The American College of Radiology designed the Breast Imaging Reporting and Database System (BI-RADS) lexicon in 1993 as a way to standardize breast imaging interpretation and reporting. Part of the goal of the BI-RADS system was to reduce confusion among referring physicians when they received breast imaging reports that were unclear about the radiologist’s recommendations for the patient. However, several recent cases handled by Martin Clearwater & Bell LLP suggests that, 27 years later, some healthcare providers may still be confused about the meaning of the BI-RADS classification, specifically that of the BI-RADS 0 category.
The BI-RADS lexicon attempts to standardize the way in which radiologists report the results of breast imaging studies. Under BI-RADS, the radiologist reports the results of an imaging study under one of six categories. Each category has a specific meaning with recommended follow-up.
The most commonly used categories are BI-RADS 1 to BI-RADS 5. The classifications for these categories are as follows:
- Category 1: Negative
- Category 2: Benign finding(s)
- Category 3: Probably benign finding(s); short-interval follow-up suggested
- Category 4: Suspicious abnormality; biopsy should be considered
- Category 5: Highly suggestive of malignancy; appropriate action should be taken
A BI-RADS 6 classification represents a known, biopsy-proven cancer. On the other end of the spectrum, the BIRADS-0 category represents an inconclusive study that requires additional imaging or comparison with prior imaging for complete evaluation.
Most BI-RADS 0 results do not result in a diagnosis of cancer. Approximately 10% of women who undergo a mammogram require additional testing. Only a small fraction of those women will require biopsy, and the overwhelming majority of those biopsies return benign results. In other words, most BI-RADS 0 mammograms will eventually turn out benign. Some, however, eventually reveal breast cancer. While no patient wants to receive a breast cancer diagnosis, those unfortunate patients will understandably want the diagnosis rendered as early as possible. A perceived delay in diagnosis often results in litigation against the radiologist and the referring physician.
Learning from Experience
Our firm has handled at least two cases in recent years where the referring physician did not coordinate further imaging for their patient who underwent a screening mammogram that our radiology clients categorized as a BI-RADS 0 result. We infer that the referring physician either did not read the radiology report or, more likely, did not understand the significance of the BI-RADS 0 result. In fact, the referring gynecologist in one case documented in the chart that she spoke to the patient about her “normal mammo.”
A BI-RADS 0 breast imaging study result is not normal. Unlike a BI-RADS 3 classification (which represents a probably benign finding requiring short interval follow-up), the BI-RADS 0 category is used when there is not enough information for the radiologist to formulate a final assessment on the imaging study. In simple terms, the radiologist needs additional testing or comparison to prior imaging before making a final determination. Part of the referring physician’s job is to act on it.
A women’s health professional ordering breast imaging studies must understand the meaning of a BI-RADS 0 result and act upon it accordingly. Although the radiologist or radiology facility will issue a letter to the patient with the results, the referring physician has a responsibility to coordinate care, communicate the need for further testing to the patient and, often, order it. When the referring physician does not understand the significance of a BI-RADS 0 result and fails to ensure that the patient undergoes additional testing, there may be a delay in follow-up testing. This in turn has the potential for a delayed diagnosis of cancer. That delay in diagnosis may result in a lawsuit. A proper understanding of breast imaging study results, followed by appropriate action on those results, may mitigate the risk of becoming a defendant in a lawsuit. Thinking that a BI-RADS 0 result was normal or that no follow-up was required will not be a viable defense.
Daniel L. Freidlin, Partner, is an attorney at Martin Clearwater & Bell LLP where he focuses his practice on the defense of medical malpractice matters. For more information, visit mcblaw.com.