UK NEQAS for General Haematology Annual Report January ...eqasitalia.it/wp-content/uploads/2011/11/H-Annual-Report-10.pdf · Advisory Groups (SAGs), who all contribute their time

© UK NEQAS (H) 2011

UK NEQAS for General Haematology

Annual Report

January – December 2010

February 2011

Scheme Director: Professor Keith Hyde Scheme Manager: Mrs Barbara De la Salle

UK NEQAS (H) PO Box 14 Watford WD18 0FJ United Kingdom WEB version: Please note that this report is formatted for double sided printing.

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Contents

1. Executive Summary ............................................................................................ 5

2. Scheme Activities ............................................................................................... 7

3. CPA Accreditation ............................................................................................ 10

4. Audit of performance targets .......................................................................... 10

5. Summary of surveys distributed ..................................................................... 11

6. Digital Morphology ............................................................................................ 12

7. Pilot schemes .................................................................................................... 12

8. New Developments ........................................................................................... 13

9. Major changes: rules, scheme design and service provision ....................... 14

10. Annual meeting and communications with participants ............................... 16 Appendices – Scheme specific reports

Appendix 1: Automated Schemes report Appendix 2: Morphology and related Schemes report Appendix 3: Haemoglobinopathy Schemes report Appendix 4: Red Cell Enzymes Scheme report Appendix 5: Red Cell Volume Scheme report

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Executive Summary

This document reports the activity of UK NEQAS for General Haematology (UK NEQAS (H)) for the period January to December 2010. All data included in the report cover the period January – December 2010 unless otherwise stated.

The content of the report remains the copyright of UK NEQAS (H) and may only be published with the permission of the Scheme Director.

The Scheme acknowledges the major input of the members of the Steering Committee and Scientific Advisory Groups (SAGs), who all contribute their time and expertise to the improvement of UK NEQAS (H) services to participants.

Organisation and Quality Management The scheme was assessed, together with UK NEQAS BTLP and UK NEQAS FMH, by CPA in May 2010, resulting in 9 non-conformities and one observation. All the non- conformities have been cleared. The next scheduled accreditation inspection will be in 2012 and will be include a pre-assessment visit by UKAS in preparation for accreditation against the new ISO17043 standards. The scheme achieved its performance targets to March 2010, with the exception of meeting deadlines for return of reports. This will not be improved until all reports are returned electronically, which will occur in 2011. The Scheme did not achieve its target for distribution of surveys: one distribution was delayed due to problems with supply from NHSBT, as a result of bad weather. There are no outstanding quality problems with survey material quality, with the exception of the supply of particulate marrow slides.

Personnel The Executive Assistant and Database Specialist posts have been made permanent. Two band 6 EQA scientists have been appointed to cover expanded workload and the retirement of a senior scientist from full time work. Two part time posts have also been created: one senior scientist to undertake R&D and a haemoglobinopathy specialist post. The Scheme Director and Manager will undertake an internal review of staff structure in 2011 to ensure adequate succession planning.

Premises and environment The Scheme is located with UK NEQAS BTLP at Watford General Hospital. The host organisation, the West Herts Hospitals NHS Trust hosts the Schemes according to an annually reviewed Memorandum of Agreement.

Equipment, IT and materials Additional imaging equipment has been ordered for delivery early in 2011.

The Scheme replaced its flow cytometer early in 2010.

The transfer of all schemes to web based operation is near completion. There are some remaining problems around generating on-line reports for some schemes, but these are in hand. Re-registration will be done on-line in 2011.

Survey material remains a major challenge to the Scheme; the support of NHSBT is appreciated. The provision of cellular survey material to support EQA for new parameters at clinically significant analyte levels, in a format that resembles patient specimens, remains a major development item. The Scheme has undertaken preliminary work on an alternative stabilised material with a commercial partner.

Design and Organisation The Scheme has undertaken significant work on the development of pilot schemes for nucleated red cell counting and ESR; NRBC pilot scheme was introduced in 2010 and an ESR pilot scheme will be distributed in 2011.

The number of surveys in the Automated Differential Count, Reticulocyte and G6PD schemes increased from 4 to 6 annually in April 2010.

Major changes to the Abnormal Haemoglobins Scheme have been agreed with the Special SAG.

The Scheme has recruited new members to the Morphology, General and Special SAGs. Dr Adrian Copplestone has taken over as Chair of the Steering Committee, in place of Professor Sam Machin. Dr John Burthem has taken the position of Chair of the Morphology SAG, in place of Dr David Swirsky.

Scheme Operation Participant laboratory numbers declined slightly from March 2009 to March 2010, although the numbers of individual analysers and the number of POCT participants continued to grow.

The Digital Morphology CPD scheme continues to grow, with over 2000 UK participants in 150+ laboratories. Plans are in hand to roll this scheme out to non-UK participants. Work on a malaria learning resource is complete and has been demonstrated to participants.

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The Scheme continues to supply 6 month overall summary reports on participant performance in Abnormal Haemoglobins and Newborn Sickle Screening to the NHS Sickle and Thalassaemia Screening Programme.

Professor Barbara Bain and Dr John Parker-Williams have provided expert comment on the Blood Films reports, and Dr Keith Patterson has been recruited in addition.

Overall, performance of individual UK laboratories has not given any major causes for concern.

The report on Hb A2 measurement, commissioned from Sheffield Teaching Hospitals and supported by the NHS Sickle and Thalassaemia Programme, was published in 2010 and will be the focus of a discussion workshop with manufacturers, organised by the National Programme.

The Rapid Diagnostic Testing for Malaria Scheme, operated in collaboration with UK NEQAS for Parasitology, will be submitted for full scheme status in 2012.

The DNA Diagnostics for Haemoglobinopathies Scheme will be fully reviewed and work undertaken to develop performance monitoring.

Meetings and Communications The Scheme held a 2 day 13

th Annual Participants’ Symposium for 250 delegates in Birmingham October

2010 and has contributed to other meetings, user groups and significant external organisations.

The Scheme has drafted for publication a paper on thrombocytopenic platelet counting, for submission in 2011. Approximately 10 abstracts were accepted at national and international meetings; three were upgraded to oral presentations.

Professor Keith Hyde, Scheme Director Mrs Barbara De la Salle, Scheme Manager February 2011

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Scheme Activities for 2010

Location

The Scheme continues to occupy dedicated facilities on the Ground Floor of the Pathology Block at Watford General Hospital, which it shares with UK NEQAS BTLP and UK NEQAS FMH.

The Scheme acknowledges the support of its activities by the West Hertfordshire Hospitals NHS Trust.

Staffing

Mrs Anne Mahon, Senior Scientist, retired in September 2010 and then returned to work on a part-time basis in October, taking a new post created to undertake development work. The Scheme has appointed 2 band 6 staff: Miss Nikki Emodi started in August 2010 and Mrs Veronica Cofie in November 2010.

The Scheme has obtained permission to recruit a part-time (0.4 WTE) specialist haemoglobinopathy consultant. Dr Barbara Wild, the current chair of the Special Scientific Advisory Group, has been appointed to the post.

The position of database specialist, shared with UK NEQAS (BTLP) has been made permanent and Mr Vasilis Rapanakis appointed to the post.

Ms Kerri-Louise Canvin, Senior Administrative Assistant shared with UK NEQAS BTLP, went on maternity leave at the end of November 2010 and Mr Ken Grundy has been appointed in her place.

The Scheme Director is Professor Keith Hyde. The current scheme establishment supporting Professor Hyde is listed below. All are full time unless stated otherwise:

Scheme Manager and Deputy Director – Mrs Barbara De la Salle Scheme Deputy Manager and Data Manager – Mr Paul McTaggart Principal EQA Scientist and Morphology Lead – Mrs Zuotimi Eke Senior EQA Scientist – Dr Mary West (0.8WTE) Senior EQA Scientist (0.6WTE) – Mrs Anne Mahon Haemoglobinopathy Specialist Consultant (0.4WTE) – Dr Barbara Wild EQA Scientist – Miss Nikki Emodi EQA Scientist – Mrs Veronica Cofie Medical Laboratory Assistant – Mr James Hindell Database specialist (shared with UK NEQAS BTLP)

Logistics staff: Operations supervisor and 4 assistant staff (all shared with UK NEQAS BTLP)

Administrative staff: Executive Assistant, Senior Administrative Assistant, 2 Clerical Assistants (all shared with UK NEQAS BTLP).

IT and website

The information website has been maintained and extensively used throughout the year. The database specialist has started a redesign of the information website.

The scheme has worked with UK NEQAS BTLP and FMH to implement web-based participant re-registration for the participation period April 2011 – March 2012. This will be an in-house developed system, pending other wider changes within the UK NEQAS organisation.

The use of web based data return for the automated counting schemes continues at approximately 80% of participants. Web based return of results for Blood Films for Morphology, including manual differential counts, Blood Films for Parasite Identification, Cytochemistry, Red Cell Enzymes and Red Cell Volume is largely complete, although there remain some issues with on-line report return that are still to be resolved.

The on-line modules for the Abnormal Haemoglobins and Newborn Sickle Screening schemes have been written and the Abnormal Haemoglobins on-line data return will be tested in parallel for the February distribution.

Together with UK NEQAS for BTLP and FMH, the scheme has implemented an electronic client management system for logging participant calls and consequent actions.

Scheme Profile

The Scheme took a high profile role at the International Society for Laboratory Haematology meeting in Brighton in May 2010, including organising a successful a well attended exhibition stand; presenting 6 posters and 2 short oral presentations, and the scheme manager being an invited speaker on the main conference programme.

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Steering Committee

The Overarching General Haematology Steering Committee met in Birmingham on October 19 2010.

The Morphology SAG met in January 2010 in Manchester, including a preliminary meeting the day before to review and select blood film cases for the following year.

The General SAG met in March 2010 in London.

The Special SAG met in June 2010 in London.

A full list of Steering Committee and SAG members is available from the Scheme Office.

General Haematology SAG related activities

Collaborative work on the accuracy of platelet counting in thrombocytopenic specimens has continued. Data from thrombocytopenic specimens distributed since 2006 has been analysed and a draft paper prepared.

The frequency for Reticulocyte and ADLC surveys was changed from 4 per year each (quarterly) to 6 per year each (2 monthly) in April 2010.

The scheme received pilot funding from CPA to support the development of pilot schemes in NRBC counting and ESR.

The first pilot NRBC exercise was distributed in August 2010 using commercially prepared material and another is planned in early 2011. Further work on the development of an in-house survey material continues, as commercial material is not available for all analyser types.

Development work on survey material for an ESR pilot scheme. The most appropriate material seems to be donor whole blood with added waste myeloma plasma, obtained by plasmapheresis.

A full schedule of 4 distributions was made in the Blood Component Quality Monitoring Pilot scheme, with specimens at high Hb and platelet levels such as are found in blood components for transfusion.

The Scheme continues to operate 2 bespoke inter-laboratory EQA schemes, one for Quest Diagnostics clinical trials laboratories in collaboration with UK NEQAS for Clinical Chemistry, and another for 100 laboratories based in Ethiopia.

The number of POCT sites based in Mental Health Units and other nurse operated POCT units, participating in FBC and ADLC is greater than 180. The scheme has piloted an arrangement by which data is returned in a cumulative spreadsheet extracted directly from the POCT LIMS system.

The scheme has had initial discussions with a middleware company on the feasibility of direct data capture.

A Biomedical Scientist working in the Pathology Department at Watford General Hospital successfully completed his MSc project on the preparation of a survey material for the assessment of % hypochromasia. This information was presented at the Annual Participants’ meeting in October 2010.

A BSc student Biomedical Scientist from the Pathology Department at Watford General Hospital will undertake an undergraduate project to validate the performance of the ICSH Haemoglobin reference method in the Unit.

Nikki Emodi will undertake her MSc project on the external quality assessment of blood gas analysers in POCT haemoglobin measurement, in comparison to HemoCue instruments and large, laboratory analysers. This follows the SHOT 2009 report, which recommended this action.

A proposal for an MSc project on the EQA of MPV and RDW remains in preparation.

The Scheme undertook an initial pre-pilot exercise in Post analytical interpretation of analyser scatterplots, with other European EQA providers, in January 2010, followed by a full distribution to 76 UK laboratories in August 2010. The scheme was well received by participants and another distribution will be made in 2011. Participants will be recruited at re-registration 2011.

Special Haematology SAG related activities

The DNA Haemoglobinopathies pilot scheme made a distribution in 2010 using archive material. A prototype for the recruitment of new donors for the scheme is under review.

The Scheme has made some progress in the recruitment of a donor panel for Abnormal Haemoglobins survey material. A volunteer donor has been successfully bled and ‘steered’ through the NHSBT testing process. This will be pursued further in 2011, with the assistance of SAG members.

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The Scheme Manager continues to make 6 monthly reports to the National Sickle and Thalassaemia Screening Programme on participant performance.

The report on Hb A2 performance was completed by Hannah Batterbee and released to the National Programme in August 2010. A follow up workshop to discuss a way forward on Hb A2 standardisation has been arranged by the National Programme in February 2011, and will be attended by the Scheme Director and Manager.

The SSAG agreed to a major change in the Abnormal Haemoglobins scheme design, which will allow a better use of survey material. Two separate pools of survey material will be used, one for sickle screening and the other for fraction identification and quantitation. This change will be implemented at the February 2011 distribution.

The comment codes for Abnormal Haemoglobins and Newborn Sickle screening have been reviewed and updated.

The G6PD scheme changed from 4 distributions of 3 specimens to 6 distributions of 2 specimens per year in April 2010, allowing more frequent performance monitoring.

Defibrinated sheep blood has been used throughout 2010 for deficient G6PD survey material and the incidence of unsatisfactory specimen quality has been significantly reduced both in terms of clotted specimens and resistance to lysis.

Distribution of the ‘top tips’ sheet for successful performance of G6PD assays has been delayed pending comments from Professor Luzzatto. This will be given a further review before distribution.

Dr Adrian Stephens has resigned from the SSAG and his responsibility for G6PD has been taken up by Mr Martin Jarvis.

Morphology SAG related activities

The Digital Morphology CPD scheme continues to progress. Almost 2000 individual practitioners are registered with the scheme, in 150 UK laboratories. The scheme has engaged a marketing consultant to work with current non-UK agents and to explore new territories.

Zuotimi Eke gave an update on the progress of the scheme to the EQALM working group on virtual microscopy.

The malaria digital teaching resource has been completed by Dr John Burthem and the scheme is exploring the best means of delivery.

The scheme is supporting work on the review and organisation of the digital library resource held at the Manchester Royal Infirmary.

The UK NEQAS Research Associate working on the WHO supported photogallery and teaching programme is nearing the completion of the project, and has been offered a post-doctoral position to continue work on e-learning resources at Manchester Metropolitan University.

The Malaria Rapid Diagnostic Pilot scheme has continued throughout the year. Because of contradictory results with kits from different manufacturers, no reports were issued throughout the year, to allow the accumulation of a substantial body of data. This was issued as a single combined report in the first quarter of 2010.

Expert comments on the Blood and Parasite Films continues to be provided by Dr John Parker-Williams and Professor Barbara Bain. They have been joined by Dr Keith Patterson.

Dr David Swirsky resigned as Chair of the MSAG in 2010 as a result of ill-health and the position was taken by Dr John Burthem.

Representation on External Committees

The Scheme Director and Manager are members of a number of external, national and international committees, including the Laboratory Subgroup for the National Sickle and Thalassaemia Screening Programme, the Quality Assurance for Dried Blood Spot Screening Group, the UK PT Group, the BCSH General Haematology Task Force, the ICSH, the European Network for Rare and Congenital Anaemias (ENERCA) and European Quality Assurance in Laboratory Medicine (EQALM) organisation.

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CPA Accreditation

The UK NEQAS Centre at Watford General Hospital was assessed on May 18 – 20 2010. The visit covered all 3 schemes provided from the Unit (General Haematology, Blood Transfusion Laboratory Practice and Fetomaternal Haemorrhage). There were 9 non-conformities and one observation, all of which were cleared by November 2010.

The next full assessment visit will be in 2012 and will be undertaken by UKAS against ISO17043. Mrs Dalila Benkhaled (UK NEQAS BTLP staff) is currently working additional hours to complete a gap analysis to identify the additional work required to achieve the ISO17043 standards.

UK NEQAS (H) holds accreditation for the following schemes: Full Blood Count (022/0063) ADLC (022/0071) Reticulocyte counting (022/0065) Blood Films for Morphology and Parasite Identification (022/0064) Cytochemistry (022/0066) Abnormal Haemoglobins (022/0068) Newborn Sickle Screening (022/0280) Red cell enzymes (022/067) Red cell volume (022/0069) Vitamin B12 Absorption Tests (022/0070)

Audit of Performance Targets

Audit of Performance Targets: April 2009 – March 2010

The Scheme assesses performance against the performance targets listed in the Unit Quality Policy for the period April to March each year.

Distribution of survey specimens to schedule: This fell to 90% (target 100%) as a result of adverse weather in January 2010, which caused the NHSBT to be unable to supply donor blood for preparation of Abnormal Haemoglobins survey material. The 1001AH distribution was delayed by one month.

Physical integrity of specimens: Target achieved for all but G6PD sheep blood specimens. This was corrected during 2010.

Packing errors: These remain low, at less than 0.5%.

Specimen quality: Target achieved for most specimens distributed. The major problems remain:

1. Blood films unsatisfactory returns are higher than limit set but most of those reporting the slides as unsatisfactory still return results.

2. Bone marrow slides remain a problem – actions included in the quality improvement plan (QIP) for 2010.

3. G6PD survey material prepared from sheep blood had problems with clotting after distribution. This was included in the QIP for 2010 and has been resolved by the use of defibrinated blood.

Feedback to participants: Target achieved for return of web based reports (automated schemes, covering 80% of participant returns). There remained delays in the return of paper based reports, due to the need to obtain external expert comment or provide more detailed analysis. If this is required for just one report, then all the reports in that posting are delayed. It is anticipated that this will improve once web based reporting is available for all schemes.

Complaints: A total of 9 complaints were received in the year 2009 - 2010. Previous years totals were 12 (2008-2009) and 9 (2007-2008). Complaints covered a range of areas, there was no particular trend.

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Summary of surveys distributed

The total number of laboratories declined slightly in the year to March 2010. This was due to rationalisation of services. No single scheme suffered a greater decline than any other and in some cases (e.g. UK FBC participants) there was a modest increase, probably as a result of increased point of care testing provision.

Table 0-1. Number of Laboratories registered by Scheme – March 2010

Scheme FB DL RE AH G6 BF/PA HS SB NH RV

UK 608 530 319 304 157 369 180 60 26 34

Non-UK 406 247 162 124 69 175 26 23 4 0

Total 1014 777 481 428 226 544 206 83 30 34

Key; FB = Full Blood Count DL = Automated Differential Leucocyte Count (ADLC) RE = Reticulocyte Count AH = Abnormal Haemoglobins, Hb A2, Hb F & Hb S G6 = Red Cell Enzymes (G6PD) BF = Blood Films for Morphology PA = Blood Films for Parasite Identification HS = Cytochemistry (Haemosiderin) SB = Cytochemistry (Sudan Black/Myeloperoxidase) NH = Newborn Sickle Screening RV = Red Cell Volume Table 0-2. Participation by Laboratory Type

March 2010 March 2009 March 2008

NHS laboratories 366 378 408

NHS POCT 140 95 78

UK Private laboratories 122 122 127

UK Other laboratories 30 60 60

Non-UK laboratories 465 488 552

TOTAL 1123 1143 1225

Twelve main survey distributions were made during the year with separate distributions of some specialist surveys and pilot studies. Each distribution contained Full Blood Count specimens with other surveys distributed on a less frequent basis (4, 6 or 8 times per year). The annual distribution schedule is sent to all participants at re-registration.

Newborn sickle screening specimens were made on a monthly basis.

4 distributions of the blood component monitoring scheme were made.

1 distribution of the DNA Diagnostics for Haemoglobinopathies was made.

The detailed content of each survey distributed is included in the survey specific reports in Appendices 1 – 5. Examples of the reports for each accredited UK NEQAS (H) scheme are available from the Scheme Office.

Further details of the Scheme operation may be found in the Scheme Handbook, available to download from the Scheme website (www.ukneqash.org).

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Digital Morphology

Digital Morphology CPD Scheme

The Digital Morphology CPD Scheme was launched in April 2008. The scheme utilises large scale,

stitched ‘virtual slides’ prepared in collaboration with colleagues at Manchester Royal Infirmary and

distributed on the world wide web using commercial software, which has the functionality of a ‘virtual

microscope’. The scheme is designed for individuals rather than organisations but laboratory managers

can register a group of staff and manage their participation on-line. The scheme offers immediate

feedback in the form of annotations to the slide as soon as the participant has made their submission.

Further feedback on performance is given once the case has closed, when participants are able to

complete a reflective note and download a CPD certificate.

Over 2000 participants have registered in more than 150 UK laboratories. The scheme is working with

the software providers to establish a registration process for non-UK laboratories. The capacity and

robustness of the scheme will be increase in 2011 with the installation of additional imaging equipment.

The Chairman of the Morphology Scientific Advisory Group, Dr John Burthem, has completed a malaria

teaching resource for use on-line and the Scheme is looking at the most appropriate delivery mechanism

for this.

The following cases have been issued in 2010:

0906DM Acute myelomonocytic leukaemia

1001DM Primary polycythaemia with dimorphic erythrocyte populations

1002DM Myelofibrosis transforming to acute leukaemia with previous splenectomy

1003DM Hereditary pyropoikilocytosis

1004DM Hairy cell leukaemia

Pilot Schemes

RDT Malaria

This pilot scheme has been developed in collaboration with UK NEQAS for Parasitology.

Four surveys (2 specimens each) for Rapid Diagnostic Testing for Malaria have been distributed at the

same time as each Blood Films for Parasite Identification. These specimens are only distributed to

laboratories that have registered an interest in this pilot scheme.

A cumulative report on the 4 surveys distributed in 2009 was distributed early in 2010. The individual

reports were held back to allow a full review of data. This showed a different sensitivity of kits at varying

parasite load.

The scheme will go live in 2012.

DNA Diagnostics for Haemoglobinopathies

One distribution of 2 specimens was made in December 2009 (0901DN) using first 2 cell line cases

prepared at the National Genetics Laboratory in Manchester. A second distribution was made in 2010

(1001DN), using archive material. The report for survey 1001DN is in preparation.

The Scheme has developed a pack to assist with the recruitment of cases from additional sources. This

pack contains instructions, patient information, consent forms, specimen tubes, postage labels etc. and is

designed to minimise the amount of work for the clinician recruiting a patient. This pack is being reviewed

by members of the Special SAG.

Dr Barbara Wild has been recruited to the UK NEQAS (H) staff and is planning a review questionnaire on

the development of the Scheme, with the primary objective of developing performance monitoring.

The scheme acknowledges the essential support and expert advice of Professor Swee Lay Thein, Kings

College Hospital, London, in the operation of this pilot scheme.

FBC: Blood Component Quality Monitoring

Four distributions of the Blood Component Quality Monitoring Pilot were made in 2010. Each survey

contained 2 red cell specimens and 2 platelet specimens. Participants are asked to test the red cell

specimens for haemoglobin and haematocrit; the platelet specimens are for platelet counts at the levels

found in therapeutic platelet concentrates.

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The scheme continues to be supported by the NHSBT for its participant laboratories, the equivalent

organisations in Scotland, Wales and N. Ireland, and now attracts a small number of participants in

Europe.

A review meeting will be held in 2011 to decide on a system for performance monitoring and whether the

scheme will develop to a full scheme.

Nucleated RBC Counting

A pilot exercise using both commercial and in-house developed survey material was undertaken for

NRBC counting in 2009. The first distribution of the pilot scheme was made in August 2010 and another

is planned in February 2011. Funding from CPA (EQA) was obtained to support this pilot scheme.

Other Developments

ESR Pilot Scheme

In-house work and an initial pre-pilot exercise have been undertaken and initial surveys are planned for

2011. Funding from CPA (EQA) was obtained to support this pilot scheme.

Functional Iron Deficiency Parameters

A successful MSc project on the development of a material for the measurement of % hypochromasia

was undertaken by an MSc student working at Watford General Hospital and studying at Kingston

University. This work will be reviewed at the General SAG in March 2011.

MPV and RDW

The Scheme has started preliminary work on the preparation of a second proposal for an MSc project,

with a student working with a GSAG member, to look at the use of UK NEQAS FBC material for the

assessment of performance of MPV and RDW.

Survey Material Stabilisation

The Scheme has done some initial work with a commercial company on the stabilisation of material for

use in automated counting.

Hb measurement by Blood Gas Analysers in POCT

A member of Scheme staff is undertaking an MSc project to compare the performance of Hb

measurement on blood gas analysers in point of care testing compared to HemoCue analysers and large

laboratory analysers. This will form the basis of point of care Hb pilot scheme.

Hb A2 Performance Assessment

Following the initial work published in Hannah Batterbee’s report on Hb A2 measurement, the Scheme is

planning additional work on the factors that affect performance monitoring of this analyte.

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Major changes to rules and scheme design

Disclosure of performance

The Scheme Manager made 2 reports to the NHS Sickle and Thalassaemia Programme on the overall

performance of participants in England in the Haemoglobinopathy surveys for 2010. Data in these

reports are anonymised, although the Programme has expressed the wish to receive additional details

concerning participant identity. The Programme wrote to all laboratories within their remit, jointly with the

Scheme Director, to request them to complete a quarterly return to the Programme to identify any contact

between the Scheme and the participant concerning performance.

JWG Conditions of Participation

The Joint Working Group on Quality Assurance conditions of participation are available for all participants

from the JWG website. Participants are made aware of the Conditions at re-registration and agree that

by signing their re-registration form, they agree to these conditions.

FBC scheme

Instrument groupings in the FBC scheme are regularly reviewed. Given the changes in technology and

instruments available on the market, the names of the instrument groups will be reviewed and updated.

ADLC scheme

The frequency of this scheme was raised from 4 to 6 per year from April 2010, with 2 specimens per

distribution; the total number of specimens per annum has increased from 8 to 12. Matrix H was

withdrawn in December 2009 and has not been replaced with an alternative, as the number of

instruments using this matrix is in sharp decline. Matrix J was split so that the Sysmex XS instruments

are monitored as a separate group. The Cell Dyn 3500/3700 group is declining in numbers and will soon

become statistically non-viable.

Reticulocyte scheme


distribution; the total number of specimens per annum remains the same. All manual methods are to

reported together, with a removal of analysis by different stain type. The number of GenS analysers is

decreasing and this group will be retired in the near future.

Abnormal Haemoglobins

A major change to the Abnormal Haemoglobins scheme will be implemented in February 2011. This

change was agreed with the Special SAG in June 2010 and will coincide with implementation of web

entry for this scheme. Briefly, the scheme will be split into 2 sections: Emergency Sickle Screening and

Full Participation, with separate specimen pools for each part. Laboratories registered for Sickle

Screening only will receive only the emergency sickle screening specimens; those registered for Full

Participation will receive both the sickle screening and the full participation specimens.

This will allow better assessment of sickle screening performance using a different material pool from full

participation, and will allow laboratories registered for Full Participation to test specimens in the same way

as they would clinical material, for fraction identification, quantitation and interpretation. The scheme will

also gather the methods used for fraction identification. A major driver for this change is the need to

make best use of scarce survey material. Currently, approximately one third of laboratories are

registered for sickle screening only and they are supplied with material pools from specially recruited

donors or pools that have undergone extensive manipulation to alter quantities of component fractions.

The interpretative comment codes used in the scheme have been revised by the Special SAG members.

The NHS Sickle and Thalassaemia Screening Programme now asks laboratories within their

responsibility to report any contact from the Scheme concerning performance to be reported to them on a

quarterly basis. The Scheme continues to supply the Programme with a general 6 monthly report on

performance.

Newborn Sickle Screening

The interpretative comment codes used in the scheme have been revised by the Special SAG members.

The NHS Sickle and Thalassaemia Screening Programme now asks laboratories within their

responsibility to report any contact from the Scheme concerning performance to be reported to them on a

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quarterly basis. The Scheme continues to supply the Programme with a general 6 monthly report on

performance.

The dried blood spot survey material will be validated for use with capillary electrophoresis.

Blood Films for Morphology and Parasite Identification

The Scheme’s main expert advisors have reviewed and updated the coded comments used.

Rapid Diagnostic Testing for Malaria Pilot

Shadow performance monitoring will be developed in preparation for this scheme going live in 2012.

Cytochemistry

The manner of reporting results to the scheme is currently under review by the Scheme’s main expert

advisors, for reporting of both Iron Stains and Sudan Black B. As soon as the new format is agreed, this

will be implemented for web entry of results.

Manual Differential

The reporting of this scheme has also undergone revision. The format for reporting nucleated RBC (i.e.

absolute numbers or %) is under review, and additional categories (smear or unidentifiable cells, other

cells) added to the differential reports. Once these changes are agreed, they will be implemented for web

entry of results.

G6PD


distribution; the total number of specimens per annum remains the same.

Submitting results

From April 2011, all results entered on-line will be accepted for analysis, whether or not the ‘Submit’

command has been clicked. This will remove a major area of confusion for participants and a source of

erroneous non-participation penalties. You are still encouraged to ‘Submit’ once your results are

complete, as this will allow us to download results in batches before the closing date, if necessary.

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Annual Participants’ Symposium and other Communications Annual Participants’ Symposium

The 13th Annual Participants’ Symposium was held at the National Motorcycle Museum, Birmingham, on

October 19 and 20, 2010. The meeting was well attended by approximately 240 delegates. The theme

for the meeting Harmonisation in Haematology with a plenary address opened by Dr Ian Barnes, National

Director of Pathology. This was the first time that the meeting was held over 2 days, with half day

workshops on participants’ expectations on automated counting EQA and digital morphology on the first

day and a full scientific programme on the second day. A total of 94 evaluation forms were received from

delegates. Not all delegates attended all parts of the meeting and not all responded to all questions.

SECTION A: PROGRAMME EVALUATION

(Number of ticks)

Strongly Disagree

Disagree Agree Strongly

Agree

The programme was relevant to my

educational needs 1 1 69 21

The level of subject matter was good 1 2 71 20

Adequate time was given for discussion 1 8 56 28

The venue was good 1 2 43 46

The lecture facilities were good 1 0 50 44

The food provided was good 1 2 47 43

SECTION B: LECTURE /SESSION EVALUATION (Number of ticks for each lecture and session on a scale of 1-5, where 1 is the lowest (worst) score and 5 the highest (best) score) TUESDAY 19 OCTOBER 2010 - Afternoon Workshops

Workshop: Digital Morphology 1 2 3 4 5

Digital Morphology work-up 0 3 9 20 12

Malaria ‘wikipedia’ 0 0 6 13 25

Session Overall 0 0 8 20 16

Workshop: New Parameters 1 2 3 4 5

New Parameters EQA 0 2 9 17 4

The Clinical Relevance of MPV 0 1 9 18 3


WEDNESDAY 20 OCTOBER 2010

Morning Session

1 2 3 4 5

Harmonisation in Haematology 2 3 15 44 27

UK NEQAS Haematinics Assay 2 9 24 33 21

UK NEQAS Leucocyte Immunophenotyping 1 4 17 45 19


Afternoon Session

1 2 3 4 5

General Haematology: Automated Counting 0 5 20 50 15

Haemoglobinopathies: How is my laboratory performing? 1 8 23 42 12

Morphology: Digital Morphology Up-date and Developments

0 2 16 43 27


Page 16

The 2011 Participants’ Meeting will be held at York Racecourse on October 13. This will be a one day

meeting because of the proximity to the IBMS Congress and the theme will be ‘Maintaining Quality in the

Liberated NHS’.

Contribution to other meetings for participants

In addition to the main Participants’ Symposium, the scheme has been involved in other activities designed to update participants on scheme activities in 2010, including:

Presentation at the Menarini user group meeting (Barbara De la Salle). Presentation at the Sysmex user group meeting (Paul McTaggart). Presentation at the Siemens user group meeting (Barbara De la Salle and Paul McTaggart).

Other Feedback

CPA questionnaires showed overall satisfaction with Scheme performance.

The Scheme Director and Manager have proposed that the UK NEQAS organisation employs the skills of an external analyst to survey participants’ perceptions of the service supplied by UK NEQAS as a whole. This will inform Scheme practice and development. This suggestion has been adopted by the UK NEQAS Executive and will start in 2011.

The Digital Morphology CPD Scheme has developed a set of performance indicators with the software company that supports the scheme.

Complaints

The Scheme received 9 complaints in the year April 2009 – March 2010. There was no particular trend in these, most related to administrative issues.

Participants’ individual reports

The main mode of communication with participants is by individual performance reports.

Posters, publications and presentations

Posters and short papers i. BSH 2010: Short paper on Performance Assessment in Newborn Sickle

Screening. Posters on Hb A2 measurement, Digital Morphology, Hb measurement.

ii. ISLH 2010: Short papers on ‘UK NEQAS: 40 years of quality’, and Digital Morphology. Posters on Hb A2 measurement, Newborn Sickle Screening, Manual Differential Counting, Digital Morphology.

Publications Paper on Platelet counting in thrombocytopenic specimens drafted for publication.

ISLH 2010 meeting in Brighton, UK Barbara De la Salle was invited to speak on ‘POCT: a novel approach in a Mental Health Setting’.

EQALM 2010 meeting, Lisbon, Portugal i. Zuotimi Eke gave an update presentation on the Digital Morphology scheme

developments to the EQALM Virtual Microscopy Working Group. ii. Barbara De la Salle was invited to talk on ‘Discrepancies in Automated Counting

EQA’.

Page 17

General Haematology

Annual Report 2010 Appendix 1 - page 1

ANNUAL REPORT 2010 – APPENDIX 1

AUTOMATED COUNTING SCHEMES REPORT

Full Blood Count

List of analytes

WBC (109/L)

Hb (g/dL) RBC (10

12/L)

PCV (L/L) MCV (fL) MCH (pg) MCHC (g/dL) Platelets (10

9/L)

Blood Count Scheme participation

Table 1-1 shows the change in participants registered and Table 1-2 the numbers of instruments

registered in the different analyser groups, at the end of the last full participation year.

Table 1-1. Registration for Blood count

Laboratories Systems

Total UK Total UK

March 2008 1002 571 2117 1274

March 2009 1024 600 2249 1621

March 2010 1014 608 2257 1387

Table 1-2. Numbers of different analysers registered by group (excluding miscellaneous)

Instrument Group March 2010 March 2009

Total UK Total UK

Cell-Dyn 3000 Series 39 2 43 5

ABX Instruments 13 9 88 69

Coulter T Series 69 32 56 36

Coulter S Plus Series 326 175 383 228

Cell-Dyn 1600 & 1700 18 4 21 4

Cell-Dyn 4000 & Sapphire 59 24 65 47

ABX Pentra Series 206 145 108 87

Bayer ADVIA 120 297 151 298 160

HemoCue B-Hemoglobin 287 245 367 323

Cell-Dyn 3200 & Ruby 44 16 42 17

Sysmex SF3000 22 7 27 19

Sysmex K Series 72 44 70 55

Sysmex SE Series ~ ~ 9 0

Sysmex XE2100 369 255 361 271

Sysmex XT Series 139 92 137 75

Sysmex pocH-100i 194 168 180 137

The remaining instruments in the Sysmex SE group were transferred to the miscellaneous group

between April 2009 and March 2010.


Specimens distributed

Two specimens of partially fixed human whole blood were included in each of the twelve surveys

distributed in each year.

The range of all methods means for the main analytes that have been included for scoring has been as

follows:

Parameter Jan – Dec 2010 Jan – Dec 2009

Hb (g/dl) 4.8 – 18.7 7.8 – 19.9

RBC (1012

/L) 1.57 – 6.15 2.46 – 6.60

WBC (109/L) 0.7 – 30.5 0.5 – 29.0

Platelets (109/L) 7 - 626 11 - 506

The following adjustments to parameters were made during the period under review (24 specimens in

total):

4 specimens were distributed with a raised WBC (> 11 x 1012

/L)

6 specimens were distributed with a decreased WBC (< 3.0 x 109/L)

2 specimens were distributed with increased Hb (> 16 g/dL) and RBC

10 specimens were distributed with decreased Hb (< 11 g/dL) and RBC

9 specimens were distributed with decreased platelets (< 150 x 109/L). Of these specimens, 1

had a count of less than 10 x 109/L, 2 had counts between 11 – 20 x 10

9/L, 1 had a count

between 21 – 50 x 109/L and 5 had counts between 51 – 150 x 10

9/L

3 specimens were distributed with raised platelets (> 400 x 109/L).

Results of analyses

Table 1-3 shows the all method trimmed mean values for the main analytes for the surveys distributed

in the period January – December 2010.

Table 1-3. All method trimmed mean values for surveys 1001FB to 1012FB

Distribution Sample no WBC

(109/L)

RBC (10

12/L)

Hb (g/dL)

PCV (L/L)

MCV (fl)

PLT (10

9/L)

10A 1001FB1 3.71 2.92 8.6 0.26 90.2 120

1001FB2 1.04 4.14 12.7 0.39 94.6 14

10B 1002FB1 10.25 1.57 4.8 0.15 93.6 489

1002FB2 2.12 5.23 17.8 0.56 94.3 109

10C 1003FB1 21.73 5.19 15.7 0.50 97.2 626

1003FB2 5.00 2.98 9.3 0.28 94.7 167

10D 1004FB1 2.17 3.93 11.7 0.36 92.3 17

1004FB2 19.92 3.71 11.2 0.35 94.4 337

10E 1005FB1 4.87 2.90 8.5 0.26 90.9 191

1005FB2 5.39 3.35 10.4 0.32 96.5 217

10F 1006FB1 1.62 3.60 10.9 0.34 94.2 51

1006FB2 5.99 3.69 11.1 0.35 95.0 201

10G 1007FB1 7.85 5.20 15.6 0.49 94.6 140

1007FB2 14.13 4.11 11.9 0.38 93.0 230

10H 1008FB1 5.63 3.79 11.6 0.36 95.0 195

1008FB2 4.71 2.74 8.3 0.25 92.9 161

10I 1009FB1 0.70 3.71 11.5 0.36 96.3 146

1009FB2 30.48 6.15 18.7 0.59 96.2 251

10J 1010FB1 5.17 3.35 9.6 0.31 91.2 489

1010FB2 4.67 3.18 9.4 0.30 92.7 177

10K 1011FB1 3.39 4.07 12.3 0.38 94.6 24

1011FB2 0.73 3.78 11.5 0.36 94.8 7

10L 1012FB1 5.24 3.29 10.1 0.31 93.6 182

1012FB2 6.67 3.85 11.7 0.36 92.8 239

MIN 0.70 1.57 4.8 0.15 90.2 7

MAX 30.48 6.15 18.7 0.59 97.2 626


Performance of participants

Participants are monitored for analytical performance and participation. All participants, UK and non-

UK are notified of their scores at each survey but only the performance of UK participants providing a

clinical service is managed actively. Full details of the performance monitoring process may be found

in the Scheme Participants’ Handbook (available to download from www.ukneqash.org) and in the

Performance Monitoring Key Principles document, which is included in Appendix 8.

A participant’s performance is reviewed by the Scheme Director / Manager if their analytical

performance score rises above 100 for any parameter, and an ‘unsatisfactory performance (UP)’ letter

is sent; if this is not resolved at the next survey, a ‘persistent unsatisfactory performance (PUP)’

escalation letter is sent. The head of department / quality manager is contacted by telephone if the

performance problem persists to a third survey and the matter is referred to the Scheme Director for

further appropriate action, including referral to the NQAAP.

Note for the purpose of performance monitoring each analyser (‘system’ in table 1-1) is regarded as

an individual participant.

General information concerning performance issues

No Beckman Coulter LH780 user continues to have an MCV problem as a result of using Isoton

IV. The scheme suspects that this is because they have reverted to using Isoton III.

The scheme has continued to monitor Sysmex XE2100 users utilising the RPU1000 reservoir

diluent system. These data are in the process of being analysed to determine any impact on

MCV. No Sysmex XE2100/RPU 1000 user has had an unsatisfactory performance score for

MCV.

Following discussions with other Haematology Division schemes, it has been decided that

participant will no longer receive a non-participation score for failing to use the ‘submit’ button

when entering data on-line. This will harmonise practise across the Division and remove a cause

of participant complaint. After April 2010, any ‘unsubmitted’ data will be collected at survey

closing day, on the assumption that participants are happy to submit the data without further

modification. This has been notified to participants at re-registration

The main performance issue is late or non-return of data from point of care testing sites. In some

cases, this is due to logistical difficulties, with sites not receiving specimen packages at a time

convenient for analysis, or having difficulty in passing a single set of EQA specimens around a

number of geographically separate sites within a hospital in time. The scheme is considering how

services can be adapted to resolve this to participants’ satisfaction.


Automated Differential Leucocyte Count (ADLC)

ADLC scheme analytes

Differential leucocyte count as determined by automated instruments producing three and five

population counts.

ADLC scheme participation

The current registration for ADLC is shown in Table 1-4.

Table 1-4. Registration for ADLC


Total UK Total UK

March 2008 739 495 1360 920

March 2009 769 520 1485 978

March 2010 777 530 1496 994

ADLC scheme specimens distributed

Survey material is purchased from R&D Systems, USA, and two specimens from seven different

matrices or material types are available for each survey. Table 1-5 shows the matrices that have

been supplied during the review period. Matrix H (Sysmex SE and SF series instruments) was

withdrawn by R&D Systems at the end of the previous review period (after survey 0904DL); since

relatively few participants were affected and the number of instruments in the group was declining

rapidly, no alternative material was sought.

Table 1-5. Survey material types for ADLC

Material type

(matrix)

Differential

population Instruments

A 3 population Serono (Baker), Sysmex (excluding NE & SE), Cell Dyn

B 3 population ABX, Coulter, Medonic, Diatron

C 5 population Cell Dyn 3000 & 4000 series, Cell Dyn Sapphire,

Cell Dyn Ruby, HyCel Diana

D 5 population Siemens ADVIA 120, Siemens ADVIA 2120

E 5 population Coulter StkS, MaxM, GenS, HMX & LH series

G 5 population ABX Pentra, Argos, Helios & Coulter Ac*T5 Diff

J 5 population Sysmex XE and XT series

Six surveys, 1001DL – 1006DL, have been distributed in the review period January – December

2010.

Results of analyses

Participants are given a statistical analysis of their total WBC in addition to the analysis of the

automated differential leucocyte count, but this is not performance monitored.


The analysis of results for matrices C, D and G were sub-divided by instrument type for all 6 surveys,

results for matrix J for surveys 1003 – 1006DL.

Table 1-6 shows the range of method group trimmed means for neutrophils and lymphocytes for each

matrix distributed during the review period.

Table 1-6. Range of neutrophil (granulocyte) and lymphocyte values 1001 - 1006DL

Matrix Range of Method Trimmed Means

Neutrophils (x 109/L) Lymphocytes (x 10

9/L)

A 1.40 – 4.72 0.25 – 13.38

B 0.76 – 17.15 0.54 – 17.32

C

(CD3200/4000) 1.73 – 16.10 0.22 – 3.65

C

(CD3500/3700) 1.54 – 15.69 1.15 – 3.60

D (Siemens Advia 120

etc) 1.39 – 12.85 0.82 – 2.77

D (Siemens Advia 2120)

1.38 – 12.63 0.59 – 2.74

E 1.96 – 15.69 1.57 – 4.57

G

(Pentra 120 etc) 0.94 – 11.33 0.33 – 1.65

G

(Pentra 60 etc) 1.49 – 14.37 0.62 – 2.57

J

(Sysmex XE/XT) 1.83 – 11.82 0.67 – 5.10

J

(Sysmex XS)

Surveys 1003 –

1006DL

2.19 – 11.98 0.51 – 4.22


Performance is monitored in the same format as the FBC scheme. Performance is monitored for

Neutrophils and Lymphocytes only.


Reticulocyte Counting

List of analytes

Reticulocytes (109/L)

Participation for Reticulocyte Counting

The number of laboratories registered for reticulocyte count is shown in Table 1-7. Participants may

register both automated and/or manual systems. The number of participants registered for manual

microscopic counting continues to decrease slowly. Although the number of registered sites has

decreased, the number of analysers (‘systems’) has increased. This reflects the rationalisation of

pathology services.

Table 1-7. Reticulocyte registration


Total UK Total UK

March 2008 490 336 797 567

March 2009 485 321 873 599

March 2010 478 317 874 599


One survey of 3 whole blood specimens (1001RE) and four surveys of 2 specimens (1002RE –

1005RE) have been distributed during the review period, in line with the change in distributions from 4

to 6 introduced in April 2010. Commercial specimens are used for raised reticulocyte counts (4

specimens per annum) and a separate, commercial matrix (specimens REX1 and REX2) is supplied

for the Beckman Coulter Gen S and LH group of instruments. The use of this matrix is analogous to

the separate, instrument specific matrices that are supplied for ADLC surveys.

Results of analyses

Table 1-8 shows the statistical summary for the automated methods (except for matrix X) for the

survey material distributed and table 1-9 the equivalent manual method values. Table 1-10 shows the

results for the Beckman Coulter LH series instrument group (using matrix X).

Table 1-8. Automated methods results 1001RE – 1005RE (excludes LH and GenS)

Survey Specimen Number Trimmed mean

(x109/L)

RE1 588 114

1001RE RE2 588 227

RE3 580 70

1002RE RE1 593 209

RE2 590 85

1003RE RE1 590 45

RE2 589 71

1004RE RE1 603 28

RE2 603 278

1005RE RE1 594 247

RE2 592 25


Table 1-9. Manual methods results 1001RE – 1005RE


(x109/L)

RE1 63 133

1001RE RE2 63 278

RE3 63 62

1002RE RE1 60 292

RE2 62 76

1003RE RE1 58 37

RE2 58 75

1004RE RE1 53 20

RE2 52 288

1005RE RE1 55 276

RE2 55 26

Table 1-10. Results for Beckman Coulter LH group 1001RE – 1005RE (including REX matrix)


(x109/L)

1001RE REX1 131 198

REX2 133 340

RE3 132 29

1002RE REX1 136 318

REX2 136 20

1003RE REX1 134 21

REX2 134 187

1004RE REX1 127 29

REX2 128 208

1005RE REX1 136 28

REX2 133 207


Performance is monitored in the same format as the FBC scheme.

General Haematology



MORPHOLOGY SCHEMES REPORT

Blood Films for Morphology, Manual Differential Counting and Parasite Identification List of analytes

Blood films for morphology comments, fixed in methanol and stained with May Grünwald-

Giemsa. Occasionally, fixed but unstained slides are distributed for participants to stain.

A 200 cell differential is requested on 4 of the 16 Morphology slides distributed each year.

Blood films for parasite identification, fixed in methanol and stained as appropriate for specific

parasites. The stained parasite films are supplied by the Department of Clinical Parasitology,

the Hospital for Tropical Diseases, London.

Laboratories registered

Most participants register for both Blood Films for Morphology and Parasite Identification, although some register for Blood Films for Morphology only. Registration is shown in Table 2-1.

Table 2-1. Registration for Blood films

Blood Films Parasite Films

Total UK Total UK

March 2008 538 367 515 353

March 2009 539 372 512 356

March 2010 544 369 515 350

Specimens distributed Morphology films are stained by May Grünwald-Giemsa, although occasionally an unstained methanol fixed film is distributed. There is close collaboration between the UK NEQAS for General Haematology and the UK NEQAS for Parasitology, which provides parasite films and teaching sheets for the scheme, and acts as referee for the parasite species present. 8 distributions of Blood Films for Morphology were made between January – December 2010 (1001BF – 1008BF) and 4 distributions of Blood Films for Parasite Identification (1001PA – 1004PA).

The morphology films distributed are shown in Table 2-2 and the parasite films are included in Table 2-3.

Table 2-2. Morphology films distributed for surveys 1001BF to 1008BF

Specimen Diagnosis

1001BF1 Megaloblastic anaemia 1001BF2 Acute myeloid leukaemia

1002BF1 * Chronic granulocytic leukaemia 1002BF2 Pneumonia with infective leucocytosis

1003BF1 Pyruvate kinase deficiency 1003BF2 Microfilaria

1004BF1 * Acute myeloid leukaemia (M2) 1004BF2 Mantle cell lymphoma

1005BF1 Chronic lymphocytic leukaemia with idiopathic thrombocytopenic purpura 1005BF2 Hb E/beta zero thalassaemia, post splenectomy

1006BF1 * Myeloproliferative disorder 1006BF2 Beta thalassaemia trait, in pregnancy

1007BF1 Severe iron deficiency anaemia 1007BF2 Chest infection and cyclosporin induced TTP post BM transplant for AML

1008BF1 * Chronic granulocytic leukaemia 1008BF2 Idiopathic thrombocytopenic purpura with infection/inflammation

* A differential count was requested on these four cases.


Table 2-3. Summary of parasite films 1001PA to 1004PA

Specimen Parasite

1001PA1 Microfilaria of Loa loa

1001PA2 Trophozoites of Plasmodium falciparum

1002PA1 Negative for parasites

1002PA2 Trophozoites of Plasmodium malariae (Thick film)

1003PA1 Trophozoites of Plasmodium falciparum (Thick film)



1004PA2 All stages of Plasmodium vivax

Results of analyses

The Blood Films for Morphology scheme is currently operated on an educational basis. Participants report up to 5 morphological features and the frequency of reporting of each feature is reported back to them. They are also invited to offer a morphological diagnosis and the actual case details are reported as part of the expert comment from the scheme specialist advisor.

As the Hospital for Tropical Diseases acts as a referee for parasites present, incorrect returns are easier to identify. Table 2-4 summarises performance for parasite identification in the films, table 2-5 the results for thick films and table 2-6 the UK level of performance in quantifying percent parasitaemia of P. falciparum. In some cases, participants do not code their results but may correctly identify the parasite present in a written comment. Some participants that see malarial parasites infrequently in clinical practice use the ‘Malarial Parasites Present’ code; in the case of patients’ specimens, they would report a case as positive or negative and refer to a reference centre for species identification.

Table 2-4. Parasite identification codes reported for thin films (correct result in bold)

Slide No. P.

vivax

P.

ovale

P.

falciparum

P.

malariae

No

parasites 1

Micro-

filaria

Trypan-

osomes

Other/

No code 2

1001PA1 480 1 0 1 0 9 465 1 3

1001PA2 480 18 3 454 3 0 1 0 1

1002PA1 463 17 3 47 13 372

3 0 8

1003PA2 472 38 40 356 21 5 1 0 11

1004PA1 475 41 28 401 5 0 0 0 0

1004PA2 475 419 45 2 8 0 0 0 1

Notes: 1 Includes participants that used the code for ‘Normal Film’

2 Includes participants that use the code for ‘Malarial parasites present’

Table 2-5. Results for thick films

Specimen No. Malarial parasites present No parasites seen Other / No comment

1002PA2 463 311 139 13

1003PA1 472 435 27 10


Specimen 1002PA2 had a low parasitaemia and was not an easy case, especially for laboratories not accustomed to reviewing thick films. The number of participants included in the malarial parasites present category above includes those that reported a species.

Table 2-6 Percentage parasitaemia for films with trophozoites of P. falciparum – UK laboratories

Specimen No. Median% est. SD CV% Reported range

(%) Reference % value

1

1001PA2 277 0.9 0.52 57.8 0.006 – 6.0 0.4

1003PA2 200 0.2 0.2 126 0.001 – 35.0 0.02

1004PA1 265 3.4 1.8 54 0.6 – 35.0 2.5

Notes:

1 Reference values provided by the Clinical Parasitology Department, HTD.

Performance assessment Participants are scored for participation for both parts of the scheme. There is no analytical performance scoring for these surveys currently. Participants are sent a letter for failing to report the presence of P. falciparum and for a percent parasitaemia result that is outside ± 3SD and is clinically significant. In the event that a participant makes an error in the Blood Films for Parasite Identification part of the scheme in 2 out of 3 consecutive surveys, they would be classed as a persistent unsatisfactory performer. Development of scoring will require some allowance for those laboratories that see malaria infrequently and do not have the expertise to undertake species identification.


Cytochemistry List of analytes

Iron stain (Perls’ stain)

Sudan Black B stain (SBB) Laboratories registered

The laboratories registered are shown in Table 2-7.

Table 2-7. Registration for Cytochemistry surveys

Iron Stain SBB

All UK All UK

March 2008 210 183 100 77

March 2009 207 181 93 71

March 2010 206 180 83 60


Unfixed blood films are distributed for SBB with a second set of methanol fixed films for Romanowsky staining to enable verification of the presence of blast cells. Methanol fixed films are distributed for Haemosiderin. Two films have been distributed in each survey for the tests as shown in Table 2-8.

Table 2-8. Tests distributed for Cytochemistry surveys

Test Specimen

Iron stain 1001CY1

1001CY2

SBB 1002CY1

1002CY2

Iron stain 1003CY1

1003CY2

SBB 1004CY1

1004CY2

The main difficulty for the scheme is the provision of particulate bone marrow slides for Iron staining. The Scheme Director appreciates that the slides provided would not be considered satisfactory for patients’ specimens, but stresses the difficulty in making 200 slides with particles. Results of analyses

The scheme is offered for educational purposes only. There is no scoring.

The possibility of distributing a number of specimens as digital images, with occasional slides to test staining, remains under consideration. Additional imaging capacity will be available in 2011 and this option may become feasible.

General Haematology



HAEMOGLOBINOPATHY SCHEMES REPORT

Abnormal Haemoglobins/Hb A2/Hb F/Hb S

List of analytes

Sickle screen (SCT)

Fraction identification (ID)

Quantitation of Hb A2, Hb F and Hb S as appropriate

Assessment of assay result in terms of in-house reference range for Hb A2 and Hb F

Suggested interpretation of results


The registration for the abnormal haemoglobins scheme is shown in Table 3-1. Laboratories may

register methods for sickle screening test, fraction identification and quantitative assay of Hb A2, Hb F

and Hb S. There are 2 levels of registration: sickle screening test only and full participation.

Table 3-1. Registration for Abnormal Haemoglobins

Laboratories Full participation Sickle screen only

Total UK Total UK Total UK

March 2008 421 292 292 185 129 107

March 2009 426 301 281 183 145 118

March 2010 428 304 278 181 150 123


Three specimens of human whole blood in CPD-A1 anticoagulant were distributed in 6 surveys 1001

– 1006AH, together with brief clinical details and full blood count details for each specimen.

Table 3-2. Specimens distributed 1001 – 10906AH

Survey Specimen Content

1001AH

1001AH1 Sickle cell carrier, partner of pregnant beta thalassaemia woman

1001AH2 Pregnant woman, probable iron deficiency

1001AH3 Raised Hb F

1002AH

1002AH1 Sickle cell carrier with Hb H disease

1002AH2 Pregnant woman, sickle cell carrier

1002AH3 Probable alpha plus thalassaemia &/or iron deficiency

1003AH

1003AH1 No evidence of a haemoglobin variant or thalassaemia

1003AH2 Sickle cell carrier, partner of pregnant beta thalassaemia woman

1003AH3 Pregnant woman, slight microcytosis

1004AH

1004AH1 Beta thalassaemia carrier

1004AH2 No evidence of a haemoglobin variant or thalassaemia

1004AH3 Pregnant woman, sickle cell carrier

1005AH

1005AH1 Hb C carrier

1005AH2 Delta – beta thalassaemia carrier

1005AH3 Pregnant woman with slightly raised Hb F

1006AH

1006AH1 Alpha plus thalassaemia &/or iron deficiency

1006AH2 HPFH carrier, partner of sickle cell carrier

1006AH3 Pre-op sickle cell carrier


Results of analyses

Table 3-3 gives a summary analysis of sickle cell test and fraction identification results, tables 3-4, 3-5

and 3-6 give summary analyses of Hb A2, Hb F and Hb S quantitation.

Table 3-3. Sickle cell test and Fraction ID results for surveys 1001 – 1006AH

Specimen No. Mean

Hb S % SCT Pos

SCT Neg

Fraction ID

Correct Incorrect

1001AH1 1001AH2 1001AH3

339 333 332

39.3

337 3 4

2 330 328

238 243 236

9 1 7

1002AH1 1002AH2 1002AH3

350 350 338

21.1 39.4

344 347

1

6 3

337

235 236 238

8 7 4

1003AH1 1003AH2 1003AH3

339 350 336

36.0

350

339

336

242 232 231

3 9 8

1004AH1 1004AH2 1004AH3

329 327 338

39.4

5 3

336

324 324

2

234 236 227

2 1 9

1005AH1 1005AH2 1005AH3

338 337 337

6

1

332 337 337

235 244 245

13 4 2

1006AH1 1006AH2 1006AH3

335 335 336

36.3

4

335

331 335

1

255 253 247

3 4 8

Note

Some participants are registered for SCT only; hence the Fraction ID numbers are fewer than the totals for SCT.

The incorrect fraction ID results do not include participants that have failed to report the presence of Hb A, although these results are reported back to the participant as incorrect.

Specimens with a significantly raised Hb F (>5%) are not reported as incorrect for fraction identification if Hb F is not reported but participants are reminded that this fraction should be detectable by all fraction identification methods.


Table 3-4. Hb A2 quantitation 1001 – 1006AH – all methods results

Specimen No. Mean

Hb A2 % GCV Reported range

Number of outliers

<-3SD >+3SD

1001AH2 1001AH3

260 260

2.9 2.4

7.8 8.6

1.0 – 3.5 1.0 – 5.8

3 2

0 1

1002AH3 260 2.9 8.1 1.9 – 5.9 2 1

1003AH1

1003AH3 265 265

2.5 2.8

8.1 7.1

1.7 – 3.9 2.0 – 4.3

2 8

2 2

1004AH1 1004AH2

250 251

4.8 2.3

8.6 8.0

3.3 – 6.4 1.6 – 3.2

4 2

1 1

1005AH2 1005AH3

279 279

2.1 2.35

9.6 7.7

1.3 – 2.8 1.8 – 3.2

2 0

1 1

1006AH1 1006AH2

276 273

2.8 1.9

6.6 11.1

0.6 – 4.9 0.5 – 2.7

3 3

4 1

Table 3-5. Hb F quantitation 1001AH - 1006AH – all methods results, trimmed mean >3%

Specimen No. Mean

Hb F % GCV Reported range

Number of outliers

<-3SD >+3SD

1001AH3 256 5.9 8.1 0 – 10.2 2 3

1005AH2 1005AH3

280 279

14.5 5.6

8.6 7.8

8.5 – 22.0 2.7 – 9.0

3 2

1 1

1006AH2 273 20.2 8.4 0 – 35.0 7 3

Note: Specimens with all methods trimmed mean results of <3% are not included as many

participants report their results as ‘less than 1 or 0.5’ once the ALTM falls below this level, which

skews statistical assessment.

Table 3-6. Hb S quantitation 1001AH - 1006AH – all methods results

Specimen No. Mean

Hb S % GCV Reported range

Number of outliers

<-3SD >+3SD

1001AH1 248 39.3 3.4 1 – 47.0 4 1

1002AH1 1002AH2

249 248

21.1 39.4

4.9 3.2

14.6 – 39.9 0 – 46.3

1 0

2 1

1003AH2 253 36.0 3.4 18.7 - 41.1 1 3

1004AH3 240 39.4 3.1 33.1 – 43.1 3 0

1006AH3 264 36.3 3.6 27 – 41.2 3 0


General Performance Issues

Participants are scored for Sickle cell testing, Hb A2 and Hb S quantitation. Analytical performance

scores for Hb A2 and Hb S are calculated in the same way as for the FBC scheme, SCT is scored with

50 penalty points for an incorrect result.

There are no non-participation issues in the Abnormal Haemoglobins scheme, with a mean return rate

of over 95% for all participants during the year. The participation rate for UK full participants is even

higher than this.

There are no persistent performance issues for Sickle cell test or Fraction ID. Analysis of overall

performance in SCT shows that 0.6% of negative SCT results were reported as positive (27/4366

results), and 1.0% of positive SCT results were reported as negative (14/1733), for specimens with an

all methods trimmed mean Hb S value of >20%. Some of these false positive / negative results may

be due to clerical errors; where UK participants are asked to retest following an incorrect result, the

repeat result has always been within consensus. The incorrect fraction ID results noted include

clerical errors and participants reporting non-specified fractions.

Participants have been asked to suggest an interpretive comment for their results, using a set of

coded comments. This part of the scheme is not subject to performance monitoring and is not

reviewed here as the quantity of information is very large. Further information may be found in the

supplementary report issued for each survey.

Mrs Hannah Batterbee, of Sheffield Teaching Hospitals NHS Trust, was seconded to the Scheme to

undertake an in-depth review of Hb A2 performance in UK NEQAS (H). This report was published in

2010 and may be downloaded from www.ukneqash.org. The report showed a bias in the

performance of different HPLC analysers and will form the focus of a workshop organised for

February 2011 by the NHS Sickle and Thalassaemia Screening Programme, to be attended by the

representatives of the manufacturers, members of the Programme and international experts on Hb A2

standardisation.


Newborn Sickle Screening

List of analytes

Clinically significant Hb variants in umbilical cord blood for identification

Interpretation of fraction identification

Participants registered

Table 3-1. Registration for Newborn Sickle Screening

Laboratories

Total UK

March 2008 27 26

March 2009 27 26

March 2010 30 26

All 13 newborn sickle screening laboratories in England are registered in this scheme. The primary

screening laboratories and their secondary, confirmatory laboratories are registered as a single

participant. Several other laboratories also participate: these include laboratories that undertake

newborn sickle screening in Scotland, Wales, Northern Ireland and the Republic of Ireland, and a

small number of laboratories keen to maintain skills in this area. A small number of large non-UK

screening laboratories have joined the scheme in the year.


Specimens are distributed as dried blood spots of umbilical cord blood. 3 specimens are distributed

with each survey, with ethnic origin, birthweight and gestation. Surveys are distributed monthly.

Specimens are validated for testing by HPLC and IEF; some participants using capillary

electrophoresis (CE) have now registered. The scheme is undertaking work to validate the

performance of the survey material on this system.

Specimen quality has been good with the exception of one specimen that was reported unsatisfactory

by 5 participants, due to the dried blood spot giving too weak an eluate.

Results of analyses

Table 3-2 shows the specimens distributed from January – December 2010 and the number of

laboratories within/outwith consensus. The notes to the table give an indication of errors made,

especially if a UK screening laboratory is concerned.

Participants’ performance

Participants are scored for non-participation, analytical performance and interpretation of results.

There is one laboratory that is a persistent unsatisfactory performer for non-participation: this

participant is a commercial manufacturer that does not provide a clinical service and wishes to receive

survey material for internal testing purposes. The Scheme is willing to support this while there is

adequate survey material available. Occasional other laboratories have not returned results by the

closing date. In two instances, UK screening laboratories failed to return results, on one occasion

results were returned late.

There have been 6 analytical errors, compared to 4 in 2009 and 7 in 2008. The greatest proportion of

errors was seen in 2 Hb E carrier specimens. No UK screening laboratory made an analytical error.

There have been no errors in interpretation of results for the full year; where a laboratory has made

an analytical error, they are not scored for interpretation.


Table 3-2. Results from January – December 2010

Specimen Consensus result No. of

participants Within

consensus Outwith

consensus

1001NH1 FA

28

28 0

1001NH2 FA 28 0

1001NH3 FAS 28 0

1002NH1 FAS

29

29 0

1002NH2 FS 29 0

1002NH3 FA 29 0

1003NH1 FAS

27 2

26 1 1

1003NH2 FA 27 0

1003NH3 FAC 27 0

1004NH1 FA + ?Hb Barts 3

29

29 0

1004NH2 FAS 29 0

1004NH3 FAS 29 0

1005NH1 FAC

29

29 0

1005NH2 FA 29 0

1005NH3 FA 29 0

1006NH1 FS

29 4

29 0

1006NH2 FAS 29 0

1006NH3 FAS 29 0

1007NH1 FA

28 5

28 0

1007NH2 FA 28 0

1007NH3 FAE 26 2 6

1008NH1 FAE

30

28 2 7

1008NH2 FAS 30 0

1008NH3 FS 29 1 8

1009NH1 FA

31

31 0

1009NH2 FAC 31 0

1009NH3 FA 31 0

1010NH1 FAS

33

33 0

1010NH2 FAS 33 0

1010NH3 FAC 33 0

1011NH1 FAS

32

32 0

1011NH2 FA 32 0

1011NH3 FA 27 9

0

1012NH1 FAC

33

33 0

1012NH2 FAC 33 0

1012NH3 FAS 33 0

Notes: 1 1 non-screening lab reported this specimen as Hb F + Hb A + Hb D.

2 1 UK screening lab did not return results.

3 The consensus result was accepted as Hb F + Hb A. 9 labs reported an ‘other’ variant, possibly Hb

Barts. 4 1 UK screening lab returned results late.

5 1 UK screening lab failed to return a result.

6 2 non-screening labs reported the Hb E as ‘other’, 1 interpreted the fraction as Hb A2.

7 2 labs incorrectly reported the Hb E fraction; none was a UK screening laboratory

8 1 non-UK lab reported a small Hb A peak but also had a technical problem; they gave a clinically

correct interpretation. 9 5 laboratories reported this specimen unsatisfactory.

General Haematology



RED CELL ENZYMES SCHEME REPORT

Red cell G6PD

List of analytes

G6PD screening test

G6PD quantitation Assessment of quantitation by the participant in terms of in-house reference range


The registration for red cell G6PD is shown in Table 4-1. Laboratories may register for screening test,

quantitative assay, or both.

Table 4-1. Registration for red cell G6PD

Laboratories

Total UK

March 2008 235 165

March 2009 224 158

March 2010 226 157

Specimens sent out for analysis

Three specimens have been distributed in one survey (1001G6) and 2 in each of the other 4 surveys

(1002G6 – 1005G6) in the review period. The survey specimens were prepared from human whole

blood in CPD-A1 anticoagulant (clearly normal) and sheep whole blood in CPD-A1 anticoagulant

(clearly deficient). Occasional specimens (1003G61 in the review period) are prepared from a mixture

of sheep and human blood, to give intermediate assay values.

Results of analyses

Table 4-2 shows the screening test results, with the survey trimmed mean value. The consensus

result is shown in bold type. Table 8-3 shows the summary of G6PD quantitative assay results at

30°C.

Table 4-2. G6PD Screening results (consensus result in bold type)

Specimen

Survey trimmed

mean IU/gHb at

30°C

Screening Results

(Number of laboratories)

Deficient Not deficient Equivocal

1001G61

1001G62

1001G63

0.9

7.9

6.9

128

4

4

0

126

124

2

0

2

1002G61

1002G63

7.4

0.7

2

130

129

2

2

1

1003G61

1003G62

4.5

10.5

34

0

39

124

56

4

1004G61

1004G62

0.6

8.6

127

2

1

124

1

3

1005G61

1005G62

0.8

0.7

115

118

4

3

8

6


Table 4-3. G6PD quantitative assay results at 30°C

Specimen No. Trimmed mean

IU/gHb at 30°C SD Reported Range

Outliers

<-3SD >+3SD

1001G61

1001G62

1001G63

71

69

71

0.9

7.9

6.9

0.24

1.16

1.04

0.1 – 6.5

1.6 – 11.0

3.7 – 11.4

1

1

1

4

0

2

1002G61

1002G62

68

68

7.4

0.7

1.0

0.2

2.5 – 65.3

0.3 – 9.1

2

0

2

7

1003G61

1003G62

66

66

4.5

10.5

0.7

1.4

0.6 – 6.1

5.3 – 17.0

3

3

0

2

1004G61

1004G62

63

64

0.6

8.6

0.2

1.2

0 – 6.4

4.8 – 13.8

0

2

2

3

1005G61

1005G62

68

68

0.8

0.7

0.2

0.2

0.1 – 31.0

0.2 – 7.8

1

0

2

6

Participants’ performance Participants are scored for non-participation and analytical performance (screening and quantitative assay). Specimen 1003G61 was scored for quantitative assay but was withdrawn from scoring for qualitative screening, as there was an equivalent split of participants that reported this specimen, which had a G6PD assay value of 4.5 IU/gHb at 30°C.

For screening test results, 3.5% (23/650) of results for ‘not deficient’ specimens were incorrectly

reported as deficient / equivocal (compared to 4.4% for 2009) and 4.3% (28/646) of results for

‘deficient’ specimens were incorrectly reported as not deficient / equivocal (compared to 5.6% for

2009).

A small number of laboratories (3 – 6) continue to perform the quantitative assay at 25°C and there is

a 60:40 split between laboratories using 30 or 37°C. The UK NEQAS (H) Special Scientific Advisory

Group has expressed the view that these assays should be undertaken at 37°C.

General Haematology



RED CELL VOLUME SCHEME REPORT

Red Cell Volume

List of analytes

Total Red Cell Volume (mL)

Percentage of predicted mean normal Red Cell Volume (%PN)


Table 5-1. Registration for Red Cell Volume

Laboratories

Total UK

March 2008 43 42

March 2009 38 38

March 2010 34 34

Specimens sent out for analysis

Each survey includes one set of specimens, which comprise one case:

1:100 dilution of the original suspension of 51

Cr labelled patient red cells (injection

specimen)

Patient's whole blood specimen collected 30 min after injection of labelled cells.

The scheme now sends a PCV value with each specimen.

1001RV 51 year old, female with a raised RCV (69.5 kg)

1002RV 65 year old, female with a raised RCV (102.5 kg)

1003RV 39 year old, male with a normal RCV (92 kg)

1004RV 52 year old, male with a normal RCV (52.5 kg)

Results of analyses

Table 5-2. Summary of survey analysis

Survey No Median Est.

SD Reported

range

Results

<-2SD

Results

>+2SD

ICSH normal

range (ml)

1001

Total RCV (mL)

%PN

26

26

2498

170

119

7.7

2352 – 3165

165 - 176

0

0

2

2

1101 - 1835

1002

Total RCV

%PN

28

28

3007

174

133

8.1

2737 – 3245

159 - 189

1

0

0

0 1290 - 2150

1003

Total RCV

%PN

27

27

2500

107

67

2.9

2279 – 2627

98 – 113

2

1

0

0

1744 – 2908

1004

Total RCV

%PN

26

26

1600

104

31

1.8

1518 – 1835

99 - 119

2

2

2

3

1153 - 1921

Participants’ performance Participants are scored for participation, Total RCV and %PN.

© UK NEQAS (H) 2011

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