Mammography Facility Inspections - Attachment G

ATTACHMENT G

Guidance for Additional Mammography Review (AMR)

FDA may require AMR to see if the mammography quality at a facility may present a "serious risk to human health" (21 CFR 900.12(j)).The term "mammography quality" encompasses all aspects of quality related to the production and interpretation of a mammogram. This may include aspects of the clinical image quality as well as other issues related to quality. Examples of reasons to require an AMR are:

1. Inspection observations

   1. Level 1 phantom image failure

   2. Interpreting physician

      1. Medical license: never licensed to practice medicine in a State

      2. Does not have board certification or the required initial mammography training (2 or 3 months)

      Note: DMQRP routinely scans MPRIS Web for inspection observations under A and B above and may follow up with districts regarding these observations. Level 1 phantom image scores are very rare. For this reason, each score must be verified using the procedure outlined in Appendix 3 of the MQSA inspection procedures. For level 1 observations for interpreting physicians, most facilities will be able to produce documentation to show that the physician is qualified. For licensure, level 1 observations are almost always cited for missing documentation or expired licenses. Facilities are usually able to produce the license or documentation that the physician has renewed his or her license. If the facility is cited for a physician not having board certification or two/three months training in mammography, it usually is able to produce the documentation. For guidance for using AMR for these observations, go to the Policy Guidance Help System at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm.

   3. A combination of inspection observations, which results in a reasonable probability that mammography quality has been seriously compromised and may represent a serious risk to human health.

2. Other

   1. A combination of observations from various sources (inspections, complaints, interpreting physicians, etc.) which results in a reasonable probability that mammography quality has been seriously compromised and may represent a serious risk to human health.

   2. Investigations of allegations or complaints that indicate a reasonable probability exists that mammography quality has been seriously compromised and may represent a serious risk to human health. Under this category, FDA can require AMR without documented violations of MQSA.

   3. Uncertified facility

      If a facility had performed mammography without a certificate for at least 90 days, FDA may require AMR.

   4. Clinical image review by an accreditation body

      If an accreditation body, during a review of mammograms for accreditation, reaccreditation, or for any other reason, finds that the quality of mammography may represent a serious risk to human health, this body should notify FDA within two working days. Based on this information, FDA may require AMR.

Note: An AMR may be performed regardless of whether a regulatory action will or will not be taken by the agency.