Document ‘informed refusal’ just as you would informed consent

A parent refused pneumococcal vaccine for her infant. Later, the infant died of overwhelming pneumococcal sepsis from a strain in the vaccine, and the parent sued the physician.

At trial, the parent and physician both acknowledged that the vaccine was recommended, but the parent stated that the risk of death wasn't mentioned during the discussion. If it had been discussed, she stated, the infant would have received the vaccine. A verdict was awarded to the plaintiff for failure by the provider to warn of the risk.

Most physicians are aware of the concept of informed consent, but many states now recognize “informed refusal” as well.

A legal basis on informed refusal is found in Truman v. Thomas, 1980. A patient elected not to have a Pap smear because of cost. The physician did not disclose the risks of not having the test, and later the patient died from metastatic cervical cancer. The court concluded that the physician had a fiduciary duty to explain the potentially fatal consequences of the patient’s decision to forgo the test.

Generally, parents have broad legal protections to decide on care for their children, even if there may be a negative consequence of that decision, unless there is a direct threat to the child’s life.

Parental refusal of care or medical recommendations for a child is common, even when the treatment may be lifesaving. For example, vitamin K refusal in newborns has increased dramatically. A recent study showed that 3% of hospital deliveries and up to 30% of birthing center deliveries in Tennessee declined this simple therapy despite an 80-fold increased risk of vitamin K deficiency bleeding in unprotected newborns (http://bit.ly/2OroXpx).

Among parents who refuse, 70% state they have gotten information about vitamin K from the internet, though one-third do not know that the risk of bleeding is a consequence of failure to provide vitamin K to newborns. Parents who refuse vitamin K for their newborns need to be informed refusers of this treatment, and providers must be a central part of that process.

Similarly, 2% of the nearly 4.3 million infants born annually in the United States do not have small blood samples taken from their heels during the first week of life for newborn screening tests, largely due to parental refusal for religious or other reasons. They pose another potential medical liability risk for providers (http://pedsinreview.aappublications.org/content/32/11/490).

Since Truman v. Thomas in 1980, many states have reaffirmed the principle of informed refusal and several additional cases have supported the idea; no states have rejected the concept.

The requirements of informed refusal are the same as informed consent. Providers must explain:

• the proposed treatment or testing;
• the risks and benefits of refusal;
• anticipated outcome with and without treatment; and
• alternative therapies, if available.

Documentation of this discussion, including all four components, in the medical record is critical to mounting a successful defense from a claim that you failed to warn about the consequences of refusing care.

Since state laws vary, it is good practice to check with your malpractice carrier about preferred risk management documentation. Generally, the facts of these discussions should be included and signed by the caretaker. This conversation and documentation should not be delegated to other members of the health care team. At least one state has affirmed through a Supreme Court decision that informed consent must be obtained by the provider performing the procedure and not another team member; it is likely the concept of informed refusal would bear the same requirements.

Perhaps the most common scenario for practicing pediatricians is a parent refusing immunizations or altering the recommended vaccine schedule. The percent of pediatricians who reported encountering parents who refuse to have their children immunized with one or more vaccines increased from 75% in 2006 to 88% in 2013 (http://bit.ly/2QqeEza).

As the vignette above shows, the provider has a duty to inform about both risks and benefits when a parent refuses an immunization. In this case, the physician ordering the vaccine is responsible, not the nurse administering it.

The AAP Refusal to Vaccinate form can be used to document informed refusal in the medical record (see resource). It clearly lays out the consequences of vaccine refusal. Providers should not accept alternate forms or allow parents to redact portions of the form.

If a caretaker refuses to sign, the document still should be included in the patient record with a note stating the information was discussed with the patient.

Continuing care for a patient who refuses to acknowledge the informed refusal is an individual decision by each practice (or physician).

This concept also can apply to patients or their parents/legal representatives reluctant to take recommended medication, receive therapy, or obtain lab or radiographic testing.

Documentation in the record of the recommendation, potential consequences and outcomes, and the alternatives (if available) should be stated clearly.

Takeaway points

• Pediatricians regularly encounter parents who decline care for their children, which may result in severe medical consequences.
• Claims of failure to warn of these consequences have been successfully litigated against physicians.
• Clearly documented informed refusal creates a record of the interaction between patients/parents and providers, and can show that the provider performed his or her duty to fully inform them of risks associated with refusals.
• Use the AAP Refusal to Vaccinate form each time a vaccine is refused; consider similar documents for other areas where refusal is common (i.e., vitamin K refusal in the newborn nursery).
• Note in the medical record when parents have refused newborn screening tests during the first week of an infant’s life. If possible, obtain copies of signed informed refusal forms from your state or birth hospital.

Dr. Scibilia is a member of the AAP Committee on Medical Liability and Risk Management.