Checklist Phase 2 - Assessment

Has the laboratory formulated quality controls to guard the quality of each process step in each procedure?

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Are internal quality control results recorded in a register?

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Are internal quality control protocols included in all relevant SOPs?

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Does the laboratory have an SOP for Internal Quality Control that contains:

  • An explanation on the concept of internal quality control
  • The general procedure for performing an internal quality control
  • Procedure for developing internal quality control materials
  • The procedure for periodic review of internal quality controls
  • The procedure to follow when an internal quality control fails

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Does the laboratory monitor internal quality control results and act on quality control failures?

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Are internal quality control results continuously monitored?

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Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends?

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Is reporting of results halted when internal quality controls deviate/fail?

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Does the laboratory participate in proficiency testing/inter-laboratory comparison schemes for all the examinations performed?

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If participation in a proficiency testing scheme or organization of an inter-laboratory comparison for a certain test is not possible: does the laboratory have a rechecking/retesting system to compare results?

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If results of proficiency testing/inter-laboratory comparisons are deviating/incorrect, does the laboratory act with performing an analysis to identify the causes of the problem and does it implement corrective actions, and, if possible, preventive actions?

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Does the laboratory have an SOP for participation in a proficiency testing scheme and/or an inter-laboratory comparison scheme?

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If the laboratory is the organizer of an inter-laboratory comparison scheme, does the SOP for External Quality Assessment include the procedure for organizing this?

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If the laboratory rechecks/retests samples for a certain test (in case no PT or inter-laboratory comparison was possible), does the SOP for External Quality Assessment include the procedure for organizing this?

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