Equipment. Only equipment designed specifically for mammography qualifies for certification.
Medical Records and Mammography Reports. Summary data written in lay terms must be sent directly to all patients as soon as possible. Mammography films and reports must be retained for at least 5 years and up to 10 years, and labeled according to Food and Drug Administration (FDA) regulation.
Quality Assurance. Quality control testing protocols must be used and maintained by each facility, including mammography equipment evaluations and an annual physics survey. Documentation of daily, weekly, quarterly, semiannual, and annual quality control tests must be retained for FDA inspections
Mammography Medical Outcomes Audit. An interpreting physician must annually review the medical outcomes audit data.
Consumer Complaint Mechanism. Facilities must establish a written and documented system for collecting consumer complaints.
Current Accreditation Bodies. American College of Radiology (ACR), Iowa, Arkansas, and Texas.
Responsibilities of Accreditation Bodies. Accreditation bodies must monitor facility compliance with quality standards, review clinical and phantom images from each facility at least once every 3 years, conduct annual onsite visits of at least 5 percent of the facilities it accredits, and maintain a consumer complaint system.
Accreditation Body Audit. FDA will evaluate the performance of each accreditation body annually.
Facility Accreditation. Facilities must submit verification that personnel, equipment, and practices conform to established quality standards to be eligible for accreditation.
Responsibilities of Certification Bodies. Certification bodies must issue Mammography Quality Standards Act (MQSA) certificates allowing accredited facilities to operate lawfully, and must perform annual inspections of each certified facility.
Fees. The facility undergoing inspection is responsible for all inspection fees. As of October 1, 2003, a fee of $1,749 is charged for the first mammography unit inspected, and $204 for every unit thereafter. Follow-up inspection fees are $991.
Level 1: Failure to meet a key MQSA requirement that may seriously compromise mammography quality. The facility is given 15 days to respond with corrective actions.
Level 2: All critical MQSA requirements met, yet a significant mammography quality item overlooked. The facility is given 30 days to respond,
Level 3: A minor deviation from MQSA standards. The facility is given until next annual inspection to address the problem, although it is advised to correct it as soon as possible,
FDA may impose one or more of the following sanctions:
Directed Plan of Correction, allowing facility to correct violations in a timely manner, while being monitored by FDA.
Patient and Physician Notification, requiring facilities to inform those that may be at risk due to unacceptable image quality or other conditions that could cause significant negative impact on patient health. Follow-up Inspection.
Certificate Revocation or Suspension.
Civil Money Penalties of up to $10,000 per examination or per violation per day may be applied to facilities performing mammography services without proper certification or for other significant violations.
Members. FDA appoints members from the community of physicians, health professionals, consumer organizations, and industry representatives.
Responsibilities. The NMQAAC advises FDA on appropriate quality standards, assists in the development of sanctions, designs a method to investigate consumer complaints, reports on new developments in breast imaging, determines whether a shortage of health professionals exists, and measures the costs and benefits of MQSA compliance.