What Counts as a Resolved Case: The Documentation Standard Your Audit Depends On

The medical outcome audit assumes you know what happened to every patient you called back.

In a perfect audit, each woman who returned for additional imaging, received a biopsy recommendation, or had a needle placed has a documented outcome. The pathology report arrived, or the diagnostic workup was negative, or the surveillance interval concluded without findings. The case is closed. You know whether she was a true positive or a false positive, and you can count her.

Most audits are not perfect. The question is what to do with the cases that are not.

What the regulation requires

The Mammography Quality Standards Act requires facilities to maintain a medical outcomes audit that tracks the outcomes of positive assessments. The FDA specifies this at 21 CFR 900.12(f), and the requirement has been in place since the original MQSA went into effect.¹

What the regulation does not specify, precisely, is when a case is considered resolved. The ACR BI-RADS Atlas provides the practical framework most facilities follow.²

The three clocks

Follow-up does not happen on one schedule. BI-RADS assessment categories create three different resolution timelines, and your documentation system needs to track all three.²

Category 0 cases resolve at the diagnostic workup. When the additional imaging is complete and an assessment is issued, the outcome of the screening examination is known. If the diagnostic workup results in a negative assessment, the screening recall is a false positive. If it results in a biopsy recommendation, the case moves to the next clock.

Category 3 cases resolve at the surveillance interval return, typically four to six months. A woman who returns, has her interval imaging read as stable or improved, and is returned to routine screening is a false positive for the original screening examination. A woman who does not return is not yet resolved.

Category 4 and 5 cases resolve at tissue diagnosis. The biopsy pathology report determines whether the finding was malignant or benign. A woman whose biopsy is not performed, or whose pathology report cannot be obtained, is not yet resolved.

The unresolved case is not a false positive

This is the point that costs facilities the most in audit accuracy.^3,4

When a patient is lost to follow-up, does not return for her interval imaging, or has her biopsy performed at another facility and the report never reaches you, she is unresolved. She is not a false positive. She is not a true positive. She is a case you cannot audit at all, and she cannot contribute to any of your denominators.

The practical consequence is not neutral. An audit built on a partial denominator produces a positive predictive value that cannot be compared to published benchmarks. If the unresolved cases are systematically drawn from a specific BI-RADS category or a particular radiologist's reads, the distortion is not random. The practice looks either better or worse than it actually is, depending on which direction the missing data pulls.

What documentation is actually required

A resolved case needs a documented outcome, not just a documented attempt. Sending a letter is not resolution. Leaving a voicemail is not resolution. Resolution requires a known outcome: the workup result, the surveillance return, or the pathology report.

The ACR recommends that facilities actively pursue outcomes for cases that have not self-resolved.² For Category 0 cases, the diagnostic facility should be contacted if internal records do not show a return. For Category 3 cases, outreach at the expected return window is the standard practice. For Category 4 and 5 cases, obtaining the pathology report, even when the biopsy was performed elsewhere, is necessary for the case to count.

Facilities that document attempts without documented outcomes will find, at inspection, that those cases cannot carry audit weight. The MQSA inspector is not required to give credit for effort.

The starting point

Count your unresolved cases before you report your audit numbers. If more than five to ten percent of your positive assessments from the audit period have no documented outcome, your denominators are soft and your positive predictive values are unreliable.

That is not a failing grade. It is a measurement problem, and measurement problems are fixable. The fix starts with knowing the size of the gap.

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References

1. Mammography Quality Standards Act and Program. U.S. Food and Drug Administration. Medical outcome audit requirement at 21 CFR 900.12(f). Accessed August 2026.
2. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System, 5th edition. American College of Radiology; 2013. Follow-up and Outcome Monitoring section. Establishes assessment category resolution timelines and documentation standards for the medical outcomes audit.
3. Linver MN, Osuch JR, Brenner RJ, Smith RA. The mammography audit: a primer for the Mammography Quality Standards Act (MQSA). AJR Am J Roentgenol. 1995;165(1):19-25.
4. Funaro K, Ataya D, Niell B. Understanding the mammography audit. Radiol Clin North Am. 2021;59(1):41-55. doi:10.1016/j.rcl.2020.09.009. PMID 33222999.

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About the Author

Richard D. Lippert Jr. is the founder and CEO of Mammologix LLC. He has more than thirty years in breast imaging program operations, is clinically trained in radiologic technology and mammography, and has tracked FDA MQSA National Statistics monthly since December 2002.