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New Flexible Policy for Accrediting Mobile Mammography Units - 5-7-2004

The ACR has recently received approval from the Food and Drug Administration to allow more flexibility for facilities accrediting mobile mammography units. Hospitals and clinics with a mobile unit in addition to their fixed units may now accredit their mobile units under their fixed facility's accreditation and MQSA certificate number. Prior to this, they were required to accredit and certify the mobile unit as an entirely separate facility. In addition to other benefits, this will allow the facility to combine medical audits from patients examined on both their fixed and mobile mammography units. Go to the ACR's Mobile Mammography Accreditation Policy for complete information on this and other changes.

Mobile Mammography Accreditation Policy

Mobile units provide a valuable service to patients, particularly in underserved urban or rural areas. Although maintaining quality may be more challenging in a mobile environment, it can be done with careful attention from the lead interpreting physician, facility management and staff. Patients must be assured that mobile facilities are appropriately accredited and certified. Because the communities they serve differ, mobile providers operate under a wide variety of business scenarios. For example, some mobile units are owned and operated by a fixed mammography facility and utilize the same personnel. Others are owned by a single entity but provide services at various sites, many with their own interpreting physicians. This variability complicates accreditation and certification of these providers under the Mammography Quality Standards Act (MQSA) and the Food and Drug Administration's (FDA) regulations.

• By regulation, facility means a "hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities, including the following: operation of equipment to produce a mammogram, processing of the mammogram, initial interpretation of the mammogram, and maintaining viewing conditions for that interpretation." A facility will receive a unique MAP ID and an MQSA certificate with a unique MQSA ID.
• A facility may only designate one owner on its application for accreditation. FDA guidance specifies that, "under MQSA, an owner/operator of a mammography facility is always responsible for the activities of that facility." Any potential compliance actions will be addressed to the "most responsible person" (owner) of the facility, regardless of the number of sites a mobile unit may visit.
• By regulation, the facility "shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program meets all [FDA] requirements." The FDA further clarifies this in guidance: "While a facility can change who is designated as the lead interpreting physician, there can be only one lead interpreting physician at any one time."
• By regulation, each facility must "establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility." At this time, the FDA does not allow different facilities to combine outcome data even if the physicians are the same.
• The FDA requires the MQSA-certified facility's name to be identified on the mammogram, the report and the lay summary.

After recent consultation with the FDA, the ACR has changed its mobile mammography accreditation policy to allow more flexibility in accrediting mobile units while ensuring that these facilities comply with the FDA regulations. In general, mobile units may apply for accreditation as follows (see examples below):

• Scenario I: A mobile unit operating under a fixed, accredited and certified facility (utilizing the same personnel) may either accredit as an additional unit under the facility's MQSA certification or may accredit and certify as an entirely separate facility. If the fixed facility chooses to accredit the mobile unit under their existing MQSA certificate, the FDA will require them to bring the mobile unit to their fixed site during MQSA inspections.
• Scenario II: A mobile unit owned and operated by a single entity must designate a single lead interpreting physician in order to accredit and certify as one facility.
• Scenario III: A mobile unit owned by a single entity servicing multiple sites with different lead interpreting physicians must accredit and certify as separate facilities.

Effective immediately, all mobile facilities accrediting for the first time and existing mobile facilities renewing their accreditation must accredit according to this new policy. Please contact the ACR Mammography Accreditation Program at (800) 227-6440 if you have questions.