The CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports; Final Rule (45 CFR Part 164) was published on February 6 and will become effective April 7, 2014. This rule provides individuals the right to access their own test reports directly from laboratories. The intention is that these changes to the CLIA regulations and the HIPAA Privacy Rule will 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. The final rule can be found here.

All laboratory reports, including histocompatibility reports, are covered by the rule. The rule precludes limiting a patient's access to "sensitive" test reports with a sole exception:
"The limited exception is for cases where a licensed health care professional has determined, in the exercise of professional judgment, that the access requested is reasonably likely to endanger the life or physical safety of the individual or another person, and the individual is provided a right to have the denial of access reviewed by an unaffiliated health care professional." This will not apply to most reports.

It is likely that your institution is already working on a way to permit patients to access their laboratory reports through the Health Information Technology for Economic and Clinical Health (HITECH) Act. We suggest you contact your institution's Information Technology group to find out what you need to do to make your lab reports available and how you can be assured that they are being released only to the patient or other "authorized person."

One aspect of this rule that will be challenging for histocompatibility laboratories is the generation of reports that have results for multiple individuals (for example, typing and/or crossmatch results from one or more donors and a recipient). It will be important to ensure these reports do not to violate the HIPAA privacy of other individuals. Again, we urge you to work with your institution's Information Technology and Legal groups to determine how best to address these issues.   

The podcast recording entitled, "The New Kidney Allocation System: What Referring Physicians Need to Know" is now available on the Transplant Pro website.  

 
UNOS will provide resources that transplant professionals can use to help educate both their patients as well as other medical professionals who work in dialysis and treat kidney disease.  All resources will be available online as they are developed, including a brochure for patients explaining what will change.  A list of some of the professional education sessions that start later this month may be found through TransplantPro at:  http://transplantpro.org/education-on-the-new-kidney-allocation-system-is-a-focus-for-2014/.
 
If you have specific questions about the kidney allocation system, you may contact Regional Administration.  For questions regarding education and training that will be provided, you may contact UNOS Instructional Innovations at education@unos.org

The FDA has issued the following notices that may be of interest to you.

http://www.gpo.gov/fdsys/pkg/FR-2014-03-05/html/2014-04813.htm

 
http://www.gpo.gov/fdsys/pkg/FR-2014-03-05/html/2014-04812.htm  

Click here for more information. 

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