4.2 Responsibilities of the TB laboratory network at different levels

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4.2.1 National TB reference laboratory

  • Acts as supervising reference laboratory for the regional laboratories.
  • Performs, culture for mycobacterium, both solid & liquid (MGIT), Molecular Line Probe Assay (LPA), NGS (Next Generation Sequencing), drug susceptibility testing (1st & 2nd line) and species identification as well as microscopy and Xpert MTB/RIF assay (GeneXpert) in special situation.
  • Takes the lead in reviewing and introducing new diagnostic tools in country
  • Ensures proficiency of the NTP staff for carrying out good quality diagnosis by providing technical training and periodic supervision of the activities of the regional laboratories.
  • Collaborates with the WHO-accredited supranational reference laboratory (SNRL) designated for Bangladesh.
  • Implements quality assurance for regional and, if necessary, other tertiary Labs like chest diseases clinics and hospitals, upazilla and other special services laboratories.
  • Provides guidance to the National TB Control Programme on strengthening the TB Laboratory Network
  • Provides strategic oversight to ensure the effective management of laboratories in the network, the quality of the testing, and the efficient use of the network’s services and TB diagnostics
  • Provides input to the NSP and costing for the TB diagnostic network
  • Supervises regional and intermediate level laboratories’ implementation and use of bacteriological methods, as well as the laboratories’ performance monitoring of peripheral laboratories
  • Establishes and manages a system to oversee, monitor and supervise all labs in the network either directly or through RTRLs under the oversight of the NTRL
  • Manages QA of all procedures performed at intermediate-level laboratories including microscopy, culture, and DST
  • Conducts EQA for GeneXpert, DST (genotypic and phenotypic) test and work as second controller for TB Microscopy laboratories
  • Conducts operational research, studies, surveys etc.
  • Ensures recording and reporting as per national policy.
  • Capacity building for peripheral laboratory staff by providing trainings on different diagnostic tools and procedures.
  • Collects key performance indicators (KPIs) of WRD, analyze and provide feedback to NTP and RTRLs

4.2.2 Regional TB reference laboratory

  • Performs GeneXpert, Culture and DST for MTB isolates to determine resistance to antiTB agents (solid and liquid)
  • Performs FL/SL-LPA according to national diagnostic algorithms
  • Performs digestion and decontamination of specimens, inoculates cultures
  • Inoculates cultures to isolate and identify MTB from pulmonary and EP TB samples
  • Refers positive cultures to appropriate reference laboratory for extended DST as required and unable to perform
  • Ensures laboratory commodity management systems are in place and functional for the respective tiers under the jurisdiction of the RTRL
  • Checks compliance with the diagnostic algorithm and identifying issues with the diagnostic network in the region including GX performance
  • Ensures that updated recording and reporting formats are being used in the region
  • Implements the biosafety and biosecurity activities at peripheral level in coordination with NTRL
  • Supervises and monitors the performance of peripheral laboratories and compliance
  • Provides assistance to investigate and correct problems.
  • Provides training at the regional level
  • Engages in PT and QI activities for peripheral laboratories
  • Conducts EQA for TB Microscopy Laboratory as second controller
  • Conducts regional supervision and mentorship for QMS
  • Collects KPIs of WRD, analyze and provide feedback to NTP and Districts/upzilla in the region
  • Train laboratory technicians on GeneXpert operation and supervises peripheral-level staff in microscopy and the use of WHO recommended rapid diagnostic tests
  • Collaborates with NTRL for panel testing, provided support in implementing and validating new diagnostics, assistance with laboratory development and implementing strategies
  • Ensures recording and reporting as per national policy

4.2.3 Peripheral laboratory

  • Performs microscopy/GeneXpert MTB/Rif assay, TrueNat
  • Participates in EQA
  • Ensures recording and reporting as per national policy
  • Ensure appropriate biosafety measures in place

NTRL & RTRLs are performing liquid culture (MGIT) and Line Probe Assay (LPA) of 2nd line drugs for confirmed RR TB cases to ensure early diagnosis of PreXDR and XDR TB patients. All bacteriological examinations including smear microscopy, Culture-DST, GeneXpert and LPA are provided free of cost.