Experts call for widening scope of lab test exchange

Federal and state regulators should update laws to enable the wider and smoother exchange of test results between labs and healthcare providers as well as patients in some cases, healthcare experts told a federal health IT panel today.

Although regulations are the greatest barrier to the exchange of lab orders and tests, the lack of universal standards is also an impediment, according to providers and lab vendors testifying at a hearing of the information exchange workgroup of the federal Health IT Policy Committee. 

Micky Tripathi, co-chairman of the panel, said the ability to exchange lab test results is essential to the meaningful use of electronic health records. “We’re not going to be able to make a lot of progress on any higher level ambitions until we can get our arms around some of the nitty-gritty details, like the exchange of lab results and greater standardization,” Tripathi said.

Dr. Phil Marshall, vice president of product strategy at WebMD Health Services, said the key policy that needs to be changed is the Clinical Laboratory Improvement Act (CLIA), which requires that lab results be sent only to the physician who ordered a test.

The regulation should be changed to allow results to be shared with a physician who might also use the results and, upon request, the patient as well, he said. “We believe that is a good first step, although we recognize that many restrictive state laws would still have to be addressed in order to have convenient access by consumers nationwide,” Marshall said.

The federal law defers to a variety of state interpretations, he said. And few states and health plans let consumers access their lab results. 

The Health Insurance Portability and Accountability Act also should be revised to treat lab data like other protected health information and subject to privacy protections, he said. 

Angela Brice-Smith, deputy director of CMS’ IT infrastructure workgroup, said CMS could consider revising its guidance to the states on CLIA in order to address the issue. “I do not see CLIA as a significant barrier,” she said. “That doesn’t mean we may not need to revise some of our guidelines. It would be faster if we can use interpretive guidelines instead of regulatory change to do this.”

The lack of agreement on a universal set of standards for messaging, vocabulary and definitions also continues to slow the building of interfaces with labs, said Dr. Sarah Chouinard, medical director of Primary Care Systems Inc., a federally qualified health center in West Virginia.

“Standardization of messaging and vocabulary with clear interpretation on restrictions for lab data access would greatly improve the ability to create interfaces and exchange and aggregate data,” she said.

Yet maintaining electronic lab interfaces is itself a challenge, said Laura Rosas, director of policy and compliance for the New York City Primary Care Information Project. The project is part of the New York City Department of Health and Mental Hygiene. “Lab interfaces are the poster child for the fragmentation of our healthcare systems,” she said.

It takes up to 14 weeks to deploy an interface with a lab, she said. That includes identifying the vocabulary and definition requirements, exchanging Health Level 7 files, crosswalks for variations in specifications, configuration, code changes and testing, Rosas said.

“It has proven nearly impossible under current processes to ensure that practices have an electronic lab interface at the same time they go ‘live’ on their EHR,” Rosas said. Many of the practices have developed complicated workarounds while they waited months to have a working interface.