State inspectors say oversight lacking at Cary birthing center

The medical director is supposed to be available at all times to provide consultations to the certified nurse midwives handling deliveries, according to the report, along with providing routine clinical supervision of midwives, monthly reviews of patient medical charts, quarterly reviews of quality measures and assisting with the transfer of newborns to local hospitals, as needed.

The report notes concerns with five of 10 deliveries inspectors reviewed, including insufficient overnight staffing, inadequate monitoring of fetal heart rates and confusion over where to transfer a newborn needing medical attention.

Other problems inspectors listed in the report include no orientation process or follow-up assessments to demonstrate nurse midwives were competent in their duties, a lack of training to conduct some lab tests, inadequately stocked emergency carts and an inconsistent policy on cleaning soaking tubs used by women in labor.

Baby+Co. pushed back against the findings, which a spokeswoman called "significantly flawed."

"We have responded to [the state Department of Health and Human Services] 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," the spokeswoman said in an email.

Although the state cannot impose any fines or other penalties for the shortcomings because it doesn't regulate birth centers, officials said Baby+Co’s on-site lab, which is regulated by the federal Centers for Medicare and Medicaid Services, remains under review.

State officials also noted an "incident of potential concern" over the weekend that they are reviewing.

"We take seriously the health and welfare of all mothers and babies and are investigating this incident. We have requested access to Baby+Co’s records about the incident and will return for a site review, and are ready to take additional steps if necessary," officials said in a statement.

Baby+Co. halted all deliveries in Cary after a fourth newborn was rushed to Duke University Hospital's neonatal intensive care unit after showing distress during delivery. But the state report notes that deliveries resumed at the Cary location around Memorial Day.

The Baby+Co. spokeswoman said no more newborns have died at the Cary facility since deliveries resumed, but one of its patients lost a child before she was admitted for labor.

"There are a lot of rumors and misinformation circulating about this case that are unfounded. DHHS has asked for the ability to review the case, and we have agreed in order to clarify any misunderstandings," the spokeswoman said in an email.

One area still under review is Baby+Co’s on-site laboratory, where the federal Centers for Medicare and Medicaid Services (CMS) does have regulatory authority. DHSR is assisting CMS in that effort.

The state provided copies of its findings to the North Carolina Medical Board, the North Carolina Board of Nursing, the Midwifery Joint Committee and the Commission for the Accreditation of Birth Centers, all of which have regulatory authority over the Cary center and its clinical staff.