In human relationships, we tend to view rigid, inflexible behavior negatively. But in a network of diagnostic data, absolute consistency can be a plus.
It is that level of consistency that is the guiding principle behind the Laboratory Analytical Workflow profile, a set of standards being developed by software and instrument vendors operating as members of the IVD Industry Connectivity Consortium. The goal of the profile: to allow in vitro diagnostic analyzers from different manufacturers to communicate with each other in a plug-and-play fashion.
The LAW effort took a major step forward recently, when proponents gathered in Bern, Switzerland, for the Europe 2012 Connectathon, hosted by the consortium Integrating the Healthcare Enterprise, which is partnering with the IICC on the LAW initiative. Six companies at the Connectathon tested prototype laboratory analyzers and information systems designed to conform to the workflow. Taking part were Abbott Laboratories, Orchard Software, Roche Diagnostics, Siemens, Samsung Electronics, and Systelab Technologies.
“This was the first time we had plugged in actual laboratory devices using the new standards to get them to talk to each other,” says Eric Olson, president of the IICC and vice president of portfolio and product management for Siemens Healthcare Diagnostics. “Since each device was independently developed by a different vendor, the tests quickly flagged parts of the spec that are not yet plug-and-play, where we need to take variability out of the standards and remove any room for interpretation.”
To grasp the value of the new standards, one need look no further than the back of just about any analyzer in the lab. No matter how new the instrument, it probably connects electronically to other systems through a serial port—a technology long since superseded in consumer electronics.
The serial port is there because industry standards promulgated by the American Society for Testing and Materials dictated its use. Those standards, in place since the 1980s, are problematic not just for what they prescribe but also for what they don’t address, Olson says.
ASTM standards are very flexible, he adds. “You can use ASTM to get just about any kind of data into the data flow. The problem is that each manufacturer does that in its own way. Even among different analyzers from the same vendor, you will see very different interpretations of ASTM.”
Case in point: Orchard Software. “We have 50 flavors of ASTM interfaces,” says Rob Bush, president of Orchard and an attendee at the Connectathon. Because regulators, such as the FDA, must certify instrument interfaces, vendors find the configurations hard to tweak after implementation, he explains.
“Once they had their entire package approved by the FDA, no one wanted to go back and have the whole thing reassessed and reproved in order to make a change in how they transmit some of this data,” Bush adds.
Olson stresses that the LAW effort is more than just a refresh of ASTM standards. “It’s a change in the way that standardization works,” he says. “The guidelines for implementation say exactly what data you need to put in each field. It’s very prescriptive—there’s no room for interpretation. The objective is that when two vendors implement according to specifications, and then they try to plug their equipment together, it actually works in a plug-and-play fashion.”
From a software writer’s perspective, Bush expects robust benefits from the new workflow. “Information you couldn’t count on getting from the LIS, you can now look at the standard and say, ‘I can count on getting that,’” he says. “So you can add more functionality to your analyzer.”
With the digitization of medical records a national priority, the LAW profile dovetails with broader EMR initiatives. “You don’t have a prayer of standardizing communications at the patient-physician level if the source data is not clean from a standardization perspective,” Olson says.
Developers are working through compatibility issues identified at the European Connectathon and planning to conduct additional testing at the North American Connectathon, scheduled to begin Jan. 28, 2013, in Chicago.
“We’re looking to publish a final IHE LAW [profile] sometime in the first half of next year,” says Olson. “It’s definitely designed to have a long running life. It’s very expensive for an industry to switch gears like this, so it’s not something you want to do more than once every couple of decades.”
The global diversified growth company Roper Industries has entered into a definitive agreement to acquire Sunquest Information Systems.
Roper is purchasing the health care information systems company from the investment firms Huntsman Gay Global Capital and Vista Equity Partners.
“Our customers will find that, as part of Roper, we will continue to provide the same excellent service and support with full continuity of personnel,” says Richard Atkin, president and CEO of Sunquest. “As we move forward, we will have the financial and strategic resources necessary to provide enhanced product offerings and expand into new areas.”
Roper owns more than 30 companies in a variety of business sectors, among them the medical and scientific imaging and radio-frequency identification technology marketplaces.
Sunquest Information Systems, 877-239-6337
Roper Industries, 941-556-2601
The federal government has issued guidance on how to exchange laboratory test results using the Direct Project secure messaging protocol.
The Direct Project, launched in 2010 as part of the Nationwide Health Information Network, has focused on establishing a simple, secure, and scalable standards-based method for sending authenticated, encrypted health information over the Internet.
The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology issued the lab test results exchange guidance. The guidelines are based on recommendations from an ONC workgroup that included representatives from the CAP, LabCorp, Quest Diagnostics, and government agencies.
The workgroup determined that any electronic lab-reporting method must provide accurate, reliable, confidential, and timely delivery of laboratory results from the performing lab to the final report destination in accordance with CLIA requirements. To this end, a laboratory sending results must receive notification of delivery success or failure in a consistent, specified manner.
The ONC guidance also addresses factors that can compromise message delivery and the mitigation actions that should be taken.
The Centers for Medicare & Medicaid Services plans to issue a CLIA frequently-asked-questions document to clarify the guidelines.
The guidelines are available at wiki.directproject.org.
Zebra Technologies Corp. has purchased LaserBand, LLC, a provider of patient identification wristbands and related products.
“LaserBand’s strong and capable sales organization now has a broader range of products to sell, and Zebra’s global presence will provide new opportunities to market LaserBand products in regions outside of North America,” according to a release issued by Zebra.
Zebra Technologies markets bar-code and radio-frequency identification technology based products and related solutions for the health care marketplace.
Zebra Technologies, 800-268-1736
The Health Information Management Systems Society has released the ICD-10 Playbook Financial Risk Calculator. The tool, co-developed and powered by the health care compliance technology firm Jvion, is intended to help providers with ICD-10 planning and conversion.
The free online tool includes a short survey that covers a range of financial topics, such as cash flow, revenue, and operational cost. Survey answers are plugged into a calculator that generates individual financial risk ratings, identifies the steps the provider can take to mitigate those risks, and offers ways to augment the provider’s accounts receivables.
The survey takes about 10 to 15 minutes and is anonymous. The information generated from the calculator is displayed as a report that users of the calculator can e-mail to themselves or others.
The calculator is available at www.jvionhealth.com.
Dr. Aller is director of informatics in the Department of Pathology, University of Southern California, Los Angeles. He can be reached at email@example.com. Hal Weiner is president of Weiner Consulting Services, LLC, Florence, Ore. He can be reached at firstname.lastname@example.org.