To launch a series of successful lab results reporting pilots using Direct. These initial implementations will serve as a catalyst for the wider scale deployment of Direct as a scalable, standardized and valuable means of health information exchange for laboratory transactions.


On May 30, 2012, a small group of HIE leaders from around the country met in Washington, DC to kick-off an exciting State HIE Lab Summit & Pilot Program. The Pilot Program is focused on jump starting simple and cost-effective lab results reporting services, leveraging Direct secure messaging. Participants from Alaska, Florida, Guam, Hawaii, North Carolina and West Virginia used the working meeting format of the Summit to map out plans for delivering lab results to ambulatory providers leveraging Direct.

The composition of public and private sector pilot teams including, HISPs, EHRs, lab information system vendors, lab representatives and providers, illustrates an unprecedented level of team commitment, support and growing interest from the lab community and ambulatory providers to use Direct for labs.

Lessons learned and artifacts from the pilot teams are incorporated into Labs Over Direct: A Toolkit to Get Started document which can be found below.

State HIE Program Lab Summit Attendees (May 30, 2012)

Pilot Team
Lab Summit Attendees
  • AK Department of Health and Social Services
  • Cognosante
  • Orion Health
  • Providence Medical Center
  • State Public Health Laboratories
  • FL Agency for Health Care Administration
  • Harris Corporation
  • Health Management Associates
  • IOS Health Systems
  • MedPlus, Inc.
  • Quest Diagnostics
Guam and Hawaii
  • Apenimed
  • Clinical Laboratories of Hawaii, LLP
  • Diagnostic Laboratory Services
  • Hawaii Health Information Exchange
  • Hielix
  • Medicity
  • Office of the Governor of Guam
North Carolina
  • NC Department of Health and Human Services
  • Orion Health
  • Solstas Lab Partners
West Virginia
  • Grafton City Hospital
  • Orchard Software Corporation
  • Thomson Reuters
  • West Virginia Health Information Network

Labs Over Direct Pilot Resources

Lab Summit Materials

Labs Over Direct Pilot Work Plan Examples

Direct Subscription Agreement Examples

Direct Participation Terms and Conditions Examples

Labs Over Direct: A Toolkit To Get Started

The toolkit is designed as a “how to” guide for planning and implementing your own labs over Direct pilot project to help accelerate lab interoperability in your state or community. The information that is provided will help you to better understand promising practices, strategies and tactics that health information exchanges, sub-state exchanges and other stakeholders are using to enable lab exchange over Direct secure messaging.

Access the toolkit here:

Clinical Laboratory Improvement Amendments of 1988 (CLIA) Guidance

On Friday, November 8, 2013, the Centers for Medicare and Medicaid Services (CMS) released the following memorandum, Use of Direct for the Secure Transmission of Laboratory Test Results.

The following snippet from the memorandum provides CLIA guidance on lab results reporting over Direct secure messaging, "CMS considers that laboratories with electronic systems utilizing Direct Project transport that fully supports the Implementation Guide for Delivery Notification, and meeting all other relevant CLIA requirements, would meet CLIA regulations for an adequate electronic system for sending laboratory test results to the final report destination as specified in §493.1291(a).”

For additional details, please click on the following link to access the full memorandum: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-05.html?DLPage=56&DLSort=3&DLSortDir=ascending.

Please contact Kristina Celentano with questions or comments.