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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Contents of Records and Reports

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Citation:

900.12(c)(1)(i),(ii),(iii)(iv)(A)(B)(C)(D)(E),(v),(vi): Medical records and mammography reports — (1) Contents and terminology. Each facility shall prepare a written report of the results of each mammography examination performed under its certificate. The mammography report shall include the following information:

(i) The name of the patient and an additional patient identifier;

(ii) Date of examination;

(iii) The name of the interpreting physician who interpreted the mammogram;

(iv) Overall final assessment of findings, classified in one of the following categories:

(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.

Approved Alternative Standard:

Questions:

  1. What types of signatures are acceptable on mammography medical reports?
  2. What medical records will the MQSA inspector ask to see?
  3. What categories must be shown on mammography reports for final assessments of findings?
  4. If the assessment category is "incomplete" and the patient is referred for additional testing such as ultrasound or MRI to complete the diagnosis, must the facility revise the original report if, as a result of this referral, the assessment is changed to one of the other categories?
  5. Is it necessary to include an assessment code (e.g. 0, 1, 2, 3, 4, 5 or N, B, P, S, M, A), in addition to the assessment category, on all mammography reports? Is there a specific reporting format required?
  6. If there is more than one lesion identified on the mammographic examination, do I need to have a final assessment category for each lesion or just one assessment for the entire mammographic examination?
  7. If a facility issues an "addendum" or "comparison" report after the initial mammography report has already gone out, are these reports required to have an overall final assessment category? Must the "addendum" or "comparison" report also be provided to the referring health care provider and the patient, even if there is no change in the final assessment category or recommended course of action?
  8. A facility performs non-mammographic breast imaging studies on the same day as the mammographic examination. Must the facility issue a separate mammography report with its own final assessment category and recommendations, or can the facility issue a combined report whose final assessment category and recommendations represent the overall assessment of all the breast imaging studies performed that day?
  9. Our interpreting physicians send out reports and lay summaries under their own letterhead. Must the certified facility performing the examination be identified on the report and lay summary?
  10. Must the radiologic technologist performing the mammogram be identified in the mammography report and lay summary?
  11. Does the lay summary have to be signed by the interpreting physician?
  12. Does the lay summary have to have a final assessment category?
  13. What assessment category should be used for post lumpectomy patients, whose mammograms are otherwise negative?
  14. Is the use of an assessment code (e.g. 0, 1, 2, 3, 4, 5 or N, B, P, S, M, A) without the wording of the assessment category (e.g. Negative, Benign, etc.) sufficient to satisfy the reporting requirement?
  15. We provide assessment categories for each breast (or for each lesion) of the examination. Do we still have to provide one overall assessment category for the entire examination?
  16. When we assign a negative assessment to the mammography report, our reporting system automatically generates a normal lay summary. We have patients that have negative mammograms but for other reasons we want that person to have further work-up or even biopsy. In such cases can we assign a different assessment category to the mammography report so the correct lay summary automatically goes out? Can the medical report and lay summary have recommendations that are not the ones normally associated with a specific assessment category?
  17. Under new Centers for Medicare and Medicaid Services (CMS) guidelines, we can now charge for screening and diagnostic exams done on the same patient on the same day. Can we combine the two exams into one report or must we issue two separate reports?
  18. The American College of Radiology Breast Imaging Reporting and Data System (BIRADS) suggests that facilities subdivide the “Suspicious” assessment category into one of three subcategories (4A-Low Suspicion for Malignancy, 4B-Intermediate Suspicion for Malignancy, and 4C-Moderate Concern but not Classic for Malignancy). Can facility reports use these subcategories instead of the “Suspicious” assessment category?

 

 

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