Skip directly to search Skip directly to A to Z list Skip directly to navigation Skip directly to page options Skip directly to site content

Policy Documents

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.

Certification of Embryo Laboratories

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 pregnancy success rates 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 HHS/CDC, (2) the reporting system (NASS) and process for reporting by each ART program, (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 NASS data. Currently, ART clinics are operating under the Federal Register Notice published August 26, 2015, using the National ART Surveillance System, NASS 2.0. In addition, a Federal Register Notice announcing clarifications and modifications of certain definitions used for reporting of ART success rates was released on December 15, 2016. 

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. 7/31/2018) 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.

 

 

 Top of Page

Related Links

  • U.S. Department of Health and Human Services’ National Library of Medicine
    The National Library of Medicine’s, MedlinePlus, offers information on infertility including drugs and medications, medical terms, and other resources for care, support, and decision making.
  • Clinicaltrials.gov
    The U.S. Department of Health and Human Services maintains this registry of federally and privately supported clinical trials conducted in the United States and around the world. Searching the ClinicalTrials.gov database gives you information about a trial's purpose, who may participate, locations, and contact information to obtain more details about clinical trials on infertility and related health problems.
  • Society for Assisted Reproductive Technology
    The Society for Assisted Reproductive Technology (SART) promotes and advances the standards for the practice of assisted reproductive technology to the benefit of patients, members and society at large.
  • American Society for Reproductive Medicine
    The American Society for Reproductive Medicine (ASRM) is a multidisciplinary organization for the advancement of information, education, advocacy and standards in the field of reproductive medicine.
  • Path 2 Parenthood
  • RESOLVE: The National Infertility Association
    RESOLVE is a national consumer organization that offers support for men and women dealing with infertility. Their purpose is to provide timely, compassionate support and information to people who are experiencing infertility and to increase awareness of infertility issues through public education and advocacy.
  • Livestrong Fertility
  • American Urological Association Foundation
    The American Urological Association Foundation provides educational services and referrals to benefit patients with male infertility.

 Top of Page

Top