Quality Control & Process Improvement Flashcards
7 cards from real CLC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Control & Process Improvement flashcards as text
A laboratory consultant recommends switching from fixed-limit QC rules to patient-based QC (PBQC). The MAIN advantage of PBQC is:
Answer: It detects analytical errors using patient result distributions in real time
Patient-based QC monitors the moving average or distribution of patient results to detect shifts and trends that may indicate analytical errors as they occur.
In failure mode and effects analysis (FMEA), which calculation determines the priority for addressing a potential failure?
Answer: Risk Priority Number (RPN)
The Risk Priority Number (RPN) = Severity × Occurrence × Detectability, and higher RPNs indicate which failure modes require the most urgent corrective action.
A laboratory's sigma metric for a glucose method is calculated as 3.8. According to Six Sigma quality planning, this level requires:
Answer: Tighter QC rules and more frequent monitoring
A sigma metric of 3.8 indicates borderline performance; tighter Westgard rules and increased QC frequency are required to ensure error detection.
Which concept describes the smallest difference between two patient results that is clinically significant, used to set allowable error goals in laboratory QC?
Answer: Reference change value (RCV)
The reference change value (RCV) represents the minimum difference between serial results that is clinically meaningful, accounting for both analytical and biological variation.
A laboratory wants to validate a new point-of-care glucose meter against the central laboratory analyzer. The MINIMUM number of patient samples recommended by CLSI EP09 for a basic method comparison is:
Answer: 40 samples
CLSI EP09 recommends a minimum of 40 patient samples spanning the analytical measurement range for a valid method comparison study.
A value stream map is being created for a laboratory's chemistry testing process. Which Lean activity does the value stream map PRIMARILY identify?
Answer: Steps that add value versus non-value-added waste
Value stream mapping visualizes the entire workflow to distinguish value-adding steps from non-value-added (waste) steps that should be eliminated.
When a laboratory corrective action plan is developed after a QC failure, which element is ESSENTIAL to include for the plan to be effective?
Answer: Defined timelines and responsible parties for each action item
Effective corrective action plans must include specific action items, assigned responsible individuals, and deadlines to ensure accountability and timely resolution.