CDC FY 2021 Letter to Appropriations Leaders

To: Honorable Senators Roy Blunt and Patty Murray, the Honorable Representatives Rosa DeLauro and Tom Cole

"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 through the use of 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 provides the same result regardless of the method or instrument used or the setting where it is performed."

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