QUALITY CONTROL

Q
Q RIQAS Explained

Complete QC solutions for results you can trust

EQA

External Quality Assessment (EQA) is an essential aspect of any laboratory operation.

EQA provides a means of assessing the analytical performance of a laboratory compared
to other laboratories utilising the same methods and instruments.

Overall Objective of EQA

To develop interlaboratory comparability which allows standardisation of diagnostic testing. EQA measures a laboratory's
accuracy using 'blind' samples that are analysed as if they were patient samples. Results are returned to the scheme organiser
for statistical analysis. Laboratories receive a report comparing their individual performance against other participants in the
programme. EQA has a number of functions:

• Maintaining and improving the analytical quality of laboratory tests

• Improving interlaboratory agreement and raising standards

• Detecting equipment failures, identifying reagent problems, reviewing staff training

• Initiating and evaluating corrective actions

• Comparing different analytical methods

Participation in an EQA scheme will help produce reliable and accurate reporting of patient results. Quality results will reduce
time and labour costs, and most importantly provide accurate patient diagnosis and treatment.

RIQAS Support

RIQAS suppor t staff are on hand to offer advice and troubleshoot

technical queries.

RIQAS Programmes

• Ammonia/Ethanol • Immunosuppressant
• Anti-TSH Receptor • Lipid
• Blood Gas • Liquid Cardiac
• BNP • Maternal Screening
• Cardiac • Serology Epstein Barr Virus (EBV)
• Cerebrospinal Fluid (CSF) • Serology (HIV/Hepatitis)
• Clinical Chemistry • Serology (Syphilis)
• Coagulation • Serology (ToRCH)
• CYFRA 21-1 • Specific Proteins
• ESR • Sweat Testing
• Glycated Haemoglobin (HbA1c) • Therapeutic Drugs
• Haematology • Trace Elements in Blood
• Human Urine • Trace Elements in Serum
• Immunoassay • Trace Elements in Urine
• Immunoassay Speciality 1 • Urinalysis
• Immunoassay Speciality 2 • Urine Toxicology
1
 EQA

RIQAS is the largest international EQA scheme in the world. It is used by more than
35,000 laboratory participants in 123 countries. 32 programmes are currently available.

Accreditation

RIQAS provides certificates as proof of EQA participation and

performance for laboratory accreditation purposes.

RIQAS is a UKAS accredited Proficiency Testing Provider, No. 0010,

and is accredited to ISO/IEC 17043:2010, 'Conformity Assessment-
General Requirements for Proficiency Testing'.

Accreditation to ISO/IEC 17043:2010 highlights the superior quality

and excellence of RIQAS.

UK Performance Surveillance

• Recognised
 by the UK National Quality Assurance Advisory Panel
(NQAAP) for Clinical Pathology

• Recognised
 by the Joint Working Group on Quality Assurance
(JWG QA)

Independent Advisory Panel

RIQAS participants have access to an independent advisory panel

consisting of scientific and clinical experts. This ensures professional
and ethical conduct of the scheme and participant confidentiality.

RIQAS Facts

A good EQA scheme should have:

• Sufficient number of par ticipants • High quality material

• Effective consolidation of • Regular repor ts with rapid
programmes turnaround times
• International recognition through • Independent advisor y panel
accreditation • Flexible programme choices

2
Features and Benefits

RIQAS samples are custom-manufactured to be both stable and similar to human samples.

• A high level of participation ensures a large database of results and analytical methods, therefore increasing statistical validity.

• Programmes accepted by National and International accreditation bodies worldwide.

• H
 uman samples free from interfering preservatives increase confidence that EQA performance mirrors the performance of
patient samples.

• Optimised shipping of samples for each cycle.

• Wide range of parameters covering a broad spectrum of laboratory testing allowing for programme consolidation.

• Regular reports with rapid turnaround, ensuring corrective actions can be taken prior to analysis of subsequent samples.

 • User-friendly reports, easy to read at-a-glance, saving valuable laboratory time.

• Reduced parameter options for selected programmes offer greater flexibility, ensuring suitability for
laboratories of all sizes and budgets.

• Participant certificates provide evidence of participation in a reputable EQA scheme.

• Multi-instrument reports allow assessment of performance of all systems in the laboratory.

 • Interlaboratory group reports allow comparison of multiple

connected laboratories.

• Reference method values are provided in the Clinical

Chemistry programme for selected parameters and lots.

• Samples spanning clinically relevant levels, allows

identification of concentration related biases and ensures
accurate instrument performance.

3
 RIQAS Reports

RIQAS reports are presented in a user-friendly, one page per parameter format. This
allows easy interpretation of your analytical performance.

RIQAS Reports Multi-Instrument Reports

• S tatistical breakdown by all methods, your method and, where Laboratories can register up to five
applicable, your instrument including running means for the last 10 instruments at no extra cost. Individual
samples. reports for each instrument plus a unique
multi-instrument report are provided.
• C
 ompare your instrument group, method group and all methods using
the histogram. The multi-instrument report allows the
comparative performance of each instrument.
• Identify trends, biases and precision problems using the visual charts. Additional sample packs may be ordered as
required.
• The Target Score chart grades your performance in a moving window over
the last 20 samples, including the previous cycle.

• At-a-glance summary page for all parameters in the programme.

• Compare your result with statistically robust consensus means.

• Identify acceptable and poor performance using

fit-for-purpose performance indicators: RIQAS Facts

- SD1 Interlaborator y Group Repor ts:
- %Deviation
- Target Score The Group Repor ting facility enables laborator y groups to monitor
satellite sites. Laboratories can receive individual repor ts with the group
super visor receiving a repor t comparing the laboratories within the
group. This allows easy assessment of performance of all laboratories
within a group.

PDF Reporting

RIQAS reports can now be presented in PDF (portable

document format), offering easy review and storage of your
laboratory’s EQA data.

There are many advantages associated with PDF reporting,

increasing the usability and efficiency of data analysis.

Summary CSV files

It is possible to receive an additional summary of your

report statistics, acceptable limits and performance indicators
as a .csv file for every sample.

A retrospective statistics summary is also available four

weeks after the final date, for parameters where a result has
not been submitted on time.

4
Web-Based Data Transfer

RIQAS.Net offers easy, direct access for the submission of results and retrieval of reports
direct from the RIQAS host server.

• Available in multiple languages.

• Confidentiality and security is

maintained through the use of
password protected access.

• Submit current, corrected and future

results (normal policies apply), directly
into the RIQAS database. Receipt of
results is confirmed by e-mail.

•Multi-lingual registration identifier

provides simple identification of
multiple registrations.

• Additions and changes to assay details

can be made quickly and easily online.

• Requests for new method, instrument

and reagent codes can be made online.

• Reports are emailed in PDF format as

soon as they are prepared.

• Reports for the previous two cycles

can be downloaded from the website.

• View, print, store or distribute reports

as you wish.

• Update your laboratory's certificate

of participation details in multiple
languages.

• All that is required is web access,

Adobe Reader (for viewing reports)
and a valid password to access the
system.

• No additional software required.

5
 Participation in RIQAS

Participation in RIQAS follows these simple steps:

2
Participant registers the instruments

1
REGISTER

and methods used in their lab by Participant receives

completing the enrolment document. a set of numbered
Enrolment documents are available samples along with
from riqas.com and should be a username/
submitted 3 weeks before the cycle password to access
starts. Check RIQAS policies in RIQAS.Net.
method questionnaire.

3
Participant analyses the
sample on the recommended QUALITY CONTROL

date, carefully following the 1

instructions for use.

5 Participant receives
report by email or post

4
36.000 mg/dl
Participant enters their and reviews to assess
84.800 IU/ml
results via RIQAS.Net or on performance.
132.000 ng/ml
the return sheet and submits
electronically, by fax or post
before the final deadline.

6
Participant receives an end-of-cycle
Certificate of Participation report, a certificate of acceptable
<Name> performance and a certificate of
<Laboratory/Hospital>
participation at the end of the cycle,
provided that more than half results
are returned.
Stephen Doherty
RIQAS Manager

abc
PR-281 APR15

Randox International Quality Assessment Scheme

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, BT29 4QY, United Kingdom

7
Method changes and registration
of additional parameters can be
submitted via RIQAS.Net.

6
Standard Report

Performance data is presented in a one page format with up to seven sub-reports.

1
4

3
7

1 Text Section: Statistics for all methods, your method and instrument group (programme specific).
2 Histogram: Method and instrument comparison.
3 Multi-Method Stat Section: Enables assessment of the performance of each method.
4 Levey-Jennings Chart: Details features of your laboratory’s performance.
5 Target Score: This unique chart provides a numerical index of performance, allowing at-a-glance assessment.
6 %Deviation by Sample: Helps to identify trends and shifts in performance.
7 %Deviation by Concentration: Rapid assessment of concentration related biases.

7
 Text Section

The text section summarises the statistical information for each parameter.

2 3 4 5 6 7

9
10
RIQAS performance indicators include
11 SDI, Target Score and %Deviation.
10
12 Acceptable performance criteria:
8
10
SDI < 2
Target score > 50
%Deviation < defined acceptable limits
13
14

Performance statement appears here if performance indicators exceed limits

1 Report is presented in your chosen unit. 7 After statistical reduction, some results are excluded.

2 Number of returned results used to generate Mean for Comparison. 8 Ideally this will be your instrument group mean. If N<5 for instrument
group, your method group Mean is selected as Mean for Comparison.
3 Average value of all laboratories’ results.
9 Standard Deviation Index = Your Result - Mean for Comparison
4 Coefficient of Variation. SDPA adjusted

5 Uncertainty associated with the Mean for Comparison. 10 Running Mean average of the last 10 performance indicators is used
to monitor performance over time and concentration range.
Um = 1.25 x SD
11 Target Score - The closer a value is to 120, the better the performance.
√n

6 SDPA = Standard Deviation for Performance Assessment, calculated 12 %Deviation from the Mean for Comparison - the closer the value is to
from the Target Deviation for Performance Assessment (TDPA) and zero, the better the performance.
the Mean for Comparison.
13 Biological Variation stated for information purposes only.
SDPA = TDPA x Mean for Comparison
14 Performance limit set for this parameter.
t-value x 100

t-value = factor which represents the % of poor performers reflected

in the TDPA (t-value ~ 1.645 when ~10% laboratories achieve poor
performance) SDPA is combined with Um, where appropriate.

If Um > ( 0.3 x SDPA) then SDPAadjusted = √ ( Um2 + SDPA2 ) and

the reported value is suffixed with "a"

If Um is less than ( 0.3 x SDPA) then SDPAadjusted = SDPA

8
Histogram

The Bar Graph is intended as a quick visualisation of how your lab’s result compares to
the method mean, instrument mean and all method mean.

All methods Your instrument group

Your method group
(programme specific)

2 5

4
3

1 Total of 673 laboratories reported values between 35.96 and 36.63. 4 RIQAS reports show your unit of measurement.

2 58 laboratories reported values between 33.29 and 33.96 in your 5 25 laboratories reported values between 37.96 and 38.62 in your
method group. instrument group.

3 Your Result.

9
 Levey-Jennings Chart

SDIs reflect laboratory performance in relation to fit-for-purpose SDPAs and are useful
to monitor performance over time. Acceptable performance is SDI < 2.

8 C

4 5 6

1 Where a result has been returned, the Mean for Comparison for each 4 N = No result returned from your laboratory. No statistics are shown.
sample is indicated at the top of the chart, allowing easy assessment of
concentration related bias:
I: Instrument mean 5 Sample number.
M: Method mean
A: All method mean
2 This line indicates a change in registration details for this parameter. 6 C = Corrected results will be accepted for non-analytical errors.
Corrected results will be accepted up to 4 weeks after the final date
deadline, on application, with evidence of analysis. Late results are only
3 Your SDI (Standard Deviation Index). accepted if there has been a Randox error.

R = Incorrect results can be removed retrospectively on request.

10
Target Score Chart

The Target Score (TS) allows participants to assess their performance at a glance.
The TS relates the %Deviation of your result from the Mean to a Target Deviation
for Performance Assessment (TDPA). TDPAs are set to encourage participants to
achieve and maintain acceptable performance. TDPAs are fit-for-purpose performance
criteria which are set taking guidance from ISO/IEC17043, ISO13528 and IUPAC. Target
Deviations for Performance Assessment are also used to calculate the Standard Deviation
for Performance Assessment (SDPA).

2 Excellent

Good

Acceptable

Need for improvement

3 Unacceptable

1 This is the upper deviation limit of performance for this parameter. 2 High score >50 in the lighter shaded area represents
TDPAs are reviewed regularly and deemed fit for purpose by the acceptable, good or excellent performance.
RIQAS Advisory Panel.
3 Heavy shading for values 10 to 50 signifies poor performance.

11
 %Deviation by Sample Chart

This chart helps to identify trends and shifts in performance.

Your Result - Consensus Mean

%Deviation = x 100%
Consensus Mean

8 C

1 %Deviation from Mean for Comparison. 3 Acceptable limits of performance. These are defaulted to RIQAS
TDPAs but can be set to e.g. biological variation or regulatory
requirement on request.
2 Plot of Running Mean %Deviations (average of the last 10
%Deviations for the sample indicated).

12
%Deviation by Concentration Chart

This chart enables rapid assessment of concentration related biases. Biases at low or
high concentrations can be easily determined.

1
2

1 Current sample indicated by square. 2 %Deviation at specific concentration.

13
 Multi-Method Stat Section

This section provides an easy way of assessing the performance of other methods used
to analyse the parameter in question.

Method N Mean CV% U

m
Hexokinase 1947 36.525 3.4 0.03
Glucose oxidase 1341 37.365 6.8 0.09
Ortho Vitros MicroSlide Systems 229 34.877 3.7 0.11
GOD/02-Beckman method 47 35.538 4.5 0.29
Glucose dehydrogenase 20 36.731 3.5 0.35
Oxygen electrode 15 36.789 5.5 0.65
Vitros, DT60/DT60 II 9 34.905 5.7 0.83

14
Summary Page

Located at the back of the RIQAS Report, the Summary Page collates the key information,
allowing participants to review the performance of all parameters at-a-glance.

3 4
2

2.4

5 6 7

1 RMSDI - is the Running Mean of the 10 previous SDIs (if fewer than 3 RM %DEV - Average of the last 10 %DEV for this parameter.
10 results on file, “Too Few” is printed).
4 RMTS - Average of the last 10 Target Scores for this parameter.
2 Red triangle appears when all performance indicators (SDI, %DEV and
TS) exceed acceptable performance, i.e: when 5 Overall RMSDI = average RMSDI for this sample distribution.
SDI > 2
TS < 50 6 Overall RM%DEV = average RM%DEV for this sample distribution.
%DEV > acceptable limits set
7 Overall RMTS = average RMTS for this sample distribution.

15
 Urine Toxicology Report

Laboratory performance is presented in both quantitative and qualitative screening

formats, allowing for easy interpretation at-a-glance.
Screening Section Quantitative Section

THC 125 ng/ml

Phenobarbital 600 ng/ml
Oxazepam 250 ng/ml
Benzoylecgonine 500 ng/ml
Ethanol 20 ng/ml
Free Morphine 1500 ng/ml
Phencyclidine 25 ng/ml

16
Urine Toxicology Report
Screening Section

Qualitative comparison of screening results available for each parameter.

1
Performance History

Your Data (Last 10 Samples) Your Method (This Sample)

2 0% False Negatives 7% False Negatives

0% False Positives 0% False Positives
100% Correct Responses 93% Correct Responses

THC 125 ng/ml

11 12
Phenobarbital 600 ng/ml
Oxazepam 250 ng/ml
3 Benzoylecgonine
Ethanol
500
20
ng/ml
ng/ml Your Method (Last 10 Samples) All Methods (This Sample)
Free Morphine 1500 ng/ml
Phencyclidine 25 ng/ml 4 8% False Negatives 20% False Negatives
12% False Positives 1% False Positives
81% Correct Responses 79% Correct Responses

5
13 14
6
7
All Methods (Last 10 Samples)

22% False Negatives

8 6% False Positives
72% Correct Responses

9
15

10

1 Screening Text Section. 7 Total screening results over all your cut-offs for your laboratory’s
method.
2 Screening Results: This chart is a quick visualisation of your
performance over the last 20 samples. A result in the white section 8 Screening results for all cut-offs returned for this sample over all
indicates a correct response. A result in the upper red section indicates methods.
a False Positive response, and a result in the lower red section indicates
9 Total screening results over all cut-offs for all methods.
a False Negative response.

3 Comment section for RIQAS to provide your laboratory with 10 Screening results for other methods using same cut-off as your
additional relevant information regarding this sample, such as spiked laboratory.
metabolite concentration.
11 Performance history for this parameter, based on previous 10 samples.
4 Screening result response categories. All abbreviations indicated at the
bottom of the report page. 12 Performance of your method over all cut-offs for this sample.
Key
TN - true negative TP - true positive FN - false negative 13 Performance history of your method over all cut-offs, based on the
FP - false positive RC - sent for confirmation NT - not tested previous 10 samples.
5 Screening Summary: Your screening result shown in the appropriate 14 Performance of all methods over all cut-offs for this sample.
response category and your cut off for this sample.
15 Performance history of all methods over all cut-offs, based on the
6 Screening results for all cut-offs returned for this sample within your previous 10 samples.
method group.
17
 Urine Toxicology Report
Quantitative Section

Quantitative statistical comparison available

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1 Quantitative Text Section: Comparison statistics. Caution is needed 5 Running mean SDI = average of last 10 SDIs for this parameter
when the N value is too small to support statistical significance. (If fewer than 10 results, "Too Few" is printed).

2 Your Result. 6 Quantitative Results Histogram: This graph provides a quick

visualisation of how your quantitative result falls into the overall picture
for all methods and your method group.
3 Your Mean for Comparison.
7 All available method statistics for this sample.
• – •ˆ– • – •ˆ–
4
 % False Negatives Standard‚Deviation Index = (Your Result
% False Negatives – Mean
 % False for Comparison)
Negatives  % False Negatives
 % False Positives  % False Positives SD ofFalse
 % MeanPositives
for comparison % False Positives
18
 % Correct Responses ‚ % Correct Responses  % Correct Responses  % Correct Responses
Urinalysis Report

Your performance for each parameter is presented in a simple, convenient report.

Screening Results

1
2 11
12

4 5 6

13

14

15

8 16
10 10

9
17

1 Categories are stated in your unit. 10 Your Result.

2 Your method group and categories. 11 All categories (result options) available for this parameter for any
method (dipstick).
3 Results from all methods (dipsticks) returning results in the same
categories as your lab. 12 Your categories (available result options for chosen dipstick and unit).

4 Results from all methods for all available categories. 13 Comments Box.

5 Your Result. 14 All Categories Histogram: a quick visualisation of how your lab’s
result falls into the overall picture for all categories.
6 Performance Statement.
15 Results submitted from a category not applicable to your method.
7 Your Categories Histogram: A quick visualisation of how your lab’s
result falls into the overall picture for your categories. 16 Your categories.

8 Possible reporting categories for your method. 17 Detailed summary of results: This table enables you to see how you
compare to all other results.
9 All available methods for this parameter.
19
 Serology: Screening (Qualitative)
Report

Your performance for multiple samples is presented in a convenient single report per
quarterly distribution.

4
3

1 Your qualitative result and chosen method are presented along with 3 Your Result is shown as a black triangle on the category chart
the acceptable result based on an 80% consensus. This consensus will compared to other laboratories in groups:
be at the method level if there are >5 labs in the group or if there are
<5 labs, will be at the all method level. All Methods Your Method

2 Overall Summary shows the number of results for this parameter and 4 Summary shows performance of all the methods used to analyse
sample which are non-reactive, inconclusive or reactive. the parameter.

20
Serology: Screening (Quantitative)
Report

Your performance for multiple samples is presented in a convenient single report per
quarterly distribution.

Anti-Rubella IgG, IU/ml

60

50
Sample 2

Number of Laboratories
N Mean CV% Um SDPA Exc.

All methods 210 92.574 37.2 2.97 34.42 31

1 40
Abbott Architect 39 83.219 8.7 1.46 7.27 5

30

Your Result 84.800 SDI 0.22

RMSDI Too Few

Mean for Comparison 83.219 20

10

< 24.47 73.43 122.39 171.35 >

3
IU/ml

Method N Mean CV% Um 2

4
Biomerieux VIDAS 48 150.979 9.8 2.97
Abbott Architect 44 83.219 8.7 1.46
Roche Cobas 6000/8000 18 58.792 3.6 0.68
Abbott Axsym 17 108.206 18.0 6.09
Siemens/DPC Immulite 2000/2500 17 90.800 6.2 1.94
Roche Cobas 4000/e411 17 59.973 7.0 1.35
Siemens/Bayer ADVIA Centaur 14 120.775 11.0 5.88
Roche Elecsys 11 57.043 3.9 1.05
Diasorin Liaison 9 52.388 18.0 4.16
Roche Modular E170 9 58.949 3.9 1.08
Beckman DxI 600/800 6 125.817 7.4 4.75

1 Quantitative statistics for All Methods and Your Method are presented 3 Multi Method Statistics section provides an easy way of assessing the
in your chosen unit along with your result and your performance scores performance of the methods used to analyse the parameter.
(SDI and RMSDI).

2 Your result is presented on the bar graph as a black triangle, showing 4 Levey-Jennings chart - Your SDIs for previous 20 samples.
how you compare to:

All Methods Your Method

21
 Quantitative End-of-Cycle Report

The End-of-Cycle Report is sent to all participants at the end of each cycle and provides
a complete summary of statistics. Results can also be compared to the previous cycle.

22
Text Section (End-of-Cycle Report)

The text section summarises the statistical information for all samples.

Your assay details at the end of the cycle.

The RIQAS TDPA and biological variation
for the parameter is shown if available.

4 5 6 7 8 9 10 11 12 13 14

Sample Result Unit N Mean SDPA Um CV% SDI TS % Deviation

1 28.200 g/l 68 I 28.013 1.26 0.10 2.4 0.15 120 0.7
2 26.900 g/l 87 I 26.853 1.21 0.10 2.7 0.04 120 0.2
3 39.900 g/l 71 M 40.531 1.82 0.15 2.5 -0.36 116 -1.5
4 19.200 g/l 81 I 19.429 0.87 0.07 2.5 -0.27 120 -1.2
5 41.700 g/l 67 I 41.942 1.88 0.13 2.0 -0.09 120 -0.4
6 57.300 g/l 87 I 57.257 2.58 0.21 2.7 0.02 120 0.1
7 45.000 g/l 72 I 45.850 2.06 0.14 2.1 -0.43 108 -1.8
8 27.600 g/l 87 I 28.011 1.26 0.09 2.5 -0.34 118 -1.5
9 41.200 g/l 70 I 41.823 1.88 0.14 2.2 -0.38 113 -1.6
10 26.900 g/l 83 I 26.742 1.20 0.12 3.3 0.14 120 0.6
11 40.700 g/l 71 I 40.601 1.83 0.13 2.2 0.06 120 0.2
12 45.100 g/l 80 I 45.119 2.05 0.14 2.2 -0.18 120 -0.8
13 27.300 g/l 63 I 28.454 1.27 0.09 2.0 -0.72 86 -3.1

Summary of lab’s results and statistics are shown,

including Mean for Comparison, SDPA, %CV, Um,
SDI, Target Score, %Deviation

15

16

Table containing a summary of the lab’s performance

for previous cycle and current cycle, including Average
Absolute SDIs and %Deviations.
23
 Text Section (End-of-Cycle Report)

1 Report presented in your chosen unit 15 Cycle average of your performance indicators – Standard Deviation
Index, Target Score and %Deviation

2 Your assay details as of the last sample (Sum of SDIs returned for the
completed cycle)
Cycle Average SDI =
3 RIQAS TDPA and Biological variation (Number of samples returned in cycle)

4 Sample number
(Sum of your Target Scores returned
Cycle Average for the completed cycle)
5 Your results for each sample Target Score =
(Number of samples returned in cycle)

6 Unit your result was returned in

(Sum of your %Deviations returned

7 Number of results used for statistical analysis Cycle Average for the completed cycle)
%Deviation =
(Number of samples returned in cycle)
8 Mean for Comparison

9 SDPA = Standard Deviation for performance assessment 16 Cycle average for Absolute values of the lab’s SDI and %Deviation.
Absolute values show how far a value is from zero regardless of the
sign. This is an indication of the magnitude of accuracy.
10 Uncertainty of Mean for Comparison
(Sum of your Absolute SDIs
returned for the completed cycle)
11 Coefficient of Variation (%) Cycle Average
Absolute SDI =
(Number of samples returned in cycle)

12 Your Standard Deviation Index

(Sum of your Absolute %Deviations

13 Your Target Score Cycle Average returned for the completed cycle)
Absolute %Deviation =
(Number of samples returned in cycle)
14 Your %Deviation

24
Chart Section (End-of-Cycle Report)

Lab’s results for current cycle shown in various diagrams.

1 2

3 4

1 Levey-Jennings chart Shows your SDIs for a full cycle.

• Shows SDI (positive and negative)

x Shows absolute SDI

2 Target Score chart Shows your Target Scores for a full cycle.

3 %Deviation by sample chart Shows your %Deviations for a full cycle.

Acceptable limits equal to TDPA unless alternative limits are registered by the lab.

• Shows %Deviation (positive and negative)

x Shows absolute %Deviation

4 %Deviation by Concentration chart Shows your results for a full cycle.

25
 Current & Previous Cycle
Absolute SDIs (End-of-Cycle Report)

Based on the cycle average absolute SDI, this char t provides a visual representation
of your laboratory’s performance compared to the previous cycle.

2 3 1
5
4

1 Report title - Cycle Average Absolute SDI This shows your performance this cycle compared to the previous cycle.

2 Parameter list List of all parameters registered.

3 Results for previous cycle Indicated by open circle on the chart.

4 Results for current cycle Indicated by a closed circle on the chart.

5 Legend Cycle Average Absolute SDIs are shown for:

L Your results throughout the cycle

C All labs within your own country
W All labs Worldwide

6 Graphical representation of Absolute SDIs Acceptable performance is ≤ 2.

If Absolute SDI for current cycle is less than that for the previous cycle, this is
indicated by a green circle.
If Absolute SDI for current cycle is greater than that for the previous cycle,
this is indicated by a red circle.
The closer the circle is to zero, the better the performance.

26
Certificate of Performance
(End-of-Cycle Report)

An End-of-Cycle report will be issued for all registrations. However, the Certificate of
Performance will only be available for parameters where results for at least 50% of
samples in the cycle have been returned. Labs joining after the beginning of the cycle will
only receive the Certificate of Performance if they meet this criteria. Any parameters not
included on the Certificate of Acceptable Performance will be listed on the Notification
of Unacceptable Performance.

2 XX/X

1 3

5 6

1 Full registration address Your full registration address details

2 Your lab reference number Used to identify each lab

3 Programme / cycle number Programme and current, completed cycle number

4 Date Date End-of-Cycle report is issued

5 Parameters List of parameters broken down for which cycle absolute SDI is ≤ 2

6 Average Absolute SDI Your Cycle Average Absolute SDI

27
 Monitoring EQA Performance

Each EQA report should be evaluated and any poor performance investigated. A step
by step approach should be adopted consisting of the following three steps:

1 2 3
Investigate the source of Implement Check the effectiveness of
the problem corrective actions the corrective actions

1. Investigate the source of the problem

In order to identify the source of the problem it is useful to be aware of the most common causes of poor EQA
performance. Errors can occur at any stage of the testing process however EQA is most concerned with detecting
analytical errors i.e. errors that occur during the analysis of the sample.

Most analytical errors can be easily divided into three main areas; clerical errors, systematic errors and random errors.
Systematic errors result in inaccurate results that consistently show a positive or negative bias. Random errors on the
other hand affect precision and result in fluctuations in either direction.

The flowchar t (page 30) is designed to help you investigate any apparent poor performance.

It may be possible that, after extensive investigations, the root cause of the poor performance cannot be established.
Poor performance for a single sample could be attributed to random error. If poor performance has been noted for
several samples, a systematic error is the most likely cause and the analytical process should be reviewed.

Clerical errors Systematic errors Random errors

• Transcription errors • • Sample/Reagent prep/handling • • Bubbles in reagent •

• Incorrect units used • • Reagent/calibrator/standardisation change • • Bubbles in reagent/sample pipette •
• Incorrect sample tested • • Instrument/reagent/calibrator fault • • Temperature fluctuations •
• Incorrect method classification • • Inexperienced operators • • Poor pipetting technique •
• Calculation/conversion error • • Reagent deterioration • • Poor operator technique •
• Inappropriate method •

28
Monitoring EQA Performance

A checklist similar to the one below is extremely useful when investigating poor EQA
performance and may help you to determine the root cause of the problem and initiate
corrective actions.

Laboratory:
Cycle Number: Sample Number:
Analysis Date: Analyte:
Mean for Comparison: Lab Result: SDI: %Dev:

1. Specimen Handling d. R
 andom IQC variation on sample analysis date Y N

a. Samples received in good condition Y N e. E rror due to imprecision; check IQC in terms of
b. Samples stored/prepared appropriately Y N %Deviation compared to deviation observed in EQA Y N

c. Integrity of the sample is acceptable Y N f. IQC target correctly assigned Y N

2. Clerical 5. Calibration
a. Correct result entered Y N a. Date of last calibration
b. Correct use of decimal point and units Y N b. Calibration frequency acceptable Y N

c. C
 alculations, if any, performed correctly c. Last calibration acceptable Y N

(even if automated) Y N

d. C
 onversion factors applied to results before submission Y N 6. Instrument
a. D
 aily maintenance performed on date of sample analysis Y N

3. Registration and Mean for Comparison b. S pecial maintenance performed prior to sample analysis Y N

a. R
 egistered in the correct method/instrument group Y N c. Instrument operated correctly Y N

b. C
 hanged method or instrument without advising d. Operator fully trained Y N

RIQAS Y N

c. Mean for comparison changed due to the number of 7. Reagents

participants returning results e.g. from method to instrument Y N a. Reagents prepared and stored correctly Y N

d. An obvious bias between method and instrument means b. Reagents within open vial stability Y N

(check histogram and stats sections) Y N

8. EQA sample
4. Internal Quality Control a. Initial value
a. %
 Deviation of IQC (at similar conc to that of EQA) on b. Re-run value
sample analysis date acceptable Y N c. Issue observed in previous EQA samples at a similar
b. S hift in IQC in the periods just before and after EQA concentration (check %Deviation by concentration and
sample analysis Y N Levey Jennings charts) Y N

c. Trends in IQC in the periods before and after EQA d. All parameters affected (to the same extent) - possible
sample analysis Y N reconstitution error (check %Deviation on summary pages) Y N

Conclusion: Remedial Action:

Lab Manager: Date: Lab Director: Date:

29
 Monitoring EQA Performance

The flow chart below can be used to help identify a possible root cause for poor EQA
performance.

Is the parameter result

within acceptable limits of
performance? Verify that the reported
Review performance over result and units reflect
YES NO
the cycle • Target Score > 50 what was obtained. Has a
• SDI < 2 transcription error occurred?
• %Deviation < acceptable
limits of performance

YES NO

Verify instrument, method

Send corrected result and units are registered
correctly for each parameter.
to RIQAS along with relevant
Especially important for
documentation to support
initial submission and when
the case.
registration changes have
been made.

YES NO

Review the summary page.

Advise RIQAS of correct
Are the majority of results
details
flagged?

NO YES

There may be a problem

Review Levey-Jennings Review instrument
Review IQC results from the specific to that sample
charts. Are any points parameters and calibration.
time the EQA sample was • Incorrect sample tested
outside Has the reagent batch been
tested. • Reconstitution error
+/- 1SD? changed?
• Sample storage

NO YES Run out of control Look for shifts or trends

Look for trends within the

data
• Positive/Negative bias
Investigate and take
No further actions • Poor precision
corrective action
• Changes in performance due
to change in reagent, calibrator
or standardisation

30
Monitoring EQA Performance

2. Implement corrective actions

A corrective action is an action taken to correct a problem or non-conformance. Some errors can be readily recognised
as simple clerical errors and easily corrected. If there is evidence of systematic or random error however more detailed
corrective actions must be taken.

Systematic Error
In the event of a systematic error the following suggested actions may help to resolve the problem:

Perform Review reagent/ Prepare fresh

Recalibrate Perform staff
instrument sample storage e.g. Check pipettes reagents and
instrument training
maintenance refrigerators re-run sample

Random Error
If all possible causes have been excluded, a single unacceptable result is most likely due to random error. Re-run the
sample, if the result of repeat analysis is acceptable then corrective action is not required. If the issue persists, investigate
possible sources of systematic error.

3. Check the effectiveness of corrective actions

The effectiveness or impact of any corrective actions taken can be assessed by continuing to monitor analytical
performance over time.

31
 RIQAS Programmes

AMMONIA/ETHANOL PROGRAMME+
RQ9164 (2 ml)
2 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

Ammonia Ethanol

ANTI-TSH RECEPTOR PROGRAMME+

RQ9174 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Anti-TSH Receptor (TRAb)

BLOOD GAS PROGRAMME With target scoring

RQ9134 (1.8 ml) RQ9134/A (1.8 ml)
First registered instrument Subsequent instruments
10 Parameters 10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples
pCO2 CO2(Total) K+ Lactate
pH Ca++ Na+
pO2 Cl- Glucose

BNP PROGRAMME+
RQ9165 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

BNP*

CARDIAC PROGRAMME With target scoring

RQ9127/a (1 ml) RQ9127/b (1 ml)
2 Parameters only (choose from 7) Full 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilised samples

CK, Total CK-MB (Mass) Myoglobin Troponin T

CK-MB (Activity) Homocysteine Troponin I

CEREBROSPINAL FLUID PROGRAMME+

RQ9168 (3 ml)
12 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

Albumin α-2-globulin (electrophoresis) γ-globulin (electrophoresis) Lactate

Albumin (electrophoresis) β-globulin (electrophoresis) Glucose Protein (Total)
α-1-globulin (electrophoresis) Chloride IgG Sodium

COAGULATION PROGRAMME With target scoring

RQ9135/a (1 ml) RQ9135/b (1 ml)
5 Selected parameters only Full 17 Parameters
(aPTT, PT, TT, Fibrinogen, Antithrombin III)
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

aPTT Plasminogen Factor VII Factor XII

PT (including INR) Protein C Factor VIII D-dimer*
TT Protein S Factor IX
Fibrinogen Factor II Factor X
Antithrombin III Factor V Factor XI

PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing
32
RIQAS Programmes

CYFRA 21-1 PROGRAMME+

RQ9175 (1 ml)
1 Parameter
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

CYFRA 21-1 (Cytokeratin 19)

ESR PROGRAMME+
RQ9163 (4.5 ml)
1 Parameter (ESR)
2 samples per quarterly distribution, 1 x 12 month cycle, 12 months subcription, liquid ready-to-use samples

ESR

GENERAL CLINICAL CHEMISTRY PROGRAMME With target scoring

RQ9112 (5 ml) RQ9112/S (5 ml) RQ9113 (5 ml)
10 Parameters only 17 Parameters only Full 51 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, reference method values, lyophilised samples

ACE (Angiotensin Converting Enzyme)* Calcium HBDH PSA

Acid Phosphatase (Prostatic) Calcium (Ionised) HDL-Cholesterol Sodium
Acid Phosphatase (Total) Chloride Iron TIBC
Albumin Cholesterol Lactate T3 (Free)
Alkaline Phosphatase Cholinesterase LD (LDH) T3 (Total)
ALT (ALAT) CK, Total (CPK) Lipase T4 (Free)
Amylase (Pancreatic) Copper Lithium T4 (Total)
Amylase (Total) Creatinine Magnesium Triglycerides
AST (ASAT) D-3-Hydroxybutyrate NEFA* TSH
Bicarbonate Fructosamine Osmolality Urea
Bile Acids γGT Phosphate (Inorganic) Uric Acid
Bilirubin (Direct) GLDH Potassium Zinc
Bilirubin (Total) Glucose Protein (Total)

GLYCATED HAEMOGLOBIN PROGRAMME (HbA1c) With target scoring

RQ9129 (0.5ml)
2 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

HbA1c Total Haemoglobin

HAEMATOLOGY PROGRAMME With target scoring

RQ9118 (2 ml)
11 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, liquid ready-to-use samples

Haematocrit (HCT) Mean Cell Haemoglobin Concentration (MCHC) Platelets (PLT) Red Cell Distribution Width (RDW)
Haemoglobin (Hb) Mean Cell Volume (MCV) Plateletcrit (PCT) Total White Blood Cell Count (WBC)
Mean Cell Haemoglobin (MCH) Mean Platelet Volume (MPV) Red Blood Cell Count (RBC)

HUMAN URINE PROGRAMME With target scoring

RQ9115 (10 ml)
25 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilised samples

ACR* Creatinine Normetanephrine Protein (Total)

Albumin/Microalbumin Dopamine Magnesium Sodium
Amylase Epinephrine Osmolality Urea
Calcium Glucose Oxalate Uric Acid
Chloride Metanephrine Phosphate (Inorganic) VMA
Copper Norepinephrine Potassium 5-HIAA
Cortisol

PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing
33
 RIQAS Programmes

IMMUNOASSAY PROGRAMME With target scoring

RQ9125/a (5 ml) RQ9125/b (5 ml) RQ9125/c (5 ml) RQ9130 (5 ml)
4 Parameters only (choose from 55) 13 Parameters only (choose from 55) Full 55 Parameters Full 55 Parameters
Samples every two weeks, 2 x 6 monthly cycles, 12 month subscription (RQ9125/a, RQ9125/b, RQ9125/c), lyophilised samples
Samples every month, 1 x 12 month cycle, 12 month subscription (RQ9130), lyophilised samples

ACTH DHEA Unconjugated 17-OH-Progesterone T4 (Free)

AFP Digoxin Paracetamol T4 (Total)
Aldosterone Estriol Total* Phenobarbital Testosterone (Free)*
Amikacin* Ethosuximide* Phenytoin Testosterone (Total)
Androstenedione* Ferritin Primidone* Theophylline
β-2-Microglobulin Folate Progesterone Thyroglobulin
CA125 FSH Prolactin Tobramycin*
CA15-3 Gentamicin PSA (Free) TSH
CA19-9 GH PSA (Total) Valproic Acid
Carbamazepine hCG PTH Vancomycin
CEA IgE Salicylate* Vitamin B12
Cortisol Insulin SHBG 1-25-(OH)2-Vitamin D*
C-Peptide LH T3 (Free) 25-OH-Vitamin D
DHEA-Sulphate Oestradiol T3 (Total)

IMMUNOASSAY SPECIALITY 1 PROGRAMME+ With target scoring

RQ9141 (2 ml)
10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

1-25-(OH)2-Vitamin D Anti-TG Osteocalcin Insulin

25-OH-Vitamin D Anti-TPO Procalcitonin
C-Peptide IGF-1 PTH

IMMUNOASSAY SPECIALITY 2 PROGRAMME+

RQ9142 (2 ml)
5 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Calcitonin Procalcitonin Plasma Renin Activity Renin (Direct Concentration)

Gastrin

IMMUNOSUPPRESSANT PROGRAMME+
RQ9159 (2 ml)
4 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Cyclosporin Everolimus Sirolimus Tacrolimus

LIPID PROGRAMME With target scoring

RQ9126/a (3 ml) RQ9126/b (3 ml)
3 Parameters only (choose from 7) Full 7 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, lyophilised samples

Apolipoprotein A1 Cholesterol (Total) LDL-Cholesterol Triglycerides

Apolipoprotein B HDL-Cholesterol Lipoprotein (a)

LIQUID CARDIAC PROGRAMME With target scoring

RQ9136 (3 ml)
9 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

CK-MB Mass Homocysteine Myoglobin Troponin I

D-dimer hsCRP NT proBNP Troponin T
Digoxin

PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing
34
RIQAS Programmes

MATERNAL SCREENING PROGRAMME With target scoring

RQ9137 (3 ml)
6 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

AFP Total hCG PAPP-A Unconjugated Oestriol

free β-hCG Inhibin A

SEROLOGY (EBV) PROGRAMME+

RQ9153 (1 ml)
3 Parameters
3 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use samples

Anti-EBV VCA IgG Anti-EBNA IgG Anti-EBV VCA IgM

SEROLOGY (HIV-HEPATITIS) PROGRAMME+

RQ9151 (1.8 ml)
10 Parameters
5 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use samples

Anti-HIV-1 Anti-HCV Anti-HTLV-II HBsAg

Anti-HIV-2 Anti-HBc Anti-HTLV-1&2 Combined
Anti-HIV-1&2 Combined Anti-HTLV-I Anti-CMV

SEROLOGY (SYPHILIS) PROGRAMME+

RQ9154 (1 ml)
1 Parameter
3 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use samples

Syphilis (Methods available include immunoassay RPR, VDRL and TPHA)

SEROLOGY (ToRCH) PROGRAMME+

RQ9152 (1 ml)
12 Parameters
5 samples per quarterly distribution, 1 x 12 month cycle, 12 month subscription, Quantitative and Qualitative results, liquid ready-to-use samples

Anti-Toxoplasma IgG Anti-Rubella IgM Anti-HSV1 IgG Anti-HSV 1 1gM

Anti-Toxoplasma IgM Anti-CMV IgG Anti-HSV2 IgG Anti-HSV 2 IgM
Anti-Rubella IgG Anti-CMV IgM Anti-HSV-1&2 IgG Combined Anti-HSV I + 2 IgM Combined

SPECIFIC PROTEINS PROGRAMME With target scoring

RQ9114 (3 ml) RQ9160 (2 ml) RQ9161 (1 ml)
26 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, liquid ready-to-use samples

AFP β-2-Microglobulin IgA Lambda Light Chain (Total)

Albumin Ceruloplasmin IgE Prealbumin (Transthyretin)
α-1-Acid glycoprotein Complement C3 IgG Retinol Binding Protein
α-1-Antitrypsin Complement C4 IgM Rheumatoid Factor
α-2-Macroglobulin C-Reactive Protein Kappa Light Chain (Free) Transferrin
Anti Streptolysin O Ferritin Kappa Light Chain (Total)
Antithrombin III Haptoglobin Lambda Light Chain (Free)

SWEAT TESTING PROGRAMME+

RQ9173 (2 ml)
2 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

Chloride Sodium

PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing
35
 RIQAS Programmes

THERAPEUTIC DRUGS PROGRAMME With target scoring

RQ9111 (5 ml)
18 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Weighed-in values, lyophilised samples

Amikacin Ethosuximide Phenobarbital Tobramycin

Caffeine Gentamicin Phenytoin Valproic Acid
Carbamazepine Lithium Primidone Vancomycin
Cyclosporine Methotrexate Salicylic Acid
Digoxin Paracetamol (Acetaminophen) Theophylline

TRACE ELEMENTS IN BLOOD PROGRAMME+

RQ9172 (3 ml)
7 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Copper Lead Manganese Zinc

Iodine Magnesium Selenium

TRACE ELEMENTS IN SERUM PROGRAMME+

RQ9170 (3 ml)
10 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Aluminium Copper Manganese Zinc

Chromium Iodine Nickel
Cobalt Lead Selenium

TRACE ELEMENTS IN URINE PROGRAMME+

RQ9171 (3 ml)
11 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, lyophilised samples

Cadmium Copper Magnesium Nickel

Chromium Iodine Manganese Thallium
Cobalt Lead Molybdenum

URINALYSIS PROGRAMME+
RQ9138 (12 ml)
14 Parameters
Samples every 2 months, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

Albumin Galactose Leukocytes Specific Gravity

Bilirubin Glucose Nitrite Urobilinogen
Blood hCG pH
Creatinine Ketones Protein

URINE TOXICOLOGY PROGRAMME+

RQ9139 (5 ml)
20 Parameters
Samples every month, 1 x 12 month cycle, 12 month subscription, liquid ready-to-use samples

Benzoylecgonine d-Methamphetamine MDMA Phenobarbital

Buprenorphine EDDP Methadone Secobarbital
Cannabinoids (THC) Ethanol Nortriptyline
Cotinine* Free Morphine Norpropoxyphene
Creatinine Lorazepam Oxazepam
d-Amphetamine LSD Phencyclidine

PURPLE = The only parameters available on RQ9135/a + = Not accredited * = Pilot study ongoing
36
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LT033FEB16

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