Guidance for reporting laboratory results using Direct Project specifications arrived on July 12 from the Office of the National Coordinator for Health Information Technology (ONC).
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.
According to ONC, the workgroup, led by Robert Dieterle and John Hall, consisted of representatives from ONC, CLIA, the College of American Pathologists, LabCorp, Quest Diagnostics, Methodist Hospital of Omaha and Pathology Inc.
The workgroup reviewed all relevant documents and requirements from the CLIA regulations; guidance issued by the Department of Health & Human Services (HHS); and the Direct Project. The Direct Project is 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 determined 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. To accomplish this, 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, the workgroup said.
Working with a Tiger Team of leaders from the Direct Project Implementation Geographies Workgroup, 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 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.
Read the full Implementation Guide for Lab Results in Direct here.