#25: Issuing a Report with the Assessment “Incomplete: Need additional imaging evaluation” in Follow-Up to an Initial Report with the Assessment “Incomplete: Need prior mammograms for comparison.”

This alternative standard was approved on October 29, 2024, and is effective immediately. It has no time limit and all facilities subject to MQSA may use the alternative. It allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
The original standard is 21 CFR 900.12(c)(1)(v)(B), which states:

21 CFR 900.12(c) Medical records and mammography reports – (1) Contents and terminology …
(v) …
(B) “Incomplete: Need prior mammograms for comparison.” Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a follow up report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained.

The approved alternative standard is:

21 CFR 900.12(c) Medical records and mammography reports – (1) Contents and terminology …
(v) …
(B) “Incomplete: Need prior mammograms for comparison.” Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a follow up report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) or (c)(1)(v)(A) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained.