Mammography facilities may soon be asked to pay both the federalgovernment and a private group for authorization to stay in business. As required by the Mammography Quality Standards Act of 1992,every mammography unit in the U.S. will have to be
Mammography facilities may soon be asked to pay both the federalgovernment and a private group for authorization to stay in business.
As required by the Mammography Quality Standards Act of 1992,every mammography unit in the U.S. will have to be certified byOct. 1, 1994, or stop operation. The Food and Drug Administrationhas been charged with implementing the new law, but may have difficultymeeting the deadline because of strained resources at the agency.
Sources at the FDA say that certification will be a two-stepprocess: accreditation by a private group and on-site inspectionby an authorized representative of the federal government. Becauseof the agency's ongoing budget woes, it now appears that the costof both accreditation and inspection will have to be picked upby the facility.
The charges for these services have yet to be determined, sincethe program is in the early stages of development. Some of thecosts can be estimated, however.
The American College of Radiology, a front-runner among thegroups the FDA might choose to conduct the accreditation, charges$2500 to $2800 to accredit a facility. This accreditation is partof the ACR's voluntary program, which has been operating since1987.
The federal side of the equation, however, is not so clear.
"We don't know the bottom line as far as the inspectionfee," said Richard Gross, a staff member of the FDA's mammographyquality assurance standards program. "It's impossible atthis time to say how much."
The one certainty is that there will be a charge for the inspection,because the funds Congress allocated to the FDA for the programare insufficient. The $3 million allocated this year and $12 millionfor next year will not cover both administrative costs and theexpense of sending inspectors on-site to the 11,000 facilitiesthat perform mammography.
Just as the FDA does not know the cost of sending inspectorsto mammography centers, neither does the agency know who willconduct the inspections. The FDA would like to work exclusivelywith state radiation control officials, but that will not be possiblein all cases.
"Wyoming, for example, doesn't have a (state radiationcontrol) program and there are several states that have difficultyworking under contract with the federal government because ofthe way their budgets and personnel ceilings are managed,"Gross said. "In those situations where we can't get statesto help us under contract, FDA staff will have to do the inspections."
That's bad news for the FDA, because the agency is starvedfor personnel, according to Gross. The FDA is too understaffedto take care of the responsibilities it already has.
"When you consider that the inspectors have to be speciallyqualified to do this work, we have a lot of people to train ina short time," Gross said.
More details about the program are expected in the coming weeksas the FDA lays the groundwork for a conference in September orOctober with the mammography program's advisory committee. Thecommittee is expected to establish the criteria that facilitiesmust meet for certification.