Feedback4.2.9 Area 9 – Recording and reporting
Step 9.1 – Review and revise request for examination and reporting forms
Diagnosis
4.2.8 Area 8 – QA, QC and quality assessment
Step 8.1 – Implement a comprehensive quality assessment programme
4.2.7 Area 7 – Digital data
Step 7.1 – Develop the use of digital data and diagnostics connectivity
TST and TBST results have the advantage of being provided by the clinical staff themselves. Nevertheless, the results should be adequately registered.
4.2.6 Area 6 – Procedures
Step 6.1 – Develop SOPs
SOPs must be developed or adapted for TB infection skin or blood-based tests, for:
4.2.5 Area 5 – Supply chain
Uninterrupted availability at all testing sites of skin test materials, or reagents and disposables for IGRAs, is essential. Careful assessment of consumption rates is necessary to avoid shortage or excessive wastage of materials according to their shelf life.
Step 5.1 – Review forecasting, ordering and distribution procedures
4.2.4 Area 4 – Human resource sensitization, training and competency assessment
Step 4.1 – Develop and implement a training curriculum and strategy
4.2.3 Area 3 – Equipment and materials
Step 3.1 – Select, procure, install and set up equipment
4.2.2 Area 2 – Regulatory approval and importation of products
Step 2.1 – Complete national regulatory processes
4.2.1 Area 1 – Policies, budgeting and planning
Step 1.1 – Establish a TWG, and define roles and responsibilities
4.2 Steps for programmatic implementation of testing for TB infection
The 10 main areas in implementing a new test are listed in Box 4.1. The following sections describe the steps within each of the 10 areas.
QA: quality assurance; QC: quality control; TB: tuberculosis.