State investigators found significant problems during their investigation of a Cary birthing center where three infants died over the course of six months.
Baby+Co, which runs a handful of natural birthing centers across the country, agreed to a voluntary review of their clinical standards and operations. The Division of Health Services Regulation at the N.C. Department of Health and Human Services conducted a months-long investigation into the Cary location.
DHSR released its findings on Monday, June 12, but because DHSR doesn’t have the authority to regulate birthing centers, it can’t impose fines or penalties on the company. The Center for Medicare and Medicaid services, which does have regulatory authority, is still reviewing Baby+CO’s on-site laboratory.
The DHSR report highlights significant concerns with “medical oversight and supervision of nurse midwives, criteria used to admit and discharge patients, after-hours staffing, lab operations, documentation, and staff orientation and training.”
While investigators looked into each case where an infant died soon after birth, the report doesn’t conclude why the infant died. But the report does document several concerns including how hospital transfers were conducted during the emergencies leading up to the infants’ deaths.
The report claims Baby+Co doesn’t have a consistent and formal orientation process to validate the skills of its certified nurse midwives. In one documented instance, a CNM left shortly after delivering a baby to attend to another delivery in a different room, but was unaware that the newborn was in distress.
The mother and the newborn were left with another midwife, but state investigators voiced concern on whether the CNM handling all the deliveries is able to provide individualised attention to each patient.
Baby+Co dismissed much of the report as a product of reviewers taking a crash course on the birth center model and obstetrical care in general.
“While we thank DHHS for conducting their review, lack of familiarity with birth centers was evident in their report, resulting in significantly flawed findings,” Baby+Co administration wrote in a statement.
Baby+Co sent a 13-page letter to N.C. 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.”
After each infant death, Baby+Co conducted two separate case reviews along with partners WakeMed and EMS, and with its accrediting agency. Among the thousands of babies delivered at the Cary center, four have died since 2017 when it opened, three in a span of six months. After the most recent infant death in March, the center temporarily closed and sent all clients to WakeMed.
The Cary location reopened in May after an internal investigation.
Kate Condliffe, the chief operating officer at Baby+Co, said in the letter to N.C. DHHS that if their findings were left unaddressed or uncorrected, then they would mislead the public about the safety of Baby+Co.
“As it stands, the review does a disservice to the entire birth center model of care that has proven to be a safe and important option for parents not only in the United States but around the world,” Condliffe said.
While DHHS doesn’t have regulatory authority over natural birthing centers, the N.C. Medical Board, the N.C. Board of Nursing, the Midwifery Joint Committee, and the Commission for the Accreditation of Birth Centers all oversee the center and its staff.
Even so, lawmakers have called for increased regulations over natural birth centers. Rep. Nelson Dollar, R-Wake, chairman of the House Health and Health Care Reform committees called for regulating the centers and requested the initial investigation into Baby+Co.
Sen. Ralph Hise, R-Mitchell introduced Senate Bill 798, which would establish licensing requirements for birthing centers to promote public health, safety, and welfare. The bill is in the Senate Rules committee.
Neither Hise nor Dollar responded in time for publication.
Birthing center advocates have cautioned lawmakers from overreacting to the recent tragedies at the Cary center and introducing onerous regulations.
“This is a super upsetting situation that we find ourselves in. Let’s not make this a witch hunt,” said Suzanne Wertman, president of the N.C. Affiliate of the American College of Nurse Midwives told Carolina Journal.