Boston IVF may be only fertility center with ISO certification
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There’s a certification and set of guidelines for maintaining and aligning standards that is common in many industries — but not in the fertility space. One fertility network that has had the International Organization for Standardization (ISO) certification since 2003, however, says it has been hugely beneficial to its organization and that other clinics could find it helpful as well.
What is ISO?
ISO is a non-governmental international organization made up of 170 national standard bodies that each represent ISO in their country. The organization — which was founded in 1947 and is headquartered in Geneva, Switzerland — brings together experts to develop standards that can be applied to various industries. ISO itself does not certify organizations; instead, external certification bodies use the ISO standards to certify organizations.
While ISO certifications are popular in many industries, the certification is rare in the fertility space, which has its own standard certification and accreditation.
ISO is different from accreditation from the College of American Pathologist (CAP) or Joint Commission — standards that are common for fertility clinics in the U.S. — as it focuses more on individual processes and safety such as documents control protocols and processes, said Dr. Steven Katz, CEO of REI Protect. While CAP assesses an organization’s competency to meet specific standards of care, the ISO is more specific in terms of how the laboratory personnel handle tasks and processes.
The only ISO certified fertility center that could be confirmed by Inside Reproductive Health
Boston IVF became ISO-certified in 2003, said Michael Alper, founding partner of Boston IVF.
“When an organization gets larger, you have to make a special effort to keep things organized,” Alper said. “[ISO] really helps you get control over things, especially documents.”
Years ago, Alper asked his staff to send him every document bearing the Boston IVF name. He received thousands, many of which were older and outdated consent forms and brochures. The clinic’s documents were not organized — but Alper says ISO has helped Boston IVF implement guidelines for document control. Alper said the standards also require internal audit.
Every role has a clear job description with detailed workflows, which has “made us a better organization and much more transparent,” Alper said. Protocols, such as the process for transferring frozen embryos, are documented.
To the best of his knowledge, Boston IVF is the sole ISO-certified IVF clinic in the U.S. even as more hospitals become ISO certified, Alper said. Because ISO certification is carried out by various national and international certification bodies, they could not confirm this.
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Why ISO certification isn’t more common in IVF labs
Because there is a large focus on outcome in the fertility industry — including how many eggs are fertilized and how many people get pregnant — there also needs to be a focus on safety measurements, equipment and documentation, said Dr C. Brent Barrett, chief lab director at Boston IVF.
“One of the really critical things that ISO continues to do for us is align everyone,” Barrett said. Barret, who inspects IVF labs, said he’s found that labs can be very siloed: the nurses are often separated from the administration workers, who are separated from the physicians. Document control, standardized by ISO, has everyone on the same page, he said.
ISO has also required Boston IVF to put a strict protocol in place to deal with errors, Barret said.
Katz said fertility clinics may not have a clear understanding of the difference between ISO standards and those of the common certifications and accreditations in the fertility space.
“For IVF labs around the country, I think they’re having trouble delineating between the ISO certification and the CAP or Joint Commission accreditation,” Katz said. IVF labs may view the certification and accreditation as duplicates, and therefore not consider ISO certification, he added.
“In order for labs to spend time, energy, money, capital resources, to get ISO certified, they really have to understand what it is and how it’s differentiated from CAP or the Joint Commission accreditation,” Katz said.
ISO’s impact on the desirability of IVF labs in the marketplace
Boston IVF has changed hands three times since 2019. In late 2023, reproductive medicine group IVI RMA announced it was acquiring the North American operations of Eugin Group, including the Boston IVF fertility network. Before that, the network was owned by European private healthcare provider Fresenius Helios, which bought Eugin Group in 2020. Prior to that, NMC Health plc acquired a majority stake in Boston IVF in 2019.
Alper says that while buyers are not necessarily looking at Boston IVF’s ISO certification when determining its desirability, the culture that the standard has brought to the clinic — such as the transparency of the clinic, the team-approach to results and the focus on customer satisfaction — has helped establish the clinic’s strong position in the industry.
“Our position in the industry is partly related to that philosophy,” he added.
The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.
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