New Rule Gives Patients More Access

Yesterday the Obama Administration and the Department of Health and Human Services implemented a regulation that amends the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996 in regards to reporting of patient results. Basically, the new regulations state that patients (or their personal representatives) can receive lab results directly from the laboratory. In most cases the laboratory has 30 days to comply with the request. This regulation goes into effect 3/31/14 and laboratories must comply by 9/27/14.

So what does this mean for laboratory professionals? The language of the final rule gives laboratories a lot of flexibility in terms of dealing with a request for information. In a nutshell:

  • Individual laboratories can set up systems to receive, process, and respond to requests for results however they choose to do so.
  • If a state law is different than the federal regulation, laboratories must comply with the “more stringent” law, with “more stringent” meaning “greater rights of access.” For example, the federal regulation requires results to be given within 30 days of the request; if state law requires those results be given with 15 days, then the laboratory should follow the state law.
  • Laboratories need to have “verification of identity” policies in place. There is no mandate that requires specific forms of identification.
  • Laboratories that currently have patient portals in place may continue to use them.
  • Laboratories CANNOT require patients to make requests only through their providers; mechanisms must be in place for a patient to make requests directly to the laboratory. However, laboratories CAN require patients to make these requests directly to the laboratory.
  • Laboratories can recoup the costs of providing results to patients, but the fees must be cost-based and reflect labor, supplies, postage, and preparation of an explanation of PHI. Laboratories CANNOT charge fees that reflect the cost of searching and retrieving information, nor can they charge fees for costs associated with verification, documentation, liability insurance, maintaining systems, etc.  It should be noted that laboratories cannot withhold future lab results if a patient chooses not to pay the fee.
  • Laboratories must provide results in the form (electronic or paper) requested by the individual if readily producible.  This could be a MS Word or Excel document or PDF as well as access to an electronic portal.
  • Laboratories are required to reasonably safeguard information (electronic or paper).
  • Laboratories are not required to include test interpretations but may do so if desired.
  • Providers are encouraged, but not required, to tell patients they have access to their laboratory results directly from the laboratory.

 

Swails

-Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

 

5 thoughts on “New Rule Gives Patients More Access

    • Here’s the summary from the regulation:

      “This final rule amends the Clinical Laboratory Improvement Amendments of
      1988 (CLIA) regulations to specify that, upon the request of a 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. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test. In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to
      access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. These changes to the CLIA regulations and the HIPAA Privacy Rule 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.”

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