Obstetrics and Gynecology: Frequently Asked Patient Safety Questions

Pamela Willis, BSN, JD, Senior Patient Safety Risk Manager, The Doctors Company

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 provider will be held to the standards of the specialty that govern that procedure.

Consult your state laws, regulations, and medical and nursing board guidelines on the role of advanced practice nurses, registered nurses, licensed practical or vocational nurses, physician assistants, and medical assistants in cosmetic procedures. States differ in the types of procedures permitted under a licensee’s or unlicensed assistant’s scope of practice.

If your ob/gyn practice intends to offer cosmetic services, notify The Doctors Company to ensure professional liability coverage.

The best time to address concerns about the birth process is during the prenatal period, rather than during the stresses of labor and delivery. Providing education and answering questions when a patient has the ability to think through information carefully can help patients understand the types of situations that might arise emergently during labor. Use a written consent form to document the informed consent process, and make it an integral part of the prenatal record. Be aware, however, that the mother may revoke her consent at any time. For a more detailed discussion of informed consent, see our article, “Informed Consent: Substance and Signature.”

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 physician will be available to intervene and provide medical treatment as is deemed necessary. If a situation occurs, the 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.

ACOG has not defined “immediately available” in this context, but it addresses facility capability with points that include:

  • “Trial of labor after previous cesarean delivery should be attempted at facilities capable of performing emergency deliveries.”
  • “Facilities must have the ability to begin emergency cesarean delivery within a time interval that best considers maternal and fetal risks and benefits with the provision of emergency care.”

Hospital obstetric and anesthesia committees should work toward agreement on what an acceptable definition of “immediately available” is for them. Counsel patients requesting TOLAC, and make them aware of available resources at their chosen delivery facility and “whether such resources match those recommended for caring for women electing TOLAC.”2

The provider’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.

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 our article, “Off-Label Use: Patient Safety Implications,” and our sample form, “Off-Label Use of Prescription Drug.”

The provider’s responsibility varies by state. Some states protect the confidentiality of patients as young as age 12. Providers should be familiar with their state statutes and the types of information they are required to keep confidential from a minor’s parent or guardian. Establish a policy and procedure for treating minor patients that focuses on protecting private information, including information found on patient portals.

The responsibility for follow-up remains the same as for any tests ordered by the provider—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 extent of provider responsibility for follow-up 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. If the test is indicated due to abnormal signs or symptoms, however, as in the case of a diagnostic mammogram, the provider is obligated to continue with the follow-up procedures until the patient obtains the exam or evidence of informed refusal is documented. Detailed documentation is necessary for all follow-up attempts. See our article, “Informed Refusal,” and the form, “Refusal to Consent to Treatment, Medication, or Testing,” in our Informed Consent Sample Forms.

For additional assistance, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or patientsafety@thedoctors.com.


References

  1. 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/clinical-information/policy-and-position-statements/statements-of-policy/2018/role-of-the-obstetrician-gynecologist-in-cosmetic-procedures 
  2. American College of Obstetricians and Gynecologists. Vaginal birth after cesarean delivery. Practice Bulletin No. 205. February 2019. https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2019/02/vaginal-birth-after-cesarean-delivery
  3. American College of Obstetricians and Gynecologists. Cesarean delivery on maternal request. Committee Opinion Number 761. January 2019. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/01/cesarean-delivery-on-maternal-request

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.

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