CLSI Visits China for Business Development and Laboratory Assessment
 

CLSI Chief Executive Officer, Glen Fine, MS, MBA, CAE, and Director of Global Health Partnerships, Connie Adams, visited seven major Chinese cities in 10 days in August 2014. The trip was coordinated with Zhongshan (Sun Yat-Sen) University Daan Health Group, a CLSI member, to promote the use of CLSI's global laboratory standards in China, build lasting business relationships, and assess two community health center laboratories in the Guangdong province...
 
In This Edition: 
 
This Just In! New CLSI ProductsStandards_    

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


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.

Evaluation of Commutability of Processed Samples; Approved
Guideline--Third Edition
 | EP14-A3


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.

 

User Verification of Precision and Estimation of Bias; Approved
Guideline--Third Edition
 | EP15-A3


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.

Coming Soon From CLSI
    

CLSI Releases Version 3.0 of StatisPro™


This month, an updated version of our feature-rich method evaluation software, StatisPro 3.0, will be released. New information includes:
  • Implementation of EP09-A3, including Deming regression, Passing-Bablok regression, and bias plots
  • Implementation of EP17-A2, including study design improvements to match new guidelines and limit of detection/limit of quantitation estimation from a precision profile approach
Documents for Publication

Methods for Broth Dilution Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Approved Guideline--Second Edition (VET04-A2)
Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals; Second Informational Supplement (VET03/VET04-S2)
 

Quality Systems Regulations 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 high-risk 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, in conjunction with representatives from FDA and CMS.

 

As the regulations can be difficult to understand, the document explains each requirement in plain language, and compares it, where appropriate, to the CLIA regulations. This document explains what the QSRegs require, 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 effective.

 

More information will soon be available at www.clsi.org.



Enroll in the only program that truly implements the steps needed to determine the existing cost of quality in your lab.
 

 
Program modules in this online, self-paced program include:

  • Understanding the Basic Concepts
  • Identifying the Different Costs
  • Calculating the Costs
  • Laboratory Case Study
  • Program Summary

P.A.C.E.� continuing education credits will be provided.

CLSI Membership Corner
CLSIU   


Did you know that as a member of CLSI, you can create a 5- or 10-document specialty collection with any documents of your choice at a discounted rate?
 

Register Now! CLSI U Programs
Education   


CLSI Webinar | Molecular Methods 101: Basic Considerations for Clinical Laboratories
Only $99.00 for nonmembers! 
September 24, 2014 | 1:00-2:00 PM Eastern (US) Time
 
This program will provide an introduction to molecular diagnostics for those laboratories considering implementing or expanding testing. It will emphasize the special opportunities and challenges associated with molecular diagnostic testing and discuss how the CLSI molecular methods documents can help laboratories successfully implement testing.
 
         


Check Out Three Upcoming FREE CLSI Webinars

Introduction to the CLSI Document EP15-A3--User Verification of Precision and Estimation of Bias; Approved Guideline--Third Edition
September 16, 2014 | 1:00-1:30 PM Eastern (US) Time


Introduction to the CLSI Document EP05-A3--Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline--Third Edition
September 23, 2014 | 1:00-1:30 PM Eastern (US) Time



For more information about webinars, workshops, continuing education quizzes, and the Laboratory Quality Management System Certificate Program, visit the education section of our website.
Volunteering UpdatesVol

 

Call for Volunteers

CLSI requests nominations for volunteers to serve as members and contributors on a document development committee for a document revision.


Document Revision: Body Fluid Analysis for Cellular Composition (currently CLSI document H56)

Deadline for Submission: October 10, 2014
 

teallearnmore

Documents for Public Review

MM23 (Proposed Draft)--Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)

M52 (Proposed Draft)--Verification of Microbial Identification and Antimicrobial Susceptibility Testing Systems

 
teallearnmore
Global Health Partnerships
GHP

 

Fourth Tanzania Laboratory Achieves Accreditation


The CLSI Global Health Partnerships (GHP) program is celebrating the fourth laboratory in Tanzania to be accredited this year. The Muhimbili National Hospital Central Pathology Laboratory has been accredited by the Southern African Community Accreditation Service.

 


Job Opening: Global Health Partnerships Contractor
 

For more information, a job description, requirements, and how to apply, visit the "About CLSI" section of our website and click on "Careers."


Visit the CLSI Booth!visit
 
Critical and Point-of-Care Testing:
Real World and Emerging Applications for Improved Clinical Outcomes
San Diego, California, USA
September 18-20, 2014
 IDWeek 2014
Philadelphia, Pennsylvania, USA
October 8-12, 2014
Booth #1004
Lab Quality Confab
New Orleans, Louisiana, USA
October 21-22, 2014
APHL 2014 Newborn Screening and
Genetic Testing Symposium
Anaheim, California, USA
October 27-30, 2014
Booth #301

 

 

 

 

 

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