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Step 9.1 – Develop terms of reference and position descriptions
The successful implementation of a diagnostic test will depend on the expertise, training and experience of the laboratory personnel involved in testing. This will be particularly important for the more technically complex testing methods such as targeted NGS tests. Position descriptions – with clearly defined roles and responsibilities, and required competencies and skills – will be needed for staff undertaking diagnostic testing.
Step 9.2 – Develop and implement a training curriculum and strategy
Training and competency assessment are critical for generating quality-assured test results; they should be offered for the different levels of personnel (e.g. managers, senior technologists, technicians and laboratory assistants). Implementing a diagnostic test requires training beyond the steps required to carry out the test, and the onsite training supplied by manufacturers following installation is often too short to cover QA activities. The testing site manager must ensure that test users are trained in the operation and maintenance of the test instrument, correct performance of the test and associated QA activities.
Clinician training or sensitization must be done in parallel with training of laboratory staff, to ensure that all clinicians involved in the screening and care of people with TB understand the benefits and limitations of the new test and are sensitized to the new testing algorithm, test requisition process, specimen requirements, specimen referral procedures and interpretation of results.
Clinical staff responsible for implementing TPT require training on how to perform and interpret TB infection tests if these are used. Also, it is crucial to train nurses for injection and reading of induration. Simple protocols for training (75), and using mobile technologies for training and QC of skin testing (69), may facilitate the widespread use of these tests, even in remote settings. Practical training material is available in several languages; for example, for injection (76) and reading of results (77).
Educational material developed in the local language for health care personnel and patients is useful (78); examples are available online (79, 80).
Step 9.3 – Assess and document the competence of staff
Competency assessments should be performed, using a standardized template, after training and periodically (e.g. annually) thereafter. They should include assessment of the knowledge and skills for performing each of the tasks involved in a diagnostic test. Assessments should be conducted by an experienced test user or trainer, and should include observation of the person being assessed as that person independently conducts each of the required tasks. Proficiency testing panels may be used for competency assessments. The results of competency testing should be recorded in personnel files.
Step 9.4 – Provide for post-training mentoring and support
Post-training mentoring and support that builds on the initial training is useful. It will help to ensure success in the implementation of a diagnostic test and enable the programme to keep abreast of the latest advances in this rapidly evolving field. A support programme will also facilitate troubleshooting during the implementation of any new technology.