October 8

The licensed professional midwife shall not accept for care and shall not during pregnancy, labor and delivery and postpartum knowingly continue to provide care to a women who has or develops any of the [30] following conditions:

Condition

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State of California Department of Consumer Affairs Medical Board of Cal

M e m o r a n d u m

To: Members, Midwifery Task Force Date: October 7, 2002

From: Dr. Pat Chase, Medical Consultant

Subject: Definition of Midwifery Standard of Care and Level of Supervision

ISSUE:

Existing statute requires that a midwife practice under the supervision of a physician and refer all complications to a physician immediately (B&P section 2507, attached). There are no clarifying regulations for these mandates. The newly chaptered SB 1950 requires the Board to adopt regulations, by July 1, 2003, that define the appropriate standard of care and level of supervision required for the practice of midwifery.

BACKGROUND:

There is increasing interest worldwide in developing and applying appropriate guidelines to assure the safety of out-of-hospital births. A fundamental agreement is that only normal, low risk pregnancies should be dealt with in non-hospital settings. Given that all deliveries by Licensed Midwives are in the home and that >normal= can only be applied after the fact, the focus in defining standards of care must be on the risk factors for this setting, and for all phases of the pregnancy: antepartum, intrapartum, and postpartum.

A review of the literature as well as personal communications have provided a number

of standards currently in use for both home deliveries and for birthing centers. These included criteria from the California College of Midwives, extensive regulations in Texas, guidelines in Tennessee, criteria for both free standing and in-hospital birthing centers in California as well as longstanding exclusion criteria in the Netherlands. Given that the State of Washington has a school of midwifery and a supportive approach to the practice of midwifery, the following criteria from that State=s APilot Project for Planned Home Birth@ are discussed below as a potential basis to begin discussions regarding developing regulations in California as required in SB 1950. Washington=s project is a five year one which was implemented in January 2001 with the goal of serving pregnant clients who want to give birth in a home setting and who are at low risk for adverse birth outcomes. Providers must participate in an ongoing evaluation of the process and outcomes of the program and comply with project requirements.

The risk screening guidelines and the indications for consultation and referral were developed by a group including physicians, licensed midwives, certified nurse midwives, emergency medical technicians, a public member who had experienced a home birth, and members of the Washington State Department of Health.

It is important to note that the provider in this project may be a primary care physician, a certified nurse midwife, or a licensed midwife and that all must comply with the same requirements for consultation and referral.

Risk Screening Guidelines for Planned Home Births

The following are conditions that exclude individuals from having a planned home birth:

Previous caesarian section

Current alcohol and/or drug addiction

Significant hematological disorders/coagulopathies

History of deep venous thrombosis or pulmonary embolism

Cardiovascular disease causing functional impairment

Chronic hypertension

Significant endocrine disorders including pre-existing diabetes (type I or type II)

Hepatic disorders including uncontrolled intrahepatic cholestasis of pregnancy and/or Abnormal liver function tests

Isoimmunization, including evidence of Rh sensitization/platelet sensitization

Neurologic disorders or active seizure disorders

Pulmonary disease, active tuberculosis or severe asthma uncontrolled by medication

Renal disease

Collagen vascular disease

Current severe psychiatric illness

Cancer affecting site of delivery

Known multiple gestation

Other significant deviations from normal as assessed by the home birth provider

Indications for Consultation and Referral

1. Antepartum-Consultation required

Breech at 37 weeks

Polyhydramnios/oligohydramnios

Significant vaginal bleeding

Persistent nausea and vomiting causing a weight loss of >15 lbs.

Post-dates pregnancy (>42 weeks)

Fetal demise after 12 completed weeks of pregnancy

Significant size/dates discrepancy

Abnormal fetal non stress test

Abnormal ultrasound findings

Acute pyelonephritis

Infections whose treatment is beyond the scope of the provider

Evidence of large uterine fibroid that may obstruct delivery or other structural uterine abnormality

No prenatal care prior to third trimester

2. Antepartum-Referral required

Evidence of pregnancy induced hypertension (BP >140/90 for more than six hours

with client at rest)

Hydatidiform mole

Gestational diabetes not controlled by diet

Severe anemia unresponsive to treatment (Hgb <10, Hct, 28)

Known fetal anomalies

Noncompliance with plan of care (e.g. frequent missed appointments)

Documented placental abnormalities, significant abruption past the first trimester,

or any evidence of previa in the 3^rd trimester

Rupture of membranes before 37 weeks

Positive HIV antibody test

Documented intrauterine growth retardation

Primary genital herpes in the 1^st trimester

Development of any of the high risk conditions listed under exclusions

3. Intrapartum-Consultation required

Prolonged rupture of membranes (>24 hours and not in active labor)

Other significant deviations from normal as assessed by the provider

4. Intrapartum-Referral required

Labor before the completion of 37 weeks gestation, with known dates

Nonvertex presentation or lie at the time of delivery, including breech

Maternal desire for pain medication or referral

Active genital herpes at the onset of labor

Sustained maternal fever

*Persistent non-reassuring fetal heart rate

Thick meconium stained fluid with delivery not imminent

*Prolapse of the umbilical cord

*Maternal seizure

Abnormal bleeding (hemorrhage requires emergency transfer)

Hypertension with or without additional signs or symptoms of pre-eclampsia

Prolonged failure to progress in active labor

*Sustained maternal vital sign instability and/or shock

*Requires emergency transport

5. Postpartum- Consultation required

Significant maternal confusion or disorientation

Development of any of the applicable conditions listed previously

Other significant deviations from normal as assessed by the provider

6. Postpartum-Referral required

*Anaphylaxis or shock

Undelivered adhered or retained placenta with or without bleeding

*Significant hemorrhage not responsive to treatment

Lacerations, if repair is beyond provider=s level of expertise (3^rd or 4^th degree)

*Sustained maternal vital sign instability

Development of maternal fever, signs/symptoms of infection or sepsis

*Acute respiratory distress

*Uterine prolapse or inversion

7. Newborn-Consultation required

Apgar score 6 or < 6 at 5 minutes

Birth weight < 2500 grams

Abnormal jaundice

Other significant deviations from normal as assessed by the provider

8. Newborn-Referral required

Birth weight <2000 grams

* Persistent respiratory distress

*Persistent cardiac abnormalities or irregularities

*Persistent central cyanosis or pallor

Prolonged temperature instability

*Prolonged glycemic instability

*Neonatal seizure

Clinical evidence of prematurity (gestational age <35 weeks)

Loss of >10% of birth weight/ failure to thrive

Birth injury requiring medical attention

Major apparent congenital anomalies

Jaundice prior to 24 hours

Definitions of Consultation and Referral i.e. levels of supervision:

Consultation - The process whereby the provider who maintains primary management responsibility for the woman=s care, seeks the advice or opinion of a physician on clinical issues that are patient specific. These discussions may occur in person, by electronic communication, or by telephone.

*Requires emergency transport

Referral - The process by which the home birth provider directs the client to a physician for management (examination and/or treatment) of a particular problem or aspect of the clients care.

DECISION FOR CONSIDERATION:

What should be the content of regulations to meet the statutory requirements of SB 1950, to define the appropriate standard of care and level of supervision required for the practice of midwifery?

Attachment

2507. (a) The license to practice midwifery authorizes the holder, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn.

(b) As used in this article, the practice of midwifery constitutes the furthering or undertaking by any licensed midwife, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal. All complications shall be referred to a physician immediately. The practice of midwifery does not include the assisting of childbirth by any artificial, forcible, or mechanical means, nor the performance of any version.

(c) As used in this article, "supervision" shall not be construed to require the physical presence of the supervising physician.

(d) The ratio of licensed midwives to supervising physicians shall not be greater than four individual licensed midwives to one individual supervising physician.

(e) A midwife is not authorized to practice medicine and surgery by this article.

Medical Board of California // Midwifery program

SB 1950 ~ Original proposed regulation for Midwifery Standard

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