Authored by Julie Kirkwood, Kalorama Information Correspondent
Until surprisingly recently, the connections between laboratory instruments and laboratory computers were based on standards developed in the 1990s. For example, one of the standards, ASTM E1394 (later revised and renamed CLSI LIS2) dates back to 1997, the year before Google was invented, when dial-up modems were still used to connect to the internet and laboratory instruments were connected to computers by serial port cables.
This is a standard that laboratory instruments use to receive computerized orders and to collect and aggregate patient results.
“Seriously,” says Serge Jonnaert, president of the IVD Industry Connectivity Consortium. “I kid you not. And the majority of labs still use that standard today to send information from their instruments, albeit no longer over serial port. I mean, the instruments are now network connected, but it still very much uses an LIS1/LIS2 interface standard.”
The main problem with the old standards is that they do not standardize data, and that makes it complicated to set-up laboratory instruments. When a laboratory purchases a new instrument, it typically costs thousands of dollars to have an IT specialist make a custom connection between that instrument to the laboratory information system, or whatever computer system their institution uses.
As far back as 2005, a group of peers who worked in informatics for major vendors in the in vitro diagnostics (IVD) industry came together to work on a solution. They eventually formed a nonprofit organization, called the IVD Industry Connectivity Consortium (IICC), and they set out to rewrite the standards in a way that would promote easy connectivity. If all IVD instruments used a common communication protocol and referred to a common set of numerical codes for test names, sample types, and other useful information, clinical laboratories could easy connect any instrument from any vendor to any type of middleware or laboratory information system (LIS).
Getting Connectivity Standards Adopted in Clinical Laboratories Has Been an Uphill Climb.
In 2016, the consortium finally succeeded in publishing this new standard, called the Laboratory Analytical Workflow (LAW) Protocol, in collaboration with Integrating the Healthcare Enterprise (IHE). A year later, IICC published LIVD, a digital format that defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes.
“Whereas before it would have cost anywhere between $6,000 to $15,000 to connect an instrument to an LIS, now it’s truly a plug and play solution,” Jonnaert says.
Most major IVD vendors, including Abbott, Roche, Siemens, and Beckman Coulter, are members of the consortium and have already adopted the both standards, Jonnaert says. The U.S. Food and Drug Administration supports the effort, and in June 2018 the agency issued a guidance encouraging the use of common numerical codes for test-related data. The Clinical & Laboratory Standards Institute is in the process of recasting the LAW protocol, to be named the CLSI AUTO16 standard for next generation IVD instrument interfaces.
Yet getting these standards adopted in clinical laboratories has been an uphill climb.
For one thing, the major electronic health records vendors are lagging behind in adopting and promoting the new standards, Jonnaert says.
“Instead of taking an industry leadership role on this and saying, ‘Okay, let’s get ahead of this and roll it out,’ they’ve actually said, ‘Well, if our customers tell us to do it, we’ll do it,” Jonnaert says.
Custom connections between laboratory instruments and their computer systems are still a significant revenue stream for them.
So why aren’t customers asking their vendors to adopt the new standards?
Jonnaert believes that laboratory professionals haven’t gotten involved because they consider this an IT issue, and the IT specialists haven’t taken an interest because the laboratory tends to be a lower priority for health system IT departments, which are dealing with bigger issues such as revenue cycle management, avoiding hospital readmissions, and meaningful use.
Some LIS vendors have embraced the standards, though, including Orchard and Sunquest, Jonnaert says. And support from the FDA and the Office of the National Coordinator for Health Information Technology is another big step forward.
In the new guidance, the FDA makes a forceful argument for standardizing data among laboratory instruments and computer systems.
“Efforts to harmonize and standardize information captured and stored in electronic healthcare systems carry important implications for public health, including expediting access to patient diagnostic information for health care providers, reducing burdens on laboratories for connecting new diagnostic systems to Laboratory Information Systems (LIS), and facilitating the use of healthcare information for decision support tools, in addition to many more potential uses,” the guidance says.
The benefits of the new standard reach beyond cost savings for vendors and laboratories, Jonnaert says. When laboratory data is standardized across instruments and locations, the information can be combined and compared in new ways.
“It opens the door to have all the data flow through in a standardized format,” Jonnaert says. “… That’s when you can start looking at doing some major population analytics.”
Laboratory data from all over the United States could be probed to look for, say, a cross-correlation between a biomarker and a disease state. The test results from any laboratory in the country could be pulled together into a single dataset.
“Right now you would not be able to do that on a national level because every single data point from every single lab from every single instrument comes through differently,” Jonnaert says.
Now that the new standard is available, the consortium is encouraging clinical laboratories to ask their vendors about the IICC/IHE LAW profile and also LIVD, the digital format that standardizes predefined codes for test results.
“It’s like in football,” Jonnaert says. “We keep on moving the ball one line at a time and every time we have a little victory, we’re happy.”