Delay in diagnosis: cervical cancer
Clinical presentation
A woman in her mid-40s presented to her ob/gyn with complaints of backache, bleeding and discharge. She had been under this physician's care for three years, although this relationship involved routine visits with an advanced practice nurse and not the physician for annual physical examinations and Pap smears.
When this patient first came under the care of the APN, the first Pap smear was reported as "Class 2 with Reactive and Reparative Changes." She was treated with an oral antibiotic. A repeat Pap smear, five weeks later was reported as "Within Normal Limits (Class 1) and showing Squamous Metaplasia," a benign condition. One year later a Pap smear was reported as "Within Normal Limits (Class 1)." The third year's Pap smear obtained by the APN was also reported as "Within Normal Limits (Class 1)." All Pap smear reports stated that the specimens were "Satisfactory for Evaluation."
Physician action
When the patient called the office with a two-week history of backache, bleeding and discharge, the physician decided to see the patient himself. A repeat Pap smear was performed. Upon colposcopic examination, changes suspicious for malignancy were seen. Two areas of the cervical lesion were biopsied and a spinal x-ray was ordered along with a CBC and Chem 24 analysis. The Pap smear obtained on this visit showed Squamous Carcinoma and the biopsy from the two areas of the cervix revealed invading Squamous Carcinoma. The x-ray and blood tests were normal.
The physician referred the patient to a gynecological oncologist. A radial hysterectomy revealed the cervix to be completely invaded by cancer with invasion into the adjacent tissues and pelvic lymph nodes.
Allegations
Delay in diagnosing cervical cancer
Legal principle
The allegation against the physician was based on the assumption that the cancer could have been detected from one to three years earlier in this otherwise healthy and compliant patient. It was further alleged the cancer would not have progressed to a life-threatening condition if detected earlier. Since the time that the diagnosis of cancer was made, the actual Pap smear slides were reviewed by another pathologist, with the conclusion that for at least one year the slides were obvious for malignant cells, which were missed by the original pathologist.
Many of the routine functions in the ob/gyn’s office were performed by the APN with the patient's agreement. It was determined by expert consultants that the APN performed her duties properly and that she reviewed the reports with the physician in a consistent and appropriate manner. The medical record for this patient was legible, detailed and pertinent.
The argument could be made that the APN did not obtain specimens correctly or did not prepare the slides properly. The fact remains, that even if she did not, the specimens were reported by the lab as satisfactory. It is pathologist's responsibility to report an unsatisfactory specimen and to recommend a repeat Pap smear.
Neither the physician nor the APN had any reason to suspect that pre-cancerous or cancerous cells existed prior to the patient's symptomatic presentation, based on the previous Pap smear reports. At this office visit, the physician determined that he would see the patient himself instead of the APN examining the patient.
The details of this case demonstrated that the physician and APN met the usual standard of care.
Risk management issues
Obtain written consent from patients acknowledging their awareness of being treated by a nurse practitioner or physician assistant.
Document past medical history, including any pertinent information such as previous exams, diagnoses (normal and abnormal) and treatment.
Be specific with examination findings when documenting in the medical chart, ie., "No lesions visible on the cervix."
Initial and date all laboratory reports when received, being sure to note any specific action to be taken, for example "notified patient 9-9-98, appt made to repeat Pap smear on 10-9-98. LEL."
Utilize prompters in your office to alert the physician(s) and staff of the need to review diagnostic reports and follow-up with patients.
Maintain ongoing, continuing education for professional office staff that is relevant to their particular job descriptions.
Respond quickly by making appropriate referrals to a specialist when the patient's condition is outside your area of expertise.