ONC workgroup issues recommendations for reporting lab results

A workgroup formed by the Office of the National Coordinator for Health IT (ONC) to address the Clinical Laboratory Improvement Amendments (CLIA) requirements for reporting laboratory results using Direct Project standards recently released its recommendations.

The Direct — Laboratory Reporting workgroup, comprised of representatives from the ONC, CLIA and several other nonprofit and for-profit organizations, considered existing CLIA requirements, Department of Health and Human Services guidance and the goals of the Direct Project, an ONC initiative to create secure transmission standards for encrypted health data.

“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,” a July 12 ONC statement read. “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.”

The Centers for Medicare & Medicaid Services plans to issue more specific guidance and to formally inform accreditation agencies, laboratories and providers that the workgroup’s Direct implementation guide for delivery notification provides an acceptable technical solution for the transport of laboratory results.

The implementation guide is available here.