The I-Team first reported on Baby + Co. on March 23, when administrators announced the birthing center voluntarily stopped delivering babies at its Cary office, located at 226 Asheville Avenue.
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The center resumed delivering babies last month, according to the report.
Though North Carolina does not regulate birthing centers, the facility's managers nonetheless allowed the North Carolina Department of Health and Human Services to send a team of investigators to review its practices and protocols.
In a 36-page report, officials identified several red flags, including "medical oversight and supervision of nurse midwives, the criteria used to admit and discharge patients, after-hours staffing, laboratory operations, documentation, and staff orientation and training."
I-Team looks into how birthing centers and midwives are regulated after deaths of three newborns at Cary location
Specifically, officials derided Baby + Co for its lack of communication with its medical supervisory staff, including the supervising physician who apparently never learned of the infant deaths until days after each occurred.
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According to the report, staff interviews revealed the Medical Director/Supervising Physician "did not orient staff" and was "not on the ground working next to us."
Staffing problems extended to Baby + Co's team of Certified Nurse Midwives (CNMs), as well, with the report lamenting Baby + Co's lack of "consistent and formal orientation process to validate the skills" of its nurses. Additionally, officials found no record of any staff evaluations or "validation of competencies."
"We have not had any further newborn losses in the birth center since the losses that were previously reported," a spokesperson for Baby + Co. told ABC11 on Monday. "With the family's permission, we can confirm that a patient experienced a loss outside of the center without being admitted into labor. Our hearts and prayers are with the family involved.
There are a lot of rumors and misinformation circulating about this case that are unfounded," the spokesperson added. "DHHS has asked for the ability to review the case and we have agreed in order to clarify any misunderstandings."
In all of NC, there are only seven birthing centers. All of them have an accreditation, but they don't have any state licensing -- and that's because there's no such thing. Baby + Co. has locations throughout the U.S. and two more in North Carolina.
The national accreditation for birthing centers involves a visit and review once every three years. The midwives, though, must meet strict standards, including earning a Master's Degree in nursing.
Baby + Co also sent this statement to ABC11 on Monday:
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While we thank DHHS for conducting their review of our Cary Center, lack of familiarity with birth centers was evident in their report, resulting in significantly flawed findings. 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.
We have taken recent events in our Cary center very seriously, and have conducted a series of internal and external reviews of highly qualified clinical teams including The Institute for Perinatal Quality Improvement and the Commission for the Accreditation of Birth Centers (CABC), whose standards the report cited. All of our centers are fully accredited by the CABC and we have operated in good standing in states with birth center regulations.
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.
In a statement sent to ABC11 at the start of the investigation in April, a spokesperson for Baby+Co. said: "We have every confidence in our model of care and welcome the opportunity for review...We are licensed in the state of TN and CO where there is birth center regulation and regulators from those states have conducted site visits and a careful review of our policies, procedures and safety standards. We apply the same standards across all of our centers, including our center in Cary, NC."