Q From U: US Standards for Embryologists and Fertility Labs

April 26, 2012Carole 6 Comments »

The other day I received this question (paraphrased)  from a reader of my blog: “What, if any, training and on-going education is required for embryologists in the US ?  And, what, if any, regulations are placed on a fertility  lab in terms of passing muster or maintaining some standard?”

Well, the answer to that simple question is somewhat complex but we can start with the Clinical Lab Improvement Amendments of 1988 or CLIA’88. This legislation was passed  in 1988 and periodically updated to establish the quality standards for all laboratory testing performed in the US  to” ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed”. The Centers for Medicare and Medicaid Services (CMS) have the mandate to see that this legislation is followed and laboratories must be certified as CLIA compliant to receive Medicare or Medicaid payments. CLIA’88 defined levels of testing complexity and adjusted educational requirements for personnel according to the level of complexity. Some tests were classified as “waived” testing and so not all the standards applied. Other tests were considered moderate complexity or high complexity. Blood tests using chemical analyzers and semen analysis are examples of high complexity testing. Lab Directors must be board certified as High Complexity Lab Directors (HCLD) in order to direct laboratories  that provide high complexity testing. Board certification is in addition to advanced education (PhD, MD, or DO) and years of experience required to sit for the examination. In addition, board-certified individuals must demonstrate on-going education to keep their certification.  Several government approved testing boards including the American Board of Bioanalysis (ABB) perform this lab knowledge  certification testing and offer certification for supervisors, managers and consultants as well as lab directors.

Okay, so that sounds pretty intense, right? Well, actually not so much  because when the law was initially passed, the Society for Assisted Reproductive Technology (SART) successfully lobbied to exclude embryology labs  from CLIA’88 because there is no testing involved. Embryology procedures such as egg collection, insemination and on-going embryo culture are more procedural like research and not like testing so that point is valid. Unfortunately, that left a big gap in federal oversight for embryology labs.

In contrast, Andrology lab work clearly met the testing definition and was regulated by CLIA’88.  So in the early days of IVF,  the inspector from CAP or the Joint Commission would roar into the lab, check out our semen testing protocols and never step foot in the Embryology lab where arguably the more high risk patient activities were occurring. Even if embryology hadn’t been deliberately excluded from CLIA’88 oversight, one of the incentives for compliance with CLIA’88, namely,  receiving Medicare or Medicaid payments did not apply to embryology or IVF procedures because they weren’t covered.

In summary, Andrology labs are required to have a CLIA license for operation. Embryology labs are not required to have a CLIA license and are not required to comply with CLIA’88.

In spite of this spotty oversight, IVF labs did receive some trickle down regulation from CLIA ’88 because the same employees in the IVF lab often performed both Andrology and Embryology procedures so it was simpler to require all technicians to meet the educational and training standards expected for high complexity testing personnel, and having them work in either capacity (embryology or andrology) as needed.

The Society for Assisted Reproductive Technology (SART) issued two Professional Guidelines which use CLIA’88 as a backbone and then modify the regulations for IVF labs. The complete Guidelines can be downloaded from the ASRM website or click on the links below.  These Guidelines discuss expectations for personnel training and continuing education. The Guidelines also lay out recommendations for organizing and running an IVF lab. The only problem with these standards is that following them is voluntary. Still most programs adopt some, if not most, of the guidelines because they set patient expectations as well and clinics must compete for patients.

Revised Guidelines for Human Andrology and Embryology Laboratories (2008)

Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies (2008)

To work as an embryology technician, SART/ASRM guidelines recommend that technicians should have a college education (bachelors or masters) in either a Medical Technician program or in one of the biological, clinical, physical or chemical sciences or reproductive laboratory science. In addition, technicians should have performed at least 30 ART procedures under the supervision of their lab director or lab supervisor before performing these procedures solo. On an on-going basis, they should have 12 hours of continuing medical education and perform at least 20 ART cases a year. In the beginning. all training was in the lab and there were no academic training programs for IVF techs. That has changed and there are educational training and hands-on workshops for technicians who want to get a specific IVF education. In the old days, most of us had an animal research background, then found ourselves applying what we learned from mice, hamsters or cattle to clinical IVF. The other track was the med tech track where techs were trained in medical quality control and patient issues  but then had to learn the technical piece in hands-on training in an IVF lab.

To become a lab director of an Andrology lab, you must have a PhD (or MD or DO) and must be board-certified as a high complexity lab director. The American Board of Bioanalysis (ABB) administers the board exams after determining that an individual has the education and experience requirements to sit for the exam. In contrast, to be  an Embryology lab director, the CLIA’88 regulations are not applicable, but the SART Guidelines suggest a Bachelors or Masters degree is preferable. Some individuals became ‘grandfathered” as lab directors if they had been functioning as a lab director before the CLIA’88 regulations were in place and the board certification requirement was slowly phased in so as not to dislocate individuals already working as lab directors. A separate board certification was created for those aspiring to be Embryology Lab Directors but these are independent of any CLIA’88 requirement.

There are two other federal government agencies that have a interest in specific aspects of IVF practice. The Food and Drug Administration (FDA) has oversight for the safety of donated human cells and tissues used for medical purposes. This includes tissues like corneas, skin, cartilage that is recovered from cadavers and used in living humans. Blood donation is also regulated by the FDA. Where these  FDA interests overlap  with IVF labs is when semen, egg, or embryos are donated from one individual and used by another. The screening of potential donors who donate these reproductive tissues is regulated by the FDA. ART facilities that  engage in various processes associated with the donation of tissue are required to be registered with the FDA and undergo periodic unannounced inspections.

The Centers for Disease Control (CDC) collect various kinds of data on the US health care system. The  Fertility Clinic Success Rate and Certification Act of 1992 (Pub. L. 102-493, 42 U.S.C. 263a-1 et seq.) required all operating ART facilities to annually report their pregnancy outcomes to the Centers for Disease Control (CDC). The CDC was then tasked with  summarizing the data into a National Report and also creating a website through which the public could look up the success rates for individual programs. What is the punishment for non-reporting? The facility gets placed on a non-reporting list which is not prominently displayed on the site so it is hardly a deterrent.

SART  quickly stepped in as a go-between the CDC and the clinics so that clinics could report their data to SART (for a fee) and then SART would display the summarized data on their site and also pass it on to the CDC.  SART members are highly encouraged to use SART to report their results to the CDC although there is no federal requirement to use SART. Clinics can report directly to CDC using a data entry tool maintained by Westat.  SART warns their membership that “Failure to report when obliged to do so will trigger the routine penalty for non-reporting in force at the time of required reporting.” Which is what? The only stick SART has for non-reporting is canceling the membership of the offending clinic.

So there is relatively little US federal oversight of infertility clinics, except specific areas of interest (third party reproduction and annual success rates). There is some carry-over in the CLIA’88 requirements for Andrology labs that affects the education and training requirements of embryology techs when both types of service (Andrology and Embryology) are offered in the same lab.

Market forces are the primary external force for compliance. In order to capture the greatest market share in their area, a program must be perceived to be in compliance with the highest possible expectations for patient care and deliver the highest possible pregnancy rates. So although the CDC does not rank clinics and cautions that pregnancy rates should not be compared between two clinics because underlying patient populations may be different, these rates are still used by patients to select clinics and indirectly used by clinics to market their success rates by providing links to SART or CDC where patients can view rates.

In my experience, lab inspectors vary widely in their training and ability to determine compliance. Good labs and non-compliant labs both pass inspection.  Labs that pass inspection use this milestone as a marketing tool to advertise their program. In fact, the agencies that inspect labs will also sell the labs posters and such to help advertise their successful inspection to their customers.

The major driving force within the clinic for compliance with standards and for ensuring a high quality lab is the professional integrity of the Medical Director and Lab Director. If these key personnel are motivated to do the right thing for the right reasons, there is lots of guidance to help them create an exceptional lab. If these key personnel are interested in making money primarily and see compliance as something that occurs only when the inspector is on-site every other year, federal oversight is too weak to to ensure high quality lab operations.

Other countries who are less in love with the free market handle this differently. For example, in the United Kingdom,  the Human Fertilization and Embryo Authority (HFEA),  licenses and inspects fertility clinics in the UK to ensure that UK IVF  personnel meet expected education and training standards. Programs must present evidence that they are capable of offering high quality services before they are given a license to offer those services. Of course, this regulation goes hand in hand with the federal health care system which pays for infertility medical services for its citizens so there is a federal interest in setting quality standards. So it’s a trade-off. Here in the US, the infertility industry it is a market-driven self-pay system which is largely unregulated by the federal government. That’s not the only way to provide health care but that’s (apparently) how we like it in the US.

© 2012, Carole. All rights reserved.

6 Responses to this entry

  • It Is What It Is Says:

    Wow, Carole, thank you. Such a comprehensive answer. It is, then, as I thought, that since the area of ART is unregulated by the government, it is mostly left up to the clinic to set and maintain standards. I, frankly, am not even sure that my clinic has a Lab Director (it was once advertised on their site who their Lab Director was and as I go more intimate with the clinic uncovered that he was shared between my clinic and another, unaffiliated clinic in No CA which somewhat surprised me. In the years since, I think they have their two embryologists and that’s it.

    With so many woman and couples wanting and pushing for the requirement that insurance companies provide and cover infertility as the disease that it is, it is a case of not being able to have our cake and eat it too, likely. There is such resistance to having any governmental regulation of ART and that works in a self-pay system. I clearly don’t know enough but I am surprised that SART or ASRM hasn’t come up with a grading system or independent review board like the health dept but non-governmental, that enforces the guidelines, assigns a grading system, and requires the clinic to post their grade (like restaurants in LA do…we all want to only eat at A graded restaurants but understand that Bs have their place but no way would eat at a C) and metes out some sort of disciplinary action or sanction. I don’t know, maybe that’s too much to ask.

    Even with the best of intentions, the data reporting (to SART or the CDC) is fraught with problems so it is hard for a consumer to really know what they are getting especially when they are just starting out.

    Thanks for taking the time to respond.

  • .com Says:

    I have got an RSS reader, is there a simple way to stick in your web site
    so I obtain constant updates of your new content?

  • Carole Says:

    Yes, simply subscribe to the blog using one of the options under the “Subscribe” button on the left-side column of the webpage. You can also follow me on Twitter. I don’t use Twitter too much but do try to update my new posts. @Fertlabinsider. Thanks for your question! Carole

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  • Kristen Says:

    Thank you for this! It is very disappointing to know that a topic like this has absolutely no regulation. It is a big free-for-all. We recently did an ivf transfer of two embryos. Doctor gave me an infection during the transfer which led to the two embryos not surviving. I am learning that this doctor really answers to no one and so can get away with working in an unsterile environment. So angry about it really.

  • science gal Says:

    Thank you so much for this insight and thorough answer! I was shocked at the lack of lab regulations the embryologist knew. I worked in multiple labs which were all cap and clia regulated and there are strict policies and procedures to follow. I noticed in the ivf lab they tend to get by with what they need to do instead of focusing on quality and strict adherence. Its frustrating to argue with ivf lab about quality assurance and strict documentation as they deem it not necessary and being overly meticulous. I don’t know any other way but to follow cgmp

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