Published October 2009
Of interest to all physicians
In the April 2009 issue of the Information Letter, the CMPA published on risk management considerations for breast cancer screening. This article, Part 2 of the series, explores another key risk area, the diagnosis and management of patients presenting with clinical findings suggesting a possible lesion of the breast.
A 45-year-old woman presented to her family physician with a one centimetre palpable mass at the eight o'clock position in the right breast. Ultrasound confirmed the presence of a suspicious 1 cm solid lesion and she underwent an ultrasound-guided breast biopsy, revealing a high-grade invasive ductal carcinoma. She was referred to a surgeon who confirmed the mass on examination. He noted the biopsy had left a small ecchymosis in approximately the same location in her breast. He discussed the biopsy results and the surgical approach with the patient. During this discussion, he mentioned he could obtain a preoperative needle localization to increase accuracy but, since both he and the patient could easily palpate the lesion because of the small size of her breast, he felt this was not required.
The surgery took place six days later. The surgeon could not feel the lesion at the site of the incision, and so he extended the incision to remove the area he thought to be the tumour. The specimen was sent for histologic examination, and when the pathologist called the operating room to report the absence of neoplasia, the surgeon decided to cancel the planned axillary node dissection. He gave the patient this good news immediately post-operatively.
On the fourth post-operative day the surgeon received the final pathology report. It revealed a galactocele. He asked his secretary to call the patient and arrange for a post-operative ultrasound. He did not personally contact the patient.
A repeat ultrasound, done five days later, showed the lesion still present in the same location. It became clear that the original incision had been made in the inferior inner quadrant of the right breast, not the inferior outer (eight o'clock) position. The surgeon met with the patient the next day to disclose the adverse event, and at her request he transferred her to another surgeon. Two weeks later she underwent a partial mastectomy and axillary dissection. The pathology was confirmed as a high grade invasive ductal carcinoma without nodal metastasis.
The allegations in the ensuing legal action were: wrong site surgery, requirement for a second surgery, excessive scarring with poor cosmetic result and emotional distress caused by the delay in diagnosis.
The experts were critical of the surgical approach because the surgeon did not use a preoperative wire localization to confirm the location of the cancer for accurate excision. They commented that the reason the mass could not be found intra-operatively was that the incision was made in the incorrect quadrant of the breast. In the absence of expert support, this case was settled by the CMPA on behalf of the surgeon member.
In reviewing expert opinions on legal actions and regulatory authority (College) complaints related to breast cancer diagnosis, the CMPA identified which steps during the diagnosis and assessment of a potentially cancerous lesion might pose health risk for patients and medico-legal risk for practitioners. The main ones were:
- investigation and follow up of the results
- referral of a patient with a clinical mass or with a suspicious lesion identified on imaging to an appropriate specialist, if indicated, to confirm the diagnosis
- sampling a suspicious lesion by needle or surgical biopsy, or fine needle aspirate for cytology
- technical preparation and interpretation of a pathological specimen
This case reveals just one of several potential ways the diagnosis and management of breast cancer can be problematic.
The CMPA reviewed 164 files related to the diagnosis of breast cancer that were concluded (closed) during the period of 2003 to 2007. A previously published article examined the medico-legal issues associated with the eight cases related to breast cancer screening. In this second article, the remaining 156 cases are reviewed and focus on the diagnostic management once a lesion is suspected.
Of the 156 closed legal files and College complaints related to the diagnostic management of breast cancer during the period of 2003 to 2007, 86 were legal actions and 70 were College complaints.
|In the 86 legal civil cases identified, 45 per cent were settled in favour of the patient. By comparison, only one third of the cases in the overall CMPA experience conclude with a settlement for the plaintiff (patient). (Figure 1)
Of the 70 College complaint cases identified, 41 cases (58.5%) resulted in either a caution or disciplinary action against the physician, or the physician's voluntary resignation. (Figure 2)
|In this study, family practitioners were assigned at least some responsibility for the care in 39 per cent of both the legal and College cases, while general surgeons were assigned in 23 per cent and diagnostic imaging specialists in 11 per cent. (Figure 3)
Thirty-six per cent of the patients had some degree of permanent physical disability and experts believed 17 per cent likely died prematurely as a result of the delay in the diagnosis.
The diagnostic management process
The most significant clinical issue noted in this review was the omission of or delay in performing a specific diagnostic test or procedure, most frequently a mammogram, breast ultrasound, biopsy or manual breast examination. In one such case, experts were critical when a surgeon aspirated a suspicious solid lesion and, even though the sampling was bloody, then suggested excision was only required if the lesion grew in size. Neither further investigations nor a follow up appointment were arranged. This resulted in a 12 month delay in the diagnosis of the cancerous lesion.
The second most common clinical issue identified from the studied cases was related to misinterpretation of the diagnostic tests or specimens, namely: mammograms, ultrasounds or pathology specimens. Recognizing that these lesions can be difficult to identify, experts were critical in cases where, upon careful review, it was clear that the lesion should have been recognized on previous studies.
The third most frequent contributing factor to the delay in the diagnosis of breast cancer was failure to follow up the recommendations within the pathology, mammogram or ultrasound reports. Experts were especially critical of physicians who received an abnormal investigation result and presumed that the other treating physician would contact the patient to inform her of the result or the need for additional follow up. Experts suggested team members should clearly establish who is responsible for arranging follow up, including ordering further or repeat investigations.
Experts also commented on other high risk areas of the diagnostic work-up, such as the issue of sampling of the lesion, as was illustrated by the case presented at the beginning of this article.
All steps in the management of a suspicious breast lesion are important to reduce a potential delay of diagnosis with possible physical or emotional implications for the patient. Timely and clear communications with the patient and other involved physicians, and proper documentation and follow up of results can reduce the risk to patients and associated medico-legal issues.
Manage your risks
Following a review of the expert opinions on the legal files and comments from Colleges, the following risk management considerations were identified:
- Have you informed the patient of the possible diagnosis or differential diagnosis when the clinical examination has identified a suspicious breast lesion?
- Have you requested the appropriate investigation? Is the test available in a timely manner? If not, have you considered alternatives and discussed this with the patient?
- Have you provided the available relevant information to any consultant from whom you sought advice (i.e., the radiologist, surgeon or pathologist)?
- Have you read the investigation report carefully and considered if further investigation or referral is needed?
- Have you informed the patient of the possible diagnosis or differential diagnosis when an imaging report has identified a suspicious breast lesion?
- Do you have a system to follow up on investigations and to contact your patient with the results?
- If a biopsy of the lesion is required, have you considered techniques that might improve the accuracy of the sampling?
- When multiple physicians are involved, are the roles and responsibilities of each physician clear to the patient and to the other physicians?
- Did you inform the patient and document all steps involved in the diagnostic management of the suspected lesion?