News: CJ Exclusives

Birth center advocates caution against overzealous regulations

Putting tougher restrictions on midwives and birth centers may raise costs without saving lives, advocates say

Image courtesy Wiki Commons
Image courtesy Wiki Commons

Impulsive legislative action over four infant deaths at a Cary natural birth center operated by midwives could limit access to a healthy, lower-cost alternative for expectant mothers, says one of North Carolina’s top nurse midwives. We may fall further behind other states in access to midwifery as a result.

“This is a super upsetting situation that we find ourselves in. Let’s not make this a witch hunt,” said Suzanne Wertman, president of the N.C. Affiliate of the American College of Nurse Midwives. The national organization has set midwifery standards for education and practice since 1929, emphasizing pregnancy, childbirth, and gynecologic and reproductive health.

“The thing that distresses me most about this situation is that birth centers have had a stellar safety record when you look over the data” from the past 30 years, said Wertman, who is on the clinical faculty at UNC-Wilmington.

The Lancet medical journal in a 2014 series on midwifery said global experts recommend increasing the use of midwives to improve maternal and newborn outcomes, reduce rates of unnecessary interventions, and reduce costs. Only 10 percent of U.S. births are attended by a midwife. In many other developed nations, the rate is between 50 and 75 percent, and they achieve better outcomes.

The peer-reviewed PLOS|One study released in February ranked North Carolina worst among all U.S. states for taking full advantage of midwives’ training and abilities.

As states better integrated midwives in their health-care systems, they tended to have higher rates of spontaneous vaginal births, vaginal births after a cesarean delivery, and lower rates of premature birth, low birthweight, neonatal death, and interventions by obstetricians, such as the use of forceps or vacuum.

All of North Carolina’s birth centers are nationally accredited by the American Association of Birth Centers.

“It’s a very rigorous accreditation process that not every birth center can meet,” Wertman said.

But lawmakers and some medical groups have called birth centers’ safety into question after four newborns died over a six-month span at the Baby+Co. site in Cary. The natural birth center has delivered 1,200 babies since it opened in October 2014.

“This is an incredibly serious matter,” state Rep. Nelson Dollar, R-Wake, chairman of the House Health, and Health Care Reform committees, told the News & Observer of Raleigh. He asked the N.C. Department of Health and Human Services to launch an investigation.

“Under current state law, DHHS does not have any regulatory authority with respect to freestanding birthing centers. That means we do not have authority to license these facilities or set standards for them,” DHHS spokeswoman Kelly Haight told Carolina Journal.

“Similarly, we do not have authority to enter and inspect them. However, the department is requesting Baby+Co. allow the department to conduct a voluntary review of the Cary center,” Haight said.

She provided a letter sent April 6 by Deputy Secretary for Health Services Mark Benton to Ste’Keira Shepperson, manager of Baby+Co.’s Cary center.

“I am asking that you voluntarily allow our regulatory staff to conduct an on-site review of your Cary location. Doing so will provide the public with the assurance that quality and safety are at its highest levels,” Benton said.

A two- to three-day review by three or more DHHS personnel would include examination of patient records and center policies, and interviews with staff and parents of the deceased babies. Files would be reviewed for all stillborn babies, and newborn deaths within 10 days of delivery over the past 12 months.

Benton said no regulatory fines or penalties would be imposed, but a narrative summary of findings would be made public.

“We welcome the opportunity to share our safety standards and clinical approach with lawmakers and state health care officials,” Margaret Buxton, clinical director for Baby+Co., said in an email.

“All of our centers are accredited with CABC [Commission for the Accreditation of Birth Centers], and all of our nurse midwives are board certified,” said Buxton, who teaches at the Vanderbilt University School of Nursing. Baby+Co. has other birth centers in Charlotte; Winston-Salem; Knoxville and Nashville, Tennessee; and Wheat Ridge, Colorado.

According to information provided by Baby+Co., its facilities operate in collaboration with leading health systems, and under direction of leading physician groups near the centers. Midwives and birth centers are supposed to deal only with low-risk pregnancies, and transfer care of patients if high-risk or emergency situations evolve.

The Cary site is linked to WakeMed Health. The Charlotte and Winston-Salem sites work with Novant Health. The hospitals collaborate in the design of “robust, system-wide safety protocols and procedures” that are strictly maintained, according to the company.

Risk screenings and safety drills are conducted, surveillance data are reviewed daily, weekly, and quarterly, and clear protocols are in place for transferring emergency patients to a hospital.

Kate Bauer, executive director of the American Association of Birth Centers, told CJ the organization agrees birth centers should be regulated by state licensure, but based on best practices rather than onerous regulations. Restrictions going beyond that — such as requiring a birthing center to get a certificate-of-need from the state before it can open or expand — make birth centers needlessly expensive and less attractive for pregnant women or midwives.

Bauer said regulation should be based on evidence and national industry standards that have been proven safe and effective.

“Access to the birth center option for pregnant families depends on public trust and viable birth center models, along with regulation and licensure that ensure quality and safety but do not block access to care,” she said.

Fetal deaths at birth centers, according to her organization’s National Birth Center Study II, were 0.47 per 1,000 live births. Newborn mortality rates were 0.40 per 1,000 births. Both were comparable to low-risk hospital births, Bauer said. Only 1.9 percent of women or newborns developed complications during labor or after birth requiring an urgent transfer to a hospital.

AABC also says deliveries at birth centers typically are roughly half the cost of deliveries at hospitals when there are no complications.

Birth centers may not be licensed or regulated in North Carolina, but they face serious scrutiny when a problem occurs, Wertman said. Like hospitals and other health care settings, they conduct reviews, even for deliveries that are “near-misses.”

“It’s always from the lens of what happened. Was there anything we could have done to prevent this? What can we do better in the future?” Wertman said.

The American Association of Birth Centers can send experts to conduct reviews. Birth centers routinely bring in other outside experts.

“More births happen in the hospital, and we know what the infant mortality rate is,” Wertman said. The federal Centers for Disease Control said there were 870 infant deaths in North Carolina in 2016. The CDC lists the state’s infant mortality rate at 7.2 per 1,000 live births. That surpasses the national rate of 5.9. Only 11 states have worse rates than North Carolina.

Wertman said while Baby+Co.’s story was a tragedy, deaths at hospitals are far more troubling. She suggests more fully integrating certified nurse midwives into the health care practice while eliminating regulations that push more costly care by doctors and hospitals.

“I think there is a transparency issue when it comes to reporting hospital outcomes,” she said.  Since she makes most of her deliveries in a hospital setting, she doesn’t want to create an us-versus-them battle.

Wertman says birthing centers are the correct model to deliver babies because it’s their sole focus. Center have lower infection rates than hospitals, and don’t have systemic issues large hospitals encounter, including “overworked nurses who are working in unsafe nurse-to-patient ratios.”