Seeking to improve the quality of services at fertility clinics, the Centers for Disease Control published guidelines Wednesday that state legislatures can use as a model for inspections.
Health and Human Services Secretary Donna Shalala said issuing guidelines was the proper role for the federal government as states seek to crack down on a virtually unregulated $2 billion industry.
"What should never be left to chance is the quality of the services provided by America's fertility clinics and laboratories," Shalala told reporters on Capitol Hill.
Appearing with her, Sen. Ron Wyden, D-Ore., said many of the nation's 300 fertility clinics already comply with the standards. Wyden authored a 1992 law that required the government to set up the new standards.
He said the guidelines are "an indication to unscrupulous operators that you better clean up your act."
The guidelines aim to make sure embryology laboratories and clinics meet standards on lab procedures and equipment, record-keeping and personnel qualifications.
State action is voluntary, but some state legislators have been considering establishing some regulatory framework, especially after a few recent horror stories like the embryo mix-up at a New York lab where one woman gave birth to twins, one of which was another couple's genetic child.
"We know no one can ever guarantee that every couple who turns to a fertility clinic will be pleased with the results of the treatment. But using this model, the state governments can reassure those couples that the clinics they're using are living up to the highest standards of quality," Shalala said.
Even in the best of labs and medical practices, success is not guaranteed with reproductive techniques like in vitro fertilization.
Insurance does not always cover infertility treatment, especially the high tech approaches, so couples may spend tens of thousands of dollars on difficult and stressful procedures, with low success rates.
The Society for Assisted Reproductive Technology, which represents 90 percent of U.S. clinics, backs the model standards.