What Is SART?
I have been asked by colleagues what it is that SART really represents and what is truly the function of our Society. I would like to take a few moments to try to answer these questions.
SART is the primary organization of professionals dedicated to the practice of assisted reproductive technologies (ART) in the United States. Our organization includes over 392 member practices, representing over 85% 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.
The SART Executive Council is comprised of many individuals from diverse backgrounds dedicated to the furtherment of Assisted Reproductive Technologies.
But what exactly what does SART do?
- 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. Beginning in 2004 and reflecting the 2003 data set, SART will work to serve its members by collecting outcomes data in a web-based fashion, which will not only allow information to be transferred directly to the CDC contractor, thus fulfilling legal requirements, but will allow us to present data in a more timely and fresh fashion. This will allow physicians, embryologists, and patients to have more rapid access to outcomes. The report format will be presented in a manner which reflects input from both our professional members and patient support organizations in an effort to maximize the efficiency and meaning of the results reported.
- Practice guidelines and standards. SART has consistently played an active role in creating practice guidelines and minimum standards of care in an effort to ensure that our member practices can proudly say that they adhere to the highest standards in ART as a requirement for membership. Most recently, practice guidelines regarding assisted hatching, blastocyst transfer, and gamete and embryo donation reflecting the new FDA regulations are in preparation for publication. The impact of these practice guidelines have clearly been realized. Recent outcomes data from the Centers for Disease Control have suggested that triplet pregnancy rates have significantly declined as a result of changes in guidelines for number of embryos to transfer published in 1999. We look forward to evaluating the effect of the newest changes in the number of embryos to transfer, published in 2004, regarding the effect of single-embryo transfer. SART also holds all of its members to strict standards regarding advertising in order to better serve the public
- Government interaction. SART serves as the governmental watchdog for ART. 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 do represent 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. A recent initiative in which programs with triplet rates which were significantly 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. Similarly, programs with lower-than-expected triplet rates were commended for their outcomes. 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 to the ASRM annual meeting. In addition, the past president and the chair of the SART Registry Committee are responsible for evaluating the national outcomes of ART services, published annually in Fertility and Sterility. The SART Research Committee has provided a source of ongoing research projects which will only be enhanced by the initiation of the new internally managed and collected SART-CORS data set, which will allow more ready access to our national outcomes.
- Growth and Scope. SART currently is comprised of over 392 practice members, representing over 95% of all IVF clinics in the United States. Insurance companies have noted that SART members publish their validated data and have accredited laboratories. Indeed, some major carriers have begun to require documentation of SART membership for reimbursement.
- SART is not “them”. SART is “us”. Our Society will thrive only if there is active participation by all of 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. We are a unique group of individuals who represent the only form of medicine that has willingly validated outcomes data in an effort to provide adequate self-regulation. We should be proud.
Eric Surrey, M.D.
President
Society for Assisted Reproductive Technologies, 2004-2005
|