A leading state lawmaker is calling for a state investigation of a birth center in Cary where three newborns died in the past six months, and others say it's time for North Carolina to start licensing and overseeing the facilities that deliver hundreds of babies each year.
Baby+Co. has halted deliveries at its Cary center as it reviews all newborn deaths there since it opened in October 2014. Four newborns its midwives were assisting with have died out of more than 1,200 births, according to the company. Deliveries in Cary will resume as soon as company officials are assured the facility is safe, but Baby+Co. is not obligated to share the details of its internal review with the public.
Rep. Nelson Dollar, a Republican representing Wake County, said in an interview late Friday that he will ask the N.C. Department of Health and Human Services to conduct an investigation of the Cary site to assess the causes of the recent deaths and to guarantee public safety. Dollar said he expects Baby+Co. to cooperate even if the state health agency — which oversees hospitals, nursing homes, surgery centers and other facilities — doesn't have explicit legal authority to inspect and review the birthing facility.
"This is an incredibly serious matter," said Dollar, who chairs two health care committees in the state House. "We need to have the answers to those questions and we need to have them from some neutral people who have the expertise to get to the bottom."
In a statement emailed to The N&O on Sunday, Baby+Co. said: "We operate all of our centers to the same high safety and quality standards in every state we operate, many of which have specific birth center regulations in place. All of our centers are accredited with CABC and all of our nurse midwives are board certified. We welcome the opportunity to share our Complete Care approach with lawmakers and state healthcare officials."
Baby+Co., which operates three birth centers in North Carolina and three others in Tennessee and Colorado, updated customers by email Thursday that its internal review is taking longer than expected. In the meantime, women are being taken to nearby WakeMed Cary hospital for deliveries with the support of Baby+Co.'s nurse midwives who have practicing privileges at the hospital.
"We are moving this review forward as quickly as possible, but our effort to be thorough means that it will take a little longer," the email said. "We know this is not the news you were hoping to hear, especially for our moms and families who are at term, but the safety of you and your baby is our top priority."
Regulation for midwives
Professional organizations for birth centers and midwives say their practices are as safe as hospital deliveries for low-risk pregnancies, result in fewer unnecessary interventions, such as caesarian section deliveries and have the added advantage of costing half as much as a hospital birth.
The deaths in Cary are prompting some in the state's medical establishment to rethink the state's hands-off policy toward natural birth centers. North Carolina is one of just eight states that allows natural birth centers to deliver newborns without a state license or state oversight. At the same time the state oversees more than 700 occupational licenses and permits, covering such professions as acupuncture, cosmetology, daycare and funeral services.
Greg Griggs, executive vice-president of the N.C. Academy of Family Physicians, suggested that a spike in deaths at one facility seems to meet the definition of a situation that calls for state regulatory intervention.
"This is one of the things where we need our regulatory bodies to be able to initiate their own reviews," Griggs said.
North Carolina does enforce strict oversight of nurse midwives. The N.C. Board of Nursing licenses only nurse midwives with master's degrees, and does not allow other types of midwives, such as lay midwives, to deliver newborns. North Carolina is one of a handful of states where nurse midwives can't practice without an endorsement from a sponsoring doctor. Nurse practitioners have lobbied over the years to eliminate the sponsorship requirement, especially now that public officials are looking for ways to increase health care providers in underserved rural parts of the state.
Still, some doctors remain wary of out-of-hospital births, even through the American College of Obstetricians and Gynecologists has declared that birth center deliveries with midwives are a safe option for low-risk pregnancies. Nurse midwife Maureen Darcey, who runs the Women's Birth Center in Chapel Hill, fears that the recent developments in Cary could embolden critics to push for stringent regulations that would make it difficult for birth centers to operate here.
"It could get so onerous," Darcey said. "It could close me down possibly.
"I'm scared that something is going to happen now that will take these options away from people," she added.
Covered by insurers
Of 355 birth centers nationwide, only about a third are accredited by the Commission for the Accreditation of Birth Centers, a Pennsylvania group whose stamp of approval is trusted by some states as the basis for state licensing of birth centers. The national Medicaid program for low-income and disabled people requires birth centers to have state licenses to qualify for federal reimbursement for deliveries and other services. North Carolina's birth centers, being unlicensed, are exempted from the Medicaid standard and qualify for federal reimbursement just with the Pennsylvania group's accreditation.
Baby+Co.'s services are covered by Blue Cross and Blue Shield and other major insurers; the company has not yet worked out a Medicaid contract, it said in an email statement.
All seven birth centers in North Carolina carry the professional accreditation, which midwives describe as an intensive and thorough process that includes site inspections and mountains of paperwork.
The system that seems to have worked for years, however, is now being questioned.
"Who's accrediting the accrediting group?" asked state Rep. Greg Murphy, a Republican and a medical doctor from Pitt County, on Friday. "Obviously a cluster of incidents with fatalities is not acceptable."
Murphy, who works as a urologist, stressed that midwives are a "wonderful asset," but said it was news to him that birth centers are not licensed in the state. He cautioned that any move to regulate birth centers should be based on studying the best practices around the country.
Support for state licensing
The American Association of Birth Centers supports state licensing for birth centers. A state license promotes patient health and engenders public trust, said executive director Kate Bauer. But state regulation "has often been fraught with outright opposition or negative input from special interest groups," Bauer said.
Of the 41 states that regulate birth centers, Bauer said a fair number have requirements that the association considers overly restrictive. Bauer said birth centers do not treat medical conditions and are not medical facilities, and therefore shouldn't be required to meet every standard set for hospitals.
For example, 12 states require that a physician serve as medical director of the birth center, Bauer said. What's more, 18 states require birth centers to apply for "certificate-of-need" permits to expand facilities or build new centers. In North Carolina, such a certificate is required for expanding hospitals, major construction and costly equipment, as a safeguard against overbuilding that can drive up health care expenses.
The birth center trade association has issued model licensing guidelines that are based on accreditation standards. They include provisions limiting admission to low-risk pregnancies and establishing emergency hospital transfers, prenatal lab testing, food services and maintaining other standards.
Baby+Co. has experienced just one newborn death at its other five birth centers. It's not clear if the four deaths in Cary resulted from admitting women with high risk, from a failure to recognize complications when they developed, or from a confluence of random unforeseeable events.
"Everybody needs to know what happened there and why it happened," said Dollar, the Wake lawmaker. "What we've seen at that facility is truly a tragedy."