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U.S. Department of Health and Human Services

Radiation-Emitting Products

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MQSA Alternative Standard #12: Assessment category for "Post Procedure Mammograms for Marker Placement"

This alternative standard was approved and became effective on September 17, 2003. It has no time limit. This approved assessment category can only be used for a post procedure mammogram to confirm the deployment and position of a breast tissue marker. The lay summary, which must be provided to the patient, must be specific to the procedure. If the facility makes this post procedure examination part of the interventional study instead of a separately charged examination, then it does not fall under MQSA and the approved alternative standard does not apply.

The original standard is 21 CFR 900.12(c)(1)(iv), which states:

21 CFR 900.12(c)(1): Medical records and mammography reports

(iv) Overall 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 be 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...

The granted alternative is:

21 CFR 900.12(c)(1): Medical records and mammography reports

(iv) Overall 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 be 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:
(F) "Post Procedure Mammograms for Marker Placement"
(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...

 

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