41-A Viral Culture; Approved Guideline Online PDF

M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline

Online PDF

M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition


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


M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition


M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 31, 36 PDF and Print

M47-A QG Collection, Handling, and Transport for Blood Cultures Quick Guide Pg. 31, 36 Print

M48-A Laboratory Detection and Identification of Mycobacteria; Approved Guideline Online PDF

M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline Online PDF and Print

M51-A Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline

Online PDF

M51-S1 Performance Standards for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Informational Supplement

Online PDF

M52-Ed1 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition


M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline

Online PDF

M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline


M55-R Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report


M56-A Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline


M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement


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


MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF

MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline


MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print

(continued)

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Molecular Methods


I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition


M53-A Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline

Online PDF

MM01-A3 Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—Third Edition

Online PDF

MM03-Ed3 Molecular Diagnostic Methods for Infectious Diseases, 3rd Edition Pg. 32 PDF and Print

MM05-A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition

Online PDF

MM06-A2 Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition


MM07-A2 Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition


MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition


MM10-A Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline

Online PDF

MM11-A Molecular Methods for Bacterial Strain Typing; Approved Guideline Online PDF

MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online PDF

MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline


MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 32 Print

MM14-A2 Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition


MM16-A Use of External RNA Controls in Gene Expression Assays; Approved Guideline Online PDF

MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Pg. 33 PDF and Print

MM18-A Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline


MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline Pg. 33 PDF and Print

MM20-A Quality Management for Molecular Genetic Testing; Approved Guideline Pg. 33 PDF and Print

MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 33 PDF and Print

MM23-Ed1 Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 1st Edition





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


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


NBS03-A Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline


NBS03-A QG Algorithm for Newborn Screening of Preterm, Low Birth Weight, and Sick Newborns Quick Guide

Pg. 34 Print

NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline Pg. 35 PDF and Print

NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline Pg. 35 PDF and Print




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)


POCT01-A2 Point-of-Care Connectivity; Approved Standard—Second Edition Online PDF

POCT02-A Implementation Guide of POCT01 for Health Care Providers; Approved Guideline Online PDF

POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition Pg. 38 PDF

POCT05-A Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline Online PDF

POCT06-Ed1 Effects of Different Sample Types on Glucose Measurements, 1st Edition Pg. 38 PDF and Print

POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline


POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print

POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline


POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print

POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print

POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print

POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline Pg. 39 PDF

POCT09-A WS Instrument Selection Worksheet Pg. 39 PDF

POCT10-A2 Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline—Second Edition


POCT10-A2 CL1 Provider-Performed Microscopy Training Checklist: Competence/Validation Cumulative Record


POCT10-A2 CL2 Provider-Performed Microscopy Training Checklist: Initial or Renewal Competence/Validation Employee Training Checklist


POCT10-A2 LG Microscope Maintenance Log Online PDF and Print

POCT10-A2 QG1 Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide Online PDF and Print

POCT10-A2 QG2 Nasal Smears for Inflammatory Cells (Also Known as “Nasal Smear for Eosinophils,” “Nasal WBCs,” and “Nasal Smear for Granulocytes”) Quick Guide


POCT10-A2 QG3 Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide Online PDF and Print

POCT10-A2 QG4 Urine Sediment Examinations Quick Guide Online PDF and Print

POCT10-A2 QG5 Wet Mount Preparations and KOH Preparations Quick Guide Online PDF and Print

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EP18-A2/EP23-A WS Sources of Failure Template Pg. 44 Word

EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 45 PDF and Print

EP23-A QG EP23 Quick Reference Guide Pg. 45 PDF and Print

EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook Pg. 45 PDF and Print

EP23-A WS A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet Pg. 45 Word

GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 46 PDF and Print

GP27-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition


GP29-A2 Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition


GP31-A Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline


GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 46 PDF and Print

K2Q The Key to Quality Pg. 40 PDF and Print

POCT07-A Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline


POCT07-A RG Addressing Errors in Point-of-Care Testing Reference Guide Pg. 38, 44 Print

POCT08-A Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline


POCT08-A QG1 Corrective Action Report Quick Guide Pg. 38 PDF and Print

POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 39 Print

POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 39 PDF and Print

QMS01-A4 Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition


QMS02-A6 Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition


QMS03-A3 Training and Competence Assessment; Approved Guideline—Third Edition Pg. 21, 40 PDF and Print

QMS04-A2 Laboratory Design; Approved Guideline—Second Edition Online PDF and Print

QMS05-A2 Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory; Approved Guideline—Second Edition


QMS06-A3 Quality Management System: Continual Improvement; Approved Guideline—Third Edition


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



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


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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QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Pg. 21, 47 PDF and Print

QMS11-Ed2 Nonconforming Event Management, 2nd Edition Pg. 57 PDF and Print

QMS12-A Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality; Approved Guideline


QMS13-A Quality Management System: Equipment; Approved Guideline Online PDF and Print

QMS14-A Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline


QMS14-AES Executive Summary: Quality Management System: Leadership and Management Roles and Responsibilities


QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 41 PDF and Print

QMS16-Ed1 Laboratory Personnel Management, 1st Edition Pg. 57 PDF and Print

QMS18-Ed1 Process Management, 1st Edition Pg. 41 PDF and Print

QMS20-R Understanding the Cost of Quality in the Laboratory; A Report Pg. 41 PDF and Print

(continued)

Veterinary Medicine

VET01-A4 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard—Fourth Edition


VET01S-Ed3 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Third Informational Supplement


VET02-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline—Third Edition


VET03-A Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline


VET03/VET04-S2 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement


VET04-A2 Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline—Second Edition


VET05-R Generation, Presentation, and Application of Antimicrobial Susceptibility Test Data for Bacteria of Animal Origin; A Report


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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

Level I Organization: 70%

Level II Organization: 60%

Level III Organization: 50%

Individual Full: 25%

Individual Associate: 15%

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.


EP15 | User Verification of Precision and Estimation of Bias

This guideline describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days.


Formatted in an enhanced, full-color layout!

C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions

This guideline provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications.

Item Order Code: C24-A3 Nonmember Price: $140

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Accreditation Preparedness – Essentials for Verifying Test Performance

JUNE 2006

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APRIL 2003

NOVEMBER 2005 AUGUST 2013

SEPTEMBER 2014

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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


Accreditation Preparedness – Essentials for Verifying Test Performance

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CAP | JC

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JUNE 2012 APRIL 2003

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.


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


QMS06 | Quality Management System: Continual Improvement

This guideline considers continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program may consist of fundamental processes and common supporting elements described in this guideline.


QMS11 | Management of Nonconforming Laboratory Events

This guideline provides an outline and the content for developing a program to manage a health care service’s nonconforming events that is based on the principles of quality management and patient safety.

Item Order Code: QMS11-ANonmember Price: $180

New enhanced, full-color version coming July 2015!

Accreditation Preparedness – Laboratory Practices

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OCTOBER 2014 APRIL 2011


AUTO11 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems

This standard provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization.

Item Order Code: AUTO11-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

Visit www.clsi.org/webinars to learn more.

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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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.


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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CAP | JC

C34 | Sweat Testing: Sample Collection and Quantitative Chloride Analysis

This guideline addresses appropriate methods of collection and analysis, quality control, and the evaluation and reporting of test results.


C46 | Blood Gas and pH Analysis and Related Measurements

This guideline provides clear definitions of the quantities in current use, and provides a single source of information on appropriate specimen collection, preanalytical variables, calibration, and quality control for blood pH and gas analysis and related measurements.


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APRIL 2007 JANUARY 2015


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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.



C56 QG | Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide

Shows examples of hemolyzed, icteric, and lipemic/turbid samples. Formatted as a durable, waterproof sheet for quick reference.

Item Order Code: C56-A QGNonmember Price: $20

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.



FDA | JC

JC

JULY 2012 OCTOBER 2014

FEBRUARY 2015 OCTOBER 2014


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


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.


JC

CAP | JC

H21 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays

This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests.


H26 | Validation, Verification, and Quality Assurance of Automated Hematology Analyzers

This standard provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user

clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems.


CAP | FDA | JC

CAP | FDA | JC

JANUARY 2008MAY 2011

JUNE 2010

MARCH 2014


H21 QG | Collection, Handling, Transport, and Storage for Hemostasis Quick Guide

Outlines best practice procedures for the proper collection, transportation, and processing of blood specimens as well as storage of plasma for coagulation testing. Formatted as durable, waterproof sheets for quick reference.

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JANUARY 2008


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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


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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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.


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.


JC

NOVEMBER 2013MARCH 2009

JANUARY 2011

DECEMBER 2009

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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.

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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.

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DECEMBER 2009

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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


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.

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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.

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*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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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.


M28 | Procedures for the Recovery and Identification of Parasites From the Intestinal Tract

This guideline addresses the collection, processing, and examination of intestinal tract specimens for the identification of parasites.


JUNE 2005JUNE 2004

NOVEMBER 2008

M40 | Quality Control of Microbiological Transport Systems

This standard provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.


JUNE 2014


http://www.clsi.org


http://www.clsi.org








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.


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


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


http://www.clsi.org


http://www.clsi.org







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.


FDA | JC

NOVEMBER 2010FEBRUARY 2015

AUGUST 2013

DECEMBER 2005

MM09 | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine

This guideline addresses diagnostic sequencing using both automated capillary-based sequencers and massively parallel sequencing instruments. Topics include specimen collection and handling; isolation and extraction of nucleic acid; template preparation; sequence generation, alignment, and assembly; validation and verification; ongoing quality assurance; and reporting results.


CAP | FDA | JCFEBRUARY 2014


MM13 QG | Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide

Describes the recommended methods for the collection of molecular method samples, proper shipping conditions, and storage addressing issues including temperature, preservatives, and duration.

Item Order Code: MM13-A QGNonmember Price: $20

MARCH 2015


http://www.clsi.org


http://www.clsi.org









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.


MM19 | Establishing Molecular Testing in Clinical Laboratory Environments

This guideline provides comprehensive information for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.


MM22 | Microarrays for Diagnosis and Monitoring of Infectious Diseases

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.


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


http://www.clsi.org


http://www.clsi.org








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


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


NBS02 QG | Newborn Screening Follow-up Process Quick Guide

Describes the newborn screening follow-up process.



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

JUNE 2014 JULY 2013

JULY 2013

JULY 2013


http://www.clsi.org


http://www.clsi.org







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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.


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.


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

JC

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


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.

Item Order Code: NBS06-A QG1Nonmember Price: $20


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.

Item Order Code: NBS06-A WCNonmember Price: $20

JULY 2013

JULY 2013 JULY 2013

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http://www.clsi.org


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Phlebotomy


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.


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.


CAP | FDA | JC

MAY 2007


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


NBS01 QG | Specimen Collection and Sample Quality for Newborn Screening Quick Guide

How to Collect an Acceptable Blood Spot Specimen

Simple Spot Check


JUNE 2014 JULY 2013


http://www.clsi.org


http://www.clsi.org










Shareyourknowledgeanddisseminateinformation.

Exploreideasandparticipateingrouporprivatediscussions.

Accessexperience-basedsolutionsfromprofessionalcolleagues.

Findresourcestodoyourjobbetter,shortendecisiontimes,anddecreaserisk.

Networktofindindividualswhosharesimilargoalsandinterests.

Participate in CLSI’s online Communities to collaborate with fellow professionals!

Join today at community.clsi.org.

Membership Community – Coming Soon!

http://www.clsi.org


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http://community.clsi.org



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


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

JC

JC

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.


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


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


http://www.clsi.org


http://www.clsi.org















http://www.clsi.org/edu


http://shop.clsi.org/point-of-care-documents/POCT-PK_3.html




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.


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

JC

CAP | JC

APRIL 2010

JANUARY 2013


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.



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.


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


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


http://www.clsi.org


http://www.clsi.org






http://shop.clsi.org/point-of-care-companion-products/POCT09-WS.html





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.



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.


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.



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.


CAP | JC CAP | FDA | JC

CAP | FDA | JC CAP | JC

SEPTEMBER 2013

FEBRUARY 2009 JUNE 2011

JUNE 2011 FEBRUARY 2013


http://www.clsi.org


http://www.clsi.org


http://shop.clsi.org/quality-management-systems-documents/k2q.html







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.



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


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


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.


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.


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


http://www.clsi.org


http://www.clsi.org








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.


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


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



http://www.clsi.org


http://www.clsi.org




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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http://www.clsi.org/EP23Workshop

http://www.clsi.org/lqms


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.


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


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


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


JC

OCTOBER 2011


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


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

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EP23 Package | Laboratory Quality Control Based on Risk Management; Approved Guideline, Workbook, and Worksheet Package


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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.


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.


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.


CAP | JC

CAP | JC

CAP | JCJUNE 2012

JANUARY 2011

MARCH 2010


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



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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.


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.


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.


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.


New enhanced, full-color version coming July 2015!



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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.


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


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


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.


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.


CAP | FDA | JC

CAP | FDA | JC

DECEMBER 2005

JANUARY 2008


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


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


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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

*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


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


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



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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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.


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.


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.


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.


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.


JANUARY 2014APRIL 2008


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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.


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


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

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General Susceptibility Testing Package

Now, CLSI Standards Are a Click Away…With eCLIPSETM Ultimate Access, we have made it easy for your lab to access and use our invaluable resources for quality improvement—anytime, anywhere.

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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



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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 [email protected] to learn more.


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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


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.



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.



JULY 2015

AUGUST 2015

JUNE 2015

JUNE 2015

JULY 2015 AUGUST 2015

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Clsi 2015-catalog

Healthcare

Transcript of Clsi 2015-catalog