Description

A 39-year-old female complained of a breast lump to her OB/Gyn, who then ordered a screening mammogram that was read as normal. A year later, the patient was diagnosed with a Stage IV, invasive, ductile breast cancer in the area of her original complaint with metastasis also noted.

Key Lessons

A comprehensive and up-to-date history (patient and family) is crucial in determining a patient’s potential risk factors and need for rigorous screening.
Imaging studies should be ordered when the clinician cannot concur with the patient’s complaint.
When ordering breast imaging, the request forms should include the reason for testing, including any patient complaints or physical findings that require a diagnostic—not a screening—mammogram.
Patients should be instructed on how to accurately complete patient questionnaires.
When results of testing are inconclusive or questionable, the patient complaint should be pursued until a definitive diagnosis can be made.

Clinical Sequence

A 39-year-old female went to see her OB/Gyn after noting a lump in her left breast while showering. During that visit she explained to her physician that she was concerned because she just had a friend die of breast cancer. The physician performed a breast exam. Finding no abnormalities, he ordered a screening mammogram (breast care guidelines suggest routine screening begin at age 40).

Three months later, the patient went for her mammogram. Even though she had identified a lump, she completed the radiology questionnaire by marking the "no abnormalities" box, because her physician had not identified any on exam. The screening mammogram results noted the following: "very dense stromal pattern, which reduce the sensitivity of the study for detection of cancer; there is no focal abnormality or other findings suggestive of malignancy – recommendation: annual screening".

The patient next visited her physician three months later, when she thought she might be pregnant. At that time, the physician did not review the results of the mammogram, nor did he examine her breasts or inquire as to whether the patient had noticed any other changes.

Six months later, the patient returned to her physician for her routine annual exam. She told her physician that she could still feel the lump in her breast, and that her periods had become irregular. Examining the breasts during this visit, the physician noted a suspicious area in the patient’s left breast. A surgical consult and ultrasound detected a 2.5 cm mass. Mammogram, biopsy, MRI and laboratory testing [estrogen receptor (+) and progesterone receptor (+)] revealed a Stage IV, invasive, ductile breast cancer with metastasis to her spine. Upon further investigation it was noted that the patient had a fairly strong family history of breast cancer; a maternal aunt was diagnosed at age 50 and a paternal cousin was diagnosed at age 36. Prior to this, a family history of breast cancer had not been documented.

The patient has since undergone a radical mastectomy with axillary dissection, radiation therapy, chemotherapy and a bilateral oopherectomy. She has also sustained multiple compression fractures due to the metastasis to her spine.

Allegation

The patient sued the radiologist and radiology center that conducted the mammogram when she first complained to her OB/Gyn about a lump, alleging a delay in diagnosing her breast cancer that led to a poor prognosis.

Disposition

This case was settled in the high-range.

Hyperlinks

Analysis

Clinical Perspective

When the patient complained of a self-identified breast lump, her physician ordered a routine screening mammogram, leading to inadequate imaging, evaluation, and follow-up of a breast problem.
According to the CRICO/RMF Breast Care Management Algorithm (and others), a women 30 years or older with complaints of a breast lump should receive a “diagnostic” mammogram rather than a “screening” mammogram. Even without the physician’s knowledge of a family history or his/her confirmation of a lump on physical exam, the work-up should be aggressive until the complaint is resolved.
Pertinent clinical information was not included on the test request.
When ordering imaging studies or consultations, providers should include on the request forms all pertinent information regarding the reason for testing/consult and any significant patient complaints or physical findings. A patient’s history of feeling a lump in her breast—as well as the location of that lump—should be noted on the imaging request. This alerts the radiologist to the fact that a diagnostic study, rather than a screening study, should be performed.

Patient Perspective

The plaintiff stated that, when she went to see her physician, she was emotionally distraught at the thought she may have breast cancer because a close friend of hers had just died of the disease. She felt that her distress at the time may have colored her physician’s assessment of the situation, leading him to discount her complaint in light of her age and no knowledge of her family history.
Physicians need to be cautious about sending the wrong message to a patient when reassuring them that a breast complaint is probably not cancer. They should stress that a variety of studies may be warranted until a diagnosis can be made, encourage the patient to communicate any ongoing concerns to the physician, and follow-up as recommended.
The patient explained that she had chosen the “no abnormality” response on the imaging questionnaire because her physician had examined her breasts and found nothing unusual. The physician’s inability to palpate a lump on physical exam falsely reassured the patient that there wasn’t a problem. The guidelines require an aggressive work-up of all breast lumps, even when the physician doesn’t concur with the patient’s complaint.
When patients are asked to complete a medical form/questionnaire they should first receive instructions about the purpose of the form/questionnaire and how to best answer the questions, given their unique circumstances. Health care professionals should not take for granted that their intent is self-explanatory. People, due to their various backgrounds, cultures and education, may interpret them very differently.

Risk Management Perspective

The physician failed to obtain a complete and up-to-date family history, which included a paternal cousin who was diagnosed with breast cancer at age 36 and a maternal aunt diagnosed at age 50.
A patient’s family history often provides the first clues that he or she may be at high risk and is in need of more rigorous screening and assessment of complaints. Under the CRICO/RMF Breast Care Management Algorithm, a patient with a strong family history of breast cancer would receive annual clinical breast exams and annual mammography 5-10 years earlier than her youngest affected relative.

Family histories must also be routinely updated because the facts can change or come to light after an initial history is taken. Offices can assist providers by putting processes in place that prompt them to obtain vital information. This can be done either by using paper or electronic templates for documenting assessments or by providing patients with self-administered questionnaires to be reviewed by the provider during the encounter.
When the patient thought she might be pregnant she returned to her physician’s office. At that time the physician failed to review the results of her mammogram with her, examine her breasts or inquire as to whether she had noticed any other changes.
Follow-up of previous complaints is important to the coordination of patient care and to ensure that things don’t fall through the cracks. Keeping an active problem list can help physicians remember 1) a patient’s previous complaint(s) and 2) to inquire as to whether or not it has resolved. This should also prompt the physician to document its resolution, or if not resolved, to decide what, if anything, still needs to be done.

Legal Defense Perspective

The misinterpretation of the screening mammogram, the inadequate family history, and the delay in ordering the most appropriate diagnostic studies in this high-risk patient made the case difficult to defend, and the case was settled prior to going to trial.
Various elements of inappropriate care can lead to a claim and payment, including inadequate patient assessment and ordering of appropriate tests, incomplete documentation, inadequate follow-up and misinterpretation of studies. The patient chooses whom to sue.