Negligence in Interpretation of Pap Smears

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

Does the blank square before risk factors for cervical cancer seen in Figure 2 relieve the lab of responsibility to make further inquiry of the gynecologist's office concerning history. As defined in the Bethesda System, a cervical smear is a medical consultation and, as such, knowledge of clinical findings is essential to the proper screening and interpretation of cytologic material.

How vigorously must a laboratory pursue clinical data? Certainly a laboratory has a responsibility to secure historical information from its own prior patient records. The implementation of CLIA 1988 requires cytologic slides must be retained for no less than five years from the date of examination. All non-negative specimens should be maintained in one file within the service laboratory allowing retrieval of slides for review or study at any time. A cytotechnologist or pathologist when interpreting a specimen must be aware of the particular patient's record within the service laboratory, which should be accessible either by a fully automated record-keeping system or by hardcopy search of files at the time a specimen is being interpreted.

Therefore, the interpreter of a Pap smear is not relieved of a responsibility for acting in ignorance of important historical or other data readily ascertained from the patient's record within the service laboratory, even if misleading information is contained within the submitted requisition. Furthermore, a laboratory shares with its client gynecologists responsibility for establishing effective communication. The gynecologist must provide detailed and comprehensive clinical data. However, the laboratory cannot avoid legal responsibility for acting upon inadequate history. This was particularly true, in the illustrated case, where the administrator of the laboratory was forced to concede, upon questioning, foreknowledge of casually prepared and inaccurately encoded requisitions.

Ironically, the laboratory in question had history in its own files concerning the involved patient as serial slides of the particular patient had been reviewed by this laboratory. Though computers in the laboratory were used for billing, as a matter of policy, they were not used to identify patient records. Even though this patient's previous Pap smear had in fact been interpreted as showing ASCUS, or higher abnormality, her slides were each read routinely as if her history had been negative. The error of the gynecologist's clerical personnel in reporting an inaccurate history was thereby compounded. When questioned by deposition, neither the gynecology personnel involved, nor the laboratory personnel involved, were sufficiently aware of the practices of each other's organizations to recognize how easily miscues could occur.

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