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2014 CATALOG

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We know that today’s laboratories face many complex challenges. CLSI is an organization committed to helping you raise the standards for quality in your laboratory environment and uncover the value that greater testing accuracy, efficiency, and safety provides your health care organization.

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ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | [email protected] 1

January 2014

This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8.

A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.

M39-A4Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition

950 West Valley Road, Suite 2500, Wayne, PA 19087 USA P: 610.688.0100 Toll Free (US): 877.447.1888 F: 610.688.0700 E: [email protected] www.clsi.org

PRINT ISBN 1-56238-897-5 ELECTRONIC ISBN 1-56238-898-3

January 2014

M100-S24Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement


An informational supplement for global application developed through the Clinical and Laboratory Standards Institute consensus process.

M100_S24.indd All Pages 12/16/13 9:17 AM



November 2013

I/LA26-A2Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition

This document 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.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

I_LA26_A2.indd All Pages 11/11/13 8:44 AM


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Recently Published From CLSI

New and revised standards, published from August 2013 through April 2014, on timely clinical laboratory topics.

Find these newly published standards and more online at the CLSI Shop.

QMS15-AAssessments: Laboratory Internal Audit Program; Approved Guideline


December 2013


This document provides guidance 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.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.PRINT ISBN 1-56238-895-9 ELECTRONIC ISBN 1-56238-896-7

QMS15.indd All Pages 12/19/13 2:51 PM

M39-A4Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline— Fourth Edition




August 2013

EP09-A3Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

This document 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.


EP09_A3.indd All Pages 8/21/13 8:01 AM



September 2013

EP26-AUser Evaluation of Between-Reagent Lot Variation; Approved Guideline

This document provides guidance for laboratories on the

evaluation of a new reagent lot, including a protocol using patient

samples to detect significant changes from the current lot.


EP26_A.indd All Pages 10/17/13 1:49 PM

March 2014



H52-A2Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition

March 2014



H60-ALaboratory Testing for the Lupus Anticoagulant; Approved Guideline

EP09-A3Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline— Third Edition






October 2013

C40-A2Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition

This document provides guidance 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.


C40-A2.indd All Pages 10/15/13 8:04 AM



PRINT ISBN 1-56238-885-1 ELECTRONIC ISBN 1-56238-886-X

August 2013

MM07-A2Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition

This document 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.


MM07-A2.indd All Pages 8/15/13 8:19 AM

February 2014



MM09-A2Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition

February 2014



MM22-AMicroarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline




April 2014



EP14-A3Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition


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2014

TABLE OF CO

NTEN

TS

Table of ContentsDocument Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Index of CLSI Standards, Guidelines, and Companion Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Catalog Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Document and Product Listings by Specialty Area Automation and Informatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Clinical Chemistry and Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

General Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Hematology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Immunology and Ligand Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Method Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Microbiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Molecular Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Newborn Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Point-of-Care Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Quality Management Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Veterinary Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Featured Products EP23™ Online Workshop: Risk-Based Tools to Meet IQCP Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

StatisPro™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Infobase™ 2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

eM100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

eCLIPSE™ Ultimate Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

The Key to Quality™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

LQMS Certificate Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Order Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

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Former Document Code

New Document Code

Automation and Informatics

GP19-A2 AUTO13-A2

Clinical Chemistry and Toxicology

I/LA15-A C59-A

T/DM06-A C60-A

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

X04-R GP46-R

Method Evaluation

C28-A3c EP28-A3c

C51-A EP29-A

C53-A EP30-A

C54-A-IR EP31-A-IR


New Document Code

Method Evaluation (continued)

X05-R EP32-R

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

HS05-A2 QMS08-A2

HS10-A2 QMS09-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-A3

M37-A3 VET02-A3

M42/M49-S1 VET03/VET04-S1

M42-A VET03-A

M49-A VET04-A

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 new 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

There are more products online at the CLSI Shop. Visit www.clsi.org to find our full library of resources.Shop Online!

DO

CUM

ENT

CATE

GO

RIES

http://www.clsi.org



Method EvaluationQuality ManagementSystems

Microbiology

Newborn Screening


Share your knowledge and disseminate information.

Explore ideas and participate in group or private discussions.

Access experience-based solutions from professional colleagues.

Find resources to do your job better, shorten decision times, and decrease risk.

Network to find individuals who share similar goals and interests.

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

Communities

CLSI COM

MU

NITIES

Join today at community.clsi.org.

If you are interested in submitting content such as case studies or featured articles for the Communities, please e-mail [email protected].

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IND

EX


Document Code Document Title Location

AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard Online

AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition

Online

AUTO03-A2 Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition

Pg. 18

AUTO04-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard

Online

AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard Online

AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard Online

AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline Online

AUTO09-A Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard

Online

AUTO10-A Autoverification of Clinical Laboratory Test Results; Approved Guideline Online

AUTO11* Information Technology Security of In Vitro Diagnostic Instruments and Software Systems Pg. 56

AUTO11-A IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard Online

AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard Pg. 18

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

I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

Pg. 23

I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit

Pg. 23

LIS01-A2 Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition

Online

LIS02-A2 Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition

Online

LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System Online

LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems Online

LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer Systems

Online

LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems Online

LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory Online

LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

Online

LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

Online

All CLSI standards, guidelines, and companion products are listed in the index below. Documents published from 2009 to present are located in the catalog, and a corresponding page number is indicated in the “Location” column. Documents published before 2009 are available on the CLSI website at www.clsi.org, and are indicated with “online” in the “Location” column below.

Documents marked with an asterisk are documents that are expected to publish by June 2014.

Index of CLSI Standards, Guidelines, and Companion Products

http://www.clsi.org


http://shopping.netsuite.com/s.nl/c.1253739/it.A/id.958/.f




















IND

EX



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

Online

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

Online

C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline—Second Edition

Online

C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition

Pg. 19

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

Online

C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline Online

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

Online

C40-A2 Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition

Pg. 19

C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online

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

Pg. 19

C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline Online

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

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

Pg. 19

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

Online

C49-A Analysis of Body Fluids in Clinical Chemistry; Approved Guideline Online

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

Online

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

Online

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

Pg. 19

C58-A Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline Pg. 19

C59-A Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline

Online

C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline Online

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

Online

C62* Liquid Chromatography-Mass Spectrometry Methods Pg. 56

EP05* Evaluation of Precision of Quantitative Measurement Procedures Pg. 56

EP05-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

Pg. 26

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

Pg. 26

EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Online

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

Pg. 26

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

Online

http://www.clsi.org





















IND

EXClinical Chemistry and Toxicology


EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition

Online

EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Pg. 26

EP15* User Verification of Precision and Estimation of Bias Pg. 56

EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition

Online

EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition

Pg. 26

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

Pg. 27

EP19-R A Framework for NCCLS Evaluation Protocols; A Report Online

EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Online

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

Pg. 27

EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Pg. 27

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

Pg. 28

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

Pg. 28

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

Pg. 28

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

(continued)

General Laboratory

EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Pg. 27

GP05-A3 Clinical Laboratory Waste Management; Approved Guideline—Third Edition Pg. 20

GP05-A3 QG Waste Management Program—Audit Checklist Pg. 20

GP11-A Basic Cost Accounting for Clinical Services; Approved Guideline Online

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

Online

GP16-A3 Urinalysis; Approved Guideline—Third Edition Pg. 20

GP16-A3 WC Wall Chart—Identifiable Microscopic Entities Seen in Urine Sediment Pg. 20

GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 20

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

GP23-A Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline

Online

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

Online

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

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

Online

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

Pg. 20

GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 20

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

Pg. 21

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General Laboratory


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

Pg. 21

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

Pg. 21

GP41-A6 QG Quality Venipuncture Quick Guide Pg. 21

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

Online

GP42-A6 QG Technique for Skin Puncture in Adults and Older Children Quick Guide Pg. 21

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

Online

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

Pg. 21

GP44-A4 QG Handling, Transport, and Storage of Specimens Quick Guide Pg. 21

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

GP46-R Planning for Challenges to Clinical Laboratory Operations During a Disaster; A Report Online

H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 22

I03-A Standard for Relating Spectrophotometer Performance Characteristics to Analytical Goals; Approved Standard

Online

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

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

M29* Protection of Laboratory Workers From Occupationally Acquired Infections Pg. 57

M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third Edition

Online

M29-A3 QG Personal Protection in the Laboratory Quick Guide Pg. 36

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

Online

MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 38

QG 10 Specimen Collection Quick Guides Pg. 21

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

Pg. 52

(continued)

Hematology

H02-A5 Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition Pg. 22

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

Online

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

Online

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

Online

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

Pg. 22

H21-A5 QG Collection, Handling, Transport, and Storage for Hemostasis Quick Guide Pg. 22

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

Pg. 22

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C59-A Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline

Online

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

I/LA18-A2 Specifications for Immunological Testing for Infectious Diseases; Approved Guideline—Second Edition

Online

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. 23

I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition Online

I/LA23-A Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline

Online

I/LA25-A2 Maternal Serum Screening; Approved Standard—Second Edition Online

I/LA26-A2 Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition

Pg. 23

Hematology


H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—Second Edition

Online

H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition

Online

H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition

Online

H44-A2 Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline—Second Edition

Online

H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition

Online

H48-A Determination of Factor Coagulant Activities; Approved Guideline Online

H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline

Online

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

Pg. 22

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

Online

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

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

Online

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

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

Pg. 22

H60-A Laboratory Testing for the Lupus Anticoagulant; Approved Guideline Pg. 22

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

Pg. 37

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

(continued)

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

Pg. 23

I/LA29-A Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline

Online

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

I/LA33-A Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

Pg. 23

I/LA33-A TK Validation of Automated Systems for Immunohematological Testing Before Implementation—Sample Templates and Test Cases Toolkit

Pg. 23

I/LA34-A Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline

Online

NBS06-A Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline

Pg. 41

Method Evaluation

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

Online

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

Online

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

Online

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

Online

C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline Online

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

Pg. 19

C44-A Harmonization of Glycohemoglobin Measurements; Approved Guideline Online

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

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

Pg. 19

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

Online

EP05* Evaluation of Precision of Quantitative Measurement Procedures Pg. 56

EP05-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

Pg. 26

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

Pg. 26

EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition Online

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

Pg. 26

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

Online

EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition

Online

EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition Pg. 26

EP15* User Verification of Precision and Estimation of Bias Pg. 56

EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition

Online

(continued)

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Microbiology

AST QC QG AST QC Flow Chart Quick Guides Pg. 31

M02-A11 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition

Pg. 32

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

Online

M07-A9 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition

Pg. 32

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

Pg. 32

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

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

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

Online

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

Online

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

Pg. 32

M26-A Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline

Online

Method Evaluation


EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition

Pg. 26

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

Pg. 27

EP19-R A Framework for NCCLS Evaluation Protocols; A Report Online

EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline Online

EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 24

EP23-A WB A Practical Guide for Laboratory Quality Control Based on Risk Management Pg. 25

EP23-A WS A Sample Form for Laboratory Quality Control Based on Risk Management Pg. 25

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

Pg. 27

EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Pg. 27

EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline Pg. 27

EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

Pg. 27

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

Pg. 28

EP29-A Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline Pg. 28

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

Pg. 28

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

Pg. 28

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

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

Pg. 22

MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Online

(continued)

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Microbiology


M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition

Online

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

Pg. 32

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

Online

M29* Protection of Laboratory Workers From Occupationally Acquired Infections Pg. 57

M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third Edition

Online

M29-A3 QG Personal Protection in the Laboratory Quick Guide Pg. 36

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

Online

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

Online

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

M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition Online

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

Online

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

Online

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

Pg. 33

M39-A4 QG Collection, Handling, Transport, and Storage for Hemostasis Antibiograms: Developing Cumulative Reports for Your Clinicians Quick Guide

Pg. 33

M40* Quality Control of Microbiological Transport Systems Pg. 57

M40-A Quality Control of Microbiological Transport Systems; Approved Standard Online

M41-A Viral Culture; Approved Guideline Online

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

Pg. 33

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

Pg. 33

M44-S3Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement

Pg. 33

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

Pg. 34

M47-A Principles and Procedures for Blood Cultures; Approved Guideline Pg. 34

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

M50-A Quality Control for Commercial Microbial Identification Systems; Approved Guideline Pg. 34

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

Pg. 36

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

Pg. 36

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

Pg. 36

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

Pg. 36

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

Pg. 36

(continued)

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IND

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M56* Principles and Procedures for Detection of Anaerobes in Clinical Specimens Pg. 57

M100-S24 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement

Pg. 30

M100-S24 QG M100-S24 Tables 1A–1C Quick Guide Pg. 31

M100-S24 WC Glossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fourth Informational Supplement

Pg. 31

MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition

Online

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

Pg. 37

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

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

Online

MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 38

(continued)

Molecular Methods

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

Pg. 23

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

Pg. 36

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

Pg. 37

MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second Edition

Online

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

Pg. 37

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

Pg. 37

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

Pg. 37

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

Pg. 37

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

Online

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

MM12-A Diagnostic Nucleic Acid Microarrays; Approved Guideline Online

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

Online

MM13-A QG Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide Pg. 38

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

Pg. 37

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

MM17-A Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline Online

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

Online

http://www.clsi.org














Molecular Methods


MM19-A Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline Pg. 38

MM20-A Quality Management for Molecular Genetic Testing; Approved Guideline Pg. 38

MM22-A Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline Pg. 38


Pg. 41

(continued)

Newborn Screening

NBS01-A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition

Pg. 40

NBS01-A6 DVD Making a Difference Through Newborn Screening: Blood Collection on Filter Paper Pg. 42

NBS01-A6 QG Specimen Collection and Sample Quality for Newborn Screening Quick Guide Pg. 42

NBS02-A2 Newborn Screening Follow-up; Approved Guideline—Second Edition Pg. 40

NBS02-A2 QG Newborn Screening Follow-up Process Quick Guide Pg. 42

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

Pg. 41

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

Pg. 42

NBS04-A Newborn Screening by Tandem Mass Spectrometry; Approved Guideline Pg. 41

NBS05-A Newborn Screening for Cystic Fibrosis; Approved Guideline Pg. 41


Pg. 41

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

Pg. 42

NBS06-A QG2 Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide Pg. 42

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

Pg. 42


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

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

POCT04-A2 Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition Online

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

POCT06* Guidelines on the Impact on Glucose Measurements When Different Sample Types Are Used

Pg. 57

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

Pg. 44

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

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

Pg. 44

POCT08-A QG1 Corrective Action Report Quick Guide Pg. 44

POCT08-A QG2 Quality Control Troubleshooting Flow Chart Pg. 44

POCT08-A QG3 Quality Control Log Sheet Quick Guide Pg. 44

POCT08-A WS Instrument Selection Worksheet Pg. 44

POCT09-A Selection Criteria for Point-of-Care Testing Devices; Approved Guideline Pg. 45

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EP23-A™ Laboratory Quality Control Based on Risk Management; Approved Guideline Pg. 24

GP17-A3 Clinical Laboratory Safety; Approved Guideline—Third Edition Pg. 20

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

Online

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

Online

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

Pg. 20

GP33-A Accuracy in Patient and Sample Identification; Approved Guideline Pg. 20

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

Pg. 44

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

Pg. 44

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

Pg. 52

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

Pg. 52

QMS03-A3 Training and Competence Assessment; Approved Guideline—Third Edition Pg. 52

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

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

Pg. 53

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

Pg. 53



POCT09-A WS Instrument Selection Worksheet Pg. 45

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

Pg. 46

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

Pg. 47

POCT10-A2 LG Microscope Maintenance Log Pg. 47

POCT10-A2 QG1 Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide Pg. 47

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

Pg. 47

POCT10-A2 QG3 Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide Pg. 47

POCT10-A2 QG4 Urine Sediment Examinations Quick Guide Pg. 47

POCT10-A2 QG5 Wet Mount Preparations and KOH Preparations Quick Guide Pg. 47

POCT10-A2 WC1 Microscopic Components in Urine Sediment Wall Chart Pg. 47

POCT10-A2 WC2 Microscopic Components in Vaginal Fluid and KOH Preparations Wall Chart Pg. 47

POCT10-A2 WC3 Ectoparasites Wall Chart Pg. 47

POCT11-A2 Pulse Oximetry; Approved Guideline—Second Edition Pg. 45

POCT12-A3 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition

Pg. 45

POCT13-A2 Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline—Second Edition

Online

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

(continued)

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QMS07-A2 Application of a Quality Management System Model for Respiratory Services; Approved Guideline—Second Edition

Online

QMS08-A2 Application of a Quality Management System Model for Medical Imaging Services; Approved Guideline—Second Edition

Online

QMS09-A2 Application of a Quality Management System Model for Inpatient Medication Use; Approved Guideline—Second Edition

Online

QMS10-A A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline

Online

QMS11-A Management of Nonconforming Laboratory Events; Approved Guideline Online

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

Pg. 53

QMS13-A Quality Management System: Equipment; Approved Guideline Pg. 53

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

Pg. 53

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

Pg. 53

QMS15-A Assessments: Laboratory Internal Audit Program; Approved Guideline Pg. 53

QMS20* Understanding the Cost of Quality in the Laboratory Pg. 57

(continued)

Veterinary Medicine

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

Pg. 54

VET01-S2 Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Second Informational Supplement

Pg. 54

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

Online

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

Online

VET03/VET04-S1 Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; First Informational Supplement

Pg. 54

VET04* Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals

Pg. 57

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

Pg. 54

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CLSI references in the College of American Pathologists (CAP) Accreditation Program Checklists

Approved-level consensus standards recognized by the US Food and Drug Administration (FDA) for use in satisfying a regulatory requirement

CLSI documents referenced in The Joint Commission Laboratory Accreditation Standards chapters

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Approved 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.

NOTE: Any documents published before 2009 can be found online at www.clsi.org.

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Objectives: Describe the rationale for the standard in terms of

reducing human errors. List the key elements (identifiers) whose locations,

formats, and fonts are specified on a specimen label.

Identify the correct orientation of a specimen tube as it is to be labeled.

WEBINAR: How to Lower the Mislabel Error Rate in Your Laboratory by Implementing CLSI Document AUTO12

CLSI Standards and GuidelinesCLSI standards are built on the expertise of and consensus achieved by government, industry, and laboratory health care professionals to yield highly respected best practices for continually improving quality, safety, and efficiency in laboratory testing and reporting.

AUTO

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September 2009



AUTO03-A2Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition

Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition

This document provides standards to facilitate accurate and timely electronic exchange of data and information between the automated laboratory elements.

Members LI: $39 LII: $52 LIII: $65Nonmembers $130

SEPTEMBER 2009

AUTO03-A2April 2011



AUTO12-ASpecimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

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.


APRIL 2011

AUTO12-A

now available on demand

Speakers: Charles D. Hawker, PhD, MBA, FACB Salt Lake City, Utah, USA

Ulysses J. Balis, MD Ann Arbor, Michigan, USA

Related CLSI Document:AUTO12-A—Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

Download today at www.clsi.org/edu/on-demand.

CAPCAP JCJC FDAFDA

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December 2009



C34-A3Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition

February 2009



C46-A2Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition

July 2012



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

October 2013




March 2010



C43-A2Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition

November 2011



C58-AAssessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline

Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline—Third Edition

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


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

This document 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.


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

This document 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.


Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine; Approved Guideline—Second Edition

This document provides guidance 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.


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

This document provides guidance on establishing uniform practices necessary to produce quality data for quantitation and identification of a drug or drug metabolite using the gas chromatography/mass spectrometry method. Specific quality assurance criteria for maintaining and documenting optimal instrument performance are also presented.


Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline

This document provides guidelines for the use of automated cell counting to enumerate lamellar bodies in amniotic fluid. It describes the different counting technologies used in automated cell counters as well as methods laboratorians can use to verify/validate the lamellar body count test.


DECEMBER 2009

FEBRUARY 2009

JULY 2012

OCTOBER 2013

MARCH 2010

NOVEMBER 2011

C34-A3

C46-A2

C56-A

C40-A2

C43-A2

C58-A

CAP JC

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Shop Online! G

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Waste Management Program—Audit Checklist

Use this checklist for the regular assessment of a waste management program as part of a continual improvement process.


Wall Chart—Identifiable Microscopic Entities Seen in Urine Sediment

Handy reference with more than 30 images of elements seen in urine.


GP05-A3 QG

GP16-A3 WC

January 2011



GP05-A3Clinical Laboratory Waste Management; Approved Guideline—Third Edition

June 2012



GP17-A3Clinical Laboratory Safety; Approved Guideline—Third Edition

April 2009



GP31-ALaboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline

February 2009



GP16-A3Urinalysis; Approved Guideline— Third Edition

Clinical Laboratory Waste Management; Approved Guideline—Third Edition

Based on US regulations, this document provides guidance 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.


Clinical Laboratory Safety; Approved Guideline— Third Edition

This document contains general recommendations for implementing a high-quality laboratory safety program, which are provided in a framework that is adaptable within any laboratory.


Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline

This guideline provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing.


Urinalysis; Approved Guideline—Third Edition

This document addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis.


JANUARY 2011

JUNE 2012 APRIL 2009

FEBRUARY 2009

GP05-A3

GP17-A3 GP31-A

March 2010



GP33-AAccuracy in Patient and Sample Identification; Approved Guideline

Accuracy in Patient and Sample Identification; Approved Guideline

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.


MARCH 2010

GP33-A

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ADDITIONAL GENERAL LABORATORY COMPANION PRODUCTSG

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Quality Venipuncture Quick Guide

This Quick Guide is available in a larger 11 x 17 inch size to provide additional assistance in an accurate blood draw. The 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.


GP41-A6 QG

December 2010



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

October 2007



GP41-A6Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Sixth Edition

May 2010



GP44-A4Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition

December 2010



GP39-A6Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition

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

This document provides guidance for conducting validation and verification testing for venous and capillary blood collection tubes.


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

This document provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children.


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

This document includes criteria for preparing an optimal serum or plasma sample and for the devices used to process blood specimens.


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

This standard contains requirements for the materials, manufacturing, and labeling of venous and capillary blood collection devices.


DECEMBER 2010

BEST SELLER!

MAY 2010

DECEMBER 2010

GP34-A

GP41-A6

GP44-A4

GP39-A6

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.


Technique for Skin Puncture in Adults and Older Children Quick Guide

Includes every step in the skin puncture procedure from patient preparation to specimen collection, and container labeling.


Specimen Collection Quick Guides Buy 10 Specimen Collection Quick Guides and Save Up to 25% Off the List Price!

Quick Guides included in this set:.


C49-A/H56-A QG

GP41-A6 QG

GP42-A6 QG

GP44-A4 QG

H21-A5 QG

M29-A3 QG

M47-A QG

MM13-A QG

NBS01-A6 QG

NBS03-A QG

GP44-A4 QG

GP42-A6 QG QG 10

CAP

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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.


H21-A5 QG

May 2011



H02-A5Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition

June 2010



H26-A2Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard— Second Edition

March 2011



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

January 2008



H21-A5Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition

Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition

This document 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.


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

This document 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.


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

This document provides guidelines 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.


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

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


MAY 2011

JUNE 2010

MARCH 2011

BEST SELLER!

H02-A5

H26-A2

H59-A

H21-A5

CAP FDA JC

March 2014




Laboratory Testing for the Lupus Anticoagulant; Approved Guideline

This document provides guidance 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 the lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel.


MARCH 2014

H60-A

March 2014




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

This guideline addresses the diagnostic red blood cell 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 red blood cell counting. Points of validation and quality control, and caveats of interpretation are also discussed.


MARCH 2014

H52-A2

CAP

CAP

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FDA

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IMM

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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-A. 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.


Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline (I/LA33-A) is not included on the CD-ROM.

I/LA33-A TK

March 2009



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

November 2013




December 2009



I/LA33-AValidation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

January 2011



I/LA28-A2Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline— Second Edition

Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition

This document provides guidance 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.


Performance of Single Cell Immune Response Assays; Approved Guideline—Second Edition



Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline

This document provides guidance to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation.


Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline—Second Edition

This document provides guidelines for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays.


MARCH 2009 NOVEMBER 2013

DECEMBER 2009

JANUARY 2011

I/LA20-A2 I/LA26-A2

I/LA33-A

I/LA28-A2

CAP JC

JCFDA

CAP JCFDA

http://www.clsi.org








October 2011



EP23-ATM

Laboratory Quality Control Based on Risk Management; Approved Guideline

EP23™ Online Workshop: Risk-Based Tools to Meet IQCP RequirementsGain the tools to take on QC changes. Optimize the implementation of the EP23 guideline while you hear about the latest QC changes.

Implement CLSI Document EP23 The EP23 Online Workshop is a distance learning program that imparts the knowledge and skills necessary for the successful implementation of CLSI document EP23-A. The program consists of self-paced lessons followed by a homework assignment, a live classroom session, and a summary and evaluation section.

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Laboratory Quality Control Based on Risk Management; Approved GuidelineThis document provides guidance based on risk management for laboratories to develop quality control (QC) plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.

EP23-ATM

Use CLSI’s approved guideline for laboratory QC based on risk management to:

Obtain guidance based on risk management for laboratories.

Develop QC plans tailored to a combination of measuring system, laboratory setting, and clinical application of the test. Members LI: $51 LII: $68 LIII: $85 | Nonmembers $170

Reduce risk through a comprehensive QC plan.

Find the help you need to implement “EP23–THE RIGHT QC” in your laboratory.

Why Use EP23™?

“The EP23 guideline is a powerful resource for laboratories to use to customize their quality control plans to their own specific laboratory settings. It provides current research and views of laboratory quality control.”

– Judith A. Yost, MA, MT(ASCP) Director, Division Laboratory Services, Centers for Medicare & Medicaid Services

JCFDA

http://www.clsi.org


http://clsi.org/edu/workshops/



Earn 5.0 P.A.C.E.® Program continuing education credits for your participation.

Register today at www.clsi.org/edu/workshops.

Interact With Fellow Colleagues During the live classroom session, all participants hear and see one another’s QC plan (QCP) examples and learn from a CLSI instructor about how to enhance the details of each QCP.

Study on Your Own Schedule Self-paced lessons include the definition of risk management, an example explaining the concepts of EP23, a lesson showcasing new risk assessment concepts not typically used by laboratorians, the EP23 Workbook, the EP23 Worksheet, and CMS and individualized quality control plan (IQCP) requirements.

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EP23-A Companion Products

*The worksheet and the workbook can only be purchased individually by previous purchasers of the EP23-A document.

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

A Sample Form for Laboratory Quality Control Based on Risk Management

A Practical Guide for Laboratory Quality Control Based on Risk Management

This EP23-A package includes:

Laboratory Quality Control Based on Risk Management; Approved Guideline (EP23-A)

A Practical Guide for Laboratory Quality Control Based on Risk Management; Workbook (EP23-A WB)

A Sample Form for Laboratory Quality Control Based on Risk Management; Worksheet (EP23-A WS)

The EP23-A 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.


The EP23-A 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.


EP23-A PK

EP23-A WS*

EP23-A WB*

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Members LI: $102 LII: $136 LIII: $170 Nonmembers $340

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Why Enroll in the EP23 Online Workshop?“This course design and execution allows for more participant accountability through the use of a virtual classroom opportunity. The on-screen instructor works directly with participants on their ‘homework’ IQCP examples—a worthwhile, added-value bonus feature to the online training.”

– Peggy Mann, MS, MT(ASCP) Clinics Administration, Quality, Safety,

& Environment Program Manager Ambulatory POC Coordinator University of Texas Medical Branch Galveston, Texas, USA

CAP FDA JC

August 2004



EP05-A2Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

August 2013



EP09-A3Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

April 2003



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

June 2012



EP17-A2Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline— Second Edition

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition

This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers’ precision performance claims and determining when such comparisons are valid; as well as manufacturers’ guidelines for establishing claims.


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

This document 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.


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

This document provides guidance 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.


Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition

This document provides guidance 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.


BEST SELLER!

AUGUST 2013

BEST SELLER!

JUNE 2012

EP05-A2

EP09-A3

EP06-A

EP17-A2

METH

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FDA JC

April 2014




Evaluation of Commutability of Processed Samples; Approved Guideline—Third Edition

This document provides guidance for evaluating the commutability of processed samples by determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.


APRIL 2014

EP14-A3

CAP JC

JCFDA

http://www.clsi.org










November 2009



EP18-A2Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline— Second Edition

November 2011



EP24-A2Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition

September 2012



EP27-AHow to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

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

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.


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

This document provides a protocol for evaluating the accuracy of a test to discriminate between two subclasses of subjects when there is some clinically relevant reason to separate them. In addition to the use of receiver operating characteristic curves and the comparison of two curves, the document emphasizes the importance of defining the question, selecting the sample group, and determining the “true” clinical state.


How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

This guideline describes what an error grid is, why it is useful, and how to construct one and interpret the information. Guidance is provided for manufacturers and for the clinical laboratory.


NOVEMBER 2009 NOVEMBER 2011

SEPTEMBER 2012

EP18-A2 EP24-A2

EP27-A

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September 2009



EP25-AEvaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

User Evaluation of Between-Reagent Lot Variation; Approved Guideline

This document provides guidance for laboratories on the evaluation of a new reagent lot, including a protocol using patient samples to detect significant changes from the current lot.


Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

This document provides guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.


SEPTEMBER 2013

SEPTEMBER 2009

EP26-A

EP25-A

CAP JC

JC

JC

FDA

FDA

http://www.clsi.org








CAP FDA JC

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October 2010



EP28-A3cDefining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition

May 2010



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

January 2012



EP29-AExpression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline

August 2012



EP31-A-IRVerification of Comparabilityof Patient Results Within OneHealth Care System; ApprovedGuideline (Interim Revision)

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

This document contains guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests.


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

This document provides information to help material manufacturers in the production and characterization of commutable reference materials, as well as to assist assay manufacturers and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.


Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline

This guideline describes a practical approach to assist clinical laboratories in developing and calculating useful estimates of measurement uncertainty, and illustrates their application in maintaining and improving the quality of measured values used in patient care.


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

This document provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system.


OCTOBER 2010

MAY 2010

JANUARY 2012

AUGUST 2012

EP28-A3c

EP30-A

EP29-A

EP31-A-IR

JC

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http://www.clsi.org






ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | [email protected] 29ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | [email protected] 29

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january 2014

MICRO

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Revised cefepime disk diffusion and minimal inhibitory concentration (MIC) interpretive criteria along with dosage regimens for using susceptible-dose dependent (SDD) interpretive criteria

New cefazolin interpretive criteria and recommendations for use as a surrogate test for uncomplicated urinary tract infections to predict results for oral cephalosporins

New doripenem disk diffusion and MIC interpretive criteria with dosage regimens on which the breakpoints are based

Revised imipenem and meropenem disk diffusion and MIC interpretive criteria with dosage regimens on which the breakpoints are based

Definition for SDD with educational information explaining the introduction of SDD interpretive criteria

An example and explanation for antimicrobial agents having only susceptible interpretive criteria

Information for reporting first- and second-generation cephalosporins and cephamycins for Salmonella spp. and Shigella spp.

Updated recommendations for the placement of disks on a 100-mm plate

Aztreonam-avibactam

Biapenem

Ceftazidime-avibactam

Ceftolozane-tazobactam

Eravacycline

Surotomycin

Telavancin

M100-S24Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement This document provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8.

Members LI: $51 LII: $68 LIII: $85 | Nonmembers $170

New or revised interpretive criteria are available for the following drugs:

Added:

Quality control ranges added and/or revised for:




January 2014

Objectives:

Identify the major changes found in CLSI document M100-S24.

Design a strategy for implementing the new practice guidelines into your laboratory practices.

Develop a communication strategy for informing clinical staff of significant AST and reporting changes.

CLSI/APHL Webinar: CLSI 2014 AST Update now available on demand

Speaker: Janet A. Hindler, MCLS, MT(ASCP) Los Angeles, California, USARelated CLSI Document:M100-S24—Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement


http://www.clsi.org





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M100-S24 Companion Products

M100-S24 QGM100-S24 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. These guides serve as useful references for laboratories seeking to meet requirements for proficiency testing and accreditation. Printed on durable, waterproof sheets and detachable for convenient, shared use in the laboratory.


M100-S24 WCGlossary of Antimicrobial Terms and Abbreviations Wall Chart: Twenty-Fourth Informational Supplement

Wall chart (based on M100-S24) features important terminology (drug classes, subclasses, and dosage forms) for all antimicrobial agents featured in M100-S24. Serves as a handy reference for laboratorians in “speaking the language” when transmitting important clinical susceptibility information to the clinician. The chart also features a comprehensive listing of abbreviations used around the world to identify antimicrobials in in vitro diagnostic products such as automated susceptibility test systems and antimicrobial agent disks.


AST QC QGAST QC Flow Chart Quick Guides

The ultimate “cheat sheet” to quality control (QC) for antimicrobial susceptibility testing. 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. Also included are guides to QC testing frequency and troubleshooting. Formatted as 8 1/2 x 11 durable, waterproof sheets on a convenient detachable ring. Based on the current editions of M02, M07, and M100.


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M02-A11Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard— Eleventh Edition

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M07-A9Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition

March 2011



M24-A2Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition

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M11-A8Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition

December 2012



M27-S4Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement

Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard— Eleventh Edition

This document contains the current CLSI-recommended methods for disk susceptibility testing, criteria for quality control testing, and updated tables for interpretive zone diameters.

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Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition

This document addresses reference methods for the determination of minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution.


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

This standard provides protocols and related quality control parameters and interpretive criteria for the susceptibility testing of mycobacteria, Nocardia spp., and other aerobic actinomycetes.


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

This standard provides reference methods for the determination of minimal inhibitory concentrations of anaerobic bacteria by agar dilution and broth microdilution.


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

This document provides updated tables for the CLSI antimicrobial susceptibility testing standard M27-A3.

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M43-AMethods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline

Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline

This document provides guidelines for the performance and quality control of agar and broth microdilution antimicrobial susceptibility tests on human mycoplasmas and ureaplasmas.


OCTOBER 2011

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M39-A4Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline—Fourth Edition

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M44-A2Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline— Second Edition

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

This document describes methods for recording and analysis of antimicrobial susceptibility test data, consisting of cumulative and ongoing summaries of susceptibility patterns of clinically significant microorganisms.


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

This document provides newly established methodology for disk diffusion testing of Candida spp., criteria for quality control testing, and interpretive criteria.


JANUARY 2014

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M44-A2Zone 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-A2—Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline—Second Edition. It is available as a durable, waterproof chart for easy posting.

M44-S3 AUGUST 2009

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Collection, Handling, Transport, and Storage for Hemostasis 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, include a description of limitations of data, and provide examples of reports and graphs. Six durable, waterproof sheets are on a convenient detachable ring. The Quick Guide is based on M39-A4.


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M47-APrinciples and Procedures for Blood Cultures; Approved Guideline

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M45-A2Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition

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M50-AQuality Control for Commercial Microbial Identification Systems; Approved Guideline

Principles and Procedures for Blood Cultures; Approved Guideline This document 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.


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

This document provides guidance 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.


Quality Control for Commercial Microbial Identification Systems; Approved Guideline

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Personal Protection in the Laboratory Quick Guide

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

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

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

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

This document provides guidance for laboratorians performing human immunodeficiency virus testing and for the interpretation of results by health care providers in advanced diagnostic laboratories.


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

This document was developed to provide infection preventionists (infection control practitioners), infectious disease specialists, and microbiologists with the latest information regarding the development and implementation of a successful MRSA surveillance program.


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

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.


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

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

This document describes the guidelines for antifungal susceptibility testing by the disk diffusion method for nondermatophyte filamentous fungi (moulds) that cause invasive disease.


MAY 2010

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

Supplemental tables that provide quality control limits and epidemiological cutoff values for M51-A.

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MM06-A2Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition

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MM14-A2Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition

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

This document 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.


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

This document provides guidance 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.


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

This document 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.


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

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

This document provides guidance for the use of molecular biological techniques for detection of mutations associated with inherited medical disorders, somatic or acquired diseases with genetic associations, and pharmacogenetic response.


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

This guideline addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase PCR techniques, and includes information on specimen collection, sample preparation, test reporting, test validation, and quality assurance.


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MM13-A QG

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MM19-AEstablishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline

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MM20-AQuality Management for Molecular Genetic Testing; Approved Guideline

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Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline

This guideline provides comprehensive guidance 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.


Quality Management for Molecular Genetic Testing; Approved Guideline

This document provides guidance for implementing international quality management system standards in laboratories that perform human molecular genetic testing for inherited or acquired conditions.


Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline

This document provides guidance 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.


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CLSI Newborn Screening Standards and Guidelines: Ensuring Good Health From the Start

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July 2013



NBS01-A6Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition

Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition

This document 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.


JULY 2013

NBS01-A6May 2013



NBS02-A2Newborn Screening Follow-up; Approved Guideline —Second Edition

Newborn Screening Follow-up; Approved Guideline— Second Edition

This guideline describes the basic principles, scope, and range of follow-up activities within the newborn screening system.


MAY 2013

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Today, virtually all (>99%) of the more than 4 million infants born in the United

States each year are screened for conditions such as phenylketonuria, congenital

hypothyroidism, galactosemia, and hemoglobinopathies. CLSI’s newborn screening

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

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

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.


OCTOBER 2009

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NBS05-ANewborn Screening for Cystic Fibrosis; Approved Guideline

This document 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 testsperformed on DBS.

November 2011

Newborn Screening for Cystic Fibrosis; Approved Guideline

This document 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.


NOVEMBER 2011

NBS05-A

July 2010



NBS04 -ANewborn Screening by Tandem Mass Spectrometry; Approved Guideline

Newborn Screening by Tandem Mass Spectrometry; Approved Guideline

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.


JULY 2010

NBS04-A

November 2011



NBS06-ANewborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline

Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline

This document 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.


APRIL 2013

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NEWBORN SCREENING COMPANION PRODUCTS

Making a Difference Through Newborn Screening: Blood Collection on Filter Paper

This video 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.


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.


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

Wall chart that shows immunodeficiency disorders and T-cell receptor excision circle values in the newborn screening period.


Specimen Collection and Sample Quality for Newborn Screening Quick Guide

How to Collect an Acceptable Blood Spot Specimen

Simple Spot Check


Newborn Screening Follow-up Process Quick Guide

Describes the newborn screening follow-up process.


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.


Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide

Provides a schematic for preparing dried blood spot reference materials.


NBS01-A6 DVD

NBS03-A QG

NBS06-A WC

NBS01-A6 QG

NBS02-A2 QG

NBS06-A QG1 NBS06-A QG2

NEW

BORN

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G

©2013 Clinical and Laboratory Standards Institute. All rights reserved. | www.clsi.org

quick guideA2.13

A1

A2

A1.1A1.2

A1.3

A2.2

A2.5

A2.3

A2.4

A2.1

Preparation

Sampling Technique

Wash hands vigorously.

Wear powder-free gloves and change

gloves between newborns.

Confirm identity of newborn and

ensure that all data elements on the

form are complete, accurate, and

consistent.

Position the newborn’s leg lower than

the heart to increase venous pressure.

The puncture should be made within

the shaded area as illustrated in the

figure above.

Allow blood specimen to air dry

thoroughly on a horizontally level,

nonabsorbent, open surface, such

as a drying rack or plastic-coated test

tube rack, for a minimum of three

hours at ambient temperature.

Keep specimen away from direct

sunlight. (Do not stack or heat.)

(See Appendix F of NBS01-A6.)

A3.1

A3.2

A3.4

A3.5

A3.6

A3.3

A2.14

A3(See Appendix B of NBS01-A6.)

Failure to allow residual alcohol to

dry might dilute the specimen and

adversely affect test results.

Puncturing the heel on posterior

curvature will permit blood to flow

away from puncture, making proper

spotting difficult. Do not use previous

puncture sites.

Do not layer successive drops of blood on

the target spot. If blood flow diminishes

to incompletely fill circles, repeat

sampling technique A2.1 through A2.10.

Avoid touching the area within

the circle before and after blood

collection. Do not allow water,

feeding formulas, antiseptic solutions,

or powder from gloves or other

materials to come into contact with

the specimen card before or after use.

Do not place the specimens in the

transport container until thoroughly

dry. Insufficient drying adversely

affects test results. Use of sealed

plastic bags requires desiccation.

Ideally, transport specimens within 24

hours of collection. Include tracking

number and/or other identifiers on the

envelope in case package is misplaced.

“Milking” or squeezing the puncture site

might cause hemolysis and admixture

of tissue fluids with specimen.

After the specimen has dried, place in

an approved container for transport

(see local regulations).

Pitfalls

Wearing gloves, wipe newborn’s heel

with 70% isopropyl alcohol.

Allow heel to air dry.

*

Warm heel for puncture (incision/

stick) site. Use a commercially

available heel-warming device

containing an exothermic

thermochemical composition, or

warm the site with a soft cloth that

has been moistened with warm

water (less than 42°C) for three to five

minutes. In some situations, warming

the site may not be necessary to

increase blood flow and volume.

* Photos reprinted with permission from the New York State Department of Health, Wadsworth Center.

† Photo reprinted with permission from the Newborn Screening Reference Center, National Institutes of Health, University of the Philippines Manila.

‡ Photo reprinted with permission from Whatman, Inc.

Source Document: Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition (NBS01-A6)

*

*

‡

A2.11

A2.6

A2.10

A2.7

A2.12

A2.9

A2.8

All used items should be disposed of in an

appropriate biohazard container.

Using a sterile lancet of recommended

length, perform puncture (depth

< 2.0 mm) as illustrated or use a

retractable incision device. A retractable

incision device may provide superior

blood flow by making a standardized

incision 1.0 mm deep by 2.5 mm long.

Gently touch the filter paper card to

the blood drop and fill each printed

circle with a SINGLE application of

blood. Do not touch the filter paper

to the heel. Apply blood to one

side only. Observe the saturation

of each printed circle as the blood

flows through the filter paper. After

collection, examine both sides of the

filter paper to ensure saturation.

Gently wipe off the first drop of blood

with sterile gauze. (Initial drop contains

tissue fluids, which might dilute

sample.)

After the specimen is collected, elevate

the newborn’s foot and, using sterile

gauze, briefly apply gentle pressure to

the puncture site until the bleeding

stops. Do not apply adhesive bandages.

Apply gentle pressure with thumb

around the heel, but not near the

puncture site, and ease intermittently

as drops of blood form.

Wait for formation of large blood

droplet.

†

How to Collect an Acceptable Blood Spot Specimen

NBS01-A6 QG Newborn Screening Follow-up Process

Source Document: Newborn Screening Follow-up; Approved Guideline—Second Edition (NBS02-A2)

Screening Test

Results

Requires

Follow-up

Follow-up

Confirmation

Follow-up for

New Screening

Monitor

Biochemical/

Clinical

No Further

Tests Required

Facilitate

Counseling

Close Case

Lost

Lost

Close Case

Not Affected

Definitive Diagnosis

Lost to

Follow-up

• Facilitate Intervention/Management

• Facilitate Appropriate Services

• Maintain in Case Registry

Results Appear Definitive

Facilitate Confirmatory Testing

Definitive Diagnosis

Not

Affected

Confirmatory

Testing

CarrierResults Not Definitive

“Invalid”Screen

Negative

Is Not

Definitive

Facilitate Rescreening

(Including

No Specimen)

Screen Positive

(Including Borderline Results)

• Periodically Monitor Care Coordination

• Periodically Monitor Functional Outcomes

• Evaluate Long-Term Data

Shor

t-Ter

m F

ollo

w-u

p

Lon

g-Te

rm F

ollo

w-u

p

Lost to Follow-up PossibleAction or Outcome

Process End Point

Key


quick guide

NBS02-A2 QG

quick guide


Screen PositiveLow/Absent TREC

Normal Reference Gene

(Prepare Test DBS; Measure

TREC and Reference Gene)

Older Adult Blood

Screen NegativeNormal TREC

Normal Reference Gene

CB Units

Schematic for Preparing Dried Blood Spot Reference Materials

Source Document: Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline (NBS06-A)

NOTE: This flow chart summarizes the preparation of dried blood spot reference materials for quality control in alignment with Section 7.4.1 of CLSI document NBS06-A.

Abbreviations: CB, cord blood; DBS, dried blood spot(s); QC, quality control; SCID, severe combined immunodeficiency; TREC, T-cell receptor excision circle(s).

DBS QC Material for SCID

Screen Positive

QC Material for SCID

Screen Negative

DBS QC Material for

Failure to Amplify

InconclusiveLow/Absent TREC

Low/Absent Reference Gene

Leukodepleted Adult Blood

Prepare and Evaluate DBS Reference Materials

Deplete Mononuclear Cells Prepare Higher, Lower, and

Lowest TREC CB Pools

CB 1 CB 2 CB n

Adjust Hematocrit

NBS06-A QG2

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Collection includes: 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

NBS01-A6 QG—Specimen Collection and Sample Quality for Newborn Screening Quick Guide

o How to Collect an Acceptable Blood Spot Specimen o Simple Spot Check

NBS02-A2—Newborn Screening Follow-up; Approved Guideline—Second Edition

NBS02-A2 QG—Newborn Screening Follow-up Process Quick Guide

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

NBS04-A—Newborn Screening by Tandem Mass Spectrometry; Approved Guideline

NBS05-A—Newborn Screening for Cystic Fibrosis; Approved Guideline

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

NBS06-A QG2—Schematic for Preparing Dried Blood Spot Reference Materials Quick Guide

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

Paper documents available in a three-ring binder.


NBSSCNewborn Screening Specialty Collection

bundle and save!

Improve the health outcome and quality of life of children by collecting the best possible newborn screening blood specimens and implementing effective follow-up services.

Objectives:

Define the beginning and end of short-term follow-up and long-term follow-up.

List the differences between blood spot and point-of-care screening follow-up.

List the six primary participants involved in newborn screening follow-up.

WEBINAR: Enhancing the Quality of Follow-Up Services for Newborn Screening

Speaker: Judith Tuerck, RN, MS Oregon State Public Health Laboratory Hillsboro, Oregon, USA

Related CLSI Document:NBS02-A2—Newborn Screening Follow-up; Approved Guideline—Second Edition


NOW AVAILABLE ON DEMAND

NEW

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October 2010



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

December 2010



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

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

This document 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.


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

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.


OCTOBER 2010

DECEMBER 2010

POCT07-A

POCT08-A

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).


Quality Control Troubleshooting Flow Chart

Flow chart for noninstrumented quality control (QC) decision making for QC out of range.


Quality Control Log Sheet Quick Guide

Log sheet for noninstrumented point-of-care testing.


POCT07-A RG

POCT08-A QG2

POCT08-A QG3

POIN

T-OF-CARE TESTIN

G

Corrective Action Report Quick Guide

Report completed when any control falls outside the acceptable range.


POCT08-A QG1

Instrument Selection Worksheet

Clinical needs assessment comparison electronic worksheet, which includes items to consider when comparing point-of-care testing system specifications.


POCT08-A WS

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POIN

T-O

F-CA

RE T

ESTI

NG

POCT PKPOCT Companion Products Package

Bundle and save! This package includes:

POCT07-A RG—Addressing Errors in Point-of-Care Testing Reference Guide

POCT08-A QG1—Corrective Action Report Quick Guide (Electronic Download)

POCT08-A QG2—Quality Control Troubleshooting Flow Chart

POCT09-A WS—Instrument Selection Worksheet (Electronic Download)


bundle and save!

JC

April 2010



POCT09-ASelection Criteria for Point-of-Care Testing Devices; Approved Guideline

April 2011



POCT11-A2Pulse Oximetry; Approved Guideline— Second Edition

January 2013



POCT12-A3Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition

Selection Criteria for Point-of-Care Testing Devices; Approved Guideline

This document provides guidance 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.


Pulse Oximetry; Approved Guideline—Second Edition

Pulse oximetry is a widely used device for the clinical assessment of arterial oxygenation and pulse rate. The clinical applications, quality assessment, and limitations are discussed in this guideline.


Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition

This document contains guidelines for performance of point-of-care blood glucose meter systems that stress quality control, training, and administrative responsibility.


APRIL 2010

APRIL 2011 JANUARY 2013

POCT09-A

POCT11-A2 POCT12-A3

Instrument Selection Worksheet

Clinical needs assessment comparison electronic worksheet, which includes items to consider when comparing point-of-care testing system specifications.


POCT09-A WS

JC

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This guideline provides information on specimen collection, test methodologies, procedural steps, reporting of results, and the quality assurance aspects of provider-performed microscopy.

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

POCT10-A2 DECEMBER 2011


POCT10-A2Physician and Nonphysician Provider- Performed Microscopy Testing; Approved Guideline—Second Edition


This guideline provides information on specimen collection, test methodologies, procedural steps, reporting of results, and the quality assurance aspects of provider-performed microscopy.

December 2011

POIN

T-OF-CARE TESTIN

GObjectives:

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.

Objectives:

Define terms related to risk assessment.

Identify CLSI document EP23 as a resource for developing a laboratory quality control plan (QCP) based on risk management and review a moderate complexity example.

Determine ways to create an optimal IQCP without the use of equivalent quality control.

WEBINAR: Managing Manual Tests: Challenges and Solutions

WEBINAR: EP23™ and POCT: Tackling Risk Management

Speakers: Patricia L. Kraft, MA, MT(ASCP) Dayton, Ohio, USA Karen W. Dyer, MT(ASCP) DLM Baltimore, Maryland, USA

Speaker: James H. Nichols, PhD, DABCC, FACB Nashville, Tennessee, USA

Related CLSI Documents:

Related CLSI Document:

POCT08-A—Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved GuidelinePOCT04-A2—Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition

EP23-A™—Laboratory Quality Control Based on Risk Management; Approved Guideline

Register today at www.clsi.org/edu/webinars.

Register today at www.clsi.org/edu/webinars.

Date/Time: May 14, 2014 • 1:00–2:00 PM Eastern (US) Time

Date/Time: July 16, 2014 • 1:00–2:00 PM Eastern (US) Time

CAP JC

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http://www.clsi.org/edu/webinars

http://www.clsi.org/edu/webinars


POCT10-A2 COMPANION PRODUCTS

Fecal Leukocyte Examinations (Also Known as Stool White Blood Cells) Quick Guide

Describes the testing procedure for fecal leukocyte examinations.


Proficiency Testing Exception Response Form (for Use for Microscopic PT Only) Quick Guide

Used for proficiency testing exception responses.


Wet Mount Preparations and KOH Preparations Quick Guide

Provides the testing procedure for nonvaginal potassium hydroxide (KOH) procedures, nonvaginal oil wet mount for ectoparasites (with or without KOH), and vaginal procedures.


Microscopic Components in Vaginal Fluid and KOH Preparations Wall Chart

Shows images of cells, bacteria, microorganisms, fungus, yeast, and ectoparasites found in vaginal fluid and potassium hydroxide (KOH) preparations.


Urine Sediment Examinations Quick Guide

Provides the testing procedure for urine sediment examinations.


Microscopic Components in Urine Sediment Wall Chart

Shows images of cells, casts, noncellular material, parasites, and crystals found in urine sediment.


Ectoparasites Wall Chart

Shows images of ectoparasites.


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

Describes testing procedure for nasal smears for inflammatory cells.


POCT10-A2 QG1

POCT10-A2 QG3

POCT10-A2 QG5

POCT10-A2 WC2

POCT10-A2 QG4

POCT10-A2 WC1

POCT10-A2 WC3

POCT10-A2 QG2

POIN

T-O

F-CA

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ESTI

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

Checklist to help observers assess if provider-performed microscopy testing competence has been demonstrated by the employee.


Microscope Maintenance Log

Log for documentation of daily maintenance of a microscope for one year.


POCT10-A2 CL POCT10-A2 LG

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ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | [email protected] ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | [email protected]

The CLSI U Education Center provides laboratories with a variety of convenient and cost-effective continuing education resources.

Explore the opportunities we offer to help you put CLSI standards into practice and improve quality.

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NOW AVAILABLE ON DEMAND

The Fundamentals for Implementing a Quality Management System in the Clinical Laboratory

Improved patient care Reduced risk of medical errors Streamlined laboratory

processes Increased productivity and

efficiency Reduced costs

Enhanced employee abilities Improved customer

satisfaction Compliance with regulatory

and accreditation requirements

WEBINAR: Laboratory Internal Audit Program: Tips for Developing and Implementing an Internal Audit Process

The Key to QualityTM is designed to provide a better understanding of how a laboratory’s quality management system (QMS) can be developed.

from the Clinical and LaboratoryStandards Institute (CLSI)

This edition revises the previous version published in 2007. By using the guidance and tools in The Key to Quality, you can establish or enhance the infrastructure for a QMS or a methodology for continual quality improvement with the following outcomes:

TM

QUALITY M

ANAG

EMEN

T SYSTEMS

Objectives:

Distinguish between an internal audit program and process.

Discuss how an internal audit program and process will assist the laboratory in meeting quality and compliance requirements.

Describe the different types of internal audits and the value each provides to the laboratory’s quality program.

http://www.clsi.org




Speaker: Jennifer Schiffgens, MBA, MT(ASCP), CLSSan Francisco, California, USA

Related CLSI Document:QMS15-A—Assessments: Laboratory Internal Audit Program; Approved Guideline


CLSI’s NEW online, self-paced certificate program provides a systematic, process-oriented approach to meeting quality objectives.

Learn How to Implement Your QMS Most Effectively

Learn best practices for developing, implementing, and sustaining policies, processes, and procedures for each quality system essential.

Study on your own schedule—log in from any Internet-accessible device 24/7.

Earn 13 P.A.C.E.® continuing education credits and a certificate of achievement upon completion.

Laboratory Quality Management System (LQMS) Certificate Program

Visit www.clsi.org for details and to register.

Product Nonmember Price*The Key to Quality™ $600

QSE PDF Document Package (includes 13 documents) $800

LQMS Certificate Program $1,000

LQMS Certificate Program + The Key to Quality $1,500

LQMS Certificate Program + QSE PDF Document Package $1,600

LQMS Certificate Program + The Key to Quality + QSE PDF Document Package $2,000

* Member pricing applies. Please see page 17 of the catalog for further details.

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The Key to Quality™The Fundamentals for Implementing a Quality Management System in the Clinical Laboratory

The Key to Quality is designed to provide a better understanding of how a laboratory’s quality management system can be developed.Members LI: $180 LII: $240 LIII: $300 | Nonmembers $600

from the Clinical and LaboratoryStandards Institute (CLSI)

The fundamentals for implementing a quality management system in the clinical laboratory.

TM

QUALITY M

ANAG

EMEN

T SYSTEMS

June 2011



QMS01-A4Quality Management System: A Model for Laboratory Services; Approved Guideline— Fourth Edition



QMS02-A6Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition

February 2013

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

This document provides a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.


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

This document provides guidance 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.


JUNE 2011 FEBRUARY 2013

QMS01-A4 QMS02-A6

February 2009



QMS03-A3Training and Competence Assessment; Approved Guideline—Third Edition

Training and Competence Assessment; Approved Guideline—Third Edition

This document provides background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives.


FEBRUARY 2009

QMS03-A3

CAP JC

Find the Latest Standards at the CLSI ShopWe are always updating our online store with newly published standards and other products.

Visit www.clsi.org to place your order today!

CAP JCCAP JCFDA

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September 2012



QMS05-A2Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory; Approved Guideline—Second Edition

August 2011



QMS13-AQuality Management System: Equipment; Approved Guideline

December 2013




December 2010



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

December 2012



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

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

This guideline provides recommended criteria and easily implemented processes for qualifying, selecting, and evaluating a referral laboratory.


Quality Management System: Equipment; Approved Guideline

This guideline provides recommendations for establishing equipment management processes from selection through decommission of equipment used in the provision of laboratory services.


Assessments: Laboratory Internal Audit Program; Approved Guideline

This document provides guidance 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.


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

This document provides guidance on development of quality indicators and their use in the medical laboratory.


Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline

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 (QMS14-AES) Included!


SEPTEMBER 2012

AUGUST 2011

DECEMBER 2013

DECEMBER 2010

DECEMBER 2012

QMS05-A2

QMS13-A

QMS15-A

QMS12-A

QMS14-A

June 2011



QMS06-A3Quality Management System: Continual Improvement; Approved Guideline—Third Edition

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

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.


JUNE 2011

QMS06-A3

CAP

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JC

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CAP JCFDA

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Available Through CLSI: International Organization for Standardization (ISO) Documents

Through an agreement with the American National Standards Institute, CLSI is able to offer ISO Technical Committee 212 approved and draft standards. Customers from outside the United States may order these ISO standards from their national standards bodies.

For more information on ISO 15189, ISO 17511, and ISO 19001, and to view the complete library of ISO standards, visit www.clsi.org.

June 2010



VET03/VET04-S1Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; First Informational Supplement

September 2011



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

Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; First Informational Supplement

This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing guidelines VET03-A and VET04-A.


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

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.


JUNE 2010

SEPTEMBER 2011

VET03/VET04-S1

VET05-R

VETERINARY M

EDICIN

E

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

This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use.

Members LI: $78 LII: $104 LIII: $130Nonmembers $260 Price includes VET01-S2.

JULY 2013

VET01-A4Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Second Informational Supplement

This document provides updated tables for the CLSI antimicrobial susceptibility testing standard VET01.

VET01-S2 JULY 2013July 2013



VET01-A4Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard—Fourth Edition

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EP15User Verification of Precision and Estimation of Bias

User Verification of Precision and Estimation of Bias

This document describes the demonstration of precision, comparison of measurement procedures, and estimation of bias for clinical laboratory quantitative measurement procedures using a protocol designed to be completed within five working days or less.


COMING SOON!

EP15

Coming Soon!Be on the lookout for these new and revised standards and guidelines, which are scheduled to be published through June 2014 to address the timely issues most relevant to our members and customers.

CLSI Documents Scheduled for Publication



EP05Evaluation of Precision of Quantitative Measurement Procedures

Evaluation of Precision of Quantitative Measurement Procedures

This document provides guidance for evaluating the precision performance of quantitative measurement methods. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such methods.


COMING SOON!

EP05

SCHED

ULED FO

R PUBLICATIO

N 2014



AUTO11Information Technology Security of In Vitro Diagnostic Instruments and Software Systems

Information Technology Security of In Vitro Diagnostic Instruments and Software Systems

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


COMING SOON!

AUTO11



C62Liquid Chromatography-Mass Spectrometry Methods

Liquid Chromatography-Mass Spectrometry Methods

This document provides guidance 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.


COMING SOON!

C62

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M29Protection of Laboratory Workers From Occupationally Acquired Infections

Protection of Laboratory Workers From Occupationally Acquired Infections

Based on US regulations, this document provides guidance 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.


COMING SOON!

M29

SCH

EDU

LED

FOR

PUBL

ICAT

ION

2014



M40Quality Control of Microbiological Transport Systems



M56Principles and Procedures for Detection of Anaerobes in Clinical Specimens



POCT06Guidelines on the Impact on Glucose Measurements When Different Sample Types are Used

Quality Control of Microbiological Transport Systems

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


Principles and Procedures for Detection of Anaerobes in Clinical Specimens

This document 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.


Guidelines on the Impact on Glucose Measurements When Different Sample Types Are Used

This guideline provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests.


COMING SOON!

COMING SOON! COMING SOON!

M40

M56 POCT06



QMS20Understanding the Cost of Quality in the Laboratory

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.


COMING SOON!

QMS20



VET04Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals

Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals

This document 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.


COMING SOON!

VET04

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