EXECUTIVE SUMMARY

EMR issues can create potential liability for EPs, hospitals, and vendors under many circumstances. Examples include:

  • EMRs malfunctioning due to design flaws or interactions with other systems;
  • users creating workarounds or using features incorrectly;
  • hospitals failing to carefully evaluate EMR functionality prior to implementation;
  • ED providers receiving inadequate training or failing to participate.

Not uncommonly, an ED patient’s bad outcome can be traced back in some way to the EMR. If so, multiple parties may find themselves defendants in malpractice litigation.

“It is unlikely that a hospital, administrator, or EMR designer would be held responsible in a lawsuit simply because the EMR was poorly designed,” says Sandeep Mangalmurti, MD, JD, a member of the American College of Cardiology’s board of trustees working group on medical professional liability insurance. It is a different story if the EMR actually malfunctioned. “For example, if it failed to flag a patient’s allergies, then I suspect liability concerns would be broader,” Mangalmurti says. There are some factors one can use when determining who is ultimately found liable:

ED providers. EMRs “invite and induce human errors in numerous ways. The vendors have been collectively very imperfect, and sometimes actually careless,” says Michael Victoroff, MD, department of patient safety and risk management at COPIC. The order-entry system of some EMRs facilitated 22 different types of medication error risks, according to the results of one study.1

“The notion that EMRs help to reduce errors may not always be true,” says Edward Monico, MD, JD, assistant professor in the department of emergency medicine at Yale University School of Medicine. One reason is that EPs sometimes rely on previously documented history and parts of the exam without concern for its accuracy. In this manner, says Monico, “EMRs allow physicians and other care providers to perpetuate mistakes.”

Still, a mere documentation error is not enough for a successful lawsuit; an ED patient must be harmed because of it. “Documenting a physical exam component, which did not in fact take place, may not result in liability if it can be shown that the error did not give rise to the damage alleged,” Monico offers.

However, cases with sloppy, inaccurate charting are very difficult to defend. “False documentation can still result in charges of fraud,” Victoroff notes.

In a recent paper, author Linda Harrington, PhD, DNP, RN-BC, argued that many problematic EMR issues are wrongly blamed on users.2 “Misattribution of the causes to users delays resolution and prolongs the problems and associated risks,” says Harrington, a professor at Baylor College of Medicine in Houston.

ED providers must navigate numerous screens and menus to find potentially life-saving information and remember what data are needed and where to find that data. This reliance on memory, says Harrington, “increases EMR-associated cognitive load, which is well-documented to result in negative consequences.” Calling attention to these EMR shortcomings can backfire quickly on the ED defense team. EPs would have to admit they continued to work despite the risk to patients. “Would you work for a year in a hospital where you knew the sterilizer didn’t work reliably?” Victoroff asks. “Whose fault would that be?”

Harrington argues that ED providers have a right to expect that EMRs are functioning appropriately and contain minimal or no risk to patients and themselves. “Clinicians are not hardware or software safety experts,” Harrington notes. “And where exactly would [EPs] work, as the vast majority of hospitals have EMRs, all with known deficits?”

A peer review process can allow ED providers to air safety concerns about EMRs in a forum largely protected from legal discovery. “This isn’t for covering up bad practice, but it’s to allow sincere and open criticism without mincing words,” Victoroff offers.

The hospital. It is unknown how often hospitals are named in claims based on EMR design or function. “There are anecdotes, but we should probably assume many of these events settle off the record,” Victoroff says.

For hospitals to reduce risks, Mangalmurti advises that the selection and implementation of EMRs should be led by the people using them, not by administrators who do not appreciate all the clinical issues. Further, EDs should use clinical decision systems that are up to date with the latest guidelines.

Plaintiffs can bring the hospital into the claim by arguing that due diligence was not conducted, that the EMR was not vetted carefully before it was purchased, or that the system was not tested well enough before implementation. This is because the hospital has a duty to buy, use, and maintain equipment in good working order. “This is one weakness the jury may find in the ‘we have lousy equipment’ claim,” Victoroff cautions.

The vendor. “It’s stranger every year that plaintiffs do not seem to have figured out how to reach into the deep pockets of the vendors,” Victoroff laments.

Indemnification clauses are one way vendors insulate themselves from malpractice litigation. The “learned intermediary” defense doctrine holds that the manufacturer fulfilled its duty upon providing all necessary information to the hospital, a “learned intermediary,” which then interacts with the consumer of the product. Despite this, says Victoroff, “nothing is ironclad in contract law.” Victoroff is unaware of any ED malpractice cases in which hospitals have overcome these challenges and held vendors legally responsible.

“But one thing docs need to know is that their malpractice insurance almost certainly excludes coverage from anyone they indemnify,” Victoroff says. This means that when hospitals or EPs sign the contract stating they will “hold harmless” the vendor, any defense expenses are coming out of their own pocket.

Some hospitals are negotiating limitations on liability with vendors. “There has been a move away from boilerplate contracting with EMRs,” says Deborah E. Ballantyne, JD, a risk management analyst at the ECRI Institute. In any case, Ballantyne says it is possible a vendor could be held liable for an EMR’s design flaw — unless it was part of a modification requested by the hospital.

“The harm suffered by an ED patient may or may not be causally linked to the EMR,” Ballantyne says, noting that unless the treatment decision was a direct result of the design flaw, liability would remain with the EP. “What comes to mind is an error where the EMR consistently misidentifies lab results. If abnormal results do not generate an alert to the ED provider, the defense may have a valid argument that the EMR was at fault, and the vendor should be liable.

During malpractice litigation, it often becomes apparent that the EMR made it difficult to access important data, such as allergy information that requires multiple clicks to view. It can be hard to distinguish something the patient told a triage nurse minutes ago from years-old medical history. Auto-populated data also can create erroneous records. “These could be persuasive arguments, but may not hold the same weight as a design flaw,” Ballantyne adds.

To place liability squarely on the vendor, the hospital would need to demonstrate that the EMR was more complex to use than advertised or did not perform according to specifications. “The hospital is responsible to fully vet the EMR system,” Ballantyne notes.

The vendor could argue that user errors can be eliminated with training, raising questions about whether the hospital provided enough education to ED providers. “Training records would likely be reviewed for staff and clinicians who treated the patient at issue,” Ballantyne says.

Previously documented complaints about EMR usability, if brought into evidence, could support the EP’s contention that the EMR contributed to harm. However, this argument would not deflect liability from the hospital. “The hospital was in control of which type of EMR system was implemented,” Ballantyne explains.

The plaintiff may not even be aware that the EMR was the cause or contributing factor in the patient’s injury or death at the time the lawsuit is filed. This raises the possibility of the defendants bringing in the vendor as a third-party defendant. “Or, in the case where the vendor was also a defendant, the provider defendant would file a cross-claim, asserting whatever theories of liability fit the facts,” Ballantyne says.

According to Ballantyne, the vendor could face liability if the design flaw was known to the vendor and not disclosed or discoverable during vetting. Also, the vendor could be held liable if the design flaw provided incorrect information and that information was the primary basis for a medical decision. Ultimately, Ballantyne says, “The EP cannot delegate medical decision-making to a computer program.”

REFERENCES

  1. Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005;293:1197-1203.
  2. Harrington L. Electronic health record-related events in medical malpractice claims: User error versus use error. J Patient Saf 2018; Mar 8. doi: 10.1097/PTS.0000000000000286. [Epub ahead of print].