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Press Start: Lead an Empowered Life as a Clinical Laboratorian

HHS Publishes Final Rule on Patient Access to Their Lab results

Published March 16, 2014 1:21 AM by Glen McDaniel

Health and Human Services (HHS) has issued a final rule that requires laboratories to give patients access to their lab results. A few years ago Health and Human Services Secretary Kathleen Sebelius reaffirmed the Obama Administration commitment to patient-centered care.


A part of that initiative, she indicated, had to include a re-assessment of the whole idea of who owns the patient’s information. 


We had always believed that the patient could have access to their medical records, but even in that context, providers maintained that certain notes could still be withheld  from the patient as not a material or essential part of the record.  HIPAA (the Health Insurance Portability and Accountability Act of 1996) laid out very specific restrictions on the handling, storage, protection, and sharing or disclosing of patient information. In addition many states severely restricted the release of laboratory results. In most states, lab results can only be released to the ordering provider with very few exceptions.


This new final rule by HHS says that patients own their results and have the right to receive access to their lab results. In other words, laboratories must establish a clear process for providing patients with their results if and when patients request such results.


Both CLIA’88 and HIPAA had to be amended to allow this expanded access. Patients may still continue to receive results from their provider, of course. But under the new mandate, laboratories must give requested results (including an electronic copy) to the patient and/or the patient’s designated representative. Requested results must be provided within 30 days.


The Final Rule goes into effect April 5, with all covered entities mandated to comply by October 2 of this year.


The final rule is available at


How will your lab comply with this new mandate?


That will be very interesting fro the lab. Traditionally we don't like to give information because we don't want to be held responsible for diagnosing patients.

What do we say if a patient asks, What does this mean? Do I have hepatitis? Do I have AIDS?  I know why they are requiring this but I am wary of how it will be viewed by my colleagues in the lab. What if we just choose to refer patients to their doctors anyway. The results are ready and your doctor has them. Call his office for an interpretation.

Jonas T March 29, 2014 5:44 PM
Washington DC

I work for an HMO and they have alreday started. It's really a neat thing I think. They have a website where you need to have a password that will change frequently. As soon as your lab results are ready it will be available online.

Now it has 2 good features. Each result has value, normal range and the direction to discuss all lab results with your physician in conjunction with signs and symptoms. It also reminds you of any labs your doctor has ordered but you have not done them yet. It tells you when the last date for the order is (when teh order will expire) and whether you need to be fasting or whatever.   It is a great site.

Brendaliz Colon March 19, 2014 12:56 PM
Los Angeles CA

Wow. This is a big one. I have not heard any information about this. I don't think my manager or colleagues at work know either. This one is going to be hard for labs. I will check back and see how other labs will be handling this.

Georgina Tassel, MLS March 16, 2014 1:30 PM
Miami FL

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