Call to Aim for Global Uniformity Among Clinical Lab Test Results

A new position statement outlines steps for and emphasizes the critical importance of harmonizing test results among laboratories for providing higher quality treatment decisions.

Evidence-based guidelines are often used to help practitioners make informed patient care decisions. These guidelines frequently rely upon laboratory test results to determine if and when a specific treatment is appropriate. The American Association for Clinical Chemistry (AACC; Washington DC, USA) has released its position statement on harmonization of—providing uniformity among—clinical laboratory test results to improve patient care. The association aims to raise awareness about this essential healthcare issue and urge the medical community to work together to make harmonization a reality so that physicians receive high quality, consistent, and uniform results for making patient care decisions.

For example, with the release of the American Heart Association (AHA) and American College of Cardiology’s new cholesterol guidelines, uniform cholesterol test numbers are more important than ever. These guidelines advise doctors to include additional variables, such as gender and blood pressure, into the AHA’s risk calculator to assess a patient’s risk of cardiovascular disease and need for cholesterol-lowering drugs. Without uniform cholesterol test numbers, physicians will not have accurate risk calculator results on which to base treatment decisions.

The few laboratory tests that have been harmonized to date, such as those for cholesterol, glucose, and hemoglobin A1c, have made a marked positive impact on diagnosis and treatment of heart disease and diabetes. Harmonization has also led to reductions in healthcare spending. As a striking example, the initiative to harmonize cholesterol tests costs USD 1.7 million per year, while the health benefits it has yielded now save more than USD 338 million annually.

“Results of patient lab tests should be comparable regardless of the method used, the time they were analyzed, or the laboratory that produced them,” said AACC president Robert H. Christenson, PhD “New guidelines for cholesterol underscore this need. In situations where doctors depend on several risk factors in addition to test results to make treatment decisions, there cannot be discrepancies between test results if they are to be useful within the context of a patient’s overall health and medical history.”

To ensure progress in harmonizing all types of test results, AACC has spearheaded the International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR), an oversight body that will organize worldwide efforts. In the harmonization position statement, AACC provides basic guidance on the role laboratory organizations, clinical societies, regulatory agencies, the in vitro diagnostic industry, reference material providers, and other stakeholders can play in contributing to the ICHCLR’s endeavor.

Related Links:
American Association for Clinical Chemistry
AACC Harmonization Position Statement