SART oversight of ART in the US

February 6, 2011Carole 3 Comments »

Oversight of assisted reproductive technology (ART) in the US is not the job of a single government entity like the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom, but is provided by a crazy quilt of state medical licensing boards, professional societies, state and federal regulations (sometimes not specific to IVF)  and insurance reimbursements.The Society for Assisted Reproductive Technology (SART) is part of that quilt. SART is one of the major professional societies for medical professionals (doctors and lab technicians) who provide ART services. SART’s mission is ” to set up and help maintain the standards for ART in an effort to better serve our members and our patients”.

Toward that end, SART members who are Medical, Practice or Laboratory Directors of ART programs received a letter at the end of January 2011 reminding them of specific parameters that SART  monitors as indicators of program quality. Specifically, SART monitors pregnancy rates, embryo transfer practices and multiple birth rates. According to SART, they are looking for deficiencies in any of these three areas.

  1. A low pregnancy rate which is defined as significantly below the average of all SART members who reported data in a particular year. In 2008, that was determined to be a live birth rate per cycle of less than 16% in fresh, non-donor cycles for women in the youngest age group (under 38 years of age). Because the deficiency cut off is defined as a performance of 95% below the SART mean in any particular year, the minimal acceptable rate each year is likely to be different.
  2. The percentage of pregnancies that are triplet or more. A  rate of 9.45% or higher of these higher order pregnancies in women under 38 years of age is considered a deficiency in 2008. This 9.45% rate is the cut-off determined for 2008 which is greater than 95% above the SART mean for all reported higher order IVF pregnancies reported in women under age 38.
  3. If more than three embryos on average are transferred in women under age 35, that is considered a deficiency.

A new measure of performance that has been investigated since 2009 is the the cancellation rate or the percentage of cycles that get canceled within a few days of initiation. SART is requesting an “explanation of cycle cancellation rate of 0%”, because of in their words, a concern for  “reliability of reporting.”  Cycles get canceled for a variety of reasons, some medical, some not, so a rate of zero is unlikely and may suggest that a center is not reporting their canceled cycles.

What penalty will SART will administer to programs who have deficiencies? Quoted from the letter:

“According to the SART QA guidelines, a program deficient in any of these three categories will receive a WARNING letter and a list of program directors or laboratory directors willing to help remediate the problem at the program’s expense. This consult is voluntary.

A program found deficient two years in a row may be placed on PROBATION and will require a MANDATORY consult (SART will provide $1,000 to subsidize the site visit). If the problem is not remediated in one year, the program may lose SART membership for two years.

A program deficient three years in a row will be discussed by the SART Board for further action which, in most cases, may be due process resulting in loss of SART membership, unless there are compelling explanations for such deficiencies.”

SART’s oversight is better than nothing, I suppose, but when the big stick is that you can’t be a member of SART anymore, well, that’s hardly a deterrent to poor performance. You don’t need SART membership to be a ART provider. You can report your results directly to CDC using their reporting software, bypassing SART altogether. SART membership is not really worth much. At most, you can use SART membership in your marketing bona fides. Furthermore, programs pay to be a member of SART so how hard is SART going to bite the hand that feeds it?  It’s ludicrous really.

I like the idea of better programs consulting with weaker programs to improve the quality of the weaker program. Of course, the the medical professionals heading the weaker program have to be open to change. The consult is entirely voluntary.

Based on these SART standards,  a 17% pregnancy rate in the lowest age group (young women have the best prognosis and are usually the easiest patients to get pregnant)  is acceptable to SART. It may be acceptable to SART, but I would tell my sister to run, not walk, away from a program with such a crappy rate. The average live birth rate of all ART cycles reported to the CDC in 2007 (the most recent published national table)  was 39.6% (under 35 age group) and 30.5% in the combined 35-37 age group. SART combined both age groups for their recommendation. Either way, 17% is approximately less than half of what the average program delivers for its youngest patients.

In my opinion, SART could be more critical of twin pregnancies in line with the American College of Obstetricians advice that patients should be made aware of the risk of all multiple births and twins are included in the definition of multiple births. Obstetricians have always included twin births in the same category as higher order multiples when it comes to an increased risk of prenatal complications compared to singleton pregnancies.

The acceptance, even endorsement, by ART providers of twin pregnancies is widespread and not in line with known obstetrical risks. You can read a summary of ART surveillance by the CDC and conclusions regarding the safety of ART pregnancies, particularly non-singleton pregnancies. Interestingly, even singleton pregnancies in ART patients are at greater risk than singleton pregnancies achieved without technical assistance. With multiple births, the risks to ART patient pregnancies are even higher. SART’s implied acceptance of transferring three embryos (for a deficiency, the program must on average transfer more than 3 embryos) in the youngest age group is an indication that SART oversight is not in line with known obstetrical concerns with higher order pregnancies.

Losing a medical license, now, that’s a deterrent to poor performance. Of course, it is nearly impossible for a physician to lose their license in most states. According to my neighbor who happens to be a medical malpractice lawyer, physicians who lose their license typically have to stack up dead or severely injured patients like cord wood, sleep with or molest their patients or be obviously drunk or stoned most of the time and resistant to drug rehab.

In the absence of any of these obviously out-of-bound behaviors, physicians are unlikely to lose their license if they are below-average physicians because there is a lot of gray area in medically appropriate treatment. For instance, in spite of negative press for Octomom’s physician and condemnation of his reproductive practices by the American Society of Reproductive Medicine (ASRM), a California judge who reviewed his case is recommending that he should keep his medical license, even though he clearly exceeded what ASRM and SART would consider the  medically appropriate practice for the maximum number of embryos transferred. The California medical board still has to make the final decision in that case. In contrast to medical licensing boards, medical professional societies have little clout when it comes to raising the standards of medical care provided to ART patients.

The bottom line is that you can’t rely on the existing structure of medical oversight of ART providers to ensure that your program will give you great care. ART patients need to be educated and informed medical consumers. On what would have been President Reagan’s 100th birthday, I am reminded of his famous phrase “Trust, but verify.” I would agree that you should trust your ART provider, but only after you verify that his medical performance is at least average, if not above average.

© 2011, Carole. All rights reserved.

3 Responses to this entry

  • Jane Says:

    But SART is one of 2 tools, the other being the CDC data that we have for some method to evaluate clinics- the data is accurate- there is some validation that takes place, correct?

    You would still recommend checking SART to see live birth rates, number of embryos transferred as part of the clinic selection process, correct?

    Some clinics will tell you that what you cannot see via SART is the TYPES of cases that they agree to take on- in other words, some clinics will work with women that are more difficult cases and some screen them out…how much would you let SART guide you in your decision of where to cycle?

  • Carole Says:

    It may be helpful to explain the relationship between SART and CDC. Even some clinics seem confused about this. All ART clinics are required by federal law to report their annual pregnancy rates to the CDC. When the law first came into effect, SART was the official CDC vendor through whom data was collected. CDC become unhappy with SART as a vendor and gave the contract to another company Westat. An ART provider can fulfill their legal obligation to report to CDC by using EITHER Westat or SART. Either will send the CDC required data on to CDC. On their website, SART provides a link to a page which contains the same exact data you would see using the CDC directly. The advantage of searching the SART database on the SART website is that SART’s software is slightly easier to navigate to find your practice clinic of interest and find the reported rates. The downside of searching the SART database is that it is incomplete because not every ART practice is a SART member so you get most, but not all, ART providers in that system. You see the exact same data in each search. The SART pregnancy rates page for a clinic looks just like the CDC page. You can see types of diagnosis and types of services provided in either clinic report.

    Bottom line: I would use either SART or CDC’s database to find doctors you want to interview. The doctors you want to interview should have the highest pregnancy rates in your service area. Your service area may be your city or it might be two states over if you have the time and money to travel for the best care. You should check other public data bases like the FDA website for FDA warning letters issued to your doctor for donor related issues such as failure to follow FDA required screening procedures. The “we take the more difficult cases” argument to explain lower pregnancy rates always cracks me up. The only clinics that can afford to get selective about patient enrollment are those who already have a waiting list and can’t do any more patient volume. The idea that good clinics cherry pick patients was not something I ever saw first hand so it always seemed like a lame excuse for poor performance but perhaps I am becoming cynical. Ultimately, your interview results should guide your decision. I would NOT rely on SART membership as an absolute guarantee that your clinic is very good. Good practices/clinics/[programs exist outside of SART membership and bad practices/clinics/programs can be SART members. Unless SART becomes way more selective in its membership, it’s not a guarantee of anything.

  • Jane Says:

    Great info! Thanks so much!!

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