Thursday, April 28, 2005

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

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

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.

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

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.

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.

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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