Evaluation of the effectiveness of Lean Six Sigma Approach for SARS-CoV-2 RT-PCR Turnaround Time (TAT) improvement at a hospital-based tertiary laboratory

OBJECTIVES@#This study aims to evaluate the effectiveness of the Lean Six Sigma approach in improving procedure for (TAT) of reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 testing at The Medical City. Specific objectives of the study are to determine the following: 1) baseline sigma and average TAT (in hours); 2) post-implementation sigma and average TAT (in hours) 3) compare if there is a significant improvement between baseline and post-implementation sigma and average TAT (in hours) 4) effect on workflow efficiency.@*METHODOLOGY@#Lean Six Sigma method for quality improvement was applied using DMAIC: Define, Measure, Improve, and Control. The root causes identified were lack of manpower, equipment, space, and manual and complex processes. Then, process wastes were identified, and corresponding proposed solutions were sustained in the control phase, such as standardization and the use of automation. Measurement of turn-around time and six sigma of the process were performed for evaluation.@*RESULTS@#Results showed a significant improvement in the TAT in RT-PCR results, with most results released within 24 hours. The pre-Lean Six Sigma data on TAT were as ollows: 24.88% released within 24 hours; 65.14% released within 24-48 hours; 3.56% released within 48-72 hours, and 6.42% released in more than 72 hours. The post Lean Six Sigma TAT were as ollows: 95.32% released within 24 hours; 4.29% released within 24 to 48 hours; 0.13% released within 48-72 hours, and 0.12% released more than 72 hours. The computed sigma post-implementation was increased from 3.56 to 4.82. The p-value was calculated using the chi-square test, and the computed chi-square statistic is 1894.1021. The p-value is <0.00001 and the result is significant at p<.05. Although there is a significant decrease in the volume of samples post implementation due to the changing COVID-19 situation, real time TAT was improved. It also resulted to increased workflow efficiency with the use of lesser manpower with more appropriate utilization.@*CONCLUSION@#Applying the Lean Six Sigma method to improve quality processes in the laboratory is shown to be practical, cost-effective, and straightforward.

Correlation of clinicopathologic features of Filipino primary breast cancer patients with HER2 Subgroups classified according to the ASCO/CAP 2018 breast cancer HER2 testing guidelines

Background@#Guidelines for testing human epidermal growth factor receptor 2 (HER2) in breast cancer using fluorescence in situ hybridization (FISH) were released in 2018. These guidelines were jointly developed by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) to achieve a clearer designation of breast cancer HER2 status. Clinical correlation with other factors was also considered appropriate, especially for those cases classified under ISH groups 2, 3, and 4.@*Objective@#In this study, we examined clinicopathologic features among Filipino breast cancer patients whose HER2 status was reclassified based on the 2018 ASCO/CAP guidelines.@*Methodology@#One hundred and thirty-two (132) breast cancer cases with immunohistochemistry (IHC) equivocal results in the Medical City were enrolled from January 2017 up to December 2020. HER2 FISH results classified under groups 2, 3, and 4 were then re-evaluated for HER2-IHC status in accordance with the 2018 ASCO/CAP guidelines. The relationship between clinicopathologic features and HER2 status was analyzed using the Fisher exact test.@*Results@#Significant differences were found in histologic type, nuclear pleomorphism, mitotic rate, progesterone receptor (PR) status, and regional lymph node involvement among the reclassified ISH groups. In the conv+ group, the tumor cells did not involve the regional lymph nodes as compared to group 5, where the tumor cells were involved. The conv- group had a higher grade for nuclear pleomorphism, mitotic count, and overall Nottingham Histologic Grade than group 5. There was a significant association between progesterone receptors among the conv- group and group 1.@*Conclusion@#Filipino breast cancer cases whose HER2 status was reclassified to negative following the 2018 ASCO/CAP guidelines had statistically different clinicopathologic features from those classified as group 5.

Intraobserver and interobserver agreement in the scoring of PD-L1 (SP142) and tumor-infiltrating lymphocytes in triple negative breast cancers

Objectives@#Known for their poor outcomes, triple negative breast cancers (TNBCs) have been investigated for immune checkpoint inhibitors that target Programmed death ligand 1 (PD-L1). In the recent decade, tumor-infiltrating lymphocytes (TILs) have also become potential biomarkers. The aim of the study is to determine the reproducibility of PD-L1 scoring system for TNBC (SP142 clone) and TILs interpretation in the local setting through intra- and interobserver agreement.@*Methodology@#Forty-three primary resection specimens TNBC were evaluated on two occasions with PD-L1 (Roche VENTANA SP142 assay) and TILs by two breast pathologists and one general pathologist on physical glass slides. PD-L1 expression was determined by at least 1% positivity among immune cells within the tumoral area and contiguous peritumoral stroma while TILs was assessed based on International Immuno-Oncology Biomarker Working Group on Breast Cancer. Kappa statistic for PD-L1 and TILs categories while intraclass correlation coefficient (ICC) were assessed, with cutoffs of 0.80 and 0.70, respectively.@*Results@#The overall interrater kappa statistic for PD-L1 on the first and second rounds were weak at 0.506 (95% CI: 0.334-0.679) and minimal at 0.314 (95% CI: 0.142-0.487), respectively. Intraobserver kappa statistic for PD-L1 were varied across the three readers while interobserver kappa values for PD-L1 showed none (0.181) to moderate (0.789) agreement. The TILs intraobserver reliability showed poor to good agreement, with the highest ICC of 0.889 (95% CI: 0.805-0.938).@*Conclusion@#This study demonstrated variable intra and interobserver agreement for both TILs and PD-L1 expression. Although it is desirable to have strong to almost perfect agreement, the kappa and ICC values suggest additional room for improvement. In light of the repercussions in management of patients who will undergo immune checkpoint inhibitor therapy, regular training sessions, concurrences of equivocal results, and possible use of digital pathology as a medium in interpreting TILs and PD-L1 stains to achieve consistent results.

Metaplastic carcinoma with mesenchymal differentiation in augmented breast using liquid silicone injection: A case report

@#The relationship between the use of liquid silicone for breast augmentation and carcinogenesis remains undetermined due to limited data reported, especially regarding its risks for acquiring cancer. We documented a case of an 81-year-old woman who presented with bilateral enlarging breast masses with a known history of breast augmentation using liquid silicone. On microscopic examination, the malignancy showed both mesenchymal and epithelial components in a background of stromal changes related to liquid silicone. Based from morphology and immunohistochemistry studies (p63, CK, HMW-CK, and CK5/6, CD34, and BcL-2), this case was signed out as metaplastic carcinoma with mesenchymal differentiation. This rare case of metaplastic carcinoma with mesenchymal differentiation coexisting with liquid silicone, provides evidence supporting the link between cancer development and siliconomas.