State investigators said Monday they found significant problems at a Cary natural birth center where three infants died in the span of six months.
The N.C. Department of Health and Human Services spent two months reviewing the Baby+Co. facility and issued its findings Monday, identifying 16 areas of deficiencies at the Cary site.
In its 36-page report, the state health agency said Baby+Co. was substandard in medical oversight, supervision of nurse midwives, patient admissions, after-hours staffing and staff training. Investigators found that the medical director was not consulted in the deliveries of the three babies who died. The agency made it clear, however, that its review was not intended to determine the cause of death for any of the infants. Rather, it was to review the facility's performance according to industry standards and criteria.
The company rejected the state health agency's findings and submitted a 13-page letter challenging the state review.
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"Lack of familiarity with birth centers was evident in their report, resulting in significantly flawed findings," Baby+Co. said in a statement. "We have responded to DHHS with a robust list of factual inaccuracies and misguided conclusions that create a distorted impression of the quality of our safety systems and the professionalism of our care providers."
They called the report the "product of a 'crash course' by the reviewers," who lacked expertise in obstetrics, midwifery and birth center care and did not understand information provided during interviews with Baby+Co. staff.
During its two-month review, DHHS visited the facility, reviewed medical records and interviewed employees and families who delivered at Baby+Co. The agency noted that Baby+Co. turned over selective medical records, and the documents were so heavily redacted, they were difficult to understand.
"Several families expressed to DHSR (the state's Division of Health Service Regulation) their hope that providing information in this review process regarding their experiences could make a difference for another family," the agency report said.
One woman who delivered at Baby+Co. told state investigators the midwife delivering her baby left shortly after she delivered because she was busy delivering a baby in another room, leaving her with another midwife and unaware that her newborn was in distress.
Another family told investigators they arrived at Baby+Co. at night to a dark building and only one person on site, the nurse midwife. When the labor turned into an emergency, there was no other medical professional there to help, and the midwife had to hold the unborn child's umbilical cord in place while she used her free hand to call for help.
The report also found that physician supervision of the facility was spotty, and doctors who have served in a supervisory role included one who lived in Greensboro and another who lived in Charlotte. The current medical director, hired May 11, lives outside of Wake County and doesn't have practicing privileges at local hospitals, so Baby+Co. midwives temporarily can't deliver at WakeMed Cary, the facility's partner hospital, in the event of an emergency.
The agency noted that while it had concerns about a number of policies and practices at Baby+Co., the facility was in compliance with the birth center national accrediting organization. As a result of its own investigations, Baby+Co. has implemented a number of policy and personnel changes, including the new medical director and written job performance expectations for midwives.
Baby+Co. will not be subject to any fines or corrective actions as a result of the state's findings because the state health agency has no legal authority to inspect natural birth centers. The centers are not licensed or regulated in North Carolina, but Baby+Co. voluntarily agreed to a state review. A bill now in the legislature would allow the state to regulate natural birth centers.
The Cary facility opened in October 2014 and had delivered more than 1,200 babies until it temporarily halted deliveries in March. The center has reported four newborn deaths, three in the six months leading up to the temporary closure. After an internal investigation, Baby+Co. said it meets all safety standards and resumed delivering last month.
In a statement to The N&O in response to the report, the company said it conducted a series of internal and external reviews involving qualified outside organizations: the Institute for Perinatal Quality Improvement and the Commission for the Accreditation of Birth Centers. Baby+Co. said its birth centers produce safer outcomes for delivering moms and their newborns than hospital maternity wards.
According to The Baby+Co. statement: "Overall, our model of care has a tremendous track record of success — delivering better outcomes for women with low-risk pregnancies than hospital-based care, with lower mortality and morbidity rates and significantly lower c-section, pre-term birth and NICU admission rates."
The agency review was prompted by news coverage and by a request from Rep. Nelson Dollar, a Wake County Republican who chairs two health care committees in the state House. Dollar said the state's findings indicate the need for the the state legislature to create a licensing program for birth centers that would allow state inspectors to investigate, fine and shut down facilities that are deficient.
"I find the comments from Baby+Co. highly disturbing and disappointing," Dollar said. "If they are serious, they need to thoroughly review that report and they need to rapidly implement all the recommendations."
The Cary birth center has an arrangement for emergency transfers to WakeMed Cary hospital across the street for births that develop complications. WakeMed Cary is an investor in Baby+Co and a business partner with the natural birth center.
Baby+Co is staffed by certified nurse midwives who provide prenatal screenings and deliveries. The center's policy is to only accept low-risk pregnancies, which would exclude women with obesity, diabetes and other conditions.
Birth center advocates generally support state oversight because health care regulation fosters public confidence and ensures public safety. The North Carolina affiliate of the American College of Nurse-Midwives did not address the specific findings of the state report but issued a statement Monday endorsing the highest standards of ethics and practice in midwifery.
"We are holding the families of the newborns who died in our thoughts and offer our condolences," the statement said. "We hope that through evaluation of these tragic events we can all learn how to improve our systems of care because women and families deserve the best care possible."
The state health agency report released Monday is not the final word.
The agency's Division of Health Service Regulation is still reviewing Baby+Co.'s on-site lab, as well as an incident from this past weekend involving a Baby+Co. client who lost her baby without being admitted into labor. A spokesperson for the company said that because of rumors and misinformation circulating about the death, Baby+Co. agreed to let DHHS review the case.