Point of Care Testing Quality Verification

Inspection template for auditing POCT quality controls, operator competency, reagent expiry, control runs, and documentation practices.

Program Oversight

• POCT director or designee identified and accountable for oversight
  A responsible individual is named for POCT oversight, including review of QC, competency, and non-conformances.
• Current POCT procedure manual available at testing site
  Site has access to the current SOP or manufacturer instructions for all POCT methods in use.
• Documented review of POCT quality indicators completed on schedule
  Review includes QC trends, invalid runs, operator errors, reagent issues, and corrective actions.
• Non-conformances and corrective actions are tracked to closure
  Deficiencies are documented, investigated, and closed with evidence of follow-up.
• Testing menu matches approved POCT scope for the site
  Only approved tests, instruments, and specimen types are in use at this location.

Operator Competency

• Operator authorization list is current and matches staff performing testing
  Only approved operators are performing POCT on the date of inspection.
• Initial training documented before independent testing
  Training records show completion of method-specific training before the operator tested patients independently.
• Competency assessment completed within required interval
  Competency is current per site policy and manufacturer requirements.
• Operator can demonstrate specimen collection and test workflow
  Inspector verifies the operator understands specimen handling, timing, and result entry steps.
• Operator understands critical result escalation and documentation process
  Operator can explain how critical values are communicated and documented according to policy.

Reagent and Material Control

• All reagents and consumables are within manufacturer expiration date
  No expired strips, cartridges, calibrators, or control materials are available for patient use.
• Opened reagent or control material is labeled with open date and discard date
  Open-date tracking is visible and consistent with manufacturer stability limits.
• Storage conditions are within required temperature range
  Record actual storage temperature observed or from the current log; acceptable range should match the product IFU.
• Reagents and controls are stored to prevent contamination or mix-up
  Materials are segregated, clearly identified, and protected from environmental exposure.
• Lot numbers recorded for patient-facing reagents and controls
  Lot traceability is maintained for reagents and control materials used in testing.

Quality Control and Test Runs

• Required QC levels performed at the correct frequency
  QC frequency matches the SOP and manufacturer IFU for each POCT method.
• QC results are within acceptable limits
  Control results are reviewed and documented as acceptable before patient testing is released.
• Failed QC triggers documented troubleshooting and repeat testing
  There is evidence of investigation, repeat QC, and escalation when controls are out of range.
• Calibration or instrument verification performed when required
  Calibration, verification, or lot-to-lot checks are documented when required by the method.
• Patient test runs are traceable to operator, instrument, and date/time
  Records support traceability for each test event, including operator ID and instrument ID.

Documentation and Records

• QC logs are complete, dated, and signed or electronically attributable
  Logs show who performed QC, when it was performed, and the result.
• Corrective action documentation includes root cause and resolution
  Documentation identifies the issue, action taken, and follow-up to prevent recurrence.
• Records retained per policy and readily retrievable
  Training, QC, maintenance, and competency records can be produced promptly for review.
• Critical results and abnormal findings documented according to policy
  Critical values include notification time, recipient, and read-back or escalation documentation when required.