Negligence in Interpretation of Pap Smears

What Can Go Wrong Sometimes Does
A True Story (continued)

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.

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 1997 survived by three minor children, one disabled, all orphaned by her death. This patient's grueling struggle with invasive cervical cancer 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 1994. 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 1988 and December 1992, and had received a colposcopy (1990) for a visible lesion 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 1992 the patient stood a substantial chance of a better outcome if the Pap smear had been properly interpreted.

The mistakes made by the service laboratory in the reported case are illustrative of other cases in this author's experience. Administrative negligence allowed a cyhtotechnologist experiencing declining skill to deteriorate to a point where she became increasingly dangerous. The laboratory trivialized the function of its cytotechnologists and cytopathologists and consultants by minimizing the importance of clinical data.

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