Regulations Guiding and Governing Fertility Clinics


Many patients think that the fact that their doctor has the letters “M.D.” after their name means they will provide the best and most appropriate medical treatment. While I think this is true for most doctors, fertility care is complicated. It is complicated because there are multiple services provided that patients are unaware of besides the basic service of taking a physical exam.

There is a sonogram (is this equipment up to date and accurate?) and blood tests (Who draws the blood, how qualified are they? On which machine is the test run? Is it reliable? Did the doctor see the results?) And then there are procedures to consider: intrauterine inseminations, or egg retrievals and embryo transfers. I’m sure you have thought to ask if the lab has ever transferred the wrong embryo or sperm, but did you wonder if the air quality was optimal or if the dishes used were embryo safe? Is the outpatient surgery center certified and the staff following all protocols deemed best practice?

All of these questions can be answered by understanding the regulations and recommendations that govern and guide fertility clinics. To summarize, there are federal regulations, non-federal regulations, and legal challenges.

Federal regulations include the FDA (US Food and Drug Administration) and the CDC (Center for Disease Control). The FDA is in charge of drugs, devices and research and set laws in motion to accredit laboratories. The CDC is in charge of reporting results, and preventing spread of disease.

Non-Federal regulations include the individual state regulations and state licensing of physicians. Also included are hospital credentialing and surgery center credentialing by private organizations like the AAAHC. Medical Societies also play a role in non-federal regulations by setting standards of care and making recommendations for treatment. The medical societies that deem most important in the fertility arena are the American Board of OB/GYN (ABOG), the American Society of Reproductive Medicine (ASRM), and SART (the Society of Assisted Reproductive Technology).

SART deserves special mention, as it is a society set in motion by the CDC’s Fertility Clinic Success Rate and Certification Act of 1995. It requires all fertility clinics to submit fertility success rates annually. Approximately 10% of clinics do not report to SART and thus are in violation of this Act. However, these clinics are still allowed to remain in practice if they follow the state and federal laws that govern medical facilities/laboratories and if the physicians are licensed.

Physicians do not necessarily need to be board-certified or specialty trained (through fellowship) to practice fertility medicine. Thus, it is important for a prospective patient to know what training their doctor has received. SART collects clinic statistics and success rates annually and publishes them in a report that all individuals can access online.

SART reporting allows a prospective patient to see outcome data for a given clinic. Also, it allows them to compare this outcome data to other clinics. It only collects data on IVF cycles, including frozen embryo transfers and egg donor cycles. It does not collect data on fertility treatments, such as intrauterine inseminations or ovulation induction cycles. Nationwide data is tabulated and used by medical societies, health care companies, and academicians involved in public policy.

When evaluating the data presented in a SART report, it is important to understand the limitations. Patients are only known as a number, a diagnosis and an outcome (pregnant, not pregnant, twins, etc.) that do not give the entire story of the medical care a patient receives. However, it does allow a prospective patient to understand their odds of success and to make informed choices about the treatment they undertake.

These reports also serve a valuable role in helping clinics practice good medicine. For clinics that report data, it keeps them accountable and honest, making the clinics spend time to track down results so they understand the true outcomes of the medical treatment they provided. The reports also set standards and benchmarks to allow clinics to see how they size up compared to other clinics that may serve a similar patient population. A good clinic will strive to match the highest success rates by re-evaluating their procedures and processes, and looking to optimize patient care.

There are some negatives to SART reporting worth discussing for patients awareness. This includes rare but possible fraudulent reporting (as SART does not validate the individual outcomes), cherry-picking patients (excluding patients from getting treatment so that a given clinic’s success rate is not brought down) and a lack of collaboration between clinics since they may be competing for the same patients. There are ways to classify patients so that poorer prognosis patients’ cycles are batched or considered research cycles.

Patients can also use these statistics to compare clinics in ways that might not have significance to the care they would receive. For example, a difference in success rate of a few points may not mean one clinic is better than another. This comparison of outcomes may be detrimental to patients in continuity of care as they can clinic “shop” and switch clinics for reasons that are not meaningful medically.

Despite some misuse of the outcome reports, SART provides a valuable service to patients and clinics alike so that competition may drive improvement in patient care and patients can be informed. Every patient should know how to access SART data through the CDC and understand that the reports always lag a few years behind as it take time to collect data and it takes 9 months to have a baby!

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