CMS Updates CLIA Regulations to Accomodate Meaningful Use and HIE

CMS has released some policy changes designed to facilitate exchange of laboratory information. The response to the HIT Policy Committee, Brookings, and many other groups has been both rapid and impressive.

• Follow this link for the pdf document from CMS

The Q&A on page 15 provide the best summary.

One quotation emphasizes the need for consent when a test is requested. It would appear that consent documents that incorporate HIE provisions could be explicitly modified to include these laboratory provisions and from my non-legal perspective, assure data liquidity.

For CLIA purposes, the final report destination for test results is considered to be the authorized person or their designated agent (an agent is an individual or entity legally acting on behalf of the authorized person to receive test results); additional individuals or entity(s) who are responsible for using the test results may also receive test results from the laboratory if they are designated by the authorized person on the test requisition; individuals may be able to receive their test results directly from the laboratory where there is no State law prohibiting it.

To ensure the accurate, timely, confidential, and easily understood reporting of patient test results to the authorized person, their agent (if applicable) and others who are identified as responsible for using the test results on the requisition, a laboratory may contract with another entity to assist in the delivery of patient reports in a manner that complies with all applicable laws, including the CLIA regulatory and statutory requirements.

More explicit discussion of HIE is to be found in the Q&A section