by Dennis Ernst • April 10, 2018
"Only four states currently have any training or licensure requirements for blood collection personnel," said Ernst in statement submitted to the committee. "Most of the remaining 46 states require a license to braid hair, but not for drawing blood. That means 86% of Americans have their blood drawn by healthcare professionals for whom no training is required."
The 2-page public filing was submitted for consideration at the April meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC) at the FDA in Washington, DC. Ernst had previously addressed the group in person in 2013.
Ernst’s objective was to heighten awareness among committee members of the important contribution phlebotomists make to the accuracy of laboratory test results, and to stress the importance minimum training requirements would have on test results. “CLIA charges managers with assuring the quality of the samples they test,” said Ernst, “but how do you do that without personnel requirements for those who draw the samples? Or minimum training? How do you define ‘quality?’”
The filing cites studies showing 95 percent of diagnostic delays are caused by preanalytical errors, 26 percent of preanalytical errors have a significant effect on patient outcomes, and that preanalytical errors constitute up to 93% of all errors committed in the laboratory’s path of workflow.
CLIAC is a committee comprised of physicians, laboratory professionals, educators, public health professionals, and industry and consumer consultants established by the Secretary of U.S. Department of Health and Human Services (HHS). The purpose of the committee is to provide scientific and technical advice and guidance to the HHS regarding the need for revisions to the standards under which clinical laboratories are regulated. They also advise on the impact of proposed revisions to the standards on medical and laboratory practice, and suggest modifications of the standards to accommodate technological advances. Adoption of CLIAC’s recommendations is at the discretion of the Secretary.
Ernst offered "a full measure of my assistance and resources” to help the committee propose solutions.
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