SOCIETY FOR HEALTH ALLIED RESEARCH & EDUCATION INDIA (SHARE INDIA)

Quality Management Systems in NTEP at DMCs

Quality Management Systems in National TB Elimination Program at Designated Microscopy Centers

SHARE INDIA is being funded by the Indian Council of Medical Research (ICMR) to implement the project, Improving TB diagnosis at Designated Microscopy Centers (DMCs) by introducing quality management systems (QMS) and optimising utilization of rapid molecular diagnostics. SHARE INDIA is currently supporting projects in Delhi and Odisha to strengthen the quality of diagnosis by supporting the National TB Elimination Program’s (NTEP) goal of TB elimination in India by the year 2025.

Our Reach

Two Public Sector and Two Private Sector Designated Microscopy Centers in Delhi and Odisha

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What we deliver

A weak 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. We establish models of laboratory-driven quality systems at DMCs that 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. Under the project we developed:

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Quality Manual, SOPs and Good Documentation Practices for Designated Microscopy Centers under NTEP

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Facilitate Quality Management Systems (QMS) based on Quality Systems Essentials (QSE) in Designated Microscopy Center

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Support NTEP to strengthen laboratory Quality Assurance, Quality Control and Continuous Quality Improvement


Objectives

To assess the improvement in quality of TB diagnosis by introduction of Quality Management Systems (QMS) at Designated Microscopy Centers (DMC) in Delhi and Odisha.

1. Activities ​

The pilot project was implemented to help NTEP formulate a national policy to provide funding and technical assistance for National Scale-Up of Quality Management Systems at Designated Microscopy Centres.

Technical Assistance for National Scale-up of QMS at DMCs

The project facilitated in the development of the NTEP at the Designated Microscopy Centers to improve TB diagnosis and optimum utilization of rapid molecular diagnostics (GeneXpert MTB/Rif-CBNAAT and TrueNat MTB) and its cost implications in 2021, which was launched as pilot project in Delhi and Odisha.

The National TB Elimination program successfully collaborated with ICMR, New Delhi TB centre (NDTB) and SHARE INDIA to install four module TrueNat MTB Quattro at project sites. TrueNat is a novel molecular assay that rapidly detects TB and rifampicin resistance. The purpose of this endeavour was to introduce TrueNat MTB Quadro at the Public Sector DMCs to improve pre-analytical, analytical, and post-analytical aspects of molecular testing for TB and Rif resistance by optimizing utilization of existing CBNAAT and newly introduced TrueNat MTB Quattro.

The project-built the capacity of the NTEP staff in the project activities which included:

  • Training of Master Trainers from a pool of IRL and NRL Microbiologists and laboratory staff at DMCs to conduct assessments in QMS based on a structured checklist. The checklist was developed based on:
  • Guidelines for Quality Assurance of smear microscopy for diagnosing tuberculosis 2005 (RNTCP)
  • ISO 15189:2012 Third edition
  • TB Microscopy Network Accreditation, Global Laboratory Initiative, Stop TB Partnership
  • CLSI GP26-A4; A Quality Management System Model for Laboratory Services – Fourth Edition

The NTEP staff (DTO, MO, MO-TC, STS, STLS, TB HV, LT) at DMCs were trained in ISO 15189:2012

The staff were trained on the SOPs, Quality Manual, Logs, Work Instructions and Biosafety, QMS framework based on Quality System Essentials (QSE)

Onsite trainings were provided on all laboratory aspects involving Quality System Essentials (QSE), laboratory signages, consumables, inventory management and maintenance of equipment

Outcomes of the Training

  • Master trainers were oriented on requirements of QMS implementation at DMCs
  • Developed the mentoring plan for QMS in DMCs
  • Monitor the progress of QMS in DMCs by IRL/NRL/CTD

Train the NRL and IRL staff on QMS principles

Baseline Assessment and Mentoring visits to DMCs

Implementing QMS improves the efficiency of laboratory services, including identification of the most probable causes of error and delay in diagnosis which may have cost implications to the citizens and the health systems. Baseline assessment was conducted by IRL, NRL and ICMR project teams to assess all aspects of the healthcare cascade including pre-analytical, analytical and post-analytical phases of TB laboratory testing by evaluating the laboratory processes in Delhi and Odisha in June 2021. Subsequent, Supportive – Supervision / Mentoring visits to DMCs were conducted through site visits by IRL/NRL Microbiologist, Program Staff designated by NTEP and the SHARE INDIA project team. Frequency of visits and follow-up visits were decided based on the QMS scores and the QMS tool was used during every visit. The major criteria for re-visit included handholding to improve QMS score/Unsatisfactory EQA result.

Certification of DMCs with 5 Star rating

As per the score obtained during the assessments, the project DMCs were given a Star rating. The star rating is expected to keep the motivation of DMC staff. For example, the laboratory scoring 2 star will look forward to have a higher score and each additional star will motivate DMC staff to score higher till it reaches the 5 Star level. Additionally, Star rating will help supervisory staff and SHARE INDIA to use different skills and level of supportive supervision to bring the laboratories to 5 Star rating. The laboratories with a low score will need more hand holding in contrast with laboratories with a higher score, which will require virtual support. On being approved by ICMR, CTD and NTEP, all the DMCs scoring 5 Stars will be awarded with a ‘Certificate of Excellence in QMS’.

Certification of DMCs will be based on successful EQA performance, utilization of rapid molecular diagnostics and attainment of 5 Star rating on evaluation by external assessors (ICMR, CTD, IRL/NRL of other states). In case of unsatisfactory performance, the external assessors will provide an Action Plan for corrective measures to the DMC. A follow-up assessment of the DMC will be done after 6 months.

2. Key Achievements ​

Quality Management Systems (QMS) for Designated Microscopy Center Facilities

The pilot project was implemented to help NTEP formulate a national policy to provide funding and technical assistance for National Scale-Up of Quality Management Systems at Designated Microscopy Centres.

Developed QMS Checklist and Training Programs

  • The QMS Checklist was designed in the year 2021 to implement QMS in DMC laboratories, which was approved by ICMR and CTD.
  • A cascade training model was used effectively to deliver training through a pool of master trainers trained centrally to reach trainees at the local level.
  • Training of Masters Trainers were organised at 2 locations—Delhi and Odisha and 52 personnel were trained to be part of the Resource Pool (Master Trainers); 25 belonged to the focused states of Delhi and 27 from Odisha.
  • The Training of Master Trainers aimed to build the capacity and orient officers of NTEP and Project staff.
  • 4 DMC were trained in 1 batch on QMS across the focused districts. The state and NTEP staff were trained, mentored and monitored by the IRL/NRL with support from the state team and SHARE INDIA.
  • Baseline assessments of 4 DMC were organized and the district and state level stakeholders were closely involved in the baseline assessments and in the review of action taken.
  • Technical assistance and mentoring plan were developed to focus amongst laboratories requiring greater improvement. On-sitehand-holding and capacity building were organized for all DMCs. In line with this, a domain-wise performance of DMCs rated Grade was reviewed and those performing poorly were visited for on-site support and the rest were provided virtual assistance. The objective of both forms of technical assistance was to focus on improving the DMCs, QMS performance and achieve a Certificate of Excellence.

QMS assessment tool is designed in Microsoft-Excel. This tool consists of eight sheets that generate a domain-wise assessment score, domain-wise summary, site and domain wise final scores with star rating. It provides analysis tables for decision-making and for initiating action.

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The DMC was selected for External Assessment who scored above 90 percentage after the follow-up assessment and the findings were verified onsite.

Implemented QMS in 4 Designated Microscopy Center (DMCs) in the focused districts to ensure quality in the TB diagnosis, Treatment and Testing Services. DMCs will be awarded Certificate of Excellence from CTD and ICMR for assuring quality in TB diagnosis by February 2022.

3. Impact ​ ​

Introduce and establish models for Implementation of QMS at public and private DMCs under NTEP that can be scaled-up across the country. Quality ensures better TB case findings, diagnosis and service delivery to the TB community as aligned to India’s National Strategic Plan.

  • Optimum utilization of rapid molecular diagnostics and improvement in TB case detection and resistance to Rifampicin at DMCs by reducing errors and maintaining quality procedures for per-analytical (specimen transport and receipt at DMC), analytical (testing) and post-analytical (reporting results) procedures
  • Develop a sustainable model to develop capacity of NRL and IRL to implement QMS across the TB diagnostic network
  • Plug leakages across the entire healthcare cascade to provide quality TB services at grassroot level that are amenable to scale-up across the country