EXTERNAL QUALITY CONTROL

INTERNAL QUALITY CONTROL (IQC)

IQC REFERS TO THE SET OF PROCEDURES
UNDERTAKEN BY THE LABORATORY
STAFF FOR THE
CONTINUOUS AND IMMIDIATE
MONITORING OF LABORATORY WORK IN
ORDER TO DECIDE WHETHER THE
RESULTS ARE RELIABLE ENOUGH TO BE
RELEASED.
EXTERNAL QUALITY ASSESSMENT (EQA)

EQA REFERS TO A SYSTEM IN WHICH THE

PERFORMANCE OF A LABORATORY IS
ASSESSED
PERIODICALLY AND RETROSPECITIVELY
by an independent outside agency to indicate to the
laboratory staff where there may be shortcomings and
hence indicates a need for improving and/or changing
IQC procedures.
 Why the need for EQC ?
 Internal QC programme is suitable to determine
the reproducibility of result daily (PRECISION).

 External QC programme is useful to assess the

closeness of a result to the actual value periodically
(ACCURACY).

 IQC detects systematic errors from the original baseline.

 Systematic errors present during the baseline period

are eliminated by EQC.
 External Quality Control
 Preparation of quality control serum by recognized body.
 Controls analyzed by the participating labs.
 This gives idea about the accuracy of analysis.
 Results are tabulated monthly and sent to the sponsoring
group for data analysis.
 Mean of all peer groups calculated = target value.
 Target value compared with individual lab result.
 Standard Deviation Index
Laboratory result – Group mean
 SDI =
Group SD

 Standard deviation index or interval > 2

indicates that laboratory not in agreement with
rest of the lab in programme.
 SDI value Interpretation
0.0 Perfect comparison with peer
0.0-1.0 Satisfactory
1.0-2.0 Acceptable to marginal performance.
Some investigation of test system is
required
> 2.0 Unacceptable performance. Remedial
action required.
 PRECISION INDEX & COEFFICIENT
OF VARIATION RATIO (CVR)
Standard deviation of laboratory
PI=
Standard deviation of peer group

The control limits of PI are < 2. Its chart is similar to

SDI chart.
CV of laboratory month
CVR=
CV of peer group month
 INTERPRETATION
Ratio < 1.0 Better than peer

Ratio > 1.0 Imprecision is high

Ratio > 1.5 Investigation

Ratio > 2.0 Troubleshooting

The combined SDI/CVR chart has the ability to evaluate
the total analyte’s performance (precision and accuracy).

CVR/SDI chart
Youden plot
 Two QC materials are used
 Observed mean for material A on x- axis
 Observed mean for material B on y- axis
 Ideally point for laboratory should fall at
center of the plot
 Points that lie near the 45-degree reference line
but far from the median, indicate large systematic
error.
 Points that lie far from the 45-degree line indicate
large random error.
 Points outside the circle indicate large total error.
VIS – Variance Index Score
 Recommended by ACBI.
 Made in use by CMC, Vellore.
 To assess the performance of different lab.
 CCV – Chosen Coefficient of Variation.
 % variation =

Diff. between Participants result & Designated value

X 100
Designated value
 Analyte CCV
Glucose 7.7
Urea 10.0
Total protein 7.5
Albumin 7.5
Calcium 6.0
Cholesterol 7.5
Sodium 2.3
Potassium 5.0
Creatinine 10.0
SGOT 12.5
SGPT 17.5
ALP 15.5
 E.g.. Lab value for pl. glucose = 85 mg%
 DV = 110 mg%
 % variation = 110-85
×100
110
= 22.7
Variance index = % variation
×100
CCV
= 22.7
×100
7.7
= 295
 INTERPRETATION
 VIS < 100  Very good

 VIS 100 – 150  Acceptable

 VIS 150 – 200  Carefully look for the methods for

which results are high or low.

 VIS > 200  Not acceptable. Indicates very erroneous

results.
 Proficiency Testing
 Specimens made from common pool are
analyzed by the laboratory enrolled in the program

 Compare test results with peer groups

 >2SD = unacceptable

 CLIA’88
 5 samples 3 times/year
 PT failure means 2 of 5 incorrect results on 2 of 3
consecutive PT survey

 On probation = > 2 incorrect results

 Suspended = ≥ 2 incorrect result on 2 of 3 survey

 SUMMARY:
How to implement a QC program?
 Establish written policies and procedures
 Assign responsibility for monitoring and reviewing
 Train staff
 Obtain control materials
 Collect data
 Set target values (mean, SD)
 Establish Levey-Jennings charts
 Routinely plot control data
 Establish and implement troubleshooting and corrective
action protocols