The Expanding Requirement For Informed Consent in the Practice Of Dentistry
Two years ago it was reported the Pennsylvania Superior Court determined a dentist must obtain a patient's informed consent prior to performing a root canal procedure. At that time, it was noted this requirement represented a significant expansion of the Informed Consent Doctrine in relation to dental practices. It was further noted such an expansion often marks the beginning of a series of changes that could have a significant impact on practices.
The area of informed consent continues to receive attention by the Commonwealth's appellate court. In addition, the Pennsylvania Legislature and the State Board of Dentistry have taken actions that if passed, will impact a dentist's requirement to obtain informed consent. See Patient Alert Pennsylvania Dental Association dated ____________. As a result, now is an appropriate time to revisit the concept of informed consent.
The last time I addressed the issue of informed consent in this publication, it was in the context of an analysis of a single specific legal case. This article will highlight the major principles involved in informed consent and offer some practical suggestions how a practitioner can comply with their obligation and in turn limit their exposure from a disgruntled patient.
Informed Consent-The Battery Concept
Pennsylvania remains one of the few states that adheres to a battery concept when analyzing a patient's claim for lack of informed consent. Under current Pennsylvania law2, any unlawful or nonessential touching constitutes a battery. Therefore in a dental practice, where a patient is in a non-emergency setting and is physically and mentally capable of discussing their medical condition and treatment, for the touching (treatment) to be consensual, it must be "informed".
Not every touching or treatment requires informed consent. There are still requirements that the touching be associated with a surgical or operative procedure.3 Therefore, routine physical examination, x-rays and injections have all been found not to require informed consent. The two most frequently cited dental treatments requiring informed consent are extractions and root canals. Whether the requirement could be expanded to the treatment of cavities remains a possibility. As does the issue of routine cleanings.
The analysis of whether the consent is informed applies a prudent patient standard. In other words the dentist must "advise the patient of the material facts, risks, complications and alternatives to surgery that a reasonable person in the patient's situation would consider significant in deciding whether to have the operation. . . The goal of informed consent is to provide the patient with material information necessary to determine whether to proceed with the given procedure or to remain in the present condition".0 In distilling this requirement, the practitioner must recognize the test is not what he or she may feel is important but, instead, what a reasonable patient would want to know about the procedure regarding its risks, complications and alternatives. If a practitioner is in doubt whether a certain piece of information needs to be disclosed, it is often times better to error on the side of caution and make the disclosure.
Effective use of disclosure can limit the occurrences of disgruntled patients. If patients are fully aware of the risks and limitations of a procedure they are less likely to be dissatisfied should one of the disclosed events occur.
Suggestions For Fulfilling Informed Consent Requirements
The foregoing identifies the concepts behind the requirement for informed consent. However, they are less than crystal clear in advising a practitioner what exactly must be disclosed. Even in cases where need for informed consent is clear, i.e. extractions or under the new regulations, use of nitrous oxide, there is not a magic laundry list of the risks that must be disclosed. As a result, the practitioner must be diligent in educating themselves so as to properly advise his or her patients. The following are some suggestions that will assist in this endeavor.
Stay on Top of Your Procedures
In order to provide your patients with the information they need, you must be aware of it. With advances in treatment modalities there are changes in the way procedures are performed, the alternatives that exist and possibly the known complications. You must be aware of the current state of these matters. A recognition by the dental community of a heretofore unknown complication can render your previously acceptable informed consent practice deficient. You can satisfy this step by effectively using your continuing education credits as well as utilization of appropriate dental journals.
Document It
Although historically there has not been a requirement that a patient obtain a writing informing them of the required information, this is not the case in relation to the new requirements for use of sedation. Both the proposed amendments to the dental law and the new proposed regulations require that the patient be given written informed consent instructions.
Even absent the proposed statutory and regulatory requirements, it is good practice to make use of an appropriate informed consent form. Not only does the writing supplement the information given verbally, it serves as a stark disclosure of the information. By requiring the patients to read the form and attest that they have done so, the practitioner eliminates a signification portion of the possible claims a patient can make.
A form placed into the patient's chart which the patient has signed provides the best defense to an allegation that they were not adequately informed. Although it does not eliminate possible allegations that the patient did not understand the form or was not given sufficient time to comprehend the nature of the procedure, these allegations are tremendously weakened by proper use of a comprehensive form.
In addition to use of an informed consent form, practitioners should get in the habit of including in their patients records a notation regarding the fact the patient received information pertaining to the risks, complications and alternatives. Such notations are helpful should the practitioner be called upon to recall of the events several years later as often occurs in malpractice suits.
Substance Of the Form
There is no perfect informed consent form. Nor are there any specific elements that must be in the form. There are however several examples of forms available which you can use to tailor your specific form. The best documents comprehensively identify specific risks as well as provide a mechanism for the disclosure of other case specific information. They should require a signature and date and should require a recognition that the patient has read and understands the information.
Timing
This concept actually involves two issues; when in relation to a procedure should the consent be obtained? and how often must it be obtained in relation to repeated procedures?
In relations to the first, it is not essential that the consent be obtained the same day as treatment. The only requirement is obviously it must be obtained sometime prior to the treatment. Good practice would dictate that it be obtained close enough to the treatment that the information would still be known and understood by the patient. By way of example, if a patient is seen complaining of pain and a determination is made that extraction is the preferable treatment, informed consent can be obtained that day even though the procedure will have to be scheduled in a week.5Steps to defeat such a claim can be taken through wording of the form ("I hereby attest that I have read and understood the foregoing information and that nothing is interfering me executing this form knowingly and voluntarily" or words to that effect) and by conveying the information to someone in addition to the patient (perhaps a spouse or parent). If on the other hand, during a routine visit a need for a root canal is determined and the appropriate information given and the patient leaves without making a commitment only to return in a year requesting the root canal, the informed consent should be re-obtained.
Practitioners often asks whether they must obtain a patients' informed consent each time a particular procedure is performed. The feeling why it might not be needed is that the patient already knows the information. Despite this position, for a number of reasons it is desirable to get the informed consent for each treatment6. First, the known complications or alternatives may have changed since the last treatment. Second, the patient's individual circumstances may have changed since the last treatment. Repeating the informed consent process will increase the likelihood that these new conditions will be revealed. In addition, creating the requirement informed consent be obtained each and every time will assist in developing a procedure in the office that will minimize the chances a procedure will be performed without an appropriate informed consent. Simply stated, if there are no exceptions to the requirement of informed consent, the greater likelihood the practice will become habitual. Finally, a practitioner's defense to an allegation of lack of informed consent will be bolstered should the patient's chart reflect that the consent was given numerous times.
Parents Must Be Involved
In Pennsylvania, baring the existence of an emergency situation, the consent
of a parent or guardian must be obtained prior to the rendering of medical treatment
to an un-emancipated minor (less than 18 years of age). Similarly, if the minor
is unable to consent to the treatment they are also incapable of providing the
required informed consent. Therefore, in cases of treatment of individuals under
the age of 18, your office's informed consent procedure must include providing
the information to and, obtaining the consent from, the parent or guardian.
The foregoing are some general guidelines to consider when implementing your office's informed consent procedure. It is not intended to address every nuance or the specific facts of your individual practice. As you move forward with implementing or refining your office's procedure, you should avail yourself to the advise of counsel who routinely advise you regarding your practice. In addition, your malpractice carrier may offer risk management services that can provide advice and assist you in complying with your informed consent requirements.