AACC Announces Conference ‘Improving Clinical Laboratory Testing Through Harmonization: An International Forum’
Washington, DC, August 11, 2010
Where: National Institute for Standards and Technology, Gaithersburg, MD
When: October 26 – 27, 2010
What: The American Association for Clinical Chemistry (AACC) is convening an international, invitation-only, leadership forum with experts involved in standardization activities from professional laboratory and clinical associations, in-vitro diagnostics companies, metrology institutes and government organizations. The forum goal is to develop consensus on technical and organizational processes to achieve harmonization of results from laboratory testing procedures for which no reference measurement procedures, and in many cases no suitable reference materials exist or are likely to be developed. The small number of analytes that have well characterized reference systems available is a major impediment to more widespread standardization. Developing consensus procedures for achieving harmonization of analytes for which no reference measurement procedures exist will improve the quality of clinical laboratory testing and the confidence to establish treatment guidelines based on sound reproducible and consistent laboratory results.
The conference will address the following process topics:
1. prioritizing analytes for harmonization
2. conducting a situational analysis to determine what is needed for harmonization
3. developing a technical process to achieve harmonization for an analyte
4. assessing successful harmonization for an analyte
The significance of the conference and continuing effort to implement the recommendations coming from the conference deliberations is to improve the practice of laboratory medicine for a large group of important analytes that are not currently harmonized and for which no organization is developing procedures for harmonization. Many of these tests are currently used in clinical practice guidelines despite the lack of uniform results, and will increasingly be incorporated into guidelines as the value of evidence based practice continues to be promulgated by clinical groups. Establishing more effective processes and systems to better harmonize method results will directly benefit in-vitro diagnostics companies by providing a stronger foundation for establishing laboratory medicine best practices. Global acceptance of consensus harmonization schemes will enable cost effective compliance with a single standard endorsed by laboratory and clinical organizations. Most importantly, harmonization schemes will improve health care provider’s ability to link test results to clinical outcomes.
Why: Every day health care providers rely on the results of biochemical laboratory tests to make diagnoses, treat individuals and monitor health and disease status. When method results are not standardized (nor harmonized), a different numeric result may be obtained for the same clinical condition using different methods that measure the same analyte. Health care providers and researchers are often unaware of the extent to which test values vary from method to method, thus seriously undermining clinical decision making, research translation and the development of appropriate clinical practice guidelines. The overall public health impact and the economic consequences of the lack of harmonization are not well defined, but are significant particularly in light of the cost of misclassification of an individual’s health risk. It is desirable that results of clinical laboratory measurements for a given analyte be harmonized so they are consistent and uniform among different laboratories and different measurement procedures.
Who: For more information, contact Jean Rhame at jrhame@aacc.org or (202) 835-8744, or visit AACC’s website here.
AACC is a leading professional society dedicated to improving healthcare through laboratory medicine. Its over 9,000 members are clinical laboratory professionals, physicians, research scientists, and others involved in developing tests and directing laboratory operations. AACC brings this community together with programs that advance knowledge, expertise, and innovation
