Dear Chairwoman Murray, Chairwoman DeLauro, and Ranking Members Blunt and Cole:
As you and your colleagues work on the Fiscal Year (FY) 2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bill, we respectfully request that you increase funding for the U.S. Centers for Disease Control and Prevention (CDC) to continue its efforts to harmonize the reporting of clinical laboratory test results after funding the program in FY’22.
The undersigned organizations believe that every patient should have access to dependable and accurate clinical laboratory test results and that those test results should be harmonized. The CDC is doing incredible work harmonizing the results for several tests, and we believe with continued funding CDC could expand its efforts—benefiting clinicians and patients alike and contributing to overall efficiencies in public health and healthcare.
Clinical laboratory testing plays an important role in medical decision-making. As the healthcare delivery system moves towards a more integrated model where health information will be shared amongst providers, patients, and payers, laboratory data will be the key piece of health information that will be used to improve the quality of care using clinical guidelines, performance measures, and electronic health records. For most laboratory tests, however, a gold standard either does not exist or is not readily applied. Unfortunately, this means that a result from one clinical test method may present a different numeric value compared to another clinical test method measuring the same patient sample, even though each result is accurate within the context of its own method. Experts call this a lack of harmonization. A test that is harmonized (or standardized) provides the same result regardless of the method or instrument used or the setting where it is performed.
Congress has supported CDC’s harmonization efforts over the past several years and the agency has responded by producing several breakthroughs. Increased funding has permitted the CDC Clinical Standardization Programs to:
- Produce and distribute reference/harmonization materials for clinical standardization programs utilized by clinical laboratories and medical device manufacturers in the US and countries around the world to improve the accuracy of chronic disease biomarkers.
- substantially increase the number of harmonized biomarkers (from 10 in 2014 to 26 in 2022) available for physicians to diagnose and treat diseases such as cardiovascular disease, diabetes, certain cancers, blood pressure, bone disease, kidney disease and developmental diseases.
- Expand harmonization/standardization programming to non-traditional markers and improving point-of-care-testing devices used in clinical and in-home settings, such as those used by individuals with diabetes.
- Conduct method performance evaluations for laboratories/manufacturers and issuing performance certificates.
In just a few short years, CDC has managed to make great strides in this area. To continue this advancement, we recommend that for FY 2023 the CDC be appropriated an additional $7.2 million for activities directed by its Environment Health Laboratory. We believe this continued investment in CDC will lead to future cost savings and better health outcomes. The undersigned groups stand ready to be an ongoing resource to members of Congress on laboratory testing harmonization and we appreciate your consideration.
American Association for Clinical Chemistry
American Clinical Laboratory Association
American Medical Technologists
American Society for Clinical Laboratory Science
American Society for Clinical Pathology
American Urological Association
Association of Public Health Laboratories
College of American Pathologists
Laboratory Corporation of America Holdings
Mayo Medical Laboratories
PCOS Challenge: The National Polycystic Ovary Syndrome Association
Pediatric Endocrine Society
Society for Reproductive Investigation
Thermo Fisher Scientific