A state investigation into a Cary birthing center has identified “significant concerns,” according to the investigation summary.
Baby+Co in Cary has had at least three newborns die in the last seven months. One of those deaths has been in 2018.
A legislator requested a review, which was conducted by the N.C. Department of Health and Human Services’ Division of Health Service Regulation. DHHS does not regulate birthing centers, but Baby+Co agreed to the review.
DHSR officials were on-site from April 23 to 26 and again on May 1. Staff visited once more on May 21 to share their observations.
Investigators said they interviewed Baby+Co staff, as well as examined 10 patients records, including the three recent infant deaths, and a fourth from 2015.
Among concerns identified were “oversight and physician supervision of certified nurse midwives,” the review read.
The report stated there were no guidelines for when midwives were required to call their supervising physician.
In the review, health officials said the facility’s supervising physician “was not contacted by Baby+Co staff prior to or during the deliveries of the reviewed records that resulted in infant deaths during his tenure. For the three deaths that occurred during his tenure as medical director, he was contacted days after the deaths occurred. “
The report also highlighted other areas of concern for DHSR officials, such limited overnight staffing, confusion over when to transfer a newborn to a traditional hospital, and not having a “consistent and formal orientation process to validate the skills” of it midwives.
The DHSR report stated Baby+Co redacted its medical records to conceal the identity of patients and staff. It also redacted minutes of board meetings, which the review said made it difficult to determine when and why policies were revised.
Baby+Co responded with 13 page response of it own, calling the DHSR review’s findings “significantly flawed.”
“The report in its current form leaves the public with a distorted impression of the quality of our safety systems and professionalism of our care providers. The findings do a disservice to families and practitioners of a model of care that has a tremendous overall track record of success,” said Baby+Co in a statement.
Baby+Co said North Carolina is one of six states that requires midwives have physician supervision, however, law “does not require the physician to be on site during labor and deliveries, to be involved in orienting or training a certified nurse midwife, or to conduct any type of periodic performance review.”
The birthing center said claims that the medical director was not immediately informed about the infant deaths are inaccurate.
After the recent newborn deaths, Baby+Co halted deliveries, but the DHSR report said the facility began again around Memorial Day.
In its report, DHHS said this weekend there was an “additional incident of potential concern involving a patient of Bay+Co of Cary,” adding that investigators plan to return to the facility to conduct an official review.
In a statement, a Baby+Co spokesperson said “we have not had any further newborn losses in the birth center since the losses that were previously reported. 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.”
Because the state does not regulate birthing centers, DHHS cannot impose any fines or other penalties against Baby+Co. However, the facility’s on-site lab is still under review, which is regulated by the federal Centers for Medicare and Medicaid Services.
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