Case Study
Cancer, Death After Mistakenly Told Biopsy Normal
Description
A 53-year-old woman died from endometrial cancer after a biopsy report indicating insufficient tissue for diagnosis was mistakenly relayed to her as “normal.”
Key Lessons
- Individual clinicians must understand their role and responsibilities regarding test results and follow-up care in order to prevent serious patient consequences.
- Physicians are responsible for personally reviewing abnormal results from studies they order, and ensuring that the results and next steps are pursued in a timely way and are documented in the medical record.
- Office practice processes and policies must be developed to reliably deliver all test results to the ordering clinician for review, and communicate results (especially abnormal results) to the patient.
Clinical Sequence
A 53-year-old post menopausal female on hormone replacement therapy (> 10 years) presented to her PCP and NP several times for vaginal bleeding and pain during intercourse. The patient was treated for vaginitis, and she was referred to her gynecologist for further evaluation. She presented to her primary gynecologist three times over a six-week period with complaints of vaginal spotting. A pap smear was normal. A pelvic ultrasound showed widening of the endometrial stripe. The patient had a 16 mm stripe (normal range < 4 mm, with > 8 mm suggesting hyperplasia). Due to the abnormal bleeding and abnormal ultrasound findings, the gynecologist recommended an endometrial biopsy.
The patient deliberated a few days before deciding to have the biopsy. A covering gynecologist did the procedure because the primary gynecologist went on vacation and the patient wanted it done before she herself left for a trip. After the biopsy was completed, the gynecologist advised the patient to follow-up with her primary gynecologist when she returned.
The pathology report noted blood, mucous and scant endocervical epithelium, with immature squamous metaplasia and glycogenated squamous epithelium (normal cervical findings). However, the report also indicated there was no endometrium present (purpose of test was endometrial biopsy), indicating the tissue was insufficient for diagnosis.
Upon receiving the results, the gynecologist who performed the biopsy forwarded them to the patient’s primary gynecologist without personally reviewing the contents. When the patient called urgently for her results prior to her trip, a nurse practitioner at the health center located the report; upon seeing “normal cervical findings,” she interpreted it to mean the biopsy results were normal. The NP advised the patient of the “normal” result and documented it in the patient’s chart. She also included the result and the patient communication in an e-mail summary for the primary gynecologist when he returned.
Upon his return, the gynecologist saw the message from the NP and did not personally review the pathology report itself, assuming the covering gynecologist who did the biopsy reviewed the formal report. As a result, the biopsy was not repeated, and both the provider and the patient pursued the symptoms no further than the differential diagnosis of uterine lesions.
A year later, the patient was at a well visit with the primary gynecologist, and she mentioned continued vaginal spotting, which she “got used to.” Another pelvic ultrasound showed an endometrial stripe of 23 mm with bilateral ovarian masses. A repeat endometrial biopsy showed stage III adenocarcinoma of the uterus with metastatic ovarian cancer. The patient underwent a hysterectomy, bilateral oophorectomy, omentectomy followed by chemotherapy and radiation therapy. She eventually developed pulmonary metastases and died from the disease.
Claim Sequence
The patient’s family sued the two gynecologists, her PCP, and the NP, alleging negligence for a two-year delay in diagnosing her endometrial cancer, leading to her premature death.
Disposition
The case was settled for more than $1 million.
Analysis
- It was unclear who was responsible for review and follow-through once the pathology report was available; the primary gynecologist did not read the formal pathology report, and did not discuss the case further with the colleague who performed the biopsy.
A physician performing a diagnostic test is responsible for receiving and checking the results, as well as either following-up directly with the patient or with the referring provider. A referring physician who continues to follow a patient for the problem that gave rise to the referral, has a responsibility to read the full pathology report, not just a note in the chart by someone else. Lack of communication between providers can lead to confusion and misunderstandings as to who is responsible for coordinating the patient’s care, which can lead to important findings falling through the cracks, and ultimately to missed or delayed diagnoses. Office practices need clear communication policies and procedures regarding handoffs with specialists or covering providers. These protocols should outline each provider’s responsibilities so that outstanding issues don’t get overlooked. In addition, reliable office systems to track and reconcile test results require ordering physicians to review the result before it can be filed.
- The NP responded to an insistent patient, misinterpreted the pathology report, and told her the results of the biopsy were normal. Physicians are increasingly pressed for time with ever-growing patient panels and the subsequent bombardment of studies. Many office practices have responded by trying to alleviate some of the burden, asking nurses within their practice to communicate many of the test results to their patients. Office practices need clear guidelines around these communications. These would include who should be designated to have these conversations; their necessary qualifications; when it is appropriate for nurses to take on this responsibility, etc. A distinction between routine and significant lab reports should be clear, and the threshold should be very low for putting formal pathology reports in front of the physician before communicating findings to a patient.
- The biopsy was not repeated, and an assumption of a benign cause of the patient’s abnormal vaginal bleeding and enlarged endometrial stripe was carried forward for more than a year without further evaluation.
Abnormal findings and continuing symptoms should be explored until a definitive diagnosis is made. Closer monitoring may be required in the mean time. Non-resolving symptoms are a cue for providers to reassess clinical indicators and laboratory findings or to pursue additional studies and consultations.
- Experts for the defense could not support the care provided by the primary gynecologist, and reviews were mixed regarding the involvement of the covering gynecologist. The experts agreed that it was the primary gynecologist’s responsibility to read the pathology results and schedule a repeat biopsy.
Juries tend to support physician defendants when presented with evidence that they did what any other qualified physician in the same specialty would do. Without supportive expert reviews, a monetary settlement with the plaintiff is more likely to be in everyone’s best interest.
This page is an excerpt of a full issue of Insight.
CME: The Massachusetts Board of Registration in Medicine has endorsed each complete issue of Insights or 30-minutes of podcast episodes as suitable for 0.5 hours of Risk Management Category 1 Study in Massachusetts. You should keep track of these credits the same way you track your Category 2 credits.See More MPL Cases
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