Baseline Assessments of TB Diagnostic Centers in Selected Public and Private Centers in India and Need for Introducing Quality Management Systems

Background: Quality is sine qua non of healthcare services. Laboratory driven Quality Management Systems (QMS) are key to provide quality diagnosis. Missed diagnosis due to laboratory lacunae stymies TB control measures, amplifies morbidity, mortality and, disease transmission.Methods: The project was conceptualized with Central TB Division, National TB Elimination Program (NTEP) and, Indian Council of Medical Research (ICMR), India to perform baseline assessments for QMS at four peripheral laboratories from public and private centers at Delhi and Odisha. Data was collected using a standardized checklist. Scores were compiled for compliance to quality standards for attributes assessed across seven thematic domains.Findings: The assessment helped identify current status in terms of performance, processes followed and, areas requiring improvement. TB laboratories were found lacking in human resources and, backup staff that disrupted service delivery. Other gaps included quality aspects in documents, records, process controls in smear microscopy, optimum resource utilization and laboratory safety. Adage for missed TB diagnosis included laboratory errors, failure to document, collect and, test repeat samples for Nucleic Acid Amplification Tests (NAAT), lack of patient centric laboratory signages, equipment handling and, maintenance.Interpretation: Baseline assessments of quality at DMCs mainly focused attention on areas of greatest need to ameliorate the health system challenges and, develop roadmaps to accelerate improvement. By adapting to local context, QMS can be enacted through a shared vision in quality care to positively impact TB case finding and, optimize utilization of NAAT for diagnosis thereby setting stage for nationwide adoption and, scaleup.Funding Information: Indian Council of Medical Research, New Delhi.Declaration of Interests: None.Ethics Approval Statement: We used data from laboratory operational processes. No patient information was used; thus, there was no ethics review required for this study.