Feature Story

POC connectivity standard up but running slowly

February 2003
Karen Southwick

Point-of-care device vendors are moving—though slowly—to comply with a new industrywide standard for connectivity approved more than a
year ago.

In November 2001, NCCLS approved the vendor-neutral standard, which includes messages, protocols, and technologies to permit POC instruments from different manufacturers to communicate seamlessly with laboratory and hospital information systems. (The POCT1-A standard can be purchased online at www.nccls.org.)

Those who crafted the POCT1-A standard aim to allow new POC devices to plug-and-play, that is, register automatically with lab information systems and download information in a standardized format regardless of vendor, location, or interface. But for most device vendors, POCT1-A compliance is years away, awaiting the next upgrade cycles.

"The data-management companies and the LIS vendors say they’re ready now," says Christopher Fetters, president of the POC consulting firm Nextivity and former secretary of the committee that hammered out the POCT1-A standard, which is based on the existing HL-7. But Fetters, one of POCT1-A’s most enthusiastic proponents, concedes that until device vendors incorporate the new standard, it will be ineffectual. However, "the fact that they [vendors] have endorsed the standard is a good first step," he says.

Another step is to establish a Web site where vendors can announce conformance with the POCT1-A standard. This effort is being led by the American Association for Clinical Chemistry’s point-of-care industrial liaison committee, chaired by Jeff Perry, director of R&D for Philips Telemonitoring Services.

The ad hoc committee that created the standard—made up of vendors, consultants, users, and other interested parties—has sunset, but the members continue to support and promote the standard through various standards bodies and the AACC, Perry says. Details were still in negotiation at CAP TODAY press time, but the plan is to establish a Web site where vendors can voluntarily post information about their compliance with the new standard.

"The Web site will contain a set of documents for how POCT1-A device applications can work together," Perry says. Those documents will include a series of checklists that vendors will answer to indicate compliance, much like what happens now with the HL-7 Clinical Context Object Working Group standard. "If a vendor isn’t completely honest, what’s happened is that the market takes care of it," he adds, as competitors and customers ferret out discrepancies.

The original POCT1-A committee considered establishing a formal verification board "but members decided it was too expensive," Perry says. "And the vendors didn’t want their product releases tied to a third-party verification process."

Once the POCT1-A compliance Web site is in place, any customer who wants to find compliant devices, data managers, or LIS software can simply browse the conformance checklists.

Device makers
The POCT1-A standard "really takes off when devices are compliant," Perry notes. He has found that most vendors don’t plan to make their existing devices forward-compatible with the standard by shipping new firmware. "They’re finding it hard to get customers to pay again for something they’ve already paid for," he says. Rather, the vendors will build compliance into new devices during regular product cycles.

Roche Diagnostics appears to be the closest to having a compliant device on the market. It already has plans to roll out a new glucose meter later this year, says John Harding, clinical systems integration manager.

The Roche glucose meter will probably use an infrared port, Harding adds, allowing users to simply point it to download the data into an access point. "Handheld glucose meters are certainly where the standard makes the most sense, because the devices ‘walk’ all over the hospital," he says.

LifeScan’s SureStepFlex glucose system will be enhanced to meet compliance standards, says Rorie Morgan, informatics marketing manager. "We’re including [POCT1-A] in the design inputs" for the next release, she says. Jose Castanon, connectivity implementation manager, says LifeScan plans to make changes via software, "but we don’t know for sure what kinds of enhancements will be necessary."

Abbott Diagnostics, which sells the i-Stat analyzer and PCx glucose meter, is close to compliance with both devices. The i-Stat1 system was launched in early 2001 as the POCT1-A committee was doing its work, says Peter Karkantis, POC marketing director for Abbott. "We were a member of the committee and many of the standard’s requirements are already inherent in the i-Stat1 system," he says. He estimates that the i-Stat1 is 90 percent compliant with the standard and will be fully compliant with the next product upgrade. PCx is also POCT1-A-compliant through Abbott’s new Precision Web data manager. According to Karkantis, the i-Stat1 system is the only POC instrument available with an infrared port for automated data transfer.

Bayer Diagnostics plans to ensure that all new POC analyzers will be compliant with POCT1-A, says Paul Adams, marketing manager for POC testing information systems. Bayer will release new software for the Rapidpoint 400 blood gas POC analyzer by the end of this year, he adds. Bayer’s Rapidlink information management system will also be made to act as a POCT1-A-compliant data manager, ensuring that the legacy devices that will not be upgraded can be integrated into the standard.

Bayer’s other products, such as coagulation monitors and glucose meters, will be upgraded during product release cycles starting in 2004. Bayer will move at the same time from serial to infrared ports on most of its POC devices.

The POCT1-A standard automates transmission of such information as date and time, global ID, result, patient ID, and operator ID, all needed for a full electronic patient record. It also allows vendors to customize information in a separate messaging layer, but the manufacturers haven’t yet decided how to make use of that. "We’ll come out first with the basic information," Adams says. "If customers want more, then we’ll look at adding more. But there’s a lot of functionality included in the standard."

Biosite plans to achieve compliance with its device, the Triage Meter, which runs cardiac panels and other tests in the emergency department, says Peter Burch, platform-marketing director. "The plan is that when we upgrade the whole meter platform, we’ll make it compliant," he says.

Biosite will support the standard when it’s "prevalent. The question is when that happens," says Burch.

As for moving to wireless connectivity, he doesn’t believe that’s practical yet in a hospital setting with "all the metal in the walls and machinery." An infrared port makes sense in portable POC devices, he says, but not as much in the Triage Meter, "which sits in one place."

International Technidyne Corp.’s Hemachron coagulation monitors can be made compliant with POCT1-A through the data managers manufactured by Medical Automation Systems and Telcor. "If you want to download information directly from the instrument to the LIS, we’re not yet compliant," says Claudia Campbell-Matland, ITC’s marketing manager for new business development. But for customers who use MAS or Telcor data managers, she says, "we’re compliant."

Campbell-Matland says ITC will move toward making its instruments stand-alone compliant over the next three to five years. "We’ve specified compliance with POCT1-A for our next generation instruments," she says. "I can’t give any specifics at this point regarding timelines." ITC "fully supports the need to do this," she adds, but "all the manufacturers are in the same boat." Both vendors and customers will have to commit to new investment to achieve compliance, and that will be a gradual process, she predicts.

Others agree. Roche’s Harding says hospitals, which are usually on three- to five-year buying contracts, aren’t likely to discard old devices to update to POCT1-A. Like other vendors, he doesn’t see customers clamoring for compliant devices. "Hospitals are going to take their time buying them," he says, because of the cost of upgrading and because most have already customized some sort of connectivity.

Bayer’s Adams doesn’t think hospitals are in any hurry to switch. "Most customers hold on to their products for five to eight years," he says. "They don’t just switch because of a new standard." It will take a decade to flush out all the legacy systems and convert to the new standard, he predicts.

Biosite’s Burch isn’t sure complete compliance will ever be fully realized. "The idea is excellent, but in practice it doesn’t work that way," he says. The new standard comes too late for many customers, who have already had to figure out connectivity.

"Customers don’t seem to be all that interested in the instrument interface standard at this stage. Nirvana—that is, seamless connectivity—isn’t as important as it used to be," Burch says. "Most customers seem to be content to let the independent data-manager vendors take care of connecting instruments and providing a compliant interface to LIS."

Data managers and LIS makers
Independent data-manager vendors, such as Telcor and MAS, say they’re already compliant with POCT1-A. But since data managers act as middlemen between POC devices and lab information systems, compliance is only as good as the devices on the other ends. "We accept information in the POCT1-A standard, but we don’t control how the information comes to us," says Mark Cederdahl, vice president of sales for Telcor.

Since POCT1-A is a souped-up version of HL-7, "as we go forward we plan to do everything according to the new guidelines, with an HL-7 interface," he adds. After the standard was published, he says, his company changed its specifications to be completely compliant with POCT1-A.

With devices designed to work with Telcor’s QML POC data manager, "we translate their information to make it compliant," as with ITC, says Cederdahl. The device itself is not compliant, nor does it necessarily transmit all the information required by the POCT1-A standard. For devices that are not automated, Telcor offers manual result entry, which is also translated. "By the time it goes to the LIS, it’s compliant as far as it can be," he says.

Because devices are not yet compliant, Telcor is not plug-and-play. Customers who want to add new devices must reconfigure their software with a new driver. "It takes about 12 weeks for us to build the driver and for them to install it," Cederdahl says. For each new device type, he points out, "you’re still going to have to have a custom connection point and the cost associated with it."

MAS has a similar story. "We’re compliant to the extent that the device is compliant," says Erik Nelson, director of engineering and a member of the POCT1-A committee. "We have implemented HL-7 and XML [another protocol for browser-based information], but if the devices don’t give the information, we can’t provide it."

It’s the same on the other side with the LIS, he adds. The data manager can send only information that will be accepted by the LIS. "We have written a protocol adhering to POCT1-A on the LIS side," he says, but the vendors don’t have to adhere to it. "There are a lot more noncompliant devices than compliant," so LIS vendors aren’t hurrying to accept the standard.

Like Telcor, MAS is not plug-and-play. "By no means is this POCT1-A protocol the panacea as far as connecting all devices seamlessly," Nelson says, "but it’s closer than we were before. Now the [device] manufacturers have to be compliant."

Device manufacturers that also make data managers say the latter comply with POCT1-A, though generally only with their proprietary products because their products are designed to be closely integrated with their data managers. For example, with Abbott’s Precision Web, "PCx and i-Stat are plug-and-play," Karkantis says. Other devices require customization telling them how to send information to Precision Web.

Introduced in 2002, Precision Web, which provides POC data access from any terminal on a health care system’s intranet, "was developed with the POCT1-A standard in mind," Karkantis adds. It’s bidirectional, so customers can get data from the LIS, the POC device, and the laboratory on any PC in the hospital without having to install proprietary vendor software, Karkantis says.

LifeScan’s DataLink connects to its glucose meter and has not implemented POCT1-A, says Castanon. He predicts true plug-and-play functionality in about five years. Meanwhile, DataLink depends on integrating with independent data managers, such as those from MAS and Telcor, to comply with the standard. "Until our customers are beating down our doors saying we need this, vendors will be slow to move," he says.

On the LIS side, Siemens Medical Solutions "has been an active participant in developing an interface to meet POC connectivity standards," says Donna Roth, business manager for lab products. She adds that several hospitals have recently requested installation of a POCT1-A-compliant interface. Roth says that Siemens’ Novius Labs 26.2 and subsequent releases meet the POCT1-A connectivity standards.

Another LIS vendor, Misys Healthcare Systems, served on the POCT1-A committee. "We endorse the standard and have taken a very aggressive approach to implementing it," says Todd Ledyard, Misys product manager. "We consider ourselves to be compliant based on connectivity with the data-management systems. If the data manager supports POCT1-A, then we do. If not, then we use the format the vendor specifies."

Karen Southwick is a writer in San Francisco.