A 52-year-old woman was diagnosed with breast cancer 20 months after a screening mammogram and nine months after first being seen by her PCP for an infection around her armpit.
- Test tracking systems should include steps requiring the ordering MD to review and sign all results before they can be filed.
- The presence of a lump or area of concern prompts a diagnostic mammogram, not a screening mammogram.
- A non-specific finding and inconclusive mammogram in the presence of a palpable mass requires further workup with ultrasound.
- Missing or incomplete documentation can impede both patient care and the defense of a malpractice claim.
A 52-year-old mildly obese woman with a history of hypertension and fibrocystic breast changes was seen by her PCP for a physical exam. The patient had had yearly screening mammograms, which were negative, and she had no family history of breast cancer. The physician noted in the chart “multiple nodularity” of both breasts, but did not indicate the nodular findings were significant. A (previously-scheduled) screening mammogram conducted the following month showed no changes in the patient’s breasts.
One year later, the patient was seen again by her PCP and diagnosed with hidradenitis (a chronic, pus-producing disease process caused by obstruction of the hair follicles and secondary infection and inflammation of certain sweat glands). The PCP did not document his findings in the chart. The patient was treated with antibiotics, and returned 10 days later, when the PCP noted “hidradenitis improved.” No breast exam was documented at either visit. The patient already had an appointment for a prescheduled screening mammogram one month later.
The mammogram requisition form, under clinical history, noted “large increase left breast tissue 12:00 as opposed to right,” and the box next to the question Have you or your physician felt a lump in your breast? was checked YES (on the patient’s previous screening mammograms, this question was checked NO.) The mammogram results were reported as normal. The physician did not initial the hard copy to indicate he had reviewed the screening mammogram report, nor did he mention the findings in the medical record. He did not discuss with the patient the increased breast tissue and presence of a lump that were mentioned on the requisition form and the hard copy of the report.
Seven months later, the patient was again diagnosed with hidradenitis, which resolved with antibiotics. On exam, the PCP noted a large node on the left axilla. When the nodes persisted during two re-examinations over the next four weeks, the patient was sent for a diagnostic mammogram followed by a biopsy. She was diagnosed with inflammatory breast cancer and underwent aggressive treatment. She died four years later at age 56.
The patient’s estate sued the PCP and the radiologist, claiming that negligent failure to diagnose and treat the breast cancer earlier resulted in the patient’s death.
DispositionThe suit was settled during trial for more than $1 million.
- Experts reviewing this case found that the mammogram nine months before the cancer diagnosis was of poor quality (one of the views was overexposed and poorly compressed.)
Providers who refer patients to a specialist for evaluation depend on the expertise of the consultant and may rely on the conclusions for diagnoses or to determine treatment strategies. The radiologist who read the film could have asked for repeat films due to the poor imaging technique. Also, given the indication on the requisition that a lump was felt and there was an increase in breast tissue on one side, the radiologist should have recommended follow up with a diagnostic mammogram and, depending on the results, ultrasound.
- The PCP denied feeling a lump on the physical exam preceding the final screening mammogram; however, presence of a lump was clearly stated on the requisition form in the final report of the screening mammogram that the physician received.
A careful read of test results can reveal unexpected issues for follow-up. A prescription pad page from the PCP’s office was in the report with the words “Attention left breast 12 o’clock.” The PCP stated that he had felt no lump during the physical exam. However, he could have contacted the patient after receiving the hard copy results of the screening mammogram to explore why the mammogram order said that a lump was felt. The patient could have returned for a follow-up exam so that the PCP could re-examine her, document his findings, and make appropriate recommendations for additional imaging and follow-up. When a mass is palpated, the PCP should document a thorough breast exam in the record, and state in quotes any complaints the patient may have. Use of a diagram and descriptive notes to indicate exact location of breast complaints is highly recommended. In this situation, a diagnostic mammogram—not a screening mammogram—was indicated. A negative mammogram in the presence of a palpable mass requires continued follow-up (see the Breast Care Management Algorithm).
- This patient’s primary complaint (hidradenitis) appears to have masked discrete symptoms of breast cancer. The fact that she responded well to the antibiotics helped keep the diagnostic focus narrow.
With two disease processes in close proximity of each other, the challenge is to recognize when a single complaint may be masking a second problem, and then fully evaluate, document, and follow both concerns.
- While described as “stoic” by her PCP, the patient told her sister she was concerned about the bulge in her left armpit area and the increased size of her left breast. The sister recalled that the physician repeatedly reassured her sister, the patient, (over the phone) that it was not cancer.
Physicians need to be cautious about sending the wrong message to a patient when reassuring that a breast complaint is probably not cancer. They should stress that additional studies may be warranted, and encourage the patient to communicate any ongoing concerns to the physician.
- The PCP’s documentation was sparse at best: The abnormalities of the first breast exam (multiple nodularity) were documented, but were not referenced in future breast exams. Breast exams, if any were done, preceding her annual screening mammograms, were not documented. The PCP did not document the findings that led him to diagnose hidradenitis, nor did he document that the hidradenitis resolved.
Following up on unresolved complaints is more difficult if the complaints and their resolution are not documented in the patient record. In the PCP office, additional structure is often needed to facilitate adequate documentation and reliable flow of key information. Pre-printed forms with designated areas for certain aspects of a patient exam can help. Office protocols that designate what information patients should take from the PCP to the testing facility can foster reliability. It may also be good to give patients self administered questionnaires that can be completed in the waiting room and reviewed with the patient during the visit to clarify any information that is new to the physician or requires follow-up.
- The primary care physician in this case did not have a good follow-up system for ensuring that test results were received and reviewed with the patient. He stated that, typically, a patient calls within a week of the test and if there is no written report back, they call for the results and call the patient back.
A tracking system should ensure notification of test results to the patient and ensure that all hard copies of results are initialed by the physician before being filed. The system should also require documentation that results have been communicated with the patient.
- Incomplete documentation compromised the defense of the care this patient received. Although the physician stated he did do a breast exam at each visit, there is no clear documentation to support that.
For a claim to be considered defensible, the documentation must support the decision making process. Information not in the medical record is often more troublesome than what is recorded. Document any information that led to a diagnosis, treatment, or follow-up plan.
- The office had no records of phone conversations and no written policy or procedure regarding phone calls.
A log of patient calls can be used to document patient concerns and resolution of problems.