Feedback3.5.8 Area 8 – Recording and reporting
Step 8.1 – Review and revise request for examination and reporting forms
Step 8.2 – Review and revise laboratory and clinical registers
Step 8.1 – Review and revise request for examination and reporting forms
Operational Handbooks
3.5.7 Area 7 – Quality assurance, control and assessment
Step 7.1 – Implement a comprehensive QA programme
Step 7.2 – Establish and monitor QCs
Step 7.3 – Develop an external quality assessment programme
Step 7.4 – Monitor and analyse quality indicators
Step 7.1 – Implement a comprehensive QA programme
3.5.6 Area 6 – Digital data
Step 6.1 – Develop the use of digital data and diagnostics connectivity
Step 6.2 – Develop procedures for data backup, security and confidentiality
Step 6.3 – Develop data requirements for targeted NGS tests
Step 6.1 – Develop the use of digital data and diagnostics connectivity
3.5.5 Area 5 – Procedures
Step 5.1 – Develop SOPs
Step 5.2 – Update clinical procedures and strengthen the clinical–laboratory interface
Step 5.1 – Develop SOPs
Based on the intended use or uses of the diagnostic test, procedures must be defined, selected, developed or customized for:
3.5.4 Area 4 – Supply chain
Step 4.1 – Review forecasting, ordering and distribution procedures
Step 4.2 – Develop procedures to monitor reagent quality and shelf life
Step 4.1 – Review forecasting, ordering and distribution procedures
3.5.3 Area 3 – Equipment
Step 3.1 – Select, procure, install and set up equipment
Step 3.2 – Instrument verification and maintenance
Step 3.3 – Assess site readiness and ensure a safe and functional testing site
Step 3.1 – Select, procure, install and set up equipment
3.5.2 Area 2 – Regulatory issues
Step 2.1 – Determine importation requirements
Step 2.2 – Conduct country validation and verification studies, as required
Step 2.3 – Complete national regulatory processes
Step 2.1 – Determine importation requirements
3.5.1 Area 1 – Policies, budgeting and planning
Step 1.1 – Establish a technical working group (TWG) and define roles and responsibilities
Step 1.2 – Review WHO policies and available technical and implementation guides
Step 1.3 – Define immediate and future purposes of the test
Step 1.4 – Update national diagnostic algorithm and guidelines
Step 1.5 – Perform a situational analysis, including biosafety
2.2.3 Key implementation steps in contact investigation
In addition to planning and budgeting, NTPs should consider the following key implementation steps in contact investigation:
2.2.2 Planning and budgeting to implement or strengthen household contact investigation
Contact investigation to identify children, adolescents and other household members with TB disease and to identify those who will benefit from TPT should be a standard component of all national TB programmes. Contact investigation is good public health practice and essential to address and manage several infectious diseases such as coronavirus disease 2019 (COVID-19).