2011 Prospectus - Prospectus 2011

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2011 Prospectus - Prospectus 2011 Powered By Docstoc
					HISTOCOMPATIBILITY

                       and

 IMMUNOGENETICS




Prospectus

                      2011



       FS 27925
 Since October 2000
                                                  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        Charges for Participation (see insert)                                    5
 4.        UK NEQAS for H&I Assessment and Performance Principles                             5
 5.        Appeals Against Assessment                                                         6
 6.        Nomenclature                                                                       6
 7.        Scheme 1A - HLA Phenotyping                                                        8
 8.        Scheme 1B - HLA-B27 Testing                                                        10
 9.        Scheme 2A - Cytotoxic Crossmatching                                                11
10.        Scheme 2B - Crossmatching by Flow Cytometry                                        13
11.        Scheme 3 - HLA Antibody Specificity Analysis                                       15
                                                 st
12.        Scheme 4A1 –DNA HLA Typing at 1 Field Resolution                                   17
                                                 nd
13         Scheme 4A2 –DNA HLA Typing to 2 Field Resolution                                   19
14.        Scheme 4B - ABO Grouping by DNA-based methods                                      21
15.        Scheme 5A - HFE Typing                                                             22
16.        Pilot Scheme 5B – Interpretative: HFE Genotype and Hereditary Haemochromatosis     24
17.        Scheme 6 – “HLA” Antibody Detection                                                25
18.        Scheme 7 – HLA-B*57:01 Typing for Drug Hypersensitivity                            26
19.        Pilot Scheme 8 – HLA and Disease Typing for HLA-DR/DQ/DP only                      27
20.        Educational Scheme                                                                 28
21.        Essential Scheme Information                                                       29
         21.1       UK NEQAS for H&I                                                          29
         21.2       Steering Group                                                            29
         21.3       Prospectus                                                                29
         21.4       HLA Nomenclature                                                          29
         21.5       Test Material                                                             29
         21.6       UK National Quality Assurance Advisory Panel (UK NQAAP)                   30
         21.7       Annual Participants’ Meeting                                              30
         21.8       Endorsement by UK NEQAS for H&I                                           30
         21.9       Scheme Review and Pilot Schemes                                           30
         21.10      Procedure for the Handling of “Complaints” from Participants              30
         21.11      Appeals Against and Assessment                                            31
         21.12      Correspondence with Participants                                          31
         21.13      Policy on Testing Returned Scheme’s Material                              31
22.        Contact with UK NEQAS for H&I                                                      31
23.        List of Contact Names and Addresses                                                33
24.        Joint Working Group for Quality Assurance Guidelines for Participants              35
25.        CPA Accreditation and EQA Performance                                              37
26.        UK NEQAS for H&I and European Federation for Immunogenetics (EFI) Accreditation    37
27.        UK NEQAS for H&I Dates                                                             38




     FS 27925
Since October 2000


                                                        1
                                                           PROSPECTUS 2011

1.        DISTRIBUTION TIMETABLE

Scheme 1A             Scheme 1B             Scheme 2B              Scheme 3              Scheme 4A1 & 4B        Scheme 4A2            Scheme 6

Scheme 2A                                                          Educational           Scheme 5A              Scheme 7              Pilot Scheme 8
                                                                   Scheme
                                                                                         Scheme 5B
___________________________________________________________________________________________________________________________________________________________

11 January            18 January            25 January
                                                                   15 February           8 February
8 March               15 March              29 March                                                                                  1 March
                                                                                                                12 April
10 May                17 May                24 May
                                                                   14 June               7 June                                       21June
5 July                12 July               19 July

13 September          20 September          27 September                                                        6 September
___________________________________________________________________________________________________________________________________________________________

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                              Pilot 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              Pilot Scheme 8 – HLA and Disease Typing for HLA-DR/DQ/DP only
Scheme 4A2 – DNA HLA Typing to 2nd Field Resolution              Educational Scheme


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 24). 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 24) Guidelines 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
      •   Acutely 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
      •   Endeavour to comply with EFI EPT Rules


                                                                        2
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, laboratory participation 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:                                                                   1A and/or 4A1
 Solid organ transplantation                                                             and/or 4A2
 Haematopoietic stem cell transplantation
 HLA and disease investigations
 Unrelated haematopoietic stem cell donor registries
 Reference cell panel typing for clinical HLA antibody services
 HLA-B27 testing in:                                                                     1B
 Aid to diagnosis in B27 associated diseases
 ABO ‘blood grouping’ (using DNA) in:                                                    4B
 Solid organ transplantation
 Typing for single specific HLA specificity/allele or locus, other than HLA-             1A and/or 4A1
 B27 in:                                                                                 and/or 4A2
 Disease susceptibility/aid to diagnosis                                                 and/or 8
 Immunotherapy
 HLA antibody detection and specification in:                                            3 or 3 and 6
 Transplantation
 Platelet immunology
 Blood products support
 Crossmatching by lymphocytotoxicity in:                                                 2A
 Transplantation
 Blood products support
 Crossmatching by flow cytometry in:                                                     2B
 Transplantation
 HFE testing in:                                                                         5A and /or 5B
 Patient investigations
 Haemochromatosis family studies
 Drug hypersensitivity testing in:                                                       7
 Patient evaluation




                                                           3
PARTICIPATION IN SCHEME 1A (HLA PHENOTYPING) AND SCHEMES 4A1/4A2 (DNA HLA TYPING)

The conduct of Schemes 1A and 4A1/4A2 has attempted to keep reasonable pace with changing HLA testing
technology and typing strategies. Modifications to the participation levels of these Schemes have tried to
encompass these changes.

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

The European Federation for Immunogenetics (EFI) ’STANDARDS FOR HISTOCOMPATIBILITY TESTING version
5.6, D - HLA ALLELES AND ANTIGENS’, Standard D1.320 states: “High resolution typing is defined as (a)
identifying HLA alleles at the resolution level of 4 digits or more, 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, and (b) all
ambiguities that encompass a null allele, wherever the polymorphism is located, unless it can be demonstrated that
an expressed antigen is present on the cells.
                                                 st      nd
It is expected that laboratories that register for 1 and 2 field HLA typing 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
                st
 Serology with 1 field DNA typing                                               1A or 1A and 4A1
  st
 1 field DNA typing                                                             4A1
                   st        nd
 Combination of 1 field and 2 field DNA typing                                  4A1 and 4A2
  nd
 2 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
                                                           4
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.

The method(s) used should be those routinely employed by the laboratory for antibody testing.

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-B57/B*57/B*57:01
who are to be treated with antiretroviral drugs, notably 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-B57/B*57/B*57:01 using the method(s) they employ for routine
clinical service ‘HLA-B57’ 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 occasionally asked to provide specific EQA schemes for certain HLA alleles or groups of
alleles associated with a particular condition, e.g. DQ2 and DQ8 in celiac disease. Although in the past this has not
been done - with the exception of Scheme 1B - HLA-B27 Typing, and the recent Scheme 7 - HLA-B*57:01 Typing
for Drug Hypersensitivity, it will now be possible to provide bespoke HLA typing schemes for a small number of
participants.

Bespoke schemes will use selected stored DNA from samples previously provided for UK NEQAS for H&I’s
Schemes 4A1 and 4A2 - DNA HLA Typing, or from samples provided, by the Welsh Transplantation and
Immunogenetics Laboratory, to and tested through, the UCLA Immunogenetics Centres’ International Cell
Exchanges. Consequently, these samples are considered as ‘well-documented reference material’.

Provision of a bespoke scheme also applies to HLA antibody detection and/or specification. This would use sera
previously tested in Scheme 6 (‘HLA’ Antibody Detection) or Scheme 3 (HLA Antibody Specificity Analysis).

A further use of bespoke schemes is fulfilling the requirements of EFI Standard C4.130 “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 Susan Corbin: Susan
Corbin (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: ukneqashandi@wbs.wales.nhs.uk).

3.5     CHARGES FOR PARTICIPATION

These are shown on the insert sheet. For further information please contact:
Susan Corbin, 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: ukneqashandi@wbs.wales.nhs.uk).



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 ‘Rules for EPT Providers’ established by the EFI EPT Committee.

                                                           5
Proposed changes in Schemes’ assessment and/or the determination of satisfactory performance are brought to
the UK NQAAP for Immunology for ratification.

For all Schemes, except Pilot Scheme 5B - Interpretative: HFE Genotype and Hereditary Haemochromatosis, and
Pilot Scheme 8 - HLA and Disease Typing for HLA-DR/DQ/DP only, performance is based on establishing
consensus assignments, for HLA/ABO/HFE specificities/alleles, antibody presence/absence, antibody specificities,
cell/serum crossmatch test positive/negative, for all test samples.

Scheme 5B uses a penalty points system and, as a pilot scheme, satisfactory performance criteria have not yet
been established.

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 detail their reasons for their performance together
with any corrective actions within 20 working days of the date of the Unsatisfactory Performance’ notification.

All UK laboratories receiving ‘Unsatisfactory Performance’ notification are reported to UK NQAAP. 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.      APPEALS AGAINST ASSESSMENT

Participants who disagree with their scheme assessment(s) may appeal to the Steering Committee to have their
result(s) reviewed.

Laboratory findings and/or other evidence must be submitted in writing to the Steering Committee in support of a
non-consensus finding.

Appeals should be made to Susan Corbin – UK NEQAS for H&I Steering Committee Secretary, Welsh Blood
Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: 01443 622185; Fax: 01443 622001; e-mail:
ukneqashandi@wbs.wales.nhs.uk, who will present them at the next meeting of the Steering Committee.


6.      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.

                                                         6
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.

Please report DRB5*, DRB3* and DRB4* and not their serological equivalents, i.e. DR51, DR52 and DR53.

Use of the new nomenclature will be expected for 2011 and will be mandatory for 2012.




                                                          7
                                                                                                          SCHEME 1A

7.      SCHEME 1A – HLA PHENOTYPING

PURPOSE

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


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     REPORTING

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

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

7.2.3   Participants must make a report for each HLA locus for which they have registered.

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

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

7.2.6   Participants must only use the reporting forms provided.

7.2.7   Participants are required to make their report within 10 days.


7.3     ASSESSMENT

7.3.1   Participants will be assessed on the HLA loci contained in the phenotype, for which they are registered.

7.3.2   The consensus complete HLA phenotype for assessment is determined by at least 75% of laboratories
        agreeing each specificity.

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

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

7.3.5   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 7.4.1

7.4     SATISFACTORY PERFORMANCE

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

7.4.2   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.

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.




                                                           8
                                                                                                   SCHEME 1A

7.5     INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

7.5.1   Summary sheets of all reported specificities and supplementary information.

7.5.2   Information on methodology.

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




                                                         9
                                                                                                          SCHEME 1B

8.      SCHEME 1B - HLA-B27 TESTING

PURPOSE

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


8.1     SAMPLES

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


8.2     REPORTING

8.2.1   Participants are required to report on HLA-B27/B2708/B*27 “positivity” or “negativity”.

8.2.2   Participants must only use the reporting forms provided.

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


8.3     ASSESSMENT

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

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

8.3.3   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 8.4.1


8.4     SATISFACTORY PERFORMANCE

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

8.4.2   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.

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

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


8.5     INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

8.5.1   The HLA-B type of the donor samples.

8.5.2   Summary sheets of all reported “HLA-B27” results.

8.5.3   Information on methodology.

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




                                                         10
                                                                                                          SCHEME 2A

9.      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.


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 150µl 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.

9.1.3   Participants must test peripheral blood lymphocytes PBL/T-cells, according to their local practice and may
        additionally submit results for B-cells

9.1.4   Participants are requested NOT to test sera for reactivity after dithiothreitol treatment as sufficient material
        is not available for this test.


9.2     REPORTING

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

9.2.1   Test results should be reported as positive or negative using established local criteria.

9.2.2   Tests reported as weakly positive will be interpreted as positive for assessment purposes.

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

9.2.4   Participants must only use the reporting forms provided.

9.2.5   Participants are required to make their report within 10 days.


9.3     ASSESSMENT

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   PBL/T-cell and B-cell results are 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     SATISFACTORY PERFORMANCE

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

9.4.2   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.


                                                          11
                                                                                                        SCHEME 2A

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

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


9.5     INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

9.5.1   The HLA phenotype of the donor and specificities of the sera.

9.5.2   A summary sheet of all crossmatching results.

9.5.3   Performance information on the current and previous year’s samples.

9.5.4   Performance information (non-assessed) on hidden replicate sera.




                                                         12
                                                                                                          SCHEME 2B

10.     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.


10.1    SAMPLES

10.1.1 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.

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


10.2    REPORTING

10.2.1 At registration participants may opt for T-cell only or T-cell and B-cell crossmatch assessment.

10.2.2 Test results should be reported as positive or negative compared to the local negative control.

10.2.3 Tests reported as weakly positive will be interpreted as positive for assessment purposes.

10.2.4 Participants must only use the reporting forms provided.

10.2.5 Participants are required to make their report within 10 days.


10.3    ASSESSMENT

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

10.3.2 Crossmatching tests failing to reach the 75% consensus level will not be assessed.

10.3.3 T-cell and B-cell results will be considered independently.


10.3.4 Assessment Procedure

        All sera
        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 10.4.1


10.4    SATISFACTORY PERFORMANCE

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

10.4.2 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.

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

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




                                                         13
                                                                                                  SCHEME 2B

10.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

10.5.1 The HLA phenotype of the donor and the specificity of the sera.

10.5.2 A summary sheet of all reported crossmatching results.

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

10.5.4 Performance information (non-assessed) on hidden replicate sera.

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




                                                        14
                                                                                                           SCHEME 3

11.     SCHEME 3 - HLA ANTIBODY SPECIFICITY ANALYSIS

PURPOSE

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


11.1    SAMPLES

11.1.1 A total of twelve serum samples will be sent each year as two distributions of six samples. Volumes of
       approximately 1.5ml of serum will be distributed.


11.2    REPORTING

11.2.1 At registration participants may opt for Class I only or Class I and Class II antibody assessment.
       Participants may opt for IgG only or IgG and IgM antibody assessment.

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

11.2.3 Participants may report other antibody findings, e.g. DPB, DQA and MICA. These specificities will not be
       assessed in 2011.

11.2.4 Participants must only use the reporting forms provided.

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


11.3    ASSESSMENT

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

11.3.2 Consensus presence of a specificity is determined by at least 75% of laboratories agreeing the specificity.

11.3.3 Consensus absence of a specificity is determined by at least 95% of laboratories agreeing the absence of
       the specificity.

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

11.3.5 Assessment Procedure

        Assigning a consensus specificity                                                   Acceptable
        Missing a consensus specificity                                                     Unacceptable
        Assigning a specificity where the consensus is negative                             Unacceptable

        Each sample report of a not tested result                                           see 11.4.1


11.4    SATISFACTORY PERFORMANCE

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

11.4.2 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.

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

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




                                                           15
                                                                                                  SCHEME 3

11.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

11.5.1 Where known, the HLA phenotypes of the serum donors.

11.5.2 Summary sheets of all reported antibody findings.

11.5.3 Information on methodology.

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




                                                        16
                                                                                                         SCHEME 4A1
                                                    ST
12.     SCHEME 4A1 – DNA HLA TYPING AT 1                 FIELD RESOLUTION

IMPORTANT NOTE: From 2011 the samples supplied for Scheme 4A1 will be different from those supplied
for Scheme 4A2

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


12.1    SAMPLES

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


12.2    REPORTING


12.2.1 Participants may register for first field assessment of HLA-A, B, C, DRB1, DQA1 and DQB1 and for 1st field
       or ‘presence of’ assessment for DRB3, DRB4 and, DRB5.

12.2.2 Participants must only use the reporting forms provided.

12.2.3 Participants are required to return results within 4 weeks.


12.3    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 field type                      Acceptable

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

        Each sample report of a not tested result                                                  see 12.4.1


12.4    SATISFACTORY PERFORMANCE

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

12.4.2 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.

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

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


12.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

12.5.1 Summary sheets of all reported alleles.

                                                            17
12.5.2 Information on methodology.

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




                                                        18
                                                                                                         SCHEME 4A2
                                                    ND
13.     SCHEME 4A2 – DNA HLA TYPING TO 2                 FIELD RESOLUTION

IMPORTANT NOTE: From 2011 the samples supplied for Scheme 4A2 will be different from those supplied
for Scheme 4A1

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


13.1    SAMPLES

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


13.2    REPORTING
                           nd
13.2.1 For typing to the 2 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.
                                     nd
13.2.2 Participants registered for 2 field assessment should define all ambiguities that encompass a null allele
       wherever the polymorphism is located (see paragraph on EFI Standard D1.320).
                                                                                                                   st
13.2.3 Participants may register for HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1 and DPB1 for 1 and
        nd
       2 field assessment.

13.2.6 Participants must only use the reporting forms provided.

13.2.7 Participants are required to return results within 6 weeks.


12.3    ASSESSMENT

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

13.3.2 The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele.

13.3.3 Alleles failing to reach the 75% consensus level will not be assessed.

13.3.4 A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus.

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

13.3.6 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

        Each sample report of a not tested result                                                  see 13.4.1


13.4    SATISFACTORY PERFORMANCE

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

13.4.2 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.

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

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

                                                            19
                                                                                                   SCHEME 4A2

13.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

13.5.1 Summary sheets of all reported alleles.

13.5.2 Information on methodology.

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

13.5.4 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.

13.5.5 Participants reporting strings of alleles containing ‘null’ alleles will be notified.




                                                             20
                                                                                                       SCHEME 4B

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

PURPOSE

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


14.1    SAMPLES

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


14.2    REPORTING

14.2.1 The ABO alleles detected should be reported as fully as possible, using the appropriate nomenclature.

14.2.2 Participants must only use the reporting forms provided.

14.2.3 Participants are required to return results within 4 weeks.


14.3    ASSESSMENT

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

14.3.2 Genotypes failing to reach the 75% consensus level will not be assessed

14.3.3 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 14.4.1

14.4    SATISFACTORY PERFORMANCE

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

14.4.2 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.

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

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


14.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

14.5.1 Summary sheets of all reported ABO genotypes.

14.5.2 Information on methodology.

14.5.3 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.




                                                         21
                                                                                                         SCHEME 5A

15.     SCHEME 5A – HFE TYPING

PURPOSE

To assess participants’ ability to correctly determine HFE mutations.


15.1    SAMPLES

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


15.2    REPORTING

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

15.2.2 Participants may register to have their Ser65Cys results assessed.

15.2.3 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.

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

15.2.5 Participants must only use the reporting forms provided.

15.2.6 Participants are required to return results within 4 weeks.


15.3    ASSESSMENT

15.3.1 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.

15.3.2 Mutations failing to reach the 75% consensus level will not be assessed.

15.3.3 Assessment Procedure

        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


15.4    SATISFACTORY PERFORMANCE

15.4.1 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.

15.4.2 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.

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

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


15.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

15.5.1 A summary sheet of all reported HFE codon 63, 65 and 282 assignments.

15.5.2 Information on methodology.

                                                          22
                                                                                                  SCHEME 5A

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




                                                        23
                                                                                                      PILOT SCHEME 5B

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

PURPOSE

To assess participants’ ability to make an accurate, clear, concise and timely 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.


16.1    CLINICAL SCENARIOS

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


16.2    REPORTING

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

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

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


16.3    ASSESSMENT

16.3.1 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’.

16.3.2 Assessment Procedure                                                                 Penalty points

Each feature in agreement with an identified criterion                                                0
A principal agreed interpretative criterion not covered by the report                                 2
Other agreed interpretative criterion not covered by the report                                       1
Significant erroneous patient identifiers or errors in ‘referral information’ supplied (each error)   1

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


16.3    SATISFACTORY PERFORMANCE

16.3.1 Satisfactory performance has not yet been determined. This scheme will be informally assessed during
       2011 (pilot scheme) and it is likely that full assessment will begin in 2012.


16.4    INFORMATION / ANALYSIS PROVIDED TO PARTICIPANTS

16.4.1 Each laboratory will receive an itemisation of interpretative points applicable to each clinical scenario
       indicating how their report coincided with the criteria identified.

16.4.2 A summary of all participants’ scores will be provided.




                                                            24
                                                                                                             SCHEME 6

17.     SCHEME 6 – “HLA” ANTIBODY DETECTION

PURPOSE

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


17.1    SAMPLES

17.1.1 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.


17.2    REPORTING

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

17.2.2 Participants are required to report the presence or absence of “HLA” antibody.

17.2.3 Participants must only use the reporting forms provided.

17.2.4 Participants are required to return their results within 8 weeks.


17.3    ASSESSMENT

17.3.1 Class I and Class II specificities will be assessed separately.

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

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

17.3.4 Assessment Procedure

        Each report in agreement with the consensus presence/absence of antibody     Acceptable
        Each report not in agreement with the consensus presence/absence of antibody Unacceptable

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

17.4    SATISFACTORY PERFORMANCE

17.4.1 Satisfactory performance is making 80% of reports on all sera in agreement with the consensus findings in
       a calendar year.

17.4.2 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.

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

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


17.6    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

17.6.1 Summary sheets of all reported antibody findings.

17.6.2 Information on methodology.

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




                                                          25
                                                                                                             SCHEME 7

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

PURPOSE

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


18.1    SAMPLES

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


18.2    REPORTING

18.2.1 Participants are required to report on HLA-B*57:01 “positivity” or “negativity”.

18.2.2 Participants may report a B*57 - non-B*57:01 - allele for information purposes.
                                                st
18.2.3 Participants that routinely test to the 1 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.

18.2.4 Participants must only use the reporting forms provided.

18.2.5 Participants are required to return results within 10 days.


18.3    ASSESSMENT

18.3.1 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.

18.3.2 Results failing to reach the 75% consensus level will not be assessed.

18.3.3 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


18.4    SATISFACTORY PERFORMANCE

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

18.4.2 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.

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

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


18.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

18.5.1 Summary sheets of all reported HLA-B*57 results.

18.5.2 Information on methodology.

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




                                                           26
                                                                                                 PILOT SCHEME 8

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

PURPOSE

To assess participants’ ability to correctly determine HLADR/DQ/DP allele families/alleles.


19.1    SAMPLES

19.1.1 A total of six DNA preparations will be sent each year as two distributions of three DNA preparations.


19.2    REPORTING

19.2.1 Participants are required to report their HLA-DR and/or HLA-DQ and/or HLA-DP findings.

19.2.2 Participants must only use the reporting forms provided.

19.2.4 Participants are required to return results within 6 weeks.


19.3    ASSESSMENT

19.3.1 Not assessed.


19.4    SATISFACTORY PERFORMANCE

19.4.1 Not applicable.


19.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

19.5.1 Summary sheets of all reported HLA-DR, DQ and DP results.

19.5.2 Information on methodology.




                                                         27
                                                                                             EDUCATIONAL SCHEME

20.     EDUCATIONAL SCHEME

PURPOSE

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


20.1    SAMPLES

20.1.1 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.


20.2    REPORTING

20.2.1 Participants must only use the reporting forms provided.

20.2.2 Participants are required to report their findings within the deadline stated with the material.


20.3    ASSESSMENT

20.3.1 Not assessed.


20.4    SATISFACTORY PERFORMANCE

20.4.1 Not applicable.


20.5    INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS

20.5.1 Summary sheets of all reported findings and information on methodology will be issued after each
       distribution.

20.5.2 Relevant references will be supplied whenever possible.




                                                           28
                                                                               ESSENTIAL SCHEME INFORMATION

21.     ESSENTIAL SCHEME INFORMATION

21.1    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 24).


21.2    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 21.

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 Annual General Meeting.


21.3    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.


21.4    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 6).


21.5    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 (Pilot Scheme 8 and Educational Scheme) or a mixture of random and selected (Schemes
1B, 5A and 7).

Serum samples obtained from antenatal 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. HIV1 and 2, HBsAg and anti-HCV are tested using a chemiluminescence technique (Abbott PRISM™);
antibodies to Treponema pallidium (syphilis) is tested using TPHA (Olympus PK™ TP 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.



                                                           29
                                                                           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 approximately an equal volume of 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.


21.6    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.


21.7    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.


21.8    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.


21.9 SCHEME REVIEW AND PILOT SCHEMES

The Schemes are reviewed annually by the Steering Committee and fully discussed at the AGM. 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 AGM, questionnaires
sent to participants and discussion at UK NQAAP for Immunology meetings.


21.10 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).

Complaints made against UK NEQAS for H&I should be made in writing to: Susan Corbin, 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: ukneqashandi@wbs.wales.nhs.uk).




                                                        30
                                                                             ESSENTIAL SCHEME INFORMATION

21.11 APPEALS AGAINST AN ASSESSMENT

An appeal against an assessment, including any relevant laboratory evidence, should be made in writing to Susan
Corbin, 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: ukneqashandi@wales.nhs.uk).

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.


21.12 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.


21.13 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 accrued penalty points 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.


22.     CONTACT WITH UK NEQAS for H&I


A list of contact names and numbers is given in Section 21.

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 Susan Corbin (Schemes’ Manager).

To appeal against an assessment please put your case in writing to Susan Corbin.

                                                         31
                                                                            ESSENTIAL SCHEME INFORMATION

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
Susan Corbin. 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.

All contact, including letters and telephone calls with UK NEQAS for H&I is recorded in the Correspondence File.




                                                        32
                                                                                               CONTACTS
23.    LIST OF CONTACT NAMES AND ADDRESSES

UK NEQAS Website                                   http://www.ukneqas.org.uk/

UK NEQAS for H&I Website                           http://www.ukneqashandi.org.uk

Dr Alan Balfe                                      Biochemistry Department
Expert Advisor for Scheme 5B                       Central Pathology Laboratory, St James's Hospital
Tel: 00 353 1 4162054     Fax: 00 353 1 4103446    DUBLIN 8
e-mail: abalfe@stjames.ie                          Republic Of Ireland

Dr B Clarke                                        Transplant Immunology
Steering Committee Member                          Level 9, Gledhow Wing
Tel: 0113 2064579          Fax: 0113 2064579       St James University Hospital
e-mail: brendan.clarke@leedsth.nhs.uk              Beckett Street, LEEDS LS9 7TF

Mrs S Corbin                                       Welsh Transplantation and Immunogenetics Laboratory
Schemes’ Manager and Secretary                     Welsh Blood Service
Tel: 0144 362 2185        Fax: 0144 362 2001       Ely Valley Road
e-mail: susan.corbin@wales.nhs.uk                  Talbot Green
e-mail: ukneqashandi@wales.nhs.uk                  PONTYCLUN CF72 9WB

Dr C Darke                                         Welsh Transplantation and Immunogenetics Laboratory
Schemes’ Director                                  Welsh Blood Service
Tel: 0144 362 2020         Fax: 0144 362 2002      Ely Valley Road
e-mail: chris.darke@wales.nhs.uk                   Talbot Green, PONTYCLUN CF72 9WB

Dr Dairena Gaffney                                 DNA Laboratory
Lead Expert Advisor for Scheme 5B                  Biochemistry Department
Tel: 0141 2114597          Fax:                    Macewan Building, Glasgow Royal Infirmary
e-mail: dairena.gaffney@glasgow.ac.uk              GLASGOW G4 0SF

Mrs Julie Gelder                                   UK NEQAS Central Office
UK NEQAS Executive Manager/Company Secretary       P.O. Box 401
Tel: 0114 2611 689         Fax: 0114 2611 049      SHEFFIELD S5 7YZ
e-mail: office@ukneqas.org.uk

Dr M Hathaway                                      Tissue Typing Laboratory
Steering Committee Member                          National Blood Service
Tel: 0121 278 4116       Fax: 0121 253 4110        Vincent Drive
e-mail: mark.hathaway@nbs.nhs.uk                   Edgbaston, BIRMINGHAM B15 2SG

Dr T Horsburgh                                     Transplantation Laboratory
Steering Committee Member                          Leicester General Hospital
Tel: 0116 258 4606/7        Fax: 0116 273 3106     Gwendolen Road
e-mail: terry.horsburgh@uhl-tr.nhs.uk              LEICESTER LE5 4PW

Dr L Keen                                          Histocompatibility & Immunogenetics Department
BSHI Representative to UK NQAAP                    NHS Blood and Transplant
Tel: 0117 912 5733         Fax: 0117 991 5730      500 North Bristol Park
e-mail: leigh.keen@nhsbt.nhs.uk                    Northway, Filton, BRISTOL BS34 7QH

Dr D Pamphilon                                     Consultant Haematologist
Clinical Representative                            National Blood Service
Tel: 0117 991 2095        Fax: 0117 991 2002       Southmead Road
e-mail: derwood.pamphilon@nbs.nhs.uk               BRISTOL BS10 5ND

Dr Fotini Partheniou                               Histocompatibility & Immunogenetics
Steering Committee Member                          NHSBT
Tel: 0191 2024474           Fax: 0191 2024564      Holland Drive, Barrack Road
e-mail: fotini.partheniou@nhsbt.nhs.uk             Newcastle upon Tyne, Tyne and Wear NE2 4NQ

Mrs J Pepperall                                    Welsh Transplantation and Immunogenetics Laboratory
Steering Committee Member                          Welsh Blood Service
Tel: 0144 362 2030          Fax: 0144 362 2001     Ely Valley Road
e-mail: jennifer.pepperall@wales.nhs.uk            Talbot Green, PONTYCLUN CF72 9WB

                                                  33
                                                                                             CONTACTS

Dr D Sage                                        H&I Laboratory
Steering Committee Chairman                      NHS Blood and Transplant – Tooting Centre
Tel: 0203 1238567        Fax: 0203 1238457       75 Cranmer Terrace
e-mail: deborah.sage@nhsbt.nhs.uk                LONDON SW17 0RB

Dr G Willis                                      Molecular Genetics
Expert Advisor for Scheme 5B                     Norfolk and Norwich University Hospital
Tel: 0160 328 7068          Fax: 01603 286928    Colney Lane, NORWICH NR4 7UY
e-mail: gavin.willis@nnuh.nhs.uk

Dr J E Worthington                               The Transplantation Laboratory
Steering Committee Member                        Manchester Royal Infirmary
Tel: 0161 276 7988         Fax: 0161 276 6148    Oxford Road
e-mail: Judith.Worthington@cmft.nhs.uk           MANCHESTER M13 9WL




                                                34
                                                                                                  JWG GUIDELINES

24.     JOINT WORKING GROUP FOR QUALITY ASSURANCE (JWG) GUIDELINES FOR PARTICIPANTS

Joint Working Group for Quality Assurance : Conditions of EQA Scheme Participation

The Joint Working Group for Quality Assurance (JWG) is a multidisciplinary group accountable to the Royal College
of Pathologists for the oversight of performance in external quality assurance schemes (EQA) in the UK.
Membership consists of the Chairmen of the National Quality Assurance Advisory Panels (NQAAPs), and
representatives from the Institute of Biomedical Sciences, the Independent Healthcare Sector, the Department of
Health and CPA (UK) Ltd.
1. The Head of a laboratory is responsible for registering the laboratory with an appropriate accredited EQA
scheme.

2. The laboratory should be registered with available EQA schemes to cover all the tests that the laboratory
performs as a clinical service.

3. EQA samples must be treated in exactly the same way as clinical samples. If this is not possible because of the
use of non-routine material for the EQA (such as photographs) they should still be given as near to routine
treatment as possible.

4. Changes in the test methodology of the laboratory should be notified in writing to the appropriate scheme
organiser and should be reflected in the EQA schemes with which the laboratory is registered.

5. Samples, reports and routine correspondence may be addressed to a named deputy, but correspondence from
Organisers and NQAAPs concerning persistent poor performance (red – see below) will be sent directly to the Head
of the laboratory or, in the case of the independent healthcare sector, the Hospital Executive Director.

6. The EQA code number and name of the laboratory and the assessment of individual laboratory performance are
confidential to the participant and will not be released by Scheme Organisers without the written permission of the
Head of the laboratory to any third party other than the Chairman and members of the appropriate NQAAP and the
Chairman and members of the JWG. The identity of a participant (name of laboratory and Head of Department) and
the tests and EQA schemes for which that laboratory is registered (but not details of performance) may also be
released by the Scheme Organiser on request to the Health Authority, Hospital Trust/Private Company in which the
laboratory is situated after a written request has been received.

7. A NQAAP may, with the written permission of the Head of a laboratory, correspond with the Authority responsible
for the laboratory, about deficiencies in staff or equipment which, in the opinion of the NQAAP members, prevent
the laboratory from maintaining a satisfactory standard.

8. Laboratories’ EQA performance will be graded using a traffic light system; green will indicate no concerns, amber
poor performance, red persistent poor performance, with black being reserved for the tiny number of cases that
cannot be managed by the Organiser or NQAAP and that have to be referred to the JWG. The criteria for poor
performance (amber) and persistent poor performance (red) are proposed by the EQA scheme Steering Committee
in consultation with the EQA Provider/Scheme Organiser and approved by the relevant NQAAP.

9. When a laboratory shows poor (amber) performance the Organiser will generally make contact with the
participant in accordance with the Scheme Standard Operating Procedure for poor performance. Within 2 weeks of
a laboratory being identified as a persistent poor performer (red), the Organiser will notify the Chairman of the
appropriate NQAAP together with a resume of remedial action taken or proposed. The identity of a persistently poor
performing laboratory (red) will be made available to members of the NQAAP and JWG. The NQAAP Chairman
should agree in writing any remedial action to be taken and the timescale and responsibility for carrying this out; if
appropriate, this letter will be copied to accreditation/regulatory bodies such as CPA (UK) Ltd, UKAS and HFEA who
may arrange an urgent visit to the laboratory. Advice is offered to the Head of the Laboratory in writing or, if
appropriate, a visit to the Laboratory from a NQAAP member or appropriate agreed expert may be arranged.

10. If persistent poor performance remains unresolved (black), the NQAAP Chairman will submit a report to the
Chairman of the JWG giving details of the problem, its causes and the reasons for failure to achieve improvement.
The Chairman of the JWG will consider the report and, if appropriate, seek specialist advice from a panel of experts
from the appropriate professional bodies to advise him/her on this matter. The Chairman of the JWG will be
empowered to arrange a site meeting of this panel of experts with the Head of the Department concerned. If such
supportive action fails to resolve the problems and, with the agreement of the panel of experts, the Chairman of the
JWG will inform the Chief Executive Officer, or nearest equivalent within the organisation of the Trust or Institution,
of the problem, the steps which have been taken to rectify it and, if it has been identified, the cause of the problem.
The Chairman of the JWG also has direct access and responsibility to the Professional Standards Unit of the Royal
College of Pathologists. Should these measures fail to resolve the issues, the laboratory will be referred to the Care
Quality Commission for further action.


                                                          35
                                                                                             JWG GUIDELINES

11. Problems relating to EQA Schemes, including complaints from participating laboratories, which cannot be
resolved by the appropriate Organiser, Steering Committee or NQAAP, will be referred to the Chairman of the JWG.

Joint Working Group for Quality Assurance in Pathology, August 2010.




                                                      36
                                                                 CPA ACCREDITATION AND EQA PERFORMANCE

25.     CLINICAL PATHOLOGY ACCREDITATION (UK) LTD. (CPA) ACCREDITATION
        AND EQA PERFORMANCE

Standard H5 of “Standards for the Medical Laboratory” is reproduced with the kind permission of Clinical
Pathology Accreditation (UK) Ltd. (CPA).

Since this is directly relevant to UK NEQAS for H&I participants it is reproduced in full for your information.

H5 External quality assessment
Participation in External Quality Assessment (sometimes known as Proficiency Testing) schemes is an essential
element in informing both providers and users of the quality of the service provided. Such schemes have a major
educational component and may include either the analytical service of a laboratory and/or the interpretations
provided by individual members of staff.

H 5.1 There shall be participation in approved External Quality Assessment Scheme(s) appropriate to the
      examinations and interpretations provided [NOTES 1 and 2].

H 5.2 A record of results against the agreed performance criteria in approved EQA Schemes shall be maintained.

H 5.3 The record of the performance in EQA shall be reviewed and communicated to staff and the decisions taken
      recorded, monitored and acted upon [NOTE 3].

H 5.4 When a formal inter-laboratory comparison programme is not available, the laboratory shall develop a
      mechanism for determining the acceptability of procedures not otherwise evaluated [NOTE 4].
NOTES
1. Approved EQA Schemes are Schemes that are accredited by CPA (EQA) or by another organisation accrediting
   to standards based upon ILAC G13:2000. This should include an appropriate scientific Steering Committee and
   National Quality Assurance Advisory Panel reporting arrangements.
2. External quality assessment programmes should, as far as possible, provide clinically relevant challenges that
   mimic patient samples and have the effect of checking the entire examination process, including pre- and post-
   examination procedures.
3. For certain EQA Schemes, the permission of the participant may be required before the records of performance
   are made available to users.
4. Mechanisms may include exchange of samples and preparations such as slides and digital images between
   laboratories.
CROSS REFERENCES
• ISO 15189:2007 5.6 Assuring the quality of examination processes


                                                                    UK NEQAS FOR H&I AND EFI ACCREDITATION

26.     UK NEQAS FOR H&I AND EXTERNAL PROFICIENCY TESTING (EPT) REQUIREMENTS FOR
        EUROPEAN FEDERATION FOR IMMUNOGENETICS (EFI) ACCREDITATION

EFI have formally stated that our Schemes are acceptable as appropriate external quality assessment/external
proficiency testing schemes for laboratories applying for or renewing EFI Accreditation.

UK NEQAS for H&I will continue to work to ensure it complies with EFI Accreditation requirements for EPT.




                                                           37
27.        UK NEQAS for H&I dates for 2011
             Distribution           Result deadline            Scheme report (week beginning) Meetings (unconfirmed)

January      11th 1A01 & 1A02/11    26th 1A01 & 1A02/11
             11th 2A01 & 2A02/11    26th 2A01 & 2A02/11

             18th 1B01 & 1B02/11

             25th 2B01 & 2B02/11



February     8th 4A101-4A105/11     9th 1B01 & 1B02/11         21st 1A01 & 1A02/11            Steering Committee

             8th 4B01-4B05/11       9th 2B01 & 2B02/11         21st 2A01 & 2A02/11

             8th 5A101-5A105/11

             8th 5B01 & 5B02/11
             15th 301-306/11

             15th ED01 & ED02/11



March        1st 601-610/11         9th 4A101-4A105/11         7th 1B01 & 1B02/11             UK NQAAP

             1st 801-803/11         9th 4B01-4B05/11           7th 2B01 & 2B02/11
             8th 1A03 & 1A04/11     9th 5A101-5A105/11
             8th 2A03 & 2A04/11     9th 5B01 & 5B02/11
             15th 1B03 & 1B04/11    23rd 1A03 & 1A04/11

             29th 2B03 & 2B04/11    23rd 2A03 & 2A04/11

                                    30th ED01 & ED02/11



April        12th 4A201-4A205/11    6th 1B03 & 1B04/11         4th 5A101-5A105/11

             12th 701-705/11        13th 2B03 & 2B04/11        18th 1A03 & 1A04/11
                                    13th 801-803/11            18th 2A03 & 2A04/11

                                    27th 601-610/11            11th 4A101-4A105/11

                                    27th 701-705/11            11th 4B01-4B05/11

                                                               25th 5B01 & 5B02/11



May          10th 1A05 & 1A06/11    4th 301-306/11             2nd 1B03 & 1B04/11

             10th 2A05 & 2A06/11    25th 1A05 & 1A06/11        2nd ED01 & ED02/11

             17th 1B05 & 1B06/11    25th 2A05 & 2A06/11        9th 2B03 & 2B04/11

             24th 2B05 & 2B06/11    25th 4A201-4A205/11        16th 801-803/11

                                                               23rd 701-705/11



June         7th 4A105-4A110/11     8th 1B05 & 1B06/11         6th 601-610/11                 Steering Committee

             7th 4B05-4B10/11       8th 2B05 & 2B06/11         20th 1A05 & 1A06/11

             7th 5A106-5A110/11                                20th 2A05 & 2A06/11

             7th 5B03 & 5B04/11                                13th 301-306/11
             14th 307-312/11                                   27th 4A201-4A205/11

             14th ED03 & ED04/11

             21st 611-620/11

             21st 804-806/11



July         5th 1A07 & 1A08/11     6th 4A105-4A110/11         4th 1B05 & 1B06/11

             5th 2A07 & 2A08/11     6th 4B05-4B10/11           4th 2B05 & 2B06/11
             12th 1B07 & 1B08/11    6th 5A106-5A110/11
             19th 2B07 & 2B08/11    6th 5B03 & 5B04/11

                                    20th 1A07 & 1A08/11

                                    20th 2A07 & 2A08/11

                                    27th ED03 & ED04/11




                                                          38
26.         UK NEQAS for H&I dates for 2010 (continued)

               Distribution          Result deadline            Scheme report (week beginning) Meetings (unconfirmed)

August                               3rd 1B07 & 1B08/11         15th 1A07 & 1A08/11

                                     3rd 2B07 & 2B08/11         15th 2A07 & 2A08/11
                                     3rd 804-806/11             8th 4A105-4A110/11

                                     17th 611-620/11            8th 4B05-4B10/11

                                     24th 307-312/11            1st 5A106-5A110/11

                                                                22nd 5B03 & 5B04/11

                                                                29th 1B07 & 1B08/11

                                                                29th 2B07 & 2B08/11

                                                                29th ED03 & ED04/11



September      6th 4A206-4A210/11    21st 706-710/11            5th 804-806/11                 UK NQAAP

               6th 706-710/11        28th 1A09 & 1A10/11        26th 611-620/11
               13th 1A09 & 1A10/11   28th 2A09 & 2A10/11
               13th 2A09 & 2A10/11
               20th 1B09 & 1B10/11

               27th 2B09 & 2B10/11



October                              12th 1B09 & 1B10/11        3rd 307-312/11                 Steering Committee

                                     12th 2B09 & 2B10/11        24th 1A09 & 1A10/11

                                     19th 4A206-4A210/11        24th 2A09 & 2A10/11            Steering Committee

                                                                17th 706-710/11



November                                                        7th 1B09 & 1B10/11             UK NEQAS CONSORTIUM

                                                                7th 2B09 & 2B10/11

                                                                21st 4A206-4A210/11



December                                                                                       AGM




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