Laboratory test results are a critical component of patient care. These values help physicians diagnose disease, are critical to developing clinical guidelines that direct treatment options, and are instrumental in ongoing efforts to improve and measure the quality of patient care. AACC is working to improve clinical testing by resolving the lack of harmonization, or uniformity, among test results.
Most tests report a numeric value for healthcare providers to interpret. The range of numbers reported for a test for a certain condition may vary depending on the method used. Although labs generate test results that are correct within the context of a given method, this lack of harmonized or uniform results makes it difficult for healthcare providers or patients to compare results over time or across labs. Ensuring that labs report the same range of numeric values for a test (e.g., cholesterol), regardless of method or device, helps reduce medical errors, lower healthcare costs, and increase patients' involvement in their care decisions.
Harmonization improves patient outcomes by ensuring that tests provide the same results regardless of their manufacturer or the lab performing them.
Securing Congressional Funding for Harmonization
For several years, AACC has spearheaded a collaborative initiative involving partners in the healthcare community to gain congressional support for harmonization. This initiative led Congress to include report language in its 2015 spending bill that directed the Centers for Disease Control and Prevention (CDC) to work with the private sector to harmonize clinical laboratory results. Most recently in 2018, AACC-led efforts culminated in Congress allocating $2 million to CDC for harmonization. This funding gives CDC the resources to advance harmonization for select hormone tests, which will improve diagnosis and treatment for diseases such as hypothyroidism, chronic kidney disease, and osteoporosis. AACC is now working with its partners to make this a permanent allocation.
AACC’s lab experts Drs. David Carpentieri, Robert Fitzgerald, and Brett Holmquist visit Capitol Hill to discuss the need for lab test harmonization with Rep. Kevin Yoder (R-KS).
Together with CDC’s Dr. James Pirkle, AACC experts Drs. Darius Paduch, Stephen Master, and David Koch hold a Congressional briefing on why harmonization is vital to quality patient care.
AACC Position Statement on Harmonization
In this position statement, AACC provides guidance on how laboratory organizations, clinical societies, regulatory agencies, the in vitro diagnostic industry, and other stakeholders can contribute to harmonization efforts.
Letters to Congress in Support of Harmonization