August 5, 2004  Rough Draft / unfinished, unedited @ present

Necessary Criteria for MBC Regulations ~
Defining the ‘appropriate’ standard of practice by California LMs

Prolog / Important Background Information:  At the time of the negotiations with Senator Figueroa’s office by Citizens for Health Freedom and prior to inclusion of this provision in SB1950, two state-wide professional midwifery organizations – the California College of Midwives (state chapter of the American College of Community Midwives) and the California Association of Midwives had each developed and circulated practice guidelines which included a Statement of Philosophy, Code of Ethics, Standards of Practice and guidelines for all phases of domiciliary-based midwifery care. The goal of these standards and guidelines as developed by midwifery organizations was to facilitate midwifery practice that is both safe and competent and consistent with the history and tradition of midwifery in the US, as well as the midwifery model of care as practiced world-wide.

The California College of Midwives’ guidelines, entitled “Generally Accepted Practices”, synthesized standards and practice guidelines from the 1989 revised edition of the CAM guidelines, the College of Midwives of British Columbia (Canadian direct-entry midwives), elements from the WHO “Care in Normal Birth - a Practical Guide”, Dr. Koostermen’s List for domiciliary midwives in Holland, The Central Midwives Board handbook, 25th edition, 1962, UK, Standards and practice guidelines for the American College of Nurse-Midwives, the original Midwifery Statute for California - Section 2505, 1917 and the City of Rochester (New York) 1896 Midwifery statute (the origin of the statutory language use in the 1917, 1974 and1993 licensing laws in California). The Generally Accepted Practices were submitted to peer review by practicing midwives and to review by a physician who attended home births, an obstetrician, a medical anthropologist and an expert on the scientific literature for medical and physiological management.     

Because the Generally Accepted Guidelines were the most recently complied and most comprehensive (published 1998, updated each year), they were adopted by the Professional Liability Consortium of the American College of Community Midwives. To qualify for this group malpractice policy, all 55 LM and CNM members had to agree to abide by the ACCM/California College of Midwives’ published standards. In the three years this malpractice policy was in effect, it equated to 165 midwife years/units (55n X 3yrs), with midwives who practiced in three different states (California, Florida and New Mexico). Of the 165 midwife-years, there were just three claims (only one in California), or a claims-rate of less than 2%. By comparison, approximately 10% of obstetricians are sued annually, so the rate of litigation for physiological management is only 1/5th of that for medically interventionist care.

The efficacy of a universal midwifery standard to provide for safe and satisfactory practice by California LMs can be inferred both from the numerical claims history of the professional liability group and the specific incidents. None of the three adverse outcomes were established to be the result of substandard care on the part of the insured midwife. In particular, the single case in California was a crib death 17 hours postpartum, diagnosed at autopsy as a lethal cardiac anomaly with pulmonary stenosis. Neither the place of birth or the care provided by the practitioner was identified by the pathologist as a secondary or even a minor contributing cause.

Based on the tract record of standards already adopted by professional midwifery organizations, it can be demonstrated that the quality of this criteria and adherence to it by practitioners provides for safe and efficacious midwifery care. It is protective of the consumer, protective of the professional status of the LM and protective of the regulatory agency, reducing the disciplinary burden by lowering the number of incidents that must be investigated and potentially prosecuted by the MBC. The achievement of these vital goals clearly established the functional quality of universal midwifery standards and guidelines to be an “appropriate” standard for the practice of midwifery in California. 

If regulations proposed by the MBC do not meet the technical criteria listed below, they will not meet the practical needs of childbearing women, LMs and the regulatory burden of the MBC, consumers and professional organizations cannot support them.

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Overview & Legislative History

SB1950 directed the MBC “ to adopt regulations defining the appropriate standard of care for the practice of (licensed) midwifery” by July 2003. According to conversations with the bill’s author, the rationale for this statute was to establish that the appropriate criteria for California licensed midwives was a midwifery-based standard and not an obstetrical standard. SB 1950 mandated that a an appropriate midwifery standard should be identified in regulation and that official standard, in conjunction with expert review, should be referenced whenever the Board was contemplating or pursuing disciplinary action against a licentiate midwife.

According to the original language of the LMPA of 1993 and the 2000 amendment (SB 1479 authored by Senator Figueroa), midwifery is a distinctly defined profession separate from both the practice of medicine and the practice of nursing. Distinct qualities of community-based midwifery practice are most clearly identified in the intent language of SB 1479, Section 4, particularly subsection “c”:

 ~ THE LEGISLATURE FINDS AND DECLARES THAT:

(a) Childbirth is a normal process of the human body and not a disease.

(b) Every woman has a right to choose her birth setting from the full range of safe options available in her community.

(c) The midwifery model of care emphasizes a commitment to informed choice, continuity of individualized care, and sensitivity to the emotional and spiritual aspects of childbearing, and includes monitoring the physical, psychological, and social well-being of the mother throughout the childbearing cycle; providing the mother with individualized education, counseling, prenatal care, continuous hands-on assistance during labor and delivery, and postpartum support; minimizing technological interventions; and identifying and referring women who require obstetrical attention.(emphasis added)

(d) Numerous studies have associated professional midwifery care with safety, good outcomes, and cost-effectiveness in the United States and in other countries. California studies suggest that low-risk women who choose a natural childbirth approach in an out-of-hospital setting will experience as low a perinatal mortality as low-risk women who choose a hospital birth under management of an obstetrician, including unfavorable results for transfer from the home to the hospital. (emphasis added)

(e) The midwifery model of care is an important option within comprehensive health care for women and their families and should be a choice made available to all women who are appropriate for and interested in home birth.

LMPA prohibits medicalization  -- bans use of artificial, forcible or mechanical means by midwives and promotes normal vaginal birth –

The Licensed Midwives Practice Act of 1993 did not directly define normal birth. However, it is defined in the inverse -- abnormal birth is functionally identified as parturition (i.e. intrapartum period of labor and birth) in which there is a need to use "artificial, forcible or mechanical means". Licensed midwives are specifically prohibited by the statute from using drugs to induce or accelerate labor, podalic version to pull the baby out by the feet and forceps or vacuum extraction to facilitate delivery. 

This definition of normal recognizes that normal equates with natural (i.e., not artificially stimulated). It refers to spontaneous physiological processes that are characteristic of the healthy reproductive biology of childbearing women and can reasonably be expected to lead to normal spontaneous conclusions. Normal is also associated with a state of irreducible risk – that is, all other responses add rather than subtract risk.

This may be distilled into the following definition:

Normal as used by the LMPA would refer to a pregnancy that naturally advances to term with a live, growth-appropriate fetus/fetuses in a vertical lie, and culminating with a spontaneous labor that can reasonably be expected to lead to a spontaneous live birth of a viable neonate and conservation of the health of the mother and wellbeing of the baby.

The simplest definition of "normal birth" that is generally accepted by midwives around the world is applied to a healthy mother who is pregnant with a fetus/fetuses in a longitudinal lie (either vertex or breech) with spontaneous onset of labor between 36 1/2 weeks to 42 1/2 weeks, progressing in a timely manner through out the various stages and phases associated with physiological parturition while the mother and baby are able to remain adequately hydrated and free of distress.

The Critical Distinction ~ Physiologically-based versus Medically-based forms of Maternity Care for Healthy Women with Normal Pregnancies

The basic distinction between midwifery and medicine is the contrast between physiological management and the methods of contemporary obstetrics, which consists of a medically interventionist model applied routinely to women of all risk categories. Proponents of both models assert that their method is an effective strategy for reducing the natural risks of childbirth in healthy women with normal pregnancies. However, the consensus of the scientific literature (both historical and contemporary), identifies only physiological management as an evidence-based model of maternity care that achieves the stated goal of predictable risk reduction. Scientifically-speaking, physiological management is the safest and most efficacious method of care for healthy women with normal pregnancies.

Historically medical schools in the US have rejected physiological management . For the last hundred years the hypothesis of the obstetrical profession  has been that the advances of “modern medicine” rendered physiological management as “old-fashioned” and dangerous by comparison. They firmly believe that healthy women are better served by the routine use of medical and surgical interventions and that, ethically-speaking, medicalization should displace physiological management on principle. For these reasons, obstetrical residency programs have never taught physiologic principles to medical students. With the rarest of exceptions, graduate physicians do not utilize physiological methods.

The chasm between these two methods is large both in philosophy and in understanding. It is particularly out of balance and contentious on the obstetrical side of the issue. The obstetrical profession has always assumed that they alone have a comprehensive understanding of childbearing. In their medical paradigm, obstetricians would have a perfect knowledge of both obstetrics and midwifery while midwives would know very little about the practice of obstetrics, be dangerously ignorant of obstetrical risks and incompetent to meet the expected complications of childbirth.

In a modern-day effort to demonstrate the theory that physicians enjoy a unique and comprehensive knowledge base that midwives don’t, Dr. Thomas Joas, former MBC appointee and past president of the Board, took the psychometrically-accredited state licensing exam for midwives. At the time Dr Joas was the chair of the Medical Board’s LMPA Implementation Committee and in charge of developing the regulations for licensed midwifery practice in California. He expected to prove that without further education or training, doctors could still easily understand the principles, didactic foundation and skills of midwifery. Unfortunately, Dr. Joas failed the midwifery licensing exam. 

The Purpose and Goal of the LMPA

The purpose and goal of the LMPA is to provide professional maternity services to essentially healthy childbearing women who for personal, philosophical, cultural, economic or religious reasons have chosen non-obstetrical pregnancy and childbirth care. Explicit and implicit in the licensing statue and its amendments is the fact that the safety of such midwifery care for healthy women with normal pregnancies, in conjunction with access to appropriate obstetrical services for complications, is statistically equal to hospital-based obstetrical care for the same low and moderate risk population. Public health officials around the world agree that access to professional maternity services by physicians and by midwives makes childbirth safer than it would be without access to such care.

No California statutes requires a pregnant woman to obtain prenatal care or to be professionally attended by either a physician or midwife during labor, birth and the immediate postpartum/neonatal period. It is the obligation of maternity care professionals to meet the needs of childbearing women – as perceived and defined by the women themselves-- in such a fashion as to induce women to value and seek out professional maternity care. It can be statistically demonstrated that the professional care of a midwife vastly improves maternal and perinatal outcomes as contrasted to childbirth in women who receive no prenatal care and have unattended births. For example, perinatal loss for unattended birth in women with no prenatal care was as high as 60 per 1,000 (compared to 3 per 1,000) in a 1980 study of lay midwives in North Carolina. The current perinatal mortality rate for the US is 7 per 1,000.

Appropriate use of midwifery-based standards of practice elevates the profession to the benefit of both practitioner and society

A major benefit of an appropriate standard of practice for midwives is that it elevates the profession by standardizing or universalizing the following aspects of practice:

a. Criteria for client selection / consultation, referral, elective transfer of care, emergency transport

b. Responsibilities of the professional midwife and nature of the caregiver-client relationship, including the specific responsibilities of the client and her family 

c. Minimum practice requirements for midwifery care (the functional elements technical skills and caregiver activities for prenatal, intrapartum, postpartum, neonatal and follow-up care, etc)

d. Minimum practice requirements for advice and education offered by the licensed midwife (labs, genetic testing, coping skills, scheduling pediatric care of the neonate, etc)

e. Procedures for & content of informed consent / decline and for withdrawal of services by the midwife for whatever reason

f.  Record keeping and charting characteristics

g. Drugs and equipment (includes an automobile in serviceable condition, gas, maps, flashlight and a phone and a pager with batteries and a sense of humor for when you get lost!)

h. Associated obligations of professional practice including
            1) timely filing of birth certificates,

            2) incident reports for emergency transport and mortality/serious morbidity,

            3) statistics on the number and nature of care provided within a given period of time

Appropriate midwifery standards also elevates the profession of midwifery by promoting integration of new skills and apt use of newly miniaturized electronic technologies such as glucometers, pulse oximetry and laptop-sized fetal monitors, computer-based record-keeping systems, etc. It facilitates the performance or referral for non-stress testing for post-dates pregnancies and referral of clients to other appropriate professionals for biophysical profile, psychological counseling and other diagnostic or therapeutic benefits.

Appropriate use of midwifery-based standards of practice recognizes and respects the autonomy of the mentally competent adult woman

Appropriate standards of practice for California licensed midwives must recognize and acknowledge the childbearing woman’s legal and ethical right to choose the manner and circumstance of normal labor and birth (note Intent language of SB 1479) and that risk reduction strategies must include the consent of the mother.

Risk and risk-reduction strategies are a distinct category and different from the topic of complications. In dealing with risk and risk reduction, pertinent facts to be used in decision-making must include a balanced acknowledge the risks of associated with medicalization as well as those of declining medicalization. In addition to the immediate complications of the procedure (or the decline of that same procedure), the risk-benefit equation must include the known “sequelae” – that is delayed or downstream complications. This applies to reproductive abilities, complications in future pregnancies, such as abnormal placental conditions and medical conditions arising later, such as infertility or incontinence.

For example, the risk of cesarean as the chosen route of delivery includes 15 well-known complications (including a 13-fold increase in emergency hysterectomies) compared to only 3 specific risks for the vaginal route. (see MCA’s systemic review “What every pregnant woman needs to know about Cesarean Section” at  www.maternityWise.org) Published peer-reviewed research shows that the babies of mothers who labor spontaneously (i.e., no drugs to induction or acceleration labor) in a post-cesarean pregnancies (VBAC) have the same mortality rate (1: 2,000) as babies of first-time mothers. This is in contrast to the contemporary obstetrical custom of discouraging vaginal birth in these women and insisting instead on so-called “risk-reduction” repeat Cesareans, which actually adds the above list of 15 additional complications without improving outcomes for the baby. 

Except for “extremely rare and truly unusual circumstances”*, risk reduction must always be implemented with the consent of the parents. For mentally competent women, recognized legal principles of body integrity already acknowledge the mother's right to refuse medical treatments, procedures and surgery, even when the decline of these interventions is perceived by medical authorities to be to the disadvantage of the fetus.  (Note – above quote** is from an appellate court decision in an A_COG case that confirmed the right of mentally competent women to decline unwanted medical or surgical interventions even if there is concern about the well-being of the fetus)

The functional autonomy of the healthy, mentally competent pregnant women is a compelling human rights issue that encompasses her right, via an informed consent mechanism, to decline risk-reduction protocols, even when that results in a medically unpopular choice. Without recognition and support of this right, childbearing women with special circumstances can be and frequently are forced into extensive medical interventions for non-medical reasons even though these mothers can otherwise be expected to labor normally and give birth spontaneously to healthy neonates. This occurs because our current obstetrical system denies normal (physiological) care to women with post-dates pregnancies, a baby in a breech position, twins or post-cesarean pregnancies.

This frequently results in the non-consensual induction of labor (including use of the off-label use of Cytotec), which is associated with specific complications triggered by these powerful drugs and the necessary anesthesia. Medical management includes non-physiological breath-holding, early and/or forced pushing and often the use episiotomy and/or forceps or vacuum extraction. According to the scientific literature, this management style is associated with long-term pelvic floor damage and incontinence.

Unwillingness of obstetricians to provide labor support for VBAC or to ‘permit’ breech or twin vaginal birth results in medically unnecessary Cesarean surgery. The reasons usually cited by the obstetrical profession for this denial of normal care is hospital protocols, lack of training or experience, or reduced malpractice premiums if the physician or institution agrees not to attend vaginal breech, twins or VBAC deliveries. Certain obstetricians have stated publicly that they “don’t do labor sitting” and thus are unwilling to attending any women whose status would require them to be present during the labor – i.e., VBAC, breech or twins. Cesarean-specific sequelae include but are not limited to the following:

Direct complications of cesarean surgery for mother and baby include:

Delayed or downstream complications associated with future reproduction / pregnancy, include:

Regulations pertaining to Standards of Practice ~ origin, nature and function

Appropriate standards of practice for midwifery would not be based on obstetrical standards either in origin or in function. Obstetricians do not trained or experienced in midwifery. The “appropriate” standard for community-based midwifery would be midwifery-based.

In order to conform to the legislative intention of the LMPA, its amendments and the specific legal mandate of SB 1950, it is the opinion of consumer and professional groups that the “standard of practice” for midwives must conform to the universal standards for community-based midwifery in order to be functionally “appropriate”. Appropriate standards for California midwives would arise from the California community of midwives.

Since the promulgation of standards in regulations is, by its very nature, inflexible, such regulations  must take care to be a floor and not a ceiling -- that is, they should reflect minimum requirements for practice that will both inform the LM and protect the consumer but will not block the advance of science-based practice, additional advanced training by the individual midwife or the development of more expansive or stringent criteria or more detailed standards as adopted by professional midwifery organizations at the state or national level.

Technical Criteria for “Standards”

The term “standards of practice”, as referred to by professional groups, the legislature and the courts, is a distinct and technical category consisting of positive statements of guiding principles -- they represent a stable foundation or “floor” upon which the practitioner and the public can “stand”. For that reason, standards are a “To do” list, not a list of “no-no’s”.

Standards and associated guidelines provide protective guidance to the practitioner by delineating minimum expectations. The goal of this official information is to provide safe, “state of the art” care to consumers, protect individual clients from substandard care and protect the practitioner from litigation and accusation of unprofessional conduct that may arise out of a lack of consensus from within the profession.

Standards of practice are not the same as a scope of practice nor is it inter-changeable with “scope of practice”. The scope of practice for licensed midwives is fixed by statute, which authorizes licensed midwives to provide care for normal childbirth, prohibits the use of artificial, forcible or mechanical means and requires that significant complications be immediately referred to a physician. Re-definition of the scope of practice for California LMs is not authorized under the current SB1950 mandate to the MBC.

Standards as a technical category, must conform to the following criteria:

1. Standards of practice must be consistent with universal characteristics of community-based midwifery as defined by a consensus of professional midwifery organizations, state licensing regulations, other jurisdictions that have equivalent forms of direct-entry midwifery. Simultaneously they must also be specific to the practice conditions and licensing laws of California. 

2. Standards must be consistent with the educational qualification of California LMs -- by statutory definition, the LMPA three year educational requirement is “equivalent but not identical” to the education and scope of practice for CNMs.

3.  Standards must be consistent with and reflective of California licensing legislation and its amendments (Licensed Midwifery Practice Act of 1993 & SB 1479, including the intent language, SB 1950) and judicial decisions. Judge Roman’s 1999 OAL decision acknowledged that breech & twins are a variation of normal. Since neither of these circumstances require the use of ‘artificial, forcible or mechanical means’, he ruled that midwifery care is permitted under the LMPA scope of practice as a variation of the norm. The judge tied midwifery care for women with identified risk factors to written protocols of the caregiver LM that included advanced training and experience, specific criteria for selection of such clients and specific parameters of care, including criteria for referral and emergency transport. This OAL decision specifically acknowledged that the standards, guidelines and special circumstances protocols and special circumstances informed consent of California LM Alison Osborn as appropriate standards for LMs. 

This OAL decision also acknowledged that risk reduction, except for rare and truly unusual circumstances, must be implemented with the consent of the parents. In this instance, he confirmed the right of the childbearing to decline the risk-reduction procedures of obstetrical care (in particular, the elective performance of a cesarean section) and to choose physiological management.

4. Standards should reflect and correct real disciplinary issues -- over the last 7 years 34 LMs have been reported to the board for a real or imaged infraction of professional conduct. What are the type of complaints relative to actual or potential harm do these acquisations represent (aside from the physician supervision issue) and how would changes or creation of new standards address these problems? For instance, it is a pretty safe bet that none of the complaints involve LMs providing care to women with symptomatic cardiac or kidney disease or other major medical pathologies. The category of “complication” (which is statutorily identified) is rarely ever an issue of dispute while the category of potential risk (not specified in statue) is frequently and currently the focus of a bitter controversy.

5.  Standards must be evidence-based and include mechanisms for being updated as scientific data is added or changed (note: VBAC perinatal risk in healthy mothers with spontaneous and progressive labor is identical to that of a first-time mother)

6. Appropriate standards of practice for midwives must be therapeutically relevant -- limitations imposed on practice such as referral or transport should have clear, demonstrable value. For example, mandated transfer of a healthy baby simple because its LGA/macrosomia is not therapeutically relevant. Transfer of a big baby simply because it is big is not associated with any particular treatment and therefore is neither beneficial nor an appropriate standard.  Any standards that would routinely increase the number of non-therapeutic medical referral or transport must be eliminated in recognition that medical care is expensive to the client family or society, disruptive to the mother-baby-father-family cohort, often painful and even dangerous to the patient and burdensome to the medical system and to the obstetrician on call.

Transport must be reserved for:

a. complications that benefit from medical treatment

b. risk reduction with the consent of the parents

c. parental request regardless of medical need

d. practitioner request due to need for care that exceeds the LM’s scope of practice, experience or comfort level

7. The appropriate standard of practice for LMs must recognize that the mother’s permission or voluntary consent is the least standard that is legally acceptable. At a minimum, consent must be obtained for normal care and for medical and surgical interventions in all but "extremely rare and truly exceptional circumstances". The mother’s informed choice consent or informed decline of standard midwifery / medical interventions is a higher standard than mere permission. It should be honored in all but those emergent circumstances in which there is a clear and present danger of death or permanent disability to either mother or baby (the principle of health caregiver as proxy decision-maker) and for which medical, obstetrical or neonatal care offers a dependable treatment of acceptable risk to the individuals and society.

If the mother/parents are convinced that a proposed procedure or course of treatment (including hospitalization) would violate their core values or strongly-held religious belief or that it entails risks of iatrogenic complications that outweigh the proposed benefit, appropriate standards of practice requires that the LM formally document the informed decision of parents to decline standardized medical/midwifery care.

8. Appropriate standards of practice for midwives included evidence-based protocols to address unusual circumstances or unusual needs, as well as variations of norm and minor or temporary deviations. A well-known midwifery truism is that problematic “situations” precede complications and complications precede emergencies. In essentially healthy women with normal pregnancies, most complications can be prevented by responding appropriately to small or potential problems before they lead to an emergency. In addition to high-quality training, plenty of experience, good judgment, proper equipment and technical skills, effective ‘early interventions’ require that LMs have a well-founded and well-thought out plan or “protocol” for preventative measures and handling other unusual circumstances.

Common prenatal situations that present variations or minor deviations would include women with a slightly or temporarily elevated blood pressure (but remaining below the sill for bona fide hypertension), preventative management of impaired carbohydrate metabolism via nutritional education and dietary control with normal blood glucose level confirmed at home by the mother thru use of a glucometer.  Protocols for these situations are designed to prevent the development of full-blown hypertension or insulin-dependent diabetes. Should these preventative plans not succeed and the mother be unable to maintain normal values, this same protocols call for her to be referred to an appropriate physician.

(Note -- i don't have intrapartum example but they would be elevated temp in mother responds to hydration, non-reassuring FHTs respond to maternal hydration, position change, O2, etc.

Evidence-based standard of care, in conjunction with protocol for monitoring minor deviations from norm (using such aids as a glucometer, NST, EFM, etc) can be provided within the physiological model, making transport unnecessary and reducing useless burden to the client family and the medical care system.

Protocols must be evidence-based and can be developed by state-wide professional organizations or by individual LMs from recognized scientific literature such as textbooks and peer review journals and other credible sources. Protocols often result in specific patient education, additional levels of informed consent/decline, an increase in the quality or quantity of monitoring, and other preventative measures. 

 # 8 Unfinished

========================  Other Unfinished topics -============================

9. Refuting the ill-named "planned" home birth Pang Study - //

10. Promoting the Schlenzka Study contrasting physiological versus medical management

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