Assessment of histopathology and cytology request form documentation quality using six Sigma and Pareto analysis in Benghazi, Libya.

Abstract

Background: Histopathology and cytology request forms are pivotal in the pre-analytical phase of laboratory testing, where incomplete or erroneous documentation on these forms can compromise the entire testing process. This study aimed to assess the documentation quality and process performance of histopathology and cytology request forms using Six Sigma and Pareto analysis in three private laboratories in Benghazi, Libya.

Methods: A retrospective cross-sectional study was conducted on 1,181 request forms collected from February to April 2025. A structured checklist encompassing five documentation domains and 15 quality indicators based on WHO guidelines was used to assess form completeness. Six Sigma metrics including Defects per Unit (DPU), Defects per Million Opportunities (DPMO), Sigma level, and Yield (%), along with Pareto analysis, were applied to evaluate and prioritize quality deficiencies.

Results: None of the evaluated request forms achieved full compliance with documentation standards. The overall process performance was unacceptable, with a Sigma level of 1.707 and a yield of 58.22%. Pareto analysis revealed that approximately 80% of documentation errors originated from three key domains: requesting clinician details, personal information, and clinical information. The requesting clinician details domain was the most deficient, with a Sigma level of 1.438 and a yield of 47.5%. The personal information domain followed, with a Sigma level of 1.867 and a yield of 64.31%. The clinical information domain showed a Sigma level of 1.263 and a yield of 40.6%. In contrast, the specimen details domain exhibited relatively better performance, with a Sigma level of 2.574 and a yield of 85.86%.

Conclusions: Six Sigma and Pareto analysis were applied to identify critical deficiencies in documentation practices during the pre-analytical phase of histopathology services in Libya. The results highlight an urgent need to implement standardized staff training protocols, redesign request forms with mandatory fields, enforce accountability mechanisms, and establish robust quality monitoring systems. Low-cost tools-such as Excel-based compliance trackers and manual logbooks-can serve as effective interim solutions to enhance documentation compliance and support continuous quality improvement in resource-limited settings.