Debating the Proposed CLIA Rule

Gienna Shaw, for HealthLeaders Media , September 26, 2011

Interpreting results

Another obvious issue with direct-to-patient lab results: Most test result reports are not designed for the layperson.

"A number without a contextual relationship and without some level of interpretation is totally worthless …Relaying data to a patient is totally unrelated to relaying information to a patient," Emkes said. "Data is 'Your A1C level is 11.' Information is 'Your A1C level is 11 and oh my God we've got to get on this right now and here's what we need to do.'"

Bechtel and Leiter both agree that patients need help interpreting and understanding lab results. In fact, Leiter said, the rule would support that goal, allowing patients to "loop back around to their care team so that patients and providers can work together on how to interpret and understand lab results."

Further, she added, the rule doesn't force patients to get their lab results directly—it just gives them the option to do so.

"The idea that people won't give patients information about themselves that's legally theirs because they think patients won't understand it is no reason to oppose this rule," she said. "We don't disagree that accompanying context, explanation, and education is preferable, but we also do not believe in the idea that patients fundamentally are not equipped to decide whether and when they want to go back to their doctor with questions. This is about allowing those who want to get informed to get informed, and then decide how to use the information they receive like they would any other information in daily life."

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