Donor Screening Standards Under Scrutiny as Genetic and Legal Risks Rise

Field Pressures Prompt Call for Proactive Risk Management in Egg Donor Screening

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BY: INSIDE REPRODUCTIVE HEALTH

Increased legal challenges and the growing prevalence of commercial genetic testing are placing heightened scrutiny on egg donor screening practices within the fertility field. The combination of evolving legal landscapes and advances in genetic analysis has underscored the importance of adhering strictly to guidelines set by organizations such as the ASRM (American Society for Reproductive Medicine), ACOG (American College of Obstetricians and Gynecologists), ACMG (American College of Medical Genetics and Genomics), and the FDA.

Field experts stress that failure to meet these guidelines could lead to significant legal, ethical, and reputational risks for fertility clinics, egg banks, and associated providers. Amy Duckett, Genetic Counseling Liaison, warns, “When screening a gamete donor, it is incredibly important to follow guidelines and recommendations set by governing bodies to reduce the potential risk to donor-conceived people and their future families.”

The risk landscape has been reshaped by the widespread use of consumer-focused genetic testing platforms like 23andMe and Ancestry.com. These services make it increasingly difficult to conceal donor identities or errors in donor records. Cases of donor misrepresentation and misidentified donors are now more likely to be exposed, leading to potential lawsuits and negative media attention.

For example, the Georgia Supreme Court’s 2020 ruling in a case concerning a sperm bank’s failure to disclose critical information about a donor highlighted the legal consequences of inaccurate or withheld data. According to the court’s decision, the clinic’s failure to provide accurate medical and genetic information constituted a breach of trust and a violation of consumer protection laws. This development emphasizes the urgent need for more robust and transparent screening processes.


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Potential for Increase In Negligence Claims

Errors in donor screening can lead to serious issues for intended parents and donor-conceived individuals. Among the most pressing concerns are inaccuracies in medical records, overlooked genetic incompatibilities, and psychological evaluation deficiencies. Duckett explains, “Genetic counselors must ask themselves, even if the donor meets the bare minimum requirements, does this donor have too many possible increased risks for intended parents who are looking for the best possible chance of having a healthy child?”

Medical and legal repercussions for fertility clinics that fail to screen rigorously are significant. Undetected conditions such as a family history of bipolar disorder, heart disease, or other hereditary illnesses may result in costly and damaging litigation. Additionally, overlooked RH factor issues or inaccurate maternity/paternity information can have life-altering implications for both donors and intended parents.

A study published in the National Library of Medicine noted, "Advances in genetic testing, especially genomic testing, are likely to make family history more redundant," but the same study cautioned that this also increases "the potential for negligence claims when clinics fail to act on genetic findings."

Leading Egg Bank Implements Proactive Screening Strategies

Leading fertility providers are adopting stricter screening protocols to mitigate these risks. Comprehensive genetic testing, thorough psychological evaluations, and detailed family medical histories are becoming standard practice. Duckett emphasizes that merely meeting the minimum guidelines is no longer sufficient. “We must be proactive in screening donors to give the intended parents the best quality donor,” she states.

Some egg banks have gone beyond field requirements by implementing additional measures such as karyotyping, extensive psychological assessments, and consultations with certified genetic counselors. These steps are aimed at ensuring that donors are not only eligible under existing guidelines but also suitable for the specific needs of intended parents.

The move towards known or semi-known donation models adds another layer of complexity. This shift, driven by the advocacy of donor-conceived individuals, requires thorough education and consent processes for donors. The potential for future contact between donors and offspring necessitates that donors fully understand the long-term implications of their participation. Duckett notes, “Centers should really pause and ask themselves if a donor is right for known donation, or donation at all.”

Experts advocate for clearer donor guidance

As genetic testing technologies continue to evolve, fertility practices must remain adaptable and vigilant. The anticipated rise in genome and exome sequencing will likely provide more detailed donor profiles, but with that comes the challenge of managing an influx of complex genetic data. Field experts are advocating for clearer guidelines on how to handle this information and what responsibilities fertility centers have toward donors and intended parents.

A Swedish follow-up study of 210 oocyte and sperm donors found that "one in four donors reported a need for counseling about how to manage potential future contact with offspring from their donation." This underscores the need for ongoing psychological support and comprehensive education during the screening process.


Unlock More Opportunities for Your Clinic Today!

Grow Your Clinic and Expand Egg Donor Options—Become a Partner with MyEggBank!

Are you ready to provide more choices for intended parents and offer your clinic the opportunity to join an exclusive, national network?

As a MyEggBank Partner, You Will:

  • Increase patient satisfaction by referring them to MyEggBank’s large inventory of  both fresh donors and frozen eggs

    Take Action Now

    Visit our website to become a partner or affiliate with MyEggBank today!

 
 

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.

 
 

Summiting Mountains [] Embryologists are the unsung heroes of egg banking

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Embryologists are the unsung heroes of egg banking
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Lynn Mason’s journey from emancipated youth to Wall Street banker to CEO of IVI RMA is a climb that took personal and professional grit, and highlights her commitment to increasing access to healthcare using her collaborative and empathetic leadership.


The views and opinions expressed in this article do not necessarily represent the views of the Advertiser or of Inside Reproductive Health.

 
 

BY TARA BELLUCCI

Lynn Mason’s journey from an investment banker on Wall Street to the helm of IVI RMA is marked by a commitment to healthcare accessibility. When the largest reproductive medicine group in the world chose Mason, a relative unknown in the fertility space, to run their North American operations in November 2023, some may have been left scratching their heads. 

But Mason's career trajectory is filled with experiences that shaped her into a dynamic leader. Growing up in North Carolina, She was encouraged by her parents, neither of whom attended college, to pursue higher education. Her interest in business led her to Wall Street, where she spent six years in investment banking. This period allowed her to observe and learn from those at the pinnacle. "I got to see a whole bunch of different companies and how leaders operate," she says. "I got to truly sit in the seat of a learner with some of the biggest and best companies in the world."

Her experiences on Wall Street ignited a desire to transition to a more hands-on role within a company. She pursued an MBA and was inspired by Kent Thiry, chairman and CEO of DaVita, to consider a career in healthcare. "From that day forward, I've been in love with healthcare and what I can do to first expand access to care," she explains.


"From that day forward, I've been in love with healthcare and what I can do to first expand access to care”


Emancipated youth to top exec 

Mason’s personal life also played a significant role in her career choices. She became an emancipated youth at age 15, and the challenges she faced during this period shaped her priorities. "Access to education, access to healthcare, and access to nutrition were always on my mind," she shares. Her commitment to these areas is evident in her career moves, which include senior care (ChenMed), dialysis and kidney care (DaVita), and behavioral and mental health (Broadstep Behavioral Health).

She says her transition to the fertility industry was personal. "I have a sister who has not been able to carry a child to full term, two aunts who could not have children, and a mother who somehow had four children with one ovary," she reveals. This connection fuels her passion for ensuring that everyone has the opportunity to build a family. "I want to make sure that anyone who wants to build their family and is having a challenge or who wants to build a family on their own terms has that ability."

Mason joined IVI RMA right as the company was closing a deal to acquire Eugin’s North American assets, including Boston IVF and TRIO. The timing is coincidental, the company says, and Mason wasn’t involved in the negotiations, but was hired based on her “proven track record of scaling businesses and leading teams to develop innovative programs that provide patients with better access to quality care.”

Going forward, it’s Mason’s job to set a new vision and future for IVI RMA North America, focused on leveraging the key strengths shared by its brands — research, innovation, and patient-centered care. 

Mason chaired the NC Triangle American Hearth Association’s 2022 Go Red for Women event, one of her many philanthropic pursuits.

Leading with empathy

Mason’s leadership style is heavily influenced by her experiences at DaVita, where she learned the importance of leading with empathy. Her facility administrators were nearly all nurses, and they had some questions as to what a former investment banker had to bring to the table. One nicknamed her “Fancy Pants MBA.” 

"We constantly talked about [how] to lead with our head, our heart, and our hands," she says, “and I was doing a lot of head work and hands work with these ladies.” A turning point came when she offered a hug to a frustrated team member instead of advice, which helped her realize the importance of showing care and empathy as a leader.

“We are here to be in service to patients. And as leaders, we're here to be in service to the people who do the patient care so they can do it well,” she says. “I walk into the room wanting teammates to understand I care about the work that we do first.”

Her tenure during the beginning of the COVID-19 pandemic was another significant challenge. Mason had just taken on her first CEO role at Broadstep when the pandemic hit. "To lead through a crisis—and it really felt like a crisis for everyone and us in particular," as it was a residential care facility, she recalls. Her approach was to provide stability and solutions, showing her team that she cared deeply about their well-being and the organization’s needs.


“At Asian Egg Bank, we believe our embryologists’ expertise not only enhance the outcomes of egg banking, but also provide a vital role and the human touch that machines alone cannot replicate.”

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She emphasizes the importance of having a diverse team (if you’re not careful, “it’s easy for all of us to hire replicas of ourselves,” she says) with complementary skills and aligning them with the organization's mission and values. "I want to hire a bunch of my successors. I want people on the team who are not only subject matter experts in what they do, but are willing to engage with each other," she states. 

IVI RMA COO Iris Gonzalez worked with Mason at ChenMed, and left her 10-year stint at the company for the chance to work with her again. “The rising tide raises all ships, she's the tide,” Gonzalez says. “She knows how to observe and contemplate, ‘what are an industry's needs, what are then an organization's needs, where is my team today?’”

 

Mason hiking Mt. Kilimanjaro in 2022, where she carried the flag for the American Heart Association.

 

Climbing mountains

Mason not only climbs corporate ladders, she climbs literal mountains. She participates in Align’s Mountains and Marathons leadership immersion programs, with six months of virtual holistic leadership training. And then you climb a mountain. 

“By the time we got to Tanzania, I felt like I had already climbed my mountain. And now I just needed to physically do it,” she recalls. “I was one of the oldest people who was in this group and I felt like I had something to prove.”

The 20,000-foot climb offered her some parallels. “Healthcare is a challenging industry. Our space is highly scientifically complex,” she says. “That's okay because we can do hard things.That's what that mountain represented for me.” She hopes to get to Everest base camp one day—”we’ll see if I have this same perspective.”

Clinical and business collaboration

Under Mason’s leadership, IVI RMA aims to stay at the forefront of scientific and clinical innovations while expanding access to fertility care. "Our outcomes are the best in the nation, and that's not by our numbers; that's by health plan numbers," she proudly shares, referencing Society for Assisted Reproductive Technologies (SART) data on live births per new patient nationally compared to RMA locations

In her work and her board positions at ConvenientMD and Accanto, she sees that many segments of healthcare share the same issues. “We're actually moving a healthcare system inside of the United States to be better, no matter the lane of healthcare that it's in.” 

Dr. Thomas Molinaro, IVI RMA’s Chief Medical Officer, agrees. Molinaro has been impressed by Mason’s knowledge of the inner workings of the US healthcare system, something he on the clinical side doesn’t always have. But more importantly, “she understands scale. She understands how to take the best of what we do and bottle it and how we're going to use that across the entire network,” he says. “There’s been a more thoughtful process about growth, about expansion, about standardization, and that's been really great for us.” 

Molinaro notes the dyad partnership as an example of a new process Mason has introduced. Something Mason first saw in action at ChenMed, it features important collaboration between business and clinical operations. “Far too long have these sides been seen as in opposition,” but she “watched the two brothers Chen operate beautifully.” Molinaro says it “lets us have open and honest conversations” about the common goals between clinical and operational staff. “It's been really helpful for me to have her taking the lead on the business and operations side. I can focus on what I do best, which is taking care of patients.”

A global and tech-forward future

IVI RMA has a large and expansive network, at home and abroad. “Being across 15-plus countries, we're having discussions unlike anyone else in this space around the best scientific research coming out of various countries." It also helps patients get care wherever they are. "I received a message last week from my colleague in Spain about a patient from another country who needed help in the US. In less than 24 hours we had her set up," she shares.


“We are here to be in service to patients. And as leaders, we're here to be in service to the people who do the patient care so they can do it well.”


Mason not only champions technological innovation like AI, but using that technology to  eventually provide around the clock care. "We don't want patients to be without the answers at the moment that they want an answer. If there is a question at 2 in the morning, that person is owed an answer at 2 in the morning." While IVI RMA works to make that happen, a current example of AI integration is Boston IVF’s partnership with Alife. The first-in-the-country program they are piloting uses AI to optimize IVF medication, and helps clinicians retrieve the optimal number of eggs for each patient and reduce overall medication costs.

Mason is committed to ensuring that everyone has access to fertility care, regardless of their financial situation. "We need to make families like that possible. We need to make all kinds of families possible," she says. And she offers this advice for other fertility leaders: "Spend a lot of time with patients. Especially for those of us who are leaders in this space and have not been patients. Walk through their journey."

Lynn Mason's path from Wall Street to fertility has been a mountain of its own. Her leadership, characterized by empathy, collaboration, and innovation, is now at the top of IVI RMA North America.


 
 

The advertiser does not have full editorial control over the content of the article above. As a brought-to-you-by sponsor of IRH In Scope, the advertiser only has editorial control over what is mentioned about their company. Inside Reproductive Health maintains full editorial independence over the remainder of the article. The views and opinions expressed in this article do not necessarily represent the views of the Advertiser or of Inside Reproductive Health.


EMBRYOLOGISTS ARE THE UNSUNG HEROES OF EGG BANKING

BY: KATHRYN WOZNIAK, SENIOR EMBRYOLOGIST & LEAD CRYOBIOLOGIST AT ASIAN EGG BANK

In the intricate world of egg banking, embryologists are often the unsung heroes, playing a crucial role in ensuring the success of this delicate process. As reproductive technologies advance, the importance of skilled embryologists becomes even more apparent especially as they help push the field forward. At Asian Egg Bank, we believe our embryologists’ expertise not only enhance the outcomes of egg banking, but also provide a vital role and the human touch that machines alone cannot replicate.

With a unique combination of scientific knowledge and technical proficiencies, embryologists have a skill set that is indispensable. From the moment eggs are retrieved, embryologists meticulously handle them, ensuring optimal conditions for freezing, storage, and eventual use in fertility treatments. This role requires not only precision but also a deep understanding of the biological nuances involved.

One of the key aspects of egg banking is the vitrification process, where eggs are frozen at ultra-low temperatures to preserve them for future use. Two steps make this process particularly challenging: the timing in the equilibration and vitrification solutions, and the loading of oocytes onto the freezing device. The amount of media used in loading is crucial as well; too much or too little media can drastically alter the freezing rate, impacting the survival of the eggs. Embryologists manage this difficult task with a steady hand and expertise.

Embryologists oversee another vital step: the warming process, where the temperature of the thawing solution and the initial placement of the frozen device are critical. Any deviation from the precise protocol can compromise the eggs, highlighting the need for an experienced embryologist to oversee this process. Without an embryologist’s expertise, the success rates of egg banking would be significantly lower.

While the freezing and thawing processes are the most recognized roles of embryologists, their influence extends far beyond these steps.

Embryologists at Asian Egg Bank work closely with other specialists to develop and refine lab protocols, ensuring that every aspect of the egg banking process meets the highest standards. They also collaborate with partner clinics, providing hands-on training and technical support to ensure the successful warming and use of frozen eggs.

This collaboration is a cornerstone of the success at Asian Egg Bank, where embryologists are not just technicians, but integral members of a multidisciplinary team. Their involvement in quality assurance and outcome meetings ensures that any necessary adjustments are made to continuously improve the egg banking process.

At Asian Egg Bank, the success of the egg banking process is a testament to the collaborative efforts between embryologists and other professionals. By staying at the forefront of research and technology, and by actively contributing to scientific advancements, the embryologists at AEB are helping to push the boundaries of what’s possible in the field of fertility preservation.

Discover how Asian Egg Bank’s embryologists are leading the industry. Visit asianeggbank.com/for-professionals to learn more.

 
 

The above News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.