HISTOCOMPATIBILITY. and IMMUNOGENETICS. Prospectus

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HISTOCOMPATIBILITY

and

IMMUNOGENETICS

Prospectus

2014

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CONTENTS Page 1. Distribution Timetable 2 2. Confidentiality 2 3. Participation 2 3.1 Registration 2 3.2 Service’s Expectations 2 3.3 Guidance on Participation 3 3.4 Bespoke Schemes 5

3.5 Laboratory Performance Reports and Tables 5

3.6 Charges for Participation 5

4. UK NEQAS for H&I Assessment and Performance Principles 5

5. Nomenclature 6

6. Scheme 1A - HLA Phenotyping 7

7. Scheme 1B - HLA-B27 Testing 9

8. Scheme 2A - Cytotoxic Crossmatching 10

9. Scheme 2B - Crossmatching by Flow Cytometry 12

10. Scheme 3 - HLA Antibody Specificity Analysis 14

11. Scheme 4A1 – DNA HLA Typing at 1st Field Resolution 16

12 Scheme 4A2 – DNA HLA Typing to 2nd Field Resolution 17

13. Scheme 4B - ABO Grouping by DNA-based Methods 19

14. Scheme 5A - HFE Typing 20

15. Scheme 5B – Interpretative: HFE Genotype and Hereditary Haemochromatosis 22

16. Scheme 6 – HLA Antibody Detection 23

17. Scheme 7 – HLA-B*57:01 Typing for Drug Hypersensitivity 25

18. Scheme 8 – HLA and Disease Typing for HLA-DR/DQ/DP only 26

19. Educational Scheme 27

20. Essential Scheme Information 28

20.1 UK NEQAS for H&I 28

20.2 Steering Group 28

20.3 Prospectus 28

20.4 HLA Nomenclature 28

20.5 Test Material 28

20.6 UK National Quality Assurance Advisory Panel (UK NQAAP) 29

20.7 Annual Participants’ Meeting 29

20.8 Endorsement by UK NEQAS for H&I 29

20.9 Scheme Review and Pilot Schemes 29

20.10 Procedure for the Handling of Complaints from Participants 29

20.11 Appeals Against an Assessment 30

20.12 Non-Analytical Errors 30

20.13 Correspondence with Participants 30

20.14 Policy on Testing Returned Scheme’s Material 30

20.15 Acceptance of Participants’ Results 30

21. Contact with UK NEQAS for H&I 31

22. List of Contact Names and Addresses 32

23. Joint Working Group for Quality Assurance Guidelines for Participants 34

24. CPA Accreditation and EQA Performance 35

25. UK NEQAS for H&I and European Federation for Immunogenetics (EFI) Accreditation 35

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PROSPECTUS 2014

1. DISTRIBUTION TIMETABLE

Scheme 1A Scheme 1B Scheme 2B Scheme 3 Scheme 4A1/4B Scheme 4A2 Scheme 8

Scheme 2A Scheme 6 Scheme 5A Scheme 7 Educational

Scheme Scheme 5B

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21 January 7 January 14 January 28 January

11 February 18 February 11 February

25 March 4 March 11 March

13 May 20 May

3 June 24 June 17 June 10 June 17 June

15 July 8 July 1 July

16 September 9 September 23 September

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Scheme 1A - HLA Phenotyping Scheme 4B - ABO Grouping by DNA-based methods

Scheme 1B - HLA-B27 Testing Scheme 5A - HFE Typing

Scheme 2A - Cytotoxic Crossmatching Scheme 5B – Interpretative: HFE Genotype and Hereditary Haemochromatosis

Scheme 2B - Crossmatching by Flow Cytometry Scheme 6 – HLA Antibody Detection

Scheme 3 - HLA Antibody Specificity Analysis Scheme 7 – HLA-B*57:01 Typing for Drug Hypersensitivity

Scheme 4A1 – DNA HLA Typing at 1st Field Resolution Scheme 8 – HLA and Disease Typing for HLA-DR/DQ/DP only

Scheme 4A2 – DNA HLA Typing to 2nd Field Resolution Educational Scheme samples and Interpretive Scenarios

2. CONFIDENTIALITY

Laboratory code information is known only to the Schemes’ Director, Manager and UK NEQAS for H&I staff.

Laboratory identifiers and performance information are confidential and will not be released to a third party without the written permission of the Head of the participating laboratory. However, for UK laboratories, unsatisfactory performance will be notified to the Chairman and Members of the UK National Quality Assurance Advisory Panel (UK NQAAP) for Immunology and laboratories may be identified to the Chairman of the Joint Working Group for Quality Assurance (JWG) (see Section 23). UK laboratories identified to UK NQAAP for Immunology regarding Scheme 5A will also be identified to the UK NQAAP for Clinical Cytogenetics and Molecular Genetics.

3. PARTICIPATION

3.1 REGISTRATION

Registration forms are provided before the commencement of the UK NEQAS for H&I year.

By signing these registration forms you agree to abide by the JWG Conditions of EQA Scheme Participation (Section 23) Guidelines (UK laboratories only) and the list of Service Expectations below.

You also agree to pay the fees and any agreed courier charges in a timely manner.

3.2 SERVICE’S EXPECTATIONS

Our commitment to UK NEQAS for H&I Participants – we will: • Respect your confidentiality

• Despatch samples according to the published timetable

• Accurately maintain our contact database

• Not give participant information to anyone (except as detailed in the Prospectus)

• Provide you with all the information for you to fully participate in our schemes

• Provide schemes ‘at cost’ and will not make a profit

• Rectify assessment errors in a timely fashion

• Resolve disputes in an impartial and professional manner

• Willingly provide advice on all scheme issues

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Your commitment to UK NEQAS for H&I – you will: • Notify us if you do not receive the expected samples

• Test and interpret EQA samples as clinical specimens

• Always give the reason(s) for not testing a ‘NEQAS’ sample

• Provide up-to-date contact information

• Not share scheme findings with other laboratories until after our report has been issued

• Abide by the JWG Conditions of EQA Scheme Participation (UK laboratories only)

3.3 GUIDE TO LABORATORY TESTING/CLINICAL SERVICES AND SCHEME PARTICIPATION

Participation in a particular UK NEQAS for H & I scheme is at the discretion of individual laboratories.

As a rule, laboratories should take part in external quality assessment (EQA) schemes that reflect, as far as possible, their clinical testing practices. The simplest example is the operation of a clinical service for HLA-B27 typing and participation in Scheme 1B (HLA-B27 Testing).

UK NEQAS schemes are generally analyte, rather than technique, driven. Thus, again in the simplest situation, if clinical HLA-B27 testing is offered as a clinical service, laboratoryparticipation would be in Scheme 1B whether the method used was cell/antibody or DNA-based.

However, UK NEQAS for H & I schemes have evolved by attempting to take into account changing technologies and clinical practices. The obvious example of this is Scheme 2 where 2A assesses the outcome of cell/serum cross-matching by lymphocytotoxicity-based techniques and 2B by flow cytometry.

The following Table provides a guide to Scheme participation:

Examples of Laboratory Testing/Clinical Services: Participation

in Scheme: ‘Full’ HLA typing in:

Solid organ transplantation

Haematopoietic stem cell transplantation HLA and disease investigations

Unrelated haematopoietic stem cell donor registries

Reference cell panel typing for clinical HLA antibody services

1A and/or 4A1 and/or 4A2

HLA-B27 testing in:

Aid to diagnosis in B27 associated diseases

1B ABO ‘blood grouping’ (using DNA) in:

Solid organ transplantation

4B Typing for single specific HLA specificity/allele or locus, other than HLA-B27 in:

Disease susceptibility/aid to diagnosis Immunotherapy

1A and/or 4A1 and/or 4A2 and/or 8 HLA antibody detection and specification in:

Transplantation Platelet immunology Blood products support

3 or 3 and 6

Crossmatching by lymphocytotoxicity in: Transplantation

Blood products support

2A

Crossmatching by flow cytometry in: Transplantation

2B HFE testing in:

Patient investigations

Haemochromatosis family studies

5A and /or 5B

Drug hypersensitivity testing in: Patient evaluation

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PARTICIPATION IN SCHEME 1A (HLA PHENOTYPING) AND SCHEMES 4A1/4A2 (DNA HLA TYPING)

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In view of the increasing complexities of HLA typing methods, strategies and services the following guidelines are intended to help laboratories in their decision to participate in Scheme 1A (HLA Phenotyping) and/or Schemes 4A1/4A2 (DNA HLA Typing).

Scheme 1A is aimed at laboratories undertaking HLA-A, B, C, DR, DQ typing or any combination of these, by serology.

Participants must only register to be assessed on those loci tested using serological methods.

The Steering Committee acknowledges that many laboratories use supplementary techniques to aid in the definition and refinement of HLA specificities detected by serology.

Reporting and assessment must use HLA specificity nomenclature.

Based on previous years’ practice there will ordinarily be an expectation that the broad HLA specificities, e.g., B15, B40, DR3 and DQ3 will be subdivided into their component split specificities.

Schemes 4A1/4A2 (DNA HLA typing) will be performed by laboratories that undertake DNA based typing and, typically, might routinely perform a combination of 1st field typing (formerly known as low resolution or 2-digit typing) and 1st and 2nd field typing (formerly known as high resolution or 4-digit typing). For example, 1st field HLA-A, and B typing and 1st and 2nd field DRB1 typing. For this reason it is possible to register for any combination of HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1 and DQB1 for 1st field typing or 1st and 2nd field typing and DPB1 for 2nd field typing and provide data for DPA1 for comparison purposes. Registrants for 1st field typing can also sign up for reporting merely the presence of DRB3/4/5.

The European Federation for Immunogenetics (EFI) ’STANDARDS FOR HISTOCOMPATIBILITY & IMMUNOGENETICS TESTING version 6.1, D - HLA ALLELES AND ANTIGENS’, Standard D1.4 states: High resolution typing is defined as the identification of HLA alleles that encode the same protein sequence within the antigen binding site. HLA alleles must be identified at the level of resolution which defines the first and second fields according to WHO nomenclature by at least resolving all ambiguities: resulting from polymorphisms located within exons 2 and 3 for HLA class I loci, and exon 2 for HLA class II loci that encompass a null allele, wherever the polymorphism is located, unless it can be demonstrated that an expressed antigen is present on the cells.

It is expected that laboratories that register for HLA typing to the 2nd field will have developed a strategy to comply with this Standard with regard to the recognition of null alleles.

The following Table provides a guide to HLA typing practices and the most applicable HLA typing schemes.

HLA typing practice Scheme(s)

Serology 1A

Serology with 1st field DNA typing 1A or 1A and 4A1

1st field DNA typing 4A1

Combination of 1st field and 2nd field DNA typing 4A1 and 4A2

2nd field DNA typing 4A2

PARTICIPATION IN SCHEME 3 (HLA ANTIBODY SPECIFICITY ANALYSIS) AND SCHEME 6 (“HLA” ANTIBODY DETECTION)

Most H & I laboratories provide a service for testing of patients’ sera for the presence of antibodies directed towards HLA-class I (A, B, C) or class I and class II (DR, DQ, DP) specificities. This may be within the context of solid organ or haematopoietic stem cell transplantation, provision of blood products or the investigation of a clinical condition, e.g. thrombocytopaenia.

Many laboratories undertake this service using a two-tier system. The first stage – antibody detection determines which sera should be selected for the comprehensive second stage – antibody specificity assignment. Both stages are equally important since failure to detect the presence of antibodies during “screening” will obviously deny that serum the benefit of the often more comprehensive testing associated with antibody specification.

However, where numerous patients’ sera are tested an effective two-stage system can significantly reduce laboratory workload thus allowing more resources to be applied to the important antibody specificity assignment stage.

The test sera supplied in Scheme 6 (HLA Antibody Detection) may or may not contain HLA antibodies directed towards HLA-class I and/or class II specificities. The purpose of this Scheme is to assess the laboratory’s ability to undertake the initial “screening” process which places individual patients’ sera into the “no HLA antibodies detected” category or “HLA antibodies probably present – requires further analysis” category.

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For Scheme 3 (HLA Specificity Analysis) sera are provided that are known to contain antibodies directed towards HLA-class I and/or class II specificities.

The purpose of this Scheme is to assess the laboratory’s ability to determine the component HLA specificity or specificities in the antisera using all methods the laboratory employs for clinical samples.

PARTICIPATION IN SCHEME 7 – HLA-B*57:01 TYPING FOR DRUG HYPERSENSITIVITY

Pharmacogenetics, generally accepted as the study, or clinical testing, of genetic variation that gives rise to differing responses to drugs, is increasingly being applied to the prospective testing of patients for HLA-B*57:01 who are to be treated with the antiretroviral drug abacavir. Thus, a strong association exists between HLA-B*57:01 and the development of drug hypersensitivity reactions to abacavir.

This scheme tests participants’ ability to define HLA-B*57:01 using the method(s) they employ for routine clinical service HLA-B*57:01 testing.

PARTICIPATION IN SCHEME 8 – HLA AND DISEASE TYPING FOR HLA-DR/DQ/DP ONLY

This scheme, which uses selected DNA extracts, is aimed at laboratories that provide a service as an aid to the diagnosis of certain HLA Class II-associated diseases, e.g. actinic prurigo, coeliac disease and narcolepsy.

3.4 BESPOKE SCHEMES

UK NEQAS for H&I is able to provide specific EQA schemes for certain HLA and HFE alleles

Bespoke schemes will use selected stored DNA from samples previously tested in UK NEQAS for H&I’s Schemes. Consequently, these samples are considered as well-documented reference material.

Provision of a bespoke scheme also applies to HLA antibody detection and/or specification.

A further use of bespoke schemes is fulfilling the requirements of EFI Standard C6.4 “If a laboratory's performance

in EPT programme(s) is unsatisfactory in any category for which EFI accreditation is sought, the laboratory must: participate in an additional EPT programme in that category and document the Director’s review and any corrective action taken.”

Due to the nature of Scheme 2A - Cytotoxic Crossmatching and Scheme 2B - Crossmatching by Flow Cytometry, UK NEQAS for H&I are normally unable to supply additional sera/blood samples for these Schemes.

Requests for a bespoke scheme, giving full details of requirements, should be made to: Deborah Singleton (Schemes’ Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: 01443 622185; Fax: 01443 622001; e-mail: [email protected]).

3.5 LABORATORY PERFORMANCE REPORTS AND TABLES

Individual laboratory performance reports and performance tables will be posted to participants. Results summaries may be downloaded from the website: http://www.ukneqashandi.org.uk

Excel spreadsheets of Scheme 3 results are available on request from: [email protected]

3.6 CHARGES FOR PARTICIPATION

These are shown on the insert sheet. For further information please contact:

Deborah Singleton, Schemes’ Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: 01443 622185; Fax: 01443 622001; e-mail: [email protected]).

4. UK NEQAS FOR H&I ASSESSMENT AND PERFORMANCE PRINCIPLES

This information should be read in conjunction with each Scheme’s ASSESSMENT and SATISFACTORY PERFORMANCE sections.

Scheme assessment and satisfactory performance criteria are reviewed by the Steering Committee each year and take into account current ‘EFI EPT Standards for Providers’ established by the EFI EPT Committee.

Proposed changes in Schemes’ assessment and/or the determination of satisfactory performance are brought to the UK NQAAP for Immunology for ratification.

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The general consensus level for assignments is 75%, thus assignments reaching a 75% or greater agreement between participants will be assessed while those of <75% agreement are not assessed.

Scheme 3 - HLA Antibody Specificity Analysis - also uses a 95% consensus level for the absence of an HLA specificity.

The actual assessment procedure is detailed for each scheme under ‘Assessment Procedure’. In general reporting a consensus assignment is considered as ‘Acceptable Performance’ while reporting a non-consensus assignment is considered ‘Unacceptable Performance’.

Satisfactory performance is generally based on achieving a specified number of sample (patient) reports in agreement with consensus assignments in a calendar year.

Satisfactory performance levels are set according to those established by EFI (minimum performance standards) or greater.

For Schemes involving the assignment of a single HLA specificity/allele, an ABO ‘group’ or an HFE type the Satisfactory Performance level is set at achieving all the correct consensus assignments in all samples supplied during one calendar year.

For other schemes, some leniency regarding full compliance with consensus assignments is allowed (detailed for each scheme under ‘Satisfactory Performance’).

Laboratories not achieving ‘Satisfactory Performance’ will receive written notification of their ‘Unsatisfactory Performance’ status, as soon as it occurs, and will be expected to detail their reasons for their performance together with any corrective actions within 20 working days of the date of the ‘Unsatisfactory Performance’ notification.

Note: this does not apply to Interpretative Schemes, e.g. Scheme 5B.

All UK laboratories receiving ‘Unsatisfactory Performance’ notification are reported to UK NQAAP for Immunology. Failure to reply within 20 working days of the date of an ‘Unsatisfactory Performance’ notification or replies deemed unsatisfactory will be specifically reported to UK NQAAP for Immunology who may take further action.

5. NOMENCLATURE

Participants are requested to report their findings using the correct nomenclature relevant to the methodology used. The most recently published FULL WHO Nomenclature Report will be taken as the ‘reference’ baseline nomenclature; i.e. participants will be expected to report their findings in accord with this report as a minimum. HLA Nomenclature Reports and HLA Dictionary are available from: http://hla.alleles.org/

In addition, the Steering Committee has considered the reporting of HLA alleles and has formulated the following convention for reporting groups of alleles:

Please use the published up-to-date HLA nomenclature, see above.

Please report alleles fully, e.g. DRB4*01:02-01:03 and not as DRB4*01:02-03 which may be interpreted as DRB4*01:02-01:03 or as DRB4*01:02-03:01.

Groups of alleles should be reported as allele x / allele y, where “/” means “or”, e.g. DRB1*01:01/01:02/01:04 means DRB1*01:01 or DRB1*01:02 or DRB1*01:04.

Groups of alleles that include sequential allele numbers may be reported as allele x - allele y, where “-” means “to”, e.g. DRB1*15:01-15:04 means that the allele in question could be any of the alleles between DRB1*15:01 to DRB1*15:04 inclusive, i.e. DRB1*15:01 or DRB1*15:02 or DRB1*15:03 or DRB1*15:04.

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SCHEME 1A

6. SCHEME 1A – HLA PHENOTYPING

PURPOSE

To assess participants’ ability to use serological and supplementary methods to correctly identify HLA specificities.

6.1 SAMPLES

6.1.1 A total of ten blood samples will be sent each year as five distributions of two blood samples.

6.2 REPORTING

6.2.1 Depending on their typing strategies participants may register for HLA Class I typing only or for HLA Class I and II typing.

6.2.2 Participants must only register to be assessed on those loci tested using serological methods. 6.2.3 Participants must make a report for each HLA locus for which they have registered.

6.2.4 It is acknowledged that many laboratories use supplementary techniques to confirm serological HLA specificity assignment.

6.2.5 The report should detail the HLA phenotype using official WHO HLA specificity nomenclature.

6.2.6 Reports should be made at the split specificity level, where appropriate, using the results of the serological typing and any typing performed using supplementary techniques.

6.2.7 Participants must only use the reporting forms provided. 6.2.8 Participants are required to make their report within 10 days.

6.3 ASSESSMENT

6.3.1 Participants will be assessed on the HLA loci contained in the phenotype, for which they are registered. 6.3.2 The consensus complete HLA phenotype for assessment is determined by at least 75% of laboratories

agreeing each specificity.

6.3.3 Specificities failing to reach the 75% consensus level will not be assessed.

6.3.4 A "blank" forms part of the assessment if at least 75% of laboratories report a single specificity at a locus. 6.3.5 Assessment Procedure

Each complete HLA phenotype in agreement with the consensus phenotype Acceptable Each complete HLA phenotype not in agreement with the consensus phenotype Unacceptable

Each sample report of a not tested result see 6.4.1

6.4 SATISFACTORY PERFORMANCE

6.4.1 Satisfactory performance is obtaining nine or more complete HLA phenotypes in agreement with the consensus phenotypes in a calendar year.

6.4.2 Laboratories with unsatisfactory performance will receive written notification of their status and will be expected to reply to UK NEQAS for H&I detailing their corrective actions.

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SCHEME 1A

6.5 INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

6.5.1 Summary sheets of all reported specificities and supplementary information. 6.5.2 Information on methodology.

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SCHEME 1B

7. SCHEME 1B - HLA-B27 TESTING

PURPOSE

To assess participants’ ability to correctly determine HLA-B27/B2708/B*27 status.

7.1 SAMPLES

7.1.1 A total of ten blood samples will be sent each year as five distributions of two blood samples.

7.2.1 Participants are required to report on HLA-B27/B2708/B*27 “positivity” or “negativity”. 7.2.2 Participants must only use the reporting forms provided.

7.2.3 Participants are required to make their report within 21 days.

7.3.1 The “HLA-B27” status of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of “HLA-B27”.

7.3.2 Samples failing to reach the 75% consensus level will not be assessed. 7.3.3 Assessment Procedure

Each sample report in agreement with the consensus “HLA-B27” status Acceptable Each sample report not in agreement with the consensus “HLA-B27” status Unacceptable Each sample not reported, e.g. an equivocal or not tested result see 7.4.1

7.4.1 Satisfactory performance is making ten sample reports in agreement with the consensus “HLA-B27” status in a calendar year.

7.4.3 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology.

7.4.4 For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology.

7.5.1 The HLA type of the donor samples.

7.5.2 Summary sheets of all reported “HLA-B27” results. 7.5.3 Information on methodology.

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SCHEME 2A

8. SCHEME 2A - CYTOTOXIC CROSSMATCHING

PURPOSE

To assess participants’ ability to correctly determine cell/serum cytotoxic crossmatch status.

The Steering Committee acknowledges that this crossmatching scheme will only partially emulate current crossmatching practice.

NEW FOR 2014

Participants are invited to submit results obtained after dithiothreitol treatment.

8.1 SAMPLES

8.1.1 A total of ten blood samples and forty serum samples will be sent each year as five distributions. Each distribution will comprise of two blood samples and their two corresponding sets of four selected sera (approximately 150µl each). A serum set may include test serum replicates.

8.1.2 Each set of four sera must be tested against its corresponding blood sample.

8.1.3 Participants may test peripheral blood lymphocytes PBL/T-cells and/or B-cells, according to their local practice.

8.1.4 Participants may additionally submit results for PBL/T-cells and B-cells after dithiothreitol treatment.

8.2.1 At registration participants may opt for PBL/T-cell and/or B-cell crossmatch assessment. 8.2.2 Test results should be reported as positive or negative using established local criteria. 8.2.3 Tests reported as weakly positive will be interpreted as positive for assessment purposes. 8.2.4 Tests reported as equivocal will not be assessed.

8.2.5 Participants are requested to report reaction strength, using their own scoring system, to enable comparison between laboratories.

8.3.1 The crossmatch status of each sample is determined by at least 75% of laboratories agreeing on the positivity or negativity of each test.

8.3.2 Crossmatching tests failing to reach the 75% consensus level will not be assessed. 8.3.3 PBL/T-cell and B-cell results are considered independently.

8.3.4 Assessment Procedure

A result in agreement with the consensus findings Acceptable

A result not in agreement with the consensus findings Unacceptable

Each sample not reported, e.g. an equivocal, void or not tested result see 8.4.1

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SCHEME 2A 8.3.6 The results obtained after the dithiothreitol treatment will not be subject to the performance criteria in

2014 and will be formally assessed in 2015

8.4.1 Satisfactory performance is making 85% of reports on all sera in agreement with the consensus findings in a calendar year.

8.5.1 The HLA phenotype of the donor and specificities of the sera. 8.5.2 A summary sheet of all crossmatching results.

8.5.3 Performance information on the current and previous year’s samples. 8.5.4 Performance information (non-assessed) on hidden replicate sera.

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SCHEME 2B

9. SCHEME 2B - CROSSMATCHING BY FLOW CYTOMETRY

PURPOSE

To assess participants’ ability to correctly determine cell/serum flow cytometry crossmatch status.

The Steering Committee acknowledges that this crossmatching scheme will only partially emulate current crossmatching practice.

9.1 SAMPLES

9.1.1 A total of ten blood samples and forty serum samples will be sent each year as five distributions. Each distribution will comprise of two blood samples and their two corresponding sets of four selected sera (approximately 300µl each). A serum set may include test serum replicates.

9.1.2 Each set of four sera must be tested against its corresponding blood sample for IgG antibody binding.

9.2.1 At registration participants may opt for T-cell and/or B-cell crossmatch assessment.

9.2.2 Test results should be reported as positive or negative compared to the local negative control. 9.2.3 Tests reported as weakly positive will be interpreted as positive for assessment purposes. 9.2.4 Tests reported as equivocal will not be assessed.

9.3.1 The crossmatch status of each sample is determined by at least 75% of laboratories agreeing on the positivity or negativity of each test.

9.3.2 Crossmatching tests failing to reach the 75% consensus level will not be assessed. 9.3.3 T-cell and B-cell results will be considered independently.

9.3.4 Assessment Procedure

A result in agreement with the consensus findings Acceptable

A result not in agreement with the consensus findings Unacceptable

Each sample not reported, e.g. an equivocal, void or not tested result see 9.4.1

9.4.1 Satisfactory performance is making 85% of reports on all sera in agreement with the consensus findings in a calendar year.

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SCHEME 2B

9.5.1 The HLA phenotype of the donor and the specificity of the sera. 9.5.2 A summary sheet of all reported crossmatching results.

9.5.3 Performance information on the current and previous year’s samples for all laboratories. 9.5.4 Performance information (non-assessed) on hidden replicate sera.

9.5.5 A methodology questionnaire will be sent out at the end of each year. The information obtained will be summarised and distributed to participants.

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SCHEME 3

10. SCHEME 3 - HLA ANTIBODY SPECIFICITY ANALYSIS

PURPOSE

To assess participants’ ability to correctly determine HLA antibody specificities.

10.1 SAMPLES

10.1.1 A total of ten serum samples will be sent each year as two distributions of five samples. Volumes of approximately 1.5ml of serum will be distributed.

10.2.1 At registration participants may opt for Class I only or Class I and Class II antibody assessment.

10.2.2 Only those specificities detailed on the reporting forms will be assessed, e.g. reports of anti-A9, Bw4 and Bw6 will not be assessed.

10.2.3 Participants may report other antibody findings, e.g. DPB, DQA and MICA. These specificities will not be assessed in 2014.

10.2.4 Participants must only use the reporting forms provided.

10.2.5 Participants are required to report antibody specificities within a period of 10 weeks.

10.3.1 Class I and Class II IgG specificities will be assessed independently.

10.3.2 Consensus presence of a specificity is determined by at least 75% of laboratories agreeing the specificity. 10.3.3 Consensus absence of a specificity is determined by at least 95% of laboratories agreeing the absence of

the specificity.

10.3.4 Results failing to reach the consensus levels above will not be assessed.

10.3.5 Assessment Procedure

Assigning a consensus specificity Acceptable

Missing a consensus specificity Unacceptable

Assigning a specificity where the consensus is negative Unacceptable

10.4.1 Satisfactory performance is testing ten serum samples and getting at least 75% of specificities in agreement with the consensus findings in a calendar year.

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SCHEME 3

10.5.1 Where known, the HLA phenotypes of the serum donors. 10.5.2 Summary sheets of all reported antibody findings. 10.5.3 Information on methodology.

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SCHEME 4A1

11. SCHEME 4A1 – DNA HLA TYPING AT 1ST FIELD RESOLUTION

PURPOSE

To assess participants’ ability to correctly determine HLA alleles at the 1st field level (formerly known as low resolution or 2-digit typing).

11.1 SAMPLES

11.1.1 A total of ten blood samples will be sent each year as two distributions of five blood samples.

11.2.1 Participants may register for any of the following:HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, and DPA1 for 1st field assessment, or ‘presence of’ assessment for DRB3, DRB4 and, DRB5. DPA1 results will be assessed if sufficient results are received

11.2.2 Participants must only use the reporting forms provided. 11.2.3 Participants are required to return results within 4 weeks.

11.3.1 Participating laboratories will be assessed on the loci they designate at registration.

11.3.2 The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele. 11.3.3 Alleles failing to reach the 75% consensus level will not be assessed.

11.3.4 A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus. 11.3.5 Participants will only be assessed on those alleles that appear in the most recently published full HLA

Nomenclature Report. 11.3.6 Assessment Procedure

Each full HLA genotype in agreement with the consensus 1st field type Acceptable Each full HLA genotype not in agreement with the consensus 1st field type Unacceptable

11.4.1 Satisfactory performance is obtaining nine or more full HLA genotypes in agreement with the consensus genotypes in a calendar year.

11.5.1 Summary sheets of all reported alleles. 11.5.2 Information on methodology.

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SCHEME 4A2

12. SCHEME 4A2 – DNA HLA TYPING TO 2ND FIELD RESOLUTION

PURPOSE

To assess participants’ ability to correctly determine HLA alleles to the 2nd field level (formerly known as high resolution or 4-digit typing).

12.1 SAMPLES

12.2.1 For typing to the 2nd field, HLA alleles should be assigned on the basis of differences in exons 2 and 3 for class I and exon 2 for class II, as a minimum requirement.

12.2.2 Participants registered for 2nd field assessment should define all ambiguities that encompass a null allele wherever the polymorphism is located (see statement on EFI Standard D1.4 – page 4).

12.2.3 Participants may register for any of the following:HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, DPA1 and DPB1, for 2nd field assessment.

12.3.1 Participating laboratories will be assessed on the loci they designate at registration.

12.3.2 The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele. 12.3.3 Alleles failing to reach the 75% consensus level will not be assessed.

12.3.4 A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus. 12.3.5 Participants will only be assessed on those alleles that appear in the most recently published full HLA

Nomenclature Report. 12.3.6 Assessment Procedure

Each full HLA genotype in agreement with the consensus 1st & 2nd field type Acceptable Each full HLA genotype not in agreement with the consensus 1st & 2nd field type Unacceptable

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SCHEME 4A2

12.5.1 Summary sheets of all reported alleles. 12.5.2 Information on methodology.

12.5.3 Performance information on the current and previous year’s samples for all laboratories.

12.5.4 Sheets detailing i) the sequences that are identical over exons 2 and 3 for class I and exon 2 for class II and ii) ambiguous typing combinations (heterozygous positions identified by sequencing) defined over these exons.

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SCHEME 4B

13. SCHEME 4B - ABO GROUPING BY DNA-BASED METHODS

PURPOSE

To assess participants’ ability to correctly determine ABO blood groups by DNA-based methods.

13.1 SAMPLES

13.1.1 Laboratories performing ABO grouping by DNA-based methods, e.g. PCR-SSP, are invited to ABO group all samples from Scheme 4A1.

13.2.1 The ABO alleles detected should be reported as fully as possible, using the appropriate nomenclature. 13.2.2 Participants must only use the reporting forms provided.

13.2.3 Participants are required to return results within 4 weeks.

13.3.1 The consensus ABO genotype of each sample is determined by at least 75% of the participating laboratories agreeing the genotype.

13.3.2 Genotypes failing to reach the 75% consensus level will not be assessed 13.3.3 Assessment Procedure

Each sample report in agreement with the consensus ABO genotype Acceptable Each sample report not in agreement with the consensus ABO genotype Unacceptable

Each sample report of not tested result see 13.4.1

13.4.1 Satisfactory performance is making ten sample reports in agreement with the consensus ABO genotype in a calendar year.

13.5.1 Summary sheets of all reported ABO genotypes. 13.5.2 Information on methodology.

13.5.3 Performance information on the current and previous year’s samples for all laboratories.

NOTE

UK NEQAS for H&I has offered this Scheme since 2002; it is not intended to replace participation in the UK NEQAS for Blood Transfusion Laboratory Practice Scheme for laboratories using serological methods for ABO grouping.

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SCHEME 5A

14. SCHEME 5A – HFE TYPING

PURPOSE

To assess participants’ ability to correctly determine HFE mutations.

14.1 SAMPLES

14.2.1 All samples must be tested for the H63D (Hist63Asp) mutation and the C282Y (Cys282Tyr) mutation of the HFE gene.

14.2.2 Participants may register to have their Ser65Cys results assessed.

14.2.3 Please report using the single letter amino acid code, i.e. H and/or D for codon 63, C and/or Y for codon 282 and S and/or C for codon 65.

14.2.4 Participants are requested to report any other HFE gene mutations that they detect for participant information purposes.

14.3.1 The consensus HFE mutations for assessment are determined by at least 75% of laboratories agreeing the combination of H63D and C282Y mutations and at least 75% of laboratories agreeing the S65C mutation. 14.3.2 Mutations failing to reach the 75% consensus level will not be assessed.

Each sample report in agreement with the consensus H63D and C282Y and Acceptable S65C status (if applicable)

Each sample report not in agreement with the consensus H63D and C282Y and Unacceptable S65C status (if applicable)

Each sample not reported, e.g. an equivocal, partial or not tested result see 14.4.1

14.4.1 Satisfactory performance is making ten sample reports in full agreement with the consensus H63D and C282Y and S65C status (if applicable) in a calendar year.

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SCHEME 5A

14.5.1 A summary sheet of all reported HFE codon 63, 65 and 282 assignments. 14.5.2 Information on methodology.

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SCHEME 5B SCHEME 5B - INTERPRETATIVE: HFE GENOTYPE AND HEREDITARY HAEMOCHROMATOSIS

PURPOSE

To assess participants’ ability to make an accurate, clear and concise clinical report, appropriate for the range of clinical staff involved in a patient’s care and treatment, given HFE genotype and other relevant clinical information.

15.1 CLINICAL SCENARIOS

15.1.1 HFE genotype will be provided, together with various pieces of clinical information, on two patients twice a year.

15.2.1 Participants are expected to make a report on each of the patient scenarios.

15.2.2 Reports must be written in English and must be identical in format to that used for routine clinical reporting.

15.2.3 Participants are required to return their reports within 4 weeks.

15.3.1 For each of the patient scenarios several interpretative criteria expected to be covered by the report, will be identified and agreed by the expert assessors.

15.3.2 Scoring Procedure Penalty points

Each feature in agreement with an identified criterion 0

A principal agreed interpretative criterion not covered by the report up to 3

Other agreed interpretative criterion not covered by the report 1

Significant erroneous patient identifiers or other information errors in the report 1 (each error)

NOTE: The Expert Assessors determine the ‘principal’ and ‘other’ interpretative criteria. 15.3.3 Assessment Procedure

Each scenario where 50% or less of the possible penalty points is allocated Acceptable Each scenario where more than 50% of the possible penalty points is allocated Unacceptable

15.4.1 Satisfactory performance is obtaining 4 ‘Acceptable’ classifications in a year.

NOTE: Unsatisfactory Performance Notifications (see Prospectus, page 6) are NOT sent to participants of Interpretative Schemes.

15.5 INFORMATION / ANALYSIS PROVIDED TO PARTICIPANTS

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SCHEME 6

16. SCHEME 6 – HLA ANTIBODY DETECTION

PURPOSE

To assess participants’ ability to correctly determine the presence of HLA antibodies.

16.1 SAMPLES

16.1.1 A total of twenty serum samples will be sent each year as two distributions of ten serum samples. Volumes of approximately 1.5ml of serum will be distributed.

16.2.1 At registration participants may opt for Class I only or Class I and Class II antibody assessment.

16.2.2 Participants are required to report the presence or absence of HLA Class I or HLA-Class I and Class II antibody.

16.2.3 Participants must only use the reporting forms provided. 16.2.4 Participants are required to return their results within 10 weeks.

16.3.1 Participating laboratories will be assessed on the antibody class or classes they designate at registration. 16.3.2 The consensus findings for Class I and Class II specificities are determined separately.

16.3.3 Consensus positivity or negativity of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of Class I or Class II antibody.

16.3.4 Samples failing to reach the 75% consensus level will not be assessed.

Each report in agreement with the consensus presence/absence of Class I or both Acceptable Class I and Class II antibody (see 16.2.1 and 16.2.2)

Each report not in agreement with the consensus presence/absence of Class I Unacceptable or both Class I and Class II antibody (see 16.2.1 and 16.2.2)

Each sample not reported, e.g. an equivocal or not tested result see 16.4.1

16.3.6 The reports of participants registered for Class I and II assessment must be in agreement with the consensus Class I and Class II findings on a serum to achieve an ‘Acceptable’ classification.

16.4.1 Satisfactory performance is making 80% of reports on all sera in agreement with the consensus Class I or both the consensus Class I and Class II antibody (see 16.2.1 and 16.2.2 above) findings in a calendar year.

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SCHEME 6

16.5.1 Summary sheets of all reported antibody findings. 16.5.2 Information on methodology.

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SCHEME 7

17. SCHEME 7 – HLA-B*57:01 TYPING FOR DRUG HYPERSENSITIVITY

PURPOSE

To assess participants’ ability to correctly determine HLA-B*57:01 status.

17.1 SAMPLES

17.2.1 Participants are required to report on HLA-B*57:01 “positivity” or “negativity”. 17.2.2 Participants may report a B*57 - non-B*57:01 - allele for information purposes.

17.2.3 Participants that routinely test to the 1st field level only for clinical purposes will be expected to outline their reporting procedures for consideration by the UK NEQAS for H&I Steering Committee.

17.2.4 Participants must only use the reporting forms provided. 17.2.5 Participants are required to return results within 10 days.

17.3.1 The consensus HLA-B*57:01 status of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of HLA-B*57:01.

17.3.2 Results failing to reach the 75% consensus level will not be assessed. 17.3.3 Assessment Procedure

Each report in agreement with the consensus HLA-B*57:01 status Acceptable Each report not in agreement with the consensus HLA-B*57:01 status Unacceptable

Each sample not reported, e.g. an equivocal or not tested result see 17.4.1

17.4.1 Satisfactory performance is making ten sample reports in agreement with the consensus HLA-B*57:01 status in a calendar year.

17.5.1 Summary sheets of all reported HLA-B*57 results. 17.5.2 Information on methodology.

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SCHEME 8

18. SCHEME 8 – HLA AND DISEASE TYPING FOR HLA-DR/DQ/DP ONLY

PURPOSE

To assess participants’ ability to correctly determine HLA-DR/DQ/DP allele families/alleles.

18.1 SAMPLES

18.1.1 A total of ten DNA preparations will be sent each year as two distributions of five DNA preparations. 18.1.2 These samples have been previously tested in Scheme 4A.

18.2.1 Participants are required to report their HLA-DR and/or HLA-DQ and/or HLA-DP findings. 18.2.2 Participants must only use the reporting forms provided.

18.2.4 Participants are required to return results within 6 weeks.

18.3.1 Participating laboratories will be assessed on the loci typed for each sample.

18.3.2 Assessment will be at the 1st or 2nd field level appropriate to the individual participant’s results for each locus and for each sample. DRB3/4/5 results at the ‘presence’ or ‘absence’ level will also be accepted.

18.3.3 The consensus genotype for each locus is previously determined by at least 75% of laboratories agreeing each allele or ‘blank’ in Scheme 4A2.

18.3.4 Reports of groups of alleles will be assessed at the allele family level.

18.3.5 Participants will only be assessed on those alleles that appear in the most recently published full HLA Nomenclature Report.

Each HLA locus in agreement with the 1st or 2nd field consensus type (see 18.3.3) Acceptable Each HLA locus not in agreement with 1st or 2nd field the consensus type (see 18.3.3) Unacceptable

Each sample not reported see 18.4.1

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EDUCATIONAL SCHEME

19. EDUCATIONAL SCHEME

PURPOSE

To provide participants with a variety of interesting samples to test that offer a beneficial educational element. NEW FOR 2014

This scheme is expanded to include the distribution of clinical scenarios.

19.1 SAMPLES and CLINICAL SCENARIOS

19.1.1 A total of four samples will be sent each year as two distributions of two samples. The samples for testing may be sent as blood samples, DNA extracts or serum.

19.1.2 A total of two clinical scenarios will be sent each year.

19.2.1 Participants must only use the reporting forms provided.

19.2.2 Participants are required to report their findings within the deadline stated.

19.3.1 Not assessed.

19.4.1 Not applicable.

19.5.1 For samples, summary sheets of all reported findings and information on methodology will be issued after each distribution.

19.5.2 Relevant references will be supplied whenever possible.

19.5.3 For scenarios, a summary of all returns and comments and details of the most frequent responses will be issued after each distribution.

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ESSENTIAL SCHEME INFORMATION

20. ESSENTIAL SCHEME INFORMATION

20.1 UK NEQAS FOR H&I

UK NEQAS for H&I aims to provide a comprehensive range of EQA Schemes appropriate to laboratories operating clinical histocompatibility and immunogenetics support services. H&I laboratory support is universally required in both solid organ, e.g. renal, heart, and haematopoietic stem cell transplant programmes and for the provision of: (i) HLA typing as an aid to disease diagnosis, e.g. HLA-B27 and the spondyloarthropathies; (ii) unrelated haematopoietic stem cell donor panels and (iii) the provision of HLA matched blood products. The primary laboratory investigations are: (i) determination of HLA type; (ii) the detection and specification of antibodies directed towards HLA specificities and (iii) ‘direct’ crossmatching of patients’ sera against donors’ lymphocytes.

From time to time consideration may be given to Schemes that cover other aspects of clinical work performed in an H&I laboratory and not currently covered by other EQA Schemes.

All Schemes are open to all UK NHS and Private Sector clinical laboratories and relevant reagent manufacturers. In addition, all Schemes are available to appropriate overseas laboratories.

All participants are provided with details of participation, i.e. Joint Working Group for Quality Assurance Conditions of EQA Participation (see Section 23).

20.2 STEERING GROUP

The Schemes’ Director is advised by a Steering Committee, current members, the category of their membership and their contact details are listed in Section 22.

The Steering Committee’s constitution, including accountability, remit, composition, membership and finance are essentially as laid down in the UK NEQAS Executive’s document “Steering Committees” latest revision, October 2004 (available from UK NEQAS).

The Steering Committee meets three times a year and has a special meeting immediately after the UK NEQAS for H&I Participants’ Meeting.

20.3 PROSPECTUS

The Prospectus is revised and issued on a yearly basis. Update pages are occasionally distributed to provide notification of additions and amendments during the year.

20.4 HLA NOMENCLATURE

Nomenclature for HLA specificities and HLA alleles is complex and is continuously being reviewed and updated. The Scheme provides the website address of the latest full Nomenclature Report, HLA Dictionary and HLA Nomenclature Updates. Details of nomenclature reporting strategies for the Schemes are also provided (see Section 5).

20.5 TEST MATERIAL

Blood samples to be processed for mononuclear cells and/or DNA are usually taken from regular normal healthy blood donors, usually of north-western European extraction. Blood samples may be random (Schemes 1A, 2A, 2B, 4A and 4B) or selected (Scheme 8 and Educational Scheme) or a mixture of random and selected (Schemes 1B, 5A and 7).

Serum samples obtained from parous women are used as a source of HLA antibodies.

All material sent to participants is tested and found negative for the following disease markers: HIV, HBsAg, HCV and syphilis. HIV Ag-Ab, HBsAg and anti-HCV are tested for on the Bio-Rad Elite™ system; antibodies to Treponema pallidum (syphilis) is tested using TPHA (Olympus PK system).

However, as with all biological material of this nature they should be considered as potentially hazardous. Handle with caution and apply accepted standards of Good Laboratory Practice.

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ESSENTIAL SCHEME INFORMATION Whole blood samples used for the preparation of mononuclear cells and/or DNA are CPD-A1 blood donations. Blood samples required for mononuclear cell preparations are diluted with RPMI 1640 tissue culture medium containing tri-Sodium citrate.

DNA extracts provided will have their DNA concentrations indicated.

Blood, DNA and serum samples are transported at ambient temperature and should be processed as soon as possible on receipt.

Any samples should be treated and stored as clinical samples.

It is important to ensure sample uniformity by carefully mixing each EQA sample. IMPORTANT: All sera distributed contain 0.01% sodium azide.

20.6 UK NATIONAL QUALITY ASSURANCE ADVISORY PANEL (UK NQAAP)

The UK NEQAS for H&I schemes come under the UK NQAAP for Immunology for the monitoring and maintenance of satisfactory performance standards.

The Director/Manager reports to UK NQAAP by written report prior to each UK NQAAP meeting (usually three times per year) and by attendance at each meeting.

The H&I professional representative on the UK NQAAP for Immunology is proposed by the British Society for Histocompatiblity and Immunogenetics. This representative also sits, as an observer, on the Schemes’ Steering Committee.

20.7 ANNUAL PARICIPANTS’ MEETING

This is arranged for the end of each calendar year usually early in December. Every participating laboratory is encouraged to send at least one representative.

The primary format is: (i) a report on each Scheme; (ii) educational scientific presentations and (iii) formal opportunities for a full participant discussion of each Scheme and UK NEQAS for H&I in general.

20.8 ENDORSEMENT BY UK NEQAS FOR H&I

UK NEQAS for H&I does not endorse any equipment, reagents, calibrants, test kits or any manufacturers or suppliers.

20.9 SCHEME REVIEW AND PILOT SCHEMES

The Schemes are reviewed annually by the Steering Committee and fully discussed at the Annual Participants’ Meeting. The Steering Committee consider comments from, for example, their members, participants, professional organisations and members of the discipline, regarding the nature and operation of Schemes and the establishment of new Schemes.

The likely viability of possible new Schemes is assessed by, for example, discussion at the Annual Participants’ Meeting, questionnaires sent to participants and discussion at UK NQAAP for Immunology meetings.

20.10 PROCEDURE FOR HANDLING COMPLAINTS FROM PARTICIPANTS

Complaints made against UK NEQAS for H&I are handled through the Welsh Blood Service/Velindre NHS Trust procedures (complainant confidentiality will be maintained).

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ESSENTIAL SCHEME INFORMATION 20.11 APPEALS AGAINST AN ASSESSMENT

An appeal against an assessment, including any relevant laboratory evidence, should be made in writing to Deborah Singleton, Schemes’ Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: 01443 622085; Fax: 01443 622001; e-mail: [email protected]).

The Director and Manager will consider the appeal in the first instance. If an appeal cannot be easily approved, the Director or Manager will present the appeal at the next Steering Committee meeting for a decision. The participant laboratory will be informed of the outcome of the Committee’s decision as soon as possible (and usually within ten working days) of the Steering Committee meeting. The Committee’s decision is final.

20.12 NON-ANALYTICAL ERRORS

Non-analytical errors, e.g. clerical mistakes, are considered as part of the assessment procedure. Normally no allowance is made for these on appeal.

20.13 CORRESPONDENCE WITH PARTICIPANTS AND OTHERS

Correspondence relating to Appeals and ‘Unsatisfactory Performance’ is logged in the ‘Performance Database’ together with any actions taken by UK NEQAS for H&I.

Letters, e-mails and telephone calls regarding, for example, comments and suggestions from participants and others on the Service, and requests for assistance, are logged in the ‘Correspondence Database’.

All correspondence is acknowledged; this may be by telephone and/or letter - within ten working days. UK NEQAS for H&I’s actions are logged in the ‘Correspondence Database’.

All appropriate comments and suggestions are referred to the Steering Committee at its next meeting.

The Steering Committee’s response is usually documented by a member of the Steering Committee and forwarded to the participant as soon as possible after the meeting; normally within ten working days. A copy of this response is retained by the Schemes’ Manager.

20.14 POLICY ON TESTING RETURNED SCHEME’S MATERIAL

UK NEQAS for H&I has occasionally been asked to test Scheme’s material returned by a Participant. In the past, this request has usually come from a laboratory that has been penalised and is questioning the validity of their findings or is questioning the proper labelling of Scheme’s samples.

UK NEQAS for H&I apply stringent procedures, fully detailed in Standard Operating Procedures, for the handling of all test material, e.g. whole blood and sera. For example, units of donor blood are fully processed one at a time. All other units of blood for subsequent processing remain in a secure cabinet while the complete procedure is performed on the single unit. Labelled samples from different units of blood only come together when material is being packed for distribution. Therefore, of necessity, UK NEQAS for H&I’s practices for the collection, processing, aliquotting, labelling, packing and disposal of any remaining material and labels are such that it is not possible for blood samples to be mixed-up, disordered or incorrectly labelled.

The UK NEQAS for H&I Steering Committee, at its October 2005 meeting, unanimously agreed that UK NEQAS for H&I should not normally retest returned Scheme’s material. The Committee pointed out that returned material, whether in the primary container or not, may not be that originally dispatched and/or may have become ‘contaminated’. It also pointed out that Scheme’s samples are normally tested by a minimum of some 20 laboratories and that their unanimously reported findings always provided the basis of sample assessment.

20.15 ACCEPTANCE OF PARTICIPANTS’ RESULTS

Participants should make every effort to return their results on or before the deadline date indicated for a particular Scheme. Laboratory results will not be accepted for assessment or performance review once schemes’ results are published on the UK NEQAS for H&I website.

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ESSENTIAL SCHEME INFORMATION

21. CONTACT WITH UK NEQAS for H&I

A list of contact names and numbers is given in Section 22.

For details of other UK National External Quality Assessment Services, please contact Julie Gelder (UK NEQAS Executive Manager/Company Secretary) or see: http://www.ukneqas.org.uk/ .

For queries relating to, e.g. participation fees, day-to-day organisation of UK NEQAS for H&I Schemes, participants’ contact changes, additional material/reagents, assessment clarification, assessment anomalies, copies of reports, please contact Deborah Singleton (Schemes’ Manager).

To appeal against an assessment please put your case in writing to Deborah Singleton.

To discuss any aspect of UK NEQAS for H&I please contact the Schemes’ Director, Manager or any other member of the Steering Committee who will be pleased to help.

If you wish your views to be discussed by the Steering Committee Meeting please send your comments in writing to Deborah Singleton. Correspondence will normally be circulated only to the Steering Committee and the BSHI Representative to UK NQAAP for Immunology and will normally be anonymised before distribution.