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Preparing for Mammography or Stereotactic Breast Biopsy Inspections

Inspector Tests Performed Onsite

Mammography - The inspector will ask you to perform a phantom image test in the same manner in which you perform the test for your quality control program. The inspector will then perform measurements of the radiation output of your unit to determine the average glandular dose for the phantom.

Stereotactic Breast Biopsy - The following will be verified for the stereotactic breast biopsy unit:

  • Average Glandular Dose
  • Beam Quality Assessment (HVL)
  • AEC/Exposure Reproducibility
  • kVp Accuracy and Reproducibility
  • Digital Receptor Uniformity
  • Phantom Image Quality
  • Equipment operated from a shielded position

Quality Assurance

Please provide the inspector with the applicable quality control manuals for your mammography unit, RWS, printer, and stereotactic breast biopsy unit for reference during inspection.

The inspector will review your policies and procedures to ensure that they meet the rules for mammography and/or stereotactic breast biopsy as applicable.

Specific items of attention are:

  • Designation of QC Personnel; Lead Interpreting Physician, Quality Control Technologist, and Medical Physicist
  • Technique Charts for each mammography unit
  • Procedures for:

1. Quality Control tests or reference to the proper digital mammography unit manufacturer's QC manual.

2. Infection Control for Mammography

3. Consumer Complaint Process

Quality Control Testing Review

The inspector will review all QC records for adequate performance of each test.

  • Film Screen facilities must perform quality control tests as outlined by MQSA regulations and IAC Chapter 41.6 rules.
  • Digital and Tomosynthesis facilities must perform quality control testing as outlined by their manufacturer's quality control manual and IAC Chapter 41.6 rules, as applicable.
  • Stereotactic breast biopsy facilities must perform quality control testing as outlined in IAC Chapter 41.7 rules.

Personnel Qualifications

The inspector will review all personnel records to ensure that interpreting physicians, mammography technologists, and medical physicists meet the initial and continuing qualifications.

See the Qualification Forms tab for more details on the specific requirements.

Medical Records Review

The inspector will ask for an overview of your facility's process for providing the mammography interpretation results to both the referring physicians and the patient. The process must ensure that within 30 days of the mammography examination, each patient will receive a letter with her mammography results written in layman's terms.

The inspector will also review five (5) or more interpretation reports to ensure that they include:

  • The name of the patient and an additional patient identifier;
  • Date of examination;
  • The name of the interpreting physician who interpreted the mammogram;
  • A separate and distinct section titled "Assessment" that includes an assessment category.
  • Assessment categories are classified as one of the following:

(A) “Negative:” Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall he explained);

(B) “Benign:” Also a negative assessment;

(C) “Probably Benign:” Finding(s) has a high probability of being benign;

(D) “Suspicious:” Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

(E) “Highly suggestive of malignancy:” Finding(s) has a high probability of being malignant;

(v) In cases where no final assessment category can be assigned due to incomplete work-up, “Incomplete: Need additional imaging evaluation” shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and

(vi) Recommendations made to the health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring health care provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.

Medical Audit

Each facility must maintain a mammography medical outcomes audit program to include all mammograms interpreted as positive (Bi-RADS Category 4 or 5). Each positive assessment must be correlated with the pathology results for the associated biopsy; with documented attempts for those pathology results that are unavailable.

The inspector will want to review your facility's system for collecting and reviewing outcome data for all mammograms performed. An analysis of the positive mammogram correlation and any false negative mammograms discovered should be performed after the data has been collected. This is usually six months to one year after the reported time frame.

For example:

  • Data collected for 1/2012-12/2012
  • Monitor during 2013 for false negatives from any 2012 mammogram (negative mammograms with subsequent cancer diagnosis)
  • Review and signature by audit review physician in 12/2013
  • Inspector Review during 2014 facility inspection