eqa schemes catalogue 2018 - erndim€¦ · 2018 eqa schemes catalogue 11 september 2017 page 3 of...
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European Research Network for evaluation and improvement of screening, Diagnosis and treatment of Inherited disorders of Metabolism
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: +44 161 276 6741
Fax: +44 161 850 1145
E-mail: [email protected]
Web: www.erndim.org
2018 EQA Schemes Catalogue
11 September 2017 www.erndim.org Page 2 of 14
Contents
1. Introduction …………………………………………………..…………..………………….……………… 3
2. EQA Schemes …………………………………………………………………..…………………...….….. 4
1. Quantitative Schemes …………………………………………………………………………..…….. 4
Acylcarnitines in Serum ……………….…………………………………..………………….……. 4
Cystine in White Blood Cells ……………………….……………………..………………….……. 4
Lysosomal Enzymes (fibroblasts) ………………………….………………………………….….. 5
Neurotransmitters in CSF ………………………...............................................................…… 5
Pterins in Urine ……………………………………………..………………….………………….... 6
Purines and Pyrimidines (urine) …………………...…………………………..………………….. 6
Quantitative Amino Acids (serum) ………………………………………………………………... 7
Quantitative Organic Acids (urine) ………………………………………...…….………………... 7
Special Assays in Serum …………………………………………………………….…………….. 8
Special Assays in Urine …………………………………………………………………………..... 8
2. Qualitative Schemes ……………………………………………………………………………….. 9
Acylcarnitines in dried blood spots …………….………………………….…………………..….. 9
Congenital Disorders of Glycosylation (plasma/serum) ………………………………………... 9
Diagnostic Proficiency Testing (urine) …………………………………….…….………………... 10
Qualitative Organic Acids (urine) ………………………………………………………………….. 10
Urine Mucopolysaccharides ……………………………………………………………...………... 11
3. EQA Schemes 2018 Price List ……………………………………...…………………………….……. 12
4. Terms and Conditions of EQA Scheme Participation …………………………………...……… 13
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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.
1.2. 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 2017.
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 email the ERNDIM Administration Office ([email protected]) to request access to the ERNDIM Registration Website.
All 2018 EQA scheme orders must be submitted by 14th November 2017.
If you have any problems with registering for the 2018 EQA schemes please contact [email protected].
1.3. 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.
1.4. 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.
1.5. 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 (www.erndim.org/qadb) under Participant Information.
1.6. 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.
1.7. Appeals and Complaints Problems relating to EQA Schemes, including appeals and complaints from participating laboratories, should be referred directly to the ERNDIM Administration Office.
1.8. 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.
1.9. 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.
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2. EQA Schemes
2.1. Quantitative EQA Schemes
Acylcarnitines in serum Scheme Code: ACS
Aim: Comparison of Acylcarnitines analysis in a lab with respect to median and target values
Status: Operating as a separate full EQA scheme since 2017; some acylcarnitines were previously included in the Special Assays in serum scheme
Geographic area: Worldwide No. of samples/year: 8
Eligibility Requirements: None Sample matrix: Lyophilised, spiked human serum
No. of registrations (2017): 88 Volume/sample: 1 ml/vial
Analytes (2018): Free carnitine (C0) Tetradecanoylcarnitine (C14)
Acetylcarnitine (C2) Palmitoylcarnitine (C16)
Propionylcarnitine (C3) 3-Hydroxyhexadecanoyl-L-carnitine (C16-OH)
Butyrylcarnitine (C4) Oleoylcarnitine (C18:1)
Tiglylcarnitine (C5:1) Stearoylcarnitine (C18)
Isovalerylcarnitine (C5) 3-Hydroxystearoylcarnitine (C18-OH)
Hexanoylcarnitine (C6) Malonylcarnitine (C3-DC)
Octanoylcarnitine (C8) Methylmalonylcarnitine (C4-DC)
Decanoylcarnitine (C10) Glutarylcarnitine (C5-DC)
Cis-5-Tetradecenoylcarnitine (C14:1)
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Pedro Ruiz-Sala, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
Cystine in White Blood Cells Scheme Code: CWBC
Aim: Comparison of analysis of Cystine in White Blood Cells (WBC)
Status: Full ERNDIM EQA scheme since 2005
Geographic area: Worldwide No. of samples/year: 8 pairs of protein and WBC supernatants
Eligibility requirements: None Sample matrix: Protein is lyophilised, WBC supernatants are liquid
No. of registrations (2017): 37 Volume/sample: Pellet and supernatant equivalent to extracts from 5 ml whole blood samples
Analytes (2018): 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)
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Daniel Herrera, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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Lysosomal Enzymes (fibroblasts) Scheme Code: LEFB
Aim: 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 2006 – 2010)
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: Via Results website
Reports: Interim reports can be downloaded from the Results website during the scheme year; final report available at the end of the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Kees Schoonderwoerd, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
Neurotransmitters in cerebrospinal fluid (CSF) Scheme Code: NCSF
Aim: To educate and assess the ability of laboratories to diagnose inborn errors of neurotransmitter metabolism
Status: Pilot scheme 2014-2015, full scheme from 2016
Geographic area: Worldwide No. of samples/year: 8
Eligibility Requirements: None Sample matrix: lyophilised, spiked CSF/artificial CSF
No. of registrations (2017): 29 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
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Prof. Simon Heales, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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Pterins in Urine Scheme Code: PTU
Aim: To educate and assess the ability of laboratories to diagnose inborn errors of tetrahydrobiopterin (BH4) metabolism
Status: Pilot scheme 2014-2016, operating as a full scheme since 2017
Geographic area: Worldwide No. of samples/year: 8
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
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Prof. Nenad Blau, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
Purines and Pyrimidines (urine) Scheme Code: PPU
Aim: Comparison of Purine and Pyrimidine analysis in a lab with respect to median and target values
Status: Full ERNDIM EQA scheme since 2000
Geographic area: Worldwide No. of samples/year: 8
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
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Jörgen Bierau, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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Quantitative Amino Acids (serum) Scheme Code: QTAS
Aim: Comparison of Amino Acid analysis in a lab with respect to median and target values
Status: Full ERNDIM EQA scheme since 1993
Geographic area: Worldwide No. of samples/year: 8
Eligibility requirements: None Sample matrix: Lyophilised, spiked human serum
No. of registrations (2017): 266 Volume/sample: 1 ml/vial
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 *
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
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr Rachel Carling, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
Quantitative Organic Acids (urine) Scheme Code: QTOU
Aim: Comparison of Organic Acid analysis in a lab with respect to median and target values
Status: Full ERNDIM EQA scheme since 1993
Geographic area: Worldwide No. of samples/year: 8
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
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Mme. Clothilde Roux, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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Special Assays in Serum Scheme Code: SAS
Aim: 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
Geographic area: Worldwide No. of samples/year: 8
Eligibility Requirements: None Sample matrix: Lyophilised, spiked human serum
No. of registrations (2017): 248 Volume/sample: 5 ml/vial
Analytes (2018):
(* these analytes are not added but can be recorded
for comparison between
labs)
3 OH Butyrate 7-Dehydrocholesterol 7-Ketocholesterol C22:0 Behenic acid
C24:0 Lignoceric acid C26:0 Cerotic acid Carnitine Free Cholestane-3,5,6-triol
Cholestanol Cholesterol * Creatine Galactose
Glycosylsphingosine Guanidine acetic acid Homocysteine Lactic acid
L - Pipecolic acid LysoGb3 Methylmalonic acid NEFA *
Phytanic acid Pristanic acid Pyruvic acid
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Begoña Merinero, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
Special Assays in Urine Scheme Code: SAU
Aim: 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
Geographic area: Worldwide No. of samples/year: 8
Eligibility Requirements: None Sample matrix: Lyophilised, spiked human urine
No. of registrations (2017): 175 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
No. of shipments/year: One shipment of 8 samples in January – March
Submission deadlines: 8 deadlines from March – October (approximately 4 week intervals)
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. Begoña Merinero, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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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
Aim: To educate and assess the ability of laboratories to detect inherited disorders resulting in recognisable whole blood acylcarnitine profiles
Status: 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 Sample matrix: Dried blood spots on S&S903 filter paper
No. of registrations (2017): 123 (40-42 per centre)
Volume/sample: 35-50 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 email, fax or post to Scientific Advisor
Reports: Interim reports are emailed to participants twice per year
Annual report published in January – March of the following year
Scientific Advisors: London: Dr. Charles Turner, [email protected] Heidelberg: Dr. Claus-Dieter Langhans, [email protected]
Zurich: Dr. Ralf Fingerhut, [email protected]
Scheme Organisers: London: Dr. Charles Turner, [email protected]
Heidelberg: Dr. Claus-Dieter Langhans, [email protected]
Zurich: Dr. Ralf Fingerhut, [email protected]
Congenital Disorders of Glycosylation (plasma/serum) Scheme Code: CDG
Aim: 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 Sample matrix: Lyophilised Human plasma/serum
No. of registrations (2017): 66 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 email to Scientific Advisor
Reports: Diagnoses circulated by email 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, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected]
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Diagnostic Proficiency Testing (urine) Scheme Code: DPT
Aim: To assess test selection, analysis, interpretation and advice in the performance of tests related to the detection of inherited metabolic disorders
Status: 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
Submission of results: Via Results website
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisors: Czech Republic: Prof. Viktor Kožich, [email protected]
France: Dr. Christine Vianey-Saban, [email protected]
Netherlands: Dr. George Ruijter, [email protected]
Switzerland: Prof. Brian Fowler, [email protected]
UK: Mrs. Joanne Croft, [email protected]
Scheme Organiser: CSCQ: Dr. Xavier Albe, [email protected]
Qualitative Organic Acids (urine) Scheme Code: QLOU
Aim: 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 email, fax or post to Scientific Advisor
Reports: Interim reports are mailed to participants 3 times per year
Annual report published in January – March of the following year
Scientific Advisors: Barcelona: Dr Judit Garcia-Villoria, [email protected]
Sheffield: Mrs. Camilla Scott, [email protected] &
Dr. Jane Dalley, [email protected] [on maternity leave]
Heidelberg: Dr. Claus-Dieter Langhans, [email protected]
Scheme Organiser: CSCQ: Dr. Xavier Albe, [email protected]
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Urine Mucopolysaccharides Scheme Code: UMPS
Aim: 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
Reports: Interim reports available from the Results website during the scheme year
Annual report published in January – March of the following year
Scientific Advisor: Dr. G. Ruijter, [email protected]
Scheme Organiser: SKML: Dr. C. Weykamp, [email protected] and
CSCQ: Dr. Xavier Albe, [email protected]
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3. EQA Schemes 2018 Price List
EQA Schemes Scheme Code
2018 Prices
Euro GB Pounds* US$*
1. Quantitative Schemes
Acylcarnitines in serum ACS 307 281 367
Cystine in White Blood Cells CWBC 336 308 402
Lysosomal Enzymes (fibroblasts) LEFB 579 530 693
Neurotransmitters (CSF) NCSF 337 309 404
Pterins in Urine PTU 328 300 392
Purines and Pyrimidines (urine) PPU 340 312 407
Quantitative Amino Acids (serum) QTAS 271 248 324
Quantitative Organic Acids (urine) QTOU 323 296 387
Special Assays (serum) SAS 176 162 211
Special Assays (urine) SAU 167 153 200
Special Assays Combined (serum & urine) SAC 307 281 367
2. Qualitative Schemes
Acylcarnitines (dried blood spots) ACDB 307 281 367
Congenital Disorders of Glycosylation (serum) CDG 314 288 376
Diagnostic Proficiency Testing (urine) DPT 437 400 523
Qualitative Organic Acids (urine) QLOU 363 333 435
Urine Mucopolysaccharides UMPS 294 269 352
Mailing fee per scheme for all laboratories: 25 23 30
Please note:
• * The prices for ERNDIM EQA schemes are set in Euro and converted to GB Pounds and US$ based
upon conversion rates of 0.91604 and 1.19759 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.
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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. Email 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 email address
4. Email 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 email 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 email 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 ([email protected]) 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 1st 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
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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 ([email protected]).
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.