North Carolina lawmakers say the state's investigation into a Cary natural birth center where three babies have died confirms the need to license and regulate birth centers in this state.
“Frankly I was appalled at reading the report," said Republican Rep. Greg Murphy, a urologist from Greenville. "There are certain terms we use in medicine, 'standard of care' and 'scope of practice.' Multiple violations of these principles were noted."
Murphy said that regulation of natural birth centers will likely be taken up during the next legislative session, which starts in January.
A bill was introduced in the current session by Sen. Ralph Hise, a Republican from Spruce Pine. His bill would allow state health regulators to inspect, fine and shut down natural birth centers if they are not meeting safety standards. As birth centers are not currently licensed and regulated here, the two-month review conducted by the N.C. Department of Health and Human Services carries no enforcement authority. However, that bill is in committee and not expected to come up for a vote before lawmakers leave this summer.
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Murphy said he plans to introduce his own bill in the longer session, which will give lawmakers more time to delve into the complex issue that will require comparing standards and practices adopted in other states, and hearing testimony from obstetricians, nurse midwives and other childbirth experts.
"It is sad that we had to have a death for these problems to be found," Murphy said. "It goes to show you that oversight principles, when neglected, can lead to disastrous results. With this report, as well as input from other constituencies, we will seek to address these problems legislatively.”
The state health department's 36-page report exposes a yawning gap between medical professionals and birth center advocates on the proper degree of medical oversight of births that take place outside a hospital. Those conflicting perspectives are likely to play out in future legislative debate over the best way to regulate birth centers in the state.
"They have different interpretations of the same event," Murphy said. "This is why it's important not to rush to judgment."
The American Association of Birth Centers, a national organization in Pennsylvania, on Tuesday warned against using the state report as a basis for legislation.
"AABC strongly encourages North Carolina to implement birth center licensure that is based on the evidence and not rush to legislate in reaction to an isolated cluster of events," the organization wrote. "The monitoring of birth centers should be performed by staff trained on established standards and procedures for birth center care that have proven the test of safety and benefits to women and newborns during the past 30 years."
Many of the concerns cited by the Department of Health and Human Services are applicable for a hospital or health care facility, but don't apply to birth centers, which are not medical facilities, said Maureen Darcey, a nurse midwife and birth center operator who heads the Women's Birth & Wellness Center in Chapel Hill.
"The DHHS probably did the best they could without really good knowledge of how free-standing birth centers work," Darcey said. "I was very distressed when I saw this report."
The state health department found deficiencies in 16 areas at a Baby+Co. birth center that opened in October 2014 and has since experienced the deaths of four newborns, three of which took place in the span of six months. Baby+Co. voluntarily agreed to a site inspection and safety review by the state health department, but the company issued a rebuttal to the state's report, saying the findings were inaccurate.
North Carolina is one of just nine 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.
The agency's review was conducted by four specialists who inspect and review hospitals, clinical labs, organ transplant centers, ambulatory surgery centers, rural health clinics and abortion clinics, among other health care facilities. Under an agreement with Baby+Co., the Department of Health and Human Services assessed the Cary facility using national birth center accreditation standards.
One of the state's findings on Baby+Co. was that the doctor who served as the birth center's medical director and physician supervisor was not closely involved in the deliveries that turned into emergencies. Darcy said that medical directors are available for consultation on written guidelines and periodic reviews, but they do not participate in the day-to-day operations of the birth center.
"They're not involved in the daily care of the women coming into the birth center," said Darcey, who has practiced midwifery in this state since 1980. "Birth centers are free-standing sites for uncomplicated birth that is the domain of the nurse midwife."
Baby+Co. filed similar objections in its 13-page letter to the Department of Health and Human Services.
"NC law does not require the physician to be on site during labor and deliveries, to be involved in orienting or training a certified nurse midwife or to conduct any type of periodic performance review," the company wrote.
Baby+Co.'s letter said that the newborn deaths were reviewed by perinatal experts at Baby+Co.'s business partner, WakeMed, and the Commission on the Accreditation of Birth Centers, and stated: "None of these groups have raised the lack of physician consultation as a concern."