The Fertility Clinic Success Rate and Certification Act
The first infant conceived with Assisted Reproductive Technology (ART) in the U.S. was born in 1981. As ART use increased throughout the 1980s, there was growing concern about the quality of ART information that infertility patients were receiving.
In response to concerns about data quality and comparability, Congress enacted the Fertility Clinic Success Rate and Certification Act (FCSRCA, or Public Law 102-493) in 1992, mandating that all ART clinics report success rate data to the federal government in a standardized manner.
The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandates that clinics performing ART annually provide data for all procedures performed to the Centers for Disease Control and Prevention (CDC) and sets forth definitions and reporting requirements, specifically sections 2(a), 2(b), 2(c), 6 and 8. CDC is required to use these data to report and publish clinic-specific success rates and certification of embryo laboratories. The details on who and how needs to report in order to be compliant with the law are described in Federal Register Notices published following the FCSRCA enactment.
The FCSRCA mandates that the Secretary, Health and Human Services (HHS), through the CDC, develop a model program for the certification of embryo laboratories, to be carried out voluntarily by interested states. The requirements for reporting the certification status of embryo laboratories, including definitions, administrative requirements, and embryo laboratory standards are described in the Federal Register Notice. Currently, certification of embryo laboratories can be done by one of the three nonfederal laboratory accreditation Programs: (1) the College of American Pathologists/American Society for Reproductive Medicine (CAP/ASRM), (2) the Joint Commission on Accreditation of Healthcare Organizations (JACHO), and (3) the New York State Tissue Bank certification for ART laboratories (NYSTB). CDC does not endorse these accreditation agencies, but rather is providing available laboratory accrediting information in all annual Success Rates Reports.
Fertility Clinic Success Rates Reporting
The FCSRCA mandates that all ART clinics report success rate data to the CDC in a standardized manner. The details of reporting requirements are outlined in the Federal Register Notice, which describes: (1) who shall report to CDC, (2) the reporting system and process for reporting by each ART clinic, (3) the data items and definition to be included in the reporting database, and (4) how pregnancy success rates will be defined and reported in the annual published reports, using the data collected in the reporting database.
To monitor the burden for fertility clinics by implementation of FCSRCA, the Office of Management and Budget (OMB) needs to review and approve the ART reporting system. In compliance with the Paperwork Reduction Act, CDC publishes a list of information collection requests under review by the OMB in the Federal Register Notice. This notice announces extension of OMB approval (OMB No. 0920-0556, exp. 9/30/2012) for a period of 3 years in accordance with the FCSRCA. As required by the FCSRCA, CDC currently collects information from all clinics that offer ART services, and reports this information as specified in the Act.