INFORMED REFUSAL

INFORMED REFUSAL Legal Requirements, Best Practices, and Recent Changes to Texas Law April Blackmore, JD and student midwife

Session Outline • Texas Laws and How They are Made • Elements of Informed Choice and Refusal • Best Practices • Changes to Texas Midwifery Laws • Application to Practice—Likely Scenarios • Discussion and Questions

Texas Laws: How and When They Are Made • Statutes: Occupations Code, Health and Safety Code, etc. • Created and amended through the legislative process • Every two years • Best place to have an impact is in committee • People with wide variety of education and experience have a say • Rules: Administrative Code • Created by TDLR (Midwifery Board) • Rulemaking: ongoing process that does not depend on legislative cycle • Rulemaking process includes public comment period • Best place to have an impact is developing language and during public comment process

ACOG Committee Opinion: Refusal of Medically Recommended Treatment During Pregnancy “ When a pregnant [person] refuses medically recommended treatment, [the] decision may not result in optimal fetal wellbeing, which creates an ethical dilemma for [the midwife]. In such circumstances, the [midwife’s] ethical obligations to safeguard the pregnant [client’s] autonomy may conflict with the ethical desire to optimize the health of the fetus. The [midwife’s] professional obligation to respect a pregnant patient’s refusal of treatment may conflict with his or her personal values. Forced compliance—the alternative to respecting a patient’s refusal of treatment—raises profoundly important issues about patient rights, respect for autonomy, violations of bodily integrity, power differentials, and gender equality. Coercive interventions often are discriminatory and act as barriers to needed care.”

Elements of Informed Choice • A thorough explanation of the treatment in question • Benefits and risks of treatment, including the likelihood of success • Alternatives to treatment • Benefits and risks of no treatment, including worst case scenarios • Client has mental capacity to understand • Consent or refusal must be freely given • No coercion, undue influence, or threats

ACOG Committee Opinion No. 664 “Most important is the acknowledgement that informed consent is an ongoing process, not an event or a signature on a document, and involves a willingness on the part of the [midwife] to engage in open, nonjudgmental, and continued dialogue.”

Barriers to Informed Choice • Language Barriers • Differing Communication Styles • Timing and Need for Quick Decision • Fear of Legal Repercussions • Fear of Bad Outcome • “Beneficence-based duty to the woman with beneficence-based motivation to the fetus” • Provider Bias • Religious • Cultural • Educational • Experience

Informed Refusal Best Practices • Acknowledge that no outcome can be predicted with certainty • Affirm the client’s assessment of her own interests (personal, family, social, community) • When trying to resolve the situation, consider: • Validity of the evidence regarding potential outcomes • Severity of the prospective outcome • Burden or risk to the client • Degree of urgency • Client’s clinical understanding • Cultural, social, or value differences • Power differential • If the midwife can continue care within the scope of licensure, • Reassure the client that care plan will be honored • Continue to communicate well with the client to ensure collaboration • Do not judge or blame the client for the treatment decision • Important to keep personal feelings out of the situation. Midwife may feel offended, rejected, frustrated, frightened, or angry. Keep those feelings away from the client • Document, document, document! • If there is a bad outcome, provide resources and counseling if possible. Seek debriefing.

What to Document • The need for treatment: plain language discussion • Risks and Benefits of proposed treatment • Alternatives with risks and benefits • Possible consequences of refusing treatment • Client’s informed refusal • The reasons stated by the client for refusal • Proposed next steps?

Keys to Good Communication for Informed Refusal • Ask the client to explain her reasoning, her experience, and her values • Try to understand the context of the client’s decision • Avoid making assumptions • Acknowledge the importance of the client’s knowledge and values • Religious or cultural beliefs • Assessment of varying interests (self, family, fetus, community) • Misunderstanding of clinical situation • Experience of family or friend

RESPECT Communication Model • Rapport: See the client’s point of view. Avoid assumptions • Empathy: Remember client has come for help. Acknowledge and legitimize client’s feelings • Support: Ask about barrier and care. Involve family if appropriate. Reassure client you are willing to help • Partnership: Be flexible about control. Negotiate roles. Remind client you are working together • Explanations: Check for your own understanding. Use verbal clarification • Cultural Competence: Respect cultural beliefs; be aware of own biases; know your limitations in discussing medical issues across cultures; understand when your own communication style may not be working • Trust: Self-disclosure is difficult for many clients; keep working to establish trust; trust the client; trust birth

Emergencies • Fully informed consent may not be possible • Client retains the right to an UNINFORMED refusal • If patient is incapacitated or unconscious, “presumptive consent” may be used but only if care is critically necessary and client preference is unknown • Surrogate decision-maker should be used before presumptive consent • A previously documented or expressed refusal should be honored

Effect of New Rule ChangesRules go into effect May 1, 2019 • Client Refusal to Accept a Referral: expansion of midwife ability to continue client care • Client Refusal of a Non-emergency Transfer: creates options and obligations for continuing midwifery care • Subcategory: 42.0 Weeks and No Labor: options and obligations for continuing midwifery care • Client Refusal of Emergency Transfer: Creates new exception and legal loophole to doctrine of Client Autonomy; provides midwife with nuclear option • Client Refusal of Eye Prophylaxis: No longer necessary to get written exemption from parents

Client Refusal to Accept Referral§115.1. Definitions (new definitions). • (6) Collaboration--The process in which a midwife and a physician or another health care practitioner of a different profession jointly manage the care of a woman or newborn according to a mutually agreed-upon plan of care. • (8) Consultation--The process by which a midwife, who maintains responsibility for the woman's care, seeks the advice of a physician or another licensed health care professional or member of the health care team of a different profession. • (19) Referral--The process by which a midwife directs the client to a physician or another licensed health care professional who has current obstetric or pediatric knowledge and who is working under the supervision and delegation of a physician. • (22) Transfer--The process by which a midwife relinquishes care of the client for pregnancy, labor, delivery, or postpartum care or care of the newborn to a physician or another licensed health care professional who has current obstetric or pediatric knowledge and who is working under the supervision and delegation of a physician.

Client Refusal To Accept Referral§115.111. Coordinating Care with Other Health Care Providers. (a) A midwife shall consult with, refer to, collaborate with, or transfer to an appropriate healthcare provider or facility in accordance with the Act and this chapter. (b) If a client who is at low risk of developing complications elects not to accept a referral or a physician or associate's advice, the midwife shall: (1) continue to care for the client after discussing and documenting the risks in the midwifery record, which shall include informing the client that her condition may worsen and require transfer; (2) seek a consultation; (3) manage the client in collaboration with an appropriate health care professional; or (4) terminate care. (c) If a midwife administers any prescription medication to a client or her newborn other than oxygen and eye prophylaxis, the midwife must do so in accordance with standing delegation orders from and under the supervision of a physician. The midwife shall ensure that the orders are current (renewed annually) and comply with state law and the rules of the Texas Medical Board.

Client Refusal to Accept Referral (subset)§115.114(d) Prenatal Care (d) If a client has reached 42.0 weeks gestation and is not yet in labor, the midwife shall immediately either: (1) collaborate with a physician and obtain appropriate antenatal testing, in order to continue midwifery care; or (2) initiate transfer and document that action in the midwifery record. *Department, through consultation with the Midwives Advisory Board, has determined that the risks associated with continued gestation at 42.0 weeks require the advice and assistance of a physician. The commenters seem to misunderstand the intent and effect of the proposed rule. Section 115.1(12) already defines “normal childbirth” as “the labor and vaginal delivery at or close to term (37 up to 42 weeks) of a pregnant woman whose assessment reveals no abnormality or signs or symptoms of complications.” This definition already created the requirement of transfer at 42 weeks, but it left some ambiguity about what is meant by “42 weeks.” The proposed rule more clearly draws the line at “42.0 weeks” while also adding the option of continuing midwifery care through collaboration with a physician and appropriate antenatal testing. Therefore, rather than limiting the options for midwifery care, the proposed rule is actually expanding the options for midwifery care.

42 weeks; No Labor. What now? • “37 up to 42 weeks” comes from the definition of “Normal childbirth” in Section 115. 1. Definitions • New law adds Section 115.114(d) that attempts to broaden the scope of practice to permit the midwife to continue care beyond 42.0 weeks. • Elements • Client reaches 42.0 weeks with no labor • Midwife MUST collaborate with a physician AND obtain testing OR • Initiate transfer AND document that action

Client Refusal to Transfer for Non-emergency§115.112. Termination of the Midwife-Client Relationship. A midwife shall terminate care of a client only in accordance with this section unless a transfer of care results from an emergency situation. (1) (No change.) (2) The midwife may terminate care for any reason by: (A) providing a minimum of 14 [ 30 ] days written notice, during which the midwife shall continue to provide midwifery care[, to enable the client to select another health care provider]; (B) making an attempt to tell the client in person and in the presence of a witness of the midwife's wish to terminate care and the date that care will be terminated; (C) providing a list of alternate health care providers [referrals]; and (D) documenting the termination of care in midwifery records. (3) If a client elects not to accept a non-emergency transfer, the midwife shall: (A) terminate the midwife-client relationship; or (B) manage the client in collaboration with a physician or another licensed health care professional who has current obstetric or pediatric knowledge and who is working under the supervision and delegation of a physician.

Client Refusal to Transfer in Emergency§115.113. Transfer of Care in an Emergency Situation. (a) In an emergency situation, the midwife shall initiate emergency care as indicated by the situation and immediate transfer of care by making a reasonable effort to contact the health care professional or institution to whom the client will be transferred and to follow the health care professional's instructions; and continue emergency care as needed while: (1) transporting the client by private vehicle; or (2) calling 911 and reporting the need for immediate transfer. (b) It is an emergency if, during labor, delivery, or six hours immediately following placental delivery, the midwife determines that transfer is necessary and the client refuses transfer. The midwife shall call 911 and provide further care as indicated by the situation. The midwife shall not provide any further care after the arrival of emergency medical service (EMS) personnel but may do so if required by EMS personnel.

Transfer of Care in Emergency • Section 115.113(b) creates a loophole in the Informed Refusal doctrine • Creates a new legal ability for a midwife to declare an emergency for “refusal to transfer” • Elements • Situation must occur during labor, delivery, or six hours following placental delivery • Midwife must determine transfer is necessary • Client must refuse transfer

Transfer of Care in an Emergency Situation • Midwife Actions • Make the determination that transfer is necessary • Discuss the situation using all the elements of Informed Choice • Client must make a valid refusal • Midwife calls 911 • Midwife continues to care for client until EMS arrives • Midwife does not provide any further care unless requested by first responders. Midwife can decline

Transfer of Care in an Emergency Situation • Unknowns of New Law • What is labor? • What happens if client refuses to transfer with EMS? • What happens if EMS leaves? • Ethics are in a grey area. Creates exception to doctrine of client autonomy • Communication is key to avoiding this situation • The use of this new law is completely optional!

115.119(b) Eye Prophylaxis A midwife in attendance at childbirth who is unable to apply prophylaxis as required by Section 81.091, Health and Safety Code, due to the objection of the parent, managing conservator, or guardian of the newborn child does not commit an offense under that section and is not subject to any criminal, civil, or administrative liability or any professional disciplinary action for failure to administer the prophylaxis. The midwife in attendance at childbirth shall ensure that the administration of eye prophylaxis, or the objection of the parent, managing conservator, or guardian is entered into the medical record of the child. [must obtain a written exemption from treatment in accordance with Health and Safety Code 81.009 from any parent who refuses to allow a midwife to administer or cause to be administered eye prophylaxis in accordance with Health and Safety Code, 81.091.]

Summary: Informed Refusal New laws must be read together because they depend on each other. Can’t pick and choose. Client can always refuse midwife’s treatment suggestion, referral to another provider, or to transfer. BUT the midwife’s obligation changes depending on the situation. • Refusal of Referral: Midwife can continue to care (and document in the record), consult, collaborate, or terminate • Termination: Midwife must give 14 days notice, notify in person, and provide referrals • Refusal to Transfer Non-Emergency: Midwife must collaborate or terminate care • 42.0 weeks: Midwife MUST collaborate or transfer. Not enough to document client refusal of antenatal testing. • Refusal to Transfer Emergency: Triggered by client refusal to transfer ONLY in labor, delivery, or 6 hours after placenta AND midwife determines transfer is necessary; midwife must call 911, continue care until EMS arrives, may continue care if requested. NOTE: Department comment that the midwife is not authorized to continue care in this situation because it is not longer “normal” and thus falls outside midwife’s scope

INFORMED REFUSAL