EXECUTIVE SUMMARY

Proposed rules would eliminate gag clauses in electronic health record (EHR) vendor contracts to encourage airing of safety concerns. Some known issues cropping up in ED malpractice claims:

  • Some EHRs make it difficult for ED providers to view the most current test results.
  • The correct medication order is not always listed in the EHR.
  • Sometimes, orders entered in free text are not carried out.

Are EPs well-aware of a glitch within the electronic health record (EHR) that has almost harmed many patients? They might be wary of calling attention to it publicly due to vendor “gag clauses.” These are an example of “risk management gone wrong,” says Michael S. Victoroff, MD, a consultant on health IT in the department of patient safety and risk management at Denver-based COPIC.

Gag clauses prohibit EHR users from publishing reports of flaws, defects, malfunctions, error-inducing processes, usability problems, and other hazardous conditions. From the ED provider’s perspective, lack of clarity on the legalities of what is allowed leads to fear of speaking up. “Users may even feel they are contractually forbidden to discuss such things with any external party, including their insurance carriers. The fact that this is probably mistaken does not reduce the chilling effect,” Victoroff says.

Medical malpractice insurance carriers have not seen the volume of EHR-related claims they have been expecting over the past two decades, Victoroff notes. “Plaintiff attorneys have not figured out that EHRs play a role in many medical errors and could plausibly be named as part of the causation pathway in some cases,” he says. Despite gag clauses in some contracts, generic observations of EHR flaws (without specific attribution) are widely published. “The vendors have deep pockets, and it wouldn’t take a whistleblower to draw attention to the technology,” Victoroff says. “All it takes is a plaintiff to ask the right questions in the defendant’s deposition.”

The “learned intermediary” legal doctrine may be providing substantial protection to technology vendors, offers Victoroff. This protects suppliers by placing liability on licensed practitioners.

“It is not clear how much weight a trial court would give a non-disclosure agreement in a case where a patient came to harm because a physician felt inhibited from taking remedial action in the face of an obvious safety hazard,” Victoroff says.

Jurors are unlikely to sympathize with an EP who put a vendor contract ahead of a patient’s welfare. “In practice, most [health information technology] hazards fall in a grey zone where ‘user error’ can almost always be invoked,” Victoroff adds.

This gives cover to vendors no matter how poorly designed the EHR. “There is even a perverse liability to consider if users repeatedly raise concerns about the number of errors they intercept and yet continue to use the system,” Victoroff says. “This is a true lose-lose situation.”

New proposed rules from the Department of Health and Human Services’ Office of the National Coordinator for Health IT would forbid vendors from enforcing gag clauses.1 “The removal of these clauses would mean that EDs, and provider organizations more generally, can more easily share explicit examples of usability and safety challenges, which could decrease liability risk,” says Raj Ratwani, PhD, director of the MedStar Health Research Institute’s National Center for Human Factors in Healthcare in Washington, DC.

There is growing concern that gag clauses prevent anyone from airing problems with EHRs before people are harmed. “EHR usability issues create many dangerous situations that require extra work and careful attention to do the right thing, when doing the right thing should be the easiest thing to do,” says Dean Sittig, PhD, a professor in the School of Biomedical Informatics at the University of Texas Health Sciences Center in Houston.

Research on the usability of EHR interfaces in ED settings has shown that errors such as ordering X-rays on the wrong side or ordering medications with the wrong dose can occur with rates ranging from 16.7% to 50%.2 “During this study, we collected videos of the physician interactions with the EHR. We have posted these examples on EHRSeeWhatWeMean.org,” says Ratwani, the study’s lead author. The videos show that some EMR interfaces can be difficult to use and may contribute to errors.

Sittig has reviewed multiple malpractice lawsuits alleging ED providers missed abnormal test results that in some way involved EHR usability. In one case, a patient’s X-ray results were sorted in chronological descending order of the date, with the oldest tests listed first. The most recent X-ray report was not visible unless the EP scrolled down to locate it. The EP did not realize a new result was available and decided to send the patient home based on a previous X-ray taken before the accident. The patient, who had a broken bone, sued the EP. “There was really no excuse on the part of the doc, although the EHR made it really hard to see the new result,” Sittig says. The lawsuit was settled prior to trial. Other ED malpractice claims have revealed dangerous problems with entering orders into the EHR. Sometimes, the EP cannot find the appropriate order from a long list of medications in the EMR and enters a different order — one that is listed. Then, the EP tries to enter the correct order in free text, but the incorrect order is carried out. “Sometimes, the free text does not cross the interface,” Sittig explains. “Again, in the lawsuit, the doc has very little to stand on since she clearly ordered the wrong item.”

When unambiguous product defects are at fault, there likely will be cases in which vendors become defendants. “But one defense that is not generally going to be helpful is simply jousting at the vendor,” Victoroff says.

However, sometimes it takes a malpractice lawsuit to air dangerous issues. “These so-called gag clauses only apply to people who want to talk about these problems before there is a legal issue. Once the subpoena comes through, everything is fair game, including screen prints,” Sittig says.

Even once someone is harmed, it is still not easy for the EP defendant to point the finger at a faulty EHR. “Defendants often try to blame the EHR. But this is difficult for many reasons,” Sittig notes.

The system may be quite cumbersome in the hectic ED setting with multiple high-acuity patients in the mix. However, in the courtroom, it does not look that way. “A good EHR user — say, a trainer — can easily show a jury how the EHR should be used, and it does not look hard at all,” Sittig says. This depicts the EP defendant as incompetent or uncaring. Even blatant safety problems with EHRs can be hard for any individual ED provider to pinpoint. “EHRs are very complex, with many interacting components, any of which may not be functioning properly,” Sittig explains. “The doc may not be aware that something is wrong.”

It is not just vendors that try to prevent people from talking about problems with the EHR. Healthcare organizations also put restrictions on their employees. “For example, a hospital wouldn’t want a doc saying that the EHR was not safe at the hospital where he works,” Sittig says. “What patient would go to an ED with a known unsafe EHR?”

ED providers must feel free to speak up about EHR concerns, says Lorraine Possanza, DPM, JD, MBE, program director of the Partnership for Health IT Patient Safety at ECRI Institute. “There are multiple ways that errors could occur,” Possanza says. Questions to consider about ED care may include: How was the test ordered? Was there a drop-down menu or a default order that needed to be changed in each instance? Was there an issue when images or reports appeared across systems? How were items displayed?

“It is important to include technology safety in any risk and safety programming within an organization,” Possanza says.

Sittig recommends that hospitals, in conjunction with their EHR vendors, create easy ways for users to quickly report safety concerns. Further, he suggests IT departments carefully review comments that users enter routinely when they override clinical decision support alerts. “Researchers have demonstrated that these comments often contain excellent suggestions for improving patient safety,” Sittig says.3 Workarounds are dangerous, too. “If someone else then later reports that issue and there is no communication that a change occurred, that very workaround used previously may cause a safety issue to occur,” Possanza cautions. Possanza says these are important questions to answer on ED care:

  • If a patient requires a certain level of care identified by the ED provider, is that readily visible after the patient is admitted? For instance, the ED patient may require 1:1 monitoring, but it is not clear to inpatient providers.
  • Is there a verification process to determine that the information sent was actually received? For instance, if three prescriptions are sent to an outside pharmacy, the ED should be able to verify that all three were received.
  • Is the information received by the patient in their aftercare summary complete and accurate? For instance, medication dose and strength should be displayed, along with directions on how and when to take it.

“Organizations should encourage reporting and not punish providers for reporting safety issues, as it can have a chilling effect,” Possanza warns.

REFERENCES

  1. Federal Register. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. A proposed rule by the Health and Human Services Department, March 4, 2019. Available at: http://bit.ly/2vvIb27. Accessed May 2, 2019.
  2. Ratwani RM, Savage E, Will A, et al. A usability and safety analysis of electronic health records: A multi-center study. J Am Med Inform Assoc 2018;25:1197-1201.
  3. Aaron S, McEvoy DS, Ray S, et al. Cranky comments: Detecting clinical decision support malfunctions through free-text override reasons. J Am Med Inform Assoc 2019;26:37-43.