Knowledge Base Article

Q:

Is it appropriate for a testing laboratory to provide a copy of lab results directly to the patient or their representative?
 

A:

Yes. On February 6, 2014, CMS released a final rule that allows laboratories, upon the patient’s request (or upon the request of the patient’s personal representative), to provide access to completed lab tests results directly to the patient or their personal representative under the Clinical Laboratory Improvement Act (CLIA) and HIPAA privacy regulations. Laboratories that are HIPAA covered entities (i.e. conduct covered health care transactions electronically) are required to provide patients with access to their lab results upon request under this new rule. This final rule is effective April 7, 2014 and HIPAA covered entity laboratories have until October 6, 2014 to comply with the new rule. Prior to this new regulation, CLIA regulations limited the release of laboratory tests results to persons authorized under state law to order and/or receive test results, the person responsible for using the test results in the treatment context, and the laboratory that initially requested the test.

Hospital-based laboratories have a big advantage over independent laboratories in the implementation of this rule. Most hospital laboratories will likely handle the new requirement by directing patients to the Hospital HIM Release of Information (ROI) department. These hospital ROI departments are already knowledgeable concerning the HIPAA regulations and have processes in place to address the requirements of HIPAA, such as positive identification of the person requesting a copy of the medical record, pricing for copies, documentation of the release, etc.

For complete information, please see the CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports; Final Rule.