CLSI eNews - 12 January 2005 (Print All Articles)

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Executive Vice President's Message

The holidays are over, and the new year is a reality. 2005 looks to be a very exciting year for Clinical and Laboratory Standards Institute (CLSI). We have a new name and a renewed focus by our Executive Offices staff and volunteer leadership on the important issues to advance our vision and mission.

I would like to spend a few lines in this column discussing the strategic planning process here at CLSI. There have literally been books written about the failure of companies to effectively manage the strategic planning process, with some authors quoting that as many as 90% of all corporate strategic plans fail to achieve their desired results. Typically, the failure of strategic planning is not in idea generation, but in the successful execution of those ideas. We have made substantial progress on our CLSI Strategic Plan and its supporting tactics. Key decision criteria by our Board of Directors and Strategic Planning Committee continue to focus on delivering a plan that is broad enough to establish our long-term direction, yet specific enough that we can measure the progress, execution, and delivery of our promised results, as well as be held accountable to them. I am excited by the crystallizing effects that these efforts have had in focusing our staff and volunteer leadership on our future direction as an organization. Please look for further updates in this column for specifics about CLSI’s strategic plan once it is formally approved by the Board.

Thanks for the marvelous support you have provided during my first 60 days at CLSI. As always, comments are welcomed. I hope to see you in Baltimore at the 2005 Clinical and Laboratory Standards Institute Leadership Conference in March.


Communication. Participation. Consensus. Results.

And a new name that says it all – Clinical and Laboratory Standards Institute.

Exciting news! It’s a new year, and our new organizational name is official. What does this mean? As always, Clinical and Laboratory Standards Institute will continue to hold true to our mission and values. We will continue to provide the same globally recognized standards, undisputed credibility, and commitment to excellence that healthcare professionals from around the world rely on every day.

A new name to better reflect our true strengths, scope of work, and global membership base offers many new opportunities to develop high quality resources, disseminate our products and services more effectively, and set our organization apart.

Our branding initiative and marketing campaign continues to expand throughout 2005 – to introduce and reinforce our new name which reflects our strong commitment to our key stakeholders and our ever-expanding ability to provide documents and products that are the gold standard for best practices across the healthcare disciplines.
As part of our new identity, we have adopted a new web address:, which is now live. Feel free to take a moment to browse the new website. We value the support of our members, volunteers, and customers, and are grateful that you are part of the amazing future growth of our organization as Clinical and Laboratory Standards Institute.

2005 Clinical and Laboratory Standards Institute Leadership Conference

A dynamic, interactive program, the 2005 Clinical and Laboratory Standards Institute Leadership Conference attracts the foremost minds in the healthcare industry. This annual event, taking place 16-19 March 2005 at the Renaissance Harborplace Hotel in Baltimore, MD, combines consensus standards development meetings with in-depth breakout sessions addressing the issues of primary concern to the healthcare industry.

Clinical and Laboratory Standards Institute (CLSI) volunteers, members, and other leading technical and management laboratory professionals, IVD industry representatives, and government staff from around the world will gain insight into our most important initiatives, learn about current and future technology of QC, and  personally meet and exchange ideas with global colleagues.

New for 2005—An insightful and informative Equivalent Quality Control Workshop: QC for the Future sponsored by: AACC, ACLA, AdvaMed, ASCLS, ASCP, ASM, AMT, CAP, CDC, CMS and the FDA. This workshop will provide an opportunity for attendees to:

  • Learn about current and future QC technologies
  • Contribute to the future of QC
  • Participate in interactive discussion and breakout groups
  • Network with colleagues at the President's Reception

Plus, a meeting report, CLSI consensus guidelines with QC mechanisms, and a plan for future QC will be available following the session.

In addition, an integrated schedule of meetings will take place including:

  • Global Programs Committee
  • Membership and Marketing Committee
  • Ten area committees with the following agenda:
    > Review the status of current area committee projects
    > Evaluate progress in achieving area committee priorities for 2005
    > Resolve any outstanding issues related to advancing priority projects through the consensus process
    > Conduct an environmental scan
  • Subcommittee sessions with the following agenda:
    > Evaluate and further projects in the document development process

There's also time to network and celebrate another successful year. Special events include:

  • Meet and Greet

> On Wednesday, 16 March at 6:00 p.m. attendees have the opportunity to meet our new Executive Vice President, Glen Fine.

  • Member/Volunteer Appreciation Luncheon

> On Thursday, 17 March at noon, the Member/Volunteer Appreciation Luncheon will provide an opportunity to acknowledge the outstanding and important contributions of CLSI members and volunteers, install our newest directors, and recognize the 2005 award recipients.

  • President's Reception

> The 2005 President's Reception will be hosted by Thomas L. Hearn, Ph.D., CLSI President.

Baltimore, MD is where you have to be in March. Join your colleagues and peers at the most important consensus standardization event of the year. The 2005 Clinical and Laboratory Standards Institute Leadership Conference will be the most valuable and practical conference you’ll attend all year. Register now, or for more information about attending the conference, visit or contact the Executive Offices +610.688.0100.

Press Releases

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS)
Announces New Standard Advantageous to the Field of Prenatal Screening

CLSI/NCCLS document, Maternal Serum Screening; Approved Standard (I/LA25-A), is written for clinical laboratorians who participate in prenatal screening for open neural tube defects and Down syndrome involving AFP, hCG, uE3, DIA, and/or PAPP-A measurements, as well as for clinicians and manufacturers who have a direct interest in the tests. The standard is intended to present necessary considerations: preanalytical, analytical, and postanalytical; and to ensure the reliability of the tests, including the risk calculation, the outcome evaluation, and the accuracy of the information management. If properly applied, the four biochemical determinations (or five, if performing integrated testing with PAPP-A from the first trimester), and the risk calculations can contribute constructively to the field of prenatal screening and to the welfare of pregnant women and the fetus.

Read the complete press release.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) Announces
New Guideline on Nucleic Acid Sequencing Methods

CLSI/NCCLS document, Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (MM9-A), specifies recommendations for all aspects of the sequencing process including specimen collection and handling, isolation of nucleic acid, amplification and sequencing of nucleic acids, and general interpretation and reporting of genotyping results. It is the intent of this document to provide instruction for verifying that the sequence obtained is accurate and suitable for subsequent interpretation; to address general interpretation of the sequence; and to provide quality control/assessment considerations for each step of the process as appropriate.

Read the complete release.

View the complete listing of press releases.

Notice of Vote and Comment Deadlines for Consensus Documents

LIS Validation (AUTO8-P); Remote Access (AUTO9-P); Glucose Monitoring (AST4-A2)

Clinical and Laboratory Standards Institute (CLSI) announces that the following documents are submitted for vote as candidate-for-advancement consensus documents.

The documents and ballots are posted on Forums to delegates of Active and Associate Active member organizations. If you are a voting delegate or alternate, we request that you access Forums to obtain the candidate-for-advancement document. Login to access Forums.

The deadline for the completed ballots for AUTO8-P and AUTO9-P to be received in the Executive Offices is 12 April 2005.

AUTO8-PProtocols to Validate Laboratory Information Systems; Proposed Guideline
This document provides guidance for developing a protocol for validation of the Laboratory Information System (LIS) as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data.

AUTO9-PRemote Access to Clinical Laboratory Diagnostic Devices via the Internet; Proposed Standard
This document provides a standard communication protocol for instrument system vendors, device manufacturers, and hospital administrators to allow remote connections to laboratory diagnostic devices.  The remote connections can be used to monitor instruments’ subsystems; collect diagnostics data for remote system troubleshooting; and collect data for electronic inventory management.

-Second Notice-

The deadline for the completed ballot for AST4-A2 to be received in the Executive Offices is 7 February 2005.

AST4-A2Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline–Second Edition
This document contains guidelines for performance of point-of-care (POC) glucose monitoring systems; the guidelines stress quality control, training, and administrative responsibility.

Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the Executive Offices by the above deadline.

In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.

Find out more about Active and Associate Active membership.

Recently Approved Documents

Evaluation of Matrix Effects (EP14-A2); Maternal Serum Screening (I/LA25-A); Nucleic Acid Sequencing (MM9-A)

Clinical and Laboratory Standards Institute is pleased to announce that the following documents have been approved by the Board of Directors for publication.  See the text following this list for information on options for member and nonmember organizations to obtain copies.

EP14-A2Evaluation of Matrix Effects; Approved Guideline—Second Edition
This document provides guidance for evaluating the bias in analyte measurements that is due to the sample matrix (physiological or artificial) when two measurement procedures are compared.

-Second Notice-

I/LA25-AMaternal Serum Screening; Approved Standard
This document addresses the steps required to provide reliable screening and reporting using examples of serum markers currently in common use (AFP, hCG, uE3, DIA).  Outcome evaluation, information management, and calculation of risk are also emphasized in this standard.

MM9-ANucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline
This document addresses automated, PCR-based, dideoxy-terminator, and primer extension sequencing done on gel- or capillary-based sequencers. Topics covered include specimen collection and handling; isolation of nucleic acid; amplification and sequencing of nucleic acids; interpretation and reporting of results; and quality control/assessment considerations as appropriate.

Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community which participates in the consensus process by carefully reviewing and commenting on the standard or guideline. The listed approved consensus documents are available for purchase.

You may automatically receive or select approved-level documents as a member benefit. Find out more about joining CLSI. View membership options and benefits. 

Recently Published ISO Standards

-Published ISO/TC 76 Standards-

(ISO 15375:2004) Hanging devices for multiple use with infusion bottles - Requirements and test methods

-Second Notice-

(ISO 8536-9:2004) Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment

(ISO 8536-10:2004) Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment

(ISO 8536-11:2004) Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment

(ISO 13926-1:2004) Pen systems - Part 1: Glass cylinders for pen-injectors for medical use

To purchase these recently distributed ISO documents, shop.

Focus on Global Terminology

This month’s terms:

Confirmation, through the provision of the objective evidence, that specified requirements have been fulfilled;
NOTE: Confirmation can comprise activities such as: performing alternative calculations; comparing a new design specification with a similar proven design specifications; undertaking tests and demonstrations; and reviewing the document prior to issue.

Confirmation, through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled;
NOTE: Some components of validation include quality control, proficiency testing, validation of employee competency, instrument calibration, and correlation with clinical findings.

Editor’s Note: For example, you can verify that a life preserver is a certain size, shape color, and made of certain materials; but then you must validate whether the life preserver works as you expect it to , i.e.,  does it provide the necessary buoyancy?

For complete details on these and other internationally accepted terms, visit the Harmonized Terminology Database.  In the database, find standard, internationally preferred terms and definitions, related terms, terms that are not acceptable in the international standards community, and illustrative notes and examples.

Meeting Calendar

18-19 January 2005
SC on the Expression of Uncertainty of Measurement

2-3 February 2005
SC on Body Fluid Analysis for Cellular Composition

Check out the complete calendar of meetings.

Upcoming Events and Exhibits

What’s New in the 2005 Standards for Antimicrobial Susceptibility Testing?
Free Teleconference
January 25, 2005 • 12:30 – 2:00 p.m (EST) or
January 26, 2005 • 3:00 – 4:30 p.m. (EST)
Download Brochure for details 
Registration Information
Register Now

14-17 February 2005
Booth 1154
Dallas, TX

CLMA/ASCP ThinkLab ’05
5-8 March 2005
Lakeside Center at McCormick Place
Chicago, IL

2005 Clinical and Laboratory Standards Institute Leadership Conference
16-19 March 2005
Renaissance Harborplace Hotel
Baltimore, MD

Equivalent Quality Control Workshop: QC for the Future
18 March 2005
Renaissance Harborplace Hotel
Baltimore, MD

2005 Institute for Quality in Laboratory Medicine Conference
Recognizing Excellence in Practice
28-30 April 2005 
Omni Hotel at CNN Center
Atlanta, Georgia

Join Us

Membership is the most effective way for your organization to participate in the standards-development process and to influence the consensus process. By having an active voice, participants can work to ensure that goals of the standards and guidelines directly affecting them are practical and achievable.  

Find out more information about membership options and benefits, and download a membership brochure and application.

Maximize your participation in the voluntary consensus process. You have the opportunity to influence project development. Members are encouraged to participate as volunteers on project committees. Find out more information about volunteer participation.

New and Sustaining Members

New Members

Anna Longwell, PC, USA
Ansata Therapeutics, Inc., USA
Cepheid, USA
Chen & Chen, LLC, USA
K.C.J. Enterprises, USA
Nanosphere, Inc., USA
National Pathology Accreditation Advisory Council, Australia
Optimer Pharmaceuticals, Inc., USA
Thrombodyne, Inc., USA
XDX, Inc., USA

Associate Active

Barnes-Jewish St. Peters, USA
Central Ohio Primary Care Physicians, U.S.A.
Chinese Association of Advanced Blood Bankers, Peoples Republic of China
Laboratorio Manlab, Argentina
Peking University Shenzhen Hospital, Peoples Republic of China

Sustaining Members

NCCLS acknowledges those partnering organizations that have made a special financial commitment above and beyond their membership dues.

Gold Level

  • Ortho-Clinical Diagnostics, Inc.

Silver Level

  • Abbott Laboratories 
  • American Association for Clinical Chemistry
  • Bayer Corporation
  • BD
  • Beckman Coulter, Inc.
  • bioMérieux, Inc.
  • CLMA
  • College of American Pathologists
  • GlaxoSmithKline 
  • Pfizer Inc
  • Roche Diagnostics, Inc.

View our complete membership list.

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