Lawmakers grill VA, Oracle leaders over pharmacy-related patient safety issues

A year after hitting the pause button on a multibillion-dollar health tech project at the Department of Veterans Affairs (VA), federal lawmakers continue to have serious concerns about pharmacy software issues that could impact patient safety.

During a House Committee on Veterans’ Affairs Subcommittee hearing last week, lawmakers grilled leaders from the VA and tech company Oracle about the big-ticket electronic health record (EHR) overhaul and patient safety issues flagged by federal watchdogs.

A draft VA Office of Inspector General (OIG) report found that an error in Oracle Health’s software coding resulted in the widespread transmission of incorrect VA Unique Identifier numbers from hospitals and clinics using the new Oracle Cerner medical records system to hospitals using the "legacy" EHR, called the Veterans Health Information Systems and Technology Architecture, or VistA.

"The situation we found in our previous hearing, in May of last year, was dangerous and unsustainable, and it seems much the same today. Simply put, the medical centers using the Oracle Cerner EHR have been turned upside down," said Rep. Matt Rosendale, R-Montana, during the hearing.

"They have had to increase their pharmacy staffing by at least 20% to navigate all the bugs and workarounds—just to process roughly the same volume of prescriptions. That costs millions of dollars. But these are just five small and medium-sized hospitals. VA projects that large, complex medical centers will have to increase their pharmacy staffing by as much as 60% to mitigate the software’s problems," Rosendale said.

Since April 2020, the VA OIG has published 16 reports on the Oracle Cerner EHR, nine of them related to significant patient safety concerns such as issues with medication management, pharmacy software and patient care coordination, David Case, deputy inspector general with the VA's OIG, testified (PDF) during the House hearing last week.

While the VA corrected one issue related to the transmission of inaccurate medication information, OIG is concerned about "unresolved and insufficiently communicated pharmacy-related patient safety issues," Case said.

VA and Oracle tech leaders "did not test for medication and allergy data accuracy after that information was transmitted" to the HDR, a health data repository, from new EHR sites, Case noted. "Patients seen at both new and legacy EHR sites may be prescribed contraindicated medications and legacy EHR providers may be making clinical decisions based on inaccurate data," Case testified.

The software coding error could potentially impact 250,000 veterans, Case told lawmakers. "They may be unaware of the potential risk for medication or allergy-related event if they visit a legacy EHR site," he testified.

Case added, "While VA is making efforts to reduce this potential, we remain concerned that patients have not been informed of their individual risks, essentially being excluded as full participants in their care. Nor have we seen evidence that VA has sufficiently notified legacy EHR providers about this issue and the mitigations to safely care for these new EHR site patients."

Legacy site leaders were told to have providers perform manual medication safety checks to replace the automated checks for new EHR patients, according to Case. "These manual safety checks are complex and rely on the vigilance of pharmacists and frontline staff," Case testified.

At the VA Central Ohio Healthcare System in Columbus, where the Oracle EHR had been implemented, the OIG found a prescription backlog required a permanent 62% increase in clinical pharmacists while "pharmacy leaders had to create their own workarounds and education materials, and pharmacy staff were burned out and had low morale," Case testified.

The VA has made "incremental and steady progress" to enhance pharmacy functionality and capabilities as part of the new EHR system, Neil Evans, M.D., acting program executive director for the Electronic Health Record Modernization project, testified during the House hearing.

"VA has always said the EHR system will not go live at any site that is not ready. We also remain firm in our resolve to continue deployments of the modernized EHR system when it is ready," Evans said in his written testimony.

The latest major update to the pharmacy software occurred just a few days before the House hearing, Evans said.

Mike Sicilia, executive vice president at Oracle, testified that when Oracle took over the EHR project in 2022 it was a flawed tech project in need of significant enhancements. 

"We acknowledge that for these early sites, pharmacy has been challenging. Shortly after the acquisition in June 2022, when I came to the Hill and met with congressional stakeholders on EHRM, improving pharmacy was one of the top complaints I heard," Sicilia told lawmakers last week. "We received the required changes on contract for VA and delivered them in an expedited fashion."

In his written testimony, Sicilia said the enhanced pharmacy system Oracle has provided to VA presently is both "safe and effective, having been built to VA’s specifications and requirements."

"As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state," Sicilia wrote.

He also noted Oracle was not briefed on the draft report OIG presented to lawmakers during the hearing and wasn't given the opportunity to comment on the findings of the report.

Oracle inherited the troubled EHR project when it bought Cerner for $28 billion in June 2022.

The VA signed a $10 billion deal with health tech company Cerner in May 2018 to move from the VA’s customized VistA platform to an off-the-shelf EHR system. The goal was to align the country’s largest health system with the Department of Defense (DOD), which has already started integrating Cerner’s MHS Genesis system.

The VA has obligated about $9.4 billion to the EHR modernization program since fiscal 2018.

VA has spent roughly $5 billion of taxpayer money to implement the Oracle Cerner EHR system at five of 171 medical centers, where it has badly disrupted operations for veterans and VA providers, according to federal lawmakers. The Oracle Cerner system was first launched at Spokane’s Mann-Grandstaff VA Medical Center and several Inland Northwest clinics in October 2020.

Federal lawmakers have voiced ongoing concerns about patient safety issues related to the new medical records system. Watchdog reports found that the new EHR system had caused nearly 150 cases of patient harm at a Spokane VA hospital.

Last April, VA said it was indefinitely putting all future deployments of the Oracle-Cerner EHR on hold until it addresses problems at the five VA sites already using the system.

The VA and Oracle plan to move forward on deploying the new EHR system at the Captain James A. Lovell Federal Health Care Center in North Chicago in March. That site is a joint VA and DOD facility.

But some lawmakers questioned whether that phase of the project should continue as scheduled until the pharmacy software issues were addressed.

“I understand that the DOD is motivated to finish this deployment. That cannot come at the expense of our veterans or VA providers,” Rep. Sheila Cherfilus-McCormick, D-Florida, said during the hearing. “I hope the VA decision makers are being incredibly deliberative in deciding whether or not the go-live should be allowed to happen as scheduled.”

The Lovell Federal Health Care Center is the final deployment of the federal EHR at a DOD site and will also be the first VA deployment at a larger and more complex VA healthcare facility, Evans told lawmakers.

When the Lovell Federal Health Care Center in North Chicago goes live next month, the providers and pharmacists there will start using the system with the current enhancements Oracle has put in place, Sicilia testified.

However, Rosendale told VA and Oracle leaders progress on the software bugs represents "piecemeal, painfully slow improvements to software that seems to be fundamentally inferior to VistA."

"Even worse, many of the changes introduce new complications, unexpected errors and safety risks that the pharmacists have to manage with yet more workarounds," Rosendale said.

At the end of the hearing, Rosendale quipped, "We're $9 billion and five years into this system and we still don't have a fully functioning system."

During a separate House Committee on Veterans Affairs hearing last week about the VA's use of artificial intelligence, House lawmakers voiced concerns about the ability of the Oracle EHR to integrate AI solutions.

"We're trying to walk and chew gum at the same time. We're trying to get our providers to even learn the system much less now try to integrate artificial intelligence. This is really going to be difficult, very, very challenging," said Rep. Greg Murphy, M.D., R-North Carolina, during the hearing.

"I think you're raising a really critical point, which is that many of these AI solutions, to be truly effective, need to be carefully integrated into the existing workflows so that they actually reduce burden and reduce the number of clicks and not add yet another thing that the providers need to track or open," Charles Worthington, the VA's chief technology and chief AI officer, told lawmakers during the VA committee hearing.

Worthington said the department follows six principles for AI implementation and use, and the VA already has more than 40 AI use cases.

Murphy responded, "I worry about the ability to deliver a regular product, much less an AI product."