1. (a)

   1. (1) The LLM may provide midwifery care according to the protocols in this part only to healthy women, determined through a physical assessment and review of the woman’s health and obstetric history:

      1. (A) Who are at low risk for the development of medical or obstetric complications of pregnancy or childbirth; and
      2. (B) Whose expected outcome is the delivery of:

2. (i) A healthy newborn; and

   1. (ii) An intact placenta.
   2. (2) The LLM shall be responsible for care of the healthy newborn immediately following delivery and for the first fourteen (14) days of life (unless care is transferred to a physician or APRN specializing in the care of infants and children before that).
   3. (3) After fourteen (14) days the LLM is no longer responsible and the client should seek further care from a physician or an APRN specializing in the care of infants and children.
   4. (4) If any abnormality is suspected, including, but not limited to, a report of an abnormal genetic/metabolic screen or positive antibody screen, the newborn must be sent for medical evaluation as soon as possible but no later than seventy-two (72) hours.
   5. (5) This does not preclude the LLM from continuing to provide counseling regarding routine newborn care and breastfeeding.

3. (b)

   1. (1) Although the Department of Health Licensed Lay Midwifery program is supervised by department physicians, each LLM is encouraged to develop a close working relationship with one (1) or more specific physicians in obstetric and pediatric practice, or CNMs in obstetric practice who agree to serve as a referral/consultation source for the LLM.
   2. (2) This relationship is optional.

   3. (3) The referral physician and LLM relationship, or the CNM and LLM relationship, can be terminated by either party at any time.

      1. (c) Apprentice midwives and LLM assistants may only work under the onsite supervision of their preceptor.

         1. (d)
   4. (1) At various points during the course of midwifery care, the LLM must inform the client of the requirement for tests, procedures, treatments, medications, or referrals specified in 17 CAR § 47-301 et seq., which are for the optimal health and safety of the mother and baby, and refusal is strongly discouraged.
   5. (2) However, continuing care of a client who refuses some of these requirements is permitted if the LLM meets certain requirements as outlined in subsections (e) – (h) of this section.

4. (e) LLMs who have a current certified professional midwife (CPM) credential but do not have a Midwifery Bridge Certificate (MBC) may continue care of clients who:

   1. (1) Refuse the following tests listed in 17 CAR § 47-303(b):

      1. (A) Pap test/HPV test;
      2. (B) Test for gonorrhea and chlamydia;
      3. (C) Test for syphilis;
      4. (D) Hepatitis B test; and
      5. (E) HIV counseling and test;
   2. (2) Refuse recommended Rh immunoglobulin as outlined in 17 CAR § 47-303(e);

   3. (3) Refuse a referral or to follow advice against home birth as a result of the identification of these pre-existing conditions listed in 17 CAR § 47-304(f):

      1. (A) History of seven (7) or more deliveries;
      2. (B) Maternal age greater than or equal to forty (40) at estimated date of delivery;
      3. (C) Previous infant weighing less than five (5) pounds or more than ten (10) pounds; or
      4. (D) Pregnancy termination or loss of greater than or equal to three (3); and

   4. (4) Refuse the newborn procedures listed in 17 CAR § 47-309(d) and (e):

      1. (A) Administration of eye medication if indicated; and
      2. (B) Administration of vitamin K.

5. (f) LLMs who have both a current CPM and the MBC, or LLMs who have a CNM or CM, may continue care of clients who refuse any test, procedure, treatment, referral, or medication, except for:

   1. (1) The precluded conditions listed in 17 CAR § 47-304(e);
   2. (2) The requirement of having the risk assessments listed in 17 CAR § 47-303(a); or
   3. (3) Conditions requiring immediate transport as listed in 17 CAR § 47-306(a), 17 CAR § 47-308(a), and 17 CAR § 47-310(a).

6. (g)

   1. (1) LLMs who do not have a current CPM credential are not permitted to continue care for clients who refuse any of the required tests, procedures, treatments, medications, or referrals specified in this part except for recommended Rh immunoglobulin as outlined in 17 CAR § 47-303(e).
   2. (2) Should a client refuse Rh immunoglobulin, the LLM must follow 17 CAR § 47-102(h)(2) – (6).

7. (h) Should a client of the LLM with a CPM, CM, CNM, or CPM/MBC refuse any of the tests or procedures pursuant to subsections (e) and (f) of this section:

   1. (1) The LLM must inform the client that the LLM is only permitted to continue to provide care to the client if the LLM’s certification meets the required standard as outlined in subsections (e) and (f) of this section;

   2. (2)

      1. (A) The LLM must inform the client of the potential risks to herself or her baby.
      2. (B) It is the responsibility of the LLM to provide current evidence and adequate information, both written and verbal, to the client regarding the risks of declining the test, procedure, treatment, medication, or referral, including the risks and benefits of no action at all.
      3. (C) This must include the review of any available and relevant department-approved sources on each test, procedure, treatment, medication, or referral being refused;

   3. (3) The LLM must document the client’s refusal using the department Informed Refusal Form and include:

      1. (A) The information shared with the client as outlined in subdivision (h)(2) of this section and the department-approved sources used;

      2. (B) The client’s written assertion refusing the:

         1. (i) Test;
         2. (ii) Procedure;
         3. (iii) Treatment;
         4. (iv) Medication; or
         5. (v) Referral;
      3. (C) The client’s affirmation of her understanding and acceptance of the risks; and
      4. (D) A plan of care for the condition, including a plan for transfer of care if indicated;

   4. (4)

      1. (A) The department Informed Refusal Form must be signed and dated by both the LLM and the client and a copy must be kept by the LLM in the client’s file.
      2. (B) Signing the form shows they have discussed the risks and benefits of continuing under the care of the LLM;
   5. (5) Each signed refusal form must be documented by completing an Incident Report Form and noting the Informed Refusal on the next LLM Caseload and Birth Report Log; and

   6. (6) Documentation of refusal must be included in the client’s record in the event a client changes her mind concerning an informed refusal.

      1. (i)

   7. (1)

      1. (A) It is the responsibility of the LLM to engage in a process of continuous evaluation, beginning with the initial consultation and continuing throughout the provision of care.
      2. (B) This includes continuously assessing safety considerations and risks to the client and informing her of the same.

   8. (2)

      1. (A) The LLM is expected to use their judgment in assessing when the client’s condition or health needs exceed the LLM’s:

         1. (i) Knowledge;
         2. (ii) Experience; or
         3. (iii) Comfort level.
      2. (B) The LLM has the right and responsibility to terminate care under these circumstances.

8. (j) If any medications that are provided by the department or prescribed by a physician or CNM in accordance with this part are administered at the home birth site, the LLM shall document this in the client health record and include the following:

   1. (1) The name of the medication;
   2. (2) The lot number and date of expiration;
   3. (3) The strength and amount or dose of the medication;
   4. (4) The date and time the medication is administered;
   5. (5) The name of the prescriber; and

   6. (6) Document:

      1. (A) The name and the credentials of the nurse administering the medication; or
      2. (B) That the client, or LLM as agent to the client, administered medication to the newborn.

9. (k) The LLM is required to comply with all provisions of HIPAA (Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191).

   1. (l) The LLM is required to comply with all provisions of CLIA (Clinical Laboratory Improvement Amendments of 1988, Pub. L. No. 100-578) when tests are performed for the purpose of providing information for the health care of midwife clients.

Codification Notes: "APRN" means advanced practice registered nurse. "CEU" means continuing education unit. "CM" means certified midwife. "CNM" means certified nurse midwife. "HIV" means human immunodeficiency virus. "HPV" means human papillomavirus. "LLM" means licensed lay midwife.