Defend non-compliance with guidelines in chart

The plaintiff’s attorney will use it against you

If the reason you didn’t comply with a clinical guideline isn’t explained in the chart, a case alleging medical malpractice suddenly will become much harder to defend.

“It is important to show both your clinical reasoning and that there was an adequate reason to deviate from the guideline,” says Jonathan M. Fanaroff, MD, JD, associate professor of pediatrics at Case Western Reserve University School of Medicine and co-director of the Neonatal Intensive Care Unit at Rainbow Babies & Children’s Hospital, both in Cleveland, OH.

For example, some guidelines recommend when a sepsis evaluation should be performed on newborns, as well as when antibiotics should be started. “If antibiotics are not started and there is an adverse outcome as a result, there could be liability,” says Fanaroff. While some physicians are simply unaware of guidelines, others disagree with the reasoning and elect a different course of treatment, he explains.

A relevant clinical case was decided by the Mississippi Court of Appeals in 2006 involving a patient who was injured in a car accident and sustained burns to 18% of his body, as well as a severe inhalation injury.1 The patient developed a bedsore and sued for malpractice, claiming that the hospital was liable for failing to turn him once every two hours to prevent bedsores, as recommended in national guidelines as well as the hospital’s own policy.

“The defense countered that guidelines are by definition suggestions and not strict requirements, and that nurses and physicians have discretion to deviate from the guidelines if such a departure is warranted by the patient’s condition,” says Fanaroff.

The physicians noted that every time the patient was turned to his side, his airway clearance was obstructed and his saturation would plummet. They decided that keeping the patient in the supine position gave him the best chance to stay alive.

The court agreed that this was not negligence, noting that “...it is clear that [the hospital’s] decision to turn [the patient] less often than suggested by its internal guidelines was a product of reasoned medical analysis.”

Fanaroff says a case such as this one could be more defensible with documentation such as, “Patient noted to have airway obstruction and desaturations whenever he is turned to the side. As a result, we are unable to turn him.” It shows the rationale behind the decision-making, he says.

“If following the guideline doesn’t make sense for a particular patient, the physician needs to document why they are choosing a different diagnosis or treatment option,” he advises. (See related stories on what items to document if you’re intentionally deviating from guidelines, below, whether guidelines establish the legal standard of care, and whether guidelines will be admitted into evidence, below.)

Reference

  1. Vede v. Delta Regional Medical Center 933 So.2d 310 (Miss. Ct. App. 2006).

Sources

For more information on non-compliance with guidelines, contact:

  • Patricia Egan Daehnke, JD, Managing Shareholder, Bonne, Bridges, Mueller, O’Keefe & Nichols, Las Vegas Office/Shareholder, Los Angeles Office. Phone: (702) 383-9888 or (213) 738-5896. Email: pdaehnke@bonnebridges.com.
  • D. Clark Smith, Jr., JD, Smith Moore Leatherwood, Greensboro, NC. Phone: (336) 378-5442. Fax: (336) 433-7447. Email: Clark.Smith@smithmoorelaw.com.
  • Jonathan M. Fanaroff, MD, JD, Associate Professor of Pediatrics, School of Medicine, Case Western Reserve University, Cleveland, OH. Phone: (216) 844-3387. Fax: (216) 844-3380. Email: jmf20@case.edu.

Deviating from guidelines? Take these steps

If you are intentionally deviating from nationally accepted guidelines, consider these risk-reducing practices given by D. Clark Smith Jr., JD, an attorney at Smith Moore Leatherwood in Greensboro, NC:

• Make explicit notes in the chart as to why you are taking the course of action you are prescribing and why you are deviating from the usual course.

“This should be explained sufficiently to answer any questions by anyone reviewing the chart, either simultaneously or in retrospect,” says Smith. He advises including these items:

  • objective findings;
  • subjective findings;
  • test results;
  • diagnoses;
  • the usual course of treatment, based on guidelines;
  • the reason this case is different and calls for a different course;
  • acknowledgement of guidelines and their source;
  • a detailed explanation of the different course of treatment you are prescribing and why it is preferred;
  • an explanation of the outcome you are trying to obtain with the different course of treatment.

Smith defended a physician in a medical malpractice case who had to explain why general guidelines weren’t followed for a particular patient.

“Unfortunately, he did not document this position in the chart,” he says. “I believe the case could have been avoided if he had done so, because he won the case after he explained his position in court and had experts support him.”

For this reason, it is important for physicians to acknowledge their knowledge of a guideline and then state why they are not following it, says Smith. “This will help tremendously to convince a jury that the physician was competent and was intentional about his course of treatment, and not that he inadvertently failed to follow a guideline of which he was unaware,” he explains.

• If you are familiar with a peer-reviewed journal article that supports your position, reference it in the medical record.

• Obtain second opinions from other physicians, and document their agreement with the prescribed course.

Physicians should request a formal consultation, says Smith. They explain the potential conflict between the prescribed guideline and their alternate course of treatment and the reasons for consideration of the alternate treatment, he says. They specifically should ask the consultant’s opinion as to which way to proceed, Smith says.

If an informal consult is given, physicians should explicitly describe any discussions they had with other physicians, the identity of the physicians, the facts discussed, and the conclusions reached, he advises. “It is quite possible the consultant may not want to go on record because of fear of liability,” says Smith. “This should be a strong indication to the attending of the position experts will take against him if the matter ends up in litigation.”

This approach should help to persuade the physician to follow the guidelines instead of an alternate course of treatment. “In other words, if the attending cannot get support from other physicians and/or consultants for his position to ignore the guidelines, he should abandon his position,” he says.


Can guidelines prove breach in standard of care?

Be warned: The plaintiff’s experts might say that is so

Guidelines, per se, cannot be used to establish the standard of care, as this must be established by an expert, says D. Clark Smith Jr., JD, an attorney at Smith Moore Leatherwood in Greensboro, NC.

However, if the expert incorporates the guidelines into his or her opinion of the standard of care, they then can be used to establish standard of care, he adds. For example, the American College of Obstetricians and Gynecologists (ACOG) has published guidelines and committee opinions for several years. Smith has seen many plaintiff experts testify that these guidelines and opinions are the same as the standard of care in a particular locality. This effectively allowed the ACOG guidelines and opinions to become a statement of standard of care in that particular case, he explains.

This action occurred in spite of the cautionary language in each guideline or opinion that the document reflects emerging clinical and scientific advances as of the date issued and is subject to change, and that the information should not be construed as dictating an exclusive course of treatment or procedure to be followed, notes Smith.

“I have likewise had defense experts who argued the ACOG guidelines were just that — guidelines — and they were not to be interpreted as standard of care because they cannot define the acceptable conduct in every case and must be interpreted under the specific facts of the particular case,” he says.

Guidelines often are used against defendant physicians by getting them established by a plaintiff’s expert as the standard of care, explains Smith. “The expert then will explain how the defendant deviated from following the guideline and will opine that the failure to follow the guideline is a deviation from the standard of care, which of course equals malpractice,” he says.

Prove standard of care

Non-compliance with clinical guidelines “absolutely does not mean that the standard of care was breached,” says Jonathan M. Fanaroff, MD, JD, associate professor of pediatrics at Case Western Reserve University School of Medicine and co-director of the Neonatal Intensive Care Unit at Rainbow Babies & Children’s Hospital, both in Cleveland, OH.

“It is important to remember that standard of care is a legal concept and must be proven in every individual case,” he underscores. In addition, many guidelines have specific disclaimers noting that they do not indicate an exclusive course of treatment or serve as a standard of medical care.

“Finally, there clearly are situations in clinical medicine where deviating from the recommendations of the guideline will be appropriate,” Fanaroff says.

Physician defendant’s response

Guidelines can be used against a physician if he or she failed to follow a guideline and the plaintiff’s testifying expert opines that the standard of care required the physician to do so, says Patricia Egan Daehnke, JD, managing shareholder in the Las Vegas office and shareholder in the Los Angeles office of Bonne, Bridges, Mueller, O’Keefe & Nichols.

“The weight to be given to the guideline depends in great part on how the plaintiff’s expert testifies,” she says.

The physician defendant might respond by pointing out that guidelines do not replace a physician’s clinical judgment, are not intended to be the action to be taken in every case, and that the guidelines were created for a different purpose.

The standard of care is generally defined as that level of skill, knowledge, and care in diagnosis and treatment that other reasonably careful medical practitioners would possess and use in similar circumstances, not what an organizational checklist sets forth, adds Daehnke.

“And of course, the physician would present testimony as to his or her awareness of the guidelines and expert testimony as to the reason why the standard of care did not require such action be taken, whether set forth in a guideline or not,” she says.


Will guidelines be admissible?

They’re both a ‘sword and a shield’

Usually, it is the plaintiff who seeks to admit evidence of physician noncompliance with certain guidelines as evidence of malpractice, says Patricia Egan Daehnke, JD, managing shareholder in the Las Vegas office and shareholder in the Los Angeles office of Bonne, Bridges, Mueller, O’Keefe & Nichols. However, several states have allowed physicians to introduce evidence of compliance with relevant guidelines to show the physician met the standard of care.

Whether the jurors will be allowed to hear evidence of proffered guidelines depends to a large degree on the law the jurisdiction uses regarding the admissibility of expert opinions and the individual trial judge, Daehnke explains.

If the testifying expert attests that the guidelines are “reliable authority and relevant” or that the expert relied upon the guidelines in formulating his or her opinion as to the applicable standard of care, and the trial judge ultimately deems the guidelines relevant to the standard of care issues in the case, for example, the guidelines will be introduced into evidence.

Quality varies

Guidelines appear to be key to the U.S. government’s efforts to enhance the quality of clinical care, as evidenced by the Agency for Healthcare Research and Quality’s investment in the development of clinical practice guidelines, says Daehnke.

In addition, clinical practice guidelines have proliferated over the last decade from government agencies, professional medical societies, managed care groups, the insurance industry, other healthcare payers, and peer-review organizations.

“However, these guidelines vary in scope and quality,” says Daehnke. “Most are designed to meet the needs of the promulgating organization, rather than defining the applicable standard of care for the clinician.” For example, guidelines created for utilization review by payers or those promulgated by specialty societies sometimes conflict with other standards.

“Thus, there is a strong argument to be made that guidelines do not, nor should not, define the standard of care,” says Daehnke. “Nonetheless, in litigation and at trial, guidelines may be used as both a sword and a shield.”