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Direct Patient Access to Lab Test Results

The Department of Health and Human Services (HHS) published a final rule on February 6 that amended the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to give patients or their designated personal representative direct access to their laboratory test results. Clinical laboratories must comply with this new rule by October 4, 2014. This federal regulation preempts state laws that currently prevent patients from obtaining their test results directly from a clinical laboratory. The new regulation applies to both hospital laboratories and reference laboratories and includes both clinical and anatomical pathology test results.

Patients or the personal representative may have to request a copy of their records in writing and pay for the cost of copying and mailing the information. Laboratories must verify the identity and authority of the requesting person. The new regulation does not require a specified lag time between delivery times of lab results to physicians and patients. Laboratories must release the results within 30 days after the request unless a state law requires a quicker response. CMS believes this is ample time for an ordering physician to receive the results and discuss them with the patient. This regulation includes laboratory results performed prior to enactment. Laboratories may have a 30-day extension if they encounter difficulty retrieving archived reports

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