ECAT FOUNDATION - PARTICIPANT INFORMATION Programme and Prices 2022 - External quality Control of diagnostic Assays and Tests
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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 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
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. ECAT Foundation Page 1 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 2 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 3 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 4 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 5 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 6 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 7 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 8 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 9 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 10 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 11 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 12 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 13 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 14 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 15 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 16 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 17 of 25 M015 / Release: 270921PM
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 M015 / Release: 270921PM
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 M015 / Release: 270921PM
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 M015 / Release: 270921PM
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. ECAT Foundation Page 21 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 22 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 23 of 25 M015 / Release: 270921PM
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. ECAT Foundation Page 24 of 25 M015 / Release: 270921PM
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 ECAT Foundation Page 25 of 25 M015 / Release: 270921PM
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