ONC Announces Guidance for Reporting Lab Results using Direct Project Specifications

ONC created 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. Today the group released its findings.

This workgroup, led by Robert Dieterle and John Hall, consisted of representatives from ONC, CLIA, the College of American Pathologists (CAP), LabCorp, Quest Diagnostics, Methodist Hospital of Omaha, and Pathology Inc. The group reviewed all relevant documents and requirements from the CLIA regulations and subsequent guidance issued by the US Department of Health and Human Services (HHS) as well as the Direct Project.

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, implementations of 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.

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 & Mediaid Services (CMS) 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.