Negligence in Interpretation of Pap Smears

What Can Go Wrong Sometimes Does
A True Story

The following case, recently concluded, embraces virtually every breach of principles of practice for which a cytopathologist and laboratory can be held liable in the processing of Pap smears.

In October 1991, a 25-year-old patient completed her eighth office visit with a gynecologist since October of 1988. During this course she was attended by three different offices of gynecologists (each in a different office). Neither of her last two gynecologists requested records from the immediately preceding gynecologist. HGSIL was reported on a Pap smear in October of 1988 and colposcopy was recommended. The patient's second gynecologist, though aware that a prior Pap smear was abnormal and had resulted in a previous recommendation for colposcopy, instead performed cryotherapy. He did not perform a colposcopy until February 1990. In spite of an aceto-white lesion of the cervix being present at the time of that colposcopy, no biopsy was taken. Soon after, gynecologist "2" retired.

In June 1990, Gynecologist "3" received a history of abnormal Pap smears and a colposcopy and regrettably assumed, without asking, that the colposcopy which had been related to him historically had been accompanied by a biopsy and appropriate follow-up (in fact, this had not occurred).

In October 1991, Gynecologist "3" submitted a Pap smear to a laboratory that had never previously reviewed cytology or tissue of this patient. The Pap smear was submitted with the requisition shown in Figure 1. The gynecologist did not fill out this requisition and the clerical personnel of the gynecologist's office who completed the requisition did not secure accurate history from the patient's chart. Therefore, the clerical personnel erroneously recorded that there had been a previous Pap smear in June of 1990, which was negative. In fact, there was a Pap smear in June of 1990, which was interpreted as "ASCUS seen in a less than optimal specimen due to the absence of endocervical component." The clerical personnel also failed to record upon the requisition that there were obvious historical risk factors for cervical cancer.

The Pap smear specimen was routinely screened by a cytotechnologist, who interpreted the Pap smear as ASCUS. This technologist, unaware, because of the deficient requisition, of the patient's high-risk status, exercised discretion and did not request rescreening by the cytotechnologist supervisor or a pathologist. Instead he issued a report containing no recommendation as to follow-up.

Though Gynecologist "3" received the report indicating ASCUS and recognized the need for a colposcopy, colposcopy was not performed. In December 1992, the laboratory received from Gynecologist "3" a further Pap smear specimen of this patient accompanied by the requisition illustrated in Figure 2. The form of requisition illustrated in Figure 1 had, by this time, been modified by the service laboratory . The earlier requisition (Figure 1) was interpreted by the laboratory involved as negative for risk factors only if the requester checked "no" for "risk factors present for cervical cancer." If that area of the form was blank, it was the policy of the laboratory (honored chiefly by its breach) to regard the requisition as deficient and lacking needed historical information. The laboratory supervisor became concerned that so many requisitions were left blank under "patient history" and that it would appear that they were rendering interpretations on many slides without adequate history. The requisition was therefore changed so that, if left blank, the form was interpreted as affirmatively declaring that the history was negative. This remarkable logic obviated the need to contact the gynecologist's office to secure a history when the question was left blank.

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