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August 2019

EHRs and Patient Safety: Where Do We Stand?
By Keith Loria
For The Record
Vol. 31 No. 7 P. 14

This polarizing issue is not being settled anytime soon.

A decade ago, the HITECH Act spurred the rapid transition from paper to electronic records. Since then, EHRs have become ubiquitous to the point where nearly all hospitals are on board with the technology.

Ben Moscovitch, HIT director for The Pew Charitable Trusts, says EHRs have improved the quality and safety of care in many ways—such as by alerting clinicians to medication allergies. However, these digital records haven’t addressed some of the inherent safety issues with paper charts and have actually introduced new challenges that didn’t previously exist.

“EHRs are transforming the way patients receive care, in particular by giving clinicians new tools to provide better-quality and safer care, like helping to catch possible drug allergies,” Moscovitch says. “However, research has shown that the design, implementation, customization, and use of these systems can all contribute to safety challenges.”

Doug Thompson, principal with the health care advisory firm The Chartis Group, says the industry is in somewhat of a strange position when it comes to EHR use and patient safety. On the one hand, when properly applied, there have been many advancements in EHR capabilities that have made care much safer.

Examples include standardized electronic order sets, care pathways with integrated clinical decision support and workflows, drug selection and dosing decision support, automated surveillance and alerting, and automated workflows to improve process reliability.

“But most hospitals lag far behind in the adoption of some of these capabilities and, more importantly, in optimization of EHRs and clinical processes to meet local conditions and patient needs,” Thompson says. “So, a lot of potential, but not nearly enough actual progress.”

Therefore, government, private sector accreditation organizations, hospitals, and technology developers can all take steps to improve the safe use of EHRs.

Dean F. Sittig, PhD, a professor at The University of Texas Health Science Center at the Houston School of Biomedical Informatics, believes EHRs have improved patient safety by leaps and bounds over what was being provided by paper records.

“The problem is that now that we have EHRs, it’s easier to see the errors, and we all thought that by putting in a computer system we would stop making errors. That was the goal, but we didn’t get there,” he says. “There are still things we can do. People are making mistakes, but we can fix them.”

Sittig explains that every fix requires a little bit of time and a little bit of work, and some are harder than others, but over time, the situation will continue to improve.

“Safety has a cost and that cost is sometimes convenience or efficiency,” he notes. “A lot of people are arguing that EHRs are slowing them down and causing more work, and blaming a lot of the safety innovation for those slowdowns, but I don’t think that’s the reason.”

Positive Signs
Thompson says EHRs’ impact on patient safety varies across organizations. While some facilities experience better safety conditions, there a few instances where the technology may actually be a detriment to safer care. The latter usually occur due to poor design and unintended consequences, Thompson says, adding that, on balance, EHRs improve conditions.

For example, Texas Health Resources implemented computerized physician order entry, drug-ordering alerts, an electronic MAR (medication administration record), and bar-coded medication administration to prevent adverse drug events and reduce prescribing, transcription, and administration errors. One year after implementation, the health system reported that three of its four hospitals had reduced adverse drug events by more than 50%.

Sentara Health Care, which achieved a 50% reduction in hospital mortality ratio just a few years after EHR go-live, claimed the technology was the driving force behind a $57 million windfall in annual savings.

According to officials, the EHR system at Vanderbilt University Medical Center prevented more than 100 cases of ventilator-associated pneumonia (VAP) and 16 deaths in one year by using a clever display that showed nurses whether all elements of the VAP bundle had been delivered in a timely manner.

Small tweaks have made a big difference. For example, EHRs are now able to correct simple spelling errors through autocorrection or the underlining of questionable words. Sittig says this development helps eliminate misinformation and incorrect entries.

The EHR’s largest contribution to patient safety may be its omnipresence, Sittig says. “The biggest positive is records are available whenever and wherever,” he says. “It used to be the doctor would keep the paper chart in his office and when you went to another doctor, there was no way to get it immediately. Now with the computer, you can log on and see the record from anywhere.”

It’s not as integrated as some had hoped, with all records being in the same place, but EHR protocol is getting closer to that ideal situation.

Challenges Exist
Pew, in coordination with two children’s hospitals and one large mid-Atlantic health care system, has identified and investigated incidents in which EHRs reportedly contributed to drug prescribing and administration errors that jeopardized the safety of pediatric patients. Published in Health Affairs, the research, which examined 9,000 events, found that more than one-third involved a usability issue that contributed to a medication event, with 609 of those that either could have or did result in patient harm.

In parallel, Pew published 12 examples of how EHR usability can contribute to patient safety challenges, such as delaying a newborn from obtaining a critical blood transfusion.

Shiri Assis-Hassid, PhD, a fellow at Harvard’s Center for Research on Computation and Society, has led studies focusing on the integration of EHRs into different medical workflows (inpatient, outpatient, and complex care). The research examined how well the technology was integrated into workflow and how it impacted the delivery of patient-centered care.

With their potential to prevent mistakes and increase patient safety, Assis-Hassid says EHRs could—and should—be a helpful platform for data input and output. However, the way the technology is currently being used is problematic.

“If we look only at safety issues, I can share that many clinicians in different settings view the EHRs as difficult to work with. They do not blend seamlessly into their workflow, and, therefore, in many cases, they use workarounds,” she explains. “Workarounds are ways of carrying the same action intended to be performed in the system outside of it.”

For example, during morning rounds, clinicians tend to document by writing in patient summary reports. Several hours later, they type the information into the patient’s EHR, a period of time that could result in “lost” patient data.

Also of note is that in many cases hand-offs are conducted outside of the system, such as verbally. Therefore, important information is failing to be entered into the EHR.

“The design of EHRs makes them difficult to work with in real time, so in many cases clinicians do not use them in the room,” Assis-Hassid says. “This results in the clinicians not having the most updated data and results regarding the patient.”

In a way, system errors are the modern-day version of illegible handwriting. “Doctors are starting to let computers take over more and more of their practice, and the computer is hardly ever wrong, but if it comes up saying a dosage is 100 mg a day, the doctor is supposed to know it’s really 500 mg a day, but the doctors have basically given up a lot of that responsibility to the computer,” Sittig says. “When the computer makes a mistake, it’s a mistake for every single person that tries to order that medication and most people don’t notice it.”

Because the information is generated electronically through the EHR, many health care professionals assume it is correct.

“That’s one of the things we are working on now to solve—how to fix those errors and keep the knowledge in the computer up to date,” Sittig says. “To do that, someone has to be checking it, and with medications there are thousands and thousands of dosages depending on age, weight, race, etc, so keeping that all straight in a computer system can be difficult.”

Changes Need to Be Made
The magnitude of errors has changed and new errors have emerged, making it inevitable that change will occur within the EHR industry.

“We have to get our computers better. Right now, they are programmed by humans, and humans make mistakes, so we have to have better ways of testing our systems, designing them, and building them,” Sittig says. “Our research group developed the SAFER Guides, a set of nine guides with about 140 recommendations for practices to optimize the safety and safe use of EHRs. Health care organizations can take those guides and make sure their products are safe.”

There are other steps that can be done to better ensure that technology is reliable enough that patients aren’t at risk.

Moscovitch says it starts with obtaining better data on EHR usability and the effectiveness of current usability practices. “To do so, the 21st Century Cures Act established an EHR reporting program where ONC [Office of the National Coordinator for Health Information Technology] must collect data on—among other things—system usability,” he says. “In implementing this program, ONC should ensure that some of the usability-related measures focus on the safety-related aspects of usability.”

Moscovitch believes EHR implementations should promote safety, including the establishment of a monitoring system for potential problems. To achieve this goal, he recommends The Joint Commission include HIT safety elements in its accreditation program for hospitals.

To make EHRs more reliable, Thompson says implementation and use standards must be tweaked. He would like to see more research take place such as that being conducted by KLAS Research’s Arch Collaborative, which is gaining insights from clinicians to help find solutions to EHR frustration. Thompson also recommends the development of a mechanism that would allow organizations a better method to share success stories.

“[I would also like to see] a change in attitudes of hospital leaders to one of taking full clinical and business responsibility for the way their information systems operate and not turfing that to IT,” he says. Leaders should “[take] a benefits- or outcomes-driven approach to EHRs, where the expected outcomes are defined in advance and pursued relentlessly until they are achieved.”

Documenting Safety Concerns
Currently, there is no single repository of information on the frequency or type of EHR usability and safety issues. “That’s why it’s essential that ONC includes a focus on safety in the usability aspects of the EHR Reporting Program,” Moscovitch says, adding that such a move would offer more visibility into the problem.

Still, there are millions of anecdotes that can be found on the internet, where disgruntled health care professionals and patients share their stories on blogs, forums, message boards, and social media. Dissatisfaction also appears in scholarly articles and papers from the industry’s leading professional societies and thinkers.

“There’s plenty of material out there if you just look for it,” Thompson says. “Health care will always be risky, but it could be much safer. The United States has a lot to learn from other parts of the world about safety, quality, and the will to get it right. Too many believe in business as usual and that it can’t get better because it hasn’t been that way in the past. We need more visionary leaders to ‘dream things that never were’ and say, ‘why not?’”

An Acceptable Level?
In 2019, with approximately a decade’s worth of data and experience on EHRs, there’s still debate over whether the industry has reached an acceptable level of safety.

For Thompson, the answer is simple: “We’re not even close.”

“Almost anybody who’s been a seriously ill hospital patient or cared for one has stories to tell of life-threatening experiences that were unnecessary byproducts of the care process,” he continues. “And it’s not that we don’t know how to make things better—we don’t have the operational discipline and the will and the vision to do it.”

Recent research, such as the Health Affairs study, indicates that more work is needed to ensure that the design and implementation of EHRs don’t contribute to medical errors, a mission that will require collaboration from all stakeholders, including EHR developers, hospitals, and government.

“Things are way safer than we were 10 or 15 years ago, but we’re not as safe as we could be,” Sittig says. “It’s all about how much you are willing to pay for additional safety, because that’s going to have a cost.”

Sittig is concerned about the federal government relaxing its stance on EHR vendor performance and its ability to be a conduit to successful implementation. It’s an issue he believes needs more attention.

“I’m a big believer that we need to have more government oversight of the safety of the software as it’s developed and used in the hospitals,” he says. “I would like to see more inspection to make the health care organizations safer in terms of their electronic health records, but this administration has resisted that.”

— Keith Loria is a freelance writer based in Oakton, Virginia.



When it comes to keeping track of prescribed medications between clinic visits, many patients rely on printed medication lists automatically generated from EHRs.

An examination of the EHRs of a cohort of ophthalmology patients revealed that one-third had at least one discrepancy between the medications discussed in the clinician’s notes and those on the medication list. These findings raise concerns about patient safety and continuity of care.

The study, recently published in JAMA Ophthalmology, was conducted by investigators at the University of Michigan (UM) Kellogg Eye Center. The team examined medication-related information contained in the EHRs of patients treated for microbial keratitis between July 2015 and August 2018.

“Corneal infection is an important disease condition to study ophthalmic medication lists because the medications change rapidly,” says cornea specialist Maria Woodward, MS, MD, an assistant professor of ophthalmology and the study’s lead author.

Often, many medications are used, some requiring compounding, making telephone orders to specialty pharmacies common.

“Because of the multiple clinic visits and frequent medication changes,” Woodward says, “it is imperative to have strong verbal and written communication between providers and patients who are battling corneal infections.”

In a typical appointment, a provider verbally communicates medication instructions to the patient. At the same time, notes from that discussion are typed into an unstructured or “free text” section of the patient’s EHR by the doctor, a technician, or a medical scribe.

The patient then receives a medication list generated from the EHR as part of a printed after-visit summary.

“That summary should confirm how the provider intends medications to be used,” says Woodward, also a health services researcher at the UM Institute for Healthcare Policy and Innovation.

The team found that one-third of patients had at least one medication mismatch in their records.

While this is the first study focused on ophthalmic medications, the results are consistent with studies of medications used in other medical specialties.

“This level of inconsistency is a red flag,” Woodward says. “Patients who rely on the after-visit summary may be at risk for avoidable medication errors that may affect their healing or experience medication toxicity.”

The switch to the EHR has led to many improvements in patient care. But as this study shows, it’s not a perfect tool for the provider or the patient.

In a typical clinic visit, a prescription entered into the EHR triggers both an order to the patient’s pharmacy and an update to the medication list. But several scenarios can result in mismatches between the clinical notes and the medication list.

“Issues arise when a medication is started by an outside provider and continued at the new hospital and when patients require compounded medications that must be telephoned in to a pharmacist in the evening,” Woodward says.

These scenarios expose a shortcoming of the EHR: Data about medications (and other information) are captured in multiple formats in multiple locations.

“The only way to ensure that the medication list is completely accurate is to double-document. The same information must be entered into the clinician’s note and the formal medication list—two separate places,” Woodward says.

“In a busy clinical setting, our top priority is communicating directly with the patient and answering their questions,” she says. “We’re focused on clarifying the treatment plan and addressing concerns, so duplicating note taking does not rise to our primary mission.”

To improve both the reliability of medication information patients depend on and the accuracy of data used for research, Woodward’s study team recommends that EHR developers create software solutions to ease the burden of clinical documentation and make it easier to reconcile medication names and dosages.

— Source: University Of Michigan Institute for Healthcare Policy & Innovation