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By Rose Hoban

North Carolina’s Department of Health and Human Services has asked Baby+Co. if they can perform an investigation of the organization’s Cary-based facility where three newborns have died in the past six months.

HHS Sec. Mandy Cohen told a legislative oversight committee Tuesday any such review of the facility would be strictly voluntary because “we do not have regulatory authority here for freestanding birth centers,” the term for facilities where women can give birth outside of hospital walls.

Cohen said she would like to send in a regulatory team, such as those that visit hospitals after incidents, “to do an inspection of their policies and procedures, as well as look at patient records, all in the service of understanding what may have happened related to these children’s deaths.”

She said her department had contacted Baby+Co. by email last Friday, sending a hard copy of a letter on Monday.

A DHHS spokesman said Wednesday that Baby+Co. had asked for a meeting ahead of a full review and that the agency had agreed, “And was eager for it to occur this week.”

“It came as a great surprise to me that… this state does not regulate these [birthing centers],” said Rep. Greg Murphy (R-Greenville), a urological surgeon, during the hearing. “We’re one of eight states in the country that does not.”

“It baffled me, I’m trying to get a history of why that happens,” he said.

Maureen Darcey knows that history. She runs a different birthing center, the Women’s Birth and Wellness Center in Chapel Hill and in 1980, was one of the people working in the state’s first birthing center in North Carolina using a vacant wing of the old Siler City hospital.

“We took over the four-bed ward and made it into two birthing rooms,” remembered Darcey, a certified nurse-midwife.

She asked for regulation back then, and again in the 1990s after moving to Chapel Hill, but each time, the question of regulating and licensing birthing centers got caught up in the caustic politics of doctors versus nurses, and the question of nursing “scope of practice.” That same dynamic is playing out now in the shadow of tragedy, where a state authority has its hands tied in trying to piece together what happened to three families.

Looking for answers

Media reports began to surface about the problems at Cary’s Baby+Co. location in March, when the organization emailed expectant moms in their care that they would be sent to WakeMed Hospital to give birth as they reviewed three deaths over the course of about six months.

WakeMed said it would continue to see Baby+Co.’s patients. The hospital is a minority investor in the company and retains a relationship with the organization, but according to spokeswoman Kristin Kelly, “WakeMed and Baby+Co. are currently evaluating the collaboration and their options for the future.”

Because of the way North Carolina law is laid out, nurse-midwives actually don’t receive a license to practice. Instead, they are licensed under the auspices of a supervising physician or practice. That physician is not necessarily on the premises where midwives work, but periodically reviews a nurse-midwife’s practice and patient charts and can provide feedback.

Without a physician supervisor, a nurse-midwife can’t practice, period.

Nurse-midwives are regulated through the Joint Midwifery Committee, which is made up of members chosen by both the boards of nursing and medicine. Midwives practice under a state law that’s separate from the nursing and medical practice acts. All of these laws define the limits of a provider’s ability to practice.

A call to the board of nursing revealed that the oversight body has not yet received a complaint about Baby+Co. David Kalbacker, the governmental affairs head for the Board of Nursing, said his agency had received a complaint about one of the midwives from Baby+Co., “but when we looked at it, it was from a woman who had given birth elsewhere.” (Note: the NC Board of Nursing is a NC Health News sponsor)

“The midwife was now at Baby+Co. but her issue had nothing to do with Baby+Co.,” he said. “So we’re at a crossroads because we don’t have a complaint to work off of.”

Kalbacker noted the nursing board has authority over licensees, but not facilities such as Baby+Co.

“The nursing board generally takes the lead on their licensees,” said Jean Fisher Brinkley, spokesperson for the North Carolina Medical Board. “The Medical Board would take the lead on matters that have to do with medical supervision.”

Fisher Brinkley said she’s prohibited by law from revealing whether a complaint has been received by her organization. She also said a complaint is not required for the Medical Board to open an investigation.

One person who has received a complaint is lawmaker Sen. Mike Woodard (D-Durham), who got an email from a constituent, one of the three women who lost an infant son. The woman wrote, “we are still struggling to find the answers to explain his short life.”

Sen. Mike Woodard (D-Durham) Official NCGA portrait.

Woodard said he was moved by his constituent’s tragedy.  He also said he’s done extensive work on the issue of nurse-midwife licensure and their ability to practice more independently. Part of his interest stems from the fact that neither Person nor Caswell counties, rural areas which he represents, has an OB/GYN practicing there. He was part of a 2014 legislative study committee that found that nurse-midwives should be empowered to practice more independently in North Carolina, but the recommendation never made it into law.

“I want to be involved in proper birthing center regulation,” Woodard said. “I hope that as we move forward, we can find a balance that provides maximum amount of safety and transparency for families that chose to use birthing centers and allowing our certified nurse-midwives to continue their important profession.”

Support for regulation

During Tuesday’s meeting of the Joint Legislative Oversight Committee on Health and Human Services, Rep. Murphy noted that he’s heard from birthing center leaders that they want to be licensed and regulated by the state.

“Right now oversight is being done by these quasi-commissions kind of like JCAHO,” said Murphy, referring to the Joint Commission, a national body which accredits hospitals nationwide.

Maureen Darcey has been asking for the state to regulate birthing centers for decades. She still has a file with documents that she  prepared in the 1980s and 1990s, with draft legislation and proposals for regulations. Photo credit: Rose Hoban

“It’s been my experience with those kinds of institutions, that a lot of what’s done as far as regulation and what’s code is literally just coming out of a book that they just make up every day.”

Darcey said Murphy was right in believing birthing centers wanted to be regulated. At her Chapel Hill office on Tuesday evening, she pulled out a folder from her files titled, “B.C. Task Force, 1985” to show off a document that she said was draft statutory language that would allow for birthing centers to be licensed and regulated.

She’s asked for regulation first in 1985 but was told that since she had the only such organization in the state, there was no need. She asked again in 1995, but that request got buried in the ongoing tug-of-war between medicine and nursing.

“I was looking at notes from a meeting, and one person said, ‘If we license them, people will think they’re legitimate,’” she said.

Instead, she has accreditation from the national American Association of Birth Centers.

“The folks at the AABC prefer folks to have licensing,” she explained. That body visits Darcey’s facility every three years and goes through files, statistics, patient records, human resources standards, quality evaluation standards and more.

She pulled out the 237-page AABC standards manual.

“I gave one to Mandy Cohen,” she said. “These standards are written by physicians from Yale and Harvard and they’ve had 11 revisions since 1985. It’s evidence based and it’s standardized across the country.”

When asked what changes would take place if the state regulated her organization, Darcey responded, “not much.”

“It would legitimize us, it might help with getting insurance contracts,” she said, but the state would likely rely on the standards that she’s already using.

Dynamic time

During a birth, things can go wrong pretty quickly, explained Durham-based gynecologist Toby Ritterhoff, who stopped practicing obstetrics about a decade ago when she moved to North Carolina. “Everything is low risk until it’s not.”

“It’s a fairly dynamic time in the life of the baby where it goes from relying on the mother to where it goes through all those contractions and the stress of contractions and has to start breathing on its own,” she said. “So, it is a time when bad things can happen… there’s a lot of change.

A baby warming station in one of the birthing rooms at the Women’s Birth and Wellness Center in Chapel Hill. Photo credit: Rose Hoban

“There’s controversy about what is useful in getting the mother and baby safely through delivery, that’s for sure,” Ritterhoff said.

Tragic things happen at hospitals, too, but the state doesn’t always intervene when that happens. Most hospitals have internal quality assurance boards where all of the people involved in an incident are required to sit down and pick through the problems. From there, the hospital may decide whether or not to move forward or change their processes or even sanction a provider.

If a patient makes a complaint to a state or federal body, then regulators arrive and create a statement of deficiencies and sometimes a corrective action plan.

Darcey said there’s a parallel process at birthing centers.

“When you have a bad outcome and it’s a sentinel event, you report to the Commission for the Accreditation of Birth Centers to do a root cause analysis,” she said. “When you have it, they start to tell you what you have to do in order to keep your accreditation.

“You have to alert them and to my knowledge that happened at Baby+Co.,” she said.

A spokesman for Baby+Co. said that after each incident Baby+Co. “conducted a thorough review with our partners at WakeMed.”

“We are performing detailed case reviews with our Medical Director and hospital partners to be sure that our system of care is of the highest standards,” the spokesman wrote in an email.

Cohen said she thought this incident was a good place to start a conversation about regulating places such as Baby+Co.

“We don’t have this [authority] in our state,” Cohen said. “We’d welcome the authority to add that to the things that we oversee, but it’s not one that we do have right now.”

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Rose Hoban

Rose Hoban is the founder and editor of NC Health News, as well as being the state government reporter. Hoban has been a registered nurse since 1992, but transitioned to journalism after earning degrees...