Electronic Health Records (EHR)s Now Permitted By CLIA

Dr. David Blumenthal | March 3, 2010

On March 1, 2010, CMS, in collaboration with ONC, released guidance clarifying that the Clinical Laboratory Improvement Amendments (CLIA) permit labs to electronically exchange lab data and addressing some confusion regarding laboratory data and health IT.  This guidance was put forth in a Survey and Certification letter, including interpretive guidance and frequently asked questions.

Underlying this guidance is the clear recognition of the need for privacy and security of laboratory test results.  When such information is shared, there should be a commitment that the all test results will be protected and used by the right people and for the right reasons.

Early in 2009, I saw the need for guidance related to the electronic exchange of laboratory data since it is a key part of improving health care quality and care coordination.  We subsequently asked the Information Exchange Workgroup of the HIT Policy Committee to hold hearings on barriers to exchange of lab data and how these barriers could be overcome. Based on this input, the Center for Medicare and Medicaid Services drafted guidance that solves the following problems:

  • Encourages the use of HL7 2.5.1, LOINC, and federally recognized Nationwide Health Information Network (NHIN) specifications in the electronic exchange of lab data,
  • States that visual inspection of laboratory interfaces within an EHR installation is not required,
  • Permits patient access to test results if not prohibited by state law,
  • Supports the goals of meaningful use, and
  • Expressly allows laboratory data to be transmitted through a health information exchange (HIE).

While this guidance furthers the ability of laboratories and EHRs to electronically send and receive laboratory data, it is not a panacea and more work must be done.

If States want widespread health information for their population then they must take into account that some State laws currently prohibit the release of test reports directly to patients and even to other providers treating the patient.

We are addressing state concerns by working on policies and frameworks that allow health information to be securely exchanged. And “securely” is an important word.  I want to be clear that in all our Health IT investments, patient privacy is our top priority.  And as we move toward a new age of electronic health information technology, we are committed to putting forth policies and technology that will meet this expectation of privacy.

We encourage you to review the Survey and Certification package and provide feedback to both ONC and CMS on additional issues that remain regarding the Federal CLIA law and health IT.

–David Blumenthal, M.D., M.P.P. – National Coordinator for Health Information Technology