CLSI Fall 2014 Catalog Web1 PDF

CLSI FALL
2014 UPDATES
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CLSI Fall 2014 Updates

Table of Contents
Document and Product Listings by Specialty Area
Automation and Informatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Clinical Chemistry and Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
General Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Immunology and Ligand Assay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Method Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Microbiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Molecular Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Newborn Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Point-of-Care Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Quality Management Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Veterinary Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Featured Products
Quality System Regulation for Laboratory Developed Tests: A Practical Guide for the Laboratory. . . . . . . . 2
EP23 Online Workshop: Risk-Based Tools to Meet IQCP Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
StatisPro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CLSI Communities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Infobase 2015 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
eM100. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
eCLIPSE Ultimate Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
CLSI Crosswalks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Key to Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
LQMS Certificate Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Implementing the Cost of Quality in the Laboratory Certificate Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Webinars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Order Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
COMING SOON!
Quality System Regulation for Laboratory

Developed Tests:
A Practical Guide for the Laboratory
Attention US customers!
Do you have questions about the recent FDA notice regarding regulation of highrisk laboratory developed tests (LDTs)? CLSI has developed a series of modules
for laboratories that may soon be subject to FDA regulations, specifically
the Quality System Regulation (QSReg), 21 CFR 820. This CLSI document was
developed by experts in complying with FDA regulations, and succeeding with
FDA inspections.
As the regulations can be dicult to understand, the document explains each
requirement in plain language, and compares it, where appropriate, to the CLIA
regulations. This document explains what the QSReg requires, above and beyond
what laboratories already do for CLIA. Tips and hints are provided to give the
reader ideas about methods for complying that have been proven to be eective.
For more information, visit www.clsi.org/LDTs.
2 ORDER TODAY: Toll Free (US): 877.447.1888 | www.clsi.org | customerservice@clsi.org
CLSI Standards
CLSI 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.
AUTO11-A2
OCTOBER 2014
October 2014
AUTO11-A2
Information Technology Security of In Vitro

Diagnostic Instruments and Software
Systems; Approved StandardSecond Edition
Information Technology Security of In Vitro Diagnostic

Instruments and Software Systems; Approved Standard
Second Edition
This document provides a framework for communication of information technology security issues
between the in vitro diagnostic system vendor and the health care organization.
Members LI: $39 LII: $52 LIII: $65

Nonmembers $130
C56-A QG
Examples of Hemolyzed, Icteric, and Lipemic/Turbid Samples Quick Guide
This Quick Guide shows examples of hemolyzed, icteric, and lipemic/turbid samples, including
the sample appearance and interfering substance (influence quantity). Formatted as a durable,
waterproof sheet for quick reference.

Nonmembers $20
C57-A
COMING SOON
January 2015
C57-A
Mass Spectrometry for Androgen and
Estrogen Measurements in Serum;
Approved Guideline
Mass Spectrometry for Androgen and Estrogen Measurements

in Serum; Approved Guideline
This guideline is intended to aid the laboratorian in developing appropriate procedures for the use of
mass spectrometry in the measurement of androgens and estrogens.

Nonmembers $130
C62-A
OCTOBER 2014
October 2014
C62-A
Liquid Chromatography-Mass Spectrometry
Methods; Approved Guideline
Liquid Chromatography-Mass Spectrometry Methods;

Approved Guideline
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.

Nonmembers $130
GP23-A2
NOVEMBER 2014
November 2014
GP23-A2
Nongynecological Cytology Specimens:
Preexamination, Examination, and
Postexamination Processes; Approved
GuidelineSecond Edition
Nongynecological Cytology Specimens: Preexamination,

Examination, and Postexamination Processes;
Approved GuidelineSecond Edition
This document provides recommendations for cytology laboratories to use in developing

preexamination, examination, and postexamination processes and procedures for nongynecological
cytology specimen management.

Nonmembers $130
GP36-A
NOVEMBER 2014
November 2014
GP36-A
Planning for Laboratory Operations During
a Disaster; Approved Guideline
Planning for Laboratory Operations During a Disaster;

Approved Guideline
This document provides guidance for laboratory and health care leadership for development,
implementation, and sustainment of eective, all hazards, emergency preparedness plans supporting
nonanalytical components of clinical and public health laboratory services that may pertain to various
natural and manmade disasters. It focuses on operational, preexamination functions.

Nonmembers $130
I/LA28-A2 QG
Comparison of the Characteristics of Immunoassays Such as Enzyme-Linked
Immunosorbent Assay and Immunohistochemistry Quick Guide
This Quick Guide compares the characteristics of immunoassays and immunohistochemistry,
such as indications for use, specimen sampling distribution, detection methodology, and
interpretation of the analytical result. Formatted as four durable, waterproof sheets for quick
reference.

Nonmembers $40
EP05-A3
OCTOBER 2014
October 2014
EP05-A3
Evaluation of Precision of Quantitative
Measurement Procedures; Approved
GuidelineThird Edition
Evaluation of Precision of Quantitative Measurement Procedures;

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

Nonmembers $170
EP15-A3
SEPTEMBER 2014
September 2014
EP15-A3
User Verification of Precision and Estimation
of Bias; Approved GuidelineThird Edition
User Verification of Precision and Estimation of Bias; Approved

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

Nonmembers $170
EP14-A3
AUGUST 2014
August 2014
EP14-A3
Evaluation of Commutability of
Processed Samples; Approved Guideline
Third Edition
Evaluation of Commutability of Processed Samples; Approved

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

Nonmembers $170
Did You Know?
1,800+
ACTIVE VOLUNTEERS
collaborate in the development of
CLSI standards and guidelines.
Get Involved
Volunteer Today!
Collaborate in our consensus process to

help improve the standards that aect
your workand advance laboratory
testing quality around the world.
See the opportunities at www.clsi.org/volunteer.
EP23-A
TM
October 2011
EP23-A TM
Laboratory Quality Control Based on Risk

Management; Approved Guideline
This document provides guidance based on risk

management for laboratories to develop quality
control plans tailored to the particular combination
of measuring system, laboratory setting, and clinical
application of the test.
A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
Laboratory Quality Control Based on

Risk Management; Approved Guideline
This 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.
Use CLSIs approved guideline for laboratory QC based on risk management to:
Reduce risk through a comprehensive QC plan.
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.
Find the help you need to implement EP23THE

RIGHT QC in your laboratory.
Members LI: $51 LII: $68 LIII: $85 | Nonmembers $170
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
EP23 Online Workshop: Risk-Based Tools to Meet

IQCP Requirements
Gain the tools to take on QC changes. Optimize the implementation
of the EP23 guideline while you learn 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. This workshop aids in the understanding of which test systems
need to follow IQCP and which ones do not.
The program consists of self-paced lessons followed by a homework assignment, a
live classroom session, and a summary and evaluation section.
Enroll today at www.clsi.org/workshops.

Now Available: StatisPro 3.0!
Meet Regulatory Compliance Demands

StatisPros feature-rich software enables your laboratory to easily perform
method validation and verification while helping you conform to
accreditation or regulatory requirements.
Compare laboratory methods:

Compare quantitative or qualitative laboratory
methods using patient sample results.
Verify quantitative method performance relative
to assayed reference materials.
Establish and verify:

Repeatability (within-run precision) and precision
over days, runs, or concentrations
Linear measuring interval (reportable range)
Calibration verification (using linearity and accuracy
studies)
Reference intervals
Limit of detection or quantitation
Trueness or diagnostic accuracy
Generate professional reports:

Create high-quality charts and tables.
Whats New
in Version 3.0?
Version 3.0 has multiple
enhancements, including:
Implementation of CLSI
document EP09-A3
Deming regression
Passing-Bablok regression
Bias plots
Implementation of CLSI
document EP17-A2
Improvements to study
design to match new
guidelines
Limit of detection and
limit of quantitation
estimation from the
precision profile approach
PLUS: Complimentary access to

all CLSI documents implemented
by StatisProa $500 value!
Print or export as a PDF to share with colleagues.
Get Started With

StatisPro Today!
Try a FREE 30-day trial and discover how this software can transform
your method evaluation protocols for greater time and cost savings.
Visit www.statispro.org to obtain the trial oer.
CLSI membership discounts do not apply to StatisPro.
January 2015
M100-S25
Performance Standards for Antimicrobial
Susceptibility Testing; Twenty-Fifth
Informational Supplement
This document provides updated tables for the Clinical

and Laboratory Standards Institute antimicrobial
susceptibility testing standards M02-A12, M07-A10,
and M11-A8.
An informational supplement for global application developed through the Clinical and Laboratory Standards
Institute consensus process.
M100-S25
january 2015

This document provides updated tables for the CLSI
antimicrobial susceptibility testing standards M02-A12,
M07-A10, and M11-A8.
New or revised interpretive criteria are available for the following drugs:
New azithromycin disk diusion and
minimal inhibitory concentration
interpretive criteria for Salmonella typhi
New pefloxacin disk diusion

interpretive criteria for Salmonella spp.
for use as a surrogate test for detecting
nonsusceptibility to ciprofloxacin
Added:
Information about an epidemiological
cuto value (ECV) established
for Propionibacterium acnes with
vancomycin and how ECVs are used
New table with ECV values for
vancomycin when considering therapy for
a P. acnes infection with information on
how this ECV should be used
New Carba NP confirmatory test for

suspected carbapenemase production
New appendix detailing what ECVs are,
how they are determined, how they
are used to set clinical breakpoints, and
how ECVs can be used by the clinical
microbiology laboratory
New/revised testing recommendations

to testing carbapenemases in
Enterobacteriaceae, Pseudomonas
aeruginosa, and Acinetobacter spp.
Quality control (QC) ranges added and/or revised for:

Added Klebsiella pneumoniae ATCC
700603 to the table with QC ranges and
information on use of this strain for
routine QC testing
For anaerobes, clarified the number of QC

strains tested for routine QC
M02-A12 PK
January 2015
M02-A12
Disk Susceptibility Tests; Approved
Standard Twelfth Edition
JANUARY 2015
Performance Standards for Antimicrobial Disk Susceptibility

Tests; Approved StandardTwelfth 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.

Nonmembers $340 Price includes M100-S25.
M07-A10 PK
January 2015
M07-A10
Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically; Approved StandardTenth
Edition
JANUARY 2015
Methods for Dilution Antimicrobial Susceptibility Tests

for Bacteria That Grow Aerobically; Approved Standard
Tenth Edition
This document addresses reference methods for the determination of minimal inhibitory
concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution.

Nonmembers $340 Price includes M100-S25.
M02-A12/M07-A10 PK15
BUNDLE
M100-S25 is available only with the purchase of M02-A12, M07-A10, or
AND SAVE! both
documents.
Collection includes:
M02-A12Performance Standards for
Antimicrobial Disk Susceptibility Tests; Approved
StandardTwelfth Edition
M07-A10Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria That Grow
Aerobically; Approved StandardTenth Edition
M100-S25Performance Standards for

Antimicrobial Susceptibility Testing;
Twenty-Fifth Informational Supplement

Nonmembers $500
Quality Management
Systems
Method Evaluation
Coming Soon!
Membership
Microbiology
Newborn
Screening
Communities
Participate in CLSIs online Communities to collaborate with
fellow professionals!
Share your knowledge and disseminate
information.
Find resources to do your job better,

shorten decision times, and decrease risk.
Explore ideas and participate in group or

private discussions.
Network to find individuals who share

similar goals and interests.
Join today at community.clsi.org.

If you are interested in submitting content such as case studies or featured articles for the
Communities,
please
communities@clsi.org.
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TODAY: Toll
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M29-A4
MAY 2014
May 2014
M29-A4
Protection of Laboratory Workers From
Occupationally Acquired Infections;
Approved GuidelineFourth Edition
Protection of Laboratory Workers From Occupationally

Acquired Infections; Approved GuidelineFourth Edition
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.

Nonmembers $170
M39-A4 QG
Collection, Handling, Transport, and Storage for Hemostasis Antibiograms: Developing
Cumulative Reports for Your Clinicians Quick Guide
Based on M39-A4, this 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. Formatted as seven durable,
waterproof sheets on a convenient detachable ring.

Nonmembers $60
M40-A2
JUNE 2014
June 2014
M40-A2
Quality Control of Microbiological
Transport Systems; Approved Standard
Second Edition
Quality Control of Microbiological Transport Systems; Approved

StandardSecond Edition
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.

Nonmembers $170
M56-A
JULY 2014
July 2014
M56-A
Principles and Procedures for Detection of
Anaerobes in Clinical Specimens; Approved
Guideline
Principles and Procedures for Detection of Anaerobes in Clinical

Specimens; Approved Guideline
This document presents standardized, cost-eective, and ecient best practice processes for
anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved
patient care.

Nonmembers $170
MM03-R3
COMING SOON!
January 2015
MM03-R3
Molecular Diagnostic Methods for
Infectious Diseases; A Report
Molecular Diagnostic Methods for Infectious Diseases; A Report
This document addresses topics relating to clinical applications, amplified and nonamplified nucleic acid
methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test
performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions,
reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for
manufacturers and clinical laboratories.

Nonmembers $130
Own the Complete Library of CLSI Standards and Guidelines

COMING JANUARY 2015
customerservice@clsi.org www.clsi.org
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November 2013
I/LA26-A2
January 2015
Performance of Single Cell Immune Response

Assays; Approved GuidelineSecond Edition
M100-S25
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.
An electronic library containing

more than 200 CLSI standards
and guidelines!
This document provides updated tables for the Clinical

and Laboratory Standards Institute antimicrobial
susceptibility testing standards M02-A11, M07-A9,
and M11-A8.
An informational supplement for global application developed through the Clinical and Laboratory Standards Institute
consensus process.
Our user-friendly, searchable CD-ROM includes all documents published through December 31, 2014.
Search across and within documents

to easily locate relevant information.
Quickly find the CLSI standards information
that will help you improve testing quality.
Access the full CLSI library for less than

$15 per document for members!
Members LI: Included as a membership benefit
LII: $1,640 LIII: $2,050 | Nonmembers: $4,100
13
An Interactive Searchable Database for Drug Selection,

Interpretation, and Quality Control Procedures!
Based on CLSI Document
M100-S25
Performance Standards for Antimicrobial Susceptibility

Testing; Twenty-Fifth Informational Supplement
New Version January 2015
This online implementation of CLSIs most widely recognized antimicrobial susceptibility testing (AST) document
provides information for drug selection, interpretation, and quality control as well as the latest recommendations for
detecting resistance mechanisms, all arranged in an easy-to-use, interactive, and searchable format.
Quickly access M100-S25 information in the laboratory
all you need is a Web connection.
Customize for your institutions formulary.
Sort information by tables, organisms, and agents.
Infectious disease physicians and

pharmacistseM100 comes in a
version just for you!
eM100 Basic
eM100 Full
Members: LI$150, LII$200, LIII$250
Members: LI$75, LII$100, LIII$125
Nonmembers: $500Annual Subscription

(Up to 20 users)
Nonmembers: $250Annual Subscription

(Up to 2 users)
In eM100 Basic, you will find only

the information you need to make
informed patient recommendations.
Visit www.clsi.org or contact customerservice@clsi.org to purchase eM100 today!
e CLIPSE
TM
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Now, CLSI Standards Are

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With eCLIPSE Ultimate AccessTM, we have made it even easier for your laboratory to access
and use our invaluable resources for quality improvementanytime, anywhere.
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Gain instant access to CLSIs complete library through
With multiple user access, members within your
the eCLIPSE online portal. No hardware neededwith
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and archived CLSI documents simultaneously.
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Most Current Standards Information.
Through automated updates, eCLIPSE ensures that
your organization always has access to the newest,
most up-to-date CLSI standards and guidelines.
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Ultimate Access.
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Avoid Getting Cited for Common Deficiencies!

CLSI has developed crosswalks to ensure your laboratory is prepared
for accreditation and inspections.
CLSI References in the CAP
Accreditation Checklists
CLSI-FDARecognized
Consensus Standards
Numerous CLSI documents are

referenced in the College of American
Pathologists (CAP) Accreditation
Checklists and serve as key resources
in satisfying regulatory requirements.
CAP Accreditation Checklists are
updated regularly to include CLSI
standards, guidelines, and other
documents as references.
The US Food and Drug

Administration (FDA) maintains a
database of recognized consensus
standards. Included in the database
are more than 100 CLSI consensus
standards and guidelines, which can
easily be found using this reference.
CLSI Documents Referenced

to The Joint Commission
Laboratory Accreditation
Standards Chapters
Use this crosswalk to identify CLSI
documents that are referenced to
The Joint Commission Laboratory
Accreditation Standards Chapters.
Download these FREE CLSI crosswalks at www.clsi.org.

15
CLSI Newborn Screening Standards:

Ensuring Good Health From the Start
Collecting a few drops of a newborns blood on filter paper makes a
dierence in the quality of life for that child and his or her family! This
procedure, which is critical to newborn screening, makes it possible to
detect and treat a variety of debilitating and life-threatening disorders
before it is too late.
Based on CLSI Standard NBS01-A6
NBS01-A6 DVD
JUNE 2014
Making a Dierence Through

Newborn Screening:
Blood Collection on Filter Paper
NEWBORN
SCREENING
Making a Dierence Through Newborn Screening:

Making a Dierence Through Newborn Screening:

Based on CLSI Standard NBS01-A6
This video shows how to:

Prepare for specimen collection.
Collect blood specimens using the recommended heelstick technique with specimen
application directly onto the specimen collection device.
Handle specimens properly, maintain appropriate records, and transfer specimens to the
screening laboratory in a timely manner.
Prevent testing problems that can delay the newborns diagnosis and treatment.
Nonmembers $300
POCT04-A3
COMING SOON
January 2015
POCT04-A3
Essential Tools for Implementation and
Management of a Point-of-Care Testing
Program; Approved GuidelineThird
Edition
Essential Tools for Implementation and Management of a Pointof-Care Testing Program; Approved GuidelineThird Edition
This document provides guidance to users of in vitro diagnostic devices outside the clinical laboratory in
order to ensure reliable results comparable to those obtained within the clinical laboratory.

Nonmembers $130
POCT13-A3
COMING SOON
January 2015
POCT13-A3
Glucose Monitoring in Settings Without
Laboratory Support; Approved Guideline
Third Edition
Glucose Monitoring in Settings Without Laboratory Support;

Approved GuidelineThird Edition
This document contains guidelines for performance of point-of-care glucose monitoring systems that
stress quality control, training, and administrative responsibility.

Nonmembers $130
17
TM
from the Clinical and Laboratory

Standards Institute (CLSI)
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 laboratorys quality management
system (QMS) can be developed.
By using the guidance and tools in The Key to Quality, you can:
Improve patient care.
Reduce risk of medical
errors.
Streamline laboratory
processes.
Increase productivity and

eciency.
Improve customer
satisfaction.
Reduce costs.
Comply with regulatory and

accreditation requirements.
Enhance employee abilities.
Laboratory Quality Management

System (LQMS) Certificate Program
CLSIs online, self-paced certificate program provides a
systematic, process-oriented approach to meeting quality
objectives.
Learn How to Implement Your QMS Most Eectively

Learn best practices for developing,
implementing, and sustaining policies,
processes, and procedures for each quality
system essential.
Study on your own schedulelog in from any

Internet-accessible device anytime, anywhere.
Earn 13.0 P.A.C.E. continuing education
credits and a certificate of achievement upon
completion.
Visit www.clsi.org/edu for

details and to register.
YOU CAN PUT A COST ON QUALITY:
Learn How With CLSI Products and Programs
QMS20-R
May 2014
QMS20-R
Understanding the Cost of Quality in the

Laboratory; A Report
MAY 2014
Understanding the Cost of

Quality in the Laboratory;
A Report
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.
A CLSI report for global application.
Every time work is redone, the cost of laboratory services

therefore, the cost of qualityincreases. Consider the cost to the
laboratory and to the organizationand the potential adverse
eects on patient careof corrections needed for unacceptable
samples, quality control failures, lost reports, and erroneous
results.
This valuable report provides guidance to a laboratory in
understanding and managing the dierent types of quality costs
that aect processes, services, and financial well-being.
This report introduces the types of quality costs in laboratory
expenditures: prevention, appraisal, and internal and external
failure. It also suggests ways that laboratories can apply this
information to continually improve their processes, services, and
financial performance.
Order today at www.clsi.org/QMS20.

19
Now Available!
New eLearning Program: Implementing

the Cost of Quality in the Laboratory
Certificate Program
Do you know how much your laboratory spends on:
Supporting good quality?
Resolving problems and errors?
Preventing poor quality from occurring?
Enroll in the only program that truly implements the steps
needed to determine the existing cost of quality in your
laboratory.
Program modules in this online, self-paced eLearning
program include:
Understanding the Basic Concepts
Identifying the Dierent Costs
Calculating the Costs
Laboratory Case Study
Program Summary
4.0 P.A.C.E. continuing education credits will be
provided.
Order today at www.clsi.org/QMS20.

QMS11-A2
COMING SOON
January 2015
QMS11-A2
Nonconforming Event Management; Approved Guideline

Second Edition
Nonconforming Event Management;

Approved GuidelineSecond Edition
Grounded in the principles of quality management and patient safety, this guideline provides an
outline and content for developing a program to manage a medical laboratorys nonconforming events.

Nonmembers $170
QMS18-A
COMING SOON
January 2015
QMS18-A
Process Management; Approved Guideline
Process Management; Approved Guideline
This guideline describes four requirements for managing laboratory processes and provides suggestions
for eectively meeting regulatory and accreditation requirements, optimizing ecient use of resources,
and contributing to patient safety and positive outcomes.

Nonmembers $170
21
VET04-A2 PK
BUNDLE
AND SAVE! Members LI: $54 LII: $72 LIII: $90
Nonmembers $180
VET04-A2
September 2014
VET04-A2
Methods for Broth Dilution Susceptibility
Testing of Bacteria Isolated From Aquatic
Animals; Approved GuidelineSecond
Edition
SEPTEMBER 2014
Methods for Broth Dilution Susceptibility Testing of

Bacteria Isolated From Aquatic Animals; Approved
GuidelineSecond Edition
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.
VET03/VET04-S2
September 2014
VET03/VET04-S2
Susceptibility Testing of Bacteria
Isolated From Aquatic Animals; Second
SEPTEMBER 2014
Performance Standards for Antimicrobial Susceptibility

Testing of Bacteria Isolated From Aquatic Animals; Second
This document provides updated tables for the CLSI antimicrobial susceptibility testing guidelines
VET03-A and VET04-A2.
Learn How to Optimize Practices and Processes in

Your Laboratory.
CLSI is working to bring you educational webinars on important
topics in todays clinical laboratory.
EP05-A3 Precision Evaluation of IVD Assays

Objectives:
Understand basic concepts of precision.
Understand considerations that guide selection of precision
testing protocols for a given measurement procedure.
Apply standard protocols to establish common precision claims.
Date/Time:
November 18, 2014
1:002:00 PM Eastern (US) Time
Speaker:
Jim Pierson-Perry
Siemens Healthcare Diagnostics, Inc.

Newark, Delaware, USA
Related CLSI Document:

EP05-A3Evaluation of Precision of Quantitative Measurement Procedures; Approved GuidelineThird Edition
Diagnostic Testing Using Microarrays Guidance for

Labs (Co-hosted by APHL)
Objectives:
Discuss various solid-state and suspension
microarray technologies and their major features.
Explain the process and considerations for design and
development of microarrays for pathogen detection.
Date/Time:
November 20, 2014
Speaker:
Sherry A. Dunbar, PhD
Luminex Corporation
Austin, Texas, USA
Review the recommendations and methods specific to

implementation of microarrays for infectious diseases in the
diagnostic laboratory, including verification and validation, quality
control and quality assurance, data analysis, and interpretation.
MM22-AMicroarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline
CLSIs Guide to Planning Laboratory Operations

During a Disaster (Co-hosted by APHL)
Objectives:
Describe community and hospital approaches to disaster
preparedness and response planning, including organizational
structure, resources, and assets.
Describe, broadly, the steps to develop, maintain, and improve
your emergency operations plans.
Apply CLSI document GP36, Planning for Laboratory Operations
During a Disaster, to enhance emergency preparedness in your
facility.
Date/Time:
December 4, 2014
Speakers:
Thomas L. Williams, MD, FACB,
FASCP, FCA
Nebraska Methodist Hospital
Omaha, Nebraska, USA
Gina Potenza, CBCP, MBCI
Great Expression Dental Centers

Bloomfield Hills, Missouri, USA

GP46-RPlanning for Challenges to Clinical Laboratory Operations During a Disaster; A Report
Prices range from $99 to $195 per site. CLSI member discount is available for CLSI-only webinars.
Earn P.A.C.E.
Each participant will receive P.A.C.E. Program CE credits for each webinar.
ORDER TODAY: TollToFree
(US):
877.447.1888
CE Credits!
learn more
or to
register today, visit www.clsi.org/webinars.
Learn How to Optimize Practices and Processes in

Your Laboratory.
CLSI is working to bring you educational webinars on important
topics in todays clinical laboratory.
Clinical Microbiology and Infection Control: A

Synergistic Partnership
Objectives:
Locate recommendations from the Centers for Disease Control
and Prevention for infection control of multidrug-resistant
pathogens.
Identify infection control decisions that are most likely to require
special laboratory testing.
Date/Time:
December 10, 2014
Speaker:
Jean B. Patel, PhD, D(ABMM)
Centers for Disease Control
and Prevention
Atlanta, Georgia, USA
List tests that can guide infection control decisions.

Related CLSI Documents:
CLSI Antimicrobial Susceptibility Testing Documents
CLSI 2015 Antimicrobial Susceptibility Testing

Update (Co-hosted by APHL)
Objectives:
Identify the major changes found in the new CLSI document
M100-S25.
Design a strategy for implementing the new practice guidelines
into your laboratory practices.
Develop a communication strategy for informing clinical sta
of significant antimicrobial susceptibility testing and reporting
changes.
Dates/Times:
February 4, 2015
February 5, 2015
Speaker:
Janet A. Hindler, MCLS, MT(ASCP)
UCLA Health System
Los Angeles, California, USA

Coming January 2015: M100-S25Performance Standards for Antimicrobial Susceptibility Testing;
Twenty-Fifth Informational Supplement
Unable to attend one of these webinars? Watch CLSI webinars on demand at your
convenience. Visit www.clsi.org/webinars/on-demand for a complete listing.
Prices range from $99 to $195 per site. CLSI member discount is available for CLSI-only webinars.
Earn P.A.C.E.
Each participant will receive P.A.C.E. Program CE credits for each webinar.
ORDER TODAY: TollToFree
(US):
877.447.1888
CE Credits!
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Quality System Regulation for Laboratory

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Information Technology Security of In Vitro

Information Technology Security of In Vitro Diagnostic

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Members LI: $6 LII: $8 LIII: $10

Mass Spectrometry for Androgen and Estrogen Measurements

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Liquid Chromatography-Mass Spectrometry Methods;

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Nongynecological Cytology Specimens: Preexamination,

This document provides recommendations for cytology laboratories to use in developing

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Planning for Laboratory Operations During a Disaster;

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Evaluation of Precision of Quantitative Measurement Procedures;

Members LI: $51 LII: $68 LIII: $85

User Verification of Precision and Estimation of Bias; Approved

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Evaluation of Commutability of Processed Samples; Approved

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Did You Know?

Collaborate in our consensus process to

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Laboratory Quality Control Based on Risk

This document provides guidance based on risk

Laboratory Quality Control Based on

This document provides guidance based on risk management

Obtain guidance based on risk management

Find the help you need to implement EP23THE

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This document provides updated tables for the Clinical

Performance Standards for Antimicrobial

New pefloxacin disk diusion