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