Quality Management in the Histopathology Lab: A Single Institutional Experience from May 2018- August 2022, SPHMMC, Addis Ababa, Ethiopia.

Abstract

Abstract Background: To be of utility, the pathology report must be accurate, complete and timely. And, these three qualities, in turn, are crucially dependent on many variables in the specimen test cycle, starting from the pre-analytic to analytic to post-analytic. The last few years, especially since the first National Cancer Control Plan of Ethiopia that was published in 2015 by the Federal Ministry of Health came to be implemented on the ground, a remarkable expansion of pathology laboratories was seen across the nation. But except for one paper that tried to audit the overall capacities (as regards equipment resource) of pathology labs, no facility-based research has been carried out so far to assess the performance of pathology labs by using acceptable metrics across the whole range of the specimen test cycle. This study aims to identify different factors affecting the timeliness and completeness of pathology reports, two factors which are considered as major quality indicators. This will help identify the gaps and improve the quality of service provided by the laboratory in the future. Objective: The main objective of this study is to assess selected pre-analytical factors, analytic factors and post analytic factors affecting quality of pathology service. Methods: A retrospective chart review method was used. Sampling was done using stratified random sampling. Sample size was calculated after stratifying the cases in to each respective year starting from May 2018 to Aug 2022. A review of 1783 pathology requisition forms and final report were done. Pre-analytic factors (ID, name, age, sex, clinical information, clinical diagnosis, clinician information), analytic factors (presence of gross, microscopy and diagnosis) and post analytic factor (Turnaround time of a pathology report) were audited. Data was entered into SPSS 26 and descriptive analysis done. Result: A total of number 1783 biopsy reports were evaluated. In the study period 2018 to 2022, histopathology request forms lacked patient age in 1.5%, sex in 1.1%, medical record number in 7.2%, and patient contact information in 4 % in the patient identification information section of the requisition form, while patient full name was available in all of the cases. Clinician contact information was missing in most of the cases (85.3%) while clinician name was provided in higher percentage on request forms (82.2%). iv | P a g e Clinical history and clinical diagnosis were missing in 1 out of 4 request forms. Most of the requisition forms with incomplete data were submitted by St Paul’s Hospital Millennium Medical College (72.4%), while majority of wet surgical biopsy specimens originated from the department of Gynecology and Obstetrics, accounting for 52.4%. Specimen information was mentioned in most of the requisition forms – site in 98.5%, type of procedure in 86%, and date of procedure in 97%. All the requisition forms reviewed had gross, microscopy and diagnosis. The mean turnaround time (TAT) was 16.29 days (10th–90th percentile range, 10–26 days). The mean TAT showed gradual improvement from the year 2019 to 2022 from 18.73 (10th–90th percentile range, 10.5–27 days) to 14.5 (10th–90th percentile range, 7–25 days). Conclusion and Recommendation: The research finding show gaps in pre-analytic factors (including patient identification variables, specimen identification, etc…) that need to be improved upon, especially when considering their impact on the overall quality of the pathology report. Despite the progress and improvement seen over the past five years, the TAT for biopsy is still lagging in achieving the target set by the quality team of the department. Finally, the drafted User’s Manual must be published and distributed. Besides, the rejection criteria (see annex) developed by the quality team should also be instituted and communication between the lab and the different health facilities that send samples to the lab, especially with the different departments within SPHMMC, must be improved if the targets set by quality team are to be realized.