Table 2.

Risk assessment plan for non-integrated POCT in analytical testing phase

Risk Assessment Components	Possible sources of error	Risk Mitigation: Manage/Prevent Errors from Occurring
Testing Personnels’ Training and Competency	Not trained POCT user Not competent POCT user Improper training or expired competency records Proper POCT technique/ system maintenance /QC not being accurately followed	Central laboratory to provide proper initial training and competency Competency assessment frequency to be decided based on risk assessment Compliance monitoring Follow established policies and procedures Testing personnel training and competency records Traceability of POCT users
Test system- Calibration	Calibration omitted Calibration out and patient results reported There is no mechanism, such as an operator lockout, to ensure only trained personnel use the test system	Ensure POCT users follow standard operating procedures through trainings, competency assessment, audits Test process flow charts POCT user manual/electronically shared QC and calibration records with POCT coordinator
Test system- Maintenance	Maintenance procedures not consistent with manufacturer’s instructions	Train POCT users for POCT device maintenance
Test system-Reagent	Expired reagents Wrong lot of reagents	Train POCT users to check reagent expiry prior to use Manufacturer’s instructions to be followed for reagents storage
Test system- QC	Expired QC Wrong lot of QC Unable to interpret QC Unable to trouble shoot if QC is out	Prevent QC degradation during storage and use Training of POCT users on interpreting QC before release of patient results Maintain QC logs (manual if electronic not possible) Assure POCT user review each QC before patient result release – through trainings Training of POCT users on troubleshooting
Environment-room Temperature	Room temperature not appropriate	Daily room temperature logs POCT coordinator to sign off logs periodically
Environment- Storage conditions	Sample / reagents/ cartridge/ strips storage conditions not appropriate	Daily refrigerator temperature logs where POCT items are stored. POCT coordinator to sign off logs periodically