Section 325.5698. Medical outcomes audit.

A stereotactic breast biopsy facility shall establish and maintain a stereotactic breast biopsy medical outcomes audit program that complies with the following:

(a)    General requirements. A stereotactic breast biopsy facility shall establish a system to collect and review all of the following data:

(i)   Total number of procedures.

(ii)   Total number of cancers found.

(iii)   Total number of benign lesions.

(iv)   Total number of stereotactic breast biopsy needing repeat biopsy.

(v)   Total number of complications.

(b)   Frequency of audit analysis. The facility's first audit analysis shall be initiated not later than 12 months after the date the facility becomes registered with the department, or 12 months after the effective date of this rule, whichever date is later. The audit analysis shall be completed within an additional 12 months to permit completion of procedures and data collection. Subsequent audit analyses shall be conducted at least once every 12 months.

(c)    Audit stereotactic breast biopsy physician. A stereotactic breast biopsy facility shall designate at least 1 stereotactic breast biopsy physician to review the medical outcomes audit data at least once every 12 months. This physician shall record the dates of the audit period; analyze results based on the audit; document the results; and notify other stereotactic breast biopsy physicians of the results and the facility’s aggregate results. The audit stereotactic breast biopsy physician shall ensure that any follow-up actions are documented.

History: 2013 AACS.