The Legalities of Cone Beam Imaging
When a patient requires an imaging procedure, there are several underlying scenarios that are part of the process. These events have a complicity of legal implications. The legal implications may vary from one jurisdiction to another, regardless of whether one is referring to national, state/provincial, county/ parish, city, or municipality. The intent here is to describe legal processes that can establish guidelines consistent with good quality healthcare delivery.
Imaging procedures are required to evaluate the presence or absence of a disease state or to perform the craniofacial morphometric analyses necessary to develop dentoalveolar and craniofacial treatment plans. The latter are frequently indicated to evaluate craniofacial esthetic and functional relationships.
The indications for a cone beam computed tomography (CBCT) scan are usually associated with some degree of morbidity, hence there is an element of risk associated with either performing or abstaining from the procedure. These associated risks may be from either the physical harm from the procedure, the potential morbidity of a misdiagnosis, or the potential morbidity from a failure to diagnose. Physical harm from imaging procedures is related to the harmful biologic effects of ionizing radiations. These risks are very low and are discussed in another chapter. Legal issues associated with misdiagnosis and a failure to diagnose, as well as disclosure and informed consent and adequate documentation, are discussed here.
The utilization of any diagnostic procedure, including cone beam imaging, should be ordered and performed based on a sound knowledge of the potential diagnostic yield of the procedure. Due to the increased popularity of and excitement generated by this imaging modality, cone beam imaging is often thought of as the “gold standard” for craniofacial imaging. It is expected by novices to provide a solution to every diagnostic need. As with every diagnostic procedure that may be potentially harmful, cone beam scans should be ordered and performed when there is justification that the benefits of the examination outweigh the possible risks (European Academy of Dento- Maxillofacial Radiology). It is the duty of the oral health professional to be educated as to the diagnostic potential and to the possible benefits as well as risks of this technology.1,2
The auxiliary personnel involved in all the stages of image acquisition (patient referrals, patient history, patient preparation, image acquisition, and data- handling) must have received the appropriate education and training for proper technique and for radiation safety and protection measures for the patient as well as for the operators. Similarly, training is imperative for the dental professionals who will utilize the acquired data. Proper image selection for the diagnostic task at hand and proper reconstructions in order to yield the required information is frequently the result of training and experience together. CBCT is becoming part of the routine curriculum in most accredited graduate dental programs. Accredited continuing education courses are also available to practicing clinicians. These courses are readily found through routine Internet- based search engines. An example of one resource is listed in the reference section.3
DISCLOSURE AND INFORMED CONSENT
When an imaging procedure is requested for a patient, the patient must be given specific information about the procedure. The legal process of informing a patient about the medical procedure is referred to as disclosure. The patient is informed of the imaging procedure indicated and then the need and benefits associated with the procedure. The patient must also be informed of any harm or side effects from the procedure (biologic harm), as well as the risks associated if a disease is not diagnosed because the procedure is not performed or the patient refuses the procedure. The patient must also be informed of other possible diagnostic tests or alternate diagnostic procedures that may be available instead of the imaging procedure, for example ultrasound, standard computed tomography, serum analysis, etc. Patients must also be permitted to ask additional questions to clarify their understanding of the information that has been presented.
If this degree of disclosure has been performed, the patient has been presented with adequate information to be better informed to make a decision on whether or not to give his or her consent for the imaging procedure. The process of informing the patient with this degree of information is the knowledge base necessary for a patient to give informed consent. The components of informed consent are summarized in Box 1.1.
Box 1.1 Summary of inclusions necessary for the process of informed consent
a. the imaging procedure and the purpose of the procedure
b. potential benefits of the procedure
c. risks to the patient’ s health if the procedure is performed
d. risks to the patient’ s health if the procedure is not performed
e. opportunity for the patient, legal guardian or trustee to ask for additional information or for clarifications
From Iannucci and Howerton.19
Box 1.2 Factors that contribute to negligence with informed consent
a. lack of patient (legal guardian or trustee) consent
b. consent from a minor
c. consent from an inappropriate (illegal) guardian
d. consent from an individual under emotional duress or under the influence of drugs or alcohol
e. consent based on fraudulent or incorrect statements
f. d isclosure from unqualified (non-licensed) personnel
From Iannucci and Howerton.19
The basic tenet of informed consent is that the clinician supplies adequate medical and dental knowledge necessary for the patient to make an intelligent decision on whether or not to undergo the recommended imaging procedure. Since the written documentation of this process should be in the patient’ s record, this is best achieved with a written consent form. The informed consent (if given) is confirmed with the patient’ s signature and is often also signed by at least one witness. This consent often serves as a legal document if it contains disclosure and is obtained freely.
After an appropriate disclosure, a patient may decide to decline the procedure. In such instances, the clinician’ s ability to treat the patient may be compromised. If the dentist’ s treatment will be compromised by the lack of essential diagnostic data, the patient should be so informed. In these situations where the “untrained” patient dictates the course of the diagnostic workup and treatment and this limits the diagnostic ability of the clinician, it is often best to terminate further professional interaction.
Procedures performed on a patient without their consent is not considered good practice, that is, is negligent behavior, and is susceptible to a legal claim of malpractice. Negligence in most jurisdictions means the failure of a healthcare provider to act as an ordinary reasonable healthcare provider would act in the same or similar circumstances. This means that the act or action taken would not be performed by a reasonable clinician. In litigation scenarios, negligence may also mean failing to do something that a reasonable clinician would not do in a similar situation.
Although it may be subject to legal and professional opinion, there are several situations in which negligence can be legally determined. These situations are outlined in Box 1.2. Each situation is subject to legal and professional opinion before the decision of negligence is made.
WRITTEN DOCUMENTATION FOR AN IMAGING SCAN