Make Your Informed Consent “Bulletproof”

Strengthen your protection against litigation

By Jerry Helzner, Senior Editor

Ask any physician who has ever been sued for malpractice what it feels like when the news is delivered.

Physicians facing a malpractice charge are likely to report initial feelings of anger, guilt and disbelief, sometimes eventually leading to clinical depression, according to George W. Cibis, MD, writing in the Ophthalmic Mutual Insurance Company (OMIC) Litigation Handbook for the Ophthalmologist.

And physicians are being sued at an alarming rate. A recently released AMA survey encompassing 5,825 physicians reported that more than 60% of physicians currently in practice and above the age of 55 have been sued at least once. Though almost 65% of the claims were dropped or dismissed, 25.7% were settled, 4.5% were resolved through a dispute mechanism and 4.5% went to trial.

Given the high emotional and financial costs of being sued, ophthalmologists need to take every realistic step possible to prevent being the object of litigation. This not only includes using great care in the actual practice of medicine but also vigilance and planning regarding overall patient safety, dealing with emergencies and the all-important informed consent process.

This article will provide a number of ideas for strengthening your informed consent process, including some protective concepts that you may not have been aware of previously.

This is not an actual informed consent form. The language is derived from several sources.

Help from OMIC

Whether your insurance carrier is OMIC or another company, ophthalmologists should be aware of the wealth of overall risk management and specific informed consent advice (including sample forms) that is available on the OMIC Web site www.omic.org.

OMIC considers this advice so important that ophthalmologists who take its risk management courses can qualify for a reduction in their insurance premium.

The Consent Technologies informed consent uses a step-by-step touchscreen process that includes a voice-recorded consent.

In an OMIC paper titled “Obtaining and Verifying Informed Consent,” author Anne M. Menke, RN, PhD, an OMIC risk manager, offers a number of basic recommendations.

She begins by stating that the purpose of informed consent is “to honor the patient's right to make decisions about health care, ensure patient understanding and prevent allegations of lack of informed consent.” She writes that, “in general, the health care provider performing the diagnostic procedure or surgery must obtain informed consent for it. The duty to obtain informed consent cannot be delegated.”

Ms. Menke writes that informed consent begins as an oral agreement between the ophthalmologist and the patient reached after a discussion. The discussion includes the condition, recommended treatment or procedure, and the risks, complications, benefits and alternatives. The discussion should also include the consequences of refusing the recommended treatment or procedure. If the patient has any known risk factors that increase the likelihood of complications, side effects, or poor outcome, the ophthalmologist should explain these to the patient.

Ms. Menke cautions that this discussion should be conducted when the patient is alert and not feeling the effects of any medication that could interfere with the patient's ability to make a rational decision.

Added Risk in Elective Procedures

Ophthalmologists need to be especially careful in carrying out the informed consent process for elective surgeries.

“Most of the litigation involving elective eye surgery is not really based on negligence,” says Allen Stieglitz, CEO of Consent Technologies, which has recently introduced a computerized informed consent process that encompasses both audio and visual elements, “Most of these cases are because the patient didn't like the outcome.”

For elective procedures, Ms. Menke advises holding the discussion the day before the surgery.

“Some patients who had surgery the same day as the informed consent discussion have later sued for lack of informed consent,” she writes, “arguing that they were coerced into having the procedure and did not have time to weigh the risks and benefits.”

She advises that if the patient cannot be seen until the day of surgery because of transportation considerations or other issues, taking these few additional precautionary steps in advance will ensure that consent is “informed and voluntary.”

► Obtain information from a referring physician (if there is one), or directly from the patient via telephone or a questionnaire, about the patient's medical and ocular health. This will rule out contraindications to the procedure and screen for conditions that could affect the safety of the surgery or anesthesia (e.g., significant coronary artery disease, need for anticoagulants, etc.).
► Send the patient an unsigned copy of the procedure-specific form along with other educational information, and ask the patient to review the materials.
► At the time of the preoperative visit and consent discussion, address any questions or concerns, and ask the patient to sign the form.

Ms. Menke also offers other guidance regarding the informed consent discussion. For example, noting when a discussion is held in a language other than English by citing the language and the name of the translator, if a translator is needed. She also cites the necessity of documenting all specific patient questions and the answers provided.

However, the most complete and comprehensive informed consent discussion is worthless if it can't hold up when challenged by an unhappy patient. An ironclad informed consent process that will prevail in court is necessary to meet that challenge.

Informed Consent Documentation

The OMIC Web site provides a number of sample informed consent documents for specific ophthalmic procedures, but some ophthalmologists are looking for a documentation process that meets their comfort level.

Gary Wortz, MD, of Lebanon, Ky., is a young ophthalmologist who has been in private practice since 2008, having now expanded to four locations. While serving a residency rotation at a Veterans Administration Hospital in Lexington, Ky., he was impressed by the thoroughness of the hospital's informed consent process. The hospital used the iMedConsent (www.dialogmedical.com) package of 107 ophthalmology-specific informed consent forms and 100 patient-education documents covering eye health.

“I think OMIC does a great job and I certainly refer to their advice on risk management, but I decided that when I opened my own practice that I would use the iMedConsent materials,” Dr. Wortz says. “Their informed consents are comprehensive and require very little modification. There are also templates you can use for multiple procedures.”

Dr. Wortz says he likes the fact that the iMedConsent templates are highly specific. “There isn't much ‘fill in the blanks’ like you might see on some other templates.”

He uses the forms as part of the conversation with the patient. “I just go through the form with patients,” he says. “It's eliminated a huge worry for me.”

The cost of the complete iMedConsent package varies with the number of practice personnel, but for a single physician the price is $695 for the first year and $295 for annual renewals. Because Dr. Wortz's insurance carrier MedPro believes that iMedConsent can reduce the possibility of litigation, it offers its insured physicians a 30% discount on the cost of the iMedConsent package (this is not a discount on the insurance premium, only on the fee for iMedConsent).

Another Step in Documentation

More recently, a company called Consent Technologies (www.consenttec.com) began to offer an informed consent package that offers a relatively simple touchscreen format that allows a patient to view animations of 11 common ophthalmic procedures and record his or her understanding of what the procedure entails by touching the screen at various points in the presentation.

This format also includes a space for the patient's signature plus an opportunity to record the patient's voice as the patient avers that he or she is fully informed and aware of the procedure that will be performed.

“The voice recording is key to our informed consent process,” says Mr. Stieglitz of Consent Technologies. “In malpractice litigation, the first thing that is typically challenged is the informed consent. When you have the patient's own voice, there is no way he can say he didn't read it, he didn't understand it, it was too long or he had to sign to have the procedure done.”

The animations, which currently include such procedures as cataract surgery, intravitreal injections, LASIK surgery, YAG capsulotomy, ALT and SLT, can be viewed at home on a Web site by the patient, the patient's family and any caregivers. All of them are able to ask questions.

“This is a complete and thorough informed consent process that — if challenged — can prove that there was proper communication and that the patient was informed of all potential risks, complications and possible outcomes,” asserts Mr. Stieglitz.

Consent Technologies charges a practice a basic licensing fee for its informed consent product and an annual (per physician) maintenance fee. The company also provides storage for all of its consent forms.

“For almost any practice, the total cost of our product should be under $1,000 a year,” says Mr. Stieglitz, who anticipates obtaining discounts for his product from insurance companies that recognize its value as a risk management tool.

And while Eyemaginations (www.eyemaginations.com), a provider of in-office and Web-based patient education services, does not currently market a specific informed consent product, the company's compelling and informative animations of ophthalmic procedures can be shown to patients as a supplement to the practice's official informed consent procedure. Some ophthalmologists say they will show a patient the appropriate animation and document on the informed consent that the patient has seen this presentation and also understands and agrees to the procedure that will be done.

Assessing the Cost of Risk

It makes sense that ophthalmologists should place a high priority on having the best possible informed consent process, especially because general ophthalmologists do a greater percentage of elective procedures than physicians in most other specialties. Patients who are unhappy with the outcomes of elective eye procedures present one of the highest litigation risks to ophthalmologists.

Generally, the cost of upgrading a practice's informed consent process is not onerous and, as mentioned in this article, some insurance carriers do offer incentives to encourage participation in risk management initiatives. OM