EXECUTIVE SUMMARY

The standard of care is at the heart of most malpractice allegations, but often disputed. Internal policies and procedures must allow clinicians to follow the standard of care.

• Advancing technology can create standard of care pitfalls.

• Some policies should avoid defining a particular standard of care.

• Consider litigation trends when writing policies and procedures.


Many malpractice cases hinge on whether the defendant’s policies and procedures were consistent with the standard of care, and whether clinicians adhered to those policies and procedures. The first part should be fairly straightforward because, after all, it’s only a matter of writing the standard of care into the hospital’s policies, right?

That’s not always as easy as it sounds.

Defining the standard of care in any clinical situation is an ongoing challenge, says Kenneth N. Rashbaum, JD, partner with the Barton law firm in New York City, who has tried dozens of malpractice cases. He also has worked extensively in compliance related to electronic medical records and artificial intelligence.

“It’s the whole reason we have malpractice trials, so we can argue about the standard of care,” he says. “If you adhere too closely to what was the standard of care in 2016, but this is 2018 and nobody has updated your internal standard because you’re too busy treating patients, you’re in trouble. It’s not something you can establish one time and you’re done.”

Policies and procedures that rely on a standard of care must be reviewed every few months to ensure they are still valid, Rashbaum says. In some cases it will be possible to write evergreen policies that refer clinicians to the current standard of care in their fields, whatever that is at the moment, rather than defining it for an internal document that can become outdated.

There also can be situations in which clinicians within an organization cannot agree on the standard of care. In those cases, the solution may be only to state that clinicians are expected to use their best judgment and refer to the professional bodies and research that can guide them, Rashbaum says.

“There are situations in which the standard of care is truly controversial, and you have a case in which expert A says this and expert B says that. The textbook was outdated on the day it was published, so you don’t have a clear answer,” he says. “Trying to create a policy that says you must do X in this situation only creates problems. Writing these policies is more of an art than a science sometimes.”

Wealth of Data Can Create Risks

Keeping current with the standard of care is increasingly difficult as clinical care and technology advance at a rapid pace, Rashbaum says.

“You can be damned if you do and damned if you don’t. If you use the latest technology and rely on it excessively, you can be liable for that — but the converse is true if you don’t rely on it enough,” he says. “The standard of care is evolving particularly with technology and there are no hard and fast rules about what you should use and how much you should depend on it, other than the older technology that is clearly accepted.”

For instance, Rashbaum notes that clinicians now have more access to data than ever before and no one has yet determined how much they are obligated to include in their patient care decisions. A physician can be criticized because, in hindsight, he or she had access to relevant information but did not use it, Rashbaum says.

Access to information can lead to standards that are set unreasonably high. Beware of any policy or procedure that requires a clinician to access all available data for any particular patient or to always review the records of any set of patients.

“It’s a problem,” he says. “If you set up a policy to say you must review all outpatient records of any patient coming in to the hospital, and it’s midnight in August under a full moon and it’s raining patients, you just can’t do it. Now you don’t meet your own standard and the plaintiff is going to go to town on that.”

Avoid Outmoded Standards

There also is the danger of setting internal expectations based on outmoded standards of care. This can result in insufficient internal policies and procedures; for instance, when a clinical standard does not represent advances that provide better outcomes, or they may be outdated in how they require the use of care steps that are now known to be unnecessary or dangerous.

However, the standard of care can become almost a secondary concern if you don’t follow your own policies and procedures. The worst malpractice risk is not following a policy that is in place, Rashbaum says.

“The plaintiff is going to hound you on the fact that you didn’t even meet your own internal standards. These were standards that you freely established for yourself as signifying the proper way to care for a patient, so you can’t even say that you were doing things in the way you thought proper,” he says. “You put it on paper as saying this was what you think is proper care, and then you didn’t do it. That is deadly for the defendant.”

Include Counsel in Policy-writing

Risk managers and clinical leaders always should involve legal counsel in the establishment of policies and procedures, Rashbaum says, preferably with actively practicing malpractice defense attorneys. Unfortunately, that does not happen as regularly as it should, he says.

“These are the folks who have the in-the-trenches experience in terms of what is trending in the courts and what is the current standard of care,” Rashbaum says. “The legal counsel who are in court regularly can tell you that certain policies, or the way you have certain systems set up, are going to be problematic if you have to go to court.”

Rashbaum gives an example of how electronic medical records and computerized ordering systems commonly include prompts that question a clinician’s orders for drug dosages or other care inputs. Those prompts can improve patient safety and outcomes, but there will be times when the clinician needs to override the prompt and proceed as originally intended.

“The question is whether the record includes an override field to explain why you did it. If there isn’t, how are you going to remember why you overrode that when the lawsuit comes in three years later?” Rashbaum asks. “The prompt is technically a standard of care. If you have overridden it, haven’t you deviated from the standard of care and nicely documented for the plaintiff that you did so?”

On the other hand, clinicians may be criticized for following the computerized prompt when there were other clinical signs indicating they shouldn’t have, Rashbaum says. That is why policies must be carefully written to avoid requiring clinicians to comply with prompts that are at odds with their own best judgment, and why overrides must allow or even require a contemporaneous justification.

“When I talk to the IT folks at hospitals about this, they’re like a deer in headlights, especially if this is a proprietary system. They say, sure, they had input from legal experts before they went online, but it was all legal licensing and IT legal,” Rashbaum says. “No input from lawyers with trial experience.”

Reasonableness Is Expected

The question in most healthcare litigation will be what the plaintiff could have reasonably expected from a typical hospital or provider, says David S. Waxman, JD, partner with the law firm of Saul Ewing Arnstein & Lehr in Chicago. If something is important enough that a hospital needs to write a policy or guideline for it, then it is important enough for someone to perform the research to find out what others do, he says.

“You have to know what the state of the science is, and to assess whether their hospital’s policy is in accordance with both the marketplace and the science. It’s best, from a legal standpoint, not to be an outlier,” Waxman says. “Thorough and well-documented research ensures that policies meet this standard.”

Waxman notes a recent North Carolina case in which clinicians followed internal policies and procedures, but the plaintiff alleged that they did not meet the standard of care. In Johnson v. Wayne Memorial Hospital, Inc., the plaintiff claimed that the hospital’s policy on when a radiologist should overread an emergency room physician’s X-ray interpretation allowed too much time to pass.

The defendant prevailed when the plaintiff’s expert witness could not establish what the standard of care was, or what surrounding hospitals did in those situations. (See the story in this issue for more on that case.)

If the plaintiff had retained a better witness or the expert had conducted some supportive research, the hospital would have been in the position of proving that its policy complied with the standard of care, Waxman says.

“This could have been done, for example, by showing what similar hospitals do under the circumstances. It could have been done by showing how physicians are taught to handle such a situation,” he says. “For example, they might have shown what North Carolina teaching hospitals do about radiologist availability, or it could have been done by referring to the specialty care organizations for radiologists and emergency physicians, which have authored relevant guidelines.”

Hospitals and their departments should regularly review their policies and ensure that they are consistent with current medical literature and best practices. This is especially true when there are changes in thinking on how to address a particular condition, such as the changes regarding when to administer tPA in the ED, Waxman says.

“Outdated guidelines, in the hands of a skilled advocate on the other side of litigation, pose great danger for a hospital when an adverse patient care outcome occurs, and when the hospital’s policy is a step behind the current science,” he says.

SOURCES

• Kenneth N. Rashbaum, JD, Partner, Barton LLP, New York City. Phone: (212) 687-6262. Email: krashbaum@bartonesq.com.

• David S. Waxman, JD, Partner, Saul Ewing Arnstein & Lehr, Chicago. Phone: (312) 876-7867. Email: david.waxman@saul.com.