The New Rule for Patient Access to Lab Results

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Two Questions for HIM

On April 5, 2014, the Final Rule to amend the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the HIPAA Privacy Rule became effective. The HIPAA Amendment now allows individuals to access their lab reports directly from laboratories.

Kathy Gordon, RHIAVP of Disclosure Management

Kathy Gordon, RHIA VP of Disclosure Management

Prior to the new rule, there were basically four categories of state laws regarding direct reporting of lab test result to patients. New England states varied causing confusion for HIM professionals and laboratories.

For example, New Hampshire allowed direct patient reporting without provider approval, Vermont had no laws on the issue, and Rhode Island prohibited direct reporting.

New Rule Preempts State Law

The new rule preempts state law. It simplifies patients gaining direct access to their lab results regardless of where they live. The purpose is to provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.

According to the Federal Register, the final rule amends the CLIA regulations to specify that, upon request of the patient (or the patient’s personal representative), laboratories subject to CLIA may provide the patient, the patient’s personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient.

Two Questions for HIM

From the HIM perspective, there are two factors that must be taken into consideration.

  • Maintenance of the Authorization Form
  1. Where will the patient’s written authorization be maintained?
  2. How long will authorizations be maintained?
  • Legally Protected Diagnosis
  1. How will lab results that may indicate a legally protected diagnosis be handled?
  2. Will the staff be trained to identify privileged information as opposed to results that can be released with a general authorization?

What are your thoughts?

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