EQA Schemes Catalogue 2018

Transcription

1 EQA Schemes Catalogue 2018 ERNDIM Administration Office Manchester Centre for Genomic Medicine 6th floor, St Mary s Hospital Oxford Road, Manchester M13 9WL, UK Tel: Fax: admin@erndim.org Web: European Research Network for evaluation and improvement of screening, Diagnosis and treatment of Inherited disorders of Metabolism

2 Contents 1. Introduction EQA Schemes Quantitative Schemes Acylcarnitines in Serum Cystine in White Blood Cells Lysosomal Enzymes (fibroblasts) Neurotransmitters in CSF... 5 Pterins in Urine Purines and Pyrimidines (urine) Quantitative Amino Acids (serum)... 7 Quantitative Organic Acids (urine) Special Assays in Serum... 8 Special Assays in Urine Qualitative Schemes.. 9 Acylcarnitines in dried blood spots Congenital Disorders of Glycosylation (plasma/serum)... 9 Diagnostic Proficiency Testing (urine) Qualitative Organic Acids (urine).. 10 Urine Mucopolysaccharides EQA Schemes 2018 Price List Terms and Conditions of EQA Scheme Participation September Page 2 of 14

3 1. Introduction 1.1. ERNDIM Participant s Guide Brief information on participating in the ERNDIM EQA schemes is included in this Introduction to the 2018 EQA scheme catalogue. Further details about all aspects of participating in the ERNDIM EQA scheme can be found in the ERNDIM Participant s Guide, which can be downloaded from the ERNDIM Registration Website and can also be requested from the ERNDIM Administration Office How to register for EQA schemes Details of how to access the ERNDIM Registration Website will be sent to all existing EQA participants in September The Registration Website will show all the contact and address information which is held by ERNDIM for your laboratory. Please make sure that you: Check if the information is correct and update it where necessary Select the EQA schemes that you wish to participate in during 2018, and Submit your order New participants can the ERNDIM Administration Office (admin@erndim.org) to request access to the ERNDIM Registration Website. All 2018 EQA scheme orders must be submitted by 14 th November If you have any problems with registering for the 2018 EQA schemes please contact admin@erndim.org EQA participation fees The price list for the 2018 EQA schemes can be found on page 12 of this catalogue and also on the ERNDIM website under EQA schemes Laboratory Support Grants A limited number of Laboratory Support Grants are available to provide financial support for laboratories which due to financial restrictions find it difficult to fund participation in one or more of the ERNDIM EQA schemes. Laboratory Support Grants are awarded annually by the ERNDIM Board on a competitive basis with the aim of allowing laboratories to extend their repertoire of EQA scheme participation. If you would like to apply for a Laboratory Support Grant please complete and return the application form, which can be found on the ERNDIM website under Training and Education/Grants Educational participation Educational Participation is open to laboratories that are participating in an EQA scheme to help with setting up a new test but are not yet offering a clinical service. Please see the ERNDIM Participant s Guide for full details but, briefly, participants that select Educational Participation when registering for an EQA scheme MUST send a completed and signed Educational Declaration form to the ERNDIM Administration Office. Educational Participation in a scheme is not confirmed until the Administration Office confirms that your application has been accepted. The Educational Participation Declaration forms can be found on the ERNDIM Registration website ( under Participant Information EQA scheme timetables Details of the calendar for sample dispatches, reporting and certificates of participation can be found in the ERNDIM Participant s Guide (see 1.1). An EQA calendar is also available to download on the ERNDIM website under EQA schemes. Information is added to the calendar as it becomes available Appeals and Complaints Problems relating to EQA Schemes, including appeals and complaints from participating laboratories, should be referred directly to the ERNDIM Administration Office Invoicing & Payment Information Details of when and how you will be sent the invoice for your ERNIDM EQA scheme participations can be found in the ERNDIM Participant s Guide. The Participant s Guide can be downloaded from the ERNDIM Registration Website and can also be requested from the ERNDIM Administration Office Terms & Conditions of EQA scheme participation All participant laboratories must accept the terms and conditions on the ERNDIM Registration Website before an EQA scheme order can be submitted. The terms and conditions are on page 13 of this catalogue and can also be viewed on the ERNDIM Registration Website. 11 September Page 3 of 14

4 2. EQA Schemes 2.1. Quantitative EQA Schemes Acylcarnitines in serum Comparison of Acylcarnitines analysis in a lab with respect to median and target values Scheme Code: ACS Status: Operating as a separate full EQA scheme since 2017; some acylcarnitines were previously included in the Special Assays in serum scheme Eligibility Requirements: None No. of registrations (2017): 88 Analytes (2018): Free carnitine (C0) Acetylcarnitine (C2) Propionylcarnitine (C3) Butyrylcarnitine (C4) Tiglylcarnitine (C5:1) Isovalerylcarnitine (C5) Hexanoylcarnitine (C6) Octanoylcarnitine (C8) Decanoylcarnitine (C10) Cis-5-Tetradecenoylcarnitine (C14:1) Sample matrix: Lyophilised, spiked human serum Volume/sample: 1 ml/vial Tetradecanoylcarnitine (C14) Palmitoylcarnitine (C16) 3-Hydroxyhexadecanoyl-L-carnitine (C16-OH) Oleoylcarnitine (C18:1) Stearoylcarnitine (C18) 3-Hydroxystearoylcarnitine (C18-OH) Malonylcarnitine (C3-DC) Methylmalonylcarnitine (C4-DC) Glutarylcarnitine (C5-DC) Scientific Advisor: Dr. Pedro Ruiz-Sala, prsala@cbm.csic.es Cystine in White Blood Cells Comparison of analysis of Cystine in White Blood Cells (WBC) Status: Full ERNDIM EQA scheme since 2005 Geographic area: Worldwide Eligibility requirements: None No. of registrations (2017): 37 Analytes (2018): Scheme Code: CWBC No. of samples/year: 8 pairs of protein and WBC supernatants Sample matrix: Protein is lyophilised, WBC supernatants are liquid Volume/sample: Pellet and supernatant equivalent to extracts from 5 ml whole blood samples Cystine (nmol/aliquot) (250 µl SNT sample) Protein (PP sample) Cystine (nmol 1/2 cys/mg protein, calculated as if isolated from one 5 ml blood sample) Scientific Advisor: Dr. Daniel Herrera, daniel.herrera@nhs.net 11 September Page 4 of 14

5 Lysosomal Enzymes (fibroblasts) Scheme Code: LEFB Testing of reproducibility and ability to detect enzyme deficiencies in Lysosomal storage disorders Status: Full ERNDIM EQA scheme since 2011 (ran as a pilot scheme ) Geographic area: Worldwide No. of samples/year: 6 Eligibility Requirements: None Sample matrix: Lyophilised fibroblasts No. of registrations (2017): 75 Volume/sample: 0.5 mg lyophilised protein/standard specimen Expected Analytes (2018): Please note, as these are clinical samples enzymes may vary depending on the availability of samples. Protein Galactose-6-sulphate sulphatase alpha-galactosidase beta-galactosidase alpha-glucosidase beta-glucosidase beta-hexosaminidase A alpha-iduronidase Galactosylceramidase beta-hexosaminidase A+B Sphingomyelinase No. of shipments/year: One shipment of 6 samples in January March Submission deadlines: 3 deadlines at approximately 2-3 month intervals from March Submission of results: Reports: Scientific Advisor: Scheme Organiser: Via Results website Interim reports can be downloaded from the Results website during the scheme year; final report available at the end of the scheme year Dr. Kees Schoonderwoerd, g.schoonderwoerd@erasmusmc.nl SKML: Dr. C. Weykamp, c.w.weykamp@skbwinterswijk.nl Neurotransmitters in cerebrospinal fluid (CSF) Scheme Code: NCSF To educate and assess the ability of laboratories to diagnose inborn errors of neurotransmitter metabolism Status: Pilot scheme , full scheme from 2016 Eligibility Requirements: None No. of registrations (2017): 29 Sample matrix: lyophilised, spiked CSF/artificial CSF Volume/sample: 0.5 ml Analytes (2018): Homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA), 3- methyl dopa, 5-OH-Tryptophan (5-HTTP), HVA:5-HIAA ratio Scientific Advisor: Prof. Simon Heales, Simon.Heales@gosh.nhs.uk 11 September Page 5 of 14

6 Pterins in Urine Scheme Code: PTU To educate and assess the ability of laboratories to diagnose inborn errors of tetrahydrobiopterin (BH4) metabolism Status: Pilot scheme , operating as a full scheme since 2017 Eligibility requirements: None Sample matrix: lyophilised native and/or spiked urine No. of participants (2017): 30 Volume/sample: 1 ml urine/sample Analytes (2018): neopterin (total) biopterin (total) primapterin (total) creatinine No. of shipments/year: One shipment in January March Scientific Advisor: Prof. Nenad Blau, Nenad.Blau@med.uni-heidelberg.de Purines and Pyrimidines (urine) Scheme Code: PPU Comparison of Purine and Pyrimidine analysis in a lab with respect to median and target values Status: Full ERNDIM EQA scheme since 2000 Eligibility Requirements: None Sample matrix: Lyophilised, spiked human urine No. of registrations (2017): 51 Volume/sample: 5 ml/vial Analytes (2018): 5-OH methyluracil Adenine Adenosine AICAR Creatinine (mmol/l) Deoxy-adenosine Deoxy-guanosine Deoxy-inosine Deoxy-uridine Dihydro-thymine Dihydro-uracil Guanosine Hypoxanthine Inosine Orotic acid Pseudo-uridine Thymidine Thymine Uracil Uric acid Xanthine Scientific Advisor: Dr. Jörgen Bierau, jorgen.bierau@mumc.nl 11 September Page 6 of 14

7 Quantitative Amino Acids (serum) Scheme Code: QTAS Comparison of Amino Acid analysis in a lab with respect to median and target values Status: Full ERNDIM EQA scheme since 1993 Eligibility requirements: None Sample matrix: Lyophilised, spiked human serum No. of registrations (2017): 266 Analytes (2018): Please note, there is a core panel of amino acids which are included every year, but other special amino acids may vary from year to year for example, those marked with * Volume/sample: 1 ml/vial 2-Aminobutyric acid 5-Aminolevulinic acid Alanine Allo-isoleucine * Arginine Asparagine Aspartic Acid Aspartyl glucosamine * Citrulline Cystathionine * Cystine Glutamic acid Glutamine Glycine Histidine Homocitrulline * Homocysteine Hydroxyproline Isoleucine Leucine Lysine Methionine Ornithine Phenylalanine Pipecolic acid * Proline Saccharopine * Sarcosine * Serine Sulphocystine Taurine Threonine Tryptophan * Tyrosine Valine Scientific Advisor: Dr Rachel Carling, Rachel.Carling@viapath.co.uk Quantitative Organic Acids (urine) Scheme Code: QTOU Comparison of Organic Acid analysis in a lab with respect to median and target values Status: Full ERNDIM EQA scheme since 1993 Eligibility Requirements: None Sample matrix: Lyophilised, spiked human urine No. of registrations (2017): 126 Volume/sample: 10 ml/vial Analytes (2018): 2-OH-glutaric acid 2-methylcitric acid 3-OH-3-methylglutaric acid 3-OH-glutaric acid 3-OH-isovaleric acid 3-methylglutaconic acid 3-methylglutaric acid 4-OH-Butyric acid Adipic acid Creatinine (mmol/l) Ethylmalonic acid Fumaric acid Glutaric acid Glycolic acid Hexanoylglycine Isovalerylglycine Keto-glutaric acid Methylmalonic acid Mevalonic acid N-acetylaspartic acid Pyroglutamic acid Sebacic acid Suberic acid Tiglylglycine Vanillactic acid Scientific Advisor: Mme. Clothilde Roux, clothilde.roux@chuv.ch 11 September Page 7 of 14

8 Special Assays in Serum Scheme Code: SAS Comparison of outcome in heterogeneous group of lab-assays, relevant to the diagnosis of inborn errors of metabolism, in respect to median and target values. In addition recovery of added analyte, precision, and analytical linearity are tested Status: Full ERNDIM EQA scheme since 1993 Eligibility Requirements: None No. of registrations (2017): 248 Sample matrix: Lyophilised, spiked human serum Volume/sample: 5 ml/vial Analytes (2018): 3 OH Butyrate 7-Dehydrocholesterol 7-Ketocholesterol C22:0 Behenic acid (* these analytes are not C24:0 Lignoceric acid C26:0 Cerotic acid Carnitine Free Cholestane-3,5,6 -triol added but can be recorded Cholestanol Cholesterol * Creatine Galactose for comparison between labs) Glycosylsphingosine Guanidine acetic acid Homocysteine Lactic acid L - Pipecolic acid LysoGb3 Methylmalonic acid NEFA * Phytanic acid Pristanic acid Pyruvic acid Scientific Advisor: Dr. Begoña Merinero, bmerinero@cbm.csic.es Special Assays in Urine Scheme Code: SAU Comparison of outcome of a heterogeneous group of lab-assays, relevant to the diagnosis of inborn errors of metabolism, in respect to median and target values. In addition recovery of added analyte, precision and analytical linearity are tested Status: Full ERNDIM EQA scheme since 1993 Eligibility Requirements: None No. of registrations (2017): 175 Sample matrix: Lyophilised, spiked human urine Volume/sample: 5 ml/vial Analytes (2018): 4-OH-Glutamic acid 5-Aminolevulinic acid 5-OH-Indolacetic acid Carnitine Free Creatine Creatinine L-Cystine D,L-Glyceric acid Galactitol Glycolic Acid Guanidinoacetate Homocitrulline Homovanillic acid Lactic acid Mucopolysaccharides (Chondroitin sulfate) Orotic acid Oxalic acid L - Pipecolic acid Sialic acid Succinylacetone Sulphocysteine Scientific Advisor: Dr. Begoña Merinero, bmerinero@cbm.csic.es 11 September Page 8 of 14

9 2.2. Qualitative Schemes The qualitative schemes use clinical samples as the EQA materials. For schemes which are organised by more than one centre participants will be assigned to a centre by the Administration Office. Acylcarnitines in dried blood spots Scheme Code: ACDB Status: To educate and assess the ability of laboratories to detect inherited disorders resulting in recognisable whole blood acylcarnitine profiles Operated since 2003 (London only). In 2010 and 2017 additional centres in Heidelberg and Zurich, respectively were added due to increasing participant numbers. Geographic area: Worldwide No. of samples/year: 6 Eligibility Requirements: None No. of registrations (2017): 123 (40-42 per centre) Sample matrix: Dried blood spots on S&S903 filter paper Volume/sample: microlitre initial blood volume Analytes: Dependent upon disorder No. of shipments/year: 2 shipments of 3 samples. Shipment dates are dependent upon sample supply. Submission deadlines: 2 deadlines (6 8 weeks after sample shipment) Submission of results: Via , fax or post to Scientific Advisor Reports: Interim reports are ed to participants twice per year Scientific Advisors: London: Dr. Charles Turner, chas.turner@kcl.ac.uk Heidelberg: Dr. Claus-Dieter Langhans, Claus-Dieter.Langhans@med.uni-heidelberg.de Zurich: Dr. Ralf Fingerhut, Ralph.Fingerhut@kispi.uzh.ch Scheme Organisers: London: Dr. Charles Turner, chas.turner@kcl.ac.uk Heidelberg: Dr. Claus-Dieter Langhans, Claus-Dieter.Langhans@med.uni-heidelberg.de Zurich: Dr. Ralf Fingerhut, Ralph.Fingerhut@kispi.uzh.ch Congenital Disorders of Glycosylation (plasma/serum) Scheme Code: CDG Qualitative interpretation of sialotransferrin profiles in the screening for Congenital Disorders of Glycosylation (CDG) Status: Full ERNDIM EQA scheme since 2010 (ran as a pilot scheme in 2008 & 2009) Geographic area: Worldwide No. of samples/year: 6 Eligibility Requirements: None No. of registrations (2017): 66 Sample matrix: Lyophilised Human plasma/serum Volume/sample: 25 microlitres Analytes: Sialotransferrin isoforms No. of shipments/year: One shipment of 6 samples per year in January March Submission deadlines: 2 deadlines (April & September) Submission of results: Via to Scientific Advisor Reports: Diagnoses circulated by 2-3 weeks after each submission deadline Annual report (including full anonymised scheme results) published in January March of the following year Scientific Advisor: Dr. D.J. Lefeber, Dirk.Lefeber@Radboudumc.nl 11 September Page 9 of 14

10 Diagnostic Proficiency Testing (urine) Scheme Code: DPT Status: To assess test selection, analysis, interpretation and advice in the performance of tests related to the detection of inherited metabolic disorders Operated since 1990 (Netherlands only). In 1998 a further 3 organising centres were added (Czech Republic, France and UK) and in 2006 a fifth centre (Switzerland) was added as part of the EuroGentest project. Geographic area: Worldwide (each organising centre focuses on a separate geographic area) Eligibility Requirements: Any urine sample can be sent that a laboratory operating to expected standards would be able to diagnose, but participants should be able to perform this core panel of tests: amino acids, organic acids, oligosaccharides, mucopolysaccharides. If your laboratory does not offer this core panel of tests it may not be possible to obtain satisfactory performance and we strongly recommend that you do not register for the DPT scheme. The use of cluster labs, for instance for purines & pyrimidines, is acceptable but the participant lab is responsible for the results submitted. No. of specimens/year: 6 Sample matrix: Heat-treated human urine No. of registrations (2017): 109 (20-25 per centre) Volume/sample: Approx. 10 ml/vial Analytes: Dependent upon disorder No. of shipments/year: 1 shipment of 6 samples in February March Submission deadlines: 2 deadlines in March June Scientific Advisors: Czech Republic: Prof. Viktor Kožich, viktor.kozich@vfn.cz France: Dr. Christine Vianey-Saban, christine.saban@chu-lyon.fr Netherlands: Dr. George Ruijter, g.ruijter@erasmusmc.nl Switzerland: Prof. Brian Fowler, brian.fowler@ukbb.ch UK: Mrs. Joanne Croft, Joanne.Croft@sch.nhs.uk Scheme Organiser: CSCQ: Dr. Xavier Albe, Xavier.Albe@hcuge.ch Qualitative Organic Acids (urine) Scheme Code: QLOU To educate and assess the ability of laboratories to detect inherited disorders resulting in recognisable patterns of organic acid excretion Status: Operated since 1992 (Sheffield only), with an additional centres in Heidelberg and Barcelona added in 2002 and 2018, respectively, due to increased participant numbers. Geographic area: Worldwide No. of samples/year: 9 Eligibility Requirements: None Sample matrix: Heat-treated human urine No. of registrations (2017): 220 (110 per centre) Volume/sample: 2-3 ml/vial Analytes: Dependent upon disorder No. of shipments/year: 1 shipment of 9 samples in April May. Submission deadlines: 3 deadlines at 6-8 weeks intervals from June November Submission of results: Via , fax or post to Scientific Advisor Reports: Interim reports are mailed to participants 3 times per year Scientific Advisors: Barcelona: Dr Judit Garcia-Villoria, jugarcia@clinic.cat Sheffield: Mrs. Camilla Scott, Camilla.Scott@sch.nhs.uk & Dr. Jane Dalley, Jane.Dalley@sch.nhs.uk [on maternity leave] Heidelberg: Dr. Claus-Dieter Langhans, Claus-Dieter.Langhans@med.uni-heidelberg.de Scheme Organiser: CSCQ: Dr. Xavier Albe, Xavier.Albe@hcuge.ch 11 September Page 10 of 14

11 Urine Mucopolysaccharides Scheme Code: UMPS To educate and assess the ability of laboratories to detect mucopolysaccharidoses Status: Pilot scheme 2010 & 2011, full scheme from 2012 Geographic area: Worldwide No. of samples/year: 6 Eligibility Requirements: None Sample matrix: Lyophilised human urine No. of registrations (2017): 103 Volume/sample: 5 ml/vial Analytes: Quantitative (related to creatinine) and qualitative analysis of mucopolysaccharides with interpretation of results obtained No. of shipments/year: One shipment in of 6 samples February March Submission deadlines: 2 deadlines in April September Submission of results: Via Results Website Scientific Advisor: Dr. G. Ruijter, g.ruijter@erasmusmc.nl and CSCQ: Dr. Xavier Albe, Xavier.Albe@hcuge.ch 11 September Page 11 of 14

12 3. EQA Schemes 2018 Price List EQA Schemes 1. Quantitative Schemes Scheme Code 2018 Prices Euro GB Pounds * US$ * Acylcarnitines in serum ACS Cystine in White Blood Cells CWBC Lysosomal Enzymes (fibroblasts) LEFB Neurotransmitters (CSF) NCSF Pterins in Urine PTU Purines and Pyrimidines (urine) PPU Quantitative Amino Acids (serum) QTAS Quantitative Organic Acids (urine) QTOU Special Assays (serum) SAS Special Assays (urine) SAU Special Assays Combined (serum & urine) SAC Qualitative Schemes Acylcarnitines (dried blood spots) ACDB Congenital Disorders of Glycosylation (serum) CDG Diagnostic Proficiency Testing (urine) DPT Qualitative Organic Acids (urine) QLOU Urine Mucopolysaccharides UMPS Please note: Mailing fee per scheme for all laboratories: * The prices for ERNDIM EQA schemes are set in Euro and converted to GB Pounds and US$ based upon conversion rates of and respectively. VAT at 20% will be added to invoices for all UK laboratories. For 2018, the mailing fee per scheme will added to the invoices for ALL laboratories. Due to the increasing cost of dispatching the EQA samples we regret that it is unfortunately necessary to apply this charge to orders for ALL laboratories. 11 September Page 12 of 14

13 4. Terms and Conditions of EQA Scheme Participation 1. When registering for ERNDIM EQA schemes it is the responsibility of the person listed as the laboratory primary contact to provide the ERNDIM Administration Office with valid, up to date contact and address details, which should include: 1. and postal addresses for at least 2 named contact persons* 2. A delivery address for EQA materials 3. An invoice address and named invoice contact with address 4. address for named Head of Laboratory or Quality Manager* (this contact will only be used in certain cases of poor performance) * these contact details must be for 3 different people Any subsequent change in contact persons or address details must be sent to the ERNDIM Administration Office as soon as possible. 2. Participants are responsible for ensuring that they have obtained any import or other permits required for delivery of the EQA materials and for sending these to the ERNDIM Administration office during the Registration period. 3. Mailing charges (per scheme) will be added to the EQA order unless the participant provides the details of a courier account to be used for the sample dispatch. Any additional customs charges will be paid by the participant. 4. For participants that submit an EQA scheme order by the Registration deadline, invoices will be sent out in mid-november and will be dated 1st January of the following year, as requested by a number of laboratories. 5. If your hospital or laboratory procedures require a Purchase Order number on the invoice, this should be added to the registration form. 6. Invoices will be sent by only to the primary, secondary and invoice contacts for each laboratory. It is the responsibility of the primary laboratory contact to provide a valid invoice address, invoice contact name and invoice address. 7. The participant must check the information in the invoice. If all details are correct the invoice should be passed for payment to the appropriate finance department. If any details on the invoice are not correct the ERNDIM Administration office (admin@erndim.org) should be notified by mid-december and a revised invoice will be issued. 8. The invoice payment date will be stated on the invoice but for orders submitted within the registration period, invoice payments must be received by ERNDIM by 1 st April in the scheme year, unless an earlier date (due to late payment of a previous invoice) or later date (due to late registration) is specified. 9. For participants that submit a late registration request any invoices will be dated with the issued date and the payment date will be 1st April or 8 weeks from the issued date, whichever is later. 10. It is the responsibility of the participant laboratory to ensure that the ERNDIM invoice is paid. 11. ERNDIM accepts payments in Euro, GB pounds or US dollars and it is important that the correct bank account is used for payments in each currency. Payments which are made into the wrong bank account (for example a payment in Euros paid into the GB pounds account) can result in losses due to the bank exchange rate. Any losses which are a result of a participant making a payment into the wrong ERNDIM bank account will be borne by the participant. 12. ERNDIM is responsible solely for paying its own bank charges. Any other charges related to invoice payments must be paid by the participant. 13. Penalties for late payment of invoices are: 1. Interest charges of 1.3% per month are applied to outstanding balances after the invoice payment date. When interest is added to the outstanding balance an updated invoice with a new version number will be generated; 2. If there is still an outstanding invoice balance after the 1st July: 1. Access to the EQA scheme results will be restricted until the invoice has been paid, and 2. In the following year the invoice payment date of any invoices will be 31st January and the dispatch of samples to the laboratory in the that year will be delayed until ALL outstanding invoices have been paid; 3. If there is still an outstanding invoice balance after the 1st September, in the same year as the scheme participation, the laboratory will not be eligible to register for any ERNDIM EQA schemes until all outstanding invoices have been paid and a Certificate of Participation for the current scheme year will not be issued. ERNDIM also reserves the right to restrict access to EQA scheme results. 14. EQA samples must be treated in the same way as clinical samples. 15. Participants must not collude with other laboratories on the results of their EQA scheme participation. 16. Data derived from the use or analysis of ERNDIM EQA materials must not be used in written publications or oral presentations unless the explicit prior consent of ERNDIM has been granted. 1. If a participating laboratory wishes to use such data in a publication or presentation they must contact the ERNDIM Administration Office before submitting any documents for publication. 2. For EQA materials based on real clinical samples, permission to use the data will be dependent on the appropriate consent being in place 3. If permission to use the data is granted: a) ERNDIM must be acknowledged in the publication or presentation using a standard acknowledgement sentence which will be provided by the ERNDIM Administration Office, and b) after the data has been published a copy of the publication, with full reference/citation information, should be sent to the ERNDIM Administration Office 17. All participating laboratories are given a unique ERNDIM reference number which should be used on all invoice payments and in all correspondence with ERNDIM. 18. The fact that your laboratory participates in ERNDIM schemes is not confidential, however, the raw data and performance scores are confidential and will only be shared within ERNDIM for the purpose of 11 September Page 13 of 14

14 evaluating your laboratory s performance, (which may include sharing information between the ERNDIM schemes that you subscribe to) except in these circumstances: 1. Performance information of UK labs is shared with NQAAP. 19. ERNDIM reserves the right to share participant data anonymously with national regulatory bodies. For countries with only a few participating laboratories, to preserve anonymity, only regional data will be shared. 20. Laboratories that have unsatisfactory performance will be sent a Performance Support Letter by ERNDIM. If a laboratory does not respond to the Performance Support Letter, or has persistent unsatisfactory performance, ERNDIM reserves the right to contact the Laboratory Head or Quality Manager 21. Laboratories that do not submit any results, or do not submit sufficient results for their performance to be evaluated, will be sent a Non-submission letter. If a laboratory does not respond to the Non-submission Letter, or persistently does not submit sufficient results for their performance to be evaluated ERNDIM reserves the right to contact the Laboratory Head or Quality Manager. 22. If a laboratory does not supply the contact details for the Laboratory Head or Quality Manager, ERNDIM reserves the right to withhold the laboratory s Certificate of Participation until such time as the contact details are supplied. 23. Satisfactory performance in an EQA scheme is based solely on the laboratory s performance when analysing the QA samples supplied in that scheme year. By participating in ERNDIM schemes participants agree to these terms and conditions. Performance assessment of scheme participation is described in the ERNDIM quality documents (available on request). ERNDIM is not responsible for the performance of participating laboratories when offering a clinical diagnostics service. 24. Problems relating to EQA Schemes, including complaints from participating laboratories should be referred directly to the ERNDIM Administration Office (admin@erndim.org). 25. All documents, and the data they contain, issued by ERNDIM are copyright and may not be published in any form without the permission of the ERNDIM Executive Committee. 11 September Page 14 of 14