Electronic witnessing has been helpful, but some regulatory gaps in the U.S. remain an issue.
BY RON SHINKMAN
Two recently filed lawsuits against fertility clinics for allegedly mixing up specimens showcase how error prevention protocols have evolved in the IVF sector.
The first lawsuit was filed in state court in Oregon in late December. It accuses Oregon Health & Science University in Portland of using the wrong sperm for an IUI procedure. The allegedly botched procedure occurred in 1980, although it was apparently only discovered recently.
The plaintiffs in that suit are the child who was born as a result of the procedure and their parents. All are going by initials in the lawsuit to protect their privacy.
The family is seeking $17 million in damages. That includes $5 million in damages apiece, plus another $1 million for health issues the lawsuit alleges occurred as the result of the child having a different biological father than expected, and an additional $1 million for mental health counseling the family claims they will need going forward.
Nicole Rideout, a spokesperson for OHSU, declined to comment on the lawsuit, citing the pending litigation. However, she did note that the “OHSU Fertility clinic has a long history of providing safe, high-quality healthcare.”
The other suit was filed in state court in Palm Beach County, Fla. earlier this month. It alleges the Fertility Center of Orlando botched an IVF procedure in March 2025 and implanted embryos that belonged to someone else. The plaintiffs – who are also anonymized in their lawsuit – noted that they are “Caucasian” and the daughter the mother gave birth to in December 2025 is not. The suit alleges the clinic has not responded to requests to try and identify to whom those embryos belonged to.
A popup statement on the Fertility Center of Orlando’s website acknowledges the issue.
“We are actively cooperating with an investigation to support one of our patients in determining the source of an error that resulted in the birth of a child who is not genetically related to them,” the popup states in part. “Multiple entities are involved in this process, and all parties are working diligently to help identify when and where the error may have occurred.”
Such Errors Happen Once In Every ~125,000 Procedures
Such mixups are “incredibly uncommon” these days, according to Steven Katz, MD, chief executive officer and founder of REI Protect, an Arizona-based insurer that specializes in liability coverage for fertility clinics. It currently provides coverage for slightly more than half of such clinics in the U.S.
Katz estimates such mixups happen about four to five times a year nationwide, or about once in every 125,000 procedures performed.
According to Katz, training of clinic staff has improved over the decades to avoid specimen confusion that lead to grave errors. “How you would handle a cup of…sperm is completely different now than it was decades ago,” he said.
Although Katz was unable to estimate how the error rates have changed over the years, he noted that given the number of procedures has grown dramatically while the number of errors remains quite low suggests the new protocols are working.
Eva Schenkman, PhD, an embryology lab director and consultant based in Rocky Mount, N.C., observed that back in the early 1980s, “there really wasn’t a chain of custody” for semen. It wasn’t uncommon for such specimens to have the mother’s name on them, but not the father’s, which could cause confusion. That could be further compounded by processing such specimens simultaneously for the sake of efficiency, another practice that has mostly disappeared, she said.
REI Protect to Drop Labs Without Electronic Witnessing After 2026
But one of the most important developments in avoiding errors is electronic witnessing. That is the use of either electronic bar codes or radio frequency identification specifically tied to a specific patient. Bar codes or RFID tags are affixed to every petri dish or any other object tied to the IVF or IUI cycle. Clinic staff use laser scanners to identify those specific objects and ensure they are not mixed up. It has been inevitably replacing one and then two-person witnessing in IVF clinics in recent years.
Katz said that beginning in 2027, REI Protect will no longer insure clinics that do not use electronic witnessing. It is also offering an official “seal of approval” for practices that not only use electronic witnessing but also have additional safeguards in place.
“We’re hoping that with that seal of approval on their website, patients will pay attention to that and really focus on having their care performed in IVF labs that make the extra effort,” he said.
Katz also believes that as IVF technology progresses, automation of labs will accelerate, and that could present issues of their own that will eventually have to be mitigated.
Schenkman observed that despite the improvement in safety protocols, there are still regulatory gaps here that are frustrating. She stated that regulation is much more aggressive in the European Union than in the U.S., and that there are still 5% to 8% of embryology and andrology labs in the U.S. operating without certification from the College of American Pathologists, which includes a robust certification process for specimen chain-of-custody. And embryology and andrology labs are also not governed by the Clinical Laboratory Improvement Amendments, the federal regulations that provide oversight to practically every medical laboratory in the country.
“Yes, we’ve gotten safer over the years,” Schenkman said. “Are we where we should be? Absolutely not.”