Quality Tools and Strategy for Critical Alerts Process Improvements to Ensure Patient Safety.

Objectives A number of regulatory and accrediting bodies require the reporting of critical results on a timely basis (immediately or within the time frame established by the laboratory) to "the responsible, licensed caregiver" as timely notification of critical laboratory results can pivotally affect patient outcome. The aim of the study was to decrease the turnaround time (TAT) of critical result notification along with assurance of notification to the concerned caregiver or clinicians. The objectives was 30% reduction in the critical value notification TAT and identify factors associated with delayed reporting and root cause analysis for these factors by application of quality tools. Materials and Methods The study was conducted at the Institute of Human Behavior and Allied Sciences, Delhi, a tertiary center teaching Hospital, from April 2019 to June 2021. A value streamed Process Map of critical alert was prepared. The incidents related to failure were presented through Pareto chart. The possible causes were analyzed through the fishbone model. The failure mode prioritization was executed with Failure Mode and Effect Analysis (FMEA). Through extensive brainstorming, appropriate and feasible corrective actions were implemented. The effectiveness of the implemented plan was analyzed by reassessing the TAT of critical alert and feedback received by clinical caregivers. Results After implementation of corrective action plan using quality tools for 3 months, the average critical alert TAT was reduced to 21 minutes from 30 minutes (30% reduction). The median critical alert TAT for ICU, emergency, and IPD were reduced to 3 minutes (IQR: 1-7). During the pilot project, 156 critical value data were sent for feedback with treatment plan but was received only for 88 patients (56%). Conclusion Comprehensive utilization of quality tools has a potential role in patient safety by reducing the critical alert TAT as well as establishing an effective communication between laboratory personnel and clinicians.

The study of serum hsCRP, ferritin, IL-6 and plasma D-dimer in COVID-19: a retrospective study.

OBJECTIVES: The cut off values for serum high sensitivity C-reactive protein (hsCRP), ferritin, interleukin 6 (IL-6) and plasma D-dimer could be of profound help in detecting COVID-19 patients at risk of adverse outcomes. Therefore, the aim of the present study is to determine the cut off values of the serum hsCRP, ferritin, IL-6 and plasma D-dimer in predicting mortality in COVID-19 patients. METHODS: Four hundred RT-PCR confirmed cases of COVID-19 were sub divided into two groups based on their outcome during hospitalisation. Group I consisted of survivors and Group II consisted of non-survivors. The survivors were further divided into three sub-groups: mild, moderate and severe based on the severity of infection. The laboratory data of serum hsCRP, ferritin, IL-6 and plasma D-dimer for all these patients was retrieved from the Medical Record Section of the Hospital. RESULTS: Mean serum hsCRP, ferritin, IL-6 and plasma D-dimer levels were significantly higher in non-survivors as compared to survivors of COVID-19. The levels of these biomarkers correlated with the severity of COVID-19 illness. ROC curve analysis revealed that plasma D-dimer is having a better predictive value as compared to other parameters in predicting mortality in COVID-19. CONCLUSIONS: The serum hsCRP, ferritin, IL-6 and plasma D-dimer levels could be used in risk stratification of COVID-19 patients. The optimum cut off given by the current study could be considered in predicting adverse outcome in these patients. Amongst the many studied biomarkers, plasma D-dimer might be the best early biomarker to predict mortality in COVID-19 patients.

Evaluation of Sigma-Metric and Application of Quality Tools in Clinical Laboratory of a Tertiary Care Hospital.

Variability in analytical performance of some analyte indicated the need of evaluation of quality plan of our laboratory. We tried to put the same degree of effort into our quality metrics as we put into the laboratory processes themselves. Application of six sigma methodologies improve the quality by focusing on the root causes of the problems in performance and analyzing by flowcharts, fishbone diagrams and other quality tools. Sigma metric was calculated for laboratory parameters for a period of 8 months during 2018-19. The analytes with poor sigma metric were free Thyroxine (FT3, FT4), Sodium, Calcium and Magnesium. Sigma metric of free Thyroxine (FT3, FT4), Sodium, Calcium and Magnesium were below 3. A road map for process improvement was designed with DMAIC (Define-Measure-Analyze-Improve-Control) model to solve the issue. Possible causes for low analytical performance of the particular analytes were depicted in Fishbone diagram. The Fishbone analysis identified the water quality issues with electrolyte analysis while high ambient temperature was culprit for poor assay performance of free Thyroxine. Sigma metric of the analytical performance was assessed once again after root cause analysis. Sigmametric showed marked improvement in control phase. Identification of problems led to reduction in non value added work leading to adequate resource utilization by addressing the priority issue. Therefore, DMAIC tool with Fish bone model analysis can be recommended as a well suited method for troubleshooting in poor performance of laboratory parameter.

Tumor necrosis factor-α -308 polymorphism in North Indian rheumatoid arthritis patients and association with mRNA and serum TNF-α.

Rheumatoid arthritis (RA) is a severely disabling chronic autoimmune disorder that leads to progressive inflammation of the joints and surrounding tissues. TNF-α, a potent proinflammatory cytokine, plays a pivotal role in the pathogenesis of RA. The endogenous formation of TNF-α may be influenced by TNF-α promoter polymorphisms. Hence, the present study was designed to explore any possible association between genetic polymorphism of TNF-α -308 G/A, messenger RNA (mRNA) expression, serum levels of TNF-α, and inflammatory markers in North Indian RA patients. A total of 214 controls and 187 RA patients were recruited according to the revised American College of Rheumatology 2010 criteria. TNF-α -308 G/A genetic polymorphism within promoter region was analyzed by using PCR-RFLP. Levels of inflammatory markers and serum TNF-α were estimated by ELISA. The mRNA expression of TNF-α gene was measured by quantitative real-time PCR. Higher levels of autoantibodies (RF and anti-CCP) were present in RA patients as compared to controls. We found a positive and significant correlation of circulating TNF-α levels with RF (r = 0.18), anti-CCP (r = 0.16), and mRNA expression of TNF-α gene (r = 0.57) in RA patients. The mRNA expression levels of TNF-α was 4.5-fold higher in patients with RA as compared to controls. The heterozygous mutant variants (G/A) and homozygous mutant variants (A/A) were found to be significantly associated with RA as compared to control (OR = 1.52 and 3.02, respectively). Our observations illustrated a significant association of allele -308 A TNF-α with progression of RA. Significant and positive correlation of TNF-α levels with mRNA expression and inflammatory marker levels suggests that serum TNF-α may be a susceptibility marker for RA.