Natural birth centers have operated for years in North Carolina without state licensing and oversight, but that could change soon in the wake of three newborn deaths in six months at a Cary birth center.
Legislation introduced Thursday would regulate birth centers similarly to the way the N.C. Department of Health and Human Services regulates hospitals and other health care facilities. Under Senate Bill 798, state inspectors would be able to show up unannounced to assess safety and compliance. The bill would also allow the state to shut down a birth center by suspending its operating license, and the public could file complaints that could lead to investigations and fines.
Birth centers are non-medical facilities where women with low-risk pregnancies deliver babies in a spa-like environment without pain killers or inducing labor. The births are assisted by certified nurse midwives, as opposed to obstetricians and anesthesiologists, and women in delivery are not bound by hospital protocols that prohibit eating and sometimes restrict movement.
Nationwide, about 12 percent of deliveries at birth centers develop complications requiring that the woman and her baby be transferred to a hospital.
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Interest in regulating birth centers here followed almost immediately after Baby+Co. suspended deliveries in March. Baby+Co has experienced four newborn deaths since it opened in Cary in October 2014, including three deaths in a period of six months leading up to its decision to suspend deliveries.
"I'm actually pretty surprised they're not already licensed," said Carrboro nurse midwife Debra Fiore, who specializes in home deliveries.
Fiore, who is not familiar with the details relating to the incidents at Baby+Co., said Baby+Co. should be regulated like an out-patient facility because the birth center provides gynecological exams and other health care services.
"It's definitely patient safety — that's what it's all about," said Republican Rep. Greg Murphy, a Greenville urologist. "There's a lot of energy in trying to find out what is going on at these birth centers and how can we bring them up to a national standard."
Murphy plans to introduce his own legislation but first wants to visit birth centers and collect data on best practices.
Baby+Co. resumed delivering babies in Cary last month after an internal review and external reviews by the Institute for Perinatal Quality Improvement and by the Commission for the Accreditation of Birth Centers. The company, which operates three birth centers in North Carolina and one in in Nashville, Tenn., said in a statement that it welcomes state regulation. The company recently closed a birth center in Knoxville, Tenn. and in Wheat Ridge, Colo.
“We are very supportive of the state’s effort to implement a licensing framework for birth centers and believe the proposed legislation is a good step forward," the statement said. "We operate all of our centers with high safety and quality standards in several states, many of which have specific birth center regulations in place. We believe passionately in the model of care and its potential to improve outcomes and lower cost while offering a personalized experience for moms and families."
Because Baby+Co. is not regulated, it was not required to report problems to state officials, and the state health department lacked authority to investigate the site. As concern about public safety intensified, however, Baby+Co voluntarily allowed state investigators to visit its Cary facility — but only as long as the investigators assessed Baby+Co.'s safety and policies by industry accreditation standards, and not by state law and safety protocols. The Department of Health and Human Services plans to issue the results of its review in the coming weeks.
Additionally, the N.C. Nursing Board has received a complaint about three Baby+Co. midwives, and the N.C. Medical Board has contacted at least one Raleigh pediatrician's office about Baby+Co. The Medical Board licenses and disciplines physicians, including those acting as medical supervisors for nurse midwives at birthing centers.
The legislation to regulate birth centers was introduced Thursday by Republican Sen. Ralph Hise, a statistician from Spruce Pine who is co-chair of the Senate health care committee and co-chair of the Senate committee on appropriations for the Department of Health and Human Services. Hise was not available for comment Friday.
North Carolina is one of just eight states that allows natural birth centers to deliver newborns without a state license or state oversight. The state oversees more than 700 occupational licenses and permits, covering such professions as acupuncture, cosmetology, day care and funeral services.
Seven birth centers operate in North Carolina, and all are accredited by the The Commission for the Accreditation of Birth Centers. Of the nation's 350-plus birth centers, only about a third are accredited by the Pennsylvania organization. In North Carolina, accreditation is required for Medicaid reimbursement for deliveries; in most states, Medicaid requires state licensing to qualify for federal coverage of birth expenses.
The American Association of Birth Centers, an advocacy organization, supports the regulation of the facilities because state oversight engenders public trust and patient health. However, the association maintains that birth centers are not medical facilities and should not be required to meet the standards of health care facilities.
For example, the association maintains that state regulation should not require that a doctor serve as medical director of a birth center, or that a birth center be required to apply for a permit to build or expand a facility.
The association and the commission have not responded to requests for comment on the legislation which has passed its first reading and is currently in committee for discussion.
Murphy said that the subject of regulating birth centers likely won't get a full hearing until next year, when the legislature is in its "long session." The short session, held every other year, is typically reserved for adjusting the state budget and to work on legislation left over from last year's long session.