Practice of Medicine

Article

Written Consent Required for Pelvic Exams in Florida

July 10, 2020

Updated October 16, 2020

In early October, the Florida Board of Medicine issued an eight-page order to clarify the law. The Final Order provides some clarity to three critical issues. 

  1. Does the pelvic examination bill informed consent requirement apply to the examination of biologically male patients?
    a. Board Opinion: The pelvic examination bill informed consent requirement does not apply to the examination of biologically male patients. 
  2. Does the performance of surgery, a medical procedure or treatment on the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or eternal pelvic tissues or organs for non-diagnostic purposes constitute a pelvic exam as defined in pelvic examination bill?
    a. Board Opinion: The performance of surgery, a medical procedure or treatment on the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or eternal pelvic tissues or organs for non-diagnostic purposes does not constitute a pelvic exam.
  3. Does a discrete visual examination of the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or eternal pelvic tissues or organs constitute a pelvic exam as defined in the pelvic examination bill?
    a. Board Opinion:  A discrete visual examination of the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or eternal pelvic tissues or organs does not constitute a pelvic exam as defined in the pelvic examination bill.

The Board did not offer an opinion on whether the pelvic examination bill requires separate written informed consents identifying by name the person(s) performing the examination every time a pelvic exam is conducted during the course of treatment or care for which the patient has presented or if the bill requires written informed consent in emergent situation where the patient is unable to consent and there is no legal representative of the patient available to provide the necessary consent.

This order applies to physicians in the practice of allopathic medicine. Additional review is being conducted and petitions for declaratory statements were also sent to the Boards of Osteopathic Medicine and Nursing.

MagMutual will continue to monitor the application of this new law and provide updated recommendations as more information and clarification becomes available.

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Updated August 20, 2020

On August 7, 2020, the Florida Board of Medicine considered a Petition for Declaratory Statement from the Florida Medical Association and several other physician groups regarding SB 698. The Petition asked the Board for clarity on numerous issues. The Board approved the following portions of the Petition, which will be finalized at the October Board meeting:

  • The Board will issue a declaratory statement that consent is only required for females based on the legislative history for SB 698.
  • The Board will issue a declaratory statement that consent is not required for non-diagnostic purposes (i.e., the insertion of a catheter or the taking of a rectal temperature).
  • The Board will issue a declaratory statement that consent is not required if the examination will be visual only, without physical contact of the pelvic anatomy.

We anticipate that legislation will be introduced next year to address these and other issues as well since the Board’s legal counsel has stated that the Board does not have the ability to draft rules or add exceptions to the statute. We will update this article as more information become available.

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Effective July 1, 2020, healthcare practitioners, medical students, or any other students receiving training as a healthcare practitioner who will be performing a pelvic examination must first obtain written consent of the patient or patient’s legal representative. This new legislation, Florida Senate Bill 698, defines pelvic examination as “the series of tasks that comprise an examination of the vagina, cervix, uterus, fallopian tubes, ovaries, rectum, or external pelvic tissue or organs using any combination of modalities, which may include, but need not be limited to, the healthcare provider’s gloved hand or instrumentation.”

The legislation further specifies that the informed consent cannot be general in nature but instead must be “executed specific to, and expressly identifying the pelvic examination.” This written consent requirement applies to all pelvic examinations, whether conducted in a hospital or office setting, and whether performed under anesthesia or on a fully conscious patient. However, there are two (2) exceptions to this written consent requirement. Written consent is not required where there is a court order for a pelvic examination for the collection of evidence or if the pelvic examination is immediately necessary to avert a serious risk of imminent substantial and irreversible physical impairment of a major bodily function of the patient (i.e., an emergency situation).

This new legislation applies to anyone doing a pelvic examination by gloved hand or instrumentation on a patient, including nurses, physicians, advanced practice providers, ultrasound technicians, residents, and medical students. Therefore, medical students and residents may continue to have an opportunity to practice this skill as part of their medical education, as long as the proper consent is obtained.

There may be significant risk for failing to obtain written consent before performing a pelvic examination. This bill creates felony and misdemeanor charges for “reproductive battery,” which is intentionally inseminating a woman with someone’s DNA without the woman’s consent. However, the bill is silent on the consequences for failing to obtain written consent prior to a pelvic examination. Providers should appreciate the potential for, at the least, disciplinary actions by the Florida Board of Medicine for failing to obtain written consent before performing a pelvic exam.

In addition to a lack of clarity on consequences, this new legislation is also silent on a few more key matters (listed below) and MagMutual, at this time, is recommending a conservative approach to compliance until further guidance on these matters is issued:

  1. Frequency in obtaining consent: There is no clear guidance whether the written consent is required before every pelvic exam or if it can be obtained annually or episodically. This distinction is especially important for OB/GYN practices and hospitals treating pregnant patients. From a risk management perspective, we recommend obtaining written consent before every pelvic exam performed for all patients except laboring mothers, who may provide written consent for that episode of care. 
  1. Catheter insertion: There is currently no guidance regarding whether inserting catheters in a patient would fall under the bill’s definition of a pelvic examination. Our current recommendation is to obtain written consent before inserting any type of catheter.
  2. Gender considerations: Although the impetus for this bill appears to arise from concerns around female patients, the bill’s wording does not exempt any patient gender from these requirements. Of note, the bill’s definition of pelvic examination includes rectal exams. Thus, it is recommended to apply the bill’s requirements to all patients (female, male, transgender, etc.) needing pelvic examinations.
  3. Specialty specific impact: It is clear that OB/GYN, family practice and internal medicine specialties will be affected by this bill, but other specialists may also be impacted, such as pediatricians and radiologists performing external pelvic tissue exams or imaging. And, potentially urologists and gastroenterologists performing rectal exams. At this time, we recommend that all specialists performing external pelvic exams, including those of the rectum or any imaging involving the pelvic region, obtain written consent prior to the procedure.
  4. Identifying the examining healthcare provider(s): There is no specific guidance about including the name of the healthcare provider(s) conducting the pelvic examination in the written consent form. From a risk management perspective, it is recommended to include the name of the provider(s) performing the examination rather than generally listing the name of the practice.

Finally, no specific consent form language has been mandated by the state. The Florida Medical Association has developed a sample written consent form that can be used until further guidance is made available.

MagMutual will continue to monitor the application of this new law and provide updated recommendations as more information and clarification becomes available.

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The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.