HHS Releases Quality Standards for State Certification of Laboratories Used in Fertility Clinics

The Department of Health and Human Services today released a model certification program containing a set of quality standards states can use for inspecting and certifying laboratories used in fertility clinics that provide assisted reproductive technology (ART) such as in vitro fertilization. Certification of these laboratories by the states is voluntary and each state may choose to implement its own program based on the model.

Developed by the Centers for Disease Control and Prevention (CDC), the model certification program is mandated by the Fertility Clinic Success Rate and Certification Act of 1992. This legislation, sponsored by Senator Ron Wyden (Ore.), was implemented to ensure the quality of ART services and to furnish consumers with reliable information on pregnancy success rates of individual ART clinics.

The model consists of a set of standards for the performance of laboratory procedures, maintenance of records, qualifications for laboratory personnel, and criteria for the inspection and certification of laboratories.

"This model provides an excellent resource for states that want to develop their own programs," said HHS Secretary Donna E. Shalala. "It offers every state the sensible, science-based guidelines they need to promote the quality services Americans have a right to expect."

In developing the model, CDC consulted with individual experts, professional organizations and consumer groups with expertise in laboratory procedures and ART. Input was also provided by state programs and federal agencies with regulatory responsibilities related to laboratory practice, tissue banking, and ART. CDC will distribute the model certification program to state officials and health authorities and encourage the adoption of such a program by individual states. The full standard will be published in today's Federal Register and will be available on the World Wide Web at: http://www.phppo.cdc.gov/dls/art/art.asp.

In addition to the model certification program, CDC also publishes an annual report on pregnancy success rates for fertility clinics in the U.S. Also mandated by the Fertility Clinic Success Rate and Certification Act, the report provides valuable information to consumers who are considering ART. The report is available at: http://www.cdc.gov/nccdphp/drh/art.htm.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES