Physicians Say Proposed Midwifery Rules Put New Mothers, Infants at Risk
Public Health Feature -- December 2002
By Ken Ortolon
An attempt by lay midwives to simplify the rules governing their practice has turned into a full-fledged battle over midwives' role in delivering newborns in Texas.
Texas physicians say new rules approved by the Texas Midwifery Board and awaiting the Texas Board of Health's final approval will let lay midwives extend their scope of practice well beyond attending normal or low-risk births. Physicians who participated in the rules-revision process say the proposed regulations essentially would allow lay midwives to set their own protocols regarding potentially serious labor and delivery complications they can handle and remove all requirements that they collaborate with doctors.
"This is absolutely a safety problem," said Austin family physician Russell Thomas, DO, who represented the Texas Academy of Family Physicians (TAFP) on the committee that developed the proposed rules. "They may be increasing access or choice for pregnant women, but they're doing it at the cost of safety."
The Texas Medical Association, TAFP, the Texas Pediatric Society, the Texas Association of Obstetricians and Gynecologists, and the Texas College of Emergency Physicians oppose the rules, but were unable to prevent their adoption by the Midwifery Board in September. They hope to derail the proposal at the Board of Health, which was scheduled to meet Nov. 21 to decide whether to publish the rules for public comment.
If the rules are adopted, the fight could end up in the courts or the Texas Legislature.
Shooting for Simplicity
The midwifery rules in question govern fewer than 200 direct-entry midwives in Texas. A direct-entry, or lay, midwife is a person who has not completed medical or nursing training but who has completed a basic education course approved by the Midwifery Board and has passed a written examination.
The number of lay midwives in Texas has declined from 1,500 in the 1970s, primarily because of increased state regulation of the profession over the past two decades, including expanded training requirements that went into effect in 1997. Some physicians believe the proposed rules reflect an attempt by lay midwives to make their profession more attractive to potential colleagues.
The Midwifery Board and TDH Midwifery Program staff began to revise the rules in 2000 to comply with a legislative mandate that all state agencies review their administrative rules every four years. At the time, both the Midwifery Program staff and lay midwives complained that the existing rules were too long, not well organized, and too complicated.
Association of Texas Midwives (ATM) President Beth Overton refused to be interviewed for this article, but a statement on the group's Web site ( www.texasmidwives.com ) says the current rules are "confusing and conflicting when it comes to consumers' rights." ATM also contends the rules "are not working well when it comes to enforcing safe midwifery." The Web site did not give specifics.
Because of those complaints, the Midwifery Board appointed a committee of consumers, midwives, and physicians on the board, as well as some midwives who were not board members, to develop new rules. The committee's proposal was approved by the Midwifery Board and sent to the Board of Health in March 2001, which approved them for publication and public comment in the Texas Register.
That's when TMA and other physician groups learned the extent of the proposed revisions and intervened. At a June 2001 hearing before the Midwifery Board, physicians voiced concerns about the rules and the process by which they were developed.
Based on the physicians' comments, the board decided to restart the revision process rather than move forward, says Yvonne Feinlieb, program administrator for the TDH Midwifery Program. While Ms. Feinlieb says she felt TMA had provided input on the proposed rules before that meeting, the Midwifery Board "didn't want to send rules to the Board of Health where there were stakeholders saying they hadn't had enough opportunity for input. That would certainly be something the Board of Health would take into account."
Getting a Seat at the Table
So the Midwifery Board created a new rules-revision committee that included representatives from the midwives association, each of the concerned physicians groups, the Texas Nurses Association, and consumers. The new committee based all of its work on the draft rules developed by the first committee.
Despite many committee meetings and at least two negotiating sessions between physicians and midwives, it became obvious that a majority of the committee was not interested in substantially revising the proposed rules, says Greg Herzog, TAFP legislative aide. In a Nov. 9, 2001, letter, TMA and the four medical specialty societies told then-Midwifery Board Chair Debra Evans they were withdrawing from the rules-revision process.
"We have engaged in the discussions upon the proposed draft rules on the committee level and have, on a very limited basis, come to some consensus (e.g., on the need for peer review)," the letter said. "However, we are concerned that our point of view has not and will not receive the consideration it merits."
The physicians said that during discussions on patient safety "the discourse deteriorates and is not conducive to reaching a resolution. As discussions have progressed, it has become more and more apparent that the meetings may just further lengthen an already tired dialogue."
At Ms. Evans' urging, the physician groups continued to participate in the rules-revision process. But, Mr. Herzog says, the rules approved by the Midwifery Board in September include little substantive change from the rules pulled back last year.
Where's the Meat?
Dr. Thomas says the proposed regulations have "cut all the meat" out of the existing standards. "The previous rules did an excellent job of delineating and identifying areas where direct-entry midwives should seek assistance," Dr. Thomas said. "The new rules, as proposed, are much broader."
For example, current rules only recommend that a lay midwife consult with a physician if a pregnant woman has any of a lengthy list of conditions, such as pre-term labor during two or more previous pregnancies or delivery of an infant weighing less than five-and-a-half pounds. But they require a consultation with a physician or other health care professional with current obstetrical knowledge if an assessment reveals conditions such as a history of gestational diabetes, a prior cesarean section, chronic hypertension, AIDS or HIV, or cancer. The proposed rules simply require a midwife to recommend consultation with a physician or transfer of the patient's care to a doctor for a list of about half as many specific conditions and do not require consultation for any condition.
The rules revision pared the regulations from more than 50 pages to a mere seven.
A TMA analysis of the proposed rules concludes that the rules would increase the scope of practice of direct-entry midwives, allow them to care for mothers and newborns with difficult medical conditions, and remove the standards of care delineated in the current rules.
In addition, the proposed rules remove the current requirement that lay midwives collaborate with physicians when a mother has a high-risk medical condition. Under the proposed rules, TMA concluded, direct-entry midwives would never have to communicate with a physician again.
"The midwife would only be required to recommend that the mother seek an opinion," the analysis stated. "Instead of the midwife obtaining a consult with a physician with current obstetrical knowledge to receive advice, the onus is placed on the mother to seek and obtain care."
Dr. Thomas says the new rules place no burden on the lay midwife to consult on complicated cases beyond sending a woman in labor to the emergency room. "If the patient has a problem for which the midwife needs to refer her for a higher level of care, all she has to do is dial 911, have the ambulance come, and she's done." That, he adds, places all liability on the emergency room physician.
Additionally, Dr. Thomas says, the rules allow lay midwives to repair third- and fourth-degree lacerations of the perineum in violation of the midwifery statutes. State law allows lay midwives to use surgical instruments only to clamp and cut the umbilical cord, he says.
Finally, the medical societies contend the rules inappropriately abdicate the Midwifery Board's responsibilities to set standards for lay midwives by requiring them instead to follow the Midwives Alliance of North America Core Competencies for Basic Midwifery Practice. They state, in part, that midwives will determine the need for consultation or referral during pregnancy, labor, birth, and postpartum care; use medical intervention only as necessary; synthesize clinical observations, theoretical knowledge, intuitive assessment, and spiritual awareness as components of a competent decision-making process; and understand that the parameters of "normal" vary widely and recognize that each pregnancy and each birth are unique.
The medical societies are not the only critics of the rules. In a June 11, 2001, letter to Ms. Feinlieb, Texas State Board of Medical Examiners (TSBME) General Counsel Michele Shackelford, JD, complained that the proposed rules "result in a significant expansion of care that appears outside the statutory midwifery scope of practice. A clear delineation of the scope of practice is further compromised by language that authorizes the development of an individual scope of practice."
But not all physicians involved in revising the rules share the concerns of Dr. Thomas and the TSBME. Austin obstetrician-gynecologist Scott Simpson, MD, who wrote much of the current standards as a TDH employee in the mid-1990s, says the proposed rules accomplish the same goals as the current rules.
"The purpose of the rules is to articulate what's normal prenatal, delivery, and newborn care from what crosses over into the practice of medicine," Dr. Simpson said, "and, then, if they [lay midwives] cross over that line, have objective standards on which to base disciplinary action. I think the new rules do that, but I think the committee felt that they were not as proscriptive as the original set and didn't lay things out in as much detail. Personally, I think you get to the same point."
Dr. Simpson says the language on perineal repairs may be "a bit much," but says he has no other safety concerns. "It goes back to a woman's right to choose how and where she wants to give birth," he said. "Giving birth at home or in a birthing center is inherently riskier than giving birth in a hospital because you're not going to be able to react to an emergency situation. That's their decision."
Nearing the End
Ms. Feinlieb says the rule-making process has been a long and drawn-out affair but says the Midwifery Board wanted to ensure that all stakeholders had input. "We tried to make it a really open process to be sure that everybody who had something to say would have the opportunity to see what was happening and communicate," she said.
Once the proposed rules are approved for publication by the Board of Health, interested parties will have another 30 days to make comments. They will then go back to the Midwifery Board for approval or further revision. If ultimately adopted by the Midwifery Board, the Board of Health also would have to approve the rules before they take effect. That likely would not happen until sometime in 2003.
TMA and the other physician organizations have not decided what they might do if the rules are not amended. However, TMA officials say the association may seek legislation to roll back the rules or challenge them in court if physicians believe the final rules present patient safety concerns.
At the end of the day, Ms. Feinlieb says, the Midwifery Board wants to make sure it has approved regulations that will allow the safe practice of midwifery in Texas.
"Whether or not you agree with the format or wording or requirements of these rules, I really hope there's a better understanding now that the board is very serious about good midwifery practice and doesn't want anybody dangerous out there," she said.
While he believes all those involved in the process, including the lay midwives, are very conscientious and want to protect public safety, Dr. Thomas says these rules don't accomplish that.
"Ultimately, it will be very few, but, nevertheless, we're going to have some women and babies who are going to have poor outcomes who otherwise might not have had poor outcomes."
Ken Ortolon can be reached at (800) 880-1300, ext. 1392, or (512) 370-1392; or by email at Ken Ortolon.
December 2002 Texas Medicine Contents
Texas Medicine Back Issues