Variability in cytologic-histologic correlation practices and implications for patient safety.
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. 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 expected" (15) and "additional" data points that laboratories collected when they performed a correlation. PARTICIPANTS: American pathology laboratories. MAIN OUTCOME MEASURES: Measures were percentage of laboratories that recorded minimum expected and additional data points and the frequency with which specific minimum expected 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 expected 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 expected 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.