Allegation
The patient alleged that her physicians were negligent and fell below the professional standard of care by failing to accurately and appropriately notify the patient of her imaging results, failing to order additional imaging, failing to order or perform a follow-up clinical breast exam, failing to recommend a biopsy, and failing to make appropriate referrals. These failures resulted in a delay of treatment and the progression of invasive ductal carcinoma in the breast, causing the patient significant pain, mental suffering, and disability.
Case Details
A 41 YOF patient was referred to an imaging center by her PCP for a diagnostic mammogram due to the finding of a mass in her left breast. The mammogram impression result included a notice of a left breast lump, multiple lesions, and a breast imaging-reporting and data system (BI-RADS) assessment category 0. A BI-RADS 0 categorization indicates that critical information is missing from the mammogram and requires the referring physician, the radiologist, and the radiology facility to schedule further examination or conduct a comparison to prior mammography results.
The radiology practice sent letters notifying the patient of her need for further examination. The letters contained the patient’s inconclusive mammogram results and urged her to schedule an appointment for additional imaging studies to complete her evaluation. The practice sent two letters to the patient via regular mail, but she did not respond. A third letter was sent via certified mail, in accordance with the facility’s non-response policy, but the patient still did not respond or make contact with the practice. It was later discovered that the letters were sent to the wrong address and the patient did not receive them.
A letter with the results was also sent to the patient’s PCP from the radiology practice. However, the PCP left the patient a voice mail erroneously indicating that she did not require any follow-up appointments or further referrals.
Over two years later, the patient was examined by a physician at a different practice. She was informed that her physical exam and imaging were highly suspicious for breast cancer, and magnetic resonance imaging and a biopsy were ordered. She was subsequently diagnosed with invasive ductal carcinoma of the left breast and underwent a partial mastectomy, chemotherapy, and radiation therapy.
Expert Testimony
Defense experts did not support the PCP’s and radiologist’s care in this case. While the radiology practice followed their process and notified both the ordering physician and patient of the inconclusive results of the mammogram and the need for further imaging, the patient did not receive the notification letters due to a transposition of numbers in her address. While the patient’s PCP did receive the notification letter, he inadvertently delivered inaccurate results to the patient indicating further testing was not needed. The failure to properly notify the patient of her mammogram findings—by both the radiologist and PCP—led to a significant delay in her diagnosis and treatment, resulting in the progression of her cancer and the need for more aggressive care.
Resolution
Due to negative standard of care reviews, this case was settled.
Risk Reduction Strategies
-
Create policy for the management of all radiology exam findings, including critical, inconclusive, and incidental findings.
- Conduct regular audits to ensure that findings are managed and resolved according to policy and promptly address any process gaps.
- Educate patients about ordered tests, including why they are necessary and how the results will be communicated.
- If a patient cannot be reached by letter, alternative methods such as telephone calls, emails, or other secure communication channels should be utilized.
- Instruct patients to contact your office if they do not receive test results within a specific timeframe.
- Ensure all attempts to contact the patient, including the letters sent and phone calls made, are thoroughly documented in the medical record.
- Provide accurate patient test results. Verify that you are delivering the correct results to the appropriate patient.
- Ensure that medical records contain accurate patient demographic and contact information, including updated address, phone, and emergency contact details.
