Quality Management, Quality Assurance, Quality Control

Question 1

quality control material

Answer 1

samples used for QC procedures designed to monitor analytical activity of a method by alerting the operator when there is a problem
- concentration is known

Question 2

matrix

Answer 2

the substance used in QC which must be as close as possible to real humane species

Question 3

run

Answer 3

finite time period or number of patient samples

Question 4

Assayed control matieral

Answer 4

commercially prepared QC with a given specific mean and SD

Question 5

unassayed control matieral

Answer 5

Commercially prepared QC naterial that **Does not have specific ranges verified by the manufacturer **

Question 6

control limits

Answer 6

statistical criteria of acceptibility for particular control matieral, usually derived from the mean and SD

Question 7

control rule

Answer 7

decision critera for judging a control material as acceptable or not

Westagard MultiRules

Question 8

control chart

Answer 8

graphical method to display control results making it easier to determine if a control run is in our out of control

Question 9

accuracy

Answer 9

describes how close a test is to the true value

expressed as %

helps identify systematic error

Question 10

precision

Answer 10

refers to reproducibility of a test

expressed as %

helps to identify random error

Question 11

systematic error

Answer 11

• problem in measurement that affects all measurements in the same way
• predicatble
• measured by accuracy

Question 12

random error

Answer 12

• random events in the measurement process
• unpredictable
• measured by precision

Question 13

levy - jennings graph

Answer 13

graph consisting individual data points plotted on a graph of the mean and the control limits of the particular control level

allows us to visualize QC across time

Question 14

Shift

Answer 14

• consecutive oberservations above or below th emean
• representative of systematic error
• commonly accepted - 6 points on one side of the mean = shift

causes:
- improperly prepared reagents or controls
- change in lot numbers
- failure of an instrument

Question 15

trend

Answer 15

slow change in QC values of either rising or falling steadily acorss several days or weeks (in relation to each other)

systematic error

causes:
- reagent or lamp deterioratin
- temp fluctuation
- calibration shift

Question 16

R4s

Answer 16

one data point exceeding +2SD limit and nother data point exceeds -2SD limit (opposite directions)

Question 17

2of3s2

Answer 17

2 of 3 points exceeding either +2SD or the -2SD limit on the same side

Question 18

what testing factor has the most errors

Answer 18

preanalytical

Question 19

pre analytical

Answer 19

factors involve collection, specimen transportation and time before testing

• proper labeling
• timing of speciment collection
• proper specimen transport and carrier and temperature
• speciment holding time

Question 20

analytical factors

Answer 20

errors that occur during the testing phase

• instrument/ tech precision/accuracy
• calibration
• reagent status
• QC status

Question 21

postanalytical facotrs

Answer 21

errors that occur after test is obtained bu before resultis posted to chart or sent to physician
- computer errors
- calculation errors

Question 22

non analytical factors

Answer 22

errors not directly connected to the actual speciment testing, and more involved with the entire testing processs

• choosing approprate test
• hiring and training qualified staff
• instrument maintenance

Question 23

trend

Answer 23

data rising or falling consistently

relation is to each othe, not the mean

Question 24

shift

Answer 24

data consistently above or below the mean. relation is to the mean, not eachother.