UK NEQAS for General Haematology Annual Report January December 2010

Transcription

1 UK NEQAS for General Haematology Annual Report January December 00 February 0 Scheme Director: Scheme Manager: Professor Keith Hyde Mrs Barbara De la Salle UK NEQAS (H) PO Box 4 Watford WD8 0FJ United Kingdom WEB version: Please note that this report is formatted for double sided printing. UK NEQAS (H) 0

2 Contents. Executive Summary Scheme Activities CPA Accreditation Audit of performance targets Summary of surveys distributed Digital Morphology Pilot schemes New Developments Major changes: rules, scheme design and service provision Annual meeting and communications with participants... 6 Appendices Scheme specific reports Appendix : Automated Schemes report Appendix : Morphology and related Schemes report Appendix 3: Haemoglobinopathy Schemes report Appendix 4: Red Cell Enzymes Scheme report Appendix 5: Red Cell Volume Scheme report Page

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4 Executive Summary This document reports the activity of UK NEQAS for General Haematology (UK NEQAS (H)) for the period January to December 00. All data included in the report cover the period January December 00 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 00, resulting in 9 non-conformities and one observation. All the non- conformities have been cleared. The next scheduled accreditation inspection will be in 0 and will be include a pre-assessment visit by UKAS in preparation for accreditation against the new ISO7043 standards. The scheme achieved its performance targets to March 00, 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 0. 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 0 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 0. The Scheme replaced its flow cytometer early in 00. 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 0. 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 00 and an ESR pilot scheme will be distributed in 0. The number of surveys in the Automated Differential Count, Reticulocyte and G6PD schemes increased from 4 to 6 annually in April 00. 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 009 to March 00, 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 000 UK participants in 50+ 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. Page 4

5 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 A measurement, commissioned from Sheffield Teaching Hospitals and supported by the NHS Sickle and Thalassaemia Programme, was published in 00 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 0. The DNA Diagnostics for Haemoglobinopathies Scheme will be fully reviewed and work undertaken to develop performance monitoring. Meetings and Communications The Scheme held a day 3 th Annual Participants Symposium for 50 delegates in Birmingham October 00 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 0. Approximately 0 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 0 Page 5

6 Scheme Activities for 00 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 00 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 band 6 staff: Miss Nikki Emodi started in August 00 and Mrs Veronica Cofie in November 00. 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 00 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, 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 reregistration for the participation period April 0 March 0. 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 00, including organising a successful a well attended exhibition stand; presenting 6 posters and short oral presentations, and the scheme manager being an invited speaker on the main conference programme. Page 6

7 Steering Committee The Overarching General Haematology Steering Committee met in Birmingham on October The Morphology SAG met in January 00 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 00 in London. The Special SAG met in June 00 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 006 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 ( monthly) in April 00. 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 00 using commercially prepared material and another is planned in early 0. 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 bespoke inter-laboratory EQA schemes, one for Quest Diagnostics clinical trials laboratories in collaboration with UK NEQAS for Clinical Chemistry, and another for 00 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 80. 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 00. 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 009 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 00, followed by a full distribution to 76 UK laboratories in August 00. The scheme was well received by participants and another distribution will be made in 0. Participants will be recruited at re-registration 0. Special Haematology SAG related activities The DNA Haemoglobinopathies pilot scheme made a distribution in 00 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 0, with the assistance of SAG members. Page 7

8 The Scheme Manager continues to make 6 monthly reports to the National Sickle and Thalassaemia Screening Programme on participant performance. The report on Hb A performance was completed by Hannah Batterbee and released to the National Programme in August 00. A follow up workshop to discuss a way forward on Hb A standardisation has been arranged by the National Programme in February 0, 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 0 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 specimens per year in April 00, allowing more frequent performance monitoring. Defibrinated sheep blood has been used throughout 00 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 000 individual practitioners are registered with the scheme, in 50 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 00. 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 00 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. Page 8

9 CPA Accreditation The UK NEQAS Centre at Watford General Hospital was assessed on May 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 00. The next full assessment visit will be in 0 and will be undertaken by UKAS against ISO7043. 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 ISO7043 standards. UK NEQAS (H) holds accreditation for the following schemes: Full Blood Count (0/0063) ADLC (0/007) Reticulocyte counting (0/0065) Blood Films for Morphology and Parasite Identification (0/0064) Cytochemistry (0/0066) Abnormal Haemoglobins (0/0068) Newborn Sickle Screening (0/080) Red cell enzymes (0/067) Red cell volume (0/0069) Vitamin B Absorption Tests (0/0070) Audit of Performance Targets Audit of Performance Targets: April 009 March 00 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 00%) as a result of adverse weather in January 00, which caused the NHSBT to be unable to supply donor blood for preparation of Abnormal Haemoglobins survey material. The 00AH distribution was delayed by one month. Physical integrity of specimens: Target achieved for all but G6PD sheep blood specimens. This was corrected during 00. Packing errors: These remain low, at less than 0.5%. Specimen quality: Target achieved for most specimens distributed. The major problems remain:. Blood films unsatisfactory returns are higher than limit set but most of those reporting the slides as unsatisfactory still return results.. Bone marrow slides remain a problem actions included in the quality improvement plan (QIP) for G6PD survey material prepared from sheep blood had problems with clotting after distribution. This was included in the QIP for 00 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 Previous years totals were ( ) and 9 ( ). Complaints covered a range of areas, there was no particular trend. Page 9

10 Summary of surveys distributed The total number of laboratories declined slightly in the year to March 00. 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-. Number of Laboratories registered by Scheme March 00 Scheme FB DL RE AH G6 BF/PA HS SB NH RV UK Non-UK Total Key; FB = Full Blood Count DL = Automated Differential Leucocyte Count (ADLC) RE = Reticulocyte Count AH = Abnormal Haemoglobins, Hb A, 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-. Participation by Laboratory Type March 00 March 009 March 008 NHS laboratories NHS POCT UK Private laboratories 7 UK Other laboratories Non-UK laboratories TOTAL 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. 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 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 ( Page 0

11 Digital Morphology Digital Morphology CPD Scheme The Digital Morphology CPD Scheme was launched in April 008. 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 000 participants have registered in more than 50 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 0 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 00: 0906DM 00DM 00DM 003DM 004DM Pilot Schemes RDT Malaria Acute myelomonocytic leukaemia Primary polycythaemia with dimorphic erythrocyte populations Myelofibrosis transforming to acute leukaemia with previous splenectomy Hereditary pyropoikilocytosis Hairy cell leukaemia This pilot scheme has been developed in collaboration with UK NEQAS for Parasitology. Four surveys ( 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 009 was distributed early in 00. 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 0. DNA Diagnostics for Haemoglobinopathies One distribution of specimens was made in December 009 (090DN) using first cell line cases prepared at the National Genetics Laboratory in Manchester. A second distribution was made in 00 (00DN), using archive material. The report for survey 00DN 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 00. Each survey contained red cell specimens and 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. Page

12 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 0 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 009. The first distribution of the pilot scheme was made in August 00 and another is planned in February 0. 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 0. 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 0. 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 A Performance Assessment Following the initial work published in Hannah Batterbee s report on Hb A measurement, the Scheme is planning additional work on the factors that affect performance monitoring of this analyte. Page

13 Major changes to rules and scheme design Disclosure of performance The Scheme Manager made reports to the NHS Sickle and Thalassaemia Programme on the overall performance of participants in England in the Haemoglobinopathy surveys for 00. 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 00, with specimens per distribution; the total number of specimens per annum has increased from 8 to. Matrix H was withdrawn in December 009 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 The frequency of this scheme was raised from 4 to 6 per year from April 00, with specimens per 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 0. This change was agreed with the Special SAG in June 00 and will coincide with implementation of web entry for this scheme. Briefly, the scheme will be split into 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 Page 3

14 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 0. 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 The frequency of this scheme was raised from 4 to 6 per year from April 00, with specimens per distribution; the total number of specimens per annum remains the same. Submitting results From April 0, 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. Page 4

15 Annual Participants Symposium and other Communications Annual Participants Symposium The 3 th Annual Participants Symposium was held at the National Motorcycle Museum, Birmingham, on October 9 and 0, 00. The meeting was well attended by approximately 40 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 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 69 The level of subject matter was good 7 0 Adequate time was given for discussion The venue was good The lecture facilities were good The food provided was good SECTION B: LECTURE /SESSION EVALUATION (Number of ticks for each lecture and session on a scale of -5, where is the lowest (worst) score and 5 the highest (best) score) TUESDAY 9 OCTOBER 00 - Afternoon Workshops Workshop: Digital Morphology Digital Morphology work-up Malaria wikipedia Session Overall Workshop: New Parameters New Parameters EQA The Clinical Relevance of MPV Session Overall WEDNESDAY 0 OCTOBER 00 Morning Session Page Harmonisation in Haematology UK NEQAS Haematinics Assay UK NEQAS Leucocyte Immunophenotyping Session Overall Afternoon Session General Haematology: Automated Counting Haemoglobinopathies: How is my laboratory performing? Morphology: Digital Morphology Up-date and Developments Session Overall

16 The 0 Participants Meeting will be held at York Racecourse on October 3. 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 00, 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 0. 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 009 March 00. 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 00: Short paper on Performance Assessment in Newborn Sickle Screening. Posters on Hb A measurement, Digital Morphology, Hb measurement. ii. ISLH 00: Short papers on UK NEQAS: 40 years of quality, and Digital Morphology. Posters on Hb A measurement, Newborn Sickle Screening, Manual Differential Counting, Digital Morphology. Publications Paper on Platelet counting in thrombocytopenic specimens drafted for publication. ISLH 00 meeting in Brighton, UK Barbara De la Salle was invited to speak on POCT: a novel approach in a Mental Health Setting. EQALM 00 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 6

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18 ANNUAL REPORT 00 APPENDIX General Haematology AUTOMATED COUNTING SCHEMES REPORT Full Blood Count List of analytes WBC (0 9 /L) Hb (g/dl) RBC (0 /L) PCV (L/L) MCV (fl) MCH (pg) MCHC (g/dl) Platelets (0 9 /L) Blood Count Scheme participation Table - shows the change in participants registered and Table - the numbers of instruments registered in the different analyser groups, at the end of the last full participation year. Table -. Registration for Blood count Laboratories Systems Total UK Total UK March March March Table -. Numbers of different analysers registered by group (excluding miscellaneous) Instrument Group March 00 March 009 Total UK Total UK Cell-Dyn 3000 Series ABX Instruments Coulter T Series Coulter S Plus Series Cell-Dyn 600 & Cell-Dyn 4000 & Sapphire ABX Pentra Series Bayer ADVIA HemoCue B-Hemoglobin Cell-Dyn 300 & Ruby Sysmex SF Sysmex K Series Sysmex SE Series ~ ~ 9 0 Sysmex XE Sysmex XT Series Sysmex poch-00i The remaining instruments in the Sysmex SE group were transferred to the miscellaneous group between April 009 and March 00. Annual Report 00 Appendix - page

19 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 00 Jan Dec 009 Hb (g/dl) RBC (0 /L) WBC (0 9 /L) Platelets (0 9 /L) The following adjustments to parameters were made during the period under review (4 specimens in total): 4 specimens were distributed with a raised WBC (> x 0 /L) 6 specimens were distributed with a decreased WBC (< 3.0 x 0 9 /L) specimens were distributed with increased Hb (> 6 g/dl) and RBC 0 specimens were distributed with decreased Hb (< g/dl) and RBC 9 specimens were distributed with decreased platelets (< 50 x 0 9 /L). Of these specimens, had a count of less than 0 x 0 9 /L, had counts between 0 x 0 9 /L, had a count between 50 x 0 9 /L and 5 had counts between 5 50 x 0 9 /L 3 specimens were distributed with raised platelets (> 400 x 0 9 /L). Results of analyses Table -3 shows the all method trimmed mean values for the main analytes for the surveys distributed in the period January December 00. Table -3. All method trimmed mean values for surveys 00FB to 0FB Distribution Sample no WBC RBC Hb PCV MCV PLT (0 9 /L) (0 /L) (g/dl) (L/L) (fl) (0 9 /L) 0A 00FB FB B 00FB FB C 003FB FB D 004FB FB E 005FB FB F 006FB FB G 007FB FB H 008FB FB I 009FB FB J 00FB FB K 0FB FB L 0FB FB MIN MAX Annual Report 00 Appendix - page

20 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 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 00 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 -) 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 XE00 users utilising the RPU000 reservoir diluent system. These data are in the process of being analysed to determine any impact on MCV. No Sysmex XE00/RPU 000 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 00, 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. Annual Report 00 Appendix - page 3

21 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 -4. Table -4. Registration for ADLC Laboratories Systems Total UK Total UK March March March 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 -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 -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 0, Siemens ADVIA 0 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, 00DL 006DL, have been distributed in the review period January December 00. 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. Annual Report 00 Appendix - page 4

22 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 DL. Table -6 shows the range of method group trimmed means for neutrophils and lymphocytes for each matrix distributed during the review period. Table -6. Range of neutrophil (granulocyte) and lymphocyte values DL Matrix Range of Method Trimmed Means Neutrophils (x 0 9 /L) Lymphocytes (x 0 9 /L) A B C (CD300/4000) C (CD3500/3700) D (Siemens Advia etc) D (Siemens Advia 0) E G (Pentra 0 etc) G (Pentra 60 etc) J (Sysmex XE/XT) J (Sysmex XS) Surveys DL Performance of participants Performance is monitored in the same format as the FBC scheme. Performance is monitored for Neutrophils and Lymphocytes only. Annual Report 00 Appendix - page 5

23 Reticulocyte Counting List of analytes Reticulocytes (0 9 /L) Participation for Reticulocyte Counting The number of laboratories registered for reticulocyte count is shown in Table -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 -7. Reticulocyte registration Laboratories Systems Total UK Total UK March March March Specimens distributed One survey of 3 whole blood specimens (00RE) and four surveys of specimens (00RE 005RE) have been distributed during the review period, in line with the change in distributions from 4 to 6 introduced in April 00. Commercial specimens are used for raised reticulocyte counts (4 specimens per annum) and a separate, commercial matrix (specimens REX and REX) 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 -8 shows the statistical summary for the automated methods (except for matrix X) for the survey material distributed and table -9 the equivalent manual method values. Table -0 shows the results for the Beckman Coulter LH series instrument group (using matrix X). Table -8. Automated methods results 00RE 005RE (excludes LH and GenS) Survey Specimen Number Trimmed mean (x0 9 /L) RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE RE 59 5 Annual Report 00 Appendix - page 6

24 Table -9. Manual methods results 00RE 005RE Survey Specimen Number Trimmed mean (x0 9 /L) RE RE RE RE RE RE 60 9 RE RE RE RE RE RE 53 0 RE RE RE RE 55 6 Table -0. Results for Beckman Coulter LH group 00RE 005RE (including REX matrix) Survey Specimen Number Trimmed mean (x0 9 /L) 00RE REX 3 98 REX RE RE REX REX RE REX 34 REX RE REX 7 9 REX RE REX 36 8 REX Performance of participants Performance is monitored in the same format as the FBC scheme. Annual Report 00 Appendix - page 7