A PROPOSAL WAS QUIETLY SHOT DOWN BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES BACK IN 1998.
The content and themes expressed within the article are that of the news. The advertiser does 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 Advertiser or of Inside Reproductive Health.
This news digest brought to you by
BY RON SHINKMAN
The 144 pages of the Clinical Laboratory Improvement Amendments, known in healthcare circles as CLIA, were codified in the late 1980s. They have been regulating virtually every facet of U.S. medical laboratories since 1990.
Yet embryology labs – the linchpin of reproductive medicine practices – are exempt from CLIA. That’s despite the fact CLIA governs the andrology and endocrinology labs that often operate alongside their embryology counterparts. How this came to be is a bit of a mystery; some industry observers say politics played a role
In 1998, it appeared CLIA was on the cusp of expanding its regime to include embryology labs. The Clinical Laboratory Improvement Advisory Committee, a group of medical and laboratory experts attached to the Centers for Disease Control and Prevention that advises the U.S. Department of Health and Human Services, voted 12-2 in September 1998 to have CLIA regulate embryology labs, according to the American Board of Biologists.
However, the recommendations of CLIAC are not binding; they require the approval of the HHS Secretary. Once approved, HHS would draft regulations that would undergo a public comment period before they were finalized.
But HHS – then led by Secretary Donna Shalala – never approved CLIAC’s recommendation, according to the AAB and others familiar with CLIAC’s history. Shalala, now interim president of the New School, a university in New York City, did not respond to a request seeking comment.
Thomas “Rusty” Pool, an embryologist and director of the assisted reproductive technology laboratory at the Fertility Center of San Antonio, testified as a technical expert in favor of putting embryology labs under CLIA during a May 1998 CLIAC meeting. He testified that diagnostic data was generated when performing procedures in the embryology lab, and that given it could be used to diagnose infertility and future medical therapies, it should be governed by CLIA.
“There are unique challenges in recruiting Asian egg donors in particular, ones that require a nuanced approach and deep cultural understanding.”
Next article, continue reading ↓
Nevertheless, “there was a reticence to do that, largely from the physicians associated with fertility practices,” Pool told Inside Reproductive Health about adopting those regulations. Minutes from that meeting indicated representatives from both the American Society for Reproductive Medicine and the affiliated Society for Assisted Reproductive Technology testified against modifying CLIA to govern embryology labs.
A spokesperson from ASRM declined to comment.
Eva Schenkman, an embryology lab director and consultant based in Rocky Mount, N.C., said the reasons ASRM and SART were against the CLIAC recommendations remain unclear to this day. “I don’t think it’s ever been fully transparent,” she said.
However, Schenkman believes the primary concern was economic: Under CLIA, all laboratory directors must either be a medical doctor, osteopath or hold a doctoral degree in certain fields and have a requisite amount of laboratory experience. Doctors running fertility practices didn’t want to spend the extra money recruiting and retaining employees whose educational background would command a premium, Schenkman said. And while ASRM and SART guidelines recommend that embryology labs hire such degreed professionals, the organizations recently proposed withdrawing that qualification, a trial balloon that was quickly dropped after it received pushback from Schenkman and other embryology lab directors.
In the absence of CLIA oversight, ASRM and SART have served as the de facto regulator for many embryology labs, Schenkman said. If such a lab wants a SART membership, it must be certified every two years by either the College of American Pathologists or the Joint Commission. The former is the primary trade group for physicians engaged in laboratory medicine, while the latter is the largest accrediting body for hospitals, clinics and other medical ventures in the U.S
Both CAP and the Joint Commission adhere to standards that are either CLIA-equivalent or go beyond those regulations, according to Sharon Ehrmeyer, a professor in the department of pathology and laboratory medicine at the University of Wisconsin and author of a well-regarded compliance manual for laboratory professionals.
“CAP is a very good accreditation” to have, Ehrmeyer said, adding that CLIA accreditation does not mean “bad apple” labs with quality issues have been completely eliminated. But there are also fertility practices not affiliated with SART or ASRM whose levels of quality remain a mystery.
“I'm sure that there are some very capable people running these laboratories that feel that they don’t need to be part of CAP or Joint Commission. And they still may be doing a good job,” Ehrmeyer said. “And then there is probably some other situations where people are perhaps trying to do things on the cheap and they’re not so concerned about quality.”
But even with an accreditation from CAP or the Joint Commission, some regulatory measures are missing from embryology labs. Schenkman noted that CLIA-accredited labs are required to report individual medical errors to the Centers for Medicare & Medicaid Services, which serves as the licensing agency to medical labs under CLIA. CMS does not gather such information from embryology labs, according to Schenkman. And errors can be significant, from the loss or accidental destruction of embryos to the accidental swapping of gametes or embryos. Labs have to report assisted reproductive technology success rates to the CDC, but not errors
According to Schenkman, although embryology labs submit incident reports to CAP, “they have no way of knowing if you’re committing egregious errors, and they don’t have the ability to stop you from doing business.” She noted that is different in other countries, such as the United Kingdom, whose regulatory body suspended the license of the Homerton Fertility Centre in northeast London after its embryology lab lost embryos in three separate incidents last year.
The lack of transparency on medical errors in the fertility sector recently prompted five U.S. Senators to ask the U.S. Department of Health and Human Services Office of the Inspector General to “audit the safety standards at fertility clinics and the quality of data collected by the Centers for Disease Control and Prevention (CDC) with respect to assisted reproductive technology procedures to treat infertility.” The June 20 letter was signed by Sens. Roger Marshall of Kansas, Markwayne Mullin and Bill Lankford of Oklahoma, Bill Cassidy of Louisiana and Tommy Tuberville of Alabama. All are Republicans.
As a result, patients are walking into fertility practices in the U.S. that “may have a very low error rate, or may have had some major incidents,” Schenkman observed. “And I think patients have a right to know that – especially since most are paying out of their own pockets.”
EVERYONE WANTS ASIAN EGG DONORS, SO WHY IS IT SO HARD TO RECRUIT THEM?
BY: ALEX FRANKLIN, CMO OF ASIAN EGG BANK
Despite the increasing demand for Asian egg donors, the supply won’t be secured by a few extra “$$$ for eggs” ads on social media or billboards. There are unique challenges in recruiting Asian egg donors in particular, ones that require a nuanced approach and deep cultural understanding.
The decline in birth rates, particularly in Asian countries, is making global headlines. South Korea even plans to create a government agency to tackle the “national emergency.” How did it get to this? There are many factors, one being marriage. An NIH study found that in many East Asian contexts, marriage and childbirth are proximally linked with low fertility because of the social expectation that marriage is a precondition for childbearing. In addition, Asian American patients have decreased clinical pregnancy and live birth rates, even after receiving treatment (Purcell et al, 9).
Another reason might be social stigma and shame. They can be strong motivators, and talking about sexual and reproductive health is often taboo—not just for donors, but for prospective parents as well. Asian women may conceal any fertility issues and it can keep them from seeking treatment (Missmer et al, 3). If they do pursue treatment, certain types such as gamete donation, either sperm or egg, are typically frowned upon in both religious and cultural contexts (Cross-Sudworth, 47). When they do explore gamete donation, couples have a preference for Asian donors, as mixed ethnicity oocytes can raise even more ethical dilemmas (Culley et al, 48).
With those cultural taboos, a major factor of donor onboarding is education. We cover everything from the basics, like what exactly is egg donation and the difference between ”fresh” and frozen egg donation, to how their eggs can help members of their community. With our Donate Love campaign, Asian Egg Bank is reaching potential donors on college campuses by providing education on sexual health, and offering fertility testing, as well as free egg storage with donation.
Another block to donor recruitment is the ability to identify possible donors online. When Meta got negative press for turning over abortion seekers’ data to police in states where abortion is illegal, the company significantly reduced its ad platform’s ability to market and measure the efficacy of ads to people seeking any form of reproductive care, including egg donation. Ad targeting is now more broad, and requires more input from our multicultural donor team to craft messages that will resonate with the intended audience.
Since Asian Egg Bank only works with Asian egg donors, the donor team is multilingual; any donor can communicate in their own language, which goes a long way in making donors more comfortable with the process. The team also understands the cultural taboos and nuances, and can answer questions about them.
While Asian egg donor recruitment has its challenges, there are significant ways the Asian Egg Bank team can combat them, with cultural sensitivity, education, and community.
Discover how Asian Egg Bank is leading the path in Asian egg donorship. Visit asianeggbank.com/for-professionals to learn more.
All external links active as of 6/27/2024
External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.
