Obstetrics and Gynecology: Frequently Asked Patient Safety Questions
- Are there guidelines for obstetricians/gynecologists doing cosmetic procedures, such as laser hair removal, injectable fillers, vaginal rejuvenation, and liposuction?
- The American College of Obstetricians and Gynecologists (ACOG) issued a policy statement on the obstetrician/gynecologist’s role in cosmetic procedures: “The obstetrician/gynecologist may provide services that fill a need not adequately met in commercial sites, provide safer or more efficacious treatments than those available in nonmedical settings, or provide services as a convenience to patients. Obstetrician/gynecologists who offer procedures typically provided by other specialists should possess an equivalent level of competence.”1
If litigation arises from the performance of a cosmetic procedure, the physician will be held to the standards of the specialty that govern that procedure. Obstetrician/gynecologists who intend to offer cosmetic services should notify The Doctors Company.
- When is the proper time to address consent issues that might arise during labor and delivery, such as C-section and operative vaginal delivery?
- The best time to address concerns about the birth process is during the prenatal period rather than during the stresses of labor and delivery. A written consent form should be used to document the informed consent process and should be an integral part of the prenatal record. Be aware that the mother may revoke her consent at any time.
- When using a consent form for vaginal birth after cesarean (VBAC), how much information should the physician disclose regarding possible risks and complications?
- The consent form should list the common material risks, including the remote risk of serious disability or death to the mother or baby. When listing the risks, incorporate “the risks include but are not limited to…” or similar language to denote that it is not an all-inclusive list. Consider adding any risks that are applicable to patients with comorbidities, such as diabetes or obesity. See the VBAC consent form on our Informed Consent Samples for Obstetrics and Gynecology page.
- What does “immediately available” mean in ACOG’s VBAC guidelines?
- ACOG has not defined “immediately available” in this context, but it addresses facility capability that includes:
- A physician capable of performing an emergency C-section is onsite (in house) throughout active labor.
- Personnel capable of providing anesthesia for an emergency C-section are onsite (in house) throughout active labor.
- Designated operating room personnel—in sufficient numbers to staff an emergency C-section—are onsite (in house) throughout active labor.
“In house” implies that the providers are available to come at once, without delay. In some circumstances, in house may be extended to include the hospital campus. Likewise, the physician and anesthesia and operating personnel may not be involved in another activity that stops them from coming at once, without delay. This means that a dedicated physician, an anesthesiologist/anesthetist, and operating personnel must always be available. If any of these providers are involved in other activities that they cannot leave right away, an immediate backup must be available. The policy should be defined by the institution.2
- What is the physician’s responsibility when faced with a patient requesting a C-section (cesarean delivery on maternal request—CDMR)?
- The physician’s responsibility includes a complete discussion during the prenatal period of the benefits and risks of both vaginal and C-section deliveries. According to ACOG, “In the absence of maternal or fetal indications for cesarean delivery, a plan for vaginal delivery is safe and appropriate and should be recommended. After exploring the reasons behind the patient’s request and discussing the risks and benefits, if a patient decides to pursue cesarean delivery on maternal request, the following is recommended: in the absence of other indications for early delivery, cesarean delivery on maternal request should not be performed before a gestational age of 39 weeks; and given the high repeat cesarean delivery rate, patients should be informed that the risks of placenta previa, placenta accreta spectrum, and gravid hysterectomy increase with each subsequent cesarean delivery.”3 Document the rationale for the plan of care.
- Does a physician need to use an informed consent form for off-label use of drugs such as Cytotec for induction of labor?
- Yes. Obtain the patient’s written consent for any drug used in a manner not approved by the FDA, i.e., for a condition, in a dose, or by a route not listed on the label. Explain general information to the patient, including the manufacturer’s warnings, along with any ACOG affirmations regarding the drug’s safety and effectiveness. Address all patient questions and concerns. See the sample form titled Off-Label Use of (name of prescription drug) in our Informed Consent resource center.
- What is the physician’s responsibility when a parent requests confidential information about the treatment of his or her minor child (contraception, STDs, pregnancy, etc.)?
- The physician’s responsibility varies per state. Providers should be familiar with their state statutes. For state-specific information, please contact your patient safety risk manager at (800) 421-2368.
Establish a policy and procedure for treating minor patients. The policy should focus on protecting private information that the minor patient is entitled to keep from a parent or guardian.
- If a midwife is planning to perform a delivery under a physician’s supervision, who is responsible for obtaining the informed consent document?
- The person delivering the care (in this case, the midwife) is responsible for the informed consent process. The patient should be informed that if problems arise during the pregnancy, labor, or delivery, the supervising physician will be available to intervene and provide medical treatment as is deemed necessary. If this situation occurs, the supervising physician would be responsible for the informed consent process covering his or her involvement. For example, if a C-section becomes necessary, the physician would be responsible for obtaining consent from the patient for that procedure.
- What is the physician’s responsibility for follow-up on patients who have been ordered to have a yearly screening mammogram?
- The responsibility remains the same as for any tests ordered by the physician. All testing should have a tracking system. If results are not received within a reasonable time, contact the patient to see if the test was performed. The degree of physician responsibility depends on whether it is a routine screening or a diagnostic test. If a screening test is ordered, a simple reminder may be considered a reasonable follow-up attempt. However, if the test is indicated due to abnormal signs or symptoms, as in the case of a diagnostic mammogram, the physician is obligated to continue with the follow-up procedure until resolved. Detailed documentation is necessary for all follow-up attempts.
- American College of Obstetricians and Gynecologists. The role of the obstetrician-gynecologist in cosmetic procedures. College Statement of Policy. Reaffirmed July 2018. https://www.acog.org/-/media/Statements-of-Policy/Public/85CosmeticProcedCollege2018.pdf?dmc=1&ts=20191002T1825219681.
- American College of Obstetricians and Gynecologists. Vaginal birth after cesarean delivery. Practice Bulletin No. 205. January 24, 2019. (Replaces Practice Bulletin No. 184. August 2010.) (Interim update.) https://www.acog.org/en/Clinical%20Guidance%20and%20Publications/Practice%20Bulletins%20List.
- American College of Obstetricians and Gynecologists. Cesarean delivery on maternal request. Committee Opinion Number 761. December 20, 2018. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Cesarean-Delivery-on-Maternal-Request?IsMobileSet=false.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.