QUALITY ASSURANCE

Quality Control System in three stage process

Establishing allowable statistical limits of variation for each analytic
method
Using these limits as criteria for evaluating the QC data generated for
each test
Taking action to remedy errors when indicated.
a. Finding the cause/s of error
b. Taking corrective action
c. Reanalyzing control and patient data.
MEASURES OF CENTER: MEAN, MEDIAN & MODE
MEASURES OF SPREAD: RANGE, SD AND CV
 Terms:
Diagnostic sensitivity – ability of the test to
detect a given disease or condition.
Diagnostic specificity – ability of the test to
correctly identify the absence of a given
disease or condition.
Analytic sensitivity – ability of a method to
detect small quantities of an analyte
Analytic specificity – ability of a method to
detect only the analyte it is designed to
determine.
Positive predictive value – chance of an
individual having a given disease or condition
if the test is abnormal.
Negative predictive value – chance an
individual does not have a given disease or
condition if the test is within the reference
interval.
Efficiency - are intended to quantify how
useful a test is for a given disease or condition.
Efficiency = TP+TN/total # of tests x100
Specificity= (TN)/(TN + FP) x 100
Sensitivity = (TP)/(TP+ FN) x 100
PPV= (TP)/(TP + FP) x 100
NPV= (TN)/(TN + FN) x 100
True Negative (TN) - Individuals
without the condition who tested
negative
 True Positive (TP) Individuals with a
condition and tested positive
False Negative (FN) Individuals with
the conditions who tested negative
False Positive (FP) Individuals without
the conditions who tested posiitve
Levey Jennings Control Chart
 Multirules: Decision criteria to determine if an analytic run is
in-control; used to detect random and systemic error

12s One control observation exceeding the mean +- 2s. A warning rule that initiates testing of
control data by other rules

1 3s One control observation exceeding the mean -3s. Allows high sensitivity to random error

22s Two control observation consecutively exceeding the same +2s or -2s. Allows high
sensitivity to systemic error

R4s One control observation exceeding the +2s and another exceeding the -2s Allows detection
of random error

41s Four consecutive control observation exceeding +1s or -1s. Allows detection of systemic
error

10x Ten consecutive control observation falling on one side or the other of the mean. Allows
detection of systemic error
One control observation exceeding the mean +- 2s. A warning rule that initiates testing of control
data by other rules

One control observation exceeding the mean -3s. Allows high sensitivity to random error
Two control observation consecutively exceeding the same +2s or -2s. Allows high sensitivity to
systemic error

One control observation exceeding the +2s and another exceeding the -2s Allows detection of random
error
Four consecutive control observation exceeding +1s or -1s. Allows detection of systemic
error

Ten consecutive control observation falling on one side or the other of the mean.
Allows detection of systemic error
 Lean Six Sigma
Lean six sigma uses a problem-causes-solution methodology to improve any
process through waste elimination and variation reduction.
Lean was designed to eliminate non-value-adding steps
Six Sigma aimed to reduce variation.

It uses Define-Measure-Analyze-Improve-Control (DMAIC )

Five-step approach to process improvement.
• Define phase - explicitly describes the quality improvement issues
• Measure phase - collects data to measure the process
• Analyze phase - searches for the root cause of inefficiencies in the process.
• Improvement phase - process changes that seek to continues to measure the
process and ensures changes are maintained
• Control phase - continues to measure the process and ensures changes are
maintained
END
 4
17 22
Check for any violation in Westgard Rule.
Indicate the value of the and decide if it is due to random or
systemic error
Quiz
#1 Pregnant Non-Pregnant
hCG (+) 8 3 FP
TP
hCG (-) 2 12
FN TN
#2 Prostate CA No Prostate CA
PSA (+) 30 TP 6 FP
PSA (-) 9 45
FN TN
#3 Diabetes Non-Diabetes
FBS (>110 mg/dL) 3 TP 95 FP
FBS (70-110 mg/dl) 2 80
FN TN
#3 Chronic Kidney Disease (CKD No CKD
Creatinine (>500 umol/L) 10 TP 90 FP
Creatinine (70-110 umol/L) 5 75 TN
FN

Compute for:  PPV

 Efficacy  NPV
 Sensitivity
 Specificity
 Last Month’s QC Values (BUN mg/dl)
for establishing the QC Range
D 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
a
y
V 85 9 67 82 99 98 73 60 92 88 74 69 83 45 55 87 64 72 86 93
a
l 0
u
e

Check for any violation in Westgard Rule.

Indicate the value of the and decide if it
is due to random or systemic error
 Last Month’s QC Values (Cholesterol
mg/dl) for establishing the QC Range
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Value 125 138 150 165 110 155 138 148 175 160 140 152 135 160 135 154 160 178 148 130

Check for any violation in Westgard Rule.

Decide if it is due to random or systemic
error