President's Message
Mary Lou Gantzer, PhD, FACB
CLSI President

As a not-for-profit membership organization, the backbone of CLSI is our members. Members are vital to CLSI as their dues support our mission and they provide CLSI with its volunteer leadership. Thanks to recent member feedback, and in an effort to provide increased membership value, CLSI has decided to make changes to the membership options that have been offered.


As of January 1, 2013, CLSI will implement an overhaul of our current membership options. The CLSI staff has dedicated extensive efforts into a plan that will fit the needs voiced by member suggestions...



Vietnamese Health Officials Celebrate Graduation From New Laboratory Leadership Program


CLSI's Global Health Partnerships (GHP) recently joined with Vietnam and US officials in Hanoi to celebrate the graduation of 23 Vietnamese health officials from the first Laboratory Leadership Certificate Program. Launched in 2011, the GHP program's curriculum focused on 12 quality system essentials (QSEs) and related standards aimed at providing the officials with the skills and tools to improve laboratory efficiency and testing accuracy...


Read more and watch video here to learn more.

2013 CLSI Excellence Awards


You are invited to nominate a colleague for the 2013 CLSI Excellence Awards. The awards celebrate the achievements of volunteers who have helped improve the quality of medical care worldwide.


Nominations for the 2013 Excellence Awards may be made by any individual. The nomination may be submitted as a free-form narrative or by completing the nomination form. The selection criteria listed for each award will be used as a guide for approval. More than one recipient may be awarded in a given year. All award nominations received by December 14, 2012 are eligible for 2013 CLSI Excellence Award consideration.


Awards will be presented at the CLSI Leadership Conference Luncheon and Excellence Awards ceremony on March 13, 2013.


Click here for a listing of awards and selection criteria for each award.
October Publications 


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

When it comes to antifungal and susceptibility testing, this standard will provide key information on everything you need to know for fungal detection.


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

Learn how to apply the quality system essential for quality management and technical processes of molecular genetic testing.

Recently Published
CLSI Welcomes New Members

Thank you to our new members for their support!

 Fall Education Promotion!






All Fall 2011-Spring 2012 Archived Webinars Are Now 50% Off!



For more information and to purchase archived webinars, click here.

GHP's First Visit to Malawi Reveals Labs in Desperate Condition 



When CLSI's Global Health Partnerships (GHP) traveled to Malawi for the first time in the program's seven-year history, the staff encountered laboratories that were ill-equipped and technicians who were improperly trained and/or lacked the tools to follow basic safety guidelines... 



Visit CLSI     





December 2-6

Mandalay Bay Hotel & MGM Grand

Las Vegas, Nevada, USA

Booth #2366



Weeding Through Waived Testing; Separating the Wheat From the Chaff


November 26, 2012, 1:00-2:00 PM Eastern (US) Time


This presentation will take participants through the waived testing journey including its origin, growth, accreditation challenges, and resolutions for optimal compliance. A number of different perspectives will be addressed to provide laboratorians with options for eradicating the "weeds."


Related CLSI Documents: 

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

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


Register Now!



CLSI Webinar


 Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference 


December 11, 2012, 1:00-2:00 PM Eastern (US) Time


Automated hemolysis, icterus, and lipemia/turbidity (HIL) systems can improve HIL detection by introducing harmonization and uniformity, improving efficiency of laboratory processes and, most importantly, enhancing the accuracy of patient results. Participants will learn to describe the mechanisms of hemolysis, icterus, and lipemia/turbidity and evaluate the usefulness and interpretation of automated HIL indices. They will also learn to define, interpret, and report HIL alert indices (threshold levels) and gray zones as well as HIL interference claims in product labeling.


Did You Know?

Facts About CLSI Membership

CLSI membership gives you discounted pricing on our annual Infobase CD-Rom?

  • Infobase is a CD-Rom that is published annually and contains the entire CLSI library through December 31st of the most recent calendar year.
  • While Infobase is $4100 for nonmembers, CLSI Membership can purchase it for $2800.
  • With our annual Infobase CD you are able to quickly and easily search using key words or relevant text within multiple documents!
For more information on Infobase or any types of memberships, please contact our Membership department at


For more information on membership with CLSI, please contact
Documents for Public Review and Comment 


I/LA36 (Draft 2)-Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circle.


Comment Deadline: November 19, 2012


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, a lethal disorder of infancy, is not evident at birth and treatments are effective with early detection.


M40 (Draft 2)-Quality Control of Microbiological Transport Systems.


Comment Deadline: December 20, 2012


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.


Learn more...

Contact Us
Clinical and Laboratory
Standards Institute
950 West Valley Road, Suite 2500
Wayne, Pennsylvania 19087

 Follow us on Twitter View our profile on LinkedIn

Subscribe to eNews

Stay up-to-date with the latest eNews - sign up today!