Feedback4.4.2 Discordant results
Interpretation of discordant results
Diagnosis
3.5.10 Area 10 – Monitoring and evaluation
Step 10.1 – Monitor implementation of the diagnostic test
Step 10.2 – Monitor and evaluate impact of the diagnostic test
Step 10.1 – Monitor implementation of the diagnostic test
During the initial planning phase, countries should establish a set of key indicators and milestones that can be used to monitor the implementation process. Once the testing services have been launched, use of the services should be tracked.
3.5.9 Area 9 – Human resource training and competency assessment
Step 9.1 – Develop terms of reference and position descriptions
Step 9.2 – Develop and implement a training curriculum and strategy
Step 9.3 – Assess and document the competence of staff
Step 9.4 – Provide for post-training mentoring and support
Step 9.1 – Develop terms of reference and position descriptions
3.5.8 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
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