The following case embraces virtually every breach of principles of practice for which a gynecologist-cytopathologist and laboratory can be held liable in the processing of Pap smears.
In October 2001, a 25-year-old patient completed her eighth office visit with a gynecologist since October of 1998. 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 (high-grade squamous intraepithelial lesion) was reported on a Pap smear in October of 1998 and colposcopy (inspection of the cervix with high-intensity light and magnification) 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 (removal of out layer of skin from surface of cervix by freezing). He did not perform a colposcopy until February 2000. In spite of an aceto-white lesion of the cervix being present at the time of that colposcopy, a finding requiring further testing to rule out a precancerous condition, no biopsy was taken. Soon after, gynecologist “2” retired.
In June 2000, 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 appropriately accompanied by a biopsy and required follow-up (in fact, this had not occurred).
In October 2001, 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 2000, which was negative. In fact, there was a Pap smear in June of 2000, which was interpreted as “ASCUS a cellular abnormality suggesting, given this patient’s history, the possibility of true precancerous change. The clerical personnel also failed to record upon the requisition the 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 2002, the laboratory received from Gynecologist “3” a further Pap smear specimen of this patient accompanied by requisition. The requisition was left blank as to history. The lab assumed the history was negative.
The Pap smear specimen of December 2002 was interpreted as satisfactory and within normal limits. The specimen was not rescreened. Again the accompanying requisition contained inaccurate information. The previous Pap smear of October 2001 had in fact not been normal, but had shown ASCUS. The patient had been subject to cryosurgery and had other risk factors for cervical cancer. A simple review of the service laboratory records for this patient would have revealed that there was a previous abnormal smear and, given the policies of the service laboratory, the specimen would have automatically been rescreened. This did not occur.
Figures 3, 4, 5 and 6 represent photomicrographs of the slide which corresponds to the requisition shown in Figure 2. Figure 3 presents a panoramic view photographed at low power. Near center is a flat cluster of cells demonstrating HGSIL. Figure 4 is a higher magnification of the flat cluster of cells marked in Figure 3. Figure 5 demonstrates another cluster at high magnification of HGSIL cells with overlapped nuclei and indistinct borders surrounded by LGSIL cells. Figure 6 is an HGSIL cell with large dark irregular nucleus and high N/C (ratio of the area of cytoplasm to size of cell nucleus – High N/C ratio equals large nucleus, less than normal cytoplasm – one sign of premalignant change) compared with adjacent normals.
The photomicrographs shown and discussed here are but a few of those taken of the Pap smear specimen of December 2002. Each of these photomicrographs when shown during deposition to the cytotechnologist (who became a defendant in the case) resulted in her substantial agreement with the interpretations described above. Though similar abnormal cells were numerous in the specimen, the defendant cytotechnologist asserted she obviously had not seen these cells.
There was some question arising out of the testimony in the case as to whether the cytotechnologist’s problem had in fact been a failure to locate the cells or failure to properly interpret them. Approximately a year and a half after the interpretation of the slide in question, this cytotechnologist was discharged by her laboratory. This occurred because she interpreted as negative a slide of another patient that was rescreened as showing a HGSIL suggesting invasive cancer in a patient who was later demonstrated by biopsy to have invasive cancer. The cytotechnologist’s discharge resulted from her failure, when confronted with the discrepancy, to accept that her reading of the slide as negative was inappropriate.
In this case the service laboratory had accumulated, as required by CLIA, statistical information concerning the performance of the defendant cytotechnologist and others compared to the laboratory as a whole. Over the course of 2-1/2 years of employment, the defendant cytotechnologist consistently found squamous intraepithelial lesions at a rate far below the laboratory average by a difference sometimes as great as 5 or 6 to 1. When questioned, the physician director of the laboratory, who had not recently reviewed the data, testified with a clear memory that the defendant cytotechnologist’s performance had not only been satisfactory but that the director was unaware of a single occasion when the Defendant cytotechnologist had under-read a slide. In view of the statistical analysis it is clear that the director’s recollection was faulty, but it is also perhaps not a coincidence that, in this laboratory, pathologists rescreened few of defendant technologist’s slides sometimes averaging less than 4% per month. 10% is required by Federal regulations.
Ironically, the Defendant cytotechnologist could have preserved her position by simply agreeing she made a mistake. By this laboratory’s policies, no retraining or testing was required for misreading a single slide. A laboratory cannot wait for a pattern to develop where a cytotechnologist has missed a high-grade lesion. The pattern already evident statistically raised question concerning the ability of the cytotechnologist to identify and classify neoplasia. This should have early led to a review of her negative slides and discovery of her inadequacies. A disaster would have been avoided.
The patient died in October 2007 two months before the scheduled trial of the matter, survived by three minor children, one disabled, all orphaned by her death. Her concern at the time of her death was only that her children would be provided for. The trial was not held but the suit provided the children with the means to live well in the company of and care of their uncle. This patient’s grueling struggle with invasive cervical cancer (on ambulatory morphine pump for more than a year prior to death) is a tale not often told but occurring with regrettable frequency throughout this country. The diagnosis of the patient’s cervical cancer was made in March 2004. The patient was constantly under the care of a gynecologist who she was visiting on a regular and frequent basis, had been subjected to seven Pap smears between October 1998 and December 2002, and had received a colposcopy (2000) for a visible lesion of her cervix and no biopsy. It is obvious from the facts related that the management by the patient’s gynecologists was far less than required by accepted standards of practice. However, it is important to note that in December of 2002 the patient still had a substantial chance of a better outcome if the Pap smear had been properly interpreted.
The mistakes made by the gynecologists and lab in the reported case continue to occur. 4,900 women will die of cervical cancer this year. Many of these deaths are preventable.