A weak Quality Management System (QMS) may result in laboratory errors that can lead to both over- and under-diagnosis of TB, interruptions in service, and delayed reporting of results, leading to a negative impact on patient care. QMS provides an effective mechanism for health system improvement yielding long-term benefits in the quality, cost-effectiveness, and sustainability of public health programs. Models of laboratory-driven quality systems at Designated Microscopic Centers can lead to overall improvements in TB diagnosis by rapid molecular diagnostics as it focuses attention on areas of greatest need and accelerating improvement in areas such as staff competency, supply chain, instrument maintenance etc. Laboratories with quality systems also have a positive influence on performance in other areas of health care systems by allowing laboratories to demonstrate high standards of service delivery.

A qualitative and quantitative checklist was used to conduct baseline assessment of DMCs to identify barriers to implementation of NTEP’s policy and guidelines and developing action plan to address recommendations and corrective actions resulting from the assessment. 

Project Flow:

• Baseline Assessment of DMS​
• Recommendations, Action Plan and Corrective Action resulting from Assessment​
• Development of Training Content for QMS​
• Supportive & Mentoring Visits​
• External Assessment of DMS​
• Additional Notes
• All DMS scoring 5 Stars will be felicitated with "Certificate of Excellence" in QMS by IMR, CII & SHARE INDIA.

Data thus collected by desk review and quantitative data on laboratory performance and qualitative data was used to identify factors that either propel the QMS implementation forward, or alternatively, hinder the process. Capacity building and trainings were conducted to make incremental yields in establishment of QMS and enhance case finding activities by introduction/optimal utilization of rapid molecular diagnostics for TB. Supportive supervision, mentoring and handholding was provided to closer gaps as per baseline assessment. On closure of gaps and upon achieving 5-star rating, the DMC were certified for quality by ICMR, NTEP and SHARE INDIA.

Quality Management System (QMS) is built upon 12 Quality System Essentials (QSE). QSE in a laboratory includes effective engagement of administration, participation of competent staff, quality laboratory procedures in testing, documentation, management of inventory and equipment, continuous improvement and decision making based on facts. The ICMR funded SHARE INDIA, KIMS project was successful in introducing and implementing QMS at four DMCs under NTEP at Delhi and Odisha, an aspect often ignored for peripheral laboratories. Capacity building of NTEP staff was done in diagnostic algorithm, quality system essentials, quality indicators for CBNAAT, Truenat, smear microscopy, equipment maintenance, lab safety, documentation and quality manual, thereby also creating a pool of master trainers trained in quality systems. QMS streamlined laboratory processes including receipt of good quality sputum samples, reduced variability of test results in smear microscopy, reduced frequency of errors/invalids/indeterminates/specimen rejection for rapid molecular diagnostics (CBNAAT and Truenat) and optimized turn-around-time of laboratory test results for effective patient management at lab-clinical interface.

The laboratories at Odisha scored “above average” in QMS performance as compared to “average” performance by Delhi DMCs. The benchmark for QMS implementation was found to be at par for both public and private DMCs at Delhi, while the public DMC at Odisha performed better as compared to its private DMC. Delhi site KCC scored 71% (average) while RKM scored 72% (average). DMCs at Odisha-CHC scored 84 % (above average) while KIMS obtained 78% (above average) rating. Based on the gap analysis, a recommendation report and action plan were prepared and submitted to each laboratory for implementation of QMS. Handholding was provided by project staff to overcome the gaps. Based on final external assessment, all four laboratories scored Excellent Grades (90-100%) and were felicitated with a ‘Certificate of Excellence’ in QMS by ICMR, CTD and SHARE INDIA.

• Implementing and monitoring a comprehensive TB diagnostic laboratory driven   QMS will sow seeds in making scaling up of rapid molecular diagnostic across India cost effective.
• The project outcome will inform policy decision to scale up QMS and to include funding for quality improvement at DMCs.
• The example of DMC certification with its established structured processes and defined standards will demonstrate the benefits of systematic performance evaluation and on-going quality improvement to catalyze the impetus to improve patient care across the entire health care system.

The QMS implementation study across TB diagnostic laboratories in Delhi and Odisha was successfully completed, with all participating DMCs achieving “Excellent” grades (90–100%) and national certification for quality performance.