CDC Receives Funding to Expand Laboratory Harmonization Efforts

The FY 2018 omnibus appropriations bill, passed by Congress in late March, included a little noticed provision that could ultimately bring significant changes to the laboratory industry—$2 million for the U.S. Centers for Disease Control and Prevention (CDC) to expand its laboratory test harmonization efforts.

The bill “recognizes that certain clinical laboratory tests need harmonization to ensure that accurate results are available for correct patient care” and provided the money to the CDC’s Environmental Health Laboratory to improve standardization for hormone testing, including specifically, thyroid stimulating hormone, testosterone, and estrogen.

The CDC will provide materials to and monitor laboratories and manufacturers across the country to improve the accuracy and precision of these hormone tests, ultimately, improving diagnosis for polycystic ovary syndrome, hypothyroidism, chronic kidney disease, and osteoporosis.

“We at [the] American Association for Clinical Chemistry [AACC] are thrilled that Congress has provided this funding for an expanded CDC harmonization program,” said AACC CEO Janet B. Kreizman, in a statement. “Patients and their physicians should be free to think about the clinical implications of test results and not about whether differences in test results are due to different labs performing those tests.”

The AACC had been actively working to advocate for harmonization funding by leading efforts to raise awareness in Congress.

Test harmonization enables comparison of test results over time even if patients switch providers or laboratories switch out equipment. Advocates believe standardizing test results will ultimately reduce health care costs and medical errors by eliminating unnecessary follow-up diagnostic procedures and treatments.

To date, one of the most prominent harmonization efforts focused on cholesterol testing, which the CDC began in the 1980s. AACC says the CDC’s Lipids Standardization Program generated savings ranging from $338 million to $7.6 billion per year since its inception. But the group says that “very few lab tests” have been harmonized in the same way.

But as medicine moves more towards evidence-based practice, with a focus on clinical use of practice guidelines, harmonization becomes more important.

AACC, with the support of 18 associations (American Association for Clinical Chemistry, American Clinical Laboratory Association, College of American Pathologists), laboratories (ARUP Laboratories, LabCorp, Mayo Medical Laboratories, and Quest Diagnostics), and industry (Roche Diagnostics, Thermo Fisher Scientific) are calling that 2019 appropriations include an additional $9.2 million for CDC to continue to expand harmonization efforts.

Takeaway: The $2 million allocation to the CDC its laboratory test harmonization program may just be the beginning of standardization efforts.