Informed Consent

Where there's a will there's a way, as the saying goes, and that's becoming evident in the rough-and-tumble world of medical malpractice lawsuits. As caps on malpractice damages become increasingly common, plaintiffs are instead looking at physicians' failure to obtain informed consent as another possible lawsuit for patients who believe they've been wronged medically.

But when you think of (and treat) obtaining consent as a true extension of the physician-patient relationship, rather than part of a long checklist of things to accomplish during each patient visit, you go a long way toward increasing patient satisfaction as well as strengthening your legal position should such a case be brought against you.

What's the law?

We hope that, during a patient visit, you're not mulling over the legal ramifications of what you're doing. Of course, you want to -- and should -- be concentrating on giving the best care. But it may help you to know some background surrounding the informed consent process.

In most states, and except in emergencies, the treating physician must get the consent of the patient (or an authorized designate, like a parent or guardian, healthcare power of attorney, or family member) before performing any diagnostic procedure or medical treatment. The process is designed, in part, to protect patients against "unauthorized touching" during a medical examination or surgery, which is considered battery. And because battery is an intentional tort, it's subject to punitive damages in many states. 

While the consent requirements vary from state to state, generally the patient must be given specifics about the procedure; its risks, benefits, and likely outcomes; alternative treatments; and what likely will occur if the recommended procedure is not performed.

Know the boundaries

There are, of course, exceptions to every rule, including this one. You are not required to obtain the patient's consent before administering treatment in certain limited circumstances, including medical emergency; if the patient has waived consent; and to protect the public health (for example, mandatory smallpox vaccinations or AIDS testing in certain situations). When a patient needs urgent care and is unable to consent, most states allow treatment without prior consent if you've made reasonable attempts to contact the next of kin.

Also, in this situation, the care you provide should not exceed what's required to alleviate the emergency. A classic case of exceeding consent is operating on the wrong body part; however, courts have become more creative when deciding scope of consent. For example, you may be permitted to undertake other procedures "deemed necessary and appropriate" during a procedure if the conditions were unknown at the time the consent is signed.

This allows you to address the actual cause of the patient's complaint by, for example, removing an intestinal growth causing the symptoms of appendicitis rather than removing an otherwise healthy appendix. 

When treatment is refused

On the flip side of the coin, and just as important as your duty to obtain consent, is the patient's right to refuse treatment. Most states recognize that, in the absence of an overriding interest by the state (which may include suicide prevention or protection of viable fetuses), a competent adult can refuse "intrusions upon his person" even though the purpose of treatment is to sustain his life. The courts of most states will intervene, however, making consent unnecessary when a parent refuses to permit a blood transfusion, for instance, or a woman refuses to undergo a Caesarean section that could save her viable child. 

Although a patient may withdraw consent anytime before the start of a procedure, it is rarely an issue in the surgical setting; however, the discharge "against medical advice" is a common type of consent withdrawal in the hospital setting and always should be carefully documented with the patient's signature.

Consent: doing it right

What informed consent isn't? Simply having the patient sign a preprinted form listing treatment risks and alternatives. Rather, think of (and practice) consent as a process of information exchange and an opportunity to educate the patient.

Keeping in mind variations at the state level, here are some guidelines for obtaining consent:

• The physician who will perform the procedure should review the consent form with the patient and witness the patient's signature. This ensures that someone who knows what consent was given will be available when the procedure is performed (and, if necessary, to testify in court).
• Document any questions the patient asks as well as the answers you give. This will help defeat any claim that the patient was told to "just sign the form."
• List any foreseeable negative outcome, however unlikely. If death ever has occurred from this procedure, disclose it as a risk. On the other hand, don't include the same risks for all procedures. This could support the argument that you didn't obtain valid consent because the "real risks" of the particular procedure weren't disclosed.
• If you obtained consent well before the treatment, update it so that it is closer to the treatment date. The same applies to in-office care -- update a patient's consent for any regular treatments when updating health history or insurance information. 
• Have customized forms. Remember that each procedure requiring consent must have its own form, with its own individual listing of risks and benefits, possible outcomes, and alternatives.
• Review the consent with all personnel in the treatment room before the procedure begins and place a copy of the consent in the patient's chart before beginning the procedure.
• Ensure copies of advance directives (living wills or do-not-resuscitate orders, for instance) are in the medical record. These are needed to show that you didn't withhold care inappropriately, and that the patient's refusal to consent to treatment was honored.

Not blanket protection

Understand that obtaining consent does not shield you from malpractice liability; it only removes the patient's ability to allege battery. Finally, informed consent is not HIPAA consent. All procedures implemented in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) relate only to the release of protected health information and have nothing to do with consent to treatment. Just because a person consents to treatment does not mean he has the right to release records related to that treatment.

For example, in most states, grandparents (either in their own right or because they are standing in loco parentis) are permitted to consent to treatment for their minor grandchildren. However, they would not, under HIPAA, be permitted to authorize the release of protected information about their grandchildren.

In patients' records, any written treatment consent should be separated from any consent to release health information obtained under HIPAA.

By viewing informed consent to treatment as a process of information exchange, rather than as simply getting a patient's signature on a form, you and your staff can move toward a more consistent way of obtaining it. And when you (and your patients) understand the protections offered by the process, you're likely to decrease the risk of misunderstandings and lawsuits. And that's always a good goal to have.

Barry Herrin is an attorney and partner in the
Atlanta office of Smith Moore LLP, and is board certified
in healthcare management by the American College
of Healthcare Executives. He can be reached at
(877) 404-7466, barry.herrin@smithmoorelaw.com, or editor@physicianspractice.com.

Trish Markus is an attorney and partner in the Raleigh office of Smith Moore LLP, and is the immediate past president of the North Carolina Society of Healthcare Attorneys. She can be reached at (800) 569-5740, trish.markus@smithmoorelaw.com, or editor@physicianspractice.com.

Consent with a Tech Twist

During my residency in the mid '70s, the professors hammered home the same mantra: "Document everything. If it's not written it didn't happen."

Today, as a practicing urologist, I still realize the value of their advice, especially as it relates to informed consent to treat.

The process typically includes a conversation between a patient and a physician, with basic consent-to-treat documents. Many times, these generic documents are generated just before the proposed procedure or treatment, when the patient has little opportunity to review and understand what they say. Besides, the traditional consent document is merely a statement that the patient has previously consented to treatment by the physician-- it contains no specifics relative to the given procedure such as risks or alternative therapies.

Now, technology is making it easier for practices to manage this ubiquitous and sometimes tedious process -- and take it a step further.

Software applications can automatically generate detailed, customized consent documents for thousands of procedures, including patient education materials, illustrative anatomical images, and pre-procedure instructions. An electronic patient signature can be stored in the record. When treatment is complete, patients receive discharge information, post-procedure instructions, and drug information pamphlets. This helps you address individual health needs and concerns to enhance a patient's understanding of and satisfaction with the treatment.

Consider this approach to standardizing informed consent communications across your practice and ensure each patient receives the same standard of care. You've documented it; it happened; and you've created a safer environment for you and your patients.

James E. Gottesman, MD, is a practicing physician and medical director of Atlanta-based Dialog Medical, a provider of informed consent and patient education systems. He can be reached at jgottesman@dialogmedical.com.

This article orioginally appeared in the April 2005 issue of Physicians Practice.