ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests

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ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
ECAT FOUNDATION
External quality Control of diagnostic Assays and Tests
       with a focus on Thrombosis and Haemostasis

     PARTICIPANT INFORMATION

      Programme and Prices 2022
ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
ECAT FOUNDATION

Postal address                      Visiting address
ECAT Foundation                     ECAT Foundation
P.O. BOX 107                        Dobbeweg 1
2250 AC Voorschoten                 2254 AG Voorschoten
The Netherlands                     The Netherlands

Contact details (general)           Contact details (financial department)
T. +31 71 3030910                   T. +31 71 3030911
F. +31 71 3030919                   F. +31 71 3030919
E. info@ecat.nl                     E. finance@ecat.nl
W. www.ecat.nl

Registration no. at the Chamber of Commerce:    41174102
VAT number:                                     NL802836872B01
IBAN no.:                                       NL38 INGB 0006 9304 71
BIC code:                                       INGBNL2A
ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
INTRODUCTION

Dear Participant,

It is our pleasure to inform you in this brochure about the ECAT’s external quality programme 2022.

The ECAT Foundation is an independent and impartial organization with the objective to provide an international
External Quality Assessment Programme (EQAP) for laboratories working in the field of haemostasis and
thrombosis.
The ECAT (External quality Control of diagnostic Assays and Tests) provides this international external quality
control programme since 1994. It was started as a small-scale quality control programme only in Western
Europe. Today more than 1800 laboratories from more than 50 different countries are participating in this worldwide
programme.

Our primary aim is to contribute to quality assessment and improvement of clinical laboratories operating within the
field of thrombosis and haemostasis with respect to the diagnosis and treatment of patients.

The ECAT Foundation is based in The Netherlands but provides EQAP for assays and tests in the field of
thrombosis and haemostasis on an international scale. The programme is open for every laboratory providing
services in the mentioned discipline.

In 2022 the ECAT programme includes 37 modules for regular laboratory tests, 1 module for case studies and 1
electronic module for the pre- and post-analytical phase and a quality control programme for the CoaguChek INR
monitors. Three new programmes will be added to our programme in 2022, an APTT/PT Mixing study programme,
an ADAMTS13 functional inhibitor programme and a wild card programme. For further details see page 3. In
addition, the HIT Immunological programme will be extended to 2 surveys per year. There are also several pilot
studies scheduled. There will be a pilot study on FVIII/FIX replacement products and one on the Activated Clotting
Time (ACT). For further detail see page 19.
Via ECAT also 2 interpretative electronic modules on platelet testing of the NASCOLA (United States) are provided
as well as 14 modules for molecular biology provided by the SPMD (Germany).
The NASCOLA will run a pilot study on the post-analytical interpretation of platelet whole blood impedance
aggregation and secretion.
We also decided to start a cooperation with DEKS (Denmark) on an EQA programme for homocysteine.

We look forward to work with you also in 2022.

On behalf of the ECAT team,

      Dr. Piet Meijer
      Director

Since 25 April 2012 the EQA programme of the ECAT is accredited according to the international standard ISO/IEC
17043:2010 by the Dutch Accreditation Council (RvA). For details see page 20.

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ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
CONTENT

INFORMATION 2022 ..................................................................................................................................................... 3
      PROGRAMME CHANGES ........................................................................................................................................................... 3
      PRICES ....................................................................................................................................................................................... 3
SUBSCRIPTION INSTRUCTIONS ................................................................................................................................ 5
      Instructions and deadline.......................................................................................................................................................... 5
      Cancellation .............................................................................................................................................................................. 7
SURVEY SCHEDULE .................................................................................................................................................... 8
PROGRAMME AND PRICES ...................................................................................................................................... 10
      ANNUAL SUBSCRIPTION .......................................................................................................................................................... 10
      MAIN PROGRAMME ............................................................................................................................................................... 10
      LUPUS PROGRAMME .............................................................................................................................................................. 11
      ANTICOAGULATION PROGRAMME ......................................................................................................................................... 11
      D-DIMER PROGRAMME .......................................................................................................................................................... 11
      THROMBIN GENERATION PROGRAMME ................................................................................................................................ 11
      PFA PROGRAMME................................................................................................................................................................... 11
      THROMBOELASTOGRAHY PROGRAMME ................................................................................................................................ 11
      HIT PROGRAMME ................................................................................................................................................................... 11
      SCREEN PROGRAMME ............................................................................................................................................................ 12
      APTT / PT MIXING TEST PROGRAMME ................................................................................................................................... 12
      WILDCARD TEST PROGRAMME ............................................................................................................................................... 12
      POCT INR QC PROGRAMME .................................................................................................................................................... 12
      OTHER SURVEYS ...................................................................................................................................................................... 12
      MOLECULAR BIOLOGY (In co-operation with the SPMD, Germany) ....................................................................................... 13
      SHIPMENT COSTS .................................................................................................................................................................... 13
      HOMOCYSTEINE PROGRAMME (In co-operation with DEKS, Denmark) ................................................................................. 14
DETAILED SAMPLE INFORMATION (I) ..................................................................................................................... 15
LIST OF PARAMETERS .............................................................................................................................................. 16
DETAILED SAMPLE INFORMATION (II) .................................................................................................................... 17
PILOT STUDIES ........................................................................................................................................................... 19
POCT FOR COAGUCHEK MONITORS ...................................................................................................................... 20
      POCT INR QC Programme ....................................................................................................................................................... 21
      POCT INR QC Single kits .......................................................................................................................................................... 21
      How to order POCT Quality Control Single Kits ....................................................................................................................... 21
GENERAL INFORMATION ECAT FOUNDATION ...................................................................................................... 22
      Staff......................................................................................................................................................................................... 22
      Members of Supervisory Board ............................................................................................................................................... 22
      Website ................................................................................................................................................................................... 22
      Survey Manual ........................................................................................................................................................................ 22
      Accreditation........................................................................................................................................................................... 23
      Products and services from third parties ................................................................................................................................ 23
      Confidentiality policy .............................................................................................................................................................. 23
      Intellectual property rights and copyrights ............................................................................................................................. 24
      Provision of global survey reports ........................................................................................................................................... 24
FINANCES ................................................................................................................................................................... 25
      Contact details financial department ..................................................................................................................................... 25
      Details ECAT bank account ..................................................................................................................................................... 25
      Terms of delivery ..................................................................................................................................................................... 25

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ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
INFORMATION 2022

INFORMATION 2022
Below you will find general information about the ECAT EQA Programme 2022.

 PROGRAMME CHANGES

HIT Programme:
From 2022, the HIT-I survey will be conducted twice per year (survey 2022-HIT1 and 2022-HIT3) instead of one
survey per year.

APTT/PT Mixing Test Programme:
Mixing studies represent a simple but very useful tool for the first investigations when APTT and/or PT
prolongations are found. By mixing the patient’s sample with normal (pooled) plasma, they can help to distinguish
between factor deficiencies, the presence of specific or unspecific inhibitors or lupus anticoagulant. In this new
module the test results of the mixing tests together with the interpretation of the results will be evaluated. This
new programme will run 4 times per year. Each survey includes two samples.

Wildcard Programme:
The Wildcard Programme is meant for all kind of haemostasis parameters for which no ECAT external quality
assessment programme exist, for instance for rare analytes which are only measured by a few laboratories. With
this Wildcard Programme we offer the participant a possibility to compare their results with those of other
laboratories. The participant can make their own selection for which parameters they want to use this programme
as long as the parameter is not a part of any other ECAT programme. Only haemostasis parameters, including
contact activation parameters will be evaluated.

ADAMTS 13-III (functional Inhibitor)
A new module on functional testing of ADAMTS13 inhibitor (Bethesda assay) will be introduced. This new
programme will run once a year. The survey includes two samples.

Homocysteine
ECAT has decided to start a cooperation with DEKS on an EQA programme for homocysteine. For this reason
ECAT will end their own homocysteine programme in 2022. One of the major reasons for this programme change
is the fact that the number of participants in the ECAT programme is limited (approx. 60). By joining the DEKS
programme the total number of participants is expected to be approx. 140. This results in a better statistical
evaluation, especially on the level of the method used. We believe this is an important benefit for the participant.
DEKS will run their programme 4 times per year with two samples in each survey. All samples for the whole year
programme will be distributed to the participants by DEKS in February 2022. DEKS will provide the participants with
instructions for use, how to submit online results and how to interpret the report. DEKS will be responsible for the
evaluation of the survey results. This programme is accredited to ISO 17043 by the Danish accreditation
organisation DANAK (PT reg. no. 591).

 PRICES

General price information:

The general increase of the prices is approx. 2.75%. This is mainly caused by inflation, increasing costs for staff
and distribution of samples.

Due to a change in the shipment procedure at SPMD (courier service instead of postal service) an extra annual fee
of € 50,= will be charged per registration for one or more Molecular Biology surveys.

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INFORMATION 2022

Printed survey report:

Some laboratories still would like to have a printed copy of the report (despite the fact that their report is online
available). Due to a continuous increase in costs for printing and postal service we have to further increase the
extra annual price for printed reports from € 125.= to € 132.50. The annual subscription fee + printed report will be
€ 275.00.

Extra samples:

If you would like to receive extra samples of a specific module of the ECAT programme in every survey this needs
to be specifically indicated on the website subscription form. The default setting is your current subscription. You
can change this number to the required number of sets. The cost for a set of extra samples is 70% of the module
price and this will be added to your invoice.
We don’t provide single samples, but always send a complete set.

Please be aware that per registration you can submit results for up to 3 reagent/instrument combinations. When
you wish to report for more than 3 instruments a second registration is required.

For a detailed overview of the prices 2022 see page 10 – 14.

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SUBSCRIPTION INSTRUCTIONS 2022

SUBSCRIPTION INSTRUCTIONS

Instructions and deadline

                   Closing date subscription 2022: Friday 19 November 2021!!

For your subscription 2022 you should use the electronic subscription form on our website.
Always complete this subscription form, even when you don’t intend to change your modules!
Your subscription profile of 2021 is used as default setting, but you are able to modify the selection and to adjust
the number of required sets.
The subscription form should be fully completed before it is submitted. After submission no
modifications can be made anymore.

Instructions:
• Go to he ECAT website (www.ecat.nl) and select
  Participant Area (upper menu).

• Select the option Subscription 2022 (left menu)

• Select the blue button Subscription 2022.

• Login with your Labcode and Password

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ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
SUBSCRIPTION INSTRUCTIONS 2022

• Select the button ECAT Subscription

• Now the subscription form appears (see example below).

  -   In the column Select you can select and deselect modules.
  -   In the column Number of Sets you can indicate the required number
      of sample sets (Default is the number of sets ordered in 2021. For a
      new selected module the default is 1). For details about the pricing
      of extra sample sets see page 4.
  -   In the column Amount the total module price, excl. VAT appears.
      At the bottom of the form the total price appears. If you are obliged
      to pay VAT, this is added to the total amount.
  -   If you want to indicate an Order Number, please enter this in the
      apropriate field at the bottom of the form (see figure below). This
      order number will be used on the invoice.
  -   A confirmation e-mail is sent after submission. For this e-mail you
      can select one of the e-mail addresses currently available in our
      database.
  -   Before you are able to submit your subscription you have to accept
      the ECAT terms of delivery (at the bottom of the form – see figure
      below).
  -   With the PDF button on the bottom of the page you can create a
      PDF of the subscription form and store and/or print this form.
  -   When the subscription form is completed it should be submitted by
      selecting the Submit button at the bottom of the form.
      Only submit when the subscription form has been fully completed!

                        Order number                                          Submit button

        Accept terms of delivery        Confirmation e-mail address           PDF button

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SUBSCRIPTION INSTRUCTIONS 2022

Cancellation
If you would like to cancel in 2022 your participation in the ECAT EQA programme you can also use the ECAT
subscription application. Follow the instructions described on page 5 to get access to the subscription form.
At the bottom of this form you may find a Cancel button (see figure below).
Before you cancel, please select an e-mail address to whom the cancellation confirmation should be sent (see
figure below).

                             Confirmation e-mail address                             Cancel button

The deadline for cancellation is November 19th 2021.

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ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
PROGRAMME DETAILS 2022

SURVEY SCHEDULE

Survey        Sample dispatch date      Survey period start   Survey period end     Survey report available

MAIN PROGRAMME
2022 - M1       8 March                     15 March              12 April              10 May
2022 - M2       24 May                      31 May                28 June               2 August
2022 - M3       30 August                   6 September           4 October             1 November
2022 - M4       8 November                  15 November           13 December           24 January 2023
LUPUS PROGRAMME
2022 - L1       8 March                     15 March              12 April              10 May
2022 - L2       24 May                      31 May                28 June               2 August
2022 - L3       30 August                   6 September           4 October             1 November
2022 - L4       8 November                  15 November           13 December           24 January 2023
ANTICOAGULATION PROGRAMME
2022 - A1       8 March                     15 March              12 April              10 May
2022 - A2       24 May                      31 May                28 June               2 August
2022 - A3       30 August                   6 September           4 October             1 November
2022 - A4       8 November                  15 November           13 December           24 January 2023
D-DIMER PROGRAMME
2022 - D1                                   28 March              5 April               15 April
2022 - D2                                   13 June               21 June               1 July
              Beginning of March 2022
2022 - D3                                   12 September          20 September          30 September
2022 - D4                                   21 November           29 November           9 December
SCREEN PROGRAMME
2022 - S1                                   28 March              1 April               11 April
2022 - S2                                   9 May                 13 May                23 May
2022 - S3                                   27 June               1 July                11 July
2022 - S4                                   8 August              12 August             22 August
              Beginning of March 2022
2022 - S5                                   19 September          23 September          3 October
2022 - S6                                   31 October            4 November            14 November
2022 - S7                                   12 December           16 December           28 December
2022 - S8                                   23 January 2023       27 January 2023       6 February 2023
APTT / PT MIXING TEST PROGRAMME
2022 - MIX1     8 March                     15 March              12 April              10 May
2022 - MIX2     24 May                      31 May                28 June               2 August
2022 - MIX3     30 August                   6 September           4 October             1 November
2023 - MIX4     8 November                  15 November           13 December           24 January 2023
PFA PROGRAMME
2022 - P2       24 May                      31 May                28 June               2 August
2022 - P4       8 November                  15 November           13 December           24 January 2023
THROMBIN GENERATION PROGRAMME
2022 - TG2      24 May                      31 May                28 June               2 August
2022 - TG4      8 November                  15 November           13 December           24 January 2023
THROMBOELASTOGRAPHY PROGRAMME
2022 - T1       8 March                     15 March              12 April              10 May
2022 - T2       24 May                      31 May                28 June               2 August
2022 - T3       30 August                   6 September           4 October             1 November
2022 - T4       8 November                  15 November           13 December           24 January 2023
HIT PROGRAMME
2022 - HIT1     8 March                     15 March              12 April              10 May
2021 - HIT3     30 August                   6 September           4 October             1 November

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PROGRAMME DETAILS 2022

WILDCARD PROGRAMME
2022 - W3            30 August                     6 September           4 October                   1 November

POCT INR QC PROGRAMME
Quarter     Sample dispatch date               Survey period start    Survey period end        Survey report available
 2022 - Q1           15 February                   15 February           31 March                    30 April
 2022 - Q2           5 April                        5 April              30 June                     31 July
 2022 - Q3           5 July                         5 July               30 September                31 October
 2022 - Q4           4 October                      4 October            31 December                 31 January 2023

OTHER SUREYS
                               Survey                                                       Period
Post Analytical Platelet Function EQA (electronic survey)            Spring, Autumn (2 surveys per year)
Platelet Dense Granule exercise (electronic survey)                  Spring, Autumn (2 surveys per year)
Whole blood aggregation and secretion (pilot electronic survey)      Summer (1 survey per year)
Case studies on bleeding disorders                                   Autumn (1 survey per year)
Pre- and post-analytical electronic surveys in haemostasis           Autumn (1 survey per year)

MOLECULAR BIOLOGY (via SPMD, Germany)
  Survey    Sample dispatch date   Survey period start                   Survey period end
   MG1 1/22             9 March                       14 March              2 April
   MG1 2/22             31 August                     5 September           24 September
   MG2 1/22             9 March                       14 March              2 April
   MG2 2/22             31 August                     5 September           24 September
   SQ 1/22              9 March                       14 March              9 April
   SQ 2/22              31 August                     5 September           1 October
    DI 1/22             9 March                       14 March              9 April
    DI 2/22             31 August                      5 September          1 October

HOMOCYSTEINE PROGRAMME (via DEKS, Denmark)
  Survey    Sample dispatch date Survey period start                      Survey period end
   2022 - 01                                          14 March                25 March
   2022 - 02                                          23 May                  3 June
                        28 February 2022
   2022 - 03                                          27 August               9 September
   2022 - 04                                          7 November              18 November

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PROGRAMME DETAILS 2022

PROGRAMME AND PRICES
# Prices are excluding VAT

Annual Subscription
The annual subscription fee is mandatory for each participant and will be added to the fee for the selected
modules.
The following options are available for the annual subscription fee:
➢       internet result submission, survey report only via internet as PDF
➢       internet result submission, survey report via internet as PDF and a printed copy by postal service

                                                     ANNUAL SUBSCRIPTION
                                     The annual subscription fee is mandatory for each participant.

Description                                                                                        Price (Euro) #    Product code

Annual Subscription Fee (result submission via internet / survey report via internet)                 132.50             101
Annual Subscription Fee (result submission via internet / survey report via internet + by post)       275.00             102

                                                     NUMBER
                                                                                                             PRICE   PRODUCT
DESCRIPTION                                            OF
                                                     SURVEYS                 SURVEY CODES                   (EURO) #  CODE

MAIN PROGRAMME
Thrombophilia - I:
Antithrombin (activity and antigen), Protein C
(activity [chromogenic and clotting] and antigen),      4       2022-M1 2022-M2 2022-M3 2022-M4             375.00         402
Protein S activity, Protein S antigen (total and
free)
Thrombophilia - II
                                                        4       2022-M1 2022-M2 2022-M3 2022-M4             151.50         417
APC Resistance
Coagulation Factor - I
Factor VIII (clot and chromogenic activity),
                                                        4       2022-M1 2022-M2 2022-M3 2022-M4             187.50         406
IX (clot and chromogenic activity), XI:C and
XII:C
Coagulation Factor - II
                                                        4       2022-M1 2022-M2 2022-M3 2022-M4             187.50         407
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
(antigen, ristocetin cofactor activity, activity,       4       2022-M1 2022-M2 2022-M3 2022-M4             282.50         408
collagen binding, multimers, Factor VIII)
ADAMTS13 - I (activity and antigen)                     4       2022-M1 2022-M2 2022-M3 2022-M4             197.50         409

ADAMTS13 - II (antibodies)                              2                   2022-M2               2022-M4   128.50         410

ADAMTS13 – III (functional inhibitor)                   1                   2022-M2                          95.00         419

Factor XIII (activity and antigen)                      4       2022-M1 2022-M2 2022-M3 2022-M4             141.00         411
Fibrinolysis - I
                                                        4       2022-M1 2022-M2 2022-M3 2022-M4             137.00         412
Plasminogen, Antiplasmin
Fibrinolysis - II
                                                        4       2022-M1 2022-M2 2022-M3 2022-M4             137.00         413
t-PA, PAI-1
Haemophilia
Factor VIII (clot and chromogenic activity)             4       2022-M1 2022-M2 2022-M3 2022-M4             240.00         418
Factor IX (clot and chromogenic activity)

Factor VIII Inhibitor                                   2                   2022-M2               2022-M4   185.00         202

Factor IX Inhibitor                                     2       2022-M1                 2022-M3             185.00         201

Emicizumab                                              2                   2022-M2               2022-M4   185.00         223

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PROGRAMME DETAILS 2022

                                                NUMBER
                                                                                                         PRICE       PRODUCT
DESCRIPTION                                       OF
                                                SURVEYS                SURVEY CODES                     (EURO) #      CODE

LUPUS PROGRAMME
Lupus Anticoagulant / Antiphospholipid
                                                      4    2022-L1     2022-L2    2022-L3     2022-L4     177.50         404
Antibodies
ANTICOAGULATION PROGRAMME
Unfractionated Heparin Monitoring
                                                   4      2022-A1     2022-A2    2022-A3     2022-A4     123.50         414
(anti-Xa)
Low-Molecular Weight Heparin Monitoring
                                                   4      2022-A1     2022-A2    2022-A3     2022-A4     123.50         415
(anti-Xa)
Orgaran (anti-Xa)                                  2                  2022-A2                2022-A4      63.00         205

Fondaparinux (anti-Xa)                             2                  2022-A2                2022-A4      63.00         206

Rivaroxaban (anti-Xa)                              2                  2022-A2                2022-A4      63.00         207

Apixaban (anti-Xa)                                 2                  2022-A2                2022-A4      63.00         208

Edoxaban (anti-Xa)                                 2                  2022-A2                2022-A4      63.00         221

Argatroban (anti-IIa/dTT)                          2                  2022-A2                2022-A4      63.00         209

Dabigatran (anti-IIa/dTT)                          2                  2022-A2                2022-A4      63.00         210

D-DIMER PROGRAMME
D-Dimer                                           4       2022-D1     2022-D2    2022-D3     2022-D4     137.00         405

THROMBIN GENERATION PROGRAMME
Thrombin Generation Test                           2                  2022-TG2               2022-TG4    147.00         203

PFA PROGRAMME
PFA-100/200                                        2                  2022-P2                2022-P4     445.00         222

THROMBOELASTOGRAHY PROGRAMME
ROTEM delta
□ 1 instrument / 1 set of samples ROTEM                                                                  315.00         212
                                                  4       2022-T1     2022-T2    2022-T3     2022-T4
□ 2 instruments / 2 sets of samples ROTEM                                                                535.50         213
□ 3 instruments / 3 sets of samples ROTEM                                                                756.00         214
ROTEM sigma
□ 1 instrument / 1 set of samples ROTEM                                                                  315.00         215
                                                  4       2022-T1     2022-T2    2022-T3     2022-T4
□ 2 instruments / 2 sets of samples ROTEM                                                                535.50         216
□ 3 instruments / 3 sets of samples ROTEM                                                                756.00         217
TEG
□ 1 instrument / 1 set of samples TEG                                                                    315.00         218
                                                  4       2022-T1     2022-T2    2022-T3     2022-T4
□ 2 instruments / 2 sets of samples TEG                                                                  535.50         219
□ 3 instruments / 3 sets of samples TEG                                                                  756.00         220
CLOT-PRO
□ 1 instrument / 1 set of samples CLOT-PRO        4       2022-T1     2022-T2    2022-T3     2022-T4     315.00         224
□ 2 instruments / 2 sets of samples CLOT-PRO                                                             535.50         225
□ 3 instruments / 3 sets of samples CLOT-PPRO                                                            756.00         226
HIT PROGRAMME
HIT - I (immunological testing)                    2      2022-HIT1              2022-HIT3               215.00         204

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PROGRAMME DETAILS 2022

                              NUMBER
                                                                                                      PRICE       PRODUCT
DESCRIPTION                     OF                            SURVEY CODES
                              SURVEYS                                                                (EURO) #      CODE

SCREEN PROGRAMME
Screen - I: APTT, PT/INR                    2022- 2022- 2022- 2022- 2022- 2022- 2022- 2022-
                                  8                                                                   240.00         501
and Fibrinogen                               S1    S2    S3    S4    S5    S6    S7    S8

Screen - II: Thrombin                       2022- 2022- 2022- 2022- 2022- 2022- 2022- 2022-
                                  8                                                                   240.00         502
Time, Reptilase Time                         S1    S2    S3    S4    S5    S6    S7    S8

                                                  NUMBER                                               PRICE      PRODUCT
DESCRIPTION                                         OF                                                (EURO)
                                                  SURVEYS                SURVEY CODES                    #         CODE

APTT / PT MIXING TEST PROGRAMME
                                                              2022-      2022-    2022-     2022-
APTT / PT Mixing Test                                4                                                 200.00        503
                                                              Mix1       Mix2     Mix3      Mix4

                                                  NUMBER                                               PRICE      PRODUCT
DESCRIPTION                                         OF                                                (EURO)
                                                  SURVEYS                SURVEY CODES                    #         CODE

WILDCARD TEST PROGRAMME
Wildcard                                             1                           2022-W3               325.00        706

                                                  NUMBER                                               PRICE      PRODUCT
DESCRIPTION                                         OF                                                (EURO)
                                                  SURVEYS                SURVEY CODES                    #         CODE

POCT INR QC PROGRAMME
No annual subscription fee applicable if only participating in the POCT INR QC Programme.

POCT INR QC Programme
                                                     4       2022-Q1 2022-Q2     2022-Q3   2022-Q4     435.00        301
for CoaguChek INR monitors (any type)

* Annual shipping costs for countries outside Europe: on request.

                                                                      NUMBER                           PRICE
                                                   ORGANISED                         SURVEY                       PRODUCT
DESCRIPTION                                                             OF                            (EURO)
                                                      BY                            PERIOD(S)             #        CODE
                                                                      SURVEYS

OTHER SURVEYS

Post Analytical Platelet Function EQA
                                                  Nascola, USA           2        Spring, Autumn       205.00        701
(electronic survey)

Platelet Dense Granule exercise
                                                  Nascola, USA           2        Spring, Autumn       205.00        704
(electronic survey)
Case studies on bleeding disorders
(distribution separately from the regular             ECAT               1           Autumn            105.00        703
surveys)
Pre- and post-analytical electronic surveys
                                                      ECAT               1           Autumn            75.00         705
in haemostasis

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PROGRAMME DETAILS 2022

MOLECULAR BIOLOGY (In co-operation with the SPMD, Germany)
                                               NUMBER
                                                                                                        PRICE       PRODUCT
SURVEY      DESCRIPTION                            OF      SURVEY CODES
                                                                                                       (EURO) #       CODE
                                                SURVEY
MOLECULAR GENETICS MG1                             S
                FV-Leiden, Prothrombin, MTHFR (C677T,
MG1 Set A       A1298C), PAI-I 4G5G
                                                                     2       MG1 1/22     MG1 2/22         **           601
                FXIII V34L, GPIIIa, βFib (g455a), VKORC1
MG1 Set B       (G-1639A/C1173T), FXII c46t, FV-H1299R
                                                                     2       MG1 1/22     MG1 2/22         **           602

MG1 Set C       a1 PI, Apo E, ApoB100, ACE, CETP                     2       MG1 1/22     MG1 2/22         **           603
                Aldo B (149,174,334), HFE (H63D, C282Y,
MG1 Set D       S65C), LCT c-13910t,                                 2       MG1 1/22     MG1 2/22         **           604
                NOD2 (R702W, G908R, L1007fins C)
                M. Wilson (ATP7B-C3207A), FSAP (Marburg-I),
MG1 Set E       ITGA2 Gplalla C807T, Col1A1 SP1, VDR                 2       MG1 1/22     MG1 2/22         **           605
                (BsmI/Apal,TaqI)
                Faktor VII (R353Q), AT3 Cambridge Typ I/II,
MG1 Set F       CYP3A5*3
                                                                     2       MG1 1/22     MG1 2/22         **           606

MOLECULAR GENETICS MG2
                TPMT, CYP2C8 (K399R), CYP2C9 *2/*3,
                UGT1A1 (*28), DPYD *2A (Ex 14 skipping),
MG2 Set A       BCHE A/K, DPYD *13, DPYD D949V
                                                                     2       MG2 1/22     MG2 2/22         **           801
                (rs67376798), DPYD 1129 (rs75018182)
                K-Ras: Codon 12/13/61, BRAF V600E, BRAF
MG2 Set B       V600K, cKit D816V, NRAS Q61 (rs121913254,            2       MG2 1/22     MG2 2/22         **           802
                rs11554290, rs121913295)

MG2 Set C       HLA-B27, TNF alpha (238, 308)                        2       MG2 1/22     MG2 2/22         **           803

MG2 Set D       CYP2D6, CYP2C19 (*2/*17), CYP2C19*3                  2       MG2 1/22     MG2 2/22         **           804
                HLA B*5701, CYP2B6*6, ABCB1 (MDR1)
MG2 Set E       c.3435>T, CCR5-del-32bp
                                                                     2       MG2 1/22     MG2 2/22         **           805
                IL28B (C/T Polymorphismus), IL6 (G174C),
MG2 Set F       CYP3A4*22
                                                                     2       MG2 1/22     MG2 2/22         **           806

PRICES MG1 or MG2
 ** MG1 or MG2: One set :         € 116.00        Three sets:   € 256.00     Five sets:    € 396.00
                Two sets:         € 186.00        Four sets:    € 326.00     Six sets:     € 466.00

DNA SEQUENCING SQ
DNA Sequencing (Sequencing and corresponding diagnostic
                                                                    2        SQ 1/22      SQ 2/22       264.00          901
interpretation)

DNA ISOLATION DI
DNA Isolation (DNA isolation and FV genotyping)
The FV genotyping includes: FV-Leiden (ARG506GLN),
FV-H1299R (HIS1299ARG), FV-Cambridge (ARG306THR),                   2         DI 1/22     DI 2/22       130.00          902
FV-Hong-Kong (ARG306GLY), FII g20220a, MTHFR C677T,
HFE (H63D, C282Y, S65C)

                                                                Per registration for one or more of the Molecular Biology surveys
Extra costs for shipment of Molecular Biology surveys
                                                                an annual fee of € 50,= will be charged.

SHIPMENT COSTS
Prices includes delivery of samples by regular postal service.
When delivery of samples by courier service is required, additional costs have to be paid. These costs depend on
the country of delivery. For questions about delivery by courier service, please contact the ECAT office.
Due to a change in the shipment procedure at SPMD (courier service instead of postal service) an extra annual fee
of € 50,= will be charged per registration for one or more Molecular Biology surveys.

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PROGRAMME DETAILS 2022

HOMOCYSTEINE PROGRAMME (In co-operation with DEKS, Denmark)
                                  NUMBER
                                                                                      PRICE      PRODUCT
DESCRIPTION                         OF
                                  SURVEYS             SURVEY CODES                   (EURO) #     CODE

Homocysteine                         4      2022-01   2022-02   2022-03   2022-04     150.00        1001

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PROGRAMME DETAILS 2022

DETAILED SAMPLE INFORMATION (I)
                                                                                          Number of    Number of
                                                                                 Survey    different    vials per
Description                                                                       Code     samples       sample
                                                                                                                           Component
                                                                                          per survey      code
Thrombophilia - I
Antithrombin (activity and antigen), Protein C (activity [chromogenic and          M          2            2            Plasma, lyophilised
clotting] and antigen), Protein S activity, Protein S antigen (total and free)
Thrombophilia - II                                                                 M          2            1            Plasma, lyophilised
APC Resistance
Coagulation Factor - I
Factor VIII (clot and chromogenic activity), IX (clot and chromogenic              M          2            2            Plasma, lyophilised
activity), XI:C and XII:C
Coagulation Factor - II                                                            M          2            2            Plasma, lyophilised
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
(antigen, ristocetin cofactor activity, activity, collagen binding, multimers,     M          2            2            Plasma, lyophilised
Factor VIII)
ADAMTS13 - I (activity and antigen)                                                M          2            1            Plasma, lyophilised
ADAMTS13 - II (antibodies)                                                         M          2            1            Plasma, lyophilised
ADAMTS13 - III (functional inhibitor)                                              M          2            1            Plasma, lyophilised
Factor XIII (activity and antigen)                                                 M          2            1            Plasma, lyophilised
Fibrinolysis - I                                                                   M          2            1            Plasma, lyophilised
Plasminogen, Antiplasmin
Fibrinolysis - II                                                                  M          2            1            Plasma, lyophilised
t-PA, PAI-1
Haemophilia                                                                        M          2            1            Plasma, lyophilised
Factor VIII / Factor IX (clot and chromogenic activity)
Factor VIII inhibitor                                                              M          2            1            Plasma, lyophilised
Factor IX Inhibitor                                                                M          2            1            Plasma, lyophilised
Emicizumab                                                                         M          2            1            Plasma, lyophilised
Lupus Anticoagulant / Antiphospholipid Antibodies                                  L          1            2            Plasma, lyophilised
Unfractionated Heparin Monitoring (anti-Xa)                                        A          2            1            Plasma, lyophilised
Low-Molecular Weight Heparin Monitoring (anti-Xa)                                  A          2            1            Plasma, lyophilised
Orgaran (anti-Xa)                                                                  A          2            1            Plasma, lyophilised
Fondaparinux (anti-Xa)                                                             A          2            1            Plasma, lyophilised
Rivaroxaban (anti-Xa)                                                              A          2            1            Plasma, lyophilised
Apixaban (anti-Xa)                                                                 A          2            1            Plasma, lyophilised
Edoxaban (anti-Xa)                                                                 A          2            1            Plasma, lyophilised
Argatroban (anti-IIa/dTT)                                                          A          2            1            Plasma, lyophilised
Dabigatran (anti-IIa/dTT)                                                          A          2            1            Plasma, lyophilised
D-Dimer                                                                            D          2            1            Plasma, lyophilised
Screen - I                                                                         S          2            1            Plasma, lyophilised
APTT, PT/INR and Fibrinogen
Screen - II                                                                        S          2            1            Plasma, lyophilised
Thrombin Time, Reptilase Time
Thrombin Generation Test                                                          TG          3            1            Plasma, lyophilised
PFA-100/200                                                                        P          2            2             tubes ± additives
ROTEM delta (samples per set)                                                      T          2            1            Plasma, lyophilised
ROTEM sigma (samples per set)                                                      T          2            1            Plasma, lyophilised
TEG (samples per set)                                                              T          2            1            Plasma, lyophilised
CLOT-PRO (samples per set)                                                         T          2            1            Plasma, lyophilised
HIT - I (immunological testing)                                                   HIT         2            1        Plasma or serum, lyophilised
POCT INR QC Programme                                                              Q          4            1            Plasma, lyophilised
APTT / PT Mixing Test Programm                                                    MIX         2            1            Plasma, lyophilised
Wildcard Programme                                                                 W          2            3            Plasma, lyophilised
Homocysteine                                                                                  2            1              Plasma, liquid
Post Analytical Platelet Function EQA (electronic survey)                                     -            -                     -
Platelet Dense Granule exercise (electronic survey)                                           -            -                     -
Case studies on bleeding disorders                                                            1          1 or 2        Plasma, lyophilised
Pre- and post-analytical electronic surveys in haemostasis                                    -            -                     -
Molecular Genetics MG1                                                                        2            1        DNA preparation, lyophilised
Molecular Genetics MG2                                                                        2            1        DNA preparation, lyophilised
DNA Sequencing                                                                                5            1        DNA preparation, lyophilised
DNA Isolation                                                                                 2            1           Full blood, K-EDTA

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PROGRAMME DETAILS 2022

LIST OF PARAMETERS
Parameter                                                                Module                            Survey Code
ADAMTS-13 activity                                                    ADAMTS13 - I                              M
ADAMTS-13 antigen                                                     ADAMTS13 - I                              M
ADMATS-13 antibodies                                                  ADAMTS13 - II                             M
ADMATS-13 functional antibodies                                        ADAM13 - III                             M
Anticardiolipin antibodies (IgG, IgM)                Lupus Anticoagulant / Antiphospholipid Antibodies          L
Antithrombin activivty                                               Thrombophilia - I                          M
Antithrombin antigen                                                 Thrombophilia - I                          M
APC Resistance                                                       Thrombophilia - II                         M
Apixaban (anti-Xa)                                                       Apixaban                               A
APTT (clotting time / ratio)                                            Screen – I                              S
APTT Mixing Test                                                  APTT / PT Mixing Test                        Mix
Argatroban (anti-IIa / dTT)                                             Argatroban                              A
CLOT-PRO                                                                CLOT-PRO                                T
Dabigatran (anti-IIa / dTT)                                             Dabigatran                              A
D-Dimer                                                                  D-Dimer                                D
Edoxaban (anti-Xa)                                                      Edoxaban                                A
Emicizumab                                                             Emicizumab                               M
Factor II:C                                                       Coagulation Factor - II                       M
Factor V:C                                                        Coagulation Factor - II                       M
Factor VII:C                                                      Coagulation Factor - II                       M
Factor VIII (clot and chromogenic)                         Coagulation Factor - I / Haemophilia                 M
Factor VIII Inhibitor                                               Factor VIII Inhibitor                       M
Factor IX (clot and chromogenic)                           Coagulation Factor - I / Haemophilia                 M
Factor IX Inhibitor                                                 Factor IX Inhibitor                         M
Factor X:C                                                        Coagulation Factor - II                       M
Factor XI:C                                                       Coagulation Factor - I                        M
Factor XII:C                                                      Coagulation Factor - I                        M
Factor XIII activity                                                    Factor XIII                             M
Factor XIII antigen                                                     Factor XIII                             M
Fibrinogen (Clauss)                                                     Screen – I                              S
Fibrinogen (Derived)                                                    Screen – I                              S
Fondaparinux (anti-Xa)                                                Fondaparinux                              A
ß2-Glycoprotein I antibodies (IgG, IgM)              Lupus Anticoagulant / Antiphospholipid Antibodies          L
HIT (immunological testing)                                               HIT – I                              HIT
Homocysteine                                                          Homocysteine                          Via DEKS
INR                                                                     Screen – I                              S
INR POCT                                                        POCT INR QC Programme                           Q
Low-Molecular Heparin (anti-Xa)                             Low-Molecular Heparin Monitoring                    A
Lupus Anticoagulant                                  Lupus Anticoagulant / Antiphospholipid Antibodies          L
Orgaran (anti-Xa)                                                        Orgaran                                A
PAI-1 activity                                                        Fibrinolysis - II                         M
PAI-I antigen                                                         Fibrinolysis - II                         M
PFA-100/200                                                            PFA-100/200                              P
Plasminogen activity                                                  Fibrinolysis - I                          M
Plasmin Inhibitor (antiplasmin) activity                              Fibrinolysis - I                          M
Protein C acivity (chromogenic / clotting)                           Thrombophilia - I                          M
Protein C antigen                                                    Thrombophilia - I                          M
Protein S activity                                                   Thrombophilia - I                          M
Protein S antigen (total and free)                                   Thrombophilia - I                          M
PT (clotting time, percentage)                                          Screen – I                              S
PT Mixing Test                                                    APTT / PT Mixing Test                        Mix
Reptilase Time (clotting time / ratio)                                  Screen – II                             S
Rivaroxaban (anti-Xa)                                                  Rivaroxaban                              A
ROTEM delta                                                           ROTEM delta                               T
ROTEM sigma                                                           ROTEM sigma                               T
TEG                                                                        TEG                                  T
Thrombin Generation Test                                        Thrombin Generation Test                       TG
Thrombin Time (clotting time / ratio)                                   Screen – II                             S
t-PA antigen                                                          Fibrinolysis - II                         M
Unfractionated Heparin (anti-Xa)                            Unfractionated Heparin Monitoring                   A
Von Willebrand Factor antigen                               Von Willebrand Factor Parameters                    M
Von Willebrand Factor ristocetin cofactor activity          Von Willebrand Factor Parameters                    M
Von Willebrand Factor activity                              Von Willebrand Factor Parameters                    M
Von Willebrand Factor collagen binding                      Von Willebrand Factor Parameters                    M
Von Willebrand Factor multimers                             Von Willebrand Factor Parameters                    M
Von Willebrand Factor / Factor VIII                         Von Willebrand Factor Parameters                    M

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PROGRAMME DETAILS 2022

DETAILED SAMPLE INFORMATION (II)
                                                                        Measuring range        Number of participants
Description
                                                                           (approx.)                (approx.)
Thrombophilia - I
Antithrombin (activity and antigen), Protein C (activity
                                                                            20 – 120%                   395
[chromogenic and clotting] and antigen), Protein S activity, Protein
S antigen (total and free)
Thrombophilia - II APC Resistance                                      normal / FV Leiden               255
Coagulation Factor - I
                                                                            0 – 200%                    300
Factor VIII (clot and chromogenic activity), IX:C, XI:C and XII:C
Coagulation Factor – II
                                                                            0 – 200%                    250
Factor II:C, V:C, VII:C and X:C
Von Willebrand Factor parameters
                                                                            0 – 125%                    400
(antigen, activity, collagen binding, multimers, Factor VIII)
ADAMTS13 - I (activity and antigen)                                         0 – 125%                    135
ADAMTS13 - II (antibodies)                                                0 – 20 BU/mL                   70
ADAMTS13 - III (functional inhibitor)                                     0 – 20 BU/mL                 NEW
Factor XIII (activity and antigen)                                          0 – 120%                   180
Fibrinolysis - I Plasminogen, Antiplasmin                                   0 – 120%                    160
Fibrinolysis - II t-PA, PAI-1                                             0 – 50 ng/mL                   70
Haemophilia                                                                 0 – 100%                    130
Factor VIII inhibitor                                                     0 – 15 BU/mL                  355
Factor IX Inhibitor                                                       0 – 15 BU/mL                  260
Emicizumab                                                              therapeutic range                60
Lupus Anticoagulant / Antiphospholipid Antibodies                       negative - positive             630
Unfractionated Heparin Monitoring (anti-Xa)                               0 – 1.25 IU/mL                170
Low-Molecular Weight Heparin Monitoring (anti-Xa)                         0 – 1.25 IU/mL                310
Orgaran (anti-Xa)                                                       therapeutic range               120
Fondaparinux (anti-Xa)                                                  therapeutic range               120
Rivaroxaban (anti-Xa)                                                   therapeutic range               250
Apixaban (anti-Xa)                                                      therapeutic range               235
Edoxaban (anti-Xa)                                                      therapeutic range                90
Argatroban (anti-IIa, dTT)                                              therapeutic range                65
Dabigatran (anti-IIa, dTT)                                              therapeutic range               190
D-Dimer                                                                 normal - elevated               700
Thrombin Generation Test                                                normal / abnormal                50
PFA-100/200                                                            normal - pathological            130
ROTEM delta                                                            normal - pathological             80
ROTEM sigma                                                            normal - pathological             55
TEG                                                                    normal - pathological             15
Clot-Pro                                                               normal - pathological             5

HIT - I (immunological testing)                                         negative / positive             465

Homocysteine                                                             0 – 100 µmol/L                 140
Screen - I
APTT, PT                                                               normal – prolonged
                                                                                                        285
INR                                                                         1.0 – 5.0
Fibrinogen                                                                1.0 – 4.0 g/L
Screen - II Thrombin Time, Reptilase Time                              normal – prolonged               105
APTT / PT Mixing Test                                                  normal – prolonged              NEW
Wildcard                                                                normal / abnormal              NEW
POCT INR QC Programme                                                         2 – 4.5                    45
Post Analytical Platelet Function EQA (electronic survey)                        -                      125

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PROGRAMME DETAILS 2022

Platelet Dense Granule exercise (electronic survey)                            -                             15
Case studies on bleeding disorders                                             -                             70
Pre- and post-analytical electronic surveys in haemostasis                     -                             50

Part of the samples used in the surveys is from commercial source. For abnormal samples real patient plasma is
used when appropriate. Samples are provided as lyophilized material.

Instructions for use of the samples will be given in the Survey Manual and the Survey Instructions.

Molecular Biology
In co-operation with the SPMD in Germany several EQA programmes related to Molecular Biology are provided.

Molecular Diagnostic Testing
Twice a year an EQA programme for Molecular Diagnostic Testing is provided. There are two modules on molecular
genetic testing (MG1 and MG2), each including 6 sets with different genetic defects to be tested. Within a module
the relevant sets for participation should be selected. For details see page 13. The material provided is purified DNA.

DNA isolation
Twice a year an EQA programme for DNA isolation is provided. Here whole EDTA-blood is provided. These surveys
focus on the determination of concentration of DNA, ratio 260/280, method of identification and defined genotypes.

DNA sequencing
Twice a year an EQA programme for DNA sequencing is provided. Purified DNA is provided. DNA sequencing should
be performed and corresponding diagnostic interpretation should be given.

Special surveys
Electronic post-analytical platelet function survey:
In co-operation with the NASCOLA in the United States twice a year a post-analytical survey for platelet function
testing is provided. These surveys focus on the interpretation of aggregation patterns in combination with a case
description.

Platelet Dense-Granual Survey:
In co-operation with the NASCOLA in the United States twice per year a platelet dense-granule survey is provided.
This is an electronic challenge in which electron microscopy images have to be evaluated.

Case studies on bleeding disorders:
Case studies on bleeding disorders is a combination of analytical aspects as well as case-based interpretation of the
laboratory results. The participant will receive plasma to perform laboratory tests, which can be selected based on a
given case description. Genetic testing will be included as an option. In addition a questionnaire on the interpretation
of test results has to be completed as well. The scope of this case studies is to investigate the ability of proper
interpretation of the clinical case description and the obtained laboratory test results, resulting in the correct diagnosis.

Pre- and post-analytical survey:
This is an electronic survey in which multiple choice questions with respect to aspects of the pre- and post-analytical
phase have to be answered. Comments on the given answers are shown and an overview of the score is given.

Disclaimer:

The ECAT Foundation is not responsible for either the content or the evaluation of the test results of surveys provided
either by the NASCOLA or SPMD.

       ECAT Foundation                                                                                         Page 18 of 25
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PROGRAMME DETAILS 2022

PILOT STUDIES

FVIII/FIX Replacement products:
Accurate monitoring of factor VIII or IX levels in respectively haemophilia A and B patients treated with replacement
products is important. For this reason the ECAT Foundation wants to introduce product-specific external quality
control for FVIII and FIX replacement products. In 2022 we will start with a pilot study. In Spring 2022 participants
registered for this pilot study will receive a questionnaire to indicate for which products they want to participate. This
pilot study is free of charge.

ACT Pilot Study:
The activated clotting time (ACT) is used primarily to monitor anticoagulation (heparin), e.g. during heart bypass
surgery, coronary angioplasty or dialysis. The ACT is a point-of-care test. For this programme samples will be used
that are applicable on an ACT POCT monitor. In 2022 we will execute a pilot study on external quality control for
ACT monitors. In Spring 2022 participants who register for this pilot study will receive more detailed information
about the planned survey period. This pilot study is free of charge.

Post-Analytical Interpretation of Platelet Whole Blood Impedance Aggregation and Secretion:
This module will offer interpretation of whole blood platelet aggregation analysis based on impedance and
determination of ATP release from platelet granules detected by a chemiluminescence method. This method has
several advantages over conventional platelet light transmission aggregation testing, specifically, it requires a
smaller volume of blood, eliminates the need to generate platelet rich plasma, and often takes less time to complete
testing.
NASCOLA will offer a pilot survey in 2022 for whole blood impedance aggregometry and secretion. The survey will
consist of 4 post-analytic interpretations, and the clinical cases will include patient history, the indication for platelet
aggregation testing, analytic tracings for each agonist, and other available laboratory test results. Participants will
be asked to interpret agonist response and provide an overall interpretation of the case. Materials and result
submission will be available in an electronic format on the NASCOLA website. This pilot study is free of charge and
will be sent to participants in Summer 2022.

      ECAT Foundation                                                                                         Page 19 of 25
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POINT-OF-CARE TESTING 2022

POCT FOR COAGUCHEK MONITORS

Introduction
The ECAT Foundation provides an external quality control kit for CoaguChek INR monitors. It can be used for
quality control of reference monitors in coagulation clinics, monitors used in hospital settings, medical centres etc.
as well as individual monitors of patients.
It is possible to evaluate more than one monitor (max. approx. 5) at the same time with one quality control kit.
Because of the use of a set of 4 certified plasma samples it is possible to get, within a certain confidence interval,
insight in the correctness of INR measurement within the therapeutic interval. The results can be evaluated using
an online evaluation tool and the evaluation report per monitor is immediately available.
It is advisable to evaluate the performance of each monitor at least twice a year or after the change of a lot number
of test strips.

Examples of QC kit and evaluation tool

• Ready-to-use QC kit (excl. test strips):

• Clear instructions:
                                                     4.              The control samples must now be mixed well with the water. This should be
                                                                     done as follows:
                                                                     • Firmly hold the bottle as shown in the photo opposite.
                                                                     • Turn the bottle upside down and back up again by rotating your lower arm. (The
                                                                      bottle must not be shaken, as this will cause foam to appear in the bottle of the
                                                                      control sample. This must be avoided .)
                                                                     • Repeat this action 5 times.
                                                                     • Repeat this procedure for all control sample bottles.
                                                                     • Then leave the bottles to stand for 15 minutes.

                                                                     During this time prepare the CoaguChek monitor for use.

• Online evaluation tool:
   (evaluation report immediately available)

• Clearly structured and informative evaluation report:

      ECAT Foundation                                                                                                                   Page 20 of 25
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POINT-OF-CARE TESTING 2022

POCT INR QC 2022
For 2022 the ECAT offers the following options:

    POCT INR QC Programme

    Samples are provided as QC kit 4 times per year. Each quarter you will receive a different lot-number of the
    quality control kit. For evaluation the webtool is available and the reports per monitor are generated
    immediately. You will receive an overall evaluation report after each quarter.
    More information about the dispatch date of the kits and survey period can be found on page 9. Information
    about the cost is given on page 12.

    Registration POCT INR QC Programme:
    Registration for this POCT INR QC Programme is included in the online subscription form 2022.

    POCT INR QC Single kits

    The single kits can be ordered and evaluated at any time. For evaluation the webtool is available and the
    reports per monitor are generated immediately.

                                                                                  Price (Euro)              Product
      Description
                                                                          Excl. VAT and shipment cost **     code

      ECAT INR Quality Control single kit                                              77.50               ECAT11001

    ** Shipping and handling costs per order:     - within the Netherlands: € 12,50
                                                  - within Europe: € 25,=
                                                  - outside Europe: price on request

      For orders of more than 25 sets at once a special price can be provided.
      Orders for these POCT quality control kits will be separately invoiced from the regular EQA programme.

How to order POCT Quality Control Single Kits

In the POCT section at the ECAT website (POCT →
POCT single kit - order form) a special order form can
be found for ordering POCT QC kits. This online order
form can only be used to order a number of single kits,
Product code ECAT11001.

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GENERAL INFORMATION ECAT FOUNDATION 2022

GENERAL INFORMATION ECAT FOUNDATION

The ECAT is an independent and impartial organization. Its legal entity is a foundation directed by the director,
dr. P. Meijer. A Supervisory Board oversees the foundation and also serves as the Scientific Advisory Board.
Members of the Supervisory Board are well experienced in the field of thrombosis and haemostasis.

Staff
Name                             Position
Dr. P. Meijer                    Director
Mrs. M. Van der Voorn            Operational Manager
Dr. M. van Essen                 Programme Expert
Mrs. P. Paul                     Customer Support
Mr. C. van den Broek             IT co-worker
Mrs. A. de Haan                  Logistic co-worker
Mrs. R. van der Plas             Logistic co-worker
Mrs. W. Hoogenboom               Financial Manager
Mrs. B. de Jong-Vaane            Financial co-worker / Customer Support
Mrs. S. Mollee                   Quality Manager

Members of Supervisory Board
Name                             Specialism                                       Position
Prof. Dr. M.P.M. de Maat         Biochemist/epidemiologists/clinical chemist      Chair
Drs. F. van den Hurk             Financial specialist                             Member
Dr. W. van Gelder                Clinical chemist                                 Member
Dr. F.J.M. van der Meer          Internist                                        Member
Prof. Dr. J.C.M. Meijers         Biochemist                                       Member

Website
At the ECAT website (www.ecat.nl) there is a
specific participant area which contains the result
submission facility, survey reports, information
and documents. These sections can be accessed
with a Login function.
Each participant has his own unique username
and password. These are provided by the ECAT
office at the start of the participation.

For laboratories using our quality control for the
CoaguChek monitors an evaluation tool is
available at our website. This can be accessed
by a special login (POCT, followed by
Evaluation) from the main menu at our website.
This requires a different username and
password.
Each user has his own unique username and
password. These are provided by the ECAT
office at the start of the participation.

Survey Manual
The Survey Manual 2022, which includes detailed instructions how to perform the surveys, will become online
available before the start of the first survey.

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GENERAL INFORMATION ECAT FOUNDATION 2022

Accreditation

Since 25 April 2012 the EQA programme of the ECAT is accredited according to the international
standard ISO/IEC 17043:2010 by the Dutch Accreditation Council (RvA).

The following modules of ECATs’ EQAP are part of the accreditation scope:
   • Screen – I
   • Screen - II
   • Thrombophilia - I
   • Thrombophilia - II
   • Lupus Anticoagulant / Antiphospholipid Antibodies
   • D-Dimer
   • Coagulation Factor - I
   • Coagulation Factor - II
   • Von Willebrand Factor module
   • Factor VIII inhibitor
   • Thrombin Generation Test
   • Factor XIII
   • Fibrinolysis - I
   • Fibrinolysis - II
   • Monitoring for Anticoagulation Drugs (UFH, LMWH, Orgaran, Fondaparinux, Rivaroxaban, Apixaban,
         Argatroban, Dabigatran)

It is our intention to add new modules to the scope of the accreditation as soon as possible after the introduction.
The latest version of the scope can always be found at our website.

Products and services from third parties

ICT-related issues          Back-up services, web design and                  Health e.solutions – The
                            maintenance, web and database hosting,            Netherlands
                            POCT application.
                            Participant management and survey                 KPMD – United Kingdom
                            evaluation software, web-based data
                            submission.
Sample production           Sample production and testing for                 Affinity Biologicals – Canada
                            homogeneity and stability.                        Hyphen Biomed – France
                                                                              Technoclone – Austria
                                                                              MCA – The Netherlands
                                                                              Klinikum Augsburg – Germany
                                                                              RCPA – Australia
                                                                              R2 Diagnostics – United States

Laboratory testing          Reference laboratory for testing of               Erasmus Medical Center – The
                            homogeneity and stability.                        Netherlands
                                                                              Radboud University Medical
                                                                              Center – The Netherlands

Confidentiality policy
1. ECAT is obliged to keep confidential any and all information they acquired from participants within the scope of
   their registration.
2. Any results from research conducted by ECAT within the scope of the programme offered by ECAT that can be
   traced to a certain participant shall be confidential and shall only be notified to the relevant participant.
3. If ECAT should, on the basis of a statutory provision or court decision, be obliged to disclose confidential
   information to a third party designated by the law or the competent court, and ECAT cannot in such case invoke
   the right of non-disclosure acknowledgement or allowed under the law or by the competent court, ECAT shall
   not be obliged to pay compensation or damages, and the participant shall not have the right to dissolve the

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GENERAL INFORMATION ECAT FOUNDATION 2022

   agreement on the basis of any resultant damage. ECAT is obliged to notify affected participants of this action in
   written.
(for further details see our general terms delivery which can be found on our website)

Intellectual property rights and copyrights
1. ECAT reserves the rights and powers vested in ECAT pursuant to the intellectual property right.
2. The participant shall not be permitted to modify the items delivered or made available, unless the nature of the
   items delivered or made available should require otherwise or unless agreed otherwise.
3. Any designs, presentations, drawings, films, software or other material or files, whether electronic or
   otherwise, made by ECAT within the scope of the contract shall remain the property of ECAT, irrespective of
   whether they were handed over to the participant or to third parties, unless agreed otherwise.
4. Any and all documents provided by ECAT such as reports, advice, agreements, etc. shall exclusively be
   intended for use by the participant and they may not be reproduced, published or disclosed to third parties by
   the participant without ECAT’s permission obtained in advance, unless the nature of the documents should
   dictate otherwise.
5. ECAT reserves the right to use the know-how acquired due to the carrying out of the work for other purposes,
   insofar as no confidential information is disclosed to third parties.

(for further details see our general terms delivery which can be found on our website)

Provision of global survey reports
ECAT may provide to third parties, like distributors of the ECAT programme or diagnostic companies, global
survey reports which only demonstrate the overall statistical analysis without any traceable results to a specific
participant.

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FINANCES 2022

FINANCES

You will receive an invoice for your participation as soon as possible in 2022. When the appropriate information is
available the invoice will be sent directly by e-mail to the financial department of your hospital/institution. Otherwise
the invoice will be sent to the sample or responsible person.
Payment should be done by bank transfer. Cheques are not accepted.
When the invoice is not paid within 6 weeks after receipt of the invoice, no samples and survey reports will be
provided anymore till payment is done.

For participants of one of the EMU countries we ask for a VAT number. If the VAT number of your organization is
not available at our Financial Department, the ECAT is legally obliged to add 21% VAT to the invoice.

Contact details financial department
T. +31 71 3030911
F. +31 71 3030919
finance@ecat.nl

Details ECAT bank account
Bank office:               ING
Address:                   P.O. Box 94780
                           1090 GT Amsterdam
                           The Netherlands
Account no.:               6930471
IBAN no.:                  NL38 INGB 0006 9304 71
BIC code:                  INGBNL2A

ECAT VAT number:           NL802836872B01

Terms of delivery
The terms of delivery of the ECAT Foundation can be found on our website. If you want a printed copy, please
contact our office

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