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Section 2 of 6 · Open sections

Required section · Section 2 of 6

Three parts of an individualized quality control plan

An IQCP is a locally evidenced alternative quality-control plan, not an automatic reduction in controls. It links a risk assessment, a written QCP, and ongoing quality assessment.

The risk assessment identifies how the test system can fail; the QCP records controls that reduce those risks, including their documented timing and acceptance criteria; quality assessment monitors whether the plan works and triggers review.

Confirm current jurisdiction and accreditor applicability before adopting the plan. The opening reagent-lot event shows why the three parts must work together: identify the lot-change risk, set controls that can detect it in time, and reassess the plan after a failure.

Illustrative drawing — this picture was drawn rather than captured.

Bow-tie diagram showing a reagent lot and temperature excursion cause leading through a central failure mode of reagent degradation to a positive bias effect, with preventive barriers on the left and detection and response barriers on the right.
Figure 1Bow-tie view of the reagent-lot failure mode, with preventive barriers on the left and detection and response barriers on the right.

The three connected parts of an individualized quality control plan, in the order a laboratory builds and then maintains them.

  1. Risk assessment

    Gather laboratory-specific evidence and identify failure modes across specimen, environment, reagent, test system, and testing personnel, through preanalytic, analytic, and postanalytic phases.

  2. Quality control plan

    Select and document layered controls, stating the number, type, frequency, and acceptability criteria that address the identified risks, at least as stringent as the manufacturer's instructions.

  3. Quality assessment

    Monitor on an ongoing basis whether the plan is actually detecting and controlling failures, and document any change that forces the risk assessment to be revisited.

Knowledge checks

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Knowledge check 1

A colleague says building an IQCP for a test system means the laboratory can now run external QC less often. Is that accurate?

Choose one option.

Knowledge check 2

Which of the following are the three required parts of an IQCP as described by CMS? Select all that apply.

Choose at least 3 options.

Knowledge check 3

What operational boundary applies before a laboratory adopts an IQCP?

Choose one option.

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