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Run: Point of Care Testing Quality Verification

Point of Care Testing Quality Verification is an audit template for checking POCT oversight, operator competency, reagent control, QC runs, and recordkeeping...

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Program Oversight

A responsible individual is named for POCT oversight, including review of QC, competency, and non-conformances.
Site has access to the current SOP or manufacturer instructions for all POCT methods in use.
Review includes QC trends, invalid runs, operator errors, reagent issues, and corrective actions.
Deficiencies are documented, investigated, and closed with evidence of follow-up.
Only approved tests, instruments, and specimen types are in use at this location.

Operator Competency

Only approved operators are performing POCT on the date of inspection.
Training records show completion of method-specific training before the operator tested patients independently.
Competency is current per site policy and manufacturer requirements.
Inspector verifies the operator understands specimen handling, timing, and result entry steps.
Operator can explain how critical values are communicated and documented according to policy.

Reagent and Material Control

No expired strips, cartridges, calibrators, or control materials are available for patient use.
Open-date tracking is visible and consistent with manufacturer stability limits.
Record actual storage temperature observed or from the current log; acceptable range should match the product IFU.
Materials are segregated, clearly identified, and protected from environmental exposure.
Lot traceability is maintained for reagents and control materials used in testing.

Quality Control and Test Runs

QC frequency matches the SOP and manufacturer IFU for each POCT method.
Control results are reviewed and documented as acceptable before patient testing is released.
There is evidence of investigation, repeat QC, and escalation when controls are out of range.
Calibration, verification, or lot-to-lot checks are documented when required by the method.
Records support traceability for each test event, including operator ID and instrument ID.

Documentation and Records

Logs show who performed QC, when it was performed, and the result.
Documentation identifies the issue, action taken, and follow-up to prevent recurrence.
Training, QC, maintenance, and competency records can be produced promptly for review.
Critical values include notification time, recipient, and read-back or escalation documentation when required.

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