Raj Ratwani, Ph.D., director of MedStar Health’s National Center for Human Factors in Healthcare, has long been committed to the usability and safety of healthcare technology, such as electronic health records (EHRs). Having taken the lead on multiple studies that have examined the association between EHR usability and patient safety, Ratwani recently took his efforts up a level, spearheading a new campaign that aims to push for changes to address the known risks to patient safety and clinician burnout that stem from poor EHR usability.
The initiative from MedStar, the largest provider organization in the Baltimore-Washington metropolitan area, and the American Medical Association (AMA), was announced earlier this month and includes videos from the clinician's point of view that demonstrate the risks and challenges caused by poor EHR usability. The videos have just been made available on a new website, EHRSeeWhatWeMean.org, which specifically calls out what multiple stakeholders—policymakers, healthcare providers, EHR vendors and patients—can do in the push to improve EHR usability and safety.
MedStar is also gathering signatures on a letter to Congress encouraging them to prioritize EHR usability and safety in their oversight of new policies being put in place by the Department of Health and Human Services by the end of the month.
Ratwani, who points to a paper his team of researchers wrote last year which showed the impact that poor EHR usability could have on adult populations, and then another study later in the year looking at the association between EHR usability and harm in pediatric patients, says this recent research was a big indicator that this issue needed much more attention. “We found that nobody other than [clinicians] has a good sense of the true usability and safety challenges that we’re talking about. Without that knowledge and insight, it’s hard to get behind this issue. So we wanted people to see the issues that clinicians are having on daily basis,” Ratwani says in a recent interview with Healthcare Innovation.
One of the key studies that led Ratwani and his team to get to his point that involved 12 to 15 emergency physicians from four health systems (two using Cerner’s EHR and two using Epic’s) who were given common tasks mimicking real patient cases—placing orders for medical imaging, lab tests and medications. The findings showed huge variability in performance across the sites.
Ratwani believes that in order to truly address these kinds of usability issues in a more comprehensive way, greater transparency will be required. “One of the big challenges in this space is the contract language or ‘gag clauses’ in EHR vendors and provider organizations that can prevent this open discussion,” he says.
Although one might think that an open reporting system for EHR technology where users can report issues already exists, Ratwani says that contractual obligations have prevented it, historically. He refers to a Politico 2015 report which obtained 11 contracts between top EHR vendors and providers, finding that “Most [providers] are under gag orders not to discuss the specific failings of their systems — even though poor technology in hospitals can have lethal consequences.” The report further revealed, “With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure.”
Ratwani does note there is also a community of people who believe that these clauses do not exist, while vendors say “such restrictions target only breaches of intellectual property and are invoked rarely,” according to the Politico report. “What we do know is that people are not able to openly talk about these things, either because of the clauses, or because of intimidation or some other factor,” Ratwani says. “For example, if you picked up any of the hundreds of journal publications on EHR usability and safety, I would challenge you to find a single one that has a screenshot of an EHR interface.”
In conjunction with the campaign launch, Ratwani also co-authored an article in JAMA with Jacob Reider, M.D., former deputy director of ONC (the Office of the National Coordinator for Health IT), laying out a framework for improving EHR safety and usability. Reider, who is the current CEO of the New York-based Alliance for Better Health, and who was a former senior executive at EHR vendor Allscripts, says that having worked on the health IT development side, he was able to realize the pressure and tension between what’s good for business and good for people.
“What could be good for business might be ‘hiding’ a safety issue in an [EHR] system, or not being public about that issue, and trying to manage it internally,” says Reider, who adds he personally witnessed times when there was a product safety issue related to experience or usability, and the company would take it seriously internally, but would make sure nothing became public.
And when Reider was at ONC, he says the agency would receive reports of issues from end-users, and although ONC would bring these reports to the vendor’s attention, there was no explicit framework in place to cause ONC to make that issue public. But Reider doesn’t want to put the entire blame on the vendor community; he believes there is shared responsibility among the software developers and the providers using the products.
“If I have the wrong tires on my car because I put [them on], that’s not the fault of Volkswagen. They told me what the right tires were and I put the wrong ones on. So if one of the tires explodes on the highway, that’s my fault,” Reider offers as a comparison. “The core of what’s important is that we recognize who is responsible for what, and then we create a public resource where these matters can be posted, reported and processed. That will help us all learn,” he adds.
EHR Design—Who’s at Fault?
Depending on which side they are on, health IT stakeholders will commonly play the “blame game” when there is an issue of poor EHR usability. Reider again contends that sometimes it’s the fault of the vendors, and sometimes it’s on the providers. He explains that if developers don’t make their systems very customizable, many of their customers will complain that they want the flexibility to customize themselves. “So if the customization is rigid, that might compromise sales, but if it’s too flexible, you give the customer the opportunity to modify the system so much that they screw it up,” he says. “And most healthcare delivery organizations don’t have human factors engineers. We need to find a way to bubble these matters up because transparency will solve a lot of these problems.”
Nevertheless, in the aforementioned study from MedStar involving the four health systems using Cerner and Epic products—two vendors that were chosen since they have the largest market share—Ratwani says his team was “blown away” by the results they were seeing in terms of error rates and times to complete tasks.
He says for certain tasks, such as calculating the right dosage for a Prednisone taper, several doctors had to do calculations on paper, “even though there was a million or billion dollar software product right in front of them, or they were pulling out their mobile phones to use its calculator.” The error rates for that particular task at some sites were 50 percent, Ratwani says.
What’s more, there was also great variability among the different sites that were tested, even though the same product was being used. Ratwani believes this points to implementation issues as well as the decisions that are being made by the provider site. He also notes that while Cerner granted MedStar permission to show the EHR usability issues on the new website, Epic did not, meaning they had to mimic the issues in a simulated EHR for the campaign. “We disagree with Epic’s decision since we think full transparency is critically important. But we are respectful of it,” says Ratwani.
He and Reider both point out that federal regulations require safety testing for transportation systems and medical devices, for instance, so they ask why can’t the same infrastructure be in place for health IT? Ratwani asserts, “And those companies are not arguing about intellectual property.” He adds, “We don’t have that kind of mentality when it comes to EHRs. Even though there is bare-minimum usability testing when the product is being developed, there’s no testing when it is implemented and no further testing when upgrades or other modifications to the system are being done.”
ONC, being the health IT arm of the federal government, seems like the perfect agency to put these testing protocols and other mandates in place. To this end, the 21st Century Cures Act has required ONC to seek public feedback on the development of an EHR Reporting Program, which is intended to increase transparency and awareness of the usability of different products. ONC has issued that RFI, but did not include more information about the reporting program in its proposed regulation dropped earlier this month on interoperability and information blocking.
Reider, the former ONC employee, believes the agency doesn’t take EHR safety seriously as part of its mission. He notes it’s the administration’s perspective that government should have a smaller role in how business is operated. “Don [Rucker, current National Coordinator for Health IT] is a friend, but being a member of this administration, he views the role of ONC as [not] having a very active role in protecting the safety of these systems. It’s a philosophical perspective in what government’s role is,” Reider says.
He also says that for years, ONC has discussed creating a safety center, but plans have never evolved very far. “We really need to exert pressure, perhaps through Congress. Health IT is a young industry and people might not be at a place where they understand the important role that it plays.”
In response to Reider’s remarks, ONC, through a spokesperson, said the agency appreciates the efforts from MedStar and the AMA to improve EHR usability and safety. “We also recognize that there are examples of health IT-related adverse events and the importance of reporting these events. Many of those are intercepted by clinicians before patients are impacted,” the ONC official said.
What’s more, in November, ONC did name the winners of the Easy EHR Issue Reporting Challenge, who all created software tools that should help clinicians more easily report EHR usability and safety issues from within their typical workflow, the agency official pointed out.
And in the proposed regulation on interoperability and information blocking, there are “significant usability provisions, including prohibiting a health IT developer from stopping the communication of screenshots of the developer’s health IT except in certain conditions,” ONC’s official noted.
ONC, in the rule, is also proposing “that a developer of certified health IT must in a reasonable period of time, but not later than two years from the effective date of this rule, amend any certified health IT contract or agreement to remove or void any contractual provision that contravenes the prohibition on restricting communications regarding the specified subjects,” according to the ONC official.
As such, it appears that ONC, as directed by the Cures Act, is taking the necessary steps to address usability and patient safety issues. Ratwani says he knows that ONC is working hard, but both he and Reider express concern if the agency—which almost got its budget slashed in half last year, only to be restored by Congress—has the necessary resources to carry out these duties.
“If they don’t, Jacob and I will be writing the 20-year paper on how usability and safety challenges still exist, and we certainly don’t want to be there,” Ratwani says.