Skip to main content

CPOE regulations a “two-edged” sword

By Mike Miliard , Executive Editor

In July, the Leapfrog Group released a report on computerized physician order entry (CPOE) systems that contained some discouraging findings.

Over the course of a year and a half, the healthcare safety watchdog organization enabled 214 hospitals to use its Web-based CPOE evaluation tool, which simulates the act of a doctor writing an order in an EHR, and assesses the order entry system's reliability in avoiding errors.

The results were less than stellar: on average, the CPOE systems missed "half of the routine medication orders and a third of the potentially fatal orders" according to the report, although "nearly all of the hospitals improved their performance after adjusting their systems and protocols, and running the simulation a second time."

The report concluded that hospitals must test and monitor their CPOE systems "on an ongoing basis," and that "vendors and hospitals must collaborate more closely during the pre‐implementation and implementation phases to ensure that best practices are shared and followed." Leapfrog also called on the government to "require monitoring and improvement at implementation and on a long‐term basis."

"The federal government must exercise leadership here, because lives are at stake," said Leapfrog Chairman David Knowlton, president and CEO of the New Jersey Health Care Quality Institute. "As they define meaningful use as a standard for federal funding assistance to hospitals, they must require more than just adoption and implementation. The government must insist that hospitals and IT companies do continuous monitoring and improvement."

The meaningful use final rule, which was released not long after the Leapfrog study, doesn't get quite that specific when it comes to mandating CPOE testing (CK).

But vendors say they're in basic agreement with the report's conclusions, expressing confidence with the basic safety of their products and the testing, implementation and educational protocols they have in place – even as they're sometimes wary of further federal regulations.

"The key to long-term patient safety and success is to treat CPOE as an enabling technology that must be maintained and managed as clinical evidence evolves," says Gerry McCarthy, vice president and solution line manager, physician solutions at McKesson.

He notes that McKesson employs "a rigorous quality assurance program that focuses on both software quality and workflow design throughout our product life cycles. For example, our new Horizon Enterprise Prescription Writer tool followed an iterative development process that incorporated clinicians, engineers, quality assurance analysts, services and most importantly, customer engagement to drive the design, testing, implementation and support tools necessary to both install and maintain the system."

Moreover, "each time we come out with a new function, release or product, we perform significant amounts of testing, both automated and manual," says McCarthy. "Additionally, our customers have a complete QA environment that allows them to perform regression testing against their environment with any new product or feature that is delivered to them before the technology is moved into their production environments."

At the same time, says John Foy, MD, PhD, senior manager of product strategy at GE Healthcare IT, it's important to keep CPOE systems' risks and benefits in perspective. "Failure to be 100 percent effective in preventing all the risks is not the same as introducing new ones," he says. "It's important for people not to have inflated expectations about what the technology can do for them – but also that they not overlook significant benefits that they can get."

CPOE systems "pretty much by their nature, in order to be effectively usable, have to be customizable or tailorable to the circumstances of the particular hospital," he says. "Some things are built into the software; others are more programmable, controllable by the individual hospital to fit their environment."

But if the hospital fails to implement those rules – or fails to do so properly – then they won't get that necessary level of safety checking.

"The hospitals have to pay attention to that and do it right. And if they find places where they've missed that, then coming around and making those adjustments would ramp up the effectiveness on the next go-round,” Foy says.

That's why – beyond GE's "well-developed quality control methods and processes" and several levels of "formal and informal testing" before, during and after installation – customer education is "a standard component of the implementation program," he says.

As for Leapfrog's insistence that the government take on more oversight of CPOE testing, Foy cautions that federal regulation is "something of a two-edged sword, because you have to strike a balance between being overly prescriptive, which can inhibit innovation – or inhibit the kind of variation that might be needed to actually make things work well in different circumstances."

"I would say one has to be careful with the way government introduces regulations," says Foy. "But I think they've done a good job thus far with meaningful use regulations, having solicited and acted upon feedback from vendors and hospitals."