Thursday, April 28, 2005
49

Variability in Cytologic-Histologic Correlation Practices and Implications on Patient Safety

Dana Marie Grzybicki, Colleen M. Vrbin, and Stephen S. Raab.


Context:
The Clinical Laboratory Improvement Amendments of 1988 require that laboratories perform cytologic-histologic correlation, although the optimal methods and the value of performing correlation have not been determined.

Objective:
To determine the similarities and differences in how laboratories perform cytologic-histologic correlation.

Methods:
Design: One hundred sixty-two American laboratories were sent a letter requesting copies of the materials they used in the cytologic-histologic correlation process. The returned materials were classified into the categories of forms, logs, and tally sheets. A checklist (derived from the College of American Pathologists Laboratory Accreditation Cytopathology Checklist) was developed to classify the minimum (15) and additional data points that laboratories collected when they performed a correlation.
Setting: n/a
Participants: Volunteer American pathology laboratories.
Interventions: n/a
Main outcome measures: Percentage of laboratories that recorded minimum and additional data points. Frequency that specific minimum data points were recorded.


Results:
The response frequency was 32.1% and a total of 84 cytologic-histologic correlation materials were obtained. The only minimum variables recorded on forms or logs by more than 50% of laboratories were cytology case number, sign-out cytology diagnosis, surgical pathology case number, and sign-out surgical pathology diagnosis. Nine (17.3%) laboratories did not record data on forms, logs, or tally sheets. The mean number of minimum and additional variables recorded on forms was 6.5 and 8.7, respectively.

Conclusions:
Laboratories record data from the cytologic-histologic correlation process in a number of ways, indicating the lack of standardization of the data collection process. These findings suggest a high level of interlaboratory variability in the performance of this process, making interlaboratory comparison of false negative rates and false negative rate benchmarking impossible.

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