Short, sourced explanations of the terms, rules, and measures behind breast imaging operations. Each one covers what it is, how it works, and why it matters.
MammoTrack is the Mammologix service pillar for tracking breast imaging follow-up. It tracks what has happened, what is supposed to happen next, and what still has not happened and needs attention [1].
How it works
Mammologix organizes patient follow-up by need, status, or timeline, and builds staff-centered views, worklists, and review-ready output in formats shaped to each facility's preferences. Tracking covers touchpoints such as assessments, biopsies, outcomes, recalls, overdue status, and prior images. Mammologix can operate independently or alongside a facility's existing EMR, RIS, or mammography system [1].
Why it matters
Staff receive ready-to-use patient status views and follow-up tools instead of digging through raw data, so they can act faster. Surfacing open and overdue items makes them harder to miss.
What it means to the patient or the client
The practice receives prepared tracking output instead of a system it must operate and build reports in alone.
Sources
Mammologix. Visible workflows. Verified follow-up. Audit-ready output. Mammologix.com. Accessed October 7, 2026. https://mammologix.com/results View source (accessed October 7, 2026)
21 CFR 900.12(f)(1) requires a facility to run a system that follows up on positive mammographic assessments and correlates pathology results with the interpreting physician's findings.
How it works
The facility must establish a system to collect and review outcome data for all mammographic examinations performed. That includes follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. The data feeds the medical outcomes audit, which is analyzed for each interpreting physician and for the facility together.
Why it matters
The rule requires follow-up on every positive mammogram, not a sample. A positive mammogram with no recorded disposition is a gap in the audit.
What it means to the patient or the client
For patients: this is why a facility keeps track of what happened after an abnormal mammogram. For the client: every positive result needs a recorded outcome, including results from outside facilities and pathology labs.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
21 CFR 900.12(f)(1) has a rule for cases of breast cancer among a facility's patients that the facility learns about afterward.
How it works
When breast cancer among patients imaged at the facility subsequently becomes known to the facility, the facility must promptly initiate follow-up on surgical and pathology results. It must also review the mammographic examinations taken before the diagnosis of the malignancy.
Why it matters
The review of earlier mammograms is part of the audit loop: it shows how the facility's interpretations related to the cancer that was later found.
What it means to the patient or the client
For the client: set up a way for outside diagnoses to reach your audit, assign the follow-up on surgical and pathology results, and record the review of the earlier mammograms.
Sources
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
No. The FDA's Small Entity Compliance Guide says facilities must give each patient a written lay summary of the mammography report for every exam, and that there is no MQSA requirement for reminder notices for routine screening or for diagnostic or follow-up imaging.
How it works
The lay summary requirement is in 21 CFR 900.12(c)(2). The facility must also follow up on positive mammograms and track outcomes for the medical outcomes audit, but the rule does not require a reminder to the patient to schedule the next exam. A facility that sends reminders, tracks overdue follow-up, or escalates unresolved cases is doing it as its own practice or under State or accreditation requirements, not because MQSA requires it.
Why it matters
Reminder and tracking programs go beyond the MQSA minimum, so their design is the facility's choice.
What it means to the patient or the client
For the client: your reminder and follow-up process is a quality decision you set yourselves, so write down its rules, timing, and who owns it, and measure it against your own targets.
Sources
US Food and Drug Administration. Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff. Issued August 26, 2024. Accessed October 7, 2026. https://www.fda.gov/media/181152/download View source (accessed October 7, 2026)
21 CFR §900.12. Quality standards. eCFR. Accessed October 7, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 7, 2026)
When a formal report of test results is unclear, internally inconsistent, or incomplete in a way that changes how it must be coded, Mammologix does not guess. The item is set aside, the specific question goes back to the client, and the item is coded only after the client answers. The deciding rule is always the best interest of the client and the patient, never speed or convenience. The formal report of test results belongs to the facility, so any interpretation of what a finding means, and any correction or addendum to the report, stays with the facility's interpreting physician or designated staff.
How it works
Mammologix names the exact point that is unclear and asks about that point alone. Examples include a missing assessment category, a laterality that does not match the rest of the report, or a recommendation that conflicts with the assessment. On the assessment point, the FDA has stated that the only authorized assessment statements are those in the quality standards and the approved alternative standards (21 CFR 900.12(c)(1)(iv) and 900.18), so a report that lacks one, or uses wording that does not map to one, is a reason to ask rather than to infer [6]. The question goes to the client's designated contact, using the communication method the client prefers. How questions reach the client, and who answers them, is the client's choice; Mammologix offers a default and carries out the client's preference. Mammologix does not infer clinical meaning to fill the gap. The client's answer is what gets coded. The question and the answer are documented, so the decision can be traced later, and an unanswered item is not treated as settled. If the answer shows that the report itself needs correcting, the correction is made by the facility through its own process. Mammologix then codes from the corrected report. Regulatory floor: Section 900.12 of the MQSA regulations carries the day to day obligations for medical records and mammography reports, including the content of the report, the written lay summary sent to the patient, and the medical outcomes audit [1]. The 2023 final rule also requires that, when the interpreting physician is aware of clinical findings or symptoms despite a negative or benign assessment, the report document and address them [6]. Those requirements are a hard floor that always rules and is never configurable. Above that floor, the way a facility wants questions handled is the facility's decision.
Why it matters
Coding a result wrongly can quietly carry an error into audit statistics, patient letters, and follow-up tracking. The FDA inspects each facility location at least annually, and the inspection covers mammography medical reports and lay summaries as well as medical audit and outcome analysis records, with the facility responsible for meeting all requirements [7]. The published literature shows how often the handoffs around reported results go wrong. In one health system's review of mammography follow-up records, transcription and reporting inconsistencies appeared in 27% of mammographic reports performed outside the system [2]. A review of follow-up to abnormal cancer screening tests found that few studies looked closely at the steps and interfaces of care, including communication between providers, and that tracking systems and patient navigation were among the interventions that worked [3]. In interviews with women who had abnormal screening mammograms, those who delayed follow-up commonly described dissatisfaction with how their results were communicated [4]. A survey of primary care providers in a large health system found that missed abnormal results, with imaging studies among the most common, caused clinically important treatment delays that are likely underappreciated as a source of diagnostic error [5]. Asking one more question at the point of coding is a low cost safeguard against all of these.
What it means to the patient or the client
For the patient: the letter you receive and the follow-up you are asked to complete are built from what was actually found, confirmed by the facility that read your exam. For the client: you stay in control of what your reports mean and how questions reach you. Mammologix raises the question, records your answer, and does not substitute its own judgment for yours.
What it means at Mammologix
This is Mammologix's own view, not a regulatory or guideline statement.
We would rather ask one more question than code one wrong answer. This matches how Mammologix describes data accuracy generally: your team remains the source of the clinical and operational data, and anything that looks incomplete, inconsistent, contradictory, or unclear can be flagged for QA review, with the team reaching back to your designated contacts for clarification or correction. Once verified information comes back, the record is updated, the logic pathways are revalidated, and the resolution is logged so there is traceability.
Sources
Quality standards. 21 CFR §900.12. Electronic Code of Federal Regulations. Accessed October 19, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12 View source (accessed October 19, 2026)
Murphy DR, Meyer AND, Vaghani V, et al. Electronic triggers to identify delays in follow-up of mammography: harnessing the power of big data in health care. J Am Coll Radiol. 2018;15(2):287-295. doi:10.1016/j.jacr.2017.10.001
Zapka J, Taplin SH, Price RA, Cranos C, Yabroff R. Factors in quality care: the case of follow-up to abnormal cancer screening tests, problems in the steps and interfaces of care. J Natl Cancer Inst Monogr. 2010;2010(40):58-71. doi:10.1093/jncimonographs/lgq009
Allen JD, Shelton RC, Harden E, Goldman RE. Follow-up of abnormal screening mammograms among low-income ethnically diverse women: findings from a qualitative study. Patient Educ Couns. 2008;72(2):283-292. doi:10.1016/j.pec.2008.03.024
Wahls TL, Cram PM. The frequency of missed test results and associated treatment delays in a highly computerized health system. BMC Fam Pract. 2007;8:32. doi:10.1186/1471-2296-8-32
US Food and Drug Administration. Mammography Quality Standards Act. Final rule. Fed Regist. 2023;88(47):15126. Published March 10, 2023. Accessed October 19, 2026. https://mammologix.com/mammolibrary/mqsa-2024-final-rule-88-fr-15126 View source (accessed October 19, 2026)
US Food and Drug Administration. MQSA inspection resources. Content current as of March 28, 2024. Accessed October 19, 2026. https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program/mqsa-inspection-resources View source (accessed October 19, 2026)
