A new patient medical records system at a Spokane Veterans Affairs hospital caused nearly 150 cases of patient harm, according to a federal watchdog agency.
An inspection by the VA Office of the Inspector General (OIG) found that a new Cerner electronic health record (EHR) system, now owned by Oracle, failed to deliver more than 11,000 orders for specialty care, lab work and other services at Mann-Grandstaff VA Medical Center, the first VA facility to roll out the new technology.
The OIG is an independent oversight agency, but its report is based on the findings of a patient safety team deployed by the Veterans Health Administration.
The VA announced last month it will push off deployment of its new electronic medical records system to additional medical facilities until 2023 to address outages that have plagued the software at current sites.
The OIG review found that the new EHR sent thousands of orders for medical care to an undetectable location, or unknown queue, instead of the intended care or service location, effectively causing the orders to disappear without letting clinicians know they weren't delivered.
The intent of the unknown queue is to capture orders entered by providers that the new EHR cannot deliver to the intended location because the orders were not recognized as a “match” by the system, according to the VA watchdog.
From facility go-live in October 2020 through June 2021, the new EHR failed to deliver more than 11,000 orders for requested clinical services.
Those lost orders, often called referrals, resulted in delayed care and what a VA patient safety team classified as dozens of cases of "moderate harm" and one case of "major harm."
The clinical reviewers conducted 1,286 facility event assessments and identified and classified 149 adverse events for patients.
Oracle Cerner did not respond to a request for comment. Oracle Executive Vice President Mike Sicilia plans to testify at a Senate hearing this afternoon to answer lawmakers' questions about the status of the VA's EHR project.
Oracle closed its nearly $30 billion deal to acquire health IT giant Cerner in June, and has now inherited the company's beleaguered VA tech project.
In previous public statements, Oracle executives said the company intends to bring "substantially more resources" to the program and "deliver a modern, state-of-the-art electronic health system that will make the VA the industry standard."
Oracle engineers are already been on the ground making technical and operational changes, "with an emphasis on patient safety, to ensure the system exceeds the expectations of providers, patients, and the VA," Deborah Hellinger, vice president of global corporate communications at Oracle, said last month.
Issues with "unknown queue" in EHR system
The case identified as major harm involved a homeless patient identified as at risk for suicide. The healthcare provider entered a follow-up psychiatric care order, and the Oracle Cerner EHR sent the order to the unknown queue. The patient was not scheduled for follow-up care and later contacted the Veterans Crisis Line reporting a razor in hand and a plan to kill himself. The patient was psychiatrically hospitalized, according to the VA OIG report.
"Based on the multiple events of patient harm, insufficient mitigations that burden VHA staff, and continued risk to patient safety, the OIG remains concerned with the management of the new EHR’s unknown queue.The OIG made two recommendations to the Deputy Secretary related to Oracle Cerner’s failure to inform VA of the unknown queue and evaluation of the unknown queue technology and mitigation process," the VA watchdog said.
The OIG said there was no evidence that Oracle Cerner provided actionable information of the unknown queue to VA prior to go-live at Mann-Grandstaff.
The VA learned of the unknown queue’s existence when it opened its first Cerner trouble ticket about the problem four days after go-live, after which the VA instructed staff to monitor the queue and cancel and reenter the problem orders, according to the report.
A VA patient safety team briefed the department’s deputy secretary in October 2021 about the harm and ongoing risks. Despite those warnings, the VA has since launched the system at more facilities in Washington, Idaho, Oregon and Ohio.
Secretary of Veterans Affairs Denis McDonough told lawmakers in April he wouldn’t continue rolling out the system if those experts determined it presented risks to veterans, The Spokesman-Review reported.
“If I had known what I know today, when I was appearing before Congress, I would have answered those questions differently,” McDonough said in response to a question from The Spokesman-Review last month.
Cerner created a provider alert for their undelivered orders in February 2022, but the VA said that the solution wasn’t adequate.
The watchdog also pushed back against VA Deputy Secretary Donald Remy's responses to the draft report because he failed to address the report’s key finding that patients were harmed. "Acknowledgment of harm is a key element to promoting VA as a learning organization. Patient safety must anchor all the activities and operations of a hospital, including the EHR modernization effort," the agency said.
Remy said that Cerner and the VA were both aware of the queue’s existence before go-live, but OIG says it was provided with no evidence to support that statement and that users weren’t informed about the queue until a year after go-live.
The OIG called it "troubling" that the deputy secretary "appears to absolve Oracle Cerner for its failure to inform VA of the unknown queue while placing the blame for outcomes from the unknown queue on VHA end-users."
In a second report (PDF) released last week, the federal watch agency says VA project executives misrepresented its EHR training program.
The VA OIG also reported that two VA senior staffers responsible for training employees of the Mann-Grandstaff VA Medical Center to use the agency’s Cerner Millennium EHR system gave inaccurate data to inspectors reviewing the implementation of the software.
The federal watchdog agency initiated the report after OIG investigators reviewing the rollout of the first commercial EHR system at Mann-Grandstaff in Spokane, Washington, in October 2020 experienced “significant challenges” in receiving detailed information about efforts to train staff on the new software.
Last month, the Spokesman-Review reported on a draft of the now-published VA OIG report flagging serious patient safety risks with the new system.
In response to those media reports, House Committee on Veterans’ Affairs Chairman Mark Takano, D-California, and HVAC Subcommittee on Technology Modernization Chairman Frank Mrvan, D-Indiana, said the draft findings are "seriously troubling and contradict what we have heard from VA officials during public testimony."
The VA had planned to deploy the new health records software, which was developed by Cerner at the Puget Sound VA Health Care System, including American Lake and Seattle VA Medical Centers, this August, but will now push that project to March 2023 instead, a VA spokesperson confirmed.
Plans to deploy the platform to the VA Portland Health Care System at the Portland and Portland-Vancouver VA Medical Centers has been delayed from this November to April 2023.
The VA signed a $10 billion deal with Cerner in May 2018 to move from the VA’s customized VistA platform to an off-the-shelf EHR. The cost of the project has since ballooned to $16 billion.
The Cerner system replaces software that’s more than 30 years old, and the aim is to align the country’s largest health system with the Department of Defense, which has already started integrating Cerner’s MHS Genesis system.