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Section 3 of 6 · Open sections

Required section · Section 3 of 6

Building the risk assessment and choosing controls

A risk assessment uses laboratory-specific evidence: instructions for use, verification data, maintenance and troubleshooting records, alerts, QC and PT history, corrected reports, complaints, process maps, and competency records. Record the failure mode, likely cause, effect, safeguards, remaining risk, and chance to detect it before it reaches a patient result.

Build the QCP from the risks actually found. Internal checks, external controls, PT, calibration or maintenance, and competency are complementary layers; select their type, frequency, and levels from the applicable procedure or QCP and the evidence for this test system. No layer substitutes for a control that can detect the relevant failure sooner.

Before using a QCP, the laboratory director must sign and date the required approval without improper delegation. If the approval is missing, unsigned, or improperly delegated, do not use the QCP until the required approval is documented.

Choose a control because it can catch the stated failure in time, then document the trigger that makes the laboratory reassess the plan.

Illustrative drawing — this picture was drawn rather than captured.

Risk worksheet showing the six required columns of failure mode, cause, effect, existing control, residual risk, and detectability filled in with the reagent lot example, above a box listing the minimum evidence sources for a risk assessment.
Figure 1Risk worksheet columns filled in with the reagent-lot entry, plus the minimum sources of evidence behind it.

Illustrative drawing — this picture was drawn rather than captured.

Layered quality-control plan diagram showing internal checks, external QC, PT, calibration or maintenance, and training as complementary controls whose frequency and levels are set by the applicable procedure or QCP.
Figure 2Quality-control layers selected for the risks in the applicable procedure or QCP; each layer has its own purpose and documented timing.
Minimum risk-assessment categories and one example finding in each, from a nonwaived quantitative test system.
CategoryExample finding recorded
SpecimenWhole-blood specimen stability and mixing before loading on the analyzer
EnvironmentRefrigerator and courier temperature control for controls and reagent
ReagentNew lot verification and shipment temperature review before use
Test systemInternal electronic check scope; what it can and cannot detect
Testing personnelTraining and competency records for staff loading a new reagent lot

Knowledge checks

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Knowledge check 1

Which categories are the minimum a risk assessment must cover, according to CMS guidance? Select all that apply.

Choose at least 5 options.

Knowledge check 2

CLSI EP23, second edition, adds detectability to a risk entry alongside failure mode, cause, effect, existing control, and residual risk. What does detectability actually describe?

Choose one option.

Knowledge check 3

Under 42 CFR 493.1256, controls must be tested again in which of the following situations before patient testing resumes?

Choose one option.

Section status

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