Aims of and participation in the scheme

The aims of all UK NEQAS Schemes are primarily educational. Provision of identical samples to all participating laboratories allows inter-laboratory comparison and also identifies the overall level of performance within the UK. Corrective action taken as a result of unsatisfactory performance can lead to an improvement in proficiency within an individual laboratory. Learning from others through reports of exercises, leads to an improvement within the UK as a whole. By linking results with techniques and procedures, specific strengths and weaknesses can be identified, driving change. National guidelines are reinforced and the need for new guidelines identified.

EQA forms an essential part of quality assurance within a laboratory and provides evidence of individual laboratory performance. However, it gives only a snapshot of a laboratory’s performance at any given time and the information reported back is inevitably a retrospective view. It should be undertaken in addition to, not in place of, other quality assurance measures.

Unlike EQA results in many other disciplines, blood group serology results are not a matter of consensus, and target values are not assigned as the result of statistical analysis. The results are analysed on the basis of whether they agree with the ‘true’ result based on testing in-house and by the supplier of the material. EQA is primarily intended to identify problems with systems, techniques, processes and procedures, and although the technical and interpretative skills of the person performing the test inevitably influence the results submitted (at least where testing is manual or only partially automated), EQA does not replace the need for continued operator competency assessment.

Participation in an appropriate, accredited EQA Scheme is a requirement of accreditation to the ISO15189 standard.

Scope and frequency of tests offered
  • ABO Grouping
  • D grouping
  • Antibody detection
  • Antibody identification
  • Crossmatching
  • Red cell phenotyping
Scheme design

There are four major exercises per year, coded ‘R’, covering all routine aspects of blood group serology. In addition, a further six exercises are issued, coded ‘E’, covering antibody detection and identification only. UK participants are expected to participate in all ten exercises if they routinely undertake antibody screening and/or antibody identification. There are a few specialist departments that only undertake ABO/D typing, and these participate in only the four ‘R’ coded exercises. Non-UK participants may elect to participate in the four ‘R’ coded exercises only. Exercises are numbered sequentially from 1 to 10, prefixed with the last two digits of the year and E or R as appropriate, e.g. 14R1, 14E2, refer to the first two exercises in 2014.

Participants receive a schedule of the survey despatch dates at registration or annual re-registration. The schedule is also published on the website. Any significant changes to the schedule are highlighted on the website and participants informed by email. If you are in the UK and the exercise material has not been received within three days after the published distribution date, you should phone the Scheme for advice. Laboratories outside of the UK should contact the scheme if the exercise material has not been received within four days after the published distribution date, or within the delivery limits quoted by the courier.

EXERCISE FORMAT
  • Major ‘R’ coded exercises (four per annum) comprise:
    • Three ‘patient’ whole blood samples* for ABO and D typing, and DAT if required.
    • Three ‘patient’ plasma samples** for antibody screening, antibody identification and crossmatching.
    • Three ‘donor’ red cell samples for crossmatching and red cell phenotyping.

Whole blood samples are unsuitable for antibody screening, identification, auto control crossmatching, or phenotyping, unless indicated otherwise in the instructions. For this reason, theoretical ‘patient’ phenotypes are provided on the instruction sheet, unless the exercise format states otherwise.

Plasma samples are assumed, for the purposes of the exercise, to be from the same ‘patient’ as the corresponding whole blood sample. However, these may not always match in every respect including ABO, and it is important that they are only used for the tests indicated in the instructions and on the sample labels. It also makes them unsuitable to use as an auto control.

  • Antibody screen/identification ‘E’ coded exercises (six per annum) comprise:
    • Four ‘patient’ plasma samples for antibody screening and antibody identification.

Limited demographic details may be included with the exercise, such as age and gender, in which case these should be taken into account for interpretation of blood grouping results, and for issue of red cells.

Steering Committee

The Scheme is advised by a Steering Committee. The Committee comprises scientific and clinical members and the membership is ratified by the UK NEQAS Executive Committee. The Chairman is independent of UK NEQAS operational issues, and is currently Dr Peter Baker, Blood Transfusion Laboratory Manager, Royal Liverpool University Hospital, L7 8XP. https://www.ukneqasbtlp.org/btlpsteeringcommittee

Scope and Tests Offered

There are four exercises per year for D typing. Exercises are given a 5-digit code derived from the last two digits of the year, followed by R, a single-digit number, and a B; e.g. 14R4B.

The participating organisation receives a schedule of the survey despatch dates at registration or annual re-registration. The schedule is also published on the UK NEQAS website. Any significant changes to the schedule are highlighted on the website and participants informed by email. If the exercise material has not been received within three days after the published distribution date, please phone the Scheme for advice.

New registrations and amendments to existing registrations

Once authorised by the POCT organisation, details of new registrations or amendments to the details of existing participants are forwarded to UK NEQAS using the standard form provided.

The form is returned to the organisation by UK NEQAS confirming that the request has been authorised and implemented, and in the case of new registrations the completed form includes the PRN and other login details required for result submission.

Following an exploratory pilot exercise in 2009 which demonstrated wide variation in practice and results, the ABO titration pilot scheme was launched in 2010 and became a full UK NEQAS Scheme in April 2017. The main aim is to assess practice and improve standardisation in centres undertaking ABO titration to support ABO incompatible (ABOi) solid organ transplant, where titration results influence decisions regarding acceptance of patients to the ABOi transplant programme and suitability for transplant.

The scheme distributes plasma representing patient samples for titration, and red cells to titrate against. A ‘Standard’ technique (using BioRad (DiaMed) gel technology) has been developed as a tool to investigate variation in results and to achieve standardisation across centres. Participants are asked to submit results for the ‘Standard’ technique alongside their in-house technique where possible.

Tests Offered
  • ABO antibody titration
  • Occasional A1 typing (not currently assessed)
Samples and schedule

Each exercise contains 3 plasma samples to be titrated vs. the red cell sample provided. Additional samples may occasionally be included for A1 typing. All donations used to prepare plasma and red cell samples have been tested and found negative for HIV, HBV, HCV, HTLV, and Syphilis.

There are four distributions per year, with a 14 day period to complete testing and submit results.

Data entry / reporting

Data entry and reporting is via this website. Exercise reports include the participant’s own results and summary data for the exercise (medians and range by method and technology). An annual report will be issued with collated data and discussion of the results. An example report can be found here.

Scoring / Assessment

Scoring is applied to results obtained by the ‘Standard’ indirect antiglobulin (IAT) and ‘Standard’ direct agglutination at room temperature (DRT) techniques (and other techniques with >=20 participating laboratories).

Results with a titration value greater than one doubling dilution from the median result for that technique are scored. One penalty point is given for each result more than one doubling dilution away from the target (method median), e.g. if the target were 32, then one point would be incurred for a result of 8 or 128, two points for 4 or 256, three points for 2 or 512 etc. Penalty scores remain active for three exercises.

Performance monitoring (for UK laboratories only) is based on these scores and on return of results.

Availability to new participants

The Scheme is open to laboratories worldwide supporting ABOi solid organ transplant programmes, and also to those performing ABO titration for other clinical reasons. New participants can register their interest by emailing the scheme at [email protected] An information pack including a registration form, schedule and fee sheet will be emailed back.

Full details can be found in the participants’ manual.

Overview

The UK NEQAS red cell genotyping pilot scheme was launched in 2016, following a pre-pilot project in collaboration with ISBT in 2014/15, where one of the outcomes was recognition that EQA for ‘routine’ red cell genotyping would be useful. A UK NEQAS pilot scheme comprising four exercises per year was launched in 2016/17 and will continue for 2018/19 in the same format, with the aim of becoming a full UK NEQAS EQA Scheme in 2019/20. Future development of the Scheme will be undertaken with help from our scientific advisory group (current membership can be viewed at https://www.ukneqash.org/btlpsteeringcommittee).

Tests Offered

Genotype and predicted phenotype for D, Cc, Ee, MN, Ss, Kk, Fya, Fyb, Fy, Jka, Jkb, Doa and Dob. Each exercise comprises two whole blood samples representing samples from haemoglobinopathy patients referred for genotyping to facilitate transfusion support, and instructions for testing and reporting.

Distribution

Exercise packages are dispatched by first class post within the UK and by courier (DHL) to non-UK participants. On each distribution day, an email is sent confirming that the exercise has been dispatched.

Reporting

Data entry of results is via the UK NEQAS Haematology and Transfusion website https://www.ukneqasbtlp.org The responses (genotype and predicted phenotype) are presented as tickbox selections, using ISBT terminology. There is an ‘other’ option, for use only if is not be possible to select an option in ISBT terminology that represents the result obtained. If the result would be reported to clinicians in different terminology, this can be specified in a supplementary question in each section. A link to a table with ISBT terminology for common alleles is provided. Assessment is by comparison of each participant’s result vs. the consensus result for each allele. In the event of there not being clear consensus on a result, this will be investigated before reporting, and participants’ results reviewed in light of any further information. No scoring or performance monitoring will be applied whilst the scheme remains in the pilot phase. Reports include assessment of individual results, an indication of overall results for the exercise and a discussion. During the pilot phase whilst dedicated IT for analysis is under development, it is anticipated that reporting will take between 6 and 10 weeks.

Availability to new participants

Participation from UK and non-UK laboratories undertaking red cell genotyping is welcomed. New participants can register their interest by emailing the scheme at [email protected] An information pack including a registration form, schedule and fee sheet will be emailed back, along with answers to any specific questions.

Scope and frequency of the tests offered
Tests
  • Screening for FMH by acid elution or flow cytometry (fetal cells detected and quantification triggered)
  • Quantification of FMH in mL
    • by acid elution
    • by flow cytometry

Additional Information collected for performance monitoring for laboratories registered for acid elution

  • Initial dose of anti-D suggested
  • Referral for flow cytometry

The additional information is used to determine whether the participant would place a woman at risk of sensitisation to the D antigen in a similar clinical situation.

The Scheme distributes 12 samples per year, currently two samples six times per year.

Participants receive a schedule of the survey despatch dates at registration or annual re-registration. The schedule is also published on the website. Any changes to the schedule are highlighted on the website and participants informed by email.

Survey format

Each survey includes two whole blood samples coded to denote the year, survey and patient identity. Other forms of material, e.g. unfixed films, may be distributed on a trial basis during the year.

Questionnaires

Questionnaires regarding FMH related procedures may be issued periodically. It is extremely important that these are completed and returned so that significant associations between performance and procedures can be established and the analysis returned to participants.

Assigned values, assessment system and penalty scoring

You can find details about our assessment system and penalty scoring in the BTLP Participants' manual

Overview

The UK NEQAS BTLP antenatal antibody titration scheme (ANT) was launched in April 2018 to provide assessment for laboratories monitoring red cell antibodies in pregnancy by titration, to predict outcomes and the need for clinical interventions. The annual exercise cycle comprises four exercises. Future development of the Scheme will be undertaken with direction from the BTLP ABO Titration scientific advisory group whose remit is being expanded to cover antenatal antibody titration.

Tests Offered

Titration of red cell antibodies implicated in HDFN. Each exercise comprises one plasma sample for titration, representing a maternal sample from a woman with red cell antibodies, and accompanying questions on follow-up procedures based on the titration results obtained. Instructions for testing and reporting are provided with each exercise.

Distribution

Exercise packages are dispatched by first class post within the UK and by courier (DHL) to non-UK participants. On each distribution day, an email is sent confirming that the exercise has been dispatched.

Reporting

Data entry and reporting is via this website. Exercise reports include the participant’s own results and summary data for the exercise. During the pilot phase, until there is dedicated IT for analysis, it is anticipated that reporting will take between 4 and 6 weeks.
No scoring or performance monitoring will be applied whilst the scheme remains in the pilot phase.

Availability to new participants

Participation from UK and non-UK laboratories undertaking antenatal antibody titration is welcomed. New participants can register their interest by emailing the scheme at [email protected] An information pack including a registration form, schedule and fee sheet will be emailed back.

Overview

The UK NEQAS DAT pilot scheme was launched in 2015/16 with limited participation and the initial aim of establishing stability of the samples. The DAT pilot was opened to all participants in 2017/18 and has four distributions per year.

Tests Offered


Direct Antiglobulin Test (DAT)
Each exercise comprises two samples of red cells suspended in Alsever’s solution at a concentration (7-10%) for preparation as appropriate for the DAT technology in use.
There is no clinical context associated with the DAT exercises. Participants are requested to investigate the samples in the same way as clinical samples where a DAT is requested, i.e. initial and any follow-up DAT testing.
There is the facility to report results of testing with polyspecific AHG, anti-IgG and anti-C3d.

Distribution

Exercise packages are dispatched by first class post within the UK and by courier (DHL) to non-UK participants. The DAT exercises coincide with PTT ‘R’ coded exercises and, where laboratories are registered for both, these form part of the same delivery. On each distribution day, an email is sent confirming that the exercise has been dispatched.

Reporting

Data entry of results is via the UK NEQAS Haematology and Transfusion website https://www.ukneqasbtlp.org
Assessment is by comparison of each participant’s result vs. the expected result determined by the supplier of the material (NHSBT Reagents) and our in-house testing. No scoring or performance monitoring will be applied whilst the scheme remains in the pilot phase.
Reports include assessment of individual results, an indication of overall results for the exercise and a discussion, and are available via the UK NEQAS Haematology and Transfusion website. During the pilot phase whilst dedicated IT for analysis is under development, it is anticipated that reporting will take between 6 and 10 weeks.

Availability to new participants

Participation from UK and non-UK laboratories is welcomed. New participants can register their interest by emailing the scheme at [email protected] An information pack including a registration form, schedule and fee sheet will be emailed back, along with answers to any specific questions.

Overview

The UK NEQAS BTLP extended red cell phenotyping scheme was launched in April 2018 to provide more comprehensive assessment for laboratories phenotyping for a range of red cell antigens. The annual exercise cycle comprises four exercises. Future development of the Scheme will be undertaken with direction from the BTLP steering committee (current membership can be viewed on https://www.ukneqasbtlp.org/btlpsteeringcommittee).
A leaflet with information can be found by clicking here.

Tests Offered

Serological phenotyping for D, Cc, Ee, MN, Ss, Kk, Fya, Fyb, Fy, Jka, Jkb. Each exercise comprises two red cell samples (20-30% in Alsever’s solution) representing samples from previously untransfused patients that require phenotyping to facilitate long term transfusion support. Instructions for testing and reporting are provided with each exercise.

Distribution

Exercise packages are dispatched by first class post within the UK and by courier (DHL) to non-UK participants. On each distribution day, an email is sent confirming that the exercise has been dispatched.

Reporting

Data entry and reporting is via this website. Exercise reports include the participant’s own results and summary data for the exercise. During the pilot phase, until there is dedicated IT for analysis, it is anticipated that reporting will take between 4 and 6 weeks.
No scoring or performance monitoring will be applied whilst the scheme remains in the pilot phase.

Availability to new participants

Participation from UK and non-UK laboratories undertaking red cell phenotyping is welcomed. New participants can register their interest by emailing the scheme at [email protected] An information pack including a registration form, schedule and fee sheet will be emailed back.

PO Box 133, Watford, WD18 0WP
+44 (0) 1923 217933
+44 (0) 1923 217934
[email protected]
[email protected]
http://www.ukneqasbtlp.org/btlp.php

You should have received an annual schedule at registration or re-registration. A schedule can also be found on the UK NEQAS Haematology and Transfusion website at https://www.ukneqash.org/schedule

If they haven’t arrived by three days after the published distribution date (4 days for non-UK participants), you should phone the Scheme for advice.

Results for the Pre-Transfusion Testing and FMH Schemes can still be analysed until the reports have been published on the web. However, a non-return report will be sent in the first instance and will be replaced by a late-return report a week later. Late results do attract 50 penalty points and the testing must have been performed on or before the closing date, as we cannot guarantee the integrity of the samples after the closing date. If in doubt, contact the Scheme. This does not apply to the ABO Titration Scheme, where late results are not accepted.

Neither the adult red cells nor the cord cells are stable enough to allow us to extend the closing date further. The adult cells become crenated and make interpreting the film more difficult and the cord cells appear to become fragile and may be selectively destroyed by the preparation process for testing by flow cytometry. The steering Committee feels that it is entirely appropriate that the EQA samples are dealt within the usual turnaround times for clinical samples.

Phone the Scheme on 01923 217933 to request a repeat sample. You will be asked for your PRN and the reason for your request.

You can request a password re-set on-line by going to https://www.ukneqash.org/auth/login, entering your Lab Code / PRN or email and your Identity in the text boxes provided then clicking on the Reset your password” button. You should be presented with message stating your password reset link has been sent successfully and receive an email within a few minutes. If you do not receive the password reset email please check your junk mail folder.

To give increased security to users, each identity and password belongs to a named contact and not to an institution. It may be that the login that the laboratory is using belongs to an individual that is no longer listed as a UK NEQAS contact. When a contact is no longer registered with us, their login is inactivated.

All contacts can edit their own information and change their own passwords on-line, and main contacts can also create, remove and edit contact details: Login to www.ukneqasbtlp.org, located on the top on the website should be your initials. With your mouse hover over this to reveal a drop down menu, then select “contacts”. You should now see a list of contacts with their names and contact types. To create a new contact, click on “Create new contact” (right hand side of the page) and follow the prompts.

Given that there is only one correct result for each test, we recommend that laboratories do not have two separate registrations. We recommend that you subject one analyser to EQA and use daily IQC to assure that both are giving the same results. Alternatively, where the two analysers employ different processes, the EQA exercises can be alternated between the two, or half the samples tested on the first analyser and the other half on the second. The same approach can be used for manual testing.

Your laboratory is not registered for phenotyping and you should contact the Scheme by email to request a change in registration.

Error scores cumulate over three consecutive exercises and the graphs display penalty scores for both the current exercise (shown by the open circle) and cumulative performance (closed circle).

There is no requirement to go through a process of exclusion for antibodies to antigens of low frequency and/or of low clinical significance, with either EQA or clinical samples, so they are not listed as specificities in the ‘specificities that cannot be excluded’ section. E.g. if the Jkb antigen masks Lua on the panel, additional cells and techniques do not need to be used to exclude anti-Lua in the presence of anti-Jkb; you should not say that an antibody has been ‘positively identified’ if it is totally masked by another, as in this example. Again, using the example of anti-Jkb, if one Jk(b-) cell gives a positive reaction, and the specificity cannot not be assigned using additional cells or techniques, a UI submission should be made (there is a separate form for this), which can include specifying that an antibody to a low frequency antigen cannot be excluded.

Yes, registration certificates are available on-line for the main BTLP Pre-transfusion Testing and FMH Schemes. These currently demonstrate registration but not participation or performance: Login to www.ukneqasbtlp.org. On the top hand right corner find the drop down menu with your initials next to it and click on the initials and choose certificates. Click the Get certificate button on the relevant PRN and organisation. A PDF file will be downloaded to your computer. You can use the Search box find a particular certificate.