“To me, it’s about accountability,” registered nurse Susan Rames said of ALC’s infection control practices. “This is something that needed to be brought to light.” (Photo for Reveal by Jon Cherry)

At 52, Susan Rames was looking for a way to give back. She worked part time at a Kentucky hospital as a postpartum nurse and, with her three children nearly grown, she had some extra time during the week.

Motivated by her Christian faith, Rames decided to volunteer at ALC Pregnancy Resource Center, a crisis pregnancy center whose mission is to discourage people from seeking abortions.

The center offers free ultrasounds and needed volunteer nurses to complete a sonography training program. Rames said she liked the idea of helping women see “the truth and the life” inside their pregnant bodies so they might make “a better choice for themselves and their babies.”

After taking an online training course, Rames began in-person instruction in August 2020 at ALC’s Shepherdsville site, one of its two Louisville-area locations, doing practice ultrasounds under the supervision of a nurse manager.

That’s when she spotted the red flags.

The center was using an expired disinfectant to sanitize an essential piece of equipment for early-pregnancy ultrasounds: the transvaginal probe. And that disinfectant, medical researchers have warned in recent years, doesn’t kill the human papillomavirus, a widespread and potentially deadly sexually transmitted infection responsible for more than 90% of cervical cancers, as well as cancers of the genitals and throat.

Stopping HPV’s spread has been a major public health goal for decades.

“You’re saying you want to help these women,” Rames recalls thinking as she researched different types of high-level germ-killers on the internet. “Yet you’re potentially going to transmit an infection to them?”

Rames said she immediately went about trying to fix the problems she saw, first with her manager and then the clinic’s leadership. After four months and little response, she filed a flurry of whistleblower complaints with the state of Kentucky.

But far from resulting in any action against ALC, the complaints illustrate just how difficult it is to get any accountability for crisis pregnancy centers that offer medical services such as ultrasounds.

A key part of the anti-abortion movement’s long-term strategy, pregnancy centers have proliferated across the country in recent years, many mimicking the look and feel of medical clinics. Yet an ongoing investigation by Reveal from The Center for Investigative Reporting has shown most centers operate in a kind of regulatory dead zone, free of the significant state and federal oversight – such as regular inspections and rules to protect ultra-sensitive personal information – that most medical clinics face.

Until five years ago, Kentucky was one of the few states that did regulate pregnancy centers, but that changed in 2018 when legislators passed a law that erased the licensing requirements as part of a broader push to make it easier for hospitals to expand. Now in Kentucky, as in most of the country, pregnancy centers don’t have to be directly licensed, instead providing medical services under the professional licenses of their staff and volunteers.

Rames’ account of the problems at ALC, documented in hundreds of pages of emails, cellphone photos, research papers and other materials, highlights how the lack of regulation of pregnancy centers can put women – and, in the case of HPV, potentially even their partners and babies – at risk.

Without meaningful oversight, it’s difficult to know whether centers are complying with the latest medical protocols or cutting corners in ways that compromise clients’ safety. Even when a whistleblower such as Rames is willing to come forward, without outside watchdogs, there’s no way to ensure that changes made by centers to correct problems will stick.

“The fact that you are allowed to put yourself out there as somebody that is helping pregnant women and (are) doing pseudo-medical procedures, but have no accountability as a medical facility, is a problem that endangers people,” said Seema Mohapatra, a health law professor at Southern Methodist University.

As a registered nurse with nearly 20 years’ experience in hospital settings, Rames was highly attuned to the importance of keeping up with the latest research and complying with even the most insignificant-seeming protocols to prevent infections. “We know it is what we can’t see with the naked eye that can continue to live on surfaces & then our instruments become vectors of these pathogens,” she wrote in one complaint.

Rames first got an inkling that ALC wasn’t being as careful as it should be when she said she noticed that staff weren’t using the right type of lubricant gel on the probe that was inserted into a client’s vagina. Instead, they were using gel meant for external abdominal ultrasounds and squirting it from refillable containers that, according to ultrasound industry guidelines, might not be sterile enough for transvaginal procedures.

When Rames voiced her concerns, ALC’s nurse manager, Sara Reece, said she’d have to get permission to order the correct product because, as a nonprofit, the center’s staff “have to use their donations responsibly,” Rames later alleged to the Kentucky Board of Nursing.

Rames ended up purchasing the proper lubricant on Amazon and donating it to the center, receipts show. Reece declined requests to comment.

In early December 2020, Rames said she noticed something more troubling. Hanging on the wall next to the ultrasound machine was a plastic canister of disinfectant that staff used to soak the probe after each examination. But the expiration date, scrawled in marker, read 11/11/20 – three weeks earlier. Rames said she didn’t raise concerns at the time because she assumed someone would replace it. But the canister was still there in January 2021, now nine weeks past when it should have been tossed.

For disinfectants, the expiration date typically marks the point at which the solution becomes less potent and reliable. Rames said that after she and another volunteer-in-training asked about the solution, Reece pulled out a big jug of the disinfectant, MetriCide OPA Plus, that was used to refill the smaller container. According to its label, it too had expired, on Dec. 1, 2020, Rames said. And no one had recorded when the jug was first opened – a critical part of infection prevention protocols, the manufacturer’s packaging warned. This particular disinfectant has a shelf life of only 75 days after the container is opened. Rames photographed the expired products with her phone.

Then, at home, Rames said she made yet another disturbing discovery. MetriCide OPA Plus wasn’t the right disinfectant for the pregnancy center’s purposes. A special report from the Society for Maternal-Fetal Medicine warned that orthophthalaldehyde, MetriCide’s active ingredient, has “virtually no efficacy against” HPV.

Rames said she considered reaching out to the center’s volunteer medical director, Dr. Anita Kotheimer, but the doctor never seemed to be there when she was. So, armed with her research, Rames requested a meeting in January 2021 with ALC’s executive director at the time, Diana Cahill. “Ms. Cahill appeared to understand the importance of this issue” and said she’d talk to Reece and replace the disinfectant, Rames recounted in her whistleblower complaints. “We want to use best practices,” Cahill told her. Cahill no longer works at the center and didn’t return Reveal’s calls. ALC’s current executive director, Erica Price, also didn’t respond to requests for comment.

Still, Rames quit the training program soon after that meeting, worried that her nursing license could be in jeopardy if she continued to volunteer there. “I did not want to be associated with an organization that was betraying people’s trust,” she wrote to one state medical board. “This way of operating presented a moral, ethical, legal & professional conflict for me.”

A few weeks later, Cahill checked in with Rames, telling her that ALC had indeed changed out the expired supplies. The center also upgraded a host of its infection control protocols. Yet Rames said she worried that without any external oversight, ALC could revert to its previous practices.

“To me, it’s about accountability,” she said in an interview. “This is something that needed to be brought to light and have some other people be aware of it.”

So starting in May 2021, Rames began filing her whistleblower complaints.

First, she went to the state, but the Kentucky Cabinet for Health and Family Services no longer had the authority to investigate her allegations because of the 2018 law that eliminated licensing requirements for several types of clinics, including pregnancy centers.

If ALC had been overseen by state authorities, “there would be a way to insist that corrections be made to deficiencies that are found,” said Lois Uttley, a national health care policy consultant who teaches at Sarah Lawrence College. “Clearly, that process is not happening with crisis pregnancy centers because they are under-regulated.”

Rames also turned to Care Net and Heartbeat International, two of the largest pregnancy center networks in the country, which issue best-practice recommendations to their members, including ALC. Both responded that they would follow up with the center, but neither had any regulatory authority. “We aren’t able to provide regulatory oversight for ultrasound practices outside of our affiliation requirements,” Care Net told Rames in an email. Neither organization responded to Reveal’s questions.

The only other avenue for accountability was to appeal to state medical boards, which can discipline doctors and nurses if they violate their professional codes of conduct but have no power to oversee the facilities where they work. Rames filed a complaint with the Kentucky Board of Nursing that accused Reece of a “repeated and willful” failure to follow current infection control guidelines, contributing to a “culture of non-compliance & poor nursing practice.”

Reece said the allegations were “inaccurate.” “I take my role as nurse manager very seriously and am always open to opportunities for improvement,” she wrote to the nursing board. “I take pride, as a nurse and as a leader at ALC, in fostering a culture of safety and transparency.” Ultimately, the board concluded that there was insufficient evidence for disciplinary action.

Rames filed a second complaint with the Kentucky Board of Medical Licensure accusing Kotheimer, the medical director, of failing to adequately supervise ALC’s services.

Under the pregnancy help industry’s own guidelines, centers that offer ultrasounds must have a medical director who is a licensed physician. But Rames said she met Kotheimer, a semi-retired OB/GYN with 40 years of experience, only once for about 10 minutes at the beginning of her training and never saw her during her once-a-week shifts over about five months at the center. In Reveal’s analysis of pregnancy centers in 27 states, including Kentucky, we found that most medical directors maintain their own practices or work as volunteers, raising questions about how much time they spend on their center duties.

In her response to the board, Kotheimer insisted she played an active role at ALC and said that after Rames raised her concerns, “changes were promptly put in place.” The medical board closed the case without disciplinary action. Neither the board nor Kotheimer returned Reveal’s messages for comment.

But the boards’ failure to take action against ALC’s medical director and nurse manager doesn’t mean Rames’ concerns weren’t valid, health policy experts said. Teneille Brown, a law professor and bioethicist at the University of Utah, noted that institutionwide problems, such as sloppy infection control or poor maintenance of medical equipment, can’t be addressed by only regulating staff and volunteers.

“Imagine that a popular restaurant had an outbreak of food poisoning. The state wouldn’t hold an individual server accountable. It would hold the entire restaurant accountable,” Brown said. “It’s the same in medicine. But if the clinic is not regulated or required to have a license, good luck deterring risky practice by putting pressure on individuals.”

After months of trying to get authorities to act, Rames said she felt deflated by the fact that ALC would continue to operate without external oversight.

“It’s a public health risk. It is not known by the public that this is how these centers are operating,” Rames said. “They are doing medical procedures, but not doing it to the standard of care that you would have if you were going to your doctor or any hospital or clinic.”

Less than a year after leaving ALC, one of Rames’ daughters got pregnant. It was an unplanned pregnancy, and she gave birth in July. Rames warned her to stay away from any pregnancy centers. “Whatever you do,” she told her, “don’t go.”

Read an earlier Reveal report about crisis pregnancy centers: How anti-abortion pregnancy centers can claim to be medical clinics and get away with it.?

This article first appeared on Reveal and is republished here under a Creative Commons license.

This story was edited by Nina Martin and Andrew Donohue and copy edited by Nikki Frick.

Laura C. Morel can be reached at [email protected]. Follow her on Twitter: @lauracmorel.