BOX 3–1
MQSA Regulations Overview

  1. Quality Standards

    1. Personnel. Interpreting physicians, radiologic technologists, and medical physicists must meet initial and continuing requirements. Documentation of these requirements must be available for inspection.

    2. Equipment. Only equipment designed specifically for mammography qualifies for certification.

    3. 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.

    4. 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.

    5. Mammography Medical Outcomes Audit. An interpreting physician must annually review the medical outcomes audit data.

    6. Consumer Complaint Mechanism. Facilities must establish a written and documented system for collecting consumer complaints.

  1. Accreditation

    1. Current Accreditation Bodies. American College of Radiology (ACR), Iowa, Arkansas, and Texas.

    2. 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.

    3. Accreditation Body Audit. FDA will evaluate the performance of each accreditation body annually.

    4. Facility Accreditation. Facilities must submit verification that personnel, equipment, and practices conform to established quality standards to be eligible for accreditation.

  1. Certification

    1. Current Certification Bodies. FDA, Iowa, Illinois, and South Carolina.

    2. 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.

    3. Facility Certification. Accredited facilities are eligible for certification. Certificates are valid for 3 years, and are renewable.

  1. Inspections

    1. General. Facilities must undergo annual inspections.

    2. Inspectors. Facilities may be inspected by FDA inspectors, state or local agency inspectors under FDA contract, or inspectors from states that are certifying agencies. Federal facilities can be inspected only by FDA inspectors.

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