Mammography is a unique subspecialty within radiology where medical
malpractice considerations are guided by both tort common law as well as
statute. The Mammography Quality Standards Act (“MQSA”) was passed by
the United States (U.S.) Congress in 1992 and requires all certified
mammography facilities to meet uniform quality standards.1,2
Among the requirements are the annual certification of mammographic
facilities, minimum reading requirements for those practicing
mammography and the requirement that patients receive specified
communications from the mammographer. These requirements may be
intimidating for mammographers concerned about malpractice liability.
However, this concern can be reduced if one knows, understands and
implements the MQSA and American College of Radiology (ACR) standards
for breast imaging into their practices, as a prosecutor representing
the plaintiff will certainly know them.
This article aims to help
the reader better understand the medicolegal aspects of breast imaging
and review steps to help in one’s daily practice of breast imaging to
reduce malpractice risk. This “risk management” is better thought of as a
vehicle to provide and enhance quality of patient care and provide
uniform policies for patients. Ultimately, this should also reduce the
likelihood of a medical malpractice liability and increase one’s ability
to defend oneself if necessary. These suggestions for reducing one’s
liabilities may exceed the standards; however, they are provided to help
reduce malpractice liability.
Missed breast cancer — perception and reality
are numerous misperceptions and misunderstandings of breast imaging
liability. In the past, “the allegation that an error in the diagnosis
of breast cancer has occurred was one of the more prevalent conditions
precipitating medical malpractice lawsuits against all physicians.”3 Approximately 5% to 17% of breast cancers are missed on screening mammography,4,5 while 75% of missed cancers can be found on previous mammogram (retrospective analysis).6 Indeed, 5% to 15% of palpable breast cancers are not revealed on mammography.7 However, the perceived risk of malpractice incidence in 5 years is nearly four times higher than the actual prevalence.8,9
a number of years, breast cancer was the number one cause of
malpractice claims, and it is still among the top 5 errors in radiology
claims.10 In the last 10 years, breast cancer case indemnity
has significantly increased. There is also an incongruity between
prevalence of breast cancer in different age groups and litigation
compensation (Table 1). Almost 70% of breast imaging malpractice cases
occur in women < 50 years of age, while the prevalence of breast
cancer is < 25% in women under 509 and 78% of indemnity
paid to women under 50. This is an often poorly understood trend that
represents a significant amount of malpractice risk. Factors that
contribute to this trend are the decreased sensitivity of mammography as
breast density increases, the aggressive nature of breast malignancy in
younger patients, and the likelihood that a jury will award a higher
dollar amount to a younger female who may have a job and young children.
The mammographer must be aware of these relationships.
Mitigating risk and providing high quality mammography
radiologist must “sufficiently evaluate an abnormal mammographic
finding.” One trial lawyer said appropriately, “you physicians practice
great medicine, but you do not document this care.” An important
consideration when treating patients is to document, document and
document in the clinical report the quality of care provided to each
patient, specifying what was done and why.
Before the exam
first step in mammography begins before evaluation of images. One must
first review the nonimaging data provided to the radiologist. This
consists of 5 steps as illustrated in Table 2. In a malpractice suit,
these steps represent areas where errors and ultimately malpractice can
The second step is to obtain previous mammograms. One must
make a reasonable effort to obtain prior mammograms, which is very
necessary if significant findings are appreciated on the current exam.
If unavailable, one should document the attempt to obtain prior
mammograms and note, “will provide addendum if made available.” An
effective method is to enlist the patient’s help by including the
following statement in the patient’s report: “Please have the patient
assist in obtaining prior mammograms as our attempts have failed. This
may preclude the patient from having additional breast imaging and/or
biopsies.” It is best that comparisons be made with previous studies
dating back at least 2 years, as subtle findings, such as slower growing
cancers and postsurgical breast changes are better appreciated.
there is the evaluation of the mammogram. Demand quality images! The
radiologist is the one ultimately responsible for the quality of the
study. If the images are of poor quality, ask for additional imaging and
document this in the report. A suggested comment is: “The current
study is inadequate due to [state the technical problem] and additional
imaging [state the views] is needed at no expense to the patient.”
Imaging a patient properly provides the highest quality care and will
reduce one’s risk. Accordingly, mammographic masses and calcifications
must be visualized and localized in different views. Reasonable attempts
must be made to determine the exact location of a mass/Ca++ on 2 views. Different methods include: exaggerated craniocaudal (“CC”), roll medial or lateral CC, and tangential views.
radiologist must also ensure an adequate viewing environment and search
pattern for reviewing mammograms as described in Table 3. It is
important that as one accomplishes the steps outlined, one is sure to
back off and look at the images. Many findings can be overlooked by not
backing off and viewing the entire current and previous mammograms. One
should do this prior to using the magnification device.
quality of the exam report is as important as the interpretation of the
examination itself, and the radiologist should assure that the report
is clear and accurate. Typos and poorly written reports give a less than
optimal impression to the clinician, patient, and members of the court.
The effect of a sloppy report in court is extremely damaging. It cannot
be emphasized enough—proofread your reports. The report should
accomplish the 3 items summarized in Table 4. Radiologists are
considered the most knowledgeable in mammography and breast imaging by
the medical and legal communities. Deferring to “clinical correlation”
does not excuse the radiologist from liability for any unreasonable
interpretation or inadequate evaluation of an abnormal mammogram.
screening exam of an asymptomatic patient will most commonly fall under
BI-RADS categories 0, 1 or 2, and rarely BI-RADS 4 or 5. One should not
utilize BI-RADS 3 for a screening exam, as these cases should be
classified as BI-RADS 0, “additional imaging needed.” Of note, BI-RADS 1
or 2 results in the same patient disposition and recommendation for a
follow-up screening exam in one year. A BI-RADS 2 (benign) is more
easily defended than a BI-RADS 1 (negative) for a finding resulting in a
medical malpractice case.
Similarly, the language of a screening
exam that is placed in BI-RADS 0 is important for your colleagues who
will be reading the follow-up diagnostic imaging. Use of language, such
as “possible,” “questionable,” and “possible architectural distortion,”
is suggested given the limited diagnostic scope of a screening exam.
This allows some “wiggle room” for the mammographer reading the
follow-up diagnostic mammogram when the questionable findings are not
reproducible or are not real. It is suggested that the use of terms,
such as “pleomorphic” or “spiculated,” in a screening exam classified as
BI-RADS 0 be used cautiously, if at all. Keeping in mind that a
screening exam is limited in sensitivity and specificity, there may be
borderline findings. However, the final impression of a mammography
report should always avoid ambiguity, which is different from an
learned judge stated that “the finding of a suspicious lesion raises
the standard of care to a level whereby direct communication with the
referring physician—beyond the issuing of the report—is required.”
Another court has found that “the communication of a diagnosis so that
it may be beneficially utilized may be altogether as important as the
diagnosis itself.”10 These common law legal precedents inform the radiologist’s duties under the MQSA and ACR standards:
there are ‘suspicious’ or ‘highly suggestive of malignancy’ results,
the facility must also make reasonable attempts to communicate the
results to the referring health care provider or a responsible designee
as soon as possible.11,12
Communications should be high
quality and verifiable. Recommendations are summarized in Table 5.
Communications that are not effective and have results in settled cases
include the generic, “A voice mail message was left for Dr. [Name] the
referring physician concerning [Findings] on [date].”13
mammographic results are not only limited to radiologist-referrer
communications. On the contrary, they occur along the entire health care
system. Some areas that one should also pay close attention to are the
handling of and reading of specimen radiographs as well as biopsy
procedures. An area of risk that is often overlooked is specimen
handling. The loss of a specimen can be catastrophic, and the
implementation of an effective chain of custody system is critical to
mitigating risk. A document that proves a specimen was received by
another department (eg: pathology) will prove critical in court.
Additionally, appropriate informed consent is an important communication
before any procedure and can be more effective with the use of a
standardized form. Table 6 summarizes our recommendations.
complete and accurate role of documentation cannot be overemphasized.
Take an extra moment to ensure a complete and accurate report, the
communication with the patient and/or referring health care provider and
the appropriate recommendations. What is written cannot be changed by
another person, and what is not written is open for interpretation,
usually different, by an opposing party. The extra minute to document
may save years of legal action and a great sum of money.
are a number of legal considerations in mammography. Beginning with
the statistics of malpractice claims, the majority of litigation and
claims occur in women younger than 50. This relationship is
multifactorial and important for the radiologist to appreciate.
Mammography in patients younger than 50 poses heightened malpractice
risks, which should be addressed by risk mitigation strategies and
high-quality mammography. These risk-mitigation strategies begin from
the first patient encounter through the evaluation of past images,
interpretation of current images, and effective communication to the
patient and clinicians. A number of strategies and practice methods were
reviewed to decrease the risk of making errors, becoming the target of
malpractice litigation and making errors that appear unfavorable in a
trial. There are more areas to explore that are outside the scope and
limitations of this article. The topic of peer review and its role in
litigation, effectively handling errors, and future modalities within
breast imaging and their impact on litigation are additional areas of
discussion. Finally, it is important to go above and beyond when
documenting your best practices in breast imaging.
- Mammography Quality Standards Act Regulations, 42 U.S.C. 263 (b).
- 2. U.S. Department of Health and Human Services, Food and Drug
Administration. Mammography Quality Standards Act and Program.
Accessed Nov 19, 2012.
- Practice standards claims survey. Physician Insurers
Association of America and American College of Radiology. Rockville, MD:
Physician Insurers Association of America, 1997.
- Majid AS, de Paredes ES, Doherty RD, et al. Missed breast carcinoma: Pitfalls and pearls. Radiographics. 2003;23:881-895.
- Buist DS, Porter PL, Lehman C, et al. Factors contributing to mammography failure in women aged 40-49 years. J Natl Cancer Inst. 2004;96:1432-1440.
- Berlin L. Dot size, lead time, fallibility, and impact on survival: Continuing controversies in mammography. AJR Am J Roentgenol. 2001;176:1123-1130.
- Barlow WE, Lehman CD, Zheng Y, et al. Performance of diagnostic mammography for women with signs or symptoms of breast cancer. J Natl Cancer Inst. 2002;94:1151-1159.
- Dick JF 3rd, Gallagher TH, Brenner RJ, et al. Predictors of
radiologists perceived risk of malpractice lawsuits in breast imaging. AJR Am J Roentgenol. 2009;192:327-333.
- Howlader N. SEER Cancer Statistics Review, 1975-2009 (Vintage 2009 Populations),
National Cancer Institute. Bethesda, MD,
http://seer.cancer.gov/csr/1975_2009_pops09/, based on November 2011
SEER data submission, posted to the SEER web site, 2012.
- Phillips v Good Samaritan Hospital, 416 NE2d 646 (Ohio App 1979).
- U.S. Department of Health and Human Services, Food and Drug
Administration. Mammography Quality Standards Act of 1992: Policy
guidance help system (updated December 1, 2010).
Accessed Nov 19, 2012.
- Mammography Quality Standards Act Regulations, 21 CFR Part 900.12(c)(2)(i),(ii).
- Katz HP, Kaltsounis D, Halloran L, Mondor M. Patient safety and
telephone medicine: Some lessons from closed claim case review. J Gen Intern Med. 2008;23:517-522.
- Physician Insurers Association of America and American College of
Radiology. Practice standards claims survey. Rockville, MD: Physician
Insurers Association of America, 1985-2009.