Failure to follow up priors may create liability risk

July 1, 2005

Although it is intended to be a help, a redefined category within the Breast Imaging Reporting and Data System could prove a hindrance to radiologists. Failure to follow up patients whose screening mammograms have been assessed as a category 0 could also land interpreting physicians in legal trouble.

Although it is intended to be a help, a redefined category within the Breast Imaging Reporting and Data System could prove a hindrance to radiologists. Failure to follow up patients whose screening mammograms have been assessed as a category 0 could also land interpreting physicians in legal trouble.

The issue has taken on further significance with the release of a report on mammography quality by the Institute of Medicine in May. The IOM recommends that sites be required to follow up all patients referred for additional imaging.

BI-RADS consists of six categories, numbered zero through five. Category 0 is used after a screening exam when further imaging evaluation or prior films are needed (see chart). The category should only rarely be used when prior films are unavailable, however, said Dr. R. James Brenner, director of breast imaging at the Eisenberg Keefer Breast Center in Santa Monica, CA.

"Unless you have a foolproof system of follow-up that is closely monitored, you can invite legal redress as well as problems with the Mammography Quality Standards Act if you use category 0 as a final assessment to stand in for 'waiting for old films,'" Brenner said at the National Consortium of Breast Centers meeting in March.

The MQSA requires radiologists to render a final assessment on mammography reports; category 0 is considered an incomplete assessment, he said.

"MQSA doesn't want nebulous reports going out to surgeons and clinicians. If you choose to employ category 0, do so in a very limited way and be sure to close the loop within a week," Brenner said.

The BI-RADS committee has created stringent guidelines for use of category 0, said Dr. Carl D'Orsi, director of breast imaging at the Emory Clinic in Atlanta and chair of the committee. The problem is that not everyone follows them.

Some sites that perform screening but not diagnostic studies, for example, may use category 0 as a dumping ground for cases that need follow-up. Other sites may simply lack the resources to track every patient without prior films or those who fail to return for additional studies.

The committee revised category 0 in 2004 to better define the role of prior exams in screening mammog-raphy interpretation. The new language notes that only screening exams that require review of prior films in order to make a valid assessment should be coded 0. In such cases, use of the category should be accompanied by a recommendation for suggested workup if prior films are not received.

"If you are the individual who started the process, by recommending either prior films or additional workup, you need to follow through," D'Orsi said. "If you don't, you are liable for anything that may occur because the woman did not come back for a recall."

If the IOM recommendation is adopted by Congress, it could impose a cost burden on breast imaging centers.

"There will be a lot of gnashing of teeth if that goes through, but it is still being negotiated," D'Orsi said. "It's a complex issue, but if you just follow the guidelines, it's not that difficult. The problem is that there are two competing issues: You really should follow up every patient who receives a category 0, but most sites don't have the resources to do so."

BI-RADS ASSESSMENTCATEGORIES

0: Needs additional imaging evaluation

1: Negative

2: Benign finding

3: Probably benign finding-short interval follow-up suggested

4: Suspicious abnormality-biopsy should be considered

5: Highly suggestive of malignancy-appropriate action should be taken

Source: American College of Radiology