College of American Pathologists
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  Positive patient ID: party of one or more?


CAP Today




July 2012
Feature Story

Anne Ford

Everyone is positive about the ability of positive patient identification systems to improve patient safety. Trouble is, when it comes to one important question—is it safe for a positive patient ID product from one vendor to interface with an LIS from a different vendor?—there is no unanimous answer. We’re positive about that.

Among the companies that offer both positive patient ID and laboratory information systems, some say third-party interfacing is perfectly fine, while others say it’s safe only under certain circumstances—and at least one argues it has the potential to be unsafe.

In the last camp is Sunquest Information Systems, which offers the Collection Manager and Transfusion Manager software applications. Collection Manager is used at the point of care to verify the patient’s identity, test being ordered, and tube type in use, as well as to print specimen labels. Transfusion Manager is used to identify transfusion recipients, match blood products, and record transfusion information.

Neither solution can be interfaced with a third-party vendor’s LIS. And that’s for a very good reason, says Sunquest product manager Jonathon Northover: Doing so would result in “problems that pose a risk to patient safety.”

It’s not that Sunquest was opposed to third-party interfacing from the start. “We spent a lot of time figuring out if interfacing was a good idea,” he says. “We asked: ‘Should we interface or should we not? Let’s look at this.’ It makes no sense not to do something if clients are asking for it.”

What Sunquest found, he says, was that interfacing its positive patient ID products to a foreign LIS “risked delaying stat tests by two to five minutes” and “risked having container identification omitted from the labels.” Northover explains the delay and omission as stemming from communication errors between the positive patient ID solution and third-party LIS. “This is just from our perspective, sending data out,” he says. “We don’t even know what the limitations are on the other end. What else is not supported? We don’t know.”

“If you have a laboratory system and a point-of-care system that are all part and parcel of the same thing,” he continues, “that provides an immense comfort, an incredible assurance that it’s part of the same process. It’s reliable, it’s easy, and it’s safe. As soon as you introduce other stuff”—that is, products from other vendors—“you’re opening up a can of worms. You’re walking into the unknown. We are then reliant, as far as patient safety may be concerned, on another vendor. Why risk it?”

“Smaller, more niche third-party vendors say, ‘This is nonsense; you can easily interface,’” he says. “I’m pretty sure none of them have done the research to the extent we have.”

To a certain, albeit small, degree, Cerner director Lori Cross agrees with Northover’s perspective. “I think there’s the possibility that data and actions in one system would not be capable of being shared with the other system without custom interface work,” she says. But if an appropriate custom interface has been built, she adds, those problems should not materialize. As for stat orders being delayed or information missing from specimen labels, she says “that has not been our clients’ experience.”

Cerner markets Cerner Bridge Medical software for positive identification of medications, specimen collections, blood transfusions, intravenous smart pump programming, and breast milk, as well as for mother-baby matching. The company also offers the Cerner Millennium family of point-of-care software—CareAdmin, CareMobile, Millennium PathNet Handheld Specimen Collections, and RxStation—for positive identification of medications, specimen collections, intravenous smart pump programming, and automated dispensing device integration. The Cerner Bridge suite can be interfaced to a non-Cerner lab information system, while the Cerner Millennium point-of-care solutions are typically implemented in an integrated manner.

Because of regulatory concerns, Cerner will not interface its laboratory information system to a blood product administration system that has not received FDA 510(k) clearance. “Our position is that knowingly interfacing to a product that does not have 510(k) clearance puts our blood bank 510(k) clearance at risk,” Cross explains. “Since blood bank systems are class II medical devices, if we knowingly interface to a system that has not been evaluated to ensure that an ABO-incompatible blood transfusion could not occur, we believe that puts the client and us at risk.”

That concern aside, “we have a strong history of supporting interfaces to third-party systems,” Cross continues. “Although we do believe a Cerner system provides additional value, if a client has made an investment in a third-party system, it is our position that as long as we can work together to create an appropriate interface, then it’s the client’s decision on which way to go.”

Still, she says, using a positive patient ID solution that is an integrated component of one’s own LIS has major advantages. “With an integrated solution, you eliminate the cost of maintaining two separate systems and the cost of maintaining the interfaces.”

Then, too, “when they’re integrated, you oftentimes have better information sharing,” Cross adds. “The HL7 standard is a fantastic mechanism, but there’s always something missing. I’m not saying that to be negative about HL7, but when you have an information-sharing standard, the information they’ve created the standard for is the only information that’s moving back and forth. Collection information is outside the typical scope of orders and results.” An example of an item not typically available in a standard HL7 message is a “collection missed” status with a reschedule. “But it is our position that it is up to the client to determine whether that is a safety risk,” she says.

Gilbert Hakim, CEO of SCC Soft Computer, sees no safety risk in interfacing. “The only question is whether the statuses are passed to the user properly,” he says. “The error messages or statuses that the laboratory provides—they may not have a mechanism on the handheld phlebotomy device to display them properly. It may show up as an error or ‘operation not successful.’”

SCC markets SoftID (and SoftID.Tx). It’s an electronic positive patient tracking PDA-based solution that allows phlebotomists and nurses to verify patient identification before collecting blood. While SoftID can be interfaced with a third-party LIS, most customers choose to use it with the company’s SoftLab LIS, Hakim says.

In part, that’s because it can be costly to build the custom interface necessary to use SoftID with another company’s LIS. The cost depends on the functionality embedded in the other system, says Hakim, “and what we need to accommodate based on [the system’s] limitations. And it requires a lot more maintenance.” Then, too, “obviously we prefer to sell our own product.”

Hakim advises caution when shopping for an integrated positive patient ID/lab system. Sometimes LIS vendors buy handheld phlebotomy device companies and put their name on the devices, he says, but those products are not integrated with the company’s LIS. “They still have the same issues regarding the need to maintain separate systems.”

Siemens Healthcare takes the stance that interfacing with third-party solutions, by using industry-standard HL7 interfaces, does not introduce a greater safety risk within the Siemens product, says Brenda Carbon. Carbon is product manager for the company’s Patient Identification Check software, which is used on a handheld device at the patient’s bedside to identify the clinician, patient, and order of collection for each sample container. The product also prints labels at the bedside as samples are collected.

“We use standard HL7 interfaces to safely and effectively communicate with all kinds of systems, including any laboratory information systems,” Carbon says. “We evaluate risks to help ensure our products are safe and effective, and we have not identified any risks around interfaces within our product.”

Siemens’ philosophy: “We are partners with our customers,” she says, meaning if a customer wants to interface Patient Identification Check with a third-party LIS, Siemens will support it. “We want to be able to provide customers with the best products to meet their needs. We recognize that these systems are open.”

Siemens also offers interfaces to blood transfusion management systems. Those systems are class II medical devices, Carbon says, and they have been cleared by the FDA. “We have extensively evaluated the risks within blood management products and the potential risks created by interfacing those products to ours in order to help ensure safety when interfacing,” she says.

As for Sunquest’s Northover, well, he remains unconvinced. “You can talk to me all day about class II medical devices and how safe they are,” he says. “But that is irrelevant. My concerns are specific to the research we’ve done. And there remain specific problems [with interfacing to a third-party product] that risk safety.”

Anne Ford is a writer in Evanston, Ill.

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