Ideally, every ART cycle performed should be reported. Indeed, in 1992 Congress passed the Fertility Clinic Success Rate and Certificate Act, endorsed by ASRM and SART, which requires clinics to collect and make public the results of ART treatments. The law requires each assisted reproductive technology program to report annually to the CDC regarding pregnancy rates and whether their embryology lab is certified by the proper authority. The CDC publishes the ART Success Rates Report annually.
SART provides guidelines that serve as requirements to all SART certified fertility centers who are to report their data. The following describes not only who, but also what and how cycles are reported since some treatment cycles span different procedures and involve multiple practitioners.
- One practice involved in one cycle. The Medical Director of the SART program (“practice”) at the time the reporting is due is responsible to report every cycle performed by that practice during the requested interval (the “Reporting Year”) to SART (and hence the CDC).
- In a practice with several practitioners, the obligation to report falls to the current Medical Director, even when other practitioners in their group may have done most or even all of the work in a given ART cycle.
- Changes in personnel between the time the ART cycle occurred and the time the reporting is due do not release the current Medical Director from the obligation to report.
- Multiple practices involved in one cycle. In situations where different practices are involved with the ovarian stimulation, the oocyte retrieval, and/or the embryo transfer, the obligation in “fresh” cycles lies with the practice that accepted responsibility for the embryo culture. However, there needs to be a system in place by which prospective reporting of cycle starts is captured. In addition, all canceled cycles must be reported.
- Practices that agree to accept patients from another practice in the middle of a treatment cycle are obliged to report these cycles as their own if the patient’s oocytes or embryos are cultured in their laboratory. (In this case the requirement for prospective reporting will not be enforced.)
- Cycles involving cryopreserved eggs or embryos are to be reported by the practice that accepted responsibility for the thaw.
- Simply performing a retrieval or transfer at another facility on behalf of another practice does not trigger this obligation.
- Shared ART laboratories. Practices that share an embryology lab must report their data independently. Reporting is practice-based and not lab-based. (Example: practices A, B, C all use the same laboratory but are independent practices. Data must be submitted individually by each practice).
- Multiple sites of one Practice. Practices that have several offices and/or labs but are a single business entity may report as one practice. For practices that are SART members, reporting is based on SART number.
- Reorganized Practices. In situations where practices have reorganized since the treatment cycle was completed:
- The CDC requires reporting of all cycles performed by practices in the requested Reporting Year, regardless of any changes in personnel or practice name or location. A note describing any practice reorganization will be incorporated into the Clinic Specific Report. Practices that were in operation for less than a year during the Reporting Year have no obligation to report. However, since CDC must account for all known practices, a practice that has closed since the Reporting Year must still report or it will be listed as a nonreporter by CDC.
- For SART member Practices, reporting is expected whenever it is possible.
- If SART has issued a practice a new SART number because of personnel changes, that practice has no formal obligation to SART for reporting under the old number and therefore will not lose its SART membership for failing to report. However, this does not constitute a waiver of the CDC requirements and thus it is anticipated that reporting will still occur.
- If the departing personnel retain the old SART number associated with their prior practice, they are obliged to report if they retain access to the data. If however they no longer have access to the data at their old practice, then they will have no obligation to report to SART, providing they submit in writing a notice that they have lost access and thus cannot report.
- Practices that change only their name but retain their SART number are obliged to report cycles performed when they had a different name. The practice-specific reporting will indicate the current name, and note the name change.
- Practices that have closed and have no continuing activity as perceived by their communities will not lose their SART membership for failing to report. However, as noted above, they will be listed as nonreporters in the CDC report.
- Failure to report when obliged to do so will trigger the routine penalty for non-reporting in force at the time of required reporting.
- Ambiguous situations not covered here, and disagreements over the interpretation of these rules, will be considered and decided by the Registry Committee and Executive Council of SART in conjunction with the CDC.