Weqas

Unit 6, Parc Tŷ Glas

Llanishen
Cardiff
CF14 5DU

Tel: 02920 314750

Fax: 02920 314760
Email: contact@weqas.com

New Reports & Interpretation

Annette Thomas
 The Reports – what’s different?
• Weqas SDs have been replaced by TAE (Total Allowable Error).
• This provides a better description of the Analytical performance
specification as these are not based on the SD of the distribution,
(Clinically relevant criteria/ biological variation/ state of the art).

• Performance specification limits = target value ± TAE

• SDI has been replaced by PI (Performance Index)
• PI = (your result – target value)
(TAE/2)

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 Poor performance monitoring

Interpretation of PI and % poor PI

% poor PI
P.I. ranges

PI < 1 Good <1 Good

1–2 Acceptable

PI 1-2 Acceptable >2 Poor

PI> 2 Unacceptable (outside TAE) Distribution

Overall Laboratory SDI has been replaced by % poor PI as the overall

performance index. This represents the proportion of tests which obtained a
poor score or were not returned
e.g. you measured 30 analytes on 3 samples on 2 instruments (180 tests) and
had 5 PI scores > 2, therefore the overall % poor PI = 5/180 = 2.8%. Provides
equal weighting for all the samples rather than averaging an SDI score.

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The Reports – Manager’s Summary - Quantitative
Old Quantitative Analyte Data New
Running P.I. analyte-sample Scores
This distribution
P.I. ranges
Your % Poor P.I. 12%
<1 Good
Median all participant % 4%
1–2 Acceptable
Poor P.I.
>2 Poor
97.5th Centile % poor P.I. 14%

P.I. Scores
Location Location Name Location Name 2 Location Name 3
1
Instrument 15Character 15Character 15Character 15Character 15Character
Name Name Name Name Name Name
Instrument Serial#00001 Serial#00002 Serial#00003 Serial#00004 Serial#00005
Serial #
analyte Name
NRR NRR 0.78 N/A 5.28
1
analyte Name
NRR NRR 0.69 1.18 5.01
2
analyte Name
NRR NRR 0.58 1.29 4.95
3
analyte Name
NRR NRR 0.92 1.02 4.82
4
analyte Name
NRR NRR 0.38 1.38 5.29
5
analyte Name
NRR NRR 0.14 1.01 6.01
6
analyte Name
NRR NRR 0.68 0.84 4.92
7
analyte Name
NRR NRR 0.25 0.78 5.12
8
analyte Name
NRR NRR 0.31 N/A 4.98
9
analyte Name
NRR NRR 0.42 N/A 5.34
10
Overall %
NRR NRR 3.3% 9.5% 66.6%
poor P.I.
 The Reports – Manager’s Summary - Quantitative
Version 2: users chooses to include
Group Version: individual participant breakdown,
Version 1: user chooses not to small number of participants in the
include individual participant group
breakdown This distribution
 Group report Your % Poor P.I.Overall group 3%
FGA0001 2%
o Your % poor PI should be This distribution FGC0001 5.2%
Your Group % Poor P.I. 3% FHA0001 3.1%
calculated based on all the Median all participant % Poor P.I. 4% Median all participant % Poor P.I. 4%
tests for all the instruments 97.5th Centile % poor P.I. 14% 97.5th Centile % poor P.I. 14%

in the group Location Instrument Instrument

Overall % Poor
Serial # Name

Analyte name 10

Analyte name 11

Analyte name 12

Analyte name 13

Analyte name 14
Participant code

Analyte name 1

Analyte name 2

Analyte name 3

Analyte name 4

Analyte name 5

Analyte name 6

Analyte name 7

Analyte name 8

Analyte name 9
o Include a preference option

P.I..
for a group level user to
AB123456789C Link 0.98 ##.# ##.## ##.# ##.# ##.# 1.02 ##.# ##.# ##.# N/A N/A N/A 0.98 6.1%
choose whether or not to A1
BC123456789D North 1.52
# # # #
1.68
# # #
N/A N/A N/A 0.98 12.1
%
include the % poor P.I. for
XYZ0001
South 0.45 0.52 ##.# ##.# ##.# N/A N/A N/A 0.98 18.1
# # # %

each of the participants A2 North CD123456789E 2.58 N/A ##.#

#
##.#
#
##.#
#
N/A N/A N/A 0.98 33.3
%
A2 South DE123456789F ? ? ##.# ##.# ##.# N/A N/A N/A 0.98 81.8
within their group on this Bed 1 ? N/A
#
##.#
#
##.#
#
##.# N/A N/A N/A 0.98
%
33.3
# # # %
report A3 Link Trauma
Bed 2 ? N/A ##.#
#
##.#
#
##.#
#
N/A N/A N/A 0.98 33.3
%
XXZ0001

A4 North EF123456789G ? ? ##.# ##.# ##.# N/A N/A N/A ? 100

# # # %
A4 South FG123456789H 0.87 1.21 ##.# ##.# ##.# N/A N/A N/A 0.98 21.2
# # # %
A5 North GH123456789I 0.25 28.4 0.28 ##.# ##.# ##.# N/A N/A N/A 2.98 15.1
(H&N/ENT) 5 # # # %
18.2
ZZZ0001

Outpatients ##.# ##.# ##.# ##.# ##.# ##.# ##.# ##.# ##.# ##.# ##.# %
Clinic 1 ##.## ##.## ##.##
department # # # # # # # # # # #
 Manager’s Summary - Qualitative
Unit 6, Parc Ty Glas
Llanishen, Cardiff
CF14 5DU
office@weqas.com
Scheme Organiser: Annette Thomas

Old New

Qualitative analyte data

Running P.I. summary

This distribution
Your % Incorrect 12%
Median all participant % 4%
Incorrect
97.5th Centile % incorrect 14%

How do we calculate the % poor PI = % incorrect results

% poor PI? Participant Location Instrument Serial
Analyte Name 1 Analyte Name 2 Analyte Name 3 Analyte Name 4 Analyte Name 5

Sample 1

Sample 2

Sample 3

Sample 1

Sample 2

Sample 3

Sample 1

Sample 2

Sample 3

Sample 1

Sample 2

Sample 3

Sample 1

Sample 2

Sample 3
Name number

% of how many samples Correct Qualitative response Location

AAA001 SN0000001 Neg Pos Pos Pos Neg Pos Pos Neg Pos Neg Pos Pos Pos Pos Neg
you misclassified as a total Incorrect Qualitative response
Qualitative Performance not assessed
AAA001
Name 1
Location
Bay 2A SN0000002 Neg Pos Neg Neg Pos Pos Neg Neg Pos Neg Pos Neg Neg Pos Neg
Name 2
% of all samples assayed. N/A
NRR
Not enrolled for this analyte
Analyte enrolled but no results
AAA001
Location
Bay 2B SN0000003 NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR NRR
returned Name 2
N/S This quantitative analyte not scored Location
AAA001 SN0000004 Neg Pos Neg Equ Equ Neg N/A N/A N/A Neg Pos Neg Neg Pos Pos
for this distribution Name 3
NNR Non-numerical results submitted: P.I. Location
AAA001 SN0000005 Neg Pos Neg Pos Neg Pos Neg Pos Pos Neg Pos Neg Pos Pos Bor
not available Name 3
The Reports – Analyte Report - Quantitative
New

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 The Reports – what’s different?
Total Bilirubin (µmol/L)
Your Your result Your Method: Instrument Overall Scoring Non-
reported in standard Method Vanadate Model: Reference Scoring Method Summary Table – top 10 methods
result units Corrected Oxidation Advia Value Reference
(µmol/dL) (µmol/L) result Chemistry Value displayed
Mean 145.65 145.65 141.27
#.##
sd 5.36 5.36 10.59 B0917 sample 1 sample 2 sample 3 sample 4
Sample 1 14.5 145
U 1.537 1.537 0.738 #.### Method Name mean cv% mean cv% mean cv% mean cv%
n 19 19 322 Abaxis Piccolo (n=5) 131.2 3.4 6.4 9.7 177.0 2.4 312.2 2.0
Mean 4.03 4.03 4.35 Beckman LX/CX/DX (n=5) 140.8 2.5 4.0 51.9 188.7 2.7 341.5 1.4
#.##
sd 0.08 0.08 1.46 Diazo (n=62) 141.3 4.4 4.8 13.6 190.0 4.1 334.2 3.8
Sample 2 0.4 4
U 0.024 0.024 0.108 #.### IL Gas Analysers (n=44) 155.4 4.9 5.9 19.3 208.8 4.7 371.4 4.2
n 19 19 284 Radiometer Gas Analysers
Mean 198.02 198.02 190.67 (n=44) 149.7 5.5 5.7 26.4 202.1 4.6 359.6 3.7
#.##
sd 6.53 6.53 13.50 Rapidpoint 500 (n=6) 149.0 2.4 3.3 85.2 194.3 2.7 362.5 5.7
Sample 3 19.8 198
U 1.873 1.873 0.939 #.### Roche Diazo (n=127) 133.3 3.1 3.1 9.5 180.3 2.5 322.0 2.6
n 19 19 323 Siemens Gas Analysers
Mean 357.83 357.83 339.69 (n=4) 148.3 2.3 3.3 87.2 199.3 3.1 374.0 3.6
#.##
sd 13.57 13.57 24.08 Vanadate Oxidation (n=19) 145.7 3.7 4.0 2.1 198.0 3.3 357.8 3.8
Sample 4 35.4 354
U 3.891 3.891 1.685 #.### Vitros (T Bil) (n=3) 164.7 0.4 5.3 12.3 217.0 1.4 366.0 1.9
n 19 19 319
Results displayed in your units, can directly compare  top 10 method groups ordered in terms of
results across the columns for lab, method, decreasing values of n=#
instrument, overall and reference method.  Hyperlink allows the user to access the full method
summary table listing data for all the method
groups for that analyte

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 The Reports – what’s different?
PI Scores for this Distribution B0917
Running PI
Sample 1 2 3 4 average

scored
PI
against:
method 145.65 4.03 198.02 357.83
mean

TAE Weqas 16.70 3.52 21.48 35.84

Distribution
P.I. -0.08 -0.02 0 -0.21 0.08
This plot shows the current distribution and the previous 5
distributions in which this instrument was included, in date Critical level 150.00 µmol/L – Sigma Score 3.75
order from left (earliest distribution) to right (most recent
distribution

All the Samples are now plotted rather than just the Avg SDI States what is being used at the target value
States the performance specification limits (TAE)
Both negative and positive PIs are displayed PI score for each sample (+ or - )
Sigma score
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 Absolute –Bias plot Relative –Bias plot
Linear regression
y = 1.04 – 1.26
r = 1.0000
Your result - target

IS = 0
Sy.x = 1.09

bias key
x axis = target value
‘x’ = your current results
◊ = your previous results
° = your method mean
□ = your instrument model mean
Target value Target value

Red line represents target ± TAE, yellow line represents target ± Red line represents target ± TAE
0.5 TAE .
Previous Distributions are highlighted as separate series
Red area represents unacceptable results, PI >2
Yellow area represents acceptable results, PI = 1-2
White area represents good results, PI <1

Graph now includes previous results

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Histogram of results

80 Sample 1
250 Sample 2 70 Sample 4
70 80 Sample 3
60
60 200
50 60 50
40 150 40
30 40 30
100
20 20
50 20
10 10
0 0 0
0
123
127
132
136
141
145
149
154
158
163
167
171
0 3 6 8 11 14 17 20 22 25 28 31 167 173 179 185 191 198 204 210 216 222 228 234 301 311 321 331 341 351 360 370 380 390 400 410
μmol/L µmol/L µmol/L
µmol/L

Green – all results

Blue – Method
Pink - Instrument

Comments box
Weqas supplied comment for Total Bilirubin: Participant supplied comment for Total Bilirubin:
There is no comment for Total Bilirubin for this distribution Calibrator Lot # BB128974.
Awaiting engineer callout for scheduled maintenance

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The Reports – Analyte Report - Qualitative
New
Old

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 The Reports – what’s different?
Running PI Data Table
100% Method Instrument Sample 1 Sample 2 Sample 3
80% MethodName 2 InstrumentName Positive Positive Positive

60% Non-returns
Interpretation** Negative Negative Positive
40% Correct Spiked with xx from
Sample Description Non spiked Spiked to xx
Incorrect positive donor
20%

0% From <Associated Quantitative Analyte> results

ZZ0717 ZZ0917 ZZ1117 ZZ0118 ZZ0318 ZZ0518 Mean 5.1 7.3 23.1
SD 0.8 1.2 2.1
CV % 15.7 16.4 9.1%
Similar to the manager’s summary for qualitative Row 1: the responses reported by the User, colour coded according to the
analytes, this plot is a stacked % plot based on the performance classification assigned for that response.
performance interpretation of individual test
responses for the given analyte-instrument Where no result has been submitted, NRR would be indicated and coloured red
combination across all samples. Where no performance classification has been assigned (flagged to not score) the
response would appear with no coloured background applied
Row 2: The correct interpretation for that sample. Cut off for interpretation based
on clinical use / outcomes
Row 3: Description of the concentration / nature of the sample
Row 4 – 7: If the qualitative analyte has been associated with a quantitative
analyte in the same scheme, the table would include summary information for
that analyte.
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 Simpler and clearer than previous graphs

+ Your response

Correct response

Method Summary Table – top 10 methods displayed

sample 1 sample 2 sample 3
Detection Equivoca Equivoca Equivoca
limit Negative Positive l Negative Positive l Negative Positive l
Method 1 (n=51) 7 48 2 1 8 27 15 0 51 0
†Method 2 (n=16) 9 14 1 1 13 1 2 0 15 0 method group for the instrument to which this
Method 3 (n=25) 7 25 0 0 0 24 1 0 25 0 report relates is highlighted in bold.
Method 4 (n=30) 6 26 1 3 1 29 0 1 29 0
Method 5 (n=97) 7 92 3 2 2 90 5 0 97 0
Method 6 (n=12) 7 12 0 0 0 12 0 0 12 0
Method 7 (n=20) 7 18 2 0 0 19 1 0 20 0
Method 8 (n=4) 7 4 0 0 1 3 0 0 4 0
Method 9 (n=34) 7 31 1 2 5 26 3 1 33 0

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POCT Manager’s overview report
All the existing reports from Cuesee website will
be available but with improved formatting:

Overview report with link to reagent lot no.

Simplified report
No-results booked
Poor-performance report

Standard letters will also be made available:

Distribution letters
No results booked letter
Poor performance letter

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Other improved reports

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Simplified Reports – PI scores and % poor PI added

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Regional report – improved graphics.

for all instruments in the group, deviation reports provide absolute and % deviation from the
group mean on a per analyte basis
Available to print from your browser, or in PDF format to your email address
Regional report – available as a region/
group/ participant

A group can be
set up as an
individual lab
code with
multiple
sections or with
different lab
codes and
sections.
 15189 Compliance Report
To include:

Measurement uncertainty – Between batch SD over Provides between batch

length of batch. imprecision over length of
batch – 6 to 12 months for all
Accuracy - average bias over length of batch against sections.
reference method or peer group

Traceability to high order reference method (if available)

Sigma Score where:

δ = (TAE – Average Bias) / between batch CV%

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