ONC Releases Guidance For Reporting Lab Results Via Direct Exchange

Posted on by Frank J. Rosello

The Office of the National Coordinator for Health Information Technology (ONC) announced in mid July guidance for reporting laboratory results using Direct Project specifications.

The Direct Project develops specifications for a secure, scalable, standards-based way to establish universal health addressing and transport for participants to send encrypted health information directly to known, trusted recipients over the Internet. The project itself does not run health information exchange services. Direct exchange is quickly becoming the solution for the electronic transmission of all clinical transactions necessary for providers to achieve meaningful use of electronic health records (EHRs) in many rural areas throughout the U.S. At the end of the project, there will be one nationwide exchange, consisting of the organizations that have come together in a common policy framework to implement the standards and services.

ONC officials said the guidance was developed by the Direct Laboratory Reporting Workgroup to address the Clinical Laboratory Improvement Amendments (CLIA) requirements for the reporting of clinical laboratory results using Direct Project standards and specifications.

The workgroup reviewed all relevant documents and requirements from the CLIA regulations; guidance issued by the Department of Health and Human Services (HHS); and the Direct Project. The Direct Project a part of the Nationwide Health Information Network, created by HHS in 2010 to specify a simple, secure, scalable, standards-based way for participants to send authenticated, encrypted health information directly to known, trusted recipients over the Internet.

The workgroup concluded that any electronic reporting method must provide accurate, reliable, confidential and timely delivery of laboratory results from the performing laboratory to the final report destination to meet CLIA requirements.  The workgroup noted that to achieve this, the Direct specifications must provide the sending laboratory with positive notification of delivery success or failure in a manner consistent with other methods of electronic result delivery currently in use by accredited clinical laboratories.

An Implementation Guide for Delivery Notification has been created and approved by the Direct Laboratory Reporting Workgroup for use by clinical laboratories and senders of healthcare information that require guaranteed notification of message delivery status.

The Centers for Medicare & Medicaid Services (CMS) said it intends to issue specific guidance in the form of CLIA FAQs to inform accreditation agencies, clinical laboratories and providers that implementations of Direct that support the Implementation Guide for Delivery Notification provide an acceptable technical solution for the transport of laboratory results to the final report destination.

Click here to access the complete Implementation Guide for Lab Results in Direct.

Frank J. Rosello

is CEO & Co-Founder of Environmental Intelligence LLC.

Environmental Intelligence, LLC, is a complete, full-service healthcare IT solution provider. With a team having more than 10 years of proven clinical expertise in delivering end-to-end health IT solutions, Environmental Intelligence provides medical practices and facilities onsite expert IT consulting, installation, and implementation that is focused on physicians, their patients, and the quality of their care.

Contact us to learn more about our Physician Focused – Patient Driven® approach to Health IT.

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