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Improving Clinical Laboratory Testing through Harmonization: An International Forum

Purpose:

The AACC and NIST is hosting an invitation-only conference on global harmonization of results from clinical laboratory testing procedures for which no reference measurement procedure exists or is likely to be developed. The two-day conference will seek to strengthen quality of laboratory measurements and improve patient care by developing consensus on technical and organizational processes to achieve harmonization of clinical laboratory results.

As a result of the conference, four working groups will be created to further develop and implement the conference recommendations; they will serve as the foundation for a continuing organizational involvement in harmonizing this category of clinical laboratory testing procedures.

Professional laboratory and clinical associations, in-vitro diagnostics and pharmaceutical (companion diagnostics) companies, and government organizations from around the world concerned with or involved in standardization activities have been invited to participate to ensure global and cross disciplinary acceptance of the recommendations and plans for implementation. The result of this conference will be a dialogue within the laboratory community that will establish procedures to minimize factors that put patients at risk from non-standardized laboratory test results and will ultimately lead to improved patient care and safety.

The conference objective is to develop a consensus process to harmonize analytes for which no reference measurement procedure exists. Participants will be asked to prepare written position statements on each of the conference topics (see breakout sessions) at least three months in advance. The positions will be collated and circulated to all participants in advance of the conference. Thus, all participants will have an opportunity to review each other's positions and be prepared for fruitful discussion and consensus development at the conference.

The primary output from the conference will be:

  1. Consensus procedures for how to accomplish harmonization.
  2. Formation of working groups with specific tasks to ensure implementation of the conference recommendations.
  3. Identification of organizations willing to accept responsibility for implementing one or more of the recommendations agreed upon.
  4. A report in Clinical Chemistry on the findings and recommendations from the conference. The journal has agreed to publish the proceedings and recommendations.

Please Note: This event will be in English only. There will be no simultaneous translation.

Agenda:

The full conference agenda is available on the conference website.

Security Instructions:

All non-USA citizens will need to complete the NIST-1260 form. This form must be faxed to Donna Kimball at FAX 1-301-975-3845. It cannot be emailed. The form must be received by October 11, 2010 to ensure your entrance into the NIST campus. Failure to provide this information will result in denied access to the NIST facilities and therefore for the conference.

If you are planning on driving and parking at NIST, please email Jean Rhame at jrhame@aacc.org so that you can receive a "Dash-Board Pass" that will be required for parking on the NIST campus.

Speakers:

The full conference agenda is available on the conference website.

Details:

Start Date: Tuesday, October 26, 2010
End Date: Wednesday, October 27, 2010
Location: NIST, Gaithersburg, MD
Audience: Industry, Government, Academia
Format: Workshop

Sponsor(s):

American Association for Clinical Chemistry (AACC)
National Institute of Standards and Technology (NIST)

Registration:

Due to NIST's "secured facility" regulations, pre-registration for this meeting is REQUIRED by October 5, 2010. NO on-site registration will be available at the conference. Registration fees are $250 if registered by September 6, 2010 and $300 after September 6, 2010. No changes will be made to the registration list after October 5, 2010.

Registration is open on the conference website.

Registration Contact:

Registration is open on the conference website.

Accommodations:

Lodging information is available on the conference website.

Technical Contact:

The organizing committee will be responsible for preparing the proceedings and for coordinating the follow up working groups. The AACC does not anticipate being responsible for executing the recommended actions, but is committed to organizing the infrastructure to ensure the objectives for harmonization are accomplished. The AACC may take a role in executing recommendations if funding can be obtained for these activities.

Organizing Committee

  • Greg Miller, PhD, Virginia Commonwealth University, Co-chair
  • Gary Myers, PhD, Centers for Disease Control and Prevention, Co-chair
  • Mary Lou Gantzer, PhD, Siemens Healthcare Diagnostics Linda Thienpont, PhD, University of Gent
  • Stephen Kahn, PhD, Loyola University
  • Ralf Schoenbrunner, PhD, Life Technologies