ASCP Laboratory Operations 2

Question 1

In Westgard rules for quality control, the 1:3s rule means:

Accepted Answer

One QC result exceeds 3 standard deviations from the mean — reject the run

Answer

Ten consecutive QC values on the same side of the mean

Answer

Two consecutive QC results exceed 2 standard deviations

Answer

Four consecutive results exceeding 1 standard deviation in the same direction

Question 2

Reference interval verification in a new laboratory minimally requires:

Accepted Answer

At least 20 healthy subjects when adopting manufacturer or published reference intervals

Answer

200 healthy reference subjects

Answer

500 patients with known diagnoses

Answer

No validation if using FDA-cleared reagents

Question 3

The delta check in laboratory medicine is designed to detect:

Accepted Answer

Significant changes in a patient's results that may indicate specimen mislabeling or acute clinical change

Answer

Analytical errors in the QC material

Answer

Reagent lot-to-lot variation

Answer

Instrument calibration drift

Question 4

Which ISO standard is specifically designed for medical laboratory quality management?

Accepted Answer

ISO 15189

Answer

ISO 9001

Answer

ISO 14001

Answer

ISO 27001

Question 5

When a critical (panic) value is generated for a patient, what is the immediate required action?

Accepted Answer

Immediately notify the responsible healthcare provider and document the communication

Answer

Repeat the test before taking any action

Answer

Report the result in the LIS and wait for the provider to see it

Answer

Call the patient directly

Question 6

Root cause analysis (RCA) in the laboratory is conducted primarily to:

Accepted Answer

Identify the fundamental system or process failures that allowed an error to occur and prevent recurrence

Answer

Assign blame to the technologist who made the error

Answer

Document errors for regulatory inspection purposes only

Answer

Discipline employees who deviate from procedure