The Florida medical community has been left concerned and confused by the passage of the original Pelvic Exam Law of 2020. As we discussed in our past Blog, practitioners thought the law was too heavy and did not know how to implement it. Senator Lauren Book’s new bill, SB 716, sought to clarify consent by amending the original law. It entered into force on July 1, 2021.
The updated law revises the definition of “pelvic exam” and the situations in which consent is required for pelvic exams. Unfortunately, the new law still misses the mark in clarifying when consent is and is not required. Due to the persistent lack of clarity, it is critical that providers review policies and consent forms to ensure they understand what is expected of them when performing pelvic exams. Whether appropriate policies and consent forms have been not been implemented, now is the time to put them in place.
Definitions and requirements
The policy and procedures should specifically address the definitions and requirements described below.
- What constitutes a pelvic exam?
The definition of a pelvic exam has been clarified to indicate that it refers to “an examination of the organs of the body. female internal reproductive system using gloved hand or healthcare provider’s instruments. The term does not include “a visual assessment, imaging, or non-diagnostic medical or surgical procedure.” The law does not define what is meant by “non-diagnostic medical or surgical act”. This can lead providers to obtain consents for procedures that were not intended to require consents.
- When is consent required?
Consent is required before performing any pelvic exam. That is, unless an exception applies, as shown below.
Verbal consent and written consent are necessary before performing a pelvic exam on a conscious patient. Verbal consent alone is never sufficient.
Alone written consent is necessary before performing a pelvic exam on an anesthetized or unconscious patient, and for initial pelvic exams performed on a pregnant woman having contractions in a hospital or other facility licensed under Florida Chapter 395 (for example, emergency care center or outpatient surgery center).
- Who can give consent?
Verbal and written consent (unless only written consent is required as indicated above) must be obtained from the patient or her legal representative.
- Who is responsible for obtaining the required consent?
A health practitioner, medical student, or other student undergoing health practitioner training may not perform a pelvic exam on a female patient unless the necessary consent has been obtained, as described in section 2 above. Florida Law 456.001 (4) defines “health care practitioner” very broadly, as it includes, but is not limited to, various licensed professionals such as physicians, optometrists, massage therapists, physiotherapists, osteopathic physicians and allopathic physicians.
As with the original law, the updated law does not specify whether the practitioner is required to obtain consent personally, or whether it can be obtained by another person. A conservative approach is for the practicing practitioner to discuss the examination with the patients before obtaining the patient’s written consent. As we discussed in our previous blog, this practice reflects Florida Administrative Code 64B8-9.007 (1) for surgical consents, in which the doctor who will perform the surgery must explain the procedure to the patient and has a duty to obtain the informed consent of the patient before proceeding with the surgery. However, the physician is not required to be the person who obtains or witnesses the patient’s signature on the written form attesting to informed consent, which may be done by other medical personnel. Since the updated Pelvic Examination Act does not specify who is required to obtain consent, we recommend using the Surgical Consent Regulation as a guide.
- When is consent NOT obligatory?
Written consent is not required when the pelvic exam is:
- Court-ordered for the collection of evidence;
- Necessary for the provision of emergency services and care, as defined in Florida Statute 395,002 (9), which is defined as the medical screening, examination and evaluation by a physician or, to the extent permitted by applicable law, by other appropriate personnel under the supervision of a physician, to determine whether there is a emergency medical condition and, if done, the care, treatment or surgery by a physician necessary to relieve or eliminate the emergency medical condition, within the service capacity of the establishment;
- Necessary for a patient who has an emergency medical condition, as defined in Florida Statute 395,002 (8);
- Administered as a result of a child protection investigation conducted by the Department of Children and Families under Florida Chapter for Children’s Proceedings; Where
- Administered as a result of a criminal investigation into an alleged violation related to child abuse or neglect, under Florida law Status of human trafficking, or the Florida chapters for Sexual battery, Prostitution, Lust and indecent exposure, Child abuse, Where Obscenity.
A specific consent form is required
The consent form for a pelvic exam must be specific to pelvic examination and expressly identifies it. In addition, for a first pelvic exam performed on a pregnant woman having contractions, the consent form must “inform the patient that various pelvic exams may be done during her care and treatment at the facility.
Failure to obtain informed consent may result in criminal penalties if it is determined that it is drums. Administrative sanctions may also be brought against the healthcare professional, including revocation or suspension of their license, administrative fines and corrective measures.
Policies and procedures are required NOW
We recommend that healthcare professionals immediately review their policies and procedures to ensure that they correspond to the updated law. Staff will also need to be trained to ensure they understand the requirements.
Written policies and procedures should clearly describe:
- When written and verbal consent is required, and when only written consent is required;
- Who is responsible for obtaining consent? and
- How the health care professional performing the exam, if they do not obtain written consent directly, will be notified that consent has been successfully obtained before starting the exam.