HISTOCOMPATIBILITY. and IMMUNOGENETICS. Prospectus

Transcription

1 HISTOCOMPATIBILITY and IMMUNOGENETICS Prospectus 2014

2 CONTENTS Page 1. Distribution Timetable 2 2. Confidentiality 2 3. Participation Registration Service s Expectations Guidance on Participation Bespoke Schemes Laboratory Performance Reports and Tables Charges for Participation 5 4. UK NEQAS for H&I Assessment and Performance Principles 5 5. Nomenclature 6 6. Scheme 1A - HLA Phenotyping 7 7. Scheme 1B - HLA-B27 Testing 9 8. Scheme 2A - Cytotoxic Crossmatching Scheme 2B - Crossmatching by Flow Cytometry Scheme 3 - HLA Antibody Specificity Analysis Scheme 4A1 DNA HLA Typing at 1 st Field Resolution Scheme 4A2 DNA HLA Typing to 2 nd Field Resolution Scheme 4B - ABO Grouping by DNA-based Methods Scheme 5A - HFE Typing Scheme 5B Interpretative: HFE Genotype and Hereditary Haemochromatosis Scheme 6 HLA Antibody Detection Scheme 7 HLA-B*57:01 Typing for Drug Hypersensitivity Scheme 8 HLA and Disease Typing for HLA-DR/DQ/DP only Educational Scheme Essential Scheme Information UK NEQAS for H&I Steering Group Prospectus HLA Nomenclature Test Material UK National Quality Assurance Advisory Panel (UK NQAAP) Annual Participants Meeting Endorsement by UK NEQAS for H&I Scheme Review and Pilot Schemes Procedure for the Handling of Complaints from Participants Appeals Against an Assessment Non-Analytical Errors Correspondence with Participants Policy on Testing Returned Scheme s Material Acceptance of Participants Results Contact with UK NEQAS for H&I List of Contact Names and Addresses Joint Working Group for Quality Assurance Guidelines for Participants CPA Accreditation and EQA Performance UK NEQAS for H&I and European Federation for Immunogenetics (EFI) Accreditation UK NEQAS for H&I Dates 36 1

3 PROSPECTUS DISTRIBUTION TIMETABLE Scheme 1A Scheme 1B Scheme 2B Scheme 3 Scheme 4A1/4B Scheme 4A2 Scheme 8 Scheme 2A Scheme 6 Scheme 5A Scheme 7 Educational Scheme Scheme 5B 21 January 7 January 14 January 28 January 11 February 18 February 11 February 25 March 4 March 11 March 13 May 20 May 3 June 24 June 17 June 10 June 17 June 15 July 8 July 1 July 16 September 9 September 23 September Scheme 1A - HLA Phenotyping Scheme 1B - HLA-B27 Testing Scheme 2A - Cytotoxic Crossmatching Scheme 2B - Crossmatching by Flow Cytometry Scheme 3 - HLA Antibody Specificity Analysis Scheme 4A1 DNA HLA Typing at 1 st Field Resolution Scheme 4A2 DNA HLA Typing to 2 nd Field Resolution Scheme 4B - ABO Grouping by DNA-based methods Scheme 5A - HFE Typing Scheme 5B Interpretative: HFE Genotype and Hereditary Haemochromatosis Scheme 6 HLA Antibody Detection Scheme 7 HLA-B*57:01 Typing for Drug Hypersensitivity Scheme 8 HLA and Disease Typing for HLA-DR/DQ/DP only Educational Scheme samples and Interpretive Scenarios 2. CONFIDENTIALITY Laboratory code information is known only to the Schemes Director, Manager and UK NEQAS for H&I staff. Laboratory identifiers and performance information are confidential and will not be released to a third party without the written permission of the Head of the participating laboratory. However, for UK laboratories, unsatisfactory performance will be notified to the Chairman and Members of the UK National Quality Assurance Advisory Panel (UK NQAAP) for Immunology and laboratories may be identified to the Chairman of the Joint Working Group for Quality Assurance (JWG) (see Section 23). UK laboratories identified to UK NQAAP for Immunology regarding Scheme 5A will also be identified to the UK NQAAP for Clinical Cytogenetics and Molecular Genetics. 3. PARTICIPATION 3.1 REGISTRATION Registration forms are provided before the commencement of the UK NEQAS for H&I year. By signing these registration forms you agree to abide by the JWG Conditions of EQA Scheme Participation (Section 23) Guidelines (UK laboratories only) and the list of Service Expectations below. You also agree to pay the fees and any agreed courier charges in a timely manner. 3.2 SERVICE S EXPECTATIONS Our commitment to UK NEQAS for H&I Participants we will: Respect your confidentiality Despatch samples according to the published timetable Accurately maintain our contact database Not give participant information to anyone (except as detailed in the Prospectus) Provide you with all the information for you to fully participate in our schemes Provide schemes at cost and will not make a profit Rectify assessment errors in a timely fashion Resolve disputes in an impartial and professional manner Willingly provide advice on all scheme issues Endeavour to comply with EFI EPT Standards for Providers 2

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

5 In view of the increasing complexities of HLA typing methods, strategies and services the following guidelines are intended to help laboratories in their decision to participate in Scheme 1A (HLA Phenotyping) and/or Schemes 4A1/4A2 (DNA HLA Typing). Scheme 1A is aimed at laboratories undertaking HLA-A, B, C, DR, DQ typing or any combination of these, by serology. Participants must only register to be assessed on those loci tested using serological methods. The Steering Committee acknowledges that many laboratories use supplementary techniques to aid in the definition and refinement of HLA specificities detected by serology. Reporting and assessment must use HLA specificity nomenclature. Based on previous years practice there will ordinarily be an expectation that the broad HLA specificities, e.g., B15, B40, DR3 and DQ3 will be subdivided into their component split specificities. Schemes 4A1/4A2 (DNA HLA typing) will be performed by laboratories that undertake DNA based typing and, typically, might routinely perform a combination of 1 st field typing (formerly known as low resolution or 2-digit typing) and 1 st and 2 nd field typing (formerly known as high resolution or 4-digit typing). For example, 1 st field HLA-A, and B typing and 1 st and 2 nd field DRB1 typing. For this reason it is possible to register for any combination of HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1 and DQB1 for 1 st field typing or 1 st and 2 nd field typing and DPB1 for 2 nd field typing and provide data for DPA1 for comparison purposes. Registrants for 1 st field typing can also sign up for reporting merely the presence of DRB3/4/5. The European Federation for Immunogenetics (EFI) STANDARDS FOR HISTOCOMPATIBILITY & IMMUNOGENETICS TESTING version 6.1, D - HLA ALLELES AND ANTIGENS, Standard D1.4 states: High resolution typing is defined as the identification of HLA alleles that encode the same protein sequence within the antigen binding site. HLA alleles must be identified at the level of resolution which defines the first and second fields according to WHO nomenclature by at least resolving all ambiguities: resulting from polymorphisms located within exons 2 and 3 for HLA class I loci, and exon 2 for HLA class II loci that encompass a null allele, wherever the polymorphism is located, unless it can be demonstrated that an expressed antigen is present on the cells. It is expected that laboratories that register for HLA typing to the 2 nd field will have developed a strategy to comply with this Standard with regard to the recognition of null alleles. The following Table provides a guide to HLA typing practices and the most applicable HLA typing schemes. HLA typing practice Scheme(s) Serology 1A Serology with 1 st field DNA typing 1A or 1A and 4A1 1 st field DNA typing 4A1 Combination of 1 st field and 2 nd field DNA typing 4A1 and 4A2 2 nd field DNA typing 4A2 PARTICIPATION IN SCHEME 3 (HLA ANTIBODY SPECIFICITY ANALYSIS) AND SCHEME 6 ( HLA ANTIBODY DETECTION) Most H & I laboratories provide a service for testing of patients sera for the presence of antibodies directed towards HLA-class I (A, B, C) or class I and class II (DR, DQ, DP) specificities. This may be within the context of solid organ or haematopoietic stem cell transplantation, provision of blood products or the investigation of a clinical condition, e.g. thrombocytopaenia. Many laboratories undertake this service using a two-tier system. The first stage antibody detection determines which sera should be selected for the comprehensive second stage antibody specificity assignment. Both stages are equally important since failure to detect the presence of antibodies during screening will obviously deny that serum the benefit of the often more comprehensive testing associated with antibody specification. However, where numerous patients sera are tested an effective two-stage system can significantly reduce laboratory workload thus allowing more resources to be applied to the important antibody specificity assignment stage. The test sera supplied in Scheme 6 (HLA Antibody Detection) may or may not contain HLA antibodies directed towards HLA-class I and/or class II specificities. The purpose of this Scheme is to assess the laboratory s ability to undertake the initial screening process which places individual patients sera into the no HLA antibodies detected category or HLA antibodies probably present requires further analysis category. The method(s) used should be those routinely employed by the laboratory for antibody testing. 4

6 For Scheme 3 (HLA Specificity Analysis) sera are provided that are known to contain antibodies directed towards HLA-class I and/or class II specificities. The purpose of this Scheme is to assess the laboratory s ability to determine the component HLA specificity or specificities in the antisera using all methods the laboratory employs for clinical samples. PARTICIPATION IN SCHEME 7 HLA-B*57:01 TYPING FOR DRUG HYPERSENSITIVITY Pharmacogenetics, generally accepted as the study, or clinical testing, of genetic variation that gives rise to differing responses to drugs, is increasingly being applied to the prospective testing of patients for HLA-B*57:01 who are to be treated with the antiretroviral drug abacavir. Thus, a strong association exists between HLA-B*57:01 and the development of drug hypersensitivity reactions to abacavir. This scheme tests participants ability to define HLA-B*57:01 using the method(s) they employ for routine clinical service HLA-B*57:01 testing. PARTICIPATION IN SCHEME 8 HLA AND DISEASE TYPING FOR HLA-DR/DQ/DP ONLY This scheme, which uses selected DNA extracts, is aimed at laboratories that provide a service as an aid to the diagnosis of certain HLA Class II-associated diseases, e.g. actinic prurigo, coeliac disease and narcolepsy. 3.4 BESPOKE SCHEMES UK NEQAS for H&I is able to provide specific EQA schemes for certain HLA and HFE alleles Bespoke schemes will use selected stored DNA from samples previously tested in UK NEQAS for H&I s Schemes. Consequently, these samples are considered as well-documented reference material. Provision of a bespoke scheme also applies to HLA antibody detection and/or specification. A further use of bespoke schemes is fulfilling the requirements of EFI Standard C6.4 If a laboratory's performance in EPT programme(s) is unsatisfactory in any category for which EFI accreditation is sought, the laboratory must: participate in an additional EPT programme in that category and document the Director s review and any corrective action taken. Due to the nature of Scheme 2A - Cytotoxic Crossmatching and Scheme 2B - Crossmatching by Flow Cytometry, UK NEQAS for H&I are normally unable to supply additional sera/blood samples for these Schemes. Requests for a bespoke scheme, giving full details of requirements, should be made to: Deborah Singleton (Schemes Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: ; Fax: ; [email protected]). 3.5 LABORATORY PERFORMANCE REPORTS AND TABLES Individual laboratory performance reports and performance tables will be posted to participants. Results summaries may be downloaded from the website: Excel spreadsheets of Scheme 3 results are available on request from: [email protected] 3.6 CHARGES FOR PARTICIPATION These are shown on the insert sheet. For further information please contact: Deborah Singleton, Schemes Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: ; Fax: ; [email protected]). 4. UK NEQAS FOR H&I ASSESSMENT AND PERFORMANCE PRINCIPLES This information should be read in conjunction with each Scheme s ASSESSMENT and SATISFACTORY PERFORMANCE sections. Scheme assessment and satisfactory performance criteria are reviewed by the Steering Committee each year and take into account current EFI EPT Standards for Providers established by the EFI EPT Committee. Proposed changes in Schemes assessment and/or the determination of satisfactory performance are brought to the UK NQAAP for Immunology for ratification. For all Schemes, except Scheme 5B - Interpretative: HFE Genotype and Hereditary Haemochromatosis, 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. 5

7 The general consensus level for assignments is 75%, thus assignments reaching a 75% or greater agreement between participants will be assessed while those of <75% agreement are not assessed. Scheme 3 - HLA Antibody Specificity Analysis - also uses a 95% consensus level for the absence of an HLA specificity. The actual assessment procedure is detailed for each scheme under Assessment Procedure. In general reporting a consensus assignment is considered as Acceptable Performance while reporting a non-consensus assignment is considered Unacceptable Performance. Satisfactory performance is generally based on achieving a specified number of sample (patient) reports in agreement with consensus assignments in a calendar year. Satisfactory performance levels are set according to those established by EFI (minimum performance standards) or greater. For Schemes involving the assignment of a single HLA specificity/allele, an ABO group or an HFE type the Satisfactory Performance level is set at achieving all the correct consensus assignments in all samples supplied during one calendar year. For other schemes, some leniency regarding full compliance with consensus assignments is allowed (detailed for each scheme under Satisfactory Performance ). Laboratories not achieving Satisfactory Performance will receive written notification of their Unsatisfactory Performance status, as soon as it occurs, and will be expected to detail their reasons for their performance together with any corrective actions within 20 working days of the date of the Unsatisfactory Performance notification. Note: this does not apply to Interpretative Schemes, e.g. Scheme 5B. All UK laboratories receiving Unsatisfactory Performance notification are reported to UK NQAAP for Immunology. Failure to reply within 20 working days of the date of an Unsatisfactory Performance notification or replies deemed unsatisfactory will be specifically reported to UK NQAAP for Immunology who may take further action. 5. NOMENCLATURE Participants are requested to report their findings using the correct nomenclature relevant to the methodology used. The most recently published FULL WHO Nomenclature Report will be taken as the reference baseline nomenclature; i.e. participants will be expected to report their findings in accord with this report as a minimum. HLA Nomenclature Reports and HLA Dictionary are available from: In addition, the Steering Committee has considered the reporting of HLA alleles and has formulated the following convention for reporting groups of alleles: Please use the published up-to-date HLA nomenclature, see above. Please report alleles fully, e.g. DRB4*01:02-01:03 and not as DRB4*01:02-03 which may be interpreted as DRB4*01:02-01:03 or as DRB4*01:02-03:01. Groups of alleles should be reported as allele x / allele y, where / means or, e.g. DRB1*01:01/01:02/01:04 means DRB1*01:01 or DRB1*01:02 or DRB1*01:04. Groups of alleles that include sequential allele numbers may be reported as allele x - allele y, where - means to, e.g. DRB1*15:01-15:04 means that the allele in question could be any of the alleles between DRB1*15:01 to DRB1*15:04 inclusive, i.e. DRB1*15:01 or DRB1*15:02 or DRB1*15:03 or DRB1*15:04. Please report DRB5*, DRB3* and DRB4* and not their serological equivalents, i.e. DR51, DR52 and DR53. 6

8 SCHEME 1A 6. SCHEME 1A HLA PHENOTYPING PURPOSE To assess participants ability to use serological and supplementary methods to correctly identify HLA specificities. 6.1 SAMPLES A total of ten blood samples will be sent each year as five distributions of two blood samples. 6.2 REPORTING Depending on their typing strategies participants may register for HLA Class I typing only or for HLA Class I and II typing Participants must only register to be assessed on those loci tested using serological methods Participants must make a report for each HLA locus for which they have registered It is acknowledged that many laboratories use supplementary techniques to confirm serological HLA specificity assignment The report should detail the HLA phenotype using official WHO HLA specificity nomenclature Reports should be made at the split specificity level, where appropriate, using the results of the serological typing and any typing performed using supplementary techniques Participants must only use the reporting forms provided Participants are required to make their report within 10 days. 6.3 ASSESSMENT Participants will be assessed on the HLA loci contained in the phenotype, for which they are registered The consensus complete HLA phenotype for assessment is determined by at least 75% of laboratories agreeing each specificity Specificities failing to reach the 75% consensus level will not be assessed A "blank" forms part of the assessment if at least 75% of laboratories report a single specificity at a locus Assessment Procedure Each complete HLA phenotype in agreement with the consensus phenotype Each complete HLA phenotype not in agreement with the consensus phenotype Acceptable Unacceptable Each sample report of a not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is obtaining nine or more complete HLA phenotypes in agreement with the consensus phenotypes in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 7

9 SCHEME 1A 6.5 INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported specificities and supplementary information Information on methodology Performance information on the current and previous year s samples for all laboratories. 8

10 SCHEME 1B 7. SCHEME 1B - HLA-B27 TESTING PURPOSE To assess participants ability to correctly determine HLA-B27/B2708/B*27 status. 7.1 SAMPLES A total of ten blood samples will be sent each year as five distributions of two blood samples. 7.2 REPORTING Participants are required to report on HLA-B27/B2708/B*27 positivity or negativity Participants must only use the reporting forms provided Participants are required to make their report within 21 days. 7.3 ASSESSMENT The HLA-B27 status of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of HLA-B Samples failing to reach the 75% consensus level will not be assessed Assessment Procedure Each sample report in agreement with the consensus HLA-B27 status Each sample report not in agreement with the consensus HLA-B27 status Acceptable Unacceptable Each sample not reported, e.g. an equivocal or not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is making ten sample reports in agreement with the consensus HLA-B27 status in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 7.5 INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS The HLA type of the donor samples Summary sheets of all reported HLA-B27 results Information on methodology Performance information on the current and previous year s samples for all laboratories. 9

11 SCHEME 2A 8. SCHEME 2A - CYTOTOXIC CROSSMATCHING PURPOSE To assess participants ability to correctly determine cell/serum cytotoxic crossmatch status. The Steering Committee acknowledges that this crossmatching scheme will only partially emulate current crossmatching practice. NEW FOR 2014 Participants are invited to submit results obtained after dithiothreitol treatment. 8.1 SAMPLES 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 Each set of four sera must be tested against its corresponding blood sample Participants may test peripheral blood lymphocytes PBL/T-cells and/or B-cells, according to their local practice Participants may additionally submit results for PBL/T-cells and B-cells after dithiothreitol treatment. 8.2 REPORTING At registration participants may opt for PBL/T-cell and/or B-cell crossmatch assessment Test results should be reported as positive or negative using established local criteria Tests reported as weakly positive will be interpreted as positive for assessment purposes Tests reported as equivocal will not be assessed Participants are requested to report reaction strength, using their own scoring system, to enable comparison between laboratories Participants must only use the reporting forms provided Participants are required to make their report within 10 days. 8.3 ASSESSMENT The crossmatch status of each sample is determined by at least 75% of laboratories agreeing on the positivity or negativity of each test Crossmatching tests failing to reach the 75% consensus level will not be assessed PBL/T-cell and B-cell results are considered independently Assessment Procedure A result in agreement with the consensus findings A result not in agreement with the consensus findings Acceptable Unacceptable Each sample not reported, e.g. an equivocal, void or not tested result see PBL/T-cell and B-cell results obtained after the dithiothreitol treatment are considered independently. 10

12 8.3.6 The results obtained after the dithiothreitol treatment will not be subject to the performance criteria in 2014 and will be formally assessed in 2015 SCHEME 2A 8.4 SATISFACTORY PERFORMANCE Satisfactory performance is making 85% of reports on all sera in agreement with the consensus findings in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology 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 The HLA phenotype of the donor and specificities of the sera A summary sheet of all crossmatching results Performance information on the current and previous year s samples Performance information (non-assessed) on hidden replicate sera. 11

13 SCHEME 2B 9. SCHEME 2B - CROSSMATCHING BY FLOW CYTOMETRY PURPOSE To assess participants ability to correctly determine cell/serum flow cytometry crossmatch status. The Steering Committee acknowledges that this crossmatching scheme will only partially emulate current crossmatching practice. 9.1 SAMPLES 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 Each set of four sera must be tested against its corresponding blood sample for IgG antibody binding. 9.2 REPORTING At registration participants may opt for T-cell and/or B-cell crossmatch assessment Test results should be reported as positive or negative compared to the local negative control Tests reported as weakly positive will be interpreted as positive for assessment purposes Tests reported as equivocal will not be assessed Participants must only use the reporting forms provided Participants are required to make their report within 10 days. 9.3 ASSESSMENT The crossmatch status of each sample is determined by at least 75% of laboratories agreeing on the positivity or negativity of each test Crossmatching tests failing to reach the 75% consensus level will not be assessed T-cell and B-cell results will be considered independently Assessment Procedure A result in agreement with the consensus findings A result not in agreement with the consensus findings Acceptable Unacceptable Each sample not reported, e.g. an equivocal, void or not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is making 85% of reports on all sera in agreement with the consensus findings in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 12

14 SCHEME 2B 9.5 INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS The HLA phenotype of the donor and the specificity of the sera A summary sheet of all reported crossmatching results Performance information on the current and previous year s samples for all laboratories Performance information (non-assessed) on hidden replicate sera A methodology questionnaire will be sent out at the end of each year. The information obtained will be summarised and distributed to participants. 13

15 SCHEME SCHEME 3 - HLA ANTIBODY SPECIFICITY ANALYSIS PURPOSE To assess participants ability to correctly determine HLA antibody specificities SAMPLES A total of ten serum samples will be sent each year as two distributions of five samples. Volumes of approximately 1.5ml of serum will be distributed REPORTING At registration participants may opt for Class I only or Class I and Class II antibody assessment Only those specificities detailed on the reporting forms will be assessed, e.g. reports of anti-a9, Bw4 and Bw6 will not be assessed Participants may report other antibody findings, e.g. DPB, DQA and MICA. These specificities will not be assessed in Participants must only use the reporting forms provided Participants are required to report antibody specificities within a period of 10 weeks ASSESSMENT Class I and Class II IgG specificities will be assessed independently Consensus presence of a specificity is determined by at least 75% of laboratories agreeing the specificity Consensus absence of a specificity is determined by at least 95% of laboratories agreeing the absence of the specificity Results failing to reach the consensus levels above will not be assessed Assessment Procedure Assigning a consensus specificity Missing a consensus specificity Assigning a specificity where the consensus is negative Acceptable Unacceptable Unacceptable Each sample report of a not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is testing ten serum samples and getting at least 75% of specificities in agreement with the consensus findings in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 14

16 SCHEME INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Where known, the HLA phenotypes of the serum donors Summary sheets of all reported antibody findings Information on methodology Performance information on the current and previous year s samples for all laboratories. 15

17 SCHEME 4A1 11. SCHEME 4A1 DNA HLA TYPING AT 1 ST FIELD RESOLUTION PURPOSE To assess participants ability to correctly determine HLA alleles at the 1 st field level (formerly known as low resolution or 2-digit typing) SAMPLES A total of ten blood samples will be sent each year as two distributions of five blood samples REPORTING Participants may register for any of the following: HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, and DPA1 for 1 st field assessment, or presence of assessment for DRB3, DRB4 and, DRB5. DPA1 results will be assessed if sufficient results are received Participants must only use the reporting forms provided Participants are required to return results within 4 weeks ASSESSMENT Participating laboratories will be assessed on the loci they designate at registration The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele Alleles failing to reach the 75% consensus level will not be assessed A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus Participants will only be assessed on those alleles that appear in the most recently published full HLA Nomenclature Report Assessment Procedure Each full HLA genotype in agreement with the consensus 1st field type Each full HLA genotype not in agreement with the consensus 1st field type Acceptable Unacceptable Each sample report of a not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is obtaining nine or more full HLA genotypes in agreement with the consensus genotypes in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported alleles Information on methodology. 16

18 Performance information on the current and previous year s samples for all laboratories. 17

19 SCHEME 4A2 12. SCHEME 4A2 DNA HLA TYPING TO 2 ND FIELD RESOLUTION PURPOSE To assess participants ability to correctly determine HLA alleles to the 2 nd field level (formerly known as high resolution or 4-digit typing) SAMPLES A total of ten blood samples will be sent each year as two distributions of five blood samples REPORTING For typing to the 2 nd 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 Participants registered for 2 nd field assessment should define all ambiguities that encompass a null allele wherever the polymorphism is located (see statement on EFI Standard D1.4 page 4) Participants may register for any of the following: HLA-A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, DPA1 and DPB1, for 2 nd field assessment Participants must only use the reporting forms provided Participants are required to return results within 6 weeks ASSESSMENT Participating laboratories will be assessed on the loci they designate at registration The consensus full HLA genotype is determined by at least 75% of laboratories agreeing each allele Alleles failing to reach the 75% consensus level will not be assessed A "blank" forms part of the assessment if at least 75% of laboratories report a single allele at a locus Participants will only be assessed on those alleles that appear in the most recently published full HLA Nomenclature Report Assessment Procedure Each full HLA genotype in agreement with the consensus 1st & 2nd field type Each full HLA genotype not in agreement with the consensus 1st & 2nd field type Acceptable Unacceptable Each sample report of a not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is obtaining nine or more full HLA genotypes in agreement with the consensus genotypes in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 18

20 SCHEME 4A INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported alleles Information on methodology Performance information on the current and previous year s samples for all laboratories 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 Participants reporting strings of alleles containing null alleles will be notified. 19

21 SCHEME 4B 13. SCHEME 4B - ABO GROUPING BY DNA-BASED METHODS PURPOSE To assess participants ability to correctly determine ABO blood groups by DNA-based methods SAMPLES Laboratories performing ABO grouping by DNA-based methods, e.g. PCR-SSP, are invited to ABO group all samples from Scheme 4A REPORTING The ABO alleles detected should be reported as fully as possible, using the appropriate nomenclature Participants must only use the reporting forms provided Participants are required to return results within 4 weeks ASSESSMENT The consensus ABO genotype of each sample is determined by at least 75% of the participating laboratories agreeing the genotype Genotypes failing to reach the 75% consensus level will not be assessed Assessment Procedure Each sample report in agreement with the consensus ABO genotype Each sample report not in agreement with the consensus ABO genotype Acceptable Unacceptable Each sample report of not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is making ten sample reports in agreement with the consensus ABO genotype in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported ABO genotypes Information on methodology 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. 20

22 SCHEME 5A 14. SCHEME 5A HFE TYPING PURPOSE To assess participants ability to correctly determine HFE mutations SAMPLES A total of ten blood samples will be sent each year as two distributions of five blood samples REPORTING All samples must be tested for the H63D (Hist63Asp) mutation and the C282Y (Cys282Tyr) mutation of the HFE gene Participants may register to have their Ser65Cys results assessed 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 Participants are requested to report any other HFE gene mutations that they detect for participant information purposes Participants must only use the reporting forms provided Participants are required to return results within 4 weeks ASSESSMENT 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 Mutations failing to reach the 75% consensus level will not be assessed Assessment Procedure Each sample report in agreement with the consensus H63D and C282Y and S65C status (if applicable) Each sample report not in agreement with the consensus H63D and C282Y and S65C status (if applicable) Acceptable Unacceptable Each sample not reported, e.g. an equivocal, partial or not tested result see SATISFACTORY PERFORMANCE 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 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 21

23 SCHEME 5A 14.5 INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS A summary sheet of all reported HFE codon 63, 65 and 282 assignments Information on methodology Performance information on the current and previous year s samples for all laboratories. 22

24 SCHEME 5B SCHEME 5B - INTERPRETATIVE: HFE GENOTYPE AND HEREDITARY HAEMOCHROMATOSIS PURPOSE To assess participants ability to make an accurate, clear and concise clinical report, appropriate for the range of clinical staff involved in a patient s care and treatment, given HFE genotype and other relevant clinical information CLINICAL SCENARIOS HFE genotype will be provided, together with various pieces of clinical information, on two patients twice a year REPORTING Participants are expected to make a report on each of the patient scenarios Reports must be written in English and must be identical in format to that used for routine clinical reporting Participants are required to return their reports within 4 weeks ASSESSMENT 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 Scoring Procedure Penalty points Each feature in agreement with an identified criterion 0 A principal agreed interpretative criterion not covered by the report up to 3 Other agreed interpretative criterion not covered by the report 1 Significant erroneous patient identifiers or other information errors in the report 1 (each error) NOTE: The Expert Assessors determine the principal and other interpretative criteria Assessment Procedure Each scenario where 50% or less of the possible penalty points is allocated Each scenario where more than 50% of the possible penalty points is allocated Acceptable Unacceptable 15.4 SATISFACTORY PERFORMANCE Satisfactory performance is obtaining 4 Acceptable classifications in a year. NOTE: Unsatisfactory Performance Notifications (see Prospectus, page 6) are NOT sent to participants of Interpretative Schemes INFORMATION / ANALYSIS PROVIDED TO PARTICIPANTS Each laboratory will receive an itemisation of interpretative points applicable to each clinical scenario indicating how their report coincided with the criteria identified A summary of all participants scores General comments from the Expert Assessors on each scenario. 23

25 SCHEME SCHEME 6 HLA ANTIBODY DETECTION PURPOSE To assess participants ability to correctly determine the presence of HLA antibodies SAMPLES 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 REPORTING At registration participants may opt for Class I only or Class I and Class II antibody assessment Participants are required to report the presence or absence of HLA Class I or HLA-Class I and Class II antibody Participants must only use the reporting forms provided Participants are required to return their results within 10 weeks ASSESSMENT Participating laboratories will be assessed on the antibody class or classes they designate at registration The consensus findings for Class I and Class II specificities are determined separately Consensus positivity or negativity of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of Class I or Class II antibody Samples failing to reach the 75% consensus level will not be assessed Assessment Procedure Each report in agreement with the consensus presence/absence of Class I or both Class I and Class II antibody (see and ) Each report not in agreement with the consensus presence/absence of Class I or both Class I and Class II antibody (see and ) Acceptable Unacceptable Each sample not reported, e.g. an equivocal or not tested result see The reports of participants registered for Class I and II assessment must be in agreement with the consensus Class I and Class II findings on a serum to achieve an Acceptable classification SATISFACTORY PERFORMANCE Satisfactory performance is making 80% of reports on all sera in agreement with the consensus Class I or both the consensus Class I and Class II antibody (see and above) findings in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology. 24

26 SCHEME INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported antibody findings Information on methodology Performance information on the current and previous year s samples for all laboratories. 25

27 SCHEME SCHEME 7 HLA-B*57:01 TYPING FOR DRUG HYPERSENSITIVITY PURPOSE To assess participants ability to correctly determine HLA-B*57:01 status SAMPLES A total of ten blood samples will be sent each year as two distributions of five blood samples REPORTING Participants are required to report on HLA-B*57:01 positivity or negativity Participants may report a B*57 - non-b*57:01 - allele for information purposes Participants that routinely test to the 1 st 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 Participants must only use the reporting forms provided Participants are required to return results within 10 days ASSESSMENT 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: Results failing to reach the 75% consensus level will not be assessed Assessment Procedure Each report in agreement with the consensus HLA-B*57:01 status Each report not in agreement with the consensus HLA-B*57:01 status Acceptable Unacceptable Each sample not reported, e.g. an equivocal or not tested result see SATISFACTORY PERFORMANCE Satisfactory performance is making ten sample reports in agreement with the consensus HLA-B*57:01 status in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported HLA-B*57 results Information on methodology Performance information on the current and previous year s samples for all laboratories. 26

28 SCHEME SCHEME 8 HLA AND DISEASE TYPING FOR HLA-DR/DQ/DP ONLY PURPOSE To assess participants ability to correctly determine HLA-DR/DQ/DP allele families/alleles SAMPLES A total of ten DNA preparations will be sent each year as two distributions of five DNA preparations These samples have been previously tested in Scheme 4A REPORTING Participants are required to report their HLA-DR and/or HLA-DQ and/or HLA-DP findings Participants must only use the reporting forms provided Participants are required to return results within 6 weeks ASSESSMENT Participating laboratories will be assessed on the loci typed for each sample Assessment will be at the 1 st or 2 nd field level appropriate to the individual participant s results for each locus and for each sample. DRB3/4/5 results at the presence or absence level will also be accepted The consensus genotype for each locus is previously determined by at least 75% of laboratories agreeing each allele or blank in Scheme 4A Reports of groups of alleles will be assessed at the allele family level Participants will only be assessed on those alleles that appear in the most recently published full HLA Nomenclature Report Assessment Procedure Each HLA locus in agreement with the 1 st or 2nd field consensus type (see ) Acceptable Each HLA locus not in agreement with 1 st or 2nd field the consensus type (see ) Unacceptable Each sample not reported see SATISFACTORY PERFORMANCE Satisfactory performance is obtaining nine or more full HLA genotypes in agreement with the consensus genotypes in a calendar year 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 For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS Summary sheets of all reported HLA-DR, DQ and DP results and the original HLA type derived from Scheme 4A2 testing Information on methodology Performance information on the current year s samples for all laboratories. 27

29 28

30 EDUCATIONAL SCHEME 19. EDUCATIONAL SCHEME PURPOSE To provide participants with a variety of interesting samples to test that offer a beneficial educational element. NEW FOR 2014 This scheme is expanded to include the distribution of clinical scenarios SAMPLES and CLINICAL SCENARIOS 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 A total of two clinical scenarios will be sent each year REPORTING Participants must only use the reporting forms provided Participants are required to report their findings within the deadline stated ASSESSMENT Not assessed SATISFACTORY PERFORMANCE Not applicable INFORMATION/ANALYSIS PROVIDED FOR PARTICIPANTS For samples, summary sheets of all reported findings and information on methodology will be issued after each distribution Relevant references will be supplied whenever possible For scenarios, a summary of all returns and comments and details of the most frequent responses will be issued after each distribution. 29

31 ESSENTIAL SCHEME INFORMATION 20. ESSENTIAL SCHEME INFORMATION 20.1 UK NEQAS FOR H&I UK NEQAS for H&I aims to provide a comprehensive range of EQA Schemes appropriate to laboratories operating clinical histocompatibility and immunogenetics support services. H&I laboratory support is universally required in both solid organ, e.g. renal, heart, and haematopoietic stem cell transplant programmes and for the provision of: (i) HLA typing as an aid to disease diagnosis, e.g. HLA-B27 and the spondyloarthropathies; (ii) unrelated haematopoietic stem cell donor panels and (iii) the provision of HLA matched blood products. The primary laboratory investigations are: (i) determination of HLA type; (ii) the detection and specification of antibodies directed towards HLA specificities and (iii) direct crossmatching of patients sera against donors lymphocytes. From time to time consideration may be given to Schemes that cover other aspects of clinical work performed in an H&I laboratory and not currently covered by other EQA Schemes. All Schemes are open to all UK NHS and Private Sector clinical laboratories and relevant reagent manufacturers. In addition, all Schemes are available to appropriate overseas laboratories. All participants are provided with details of participation, i.e. Joint Working Group for Quality Assurance Conditions of EQA Participation (see Section 23) STEERING GROUP The Schemes Director is advised by a Steering Committee, current members, the category of their membership and their contact details are listed in Section 22. The Steering Committee s constitution, including accountability, remit, composition, membership and finance are essentially as laid down in the UK NEQAS Executive s document Steering Committees latest revision, October 2004 (available from UK NEQAS). The Steering Committee meets three times a year and has a special meeting immediately after the UK NEQAS for H&I Participants Meeting 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 HLA NOMENCLATURE Nomenclature for HLA specificities and HLA alleles is complex and is continuously being reviewed and updated. The Scheme provides the website address of the latest full Nomenclature Report, HLA Dictionary and HLA Nomenclature Updates. Details of nomenclature reporting strategies for the Schemes are also provided (see Section 5) TEST MATERIAL Blood samples to be processed for mononuclear cells and/or DNA are usually taken from regular normal healthy blood donors, usually of north-western European extraction. Blood samples may be random (Schemes 1A, 2A, 2B, 4A and 4B) or selected (Scheme 8 and Educational Scheme) or a mixture of random and selected (Schemes 1B, 5A and 7). Serum samples obtained from parous women are used as a source of HLA antibodies. All material sent to participants is tested and found negative for the following disease markers: HIV, HBsAg, HCV and syphilis. HIV Ag-Ab, HBsAg and anti-hcv are tested for on the Bio-Rad Elite system; antibodies to Treponema pallidum (syphilis) is tested using TPHA (Olympus PK system). However, as with all biological material of this nature they should be considered as potentially hazardous. Handle with caution and apply accepted standards of Good Laboratory Practice. 30

32 ESSENTIAL SCHEME INFORMATION Whole blood samples used for the preparation of mononuclear cells and/or DNA are CPD-A1 blood donations. Blood samples required for mononuclear cell preparations are diluted with RPMI 1640 tissue culture medium containing tri-sodium citrate. DNA extracts provided will have their DNA concentrations indicated. Blood, DNA and serum samples are transported at ambient temperature and should be processed as soon as possible on receipt. Any samples should be treated and stored as clinical samples. It is important to ensure sample uniformity by carefully mixing each EQA sample. IMPORTANT: All sera distributed contain 0.01% sodium azide 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 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 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 SCHEME REVIEW AND PILOT SCHEMES The Schemes are reviewed annually by the Steering Committee and fully discussed at the Annual Participants Meeting. The Steering Committee consider comments from, for example, their members, participants, professional organisations and members of the discipline, regarding the nature and operation of Schemes and the establishment of new Schemes. The likely viability of possible new Schemes is assessed by, for example, discussion at the Annual Participants Meeting, questionnaires sent to participants and discussion at UK NQAAP for Immunology meetings 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: Deborah Singleton, Schemes Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: ; Fax: ; [email protected]). 31

33 ESSENTIAL SCHEME INFORMATION APPEALS AGAINST AN ASSESSMENT An appeal against an assessment, including any relevant laboratory evidence, should be made in writing to Deborah Singleton, Schemes Manager, UK NEQAS for H&I, Welsh Blood Service, Ely Valley Road, Talbot Green, Pontyclun CF72 9WB. Tel: ; Fax: ; 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 NON-ANALYTICAL ERRORS Non-analytical errors, e.g. clerical mistakes, are considered as part of the assessment procedure. Normally no allowance is made for these on appeal 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, s 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 POLICY ON TESTING RETURNED SCHEME S MATERIAL UK NEQAS for H&I has occasionally been asked to test Scheme s material returned by a Participant. In the past, this request has usually come from a laboratory that has been penalised and is questioning the validity of their findings or is questioning the proper labelling of Scheme s samples. UK NEQAS for H&I apply stringent procedures, fully detailed in Standard Operating Procedures, for the handling of all test material, e.g. whole blood and sera. For example, units of donor blood are fully processed one at a time. All other units of blood for subsequent processing remain in a secure cabinet while the complete procedure is performed on the single unit. Labelled samples from different units of blood only come together when material is being packed for distribution. Therefore, of necessity, UK NEQAS for H&I s practices for the collection, processing, aliquotting, labelling, packing and disposal of any remaining material and labels are such that it is not possible for blood samples to be mixed-up, disordered or incorrectly labelled. The UK NEQAS for H&I Steering Committee, at its October 2005 meeting, unanimously agreed that UK NEQAS for H&I should not normally retest returned Scheme s material. The Committee pointed out that returned material, whether in the primary container or not, may not be that originally dispatched and/or may have become contaminated. It also pointed out that Scheme s samples are normally tested by a minimum of some 20 laboratories and that their unanimously reported findings always provided the basis of sample assessment ACCEPTANCE OF PARTICIPANTS RESULTS Participants should make every effort to return their results on or before the deadline date indicated for a particular Scheme. Laboratory results will not be accepted for assessment or performance review once schemes results are published on the UK NEQAS for H&I website. 32

34 ESSENTIAL SCHEME INFORMATION 21. CONTACT WITH UK NEQAS for H&I A list of contact names and numbers is given in Section 22. For details of other UK National External Quality Assessment Services, please contact Julie Gelder (UK NEQAS Executive Manager/Company Secretary) or see: For queries relating to, e.g. participation fees, day-to-day organisation of UK NEQAS for H&I Schemes, participants contact changes, additional material/reagents, assessment clarification, assessment anomalies, copies of reports, please contact Deborah Singleton (Schemes Manager). To appeal against an assessment please put your case in writing to Deborah Singleton. To discuss any aspect of UK NEQAS for H&I please contact the Schemes Director, Manager or any other member of the Steering Committee who will be pleased to help. If you wish your views to be discussed by the Steering Committee Meeting please send your comments in writing to Deborah Singleton. Correspondence will normally be circulated only to the Steering Committee and the BSHI Representative to UK NQAAP for Immunology and will normally be anonymised before distribution. All contact, including letters and telephone calls with UK NEQAS for H&I is recorded in the Correspondence File. 33

35 22. LIST OF CONTACT NAMES AND ADDRESSES CONTACTS UK NEQAS Website UK NEQAS for H&I Website Mrs Jeanette Ayers Transplant Immunology Laboratory Steering Committee Member Oxford Transplant Centre Tel: Fax: Churchill Hospital OXFORD OX3 7LE Dr Alan Balfe Department of Clinical Biochemistry Lead Expert Advisor for Scheme 5B Central Pathology Laboratory, LabMed Directorate Tel: Fax: St James's Hospital [email protected] DUBLIN 8, Republic Of Ireland Miss Deborah Singleton Welsh Transplantation and Immunogenetics Laboratory Schemes Manager and Secretary Welsh Blood Service Tel: Fax: Ely Valley Road [email protected] Talbot Green [email protected] PONTYCLUN CF72 9WB Dr Chris Darke Welsh Transplantation and Immunogenetics Laboratory Schemes Director Welsh Blood Service Tel: Fax: Ely Valley Road [email protected] Talbot Green, PONTYCLUN CF72 9WB Mr Patrick Flynn The Transplantation Laboratory Steering Committee Member Manchester Royal Infirmary Tel: Fax: Oxford Road [email protected] MANCHESTER M13 9WL Mrs Julie Gelder UK NEQAS Central Office UK NEQAS Executive Manager/Company Secretary P.O. Box 401 Tel: Fax: SHEFFIELD S5 7YZ [email protected] Miss Carol Hardy West Midlands Regional Genetics Service Expert Advisor for Scheme 5B Birmingham Women s NHS Foundation Trust Tel: Fax: Mindelsohn Way, Edgbaston [email protected] BIRMINGHAM B15 2TG Dr Mark Hathaway Tissue Typing Laboratory Steering Committee Member NHS Blood and Transplant Tel: Fax: Vincent Drive [email protected] Edgbaston, BIRMINGHAM B15 2SG Dr Leigh Keen Histocompatibility & Immunogenetics Department Steering Committee Member NHS Blood and Transplant Tel: Fax: North Bristol Park [email protected] Northway, Filton, BRISTOL BS34 7QH Dr Helena Lee The Transplantation Laboratory BSHI Representative to UK NQAAP Manchester Royal Infirmary Tel: Fax: Oxford Road [email protected] MANCHESTER M13 9WL Dr Edwin Massey Associate Medical Director for Patient Services Clinical Representative NHS Blood and Transplant Tel: Fax: North Bristol Park [email protected] Northway, Filton, BRISTOL BS34 7QH Dr Fotini Partheniou Histocompatibility & Immunogenetics Steering Committee Member NHS Blood and Transplant Tel: Fax: Holland Drive, Barrack Road [email protected] Newcastle upon Tyne, TYNE & WEAR NE2 4NQ 34

36 CONTACTS Mrs Jennifer Pepperall Welsh Transplantation and Immunogenetics Laboratory Steering Committee Member Welsh Blood Service Tel: Fax: Ely Valley Road Talbot Green, PONTYCLUN CF72 9WB Dr Deborah Sage H&I Laboratory Steering Committee Chairman NHS Blood and Transplant Tooting Centre Tel: Fax: Cranmer Terrace LONDON SW17 0RB Ms Ruhena Sergeant Clinical Immunology Steering Committee Member H&I laboratory, Pathology G Block Tel: Fax: Hammersmith Hospital [email protected] LONDON W12 0HS Dr Gavin Willis Molecular Genetics Expert Advisor for Scheme 5B Norfolk and Norwich University Hospital Tel: Fax: Colney Lane [email protected] NORWICH NR4 7UY 35

37 JWG GUIDELINES 23. 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. 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

38 24. CLINICAL PATHOLOGY ACCREDITATION (UK) LTD (CPA) ACCREDITATION AND EQA PERFORMANCE 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 postexamination 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: Assuring the quality of examination processes UK NEQAS FOR H&I AND EFI ACCREDITATION 25. 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. Accordingly, UK NEQAS for H&I is included in the EFI Register of EPT Programs. UK NEQAS for H&I will continue to work to ensure it complies with EFI Accreditation requirements for EPT. 37

39 26. UK NEQAS for H&I dates for 2014 Distribution Result deadline Scheme report (week beginning) Meetings (unconfirmed) January 7th 1B01&1B02/14 26th 2B01&2B02/14 14th 2B01&2B02/14 21st 1A01&1A02/14 21st 2A01&2A02/14 28th 4A1/4B 01-05/14 28th 5A 01-05/14 28th 5B01& 5B02/14 30th 1B01&1B02/14 February 11th /14 2nd 1A01&1A02/14 10th 2B01&2B02/14 11th /14 2nd 2A01&2A02/14 17th 1B01&1B02/14 11th /14 27th 4A1/4B 01-05/14 17th 1A01&1A02/14 11th ED01&ED02/14 27th 5A 01-05/14 17th 2A01&2A02/14 Steering Committee 18th 4A /14 27th 5B01& 5B02/14 18th /14 March 4th 1B03&1B04/14 2nd /14 17th 5A 01-05/14 UK NQAAP 11th 2B03&2B04/14 23rd 2B03&2B04/14 17th /14 25th 1A03&1A04/14 27th 1B03&1B04/14 31st 4A1/4B 01-05/14 25th 2A03&2A04/14 27th /14 27th ED01&ED02/14 April 3rd 4A /14 7th 2B03&2B04/14 6th 1A03&1A04/14 7th 5B01& 5B02/14 6th 2A03&2A04/14 14th 1B03&1B04/14 24th /14 14th 5B01& 5B02/14 24th /14 21st 1A03&1A04/14 21st 2A03&2A04/14 21st ED01&ED02/14 21st /14 May 13th 1B05&1B06/14 5th 4A /14 20th 2B05&2B06/14 26th /14 June 3rd 1A05&1A06/14 1st 2B05&2B06/14 9th /14 Steering Committee 3rd 2A05&2A06/14 5th 1B05&1B06/14 16th 2B05&2B06/14 UK NQAAP 10th 4A1/4B 06-10/14 15th 1A05&1A06/14 23rd 1B05&1B06/14 10th 5A06-5A10/14 15th 2A05&2A06/14 30th 1A05&1A06/14 10th 5B03&04/14 30th 2A05&2A06/14 17th /14 17th /14 17th /14 17th ED03&04/14 24th 1B07&1B08/14 July 1st 4A /14 10th 4A1/4B 06-10/14 28th 5A06-5A10/14 1st /14 10th 5A06-5A10/14 28th /14 8th 2B07&2B08/14 10th 5B03&5B04/14 15th 1A07&08/14 13th /14 15th 2A07&08/14 17th 1B07&1B08/14 20 th 2B07&2B08/14 27th 1A07&08/14 27 th 2A07&08/14 31st /14 31st ED03&04/14 38

40 26. UK NEQAS for H&I dates for 2014 (continued) Distribution Result deadline Scheme report (week beginning) Meetings (unconfirmed) August 14th 4A /14 4th 1B07&1B08/14 28th /14 28th /14 4th 2B07&2B08/14 11th 1A07&08/14 11th 2A07&08/14 11th 4A1/4B 06-10/14 September 9th 1B09&1B10/14 28th 1A09&1A10/14 1st 5B03&5B04/14 UK NQAAP 16th 1A09&1A10/14 28th 2A09&1A10/14 1st /14 16th 2A09&1A10/14 1st ED03&04/14 23rd 2B09&2B10/14 15th 4A /14 29th /14 October 2nd 1B09&1B10/14 13th 1A09&1A10/14 Steering Committee 5th 2B09&2B10/14 13th 2A09&1A10/14 13th /14 20th 1B09&1B10/14 20th 2B09&2B10/14 November UK NEQAS Consortium December Participants Meeting UK NQAAP 39