Mammography bill sets stiff quality standards

A new bill regulating quality assurance at mammography facilitiesin the U.S. established tough sanctions for centers that failannual inspections. The bill, SB-1777, was passed by the SenateOctober 7 and is poised for signing by President Bush.

The passage of SB-1777 is the culmination of a two-year effortby a national coalition of legislators and breast cancer screeningadvocates. It requires mammography centers to use dedicated equipment,qualified technologists and physicians, and to establish qualityassurance programs.

The penalty for noncompliance ranges from monetary penalties,to payment of costs for on-site monitoring, to possible facilityclosure.

The new law provides a national standard for compliance insteadof the existing patchwork of federal, state and private regulations,according to Sen. Brock Adams (D-WA), who introduced the bill.Only a handful of states currently have quality assurance lawsin place for mammography. Existing federal regulations are looselyworded and apply only to facilities that screen Medicare beneficiaries.

Under SB-1777, centers are required to be certified by theDepartment of Health and Human Services every three years, inspectedby state representatives annually, and accredited by an approvedagency.

State inspections will test beam quality, average glandulardose, phantom image quality and film processing quality. Facilitieswill have 48 hours' notice prior to an inspection, and the lawpermits states to charge fees for the annual review.

The law does not require centers to purchase new equipment,although it does stipulate that dedicated mammography units mustbe used. Nearly all of the estimated 11,000 mammography centersin the U.S. already use dedicated equipment, said Marie Zinninger,director of mammography accreditation at the American Collegeof Radiology in Reston, VA.

It is unlikely that centers will need to replace existing equipmentto satisfy the new law, she said.

"A majority of the mammography units we see are relativelynew," she said. "And centers are already replacing equipmentneeded to comply with voluntary certification."

If signed, the bill becomes effective immediately. Legislatorshave set aside $2.5 million in federal funds for fiscal year 1993and $12 million for 1994 to pay for national certification offacilities.

The ACR has expressed interest in assuming the role of accreditingagency under the new law. The ACR's accreditation program hassurveyed and accredited 9000 mammography units since 1987.

Unlike the ACR's certification program, however, the federalbill imposes punitive measures for centers that do not keep upwith the tenets of the bill.

"The ACR's program has been based on the concept of aneducational, not punitive, effort," Zinninger said. "Inour experience, centers want to do better. We support the bill,but we had hoped that same atmosphere could continue--one of improvementrather than trying to put people out of business."