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Give Us Our Damn Lab Results!!

Two years ago, the Department of Health and Human Services released proposed regulations that would allow patients to obtain their clinical lab test results directly from the lab, rather than having to wait to receive the results from their health care provider.  CDT and other consumer groups enthusiastically supported this proposed rule at the time of its release.

Yet an Administration largely characterized by increasing patient access to health information seems inexplicably unable to close the deal on this important access initiative.  As a result, patients still must wait for their providers to contact them with test results.

Under the current regulations, known as the Clinical Laboratory Improvement Amendments (CLIA), laboratories are restricted from disclosing test results to patients directly.  Instead, labs can only send the test results to health care providers, people authorized to receive test results under state law or other labs. Only a handful of states permit labs to send patients test results directly, and some of these states require the provider’s permission before patients can have the results.  The HIPAA Privacy Rule reflects this restriction, exempting CLIA-regulated labs (which are the great majority of clinical labs) from patients’ existing right to access their health information.

This existing regime has put patients at risk. A 2009 study published in the Archive of Internal Medicine indicated that providers failed to notify patients (or document notification) of abnormal test results more than 7 percent of the time. The National Coordinator for Health IT recently put the figure at 20 percent.  This failure rate is dangerous, as it could lead to more medical errors and missed opportunities for valuable early treatment.

The 2011 proposed regulations would modify CLIA to permit labs to send results directly to patients, and they would also modify the HIPAA Privacy Rule to give patients the right to access or receive their lab results.  Contrary state laws would be preempted.  Patients would have the ability to request their lab results in a particular form or format, as with their other health information; for example, patients could request a paper copy of their test results, or to have the results sent electronically to the their personal health records

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