Irecently lectured on orthokeratology (ortho-k) along with three of my colleagues at the American Academy of Optometry meeting in San Antonio, and nearly all of the questions that I received afterward were about informed consent. This is a very important part of risk management in a practice, so let’s take a look at it in some detail.
Informed consent is a legal requirement as well as an ethical requirement that each demand certain elements for completion. In contact lens practice, informed consent is important because the lens modalities that we prescribe have benefits, risks, and alternatives. Therefore, under the informed consent doctrine that is now the standard of care in modern medicine, consents are needed. There are also times, as when using ortho-k for myopia control, when disclosures of clearance/approval—or lack there-of—are necessary.
Elements of Informed Consent
When crafting an informed consent document, one of the best practices is to audit your document against the Centers for Medicare and Medicaid Services (CMS) Hospital Interpretive Guidelines for Informed Consent, available at www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf . These guidelines are the basis for the standard of informed consent used throughout the United States. In addition, there may be state-specific guidelines that must be met. So, check with your State Attorney General’s website to see whether your documents comport with those state requirements.
A standard informed consent document needs to have several basic elements. First is provider demographics. These should clearly identify which provider is providing the service, procedure, test, or medical device. The provider demographics should also clearly describe the practice location(s) where the same will be delivered.
Second, there should be a short title describing the service, procedure, test, or medical device. Ideally, the Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) code(s) that most closely describes what you are providing to the patient would need to be included.
The third required element, under a title of “Description,” is a reasonably detailed description of the service, procedure, test, or medical device in question.
Following this Description, under a title of “Benefits,” should be a list of all of the benefits of the service, procedure, test, or medical device to be delivered.
Following the Benefits description, the next element, under the title of “Risks,” should be an exhaustive list of the risks of the service, procedure, test, or medical device in question.
Next, under a title of, “Alternatives,” include any reasonable alternatives to the service, procedure, test, or medical device to be delivered. Bullet-point lists may be more impactful and understandable as opposed to comma-delineated lists for these sections.
If there is anything to disclaim, such as an off-label use under the Food and Drug Act of a legend drug, medical device, or modality, include that next under a title of “Notice of Off-Label Use.” Make a special acknowledgement of this notice by including a place for patients to write their initials.
Finally, there should be a place for patient/guardian (for minor or incompetent patients) and witness names, signatures, and the date. It is a very good idea to have the document translated into the languages that you encounter in your practice. Prepare an informed consent for all contact lens services and all surgical codes that you use. CLS