Who’s the sheriff in the Wild Wild West of ART?

May 25, 2010Carole 2 Comments »

The medical field of assisted reproduction is often referred to as the Wild Wild West of medicine. Not exactly. On the other hand, you might expect that the US strictly regulates ART labs and ART medicine. Not exactly. Imagine instead a patchwork of oversight which is a combination of federal law, state medical licensing, lab accreditation and practice guidelines developed by professional societies. ASRM has published their revised minimum standards for ART programs which are voluntary guidelines for how an IVF practice should be set up.  CLIA 88 federal regulations mandate minimum performance standards to be allowed to perform lab tests on human specimens. CLIA ’88 requires all laboratories to comply with certain standards to remain in operation.

CLIA ’88 has standards that require:

  • minimum education and training requirements for lab personnel
  • use of proficiency testing to check they are performing tests properly
  • that labs permit federal review of testing records and submit to annual inspections
  • labs to develop and maintain quality assurance programs that promote continuing improvement in services

Labs that fail to meet these standards and lose their certificate of compliance can be fined and closed. Owners can be fined or imprisoned.

CLIA ’88 specifies who can direct high complexity clinical labs. Although some lab directors were “grandfathered” in the field before requirements became more stringent, lab directors serving since 1999 are expected to be either MDs with real lab direction experience or PhDs with lab expertise. After January 1, 2006 revisions,  lab directors are expected to be board-certified as High Complexity Lab Directors (HCLD) which is dictated by law (CLIA 88) for labs that do sperm counts (Andrology labs). Generally speaking,  MDs do not have the type of lab experience and training needed to be a good lab director unless they are also Pathologists who typically run other types of clinical labs. Instead, MDs are most frequently responsible for the overall medical direction of the lab and so are the Medical Directors of the laboratory.  The Laboratory Director usually reports to the Medical Director of the fertility clinic.

CLIA ’88 regulations were not tailored to the special needs of the IVF lab. In fact, they originally only covered the sperm testing that occurs in the ART lab because sperm testing falls under the legal definition of high complexity testing. Interestingly, the arguably more important and complex activity (the baby-making part of the lab, aka. the embryology lab) was not regulated under CLIA ’88, probably because it was an emerging part of reproductive medicine in 1988 when CLIA ’88 was established as law.  So when the federal inspector comes to visit, they often gave the embryology lab a cursory inspection, but were very strict with sperm counting!!

CLIA ’88 allows labs to show compliance by becoming accredited through inspection by at least two accreditation agencies,  Joint Commission or College of American Pathologists (CAP). Both of these agencies have added embryology specific standards to their inspection checklists. CAP reproductive lab standards are published on-line. So embryology has been brought under the CLIA 88′ inspection umbrella.

The ART  professional societies (American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology) expect their members to have accredited labs which is some extra peer pressure for accreditation. There’s also the bad PR of having your CDC report show that your ART facility is not accredited.

The medical practice of ART is unusual because it is a 50:50 combination of physician procedures/skills and lab procedures/skill. Each half is regulated differently. Clinical labs are regulated by CLIA ’88.  Physicians are not directly regulated in how they practice medicine- with the possible exception of FDA regulation of donor eligibility. It is important to understand that US medical practice is regulated through three main mechanisms.  First, state licensing boards can review physician performance/conduct and grant and revoke licenses. Secondly, professional societies set voluntary guidelines for standards of care in their field. And finally, insurance companies influence physician practice by deciding which medical treatments will get paid-often based on the practice guidelines developed by medical societies.

Other countries take a different approach. In the United Kingdom, the Human Fertilisation and Embryology Authority regulates the whole field of ART and labs must be licensed to operate. Italy has the strictest ART laws,  making transferring more than three embryos or freezing embryos illegal. Italy also prohibits embryo donation, surrogacy and treating single women or same sex couples. This is a very direct regulation of the practice of medicine.

The use of third party reproduction (sperm donors, egg donors and use of surrogacy) in ART is the only medical area in which the federal government does reach in and directly modify physician practice. Determining whether an egg or sperm donor is “eligible to donate” is a medical decision but the FDA tells physicians the criteria they must use to determine donor eligibility. The FDA specifies which communicable diseases must be ruled out, what screening questions should be asked, what blood and urine tests need to run, in what time frame and how often. They also expect donor screening facilities to be registered with the FDA. The type of test kits and assay equipment used to test for each communicable disease is also specified. Most importantly, failure to adhere to these requirements can result in substantial fines and even imprisonment.

Most doctors and patients in this country would be very unhappy to have the government outlaw specific ART practices because we feel this invades our personal privacy and personal autonomy to make medical decisions. At the same time, as a society, we are incensed over some of the poor medical decisions made by doctors and patients that result in cases like the Nadya Suleman octuplets. Interestingly, the physician in the Suleman case was charged by the California Medical Board with gross negligence, which puts his medical license at risk. A date has yet to be set for his hearing by the medical board but in the mean time, ASRM has “cracked down” by expelling him from their membership rolls.

So because of this patchwork of regulation, we walk a sometimes fine line between medical regulation and medical autonomy.

What’s a patient to do?

  • Verify that your physician is licensed and in good standing. Every state keeps these records.  Most if not all states have  searchable on-line data bases.
  • Verify board certifications This is also public information and often searchable on-line.
  • Verify Lab accreditation. The Joint Commission website lets consumers check on labs through their Quality Check program. Verified CAP accreditation is noted on the CDC report for each reporting clinic but that data is two years old. Labs are required to post their Certificates of Accreditation, with valid dates in the lab.
  • Warning letters issued by the FDA to labs who are not in compliance with donor screening regulations are also public record on the CDC website. And yes, there are some reproductive labs on this list.

So now you’ve been deputized as the Sheriff in the Wild Wild West of ART.

😉 Fertility Lab Insider Scoops the ASRM Bulletin!!: Just hours after I published this post, ASRM sent me an email containing a link to  a new report on the oversight of ART. Here’s the email from ASRM that explains why they felt compelled to issue a new report.


Volume 12, Number 18

In response to claims that reproductive medicine suffers from a lack of regulatory oversight, last December the ASRM convened a meeting in Washington, DC to discuss the current state of oversight of assisted reproductive technology (ART).  In addition to the leaders of ASRM and SART, we invited experts from federal agencies, state governments, other professional societies, lawyers, ethicists and patients to help us more fully understand this complex endeavor.

Tomorrow we will be releasing a booklet entitled, “Oversight of Assisted Reproductive Technology” to the public.  The report lays out the role of the federal government, the FDA, CDC and CLIA, the role of state governments through their licensing boards and other activities and the role of professional self-regulation in ART.

The report concludes that ART is already one of the most highly regulated of all medical practices in the United States.

We hope you will find this report useful. You may view and download the report at http://www.asrm.org/uploadedFiles/Content/About_Us/Media_and_Public_Affairs/OversiteOfART%20(2).pdf

© 2010, Carole. All rights reserved.

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