Module 4: Quality Control

Question 1

4 purposes of quality control

Answer 1

1. systematic monitoring
2. detect analytical error
3. prevent reporting of incorrect patient test results
4. performance monitoring

Question 2

a definitive procedure that produces a test result

Answer 2

analytical method

Question 3

4 qualities of an analytical method

Answer 3

accurate
relevant
effective
reproducible

Question 4

ability of a method to detect small quantities of an analyte

Answer 4

analytical sensitivity

Question 5

ability of a method to detect only the analyte it is designed to determine

Answer 5

analytical specificity

Question 6

5 qualities of a control material

Answer 6

1. must be insufficient quantity
2. must last at least a year
3. aliquoted in stable form
4. minimal variation between vials
5. spans clinically important range

Question 7

what is the stable form of a control material

Answer 7

lyophilized

Question 8

two levels lf control material

Answer 8

L1 - normal control

L2- abnormal control

Question 9

what values are compared in quality control

Answer 9

determined values

expected values

Question 10

what is being tested in quality control

Answer 10

analytical methods

Question 11

for highly precise assays, control materials must be analyzed for:

Answer 11

5 days

Question 12

for less precise assays, control materials should be analyzed for

Answer 12

at least 20 days