A session at this year’s Annual Meeting—“Overcoming the Barriers to Harmonization”—will discuss key barriers to harmonization of laboratory test results, as well as approaches to addressing these challenges to ensure lab test result consistency around the world.
“I hope attendees will come away with a better understanding and appreciation of the impact that harmonization has on providing quality lab test results, which lead to improved patient care,” says Gary Myers, PhD, vice president of science and practice affairs at AACC, who will serve as moderator for this session. Myers will be joined by Greg Miller, PhD, DABCC, of Virginia Commonwealth University in Richmond, Virginia; Linda Thienpont, PhD, of Ghent University in Belgium; and Donna Young, PhD, of Roche Diagnostics in Indianapolis.
To press forward on harmonization, AACC established the International Consortium for Harmonization of Clinical Laboratory Results and in 2013 issued a position statement, “Harmonization of Clinical Laboratory Test Results.”
“The laboratory community is concerned that many healthcare professionals and patients are not aware that different measurement procedures may give different numeric values for the same test (i.e., not all measurement procedures are “harmonized”),” according to the statement. “Laboratory test results are a critical element of patient care and must be harmonized to ensure that accurate diagnoses and appropriate treatment decisions for patients are made.”
AACC has been joined in its efforts to achieve harmonization by key partners, including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Commutability and the IFCC Committee for Standardization of Thyroid Function Tests, which are co-sponsoring the Annual Meeting session.
Despite this level of international cooperation, challenges remain to achieving harmonization. The top two barriers, Myers says, include “not having adequate reference systems consisting of reference measurement procedures and reference materials to enable harmonization of the many tests used for patient care,” as well as “non-commutability of existing reference materials.”
Myers says laboratorians can take steps to overcome these barriers, such as participating in an accuracy-based proficiency testing (PT) program that uses documented commutable survey materials to assess a laboratory’s performance. If such a PT program is not available, laboratorians should “include documented commutable reference materials, where available, in analytical runs to assess performance of their testing systems,” Myers suggests.