Inter Laboratory

Comparisons
Labs for Life Project
QUALITY CONTROL TRAINING

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Inter Laboratory Comparison
(ISO: 15189; 5.6.3)
The laboratory shall participate in an inter-laboratory comparison
programme(s) (such as an external quality assessment programme
or proficiency testing programme) appropriate to the examination
and interpretations of examination results. The laboratory shall
monitor the results of the inter-laboratory comparison
programme(s) and participate in the implementation of corrective
actions when predetermined performance criteria are not fulfilled
The laboratory should participate in inter-laboratory comparison
programs that substantially fulfill the relevant requirements of
ISO/IEC 17043.
Why ILC/ EQA?
External Quality Assurance (EQA) monitor the accuracy of the
laboratory’s methods on an ongoing basis.
It enables the lab to compare itself with others using the same method
for the same analyte.
Essentially EQA involves use of the same sample in several labs and
comparing the lab’s results with that of others performing the same test
by the same method.
Participation in EQA enhances the confidence of the lab in its results. It
also enhances the users’ confidence in the lab they use for their tests.

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Common of Inter Laboratory
Comparison Programs
1. Proficiency Testing (PT/ EQAS)
2. Exchange of samples with other
laboratories

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Alternative Approaches
3. Certified reference materials
4. Samples previously examined
5. Material from cell or tissue
repositories
6. Control materials that are tested
daily in inter-laboratory comparison
programs (Peer Group)

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 Unlimited
participants (n)
Unknown
Sample
ILC -1 Frequency:
PT/EQAS Lab 1 Variable
Lab 2
Lab 3

Lab 9
PT/EQAS
Providers Lab 4

Lab 8

Lab 5

Lab 7 Lab 6
 Unlimited
participants (n)
ILC -2 Peer
Known Sample
Group Frequency: Daily
Lab 2
Lab 3
Lab 1

Lab 9
IQC Lab 4

Providers
Lab 8

Lab 5
Lab 7
Lab 6
ILC -3 Exchange Limited
Sample participants
N: Not
robust
Known
Samples
Your Lab Sample Frequency:
Variable

Lab 1 Lab 2
Let’s discuss each …….

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 Inter-lab Comparison 1
Proficiency Testing (PT/ EQAS) Programs
1. The PT provider sends laboratories several samples
from a common pool. Unknown values
2. Each laboratory analyzes these samples just as they
would patients.
3. Each laboratory reports its results to the PT provider
4. The PT provider evaluates the results according to
specified criteria.
5. The PT provider notifies each laboratory as to the
quality (proficiency) of the results in a report.

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Enrolling in EQAS
Check out the PT/ EQA options for the required test: (See annexure of
module for some suggestions)
Check out the schedules (frequency of samples)
Check out the “N”: Number of participants
Check out the report attributes
Check out the forms of calculations and computations
Check out cost…..

Talk to your management….

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Running EQA samples
The laboratory shall establish a documented procedure
Reconstitute carefully as per PT providers instructions
Run along with routine samples, just like routine samples. No special
treatment to be given to PT samples
To be run by the personnel who does routine tests on the equipment
Do not resort to self defeating actions like sending your EQA samples
elsewhere. File your own reports
Do not discuss the result with any neighbouring labs

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Reviewing EQA reports
The performance in interlaboratory comparisons shall be reviewed and
discussed with relevant staff.
When predetermined performance criteria are not fulfilled (i.e.
nonconformities are present), staff shall participate in the implementation
and recording of corrective action. The effectiveness of corrective action
shall be monitored. The returned results shall be evaluated for trends that
indicate potential nonconformities and preventive action shall be taken.

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EQAS PT Report Attributes
The following are the requirements that should be
available on PT reports
1) Analyte name 6) Mean
2) Units of reporting of a 7) Expected Range
parameter 8) SD
3) Survey sample ID 9) SDI/Z score/other
4) Reported results parameters for
5) N: the number of comparison
participating labs. 10) Grade/ Acceptability

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An EQAS result
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N
• If N is too low, statistics may not be calculated for
that peer group by the PT provider.
• The higher the N, the better an estimate of the
target value determined for that PT sample.
• The higher the N, the more data points can be used
to calculate the SD for the group.
• The higher the N, the less impact aberrant results or
incorrectly defined outliers will have on the group’s
SD and/or mean.

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Acceptable Performance Criteria
Defines the limits of acceptability for the used to determine the
limits of acceptability for the analyte
Can be determined by one of three ways
1. Target Value ± specified value
2. Percentage
3. Multiple of PT group standard deviation (SD) 2 or 3 SDs

It is the responsibility of the PT provider to clarify the method of acceptance/

rejection

It is the responsibility of lab to understand the method of acceptance/

rejection

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 EQAS Reports

What is the acceptance criterion here?

Z score, same as SDI; Lab Value or Result – Mean (of all inliers)/ Group SD should be
≤3

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Navigating an EQA report!
Graphs, Plots, Figures,
Scores
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Scoring Systems
• SDI (Standard Deviation Index) / Z score
• VIS Scores
• The Target Score (TS) and %Deviation
• %Deviation by Concentration
• Z Scoring Within and Among Labs
• Within/ Out-with consensus
Target Deviations for Performance Assessment
Standard Deviation for Performance Assessment (SDPA).
It is the responsibility of the PT provider to clarify the scoring system

It is the responsibility of lab to understand the scoring system

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Cumulative Reports
Cumulative reports will also be made available by some providers
giving a quick overview of the performance of the lab, analyte
wise.

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Within and Among Lab Z scores, AIIMS EQA

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VIS SCORING: CMC Biochemistry

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 VIS
The VIS or Variance Index Scoring is used by CMC
Vellore Biochemistry EQAS.
It uses CCV (Chosen Co-efficient of Variation) &
DV (Designated Value/ Expected value) in
calculation
CCV is Allowable Limit of Error for an analyte
(similar to TEa) the sum of both imprecision and
bias.
This method has been set & recommended by
WHO after studying the performance of many
Indian labs
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 VIS
The calculation is done in 2 steps.
% Variation [%V] = {(Reported Value – Expected value)/ Expected
Value} *100
Variance Index = (% V/ CCV) X 100

Example: If in a Glucose EQAS cycle, the Expected Value is 120 mg %

and Reported Value is 95 mg%,
% Variation [%V] = {(120-95)/ 120} X 100 = 20.8
VIS = (20.8/7.5)* 100 = 277

Lower the VIS, better the lab’s accuracy. Ideally the VIS should be less than
100. The CMC scores all VIS < 50 as zero score. Any score>400, it is given as
400. Any VIS score >150 requires investigation and corrective action.

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Comparator Histograms

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Plots
The Levey-Jennings like chart plots previous
SDI's is extremely useful for monitoring EQA
performance over time
Yundt Plots: allows quick and easy
identification of any trends or bias.

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Youden Plot

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 Youden Plots (CMC, Hemostasis)
EQA schemes use two control samples of different levels in order to
check different Clinical Decision Levels
This allows comparison of the relationship of each level’s value to the
group’s performance.
Youden plot is a rectangular chart of which the four angles correspond
to the control limits of the two control levels [-4SD - +4SD]
The acceptable part, the mid-zone and the rejected part may have
different color coding
Each dot represents a different laboratory and therefore Youden plot
describes the whole EQAS scheme
Dots (laboratories) that lie across the diagonal of the rectangular, at 45o
(The Manhattan Mean or MM), but are far from the center correspond to
laboratories with proportional analytical error

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 RESIDUAL: NARI EQAS
TARGET
VALUE -
MEAN
Inter-lab Comparison 2
Exchange of samples
 Where no formal PT program is available,
ISO recommends “exchange of samples
with other laboratories” as an alternate
method. 5.6.3.2.
 Periodicity of testing, acceptance criteria,
authority for review of acceptance should
be defined for each analyte and
documented.
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ILC -3 Exchange Limited
Sample participants
N is very
low
Known
Samples
Your Lab Sample Frequency:
3-4 months

Lab 1 Lab 2
When? What is the frequency?
What will be the acceptance criteria?
NABL 112
Non-availability of a formal national PT programme for analytes
of interest
Only few laboratories performing the test
The analyte to be measured is unstable e.g. blood gases,
ammonia
Control material of the same matrix is not available
The sample is completely consumed during performance of the
test (e.g. ESR)

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 NABL 112
When the laboratory exchanges samples with other laboratories
as an alternative approach to EQA participation, following needs
to be addressed:
In the case of comparison between 2 laboratories, one will function as
the “reference laboratory” against which the other will be compared. This is to be
documented as an MoU
When there are several laboratories, compare the result against the
“reference laboratory”-
The results obtained shall be compared statistically and for guidance, the
laboratory may refer to the most current edition of CLSI document EP9 -
Measurement Procedure Comparison and Bias Estimation Using Patient Samples.

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Inter-lab Comparison 3
peer group

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Other forms of Proficiency
Testing
Inter –Observer Variance
Qualitative PTs

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Exchange of Samples / inter observer
variance Documentation
Parameter Lab 1 Lab 2 % Difference Acceptability Comment
Criterion

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EQAS: TROUBLESHOOTING AND
CORRECTIVE ACTIONS: Spurious errors
As EQAS is appraising the analytical part of the testing, all
effort should be directed at avoiding careless mistakes
which will result in meaningless EQAS reports
1. Incorrect classification of testing methods leading the
service provider to analyze the lab’s report with the
wrong peer
2. Incorrect units / conversion leading the service provider
classify the reports as incorrect
3. Incorrect sample tested. If there is a serial number / lot
number in the lyophilized testing material caution must
be exercised in identifying the sample correctly

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EQAS: TROUBLESHOOTING AND
CORRECTIVE ACTIONS : Technical errors

Improper reconstitution/ inadequate

mixing.
o Not including all the lyophilized material
o Not following the instructions for
reconstitution
o Not using a calibrated pipette
Transcription errors

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EQAS: TROUBLESHOOTING AND
CORRECTIVE ACTIONS : Actual Analytical
errors
Relook at the IQC data; Are there trends? High/low bias?
Change in reagents?
Changes in calibrators?
Look for acceptance testing details, lot verifications.
Storage of reagents, Calibrators?
Change in the environment?
Water quality?
Operator?
Investigate Equipment performance: aspiration system, incubators,
cuvette systems, optical system, refrigeration systems
Document it!!!!.......CA Format in annexure
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5.6.4

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NABL 112
Comparability of results if the laboratory uses
• more than one measuring system where the measurements are not
traceable to the same reference material / reference method
• the biological reference interval are different,

it is essential to perform a comparability study between the systems

and prove that there is agreement in performance throughout
appropriate clinical intervals at least twice in a year using suitable
statistical procedures such as Bland - Altman plot and / or regression
analysis.
A written procedure and complete record of all such data shall be
retained till the next assessment.

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Thanks
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