#outcomes: What data are facilities responsible for collecting and reviewing?

QUESTION:

Based on what we understand, the practice must make every reasonable attempt to obtain an actual follow-up "outcome" on the disposition of all positive exams, which includes correlating pathology results with the physician's report made at their site. Is it true that this information must be used to calculate all quality indicators?

ANSWER:

Under the current and amended regulations, facilities are responsible for establishing a system to collect and review outcome data for all mammographic examinations performed, including follow-up on the disposition of all positive mammograms and correlating pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility [see 21 CFR 900.12(f)(1) of the amended regulations]. Additionally, the amended regulations will require analysis of the medical audit outcome data to include, at a minimum, a determination of the following:

• Positive predictive value – percent of patients with positive mammograms who are diagnosed with breast cancer within one year of the date of the mammographic exam.
• Cancer detection rate – of the patients examined with screening mammograms who received an assessment of "Incomplete: Need additional imaging evaluation," "Suspicious," or "Highly Suggestive of Malignancy" on the screening mammogram or on a subsequent diagnostic mammogram, the number of patients who are diagnosed with breast cancer within one year of the date of the initial screening mammogram, expressed arithmetically as a ratio per 1,000 patients.
• Recall rate – percentage of screening mammograms given an assessment of "Incomplete: Need additional imaging evaluation."

All information in this answer and all others are sourced from the MQSA Hotline at +1 (800) 838-7715. For other questions, contact Mammologix or the MQSA Program directly!