| Contact us | Sitemap | Feedback | HOME |
|
 |
 |
 |
 |
 |
 |
 |
| Failure to diagnosis Clinical presentation Approximately 10 months following her annual exam, the patient contacted the gynecologist’s office complaining of bleeding and cramping during intercourse. She was instructed to contact them if it happened again. One month later, she again contacted the office with continued complaints of bleeding and cramping during intercourse. At that time, she was seen by the gynecologist, who obtained another Pap smear. This slide was evaluated by a cytotechnologist at a different pathology laboratory as normal. Over the next few months, the patient telephoned the gynecologist’s office several more times, continuing to complain of the same symptoms. The patient changed gynecologists, continuing to complain of bleeding and cramping. A colposcopy performed at that time was positive for squamous cell carcinoma with focal invasion of the cervix and lymph node involvement. She was referred to a gynecological oncologist and underwent a hysterectomy and bilateral oophorectomy. She also had radiation therapy and chemotherapy. She suffered significant sexual dysfunction secondary to the radiation therapy and surgery, which caused her vagina to be friable, inflexible, and without lubrication. Allegation• Failure to diagnose Case analysis Both Pap smears were evaluated by cytotechnologists employed by large pathology laboratories. The claim was filed against the corporations, not individual physicians. In the course of investigating this claim, pathologists responsible for administrating the pathology labs reviewed the slides and felt they would have to be considered abnormal. However, the pathologists indicated even though the slides were abnormal, they would not have interpreted the slide as indicative of cancer. The cytotechnologist who performed the second test did not refer the slide to a pathologist pursuant to laboratory protocol. The gynecologist acted appropriately in obtaining the Pap smears on a patient complaining of bleeding and cramping during intercourse. However, since the patient continued to complain of these symptoms for approximately 16 months, it can be argued that the initial gynecologist might have been more aggressive in pursuing a definitive diagnosis. The Pap test is only a screening test and has a certain number of false negatives, reported in the literature as high as 50 percent. Studies have shown that most of these are due to sampling error, with a smaller percentage due to interpretative errors. Pathology interpretations should be correlated with clinical information about the patient. Both defense and plaintiff pathology experts indicated the specimens were abnormal and cytotechnologists missed the read both times. Pathology reports indicated the presence of endocervical cells in both cases. Missed reads led to a delay in diagnosis of cancer of the cervix with subsequent delay in treatment. Two gynecological oncology experts indicated the seven-month delay definitely made a difference in the patient’s prognosis due to the fact that the lymph node involvement could have been avoided. The fact that it was not decreased her chance of survival. The oncologists gave the patient only a 50 to 60 percent chance of five-year disease free survival. This resulted in six-figure settlements on behalf of the pathology laboratories. Risk management considerationsThe doctrine of vicarious liability applies in this situation. Physicians have vicarious liability for the acts of all non-physician personnel who assist them or are employed by them. In this case, the cytotechnologists were employed by the physicians, and as such, were agents of the corporation. Therefore the corporation was liable for their acts. Prudent risk management recommendations include verification of the qualifications and credentials of personnel hired as cytotechnologists as well as developing and implementing protocols for conditions requiring referral to a pathologist. A system needs to be in place to evaluate and document the ongoing performance of individuals who do cytology screening. This should be accomplished through the re-examination of normal and negative cases, as well as feedback on the reactive, reparative, atypical, malignant or premaliganant cases. With a high number of false negatives, quality control processes may require a higher number of rechecks on Pap tests. The cytopathology lab must have documentation of each individual’s diagnostic discrepancies and corrective action taken. Ask yourself if the personnel you supervise are undersupervised or overworked. The two Pap smears in this case were performed at different pathology laboratories. Optimally, referring physicians should utilize the same laboratory for all Pap tests performed on any given patient. However, in today’s managed care environment, this is difficult as most managed care organizations have a “preferred” lab that must be utilized. This places additional responsibility on the physicians involved to appropriately evaluate cytology results, comparing them to clinical symptoms and previous cytology results. In certain circumstances it may be prudent to pursue additional diagnostic tests earlier than previously indicated.
|
|
