SART is the primary organization of professionals dedicated to the practice of assisted reproductive technologies (ART) in the United States. Our organization includes more than 375 member practices, representing more than 85 percent of the ART clinics in our country. The mission of our organization is to set and help maintain the standards for ART in an effort to better serve our members and our patients.
Data collection. Since 1985, SART has been actively involved in the collection of data outcomes from our member programs. We have worked closely with the Centers for Disease Control in compliance with the Fertility Clinic Success Rate and Certification Act of 1992 (Wyden Act) in an effort to accurately reflect outcomes of the procedures in which we are involved. SART collects de-identified birth outcome data from its member clinics through the internet, which facilitates direct transfer to the CDC and allows earlier dissemination of outcome reports to physicians, embryologists, and patients.
Practice opinions, guidelines, and standards. SART consistently plays an active role in creating practice guidelines and minimum standards of care as a requirement for membership in an effort to ensure that our member practices can proudly say that they adhere to the highest standards in ART. Some of the most recent topics included in the practice documents include:
- Blastocyst culture and transfer in clinical-assisted reproduction
- Essential elements of informed consent for elective oocyte cryopreservation
- Genetic considerations related to intracytoplasmic sperm injection (ICSI)
- Ovarian tissue and oocyte cryopreservation
- Preimplantation genetic testing
- The role of assisted hatching in in vitro fertilization: A review of the literature
- Guidelines for gamete and embryo donation
- Guidelines for development of an emergency plan for in vitro fertilization programs
- Guidelines on number of embryos transferred
- Guidelines for human embryology and andrology laboratories
- Minimum standards for practices offering assisted reproductive technologies
Standards like these have lead to a marked decline in high-order multiple pregnancies, the appropriate use of preimplantation genetic testing, and the promotion of elective single-embryo transfer. SART also holds all of its members to strict standards regarding advertising in order to better serve the public.
Government interaction. Working in conjunction with the ASRM Public Affairs Office, members of SART have worked diligently to protect our patients and the practice of ART from inappropriate external intrusion and regulation. We have worked successfully to mitigate many of the somewhat onerous requirements that had been initially proposed by the Food and Drug Administration, including the need to quarantine all embryos derived from donor eggs. Despite these efforts, we would anticipate that FDA inspections to confirm adherence to “good tissue practice” regulations regarding handling of donor reproductive tissue may become necessary in the future. The current FDA regulations are a work in progress, and SART and its members continue to interact constantly with appropriate officers of the FDA in an effort to make this process more efficient. We play a significant role in interacting with members of Congress and their staff regarding pending legislation which may have a direct impact on our practice. SART keeps its members apprised of relevant publications in the Federal Register through informational alerts via both fax and e-mail. Another organization, the National Coalition for Oversight of Assisted Reproductive Technology (NCOART) was organized by SART and meets on a scheduled basis in an effort to bring together representatives from SART, ASRM, the FDA, CDC, RESOLVE, AFA, the American Association of Tissue Banks, the American Bar Association, and others to discuss mutual issues or concerns. In this way, SART has been able to network effectively in a small-group setting with leaders of consumer groups, professional organizations, and government agencies to exchange ideas and share information and concerns on an ongoing basis.
Quality assurance. SART has played a major role as an advocate in providing consultation in an effort to improve quality practice. SART has initiated a voluntary consultation program, which in IVF practice can obtain assistance for volunteer clinicians and laboratory directors. These consultations are carried out confidentially and in a collegial spirit to improve the quality of patient care.
SART has also worked in conjunction with the Centers for Disease Control, collecting and validating outcome data and requiring accreditation of embryology laboratories. Submitting data and allowing validation of this data is indeed a requirement for membership in SART. In addition, all SART members must have their embryology laboratories accredited by CAP/ASRM, JCHO, or NYSTB. While we certainly recognize that data collection and lab certification are time-consuming and costly tasks, we also feel that this is an obligation we must assume if we wish to continue to be self-regulated.
The SART Quality Assurance Committee has played a major role in evaluating outcomes. Recent initiatives in which programs with triplet rates which were significantly higher than the norm, delivery rates which were significantly lower than the norm, or numbers of embryos which were higher than the norm were formally contacted and asked to comment on their practice patterns and to formalize means by which changes would take place to lower these rates. This will be followed on an ongoing basis.
Research. SART is a major source of ART research. SART members provide a majority of all abstracts submitted for the ASRM Annual Meeting. In addition, the SART Research Committee has published dozens of peer-reviewed articles derived from data gathered from the SART-CORS database.
Growth and Scope. SART currently is comprised of more than 375 practice members, representing more than 85 percent of all IVF clinics in the United States. Insurance companies have noted that SART members publish their validated data and have accredited laboratories. In fact, some major carriers have begun to require documentation of SART membership for reimbursement. Our Society will thrive only if there is active participation by all its members. Elected leaders can only reflect the will of our members. In these challenging times, we must all work together to achieve these initiatives and to expand upon our past accomplishments.
Objective Outcome-based Metrics. SART is a unique group of individuals who represent one of the only forms of medicine that has willingly validated outcomes data in an effort to provide adequate self-regulation. Many consider what SART has done for assisted reproduction to be a model for healthcare in the future.