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U.S. Department of Health and Human Services

Radiation-Emitting Products

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FDA to Scrutinize MQSA Facilities with History of Noncompliance

FDA is intensifying its efforts to bring facilities with continued inspection observations under the Mammography Quality Standards Act (MQSA) into compliance with these requirements. While the vast majority of facilities have either no inspection observations or minor ones during their annual inspections, certain facilities continue to have repeat problems. Recurring problems, even if they are not the same exact problems as in the previous year or don’t show up during consecutive inspections, indicate a failure of the facility’s quality assurance program. This article focuses on this small group of facilities.

In a May 20, 2004 web site article, "Repeat Observations - The Wrong Way to Go," by W. G. Mourad, Ph.D., we defined repeat observations as findings identified by the inspection software and are listed as repeat observations at all three levels. An observation in the current inspection is termed a repeat observation if the facility was cited for it during the previous inspection. Furthermore, the observation is considered a repeat observation if it is the same type of observation, whether or not it is part of the same entity (e.g., x-ray unit, processor, darkroom, or the same personnel category). These repeat observations are contained in the MQSA Facility Inspection Report that the inspector gives to facility management after its inspection identifies repeat observations, along with all inspection findings.

Highlighting repeat observations is important. However, repeat findings are not the only indicator that FDA focuses on in its inspections. Rather, FDA looks at a facility’s performance over several inspections, not just the two most recent ones, along with the effectiveness of corrective actions taken by the facility or identified in the facility’s response to FDA.

If a facility with previous problems has new inspection observations, MQSA inspectors will look at that facility’s inspection history and will discuss these findings with facility management during the discussion at the end of the inspection. In this discussion, the inspector explains to the facility that FDA thoroughly examines facility histories and the facility’s response to the current inspectional observations when determining how to proceed in working with the facility to correct these deficiencies.

Along with the inspection report, MQSA inspectors provide facilities with a handout entitled Important Information about Your MQSA Inspection. We have added the following paragraph to this handout so that facilities with continuing problems will know what FDA expects them to include in their responses to the inspection observations:

“The steps taken to prevent the reoccurrence of the problem(s).  This should include having the facility's most responsible individual discuss these problems with the lead interpreting physician and other staff about these problems.  You should consider changes to your standard operating procedures, management practices, oversight for the quality assurance program, and recordkeeping to assure that future inspections are free from adverse observations.  A detailed explanation of any changes should be included in your response.”

We expect these facilities to permanently change a pattern of noncompliant behavior to avoid serious consequences. Nevertheless, facilities that continue to violate MQSA may be subject to additional actions, including, but not limited to, the following:

  • requiring your facility to undergo an Additional Mammography Review
  • placing your facility under a Directed Plan of Correction
  • charging your facility for the cost of on-site monitoring
  • requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information
  • seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards
  • seeking to suspend or revoke your facility’s FDA certificate
  • seeking a court injunction against your facility

We are instituting this approach as a pilot program and will reassess its effectiveness after one year.