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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Mammography Equipment Evaluations and the Annual Survey - Is Your Equipment Up to the Task?

by W. G. Mourad, Ph.D.
Information Management Branch
Division of Mammography Quality and Radiation Programs
5/5/2003

The quality of mammography at a facility is acutely affected by the equipment used to produce the mammograms. It is therefore critical to ensure that such equipment is maintained in the best possible operating condition. This requires quality control testing on a regular basis. According to MQSA final regulations, each certified facility must have:

  • A mammography equipment evaluation (MEE) conducted by a medical physicist for an x-ray unit or a processor that is new to the facility, has been disassembled and reassembled, or one that has undergone major repairs, and
  • An annual survey conducted by a medical physicist to ensure that the equipment is functioning properly (e.g., meets the minimum standards) and that the quality assurance program at the facility is adequate.

The intent of the MEE is to ensure that the equipment functions as intended by its design, both initially and after being repaired. The intent of the annual survey is to ensure that the equipment continues to function dependably, as designed, throughout its lifetime.

Having equipment that functions properly is strongly related to the quality of mammography at the facility. For this reason, MQSA emphasizes that facilities need to have a comprehensive QC program and need to be diligent in following all QC procedures. If facilities are not properly attentive to these requirements FDA issues a Level 1 (L1), Level 2 (L2), or Level 3 (L3) citation (serious, moderate, and minor, respectively) to the facility, depending on the specific inspection observation. These citations will be described and analyzed in some detail below.

To set the proper background for this analysis, we obtained inspection data over the date range of 10/1/99 to 3/31/03 (7 half-fiscal year periods). Since inspection results below will be displayed in terms of the number of facilities cited for a given violation during a half year period, we will first show the total number of facilities inspected during each of these periods, in order to keep things in perspective. Each half year period will be denoted by either H1 (for the October-through-March months) or H2 (for the April-through-September months). This format for displaying the data will be used in all the figures in this article.

The number of facilities inspected in each half year period is shown in the Table below:

Period 00-H1 00-H2 01-H1 01-H2 02-H1 02-H2 03-H1
# of Facilities Inspected 4514 4927 4486 4789 4428 4556 4355

MEE Observations

The FDA issues an L2 citation to the facility for any of the following observations:

  • Lack of an MEE for an x-ray unit (if applicable)
  • Lack of an MEE for a processor (if applicable)

Inspection results over the date range of 10/1/99 to 3/31/03 (7 half-fiscal year periods) are displayed in Figure 1. The two lines in the figure show MEE citations for the x-ray unit and for the processor, respectively. The processor line shows no processor MEE citations until the second half of FY01 because, up to that time, the inspection software included such citations under those corresponding to the x-ray unit and as a result, they were either included in the x-ray unit MEE violations, or were not separately captured by the inspection software.

The two lines in the figure show MEE citations for the x-ray unit and for the processor, respectively

Figure 1. Facility Citation for MEE violations

Facilities can minimize these violations by working with their medical physicists to ensure that new or re-installed equipment, or equipment that has had major repairs, undergo the required MEE before it is used on patients.

 

Level 1 Survey Observations

The FDA issues an L1 citation if the facility did not have an annual medical physicist survey for two successive years.

Inspection results over the date range of 10/1/99 to 3/31/03 show that facility citations for this violation were rather rare; e.g., only once in FY01 and once in FY02.

Level 2 Survey Observations

The FDA issues an L2 citation to the facility for any of the following observations:

  • Time interval between the current and previous survey exceeds 14 months
  • Time interval between inspection date and the most recent survey exceeds 14 months
  • Unsigned report or one without the ID of the person who conducted or supervised the survey
  • Incomplete survey, e.g., any of the following tests are missing or incomplete:
    • spatial resolution
    • AEC performance
    • phantom image
    • dose
    • system artifacts
    • new modality QC tests

We evaluated inspection results over the date range of 10/1/99 to 3/31/03 for items under each of the 4 main bullets. First, violations regarding the third bullet (unsigned report, etc.) were very rare, e.g., only 2 facilities in FY01 and none since then.

Facility citations regarding items under the other three bullets are displayed in Figure 2. These results show that the number of facilities cited for any of the L2 violations shown in Figure 2 has been generally decreasing but is far from ideal.

These results show that the number of facilities cited for any of the L2 violations shown in Figure 2 has been generally decreasing but is far from ideal

Figure 2. Facility Citations for Level 2 Survey Violations

 

Facilities can eliminate violations regarding the timeliness of the survey by planning ahead with their medical physicists to ensure that successive surveys are conducted annually, e.g., close to or on the anniversary of the previous survey, as required in the regulations. The FDA inspection program has been designed to allow up to 14 months between surveys in order to give facilities and medical physicists sufficient flexibility in scheduling the next annual survey. However, facilities should not use this flexibility to consistently delay the next survey to the last permissible day.

Regarding incomplete surveys, facilities can minimize such violations by requiring their medical physicists to conduct all the required tests and tasks as specified in the regulations, thus providing them with complete surveys.

 

Level 3 Survey Observations

Although Level 3 (L3) violations are considered not as serious as Level 2 and Level 1 violations and do not require a facility response, the FDA views all violations as detrimental for the quality of mammography and expects facilities to take corrective action regarding these violations as soon as possible.

The FDA issues an L3 citation to the facility for any of the following observations:

  • Incomplete survey (e.g., any of the following tests/tasks are missing or incomplete):
    • pass/fail list in the report
    • recommendations for failed items
    • physicist’s evaluation of the technologist’s QC tests
    • any of the tests not listed under L2
      • collimation assessment
      • kVp accuracy
      • kVp reproducibility
      • beam quality (HVL) measurement
      • uniformity of screen speed
      • radiation output
      • decompression (compression release)
  • Not taking timely corrective actions for items that failed in the survey.

Inspection results over the date range of 10/1/99 to 3/31/03 are displayed in Figure 3. These results show that over this period, violations due to incomplete surveys have decreased about 57% and those due to the lack of corrective actions for items that failed during the survey have decreased by about 30%. While this trend is in the right direction, it is far from ideal.

Inspection results over the date range of 10/1/99 to 3/31/03 are displayed in Figure 3

Figure 3. Facility Citations for Level 3 Survey Violations

Facilities can reduce these violations by demanding complete and compliant surveys from their medical physicists (as stated earlier) and by subsequently acting on their recommendations for corrective actions.