College of American Pathologists




February 3, 2014
© 2014 College of American Pathologists
Special Report
HHS Expands Patient Access to Laboratory Results

February 3, 2014—The Department of Health and Human Services (HHS) granted greater patient access to laboratory results in a final rule, which accepted several recommendations made by the College of American Pathologists (CAP).

The CAP has conducted an initial analysis of the rule released on February 3. Key components of it include:

  • Patients can access laboratory results upon direct request to the testing facility.
  • Laboratories generally will have 30 days to release results following the request unless a state law requires a more timely release. Laboratories may have a 30-day extension when retrieving archived results that will take longer than 30 days from the patient request.
  • Laboratories will have 240 days, or October 4, from official publication of the final rule on February 6 to comply with new requirements. This will include revising HIPAA notices of privacy practices.
  • No established time lag for laboratories to observe between delivery of test results to the ordering physician and release of the results by the laboratory.
  • The ordering physician is not required to disclose the identity of the testing laboratory to patients. However, the HHS encouraged physicians to inform patients where specimens are being sent.
  • The regulation preempts state laws that impede patients directly receiving test results from the laboratory.

The final rule amended the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulations, which cover the reporting of test results. In recent years, a federal health information technology (HIT) policy committee had found CLIA regulations prevented exchanges of HIT, and the HHS decided to revisit regulatory barriers that impede patient access to information.

In November 2011, the CAP submitted a comment letter to the HHS supporting the rule but also called for several changes. The CAP’s recommendations included support for the release of laboratory test results to patients upon request with specific modifications; no specific requirement for laboratories to observe a defined time lag between delivery of results to the physician and patient request to receive results from the laboratory; and a requirement to preempt state restrictions impeding laboratory-initiated release or discussion of test results with patients.

The HHS rule clarified that it would not require laboratories to interpret test results for patients. “Patients merely have the right to inspect and receive a copy of their completed test reports and other individually identifiable health information maintained in a designated record set by a HIPAA-covered laboratory,” the HHS stated.

Ordering physicians also will not be required to inform patients of their right to receive test results from HIPAA-covered laboratories. Federal officials believed this would be a burden on physicians; however, the HHS encouraged ordering providers to be open about testing.

“[W]henever providers send a specimen(s) to the laboratory, as opposed to the individual going to the laboratory himself or herself to provide the testing sample, we encourage providers to supply the individual with the name of the laboratory to which the specimen is being or has been sent and the other information necessary for the individual to request access from the laboratory,” the rule stated.

Additional information on the patient access rule will be included in the next edition of STATLINE and other CAP media channels.


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