Participants` manual

Participants` manual
Participants’
Handbook
UK NEQAS for
GENERAL HAEMATOLOGY
Version 6.2, published November 2015
Version 6.1 updates Version 6.0, published April 2014, with the amendments or
additions stated below.
Version 6.2 embeds these amendments in the text.
With the exception of the amendments listed, the remainder of the document remains
correct at the date of publication of the original version.
Version
6.1
6.2
Published
August
2015
November
2015
Page
18
Amendment
Participants may register for full participation or for alpha or
beta thalassaemia mutational testing only, at a reduced fee. All
receive the same samples.
13-14
UK NEQAS General Haematology subcontracts the preparation
of survey material for the Blood Films for Parasite Identification
(PA) and the Rapid Diagnostic Testing for Malaria (RD)
schemes to the Hospital for Tropical Diseases, London.
18
Participants may register for full participation or for alpha or
beta thalassaemia mutational testing only, at a reduced fee. All
receive the same samples.
15
UK NEQAS General Haematology subcontracts the preparation
of survey material for the Blood Films for Parasite Identification
(PA) and the Rapid Diagnostic Testing for Malaria (RD)
schemes to the Hospital for Tropical Diseases, London.
© UK NEQAS (H) 2015
QUICK REFERENCE
Contact us:
Postal address:
UK NEQAS (H)
PO Box 14
Watford
WD18 0FJ
UK
Telephone:
Fax:
Email:
Web:
+ 44 (0)1923 217878 (Mon – Fri 09:00 – 17:30)
+ 44 (0)1923 217879
[email protected]
www.ukneqash.org
How do I register?
Contact the Scheme Office (see above) and request a registration pack.
How do I re-register?
Between January and March of each year, participants are contacted and asked
to confirm their re-registration details for the following financial year on-line.
How do I change registered details?
Alterations to your registered details, including changes in instrument or
method details, should be sent to us in writing, either by letter, fax or email and
signed or sent by one of the named contacts, the head of the laboratory or
laboratory manager. Changes must be received at least 3 weeks before the
scheduled distribution date to be effective for that distribution.
What is the cost of participation?
Please contact the Scheme Office for a copy of the current fees sheet or a
quotation.
What is my PRN?
This is a 5 digit, unique reference number that is issued when you register and
should be quoted in all communications with the Scheme.
How do I register for Digital Morphology?
Laboratory managers can register a group of staff for Digital Morphology when
registering or re-registering for other UK NEQAS (H) services. Individual
practitioners should register via www.ukneqash.org, following the links to the
Digital Morphology home page.
When will my specimen package arrive?
Specimen packages should be received within 2 days of dispatch for
participants in the UK. Outside the UK, courier delivery usually takes up to
4 – 5 days.
What do I do if my specimen package doesn’t arrive?
Please contact the Scheme Office and request a replacement specimen pack.
Can I obtain repeat specimens?
Repeat specimens are generally available throughout the survey period to
replace specimens received in an unsatisfactory condition (i.e. broken, leaking,
i
unlabelled, haemolysed or clotted) and to replace those accidentally damaged
or misplaced in the laboratory. Specimens may be neither available nor
suitable for analysis after the survey has closed. Please contact the Scheme
office for availability of repeat specimens.
What do I do if I can’t return my results in time?
If you are unable to return your results by the closing date, you may submit
them late subject to certain conditions. Web Users should contact the Scheme
for results sheets for those surveys using the Web Results Service or download
a blank results form from the data entry website. If you use a blank form,
remember to include you participant reference number (PRN). The first report
you receive may not show your results, but a second ‘late’ report, showing your
results, will be generated before the next survey is processed. Unless we have
agreed to accept your results late without penalty, you will receive a nonparticipation score (see Performance Monitoring). Specimens analysed after
the closing date may no longer be suitable for analysis and you should contact
the scheme office for advice.
I’ve lost my web-entry instructions.
A PDF copy of the web entry instructions is available for download from the
documents section of the website (www.ukneqash.org).
I’ve forgotten my web-entry log in details.
Please contact the Scheme Office (preferably by e-mail) in the case of
forgotten login details.
Can I change my web-entry log in details?
Your web entry password can be changed by contacting the Scheme Office by
e-mail quoting your current details and your preferred password.
I have made an error when entering my results on-line.
If you realise you have made an error in your on-line submission or you submit
an incomplete set of results, contact us directly. We are able to reset your data
entry page until the closing date, allowing you to resubmit your results.
My results aren’t shown on my report!
This usually occurs because data has been submitted late or not at all, or has
not been received. If you know you have returned your results in time, contact
the Scheme immediately.
Why do I get a different answer when I calculate my own
statistics?
Results are generally loge transformed before calculating statistics, this
includes the calculation of DI value. It is not possible to calculate the SD from
the GCV using the usual formula.
Where do I find the Scheme’s Terms and Conditions?
These are available to download from the documents section of the Scheme
web-site (www.ukneqash.org)
Where do I find the JWG Conditions of Participation?
The JWG Conditions of Participation can be downloaded from
http://www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/
J/Joint_Working_Group_Conditions_of_Participation_August10.pdf
My lab manager has registered me for Digital Morphology but I
can’t see the current case?
Only participants with a current, active licence can access open cases. Ensure
you have activated your licence. If not, see your lab manager to obtain the
activation key.
ii
I haven’t received any email notifications about the Digital
Morphology cases.
Contact the UK NEQAS (H) Scheme office to verify your email address is on
the database.
I have forgotten my Digital Morphology log in details.
Contact the UK NEQAS (H) Scheme office or click on the ‘forgotten
password’ link from the Digital Morphology home page.
How do I register my staff on the UK NEQAS Parasitology
Teaching Day?
You can register staff for the Parasitology Teaching Day with your other UK
NEQAS (H) services, at re-registration. Contact the UK NEQAS (H) Scheme
office if you wish to register at other times or you wish to register additional
staff. Registration at other times is subject to availability of places.
iii
iv
THE UK NEQAS CHARITY
UK NEQAS facilitates optimal patient care by providing a
comprehensive external quality assessment service in laboratory
medicine. Through education and the promotion of best practice,
it helps ensure that the results of investigations are reliable and
comparable wherever they are produced.
UK NEQAS (H) is a member of the UK NEQAS charity and operates in
accordance with the UK NEQAS Codes of Practice (available from the UK
NEQAS Central Office website, www.ukneqas.org.uk).
The UK NEQAS charity is led by an elected President and an Executive
Committee of trustees, with representation from UK NEQAS Schemes in the
main divisions of laboratory medicine. The Executive is served by the
UK NEQAS Office, located at the Northern General Hospital in Sheffield,
which administers central UK NEQAS affairs.
UK NEQAS Charity Central Office
President:
Dr Bill Egner
Company Secretary: Mrs Julie Gelder
UK NEQAS Office
PO Box 401
Sheffield
S5 7YZ
UK
Telephone:
FAX:
Email:
Web:
+44 (0)114 261 1689
+44 (0)114 261 1049
[email protected]
www.ukneqas.org.uk
UK NEQAS (H) is part of the Haematology Division within UK NEQAS, with
UK NEQAS for Blood Transfusion Laboratory Practice, UK NEQAS for
Fetomaternal Haemorrhage, UK NEQAS for Leucocyte Immunophenotyping
and UK NEQAS for Blood Coagulation. Further details of these and all other
UK NEQAS services can be obtained from the UK NEQAS Central Office.
v
vi
CONTENTS
QUICK REFERENCE
i
THE UK NEQAS CHARITY
v
INTRODUCTION
1
UK NEQAS Compendium of Quality
1
WHY PARTICIPATE IN EQA?
2
ELIGIBILITY FOR PARTICIPATION
3
JOINT WORKING GROUP ON QUALITY ASSESSMENT CONDITIONS OF
PARTICIPATION
3
CONTACTING UK NEQAS (H)
4
COMPLAINTS AND APPEALS
5
GENERAL ADMINISTRATION
6
Location and Host Organisation
6
Scheme Staff
6
Logistics
6
Computer Systems
7
Participant Reference Number
7
Confidentiality
7
Data Protection Act (1998)
7
Value Added Tax (VAT)
8
ACCREDITATION
8
SURVEYS OFFERED
9
Survey material
9
Scheme and survey material pool identifiers
9
AUTOMATED COUNTING SURVEYS
10
Full Blood Count (FB surveys), including the Hb only option
10
Blood Component Quality Monitoring (CM surveys)
11
Automated Differential Leucocyte Count (DL surveys)
11
Reticulocyte Count (RE surveys)
12
Plasma Viscosity (PV surveys)
13
MORPHOLOGY SURVEYS
13
Blood Films for Morphology Comments, Differential Counting and Parasite
Identification (BF/DF/PA surveys)
13
Cytochemistry (CY surveys)
14
RDT Malaria (RD surveys)
14
Digital Morphology (DM surveys)
15
HAEMOGLOBINOPATHY SURVEYS
16
Abnormal Haemoglobins, Hb A2, Hb F and Hb S (AH surveys)
16
Newborn Sickle Screening (NH Surveys) using dried blood spots
17
DNA for Haemoglobinopathies (DN Surveys)
17
vii
OTHER SPECIALIST HAEMATOLOGY SURVEYS
Red Cell Enzymes (G6 surveys)
18
PILOT SCHEMES
19
EXPERIMENTAL TRIALS
19
EDUCATIONAL SCHEMES
19
Post analytical Haematology
19
Parasitology Teaching
19
REGISTRATION AND RE-REGISTRATION
20
Annual re-registration
21
Changes to registered information
21
Cancellation or suspension of participation
21
INFORMATION FOR SUCCESSFUL PARTICIPATION
23
Annual Distribution Schedule
23
UK Delivery
23
Survey package
23
Survey instruction sheets
23
Specimens and specimen handling
24
Returning results
24
Scheme Units
25
Late returns
25
Amendment of results
25
Result sheets and data entry screens
26
Survey closing and return of reports
26
SURVEY DATA ANALYSIS
27
Target value
27
Statistical processing of numerical data
27
Deviation index
28
PERFORMANCE SCORING
28
Group performance of instruments and methods
29
Non-participation Score
30
Analytical Performance Score
30
Calculation of Analytical Performance Score
31
Continuing assessment in the laboratory
32
PERFORMANCE MONITORING: KEY PRINCIPLES
viii
18
32
All participants (UK and International)
32
UK Participants
33
AH and NH Participants in English NHS Trusts
35
Confounding Factors
36
Withholding performance letters
37
Withdrawal of results or specimens from scoring
38
Equivalence with other terms
SURVEY REPORTS
38
38
Example: Blood Count Survey Reports
38
Use of reports
39
Amended reports
39
INTERNATIONAL PARTICIPANTS
40
Cost of participation
40
Registration
40
Scheme Language
40
Specimen Delivery
40
Closing dates and return of results
40
Reports and Performance Monitoring
41
Confidentiality
41
DISTRIBUTION AGENTS
41
WHO COLLABORATING CENTRE FOR QUALITY ASSURANCE IN
HAEMATOLOGY
42
OVERSIGHT OF EQA IN THE UK
43
UK NEQAS (H) Steering Committee
43
National Quality Assessment Advisory Panel (NQAAP)
45
Joint Working Group on Quality Assessment (JWG)
45
State of the art reports (BCSH & MHRA)
46
Consultation with manufacturers
46
APPENDIX 1: DEFINITION OF MATERIALS
47
APPENDIX 2: EXAMPLE INSTRUCTION SHEET
49
APPENDIX 3: EXAMPLE RESULT SHEET
50
APPENDIX 4: EXAMPLE REPORT
51
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for General Haematology: Handbook
INTRODUCTION
The UK National External Quality Assessment Service (UK NEQAS) is a
registered charity offering external quality assessment (EQA) services across
all pathology disciplines.
The primary aim of UK NEQAS is to maintain and improve performance of
diagnostic testing at a high level of proficiency, wherever testing is performed.
Participation in EQA is an established part of Quality Assurance and is actively
encouraged by professional bodies.
UK NEQAS for General Haematology (UK NEQAS (H)) is the expert centre
within UK NEQAS for all aspects of General Haematology diagnostic testing
external quality assessment (EQA). The Scheme provides EQA for automated
haematology
counting,
blood
and
bone
marrow
morphology,
haemoglobinopathies and other inherited red cell disorders.
UK NEQAS (H) offers a wide range of related EQA schemes from which
participants may select the combination that fits their laboratory profile. This
makes the Scheme flexible and adaptable to participants’ needs.
UK NEQAS (H) serves over 1300 participants, with approximately 750
laboratories and other pathology service providers in the UK and a further 600
internationally.
All UK NEQAS (H) services comply with the UK NEQAS Charity’s Code of
Practice and are offered on a not for profit basis.
UK NEQAS (H), on behalf of the World Health Organization (WHO), also
organises an International EQA Scheme (IEQAS (H)) which has been designed
mainly for developing countries. IEQAS (H) has nearly 80 participants in over
50 countries.
This Handbook contains the information you will need to participate
effectively in UK NEQAS (H). It should be kept in the laboratory and be
readily accessible to all laboratory staff. The latest version of this Handbook is
available to download from the UK NEQAS (H) website (www.ukneqash.org).
UK NEQAS Compendium of Quality
UK NEQAS has published a Compendium of Quality, illustrating the core
activities of UK NEQAS, particularly in providing performance data for tests
across the whole of pathology to diagnostic laboratories and industry and for
scrutiny of quality by the UK Accreditation Service, the Care Quality
Commission, the Medicines and Healthcare products Regulatory Agency,
provider governance systems and commissioners of services.
This Compendium ably demonstrates that the activities of UK NEQAS are
much broader than the technical accuracy and precision of results. UK
NEQAS provides electronic learning facilities, meetings and websites to
educate, train and develop the skills of the workforce in quality management
and quality improvement methodology. It is at the forefront of the
development of digital imaging techniques to provide educational packages for
personal performance and development. Advances in new technology and
processes (genomics, molecular pathology, POCT, digitisation, informatics)
require a strengthened quality assurance framework and the Compendium
provides examples of how new approaches to EQA are being developed.
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WHY PARTICIPATE IN EQA?
UK NEQAS: Helping to ensure clinical laboratory test results are
accurate, reliable and comparable wherever they are produced.
QUALITY ASSURANCE is the combination of measures taken to ensure
reliability and relevance of laboratory results, from the collection of the
specimen to the delivery of the report to the clinician. The component steps in
this process include:
 The selection of the test
 The identification of the patient
 The provision of suitable containers and collection of the specimen
 The transportation of the specimen
 The reception of the specimen in the laboratory
 The analytical procedures
 The validation of the results
 The interpretation and presentation of the results
 The delivery of the report to the clinician
Within the laboratory, two complementary processes, internal quality control
(IQC) and external quality assessment (EQA), are used to monitor
performance.
Internal Quality Control is intended to ensure that consistent, reproducible
results are achieved on a day-to-day basis. An analytical error should be
promptly identified and corrected before the test result is issued.
External quality assessment is intended to achieve inter-laboratory and, if
possible, inter-instrument harmonisation of results, and to monitor the general
level of performance in a laboratory. This assessment is long-term,
retrospective and provides periodic assessments of the way in which the
laboratory performs. Inter-laboratory surveys can be run at various levels:
international, national, regional or local. National and regional schemes
complement each other, each providing a different aspect of external quality
assessment. A national scheme may have a longer turnaround time due to the
large numbers of participants. Regional or local schemes have the advantage
of speed in giving participants the analysis of results; however, such schemes
have limitations. Statistical evaluation may be less robust due to the smaller
numbers of participants and even a few outliers may distort the results.
Furthermore, results may be biased by a consistent error, which will not be
detected until comparison is made with results obtained from a larger
population in a national scheme. The latter are more likely to be closer to the
true value.
In a national scheme, an individual laboratory can check its performance with
that of the whole country and with other laboratories using similar equipment
and procedures. The data from a national scheme enable an assessment of the
state of the art to be made, allowing the identification of faults in instruments,
reagents, control preparations and method procedures etc. When, as a result of
surveys, there has been improvement in the state of the art and a steady state is
reached, regular surveys are still needed to ensure continuation of good
practice.
A national scheme can be used to coordinate regional, local or organisational
reviews of performance, or smaller EQA schemes. In some regions,
participants may ask for a copy of their normally confidential results to be sent
to a designated regional quality control officer for review. The surveys may
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for General Haematology: Handbook
also provide a means by which control or calibration materials under
development can be evaluated in an independent critical study. Taking part in
a national scheme in addition to locally organised or regional schemes is thus
essential. It is also necessary to register for all tests available within a Scheme,
if such tests are included in the clinical services offered by the laboratory.
UK NEQAS (H) provides surveys in General Haematology at a national and
international level.
Comprehensive EQA services, as provided by UK NEQAS, test the quality of
laboratory medicine services beyond the analytical phase, with a scope that
extends to case interpretation, education and monitoring the pre and post
analytical phases.
ELIGIBILITY FOR PARTICIPATION
Participation is open to all diagnostic testing service providers, veterinary
laboratories, academic and commercial institutions in the UK and overseas.
Manufacturers are welcome to participate in all appropriate schemes or may
elect to receive summary reports only (‘information only’ participants).
There are restrictions on participation in some schemes, depending on the
availability of survey material, the instruments or kits used and the
geographical location of participants. Where possible, any such restrictions are
described in the relevant part of the ‘Surveys Offered’ section.
The Scheme office will advise if you have any queries about the suitability of
any particular survey for your needs. Participants are asked to review the UK
NEQAS General Haematology terms and conditions before registration (see
www.ukneqash.org).
JOINT WORKING GROUP ON QUALITY ASSESSMENT
CONDITIONS OF PARTICIPATION
Oversight of performance in EQA within the UK is the professional
responsibility of the Joint Working Group on Quality Assessment (JWG), a
committee of the Royal College of Pathologists (RCPath). The JWG has
established National Quality Assessment Advisory Panels (NQAAPs) for
specific disciplines to monitor the performance of UK laboratories providing a
direct or indirect clinical service and to offer advice to any laboratory with
persistent unsatisfactory performance (PUP). By registering with the Scheme,
UK participants that provide a clinical service agree to be bound by the JWG
Conditions of Participation, which may be downloaded from the JWG section
of the RCPath website (www.rcpath.org). These include the Haematology
NQAAP (“the Panel”) being informed if the participant has unresolved
performance issues.
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CONTACTING UK NEQAS (H)
UK NEQAS (H) aims to offer a participant driven Scheme. Participants are
encouraged to contact UK NEQAS (H) with comments and queries, as
feedback helps both participants to use the Scheme fully and Scheme staff to
plan appropriate developments.
Postal address:
UK NEQAS (H)
PO Box 14
WATFORD
WD18 0FJ
UK
Courier delivery:
To send anything to us by courier please contact the
Scheme Office for the street address
Telephone: (direct line)
International:
01923 217878
+ 44 1923 217878
Telephone lines are open between the hours 09:00 and 17:30 Monday to
Friday, with voice mail at other times and on public holidays.
Callers will be transferred to the appropriate member of staff according to their
enquiry. Participants are requested to have their Participant Reference Number
(PRN) available when contacting the Scheme. All calls are logged.
Fax:
(direct line)
International:
01923 217879
+ 44 1923 217879
The Scheme has the use of two fax machines and incoming documents are
automatically transferred to an available machine. However, a large volume of
traffic is received and the line can be busy, especially on survey closing date.
Please send a fax header with your fax, showing the number of pages
transmitted, your Participant Reference Number and your fax number. Given
this information, we will follow up an incomplete or illegible fax.
E-mail:
[email protected]
Website:
www.ukneqash.org
The website has information on
the Scheme as well as news items
and useful documents which may
be downloaded and printed.
Scheme Director:
Professor Keith Hyde
Contact address as above
Scheme Organiser & Deputy Director: Mrs Barbara De la Salle
Contact address as above
Steering Committee Chairman:
CD H54_Version 6.2 – Participants’ Handbook, November 2015
Professor Adrian Copplestone
Consultant Haematologist
Combined Laboratories
Derriford Hospital
Derriford Road
Plymouth, Devon
PL6 8DH
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for General Haematology: Handbook
COMPLAINTS AND APPEALS
The Director, Organiser and staff welcome the opportunity to discuss any
problem or query you may have.
If you remain unhappy with the service you have received, you should contact
the Scheme Director or Organiser by letter, email or telephone. We will
acknowledge your complaint within 5 working days and make every effort to
resolve the problem within 4 weeks. We will usually respond to you via the
same means of communication as used to contact us. All complaints are
reviewed formally by the Scheme Director or Organiser and an annual audit of
complaints is reported to the Steering Committee.
In the event that the complaint is not resolved to your satisfaction, you may
refer it to Chair of the Steering Committee, the UK NEQAS President, the
Chair of the NQAAP for Haematology or the Chair of the Joint Working Group
on Quality Assessment, as appropriate to its nature.
You have the right of appeal against a performance assessment score. This
should be addressed to the Scheme Director or Organiser and the appeal will be
dealt with in the same way as a complaint. If the investigation requires repeat
testing of the survey material sent to you, this will be undertaken independently
and anonymously by a laboratory nominated by the Chair of the Steering
Committee or the relevant Scientific Advisory Group. While an appeal is in
progress, no further action on performance will be taken, although it will
continue to be monitored. If you remain dissatisfied with the outcome of the
appeal, the final decision and resolution rests with the Chair of the NQAAP in
Haematology.
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GENERAL ADMINISTRATION
Location and Host Organisation
The Scheme is hosted by the West Herts Hospitals NHS Trust and operates
from a self-contained UK NEQAS Centre located at Watford General Hospital,
where it shares premises with the UK NEQAS for Blood Transfusion
Laboratory Practice (BTLP) and the UK NEQAS for Feto-Maternal
Haemorrhage (FMH). The Scheme has dedicated, secure office, laboratory and
logistics facilities.
The UK NEQAS Centre is part of the Clinical Support Division of the West
Hertfordshire Hospitals NHS Trust and all staff are Trust employees. In
accordance with Department of Health (DH) guidance, the Scheme is wholly
self-financing and is a cost-neutral activity for the Trust.
The Scheme gratefully acknowledges the hospitality of the West Herts
Hospitals NHS Trust and the support of colleagues in the Clinical Support
Division.
Scheme Staff
The UK NEQAS (H) Scheme Director, Professor Keith Hyde, is a Consultant
Clinical Scientist and former Director of Laboratory Medicine at the
Manchester Royal Infirmary. UK NEQAS (H) is staffed by the following
healthcare scientist and administrative staff, some of which are shared with
UK NEQAS BTLP and FMH:
Organiser and Deputy Director:
Data Manager:
Operations Manager and Morphology Lead:
Automated Counting Lead:
Haemoglobinopathy Consultant:
Scheme Scientists:
Associate practitioners:
Laboratory Assistant:
IT Manager:
Logistics Coordinator:
Administration Team Manager:
Office Manager(s):
Barbara De la Salle
Paul McTaggart
Dan Pelling
Vatsala Soni
Barbara Wild
Nikki Emodi
Nisha Lad
Gulala Karim
Paula Dynes
James Hindell
Vasilis Rapanakis
Stephen Herbert
Isabella De-Rosa
Pinky Bamhbra/Jen Rigg
Other clerical and logistics support staff are employed jointly with UK NEQAS
BTLP and FMH. This maximises the cost effective use of staff in common
areas such as administration, packing and dispatch.
The Quality Manager for the UK NEQAS Unit is Clare Milkins; this is a joint
post shared with the other Schemes based at Watford General Hospital.
Logistics
The Scheme has its own PO Box number and its own post room for the
franking of outgoing mail, which is collected directly by the Royal Mail or
courier to minimise delays. Survey material is distributed by first class mail
within the UK and we advise courier delivery to most destinations outside the
UK.
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The Scheme’s courier of choice is DHL International. Participants may opt to
use another courier or their own courier account; in these circumstances, an
administration fee will be applied to cover the additional work entailed.
Computer Systems
All Scheme data are held securely and backed up daily. Data processing is
performed using bespoke software, which has been developed in association
with the software company, KPMD (IT Solutions) Ltd. Results may be
returned using the Web Results Service and reports for most surveys are
available for secure download. Digital Morphology is hosted by SlidePath, a
Dublin based software company, utilising their Digital Slidebox™ application.
Participant Reference Number
Each participant is given a unique five digit Participant Reference Number
(PRN), which should be used in all communications with the Scheme. The
PRN issued is unique within the UK NEQAS organisation. Any new
participant registered is allocated a single PRN for use across all UK NEQAS
centres. If desired, a participant may choose to use a PRN with which they are
registered in other UK NEQAS schemes.
Where a participant registers more than one analyser or method in a scheme,
each analyser or method will be allocated a separate PRN, with the same core 5
digits but the addition of a letter suffix. Where possible, we link the PRN to
the analyser’s serial number and give the analyser the same PRN across all
schemes. We do not reuse PRNs, to avoid confusion.
Confidentiality
Registration information, raw data and performance details are confidential
between the individual participant, the Scheme Director and designated
UK NEQAS staff. The identity, performance details (and some relevant raw
data) of any UK participant may be shared with the NQAAP as part of the
reporting of persistent unsatisfactory performance. Performance data may be
shared with local management, regional QA officers, regulatory and
accrediting bodies and suppliers of equipment and reagents, where appropriate
and necessary, but only with written permission from the participant.
Participants in England registered in the Abnormal Haemoglobins, Newborn
Sickle Screening and DNA Diagnostics in Haemoglobinopathies Schemes
offering services covered by the National Sickle Cell & Thalassaemia
Screening Programme in England are asked to authorise in writing that their
identity may be disclosed to the Director of the National Programme in the
event of unsatisfactory performance.
As a part of our host NHS Trust, UK NEQAS (H) is subject to Freedom of
Information Act regulations.
Data Protection Act (1998)
The purpose of the Data Protection Act is to prevent the misuse of personal
data held on computers and to ensure that organisations holding such data
conform to certain standards. The West Hertfordshire Hospitals NHS Trust,
the host organisation for UK NEQAS (H), is registered as a data user under the
terms of the Data Protection Act. Information provided by participants on their
registration forms is held on a computer in order to identify those participants
registered for a given activity and to generate address labels for the dispatch of
material or reports. In addition, the survey results are held (as non-personal
data) on a computer for analysis. All participants are entitled to view their
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personal computer records on request. The Scheme records email addresses for
the purpose of notifying participants of survey distribution and report
availability; we will also use your email address to inform you of UK NEQAS
meetings and other EQA and pathology related activities unless you request
otherwise. We do not share participants’ email contact details with other
organisations.
Value Added Tax (VAT)
The Scheme is required by Her Majesty’s Revenue and Customs (HMRC) to
charge VAT on EQA services. In accordance with VAT regulations, VAT is
not added to invoices to participants based in other NHS Trusts within
England; all other participants (non-NHS in England, all participants in
Scotland, Wales, Northern Ireland, and European Union participants outside
the UK without a VAT registration number) will have VAT at the standard rate
applied to their bills.
ACCREDITATION
UK NEQAS (H) has been accredited since 1998 by Clinical Pathology
Accreditation (EQA) Ltd under the CPA accredited centre number 022. The
Scheme is transferring to accreditation by the UK Accreditation Service
(UKAS) to the ISO17043 standard.
UK NEQAS (H) holds accreditation for its full schemes. Pilot schemes and
some educational schemes are not accredited.
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SURVEYS OFFERED
UK NEQAS (H) is the expert centre within UK NEQAS for all aspects of
General Haematology diagnostic testing EQA. The Scheme remit covers EQA
for all areas of automated haematology counting, blood and bone marrow
morphology, haemoglobinopathies and other inherited red cell disorders. In
addition, the Scheme offers services in collaboration with other UK NEQAS
centres where diagnostic tests related to these areas cover more than one
pathology discipline.
UK NEQAS (H) offers a wide range of related EQA schemes from which
participants may select any combination that fits their laboratory profile. This
makes the Scheme flexible and adaptable to participants’ needs.
Surveys marked with an asterisk are awaiting confirmation of accreditation.
These services are operated to the same quality management system as the
accredited schemes.
Survey material
Except for some survey material that is sourced from commercial suppliers,
whole blood survey material is prepared, dispensed and tested on site. Donated
human whole blood, animal blood and some patients’ material, surplus to the
requirements for diagnostic testing, are used. Blood films for morphology and
cytochemistry are prepared from patient material, either on-site or by the
laboratory submitting the specimen; blood parasite slides and lysates for rapid
diagnostic testing for malaria are prepared by the Hospital for Tropical
Diseases, London. All slides are stained on-site, with the exception of those
for blood parasite identification.
Scheme and survey material pool identifiers
Each scheme is identified by a two letter code, e.g. FB for full blood count, DL
for automated differential leucocyte counting. The codes for the individual
schemes are shown in the scheme descriptions below. Where there are
different survey material types supplied within an individual scheme, these
have a separate code.
Survey material pools are given a unique code, comprising the last 2 digits of
the year, the chronological number of the survey within the year, the 2 letter
scheme or survey material identifier and the specimen number. For example,
the full blood count specimens distributed in April 2014, which was the fourth
full blood count distribution of the year, were coded as 1404FB1 and 1404FB2.
The blood films for morphology sent in the second blood films distribution of
2014 were coded as 1402BF1 and 1402BF2 etc.
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AUTOMATED COUNTING SURVEYS
Full Blood Count (FB surveys), including the Hb only
option

Purpose
This scheme is designed for users of automated haematology analysers
providing full blood count (FBC or CBC) data in clinical, veterinary, research,
pharmaceutical and health surveillance settings. The survey material is suitable
for all the major analyser models.
Point of care testing analysers are accommodated in this scheme, either in the
full blood count (FB) option, or in the haemoglobin only (HB) option,
depending on the parameters supplied by the instrument.

Analytes and units
o
o
o
o
o
o
o
o

White blood count (WBC)
Haemoglobin (Hb)
Red blood count (RBC)
Haematocrit (Hct)
Mean cell volume (MCV)
Mean cell haemoglobin (MCH)
Mean cell haemoglobin concentration (MCHC)
Platelet count (PLT)
Units
109/L
g/L
1012/L
L/L
fL
pg
g/L
109/L
Scheme design
Full blood count (FB) option: Two whole blood specimens are issued per
distribution, with 12 distributions per year on a monthly basis (24 specimens
per year). All participants receive the same material type, although instruments
are grouped for performance analysis. The specimens are prepared from
pooled human blood donations (collected from individually consented donors
by the UK NHS Blood and Transplant Service), partially fixed and treated with
antibiotics. Haemoglobin concentration, red blood count, white blood count
and platelet count are varied to test performance at levels of clinical decision
making. Participants may register up to 3 instruments for a single fee, with an
additional fee for each instrument above 3. A single set of survey material is
dispatched for multiple analysers. Point of care instruments that provide a full
blood count result, i.e. more than a haemoglobin result, may register in this
scheme.
Hb only (HB) option: Participants with point of care instruments that only
produce a haemoglobin result are registered in the Hb only option of the
scheme. Two whole blood specimens are provided 12 times per year. The
specimens are treated with antibiotics but not stabilised. Participants may
register up to 3 instruments for a single fee, with an additional charge for each
instrument above 3. A single set of specimens is dispatched for each analyser,
making this option convenient for analysers in multiple point of care testing
locations.
Both options are performance monitored for participation and analytical
performance, for all the parameters listed.
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
Instrument groups available
The instrument groupings available are shown in table 3 in the Performance
Scoring section. The Scheme Office can supply the most up to date list of
instrument groups.
Blood Component Quality Monitoring (CM surveys) *

Purpose
This scheme is designed as a supplement to the Full Blood Count scheme for
laboratories that prepare therapeutic blood components. The scheme supplies
specimens for haemoglobin concentration, haematocrit and platelet count at the
levels found in blood components, beyond the normal physiological ranges.

Analytes and units
Units
g/L
L/L
109/L
o Haemoglobin (Hb)
o Haematocrit (Hct)
o Platelet count (PLT)

Scheme design
Four distributions, each containing 2 red cell specimens for
haemoglobin/haematocrit and 2 platelet concentrate specimens for platelet
count, are made each year. Red cell specimens are not stabilised but are treated
with antibiotics. Platelet concentrate specimens are fully fixed. Participants
may register up to 3 analysers or modes of analysis, for a single fee.
The scheme is performance monitored for participation and analytical
performance, for all the parameters listed. Performance is monitored in a
single instrument group.
Automated Differential Leucocyte Count (DL surveys)

Purpose
This scheme is designed to complement the Full Blood Count scheme for any
participant who offers an automated differential count as part of their extended
full blood count.

Analytes
o Three or five population differential leucocyte count, as performed
using an automated haematology analyser.

Scheme design
Two specimens of commercially prepared whole blood material are distributed,
six times per year (12 specimens per year). Seven types of commercially
prepared survey material are available and the choice of material type (matrix)
is instrument dependent. Analysis of results is by material type and in some
cases by individual instrument type. Table 2 lists the matrices that are
distributed and the instruments covered by each matrix. The information in
table 2 is a guide only and the scheme office can provide the most up to date
information on availability of the scheme for particular analysers. Participants
may register up to 3 instruments for a single fee, with an additional fee for each
instrument above 3. A single set of survey material is dispatched for multiple
instruments; where a participant registers analysers that require different
matrices, these are supplied at no additional cost.
The scheme is performance monitored for participation and analytical
performance is undertaken for neutrophil and lymphocyte counts. Analysis of
other data is provided for information only.
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Table 2. Survey material types (matrices) for ADLC
Matrix
Instruments
A 3 population diff
Sysmex pocH-100i, Sysmex KX21, Sysmex XP-300,
Abbott Cell-Dyn Emerald
B 3 population diff
Horiba BX Micros 60, Horiba ABX Micros CRP,
Beckman Coulter Ac•T Diff, Mindray BC-3200,
Nihon Kohden CellTac MEK 6318K, Siemens Advia 60
C 5 population diff
Abbott Cell-Dyn 3200, Abbott Cell-Dyn 3700,
Abbott Cell-Dyn 4000, Abbott Cell-Dyn Ruby,
Abbott Cell-Dyn Sapphire
D 5 population diff
Siemens ADVIA 120, Siemens ADVIA 2120, Siemens ADVIA 2120i
E 5 population diff
Beckman Coulter Gen S, Beckman Coulter HMX,
Beckman Coulter LH500, Beckman Coulter LH750,
Beckman Coulter LH755, Beckman Coulter LH780
Beckman Coulter MaxM, Beckman Coulter Unicel DxH 600,
Beckman Coulter Unicell DxH 800
G 5 population diff
Horiba ABX Pentra 60, Horiba ABX Pentra 80,
Horiba ABX Pentra 120, Horiba ABX Pentra DF 120,
Horiba ABX Pentra DX 120, Horiba ABX Pentra DX Nexus,
Beckman Coulter Ac•T 5 Diff
J 5 population diff
Sysmex XE2100, Sysmex XE2100D, Sysmex XE2100L,
Sysmex XE5000, Sysmex XN-1000, Sysmex XN-2000,
Sysmex XN-9000, Sysmex XS800i, Sysmex XS1000i,
Sysmex XT1800i, Sysmex XT2000i, Sysmex XT4000i
Reticulocyte Count (RE surveys)

Purpose
This scheme is designed for the performance monitoring of reticulocyte
counting by automated analysers or visual, microscopy methods.

Analytes and units
Units
109/L
o Reticulocyte count

Scheme design
Two whole blood specimens are distributed six times per year (12 specimens
per year). For most analyser types, four specimens per year are commercially
produced; the remainder are prepared by UK NEQAS (H) from partially fixed
human whole blood, as for the full blood count specimens. Both types of
material should be suitable for manual staining methods and automated
reticulocyte counts. Beckman Coulter LH series analysers require a separate
survey material (Matrix X). Participants may register up to 3 instruments for a
single fee, with an additional fee for each instrument above 3. A single set of
survey material is dispatched for multiple instruments; where a participant
registers instruments that require different matrices, these are supplied at no
additional cost.
The scheme is performance monitored for participation and analytical
performance. Performance monitoring for automated counting methods is by
instrument group, and all microscopy methods are analysed in a single group.
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Plasma Viscosity (PV surveys) *

Purpose
This scheme monitors the performance of plasma viscosity.

Analytes and units
Units
mPas
o Plasma viscosity

Scheme design
Two specimens of plasma are distributed 12 times per year (24 specimens per
year). Survey material is prepared from donated plasma surplus to that
required for therapeutic use. The viscosity of the plasma is manipulated and
the material treated with antibiotics and an antifungal.
Analysis of results is by all methods and by instrument group, where there are
sufficient instruments available. Participants may register up to 3 instruments
for a single fee.
The scheme is monitored for participation and analytical performance.
Performance is monitored against all methods and instrument group, where
sufficient instruments are registered.
MORPHOLOGY SURVEYS
Blood Films for Morphology Comments, Differential
Counting and Parasite Identification (BF/DF/PA surveys)

Purpose
This scheme is designed to maintain and improve skills in blood film
morphology, manual differential counting and blood parasite identification.
Participation is by organisation. Participants may opt out of blood parasite
identification, if this is not a service that is offered as part of their clinical
repertoire; however, many sites in this situation choose to remain in this part of
the scheme for educational purposes. The fee is the same, whatever the level
of participation.

Analytes
o Peripheral blood films (with occasional bone marrow films) for the
identification of significant morphological features (BF slides)
o A 200 cell differential count is requested on selected blood films (DF
surveys) and results are returned as both percentage and absolute
counts
o Peripheral blood films for the detection and identification of blood
parasites (PA slides)
o A parasitaemia count (%) is requested if Plasmodium falciparum or
P. knowlesi is present

Scheme design
Two blood films for morphology comments are distributed eight times per year
(16 BF slides per year). A WBC differential is requested on four of the BF
slides each year (4 DF cases per year). Two blood films for blood parasite
identification are distributed four times per year (8 PA slides per year). Films
for morphology are fixed in methanol and stained with May-Grünwald-
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Giemsa; films for parasite identification are fixed in methanol or acetone and
stained as appropriate for the specific parasite
The scheme is monitored for participation, gross errors of morphological
identification, blood parasite detection and species identification and percent
parasitaemia counting (P. falciparum and P. knowlesi infections). DF surveys
are reported in summary format only, without individual participant
performance assessment.
The performance assessment of blood films for parasite identification is under
review and a new system is being shadow scored in 2014.
Cytochemistry (CY surveys)

Purpose
This scheme is designed to monitor the performance of iron stain for bone
marrow and urinary haemosiderin, and the performance of Sudan Black B
(SBB) or myeloperoxidase (MPO) stain.

Analytes
o Iron stain (Perls’ stain)
o Sudan Black B (SBB) or Myeloperoxidase (MPO)
Participants may register for one slide type or both. For Iron Stain, participants
are asked to stain the films for iron and to score the strength of the staining
reaction; additionally, they are asked to report the presence of sideroblasts. For
SBB/Myeloperoxidase, participants are asked to stain the films and report the
results as positive or negative and the strength of the staining reaction in
specific cell groups.

Scheme design
Two slides of either bone marrow or peripheral blood are issued per
distribution for either Iron Stain or SBB/Myeloperoxidase, with four
distributions per year (8 slides per year in total). Bone marrow slides for Iron
Stain are fixed in methanol; peripheral blood films for SBB are unfixed and are
accompanied by a methanol fixed film of the same case for Romanowsky
staining.
The scheme is monitored for participation. The analytical results are reported
to participants for self-assessment purposes.
RDT Malaria (RD surveys) *

Purpose
This scheme is designed to assess the performance of rapid diagnostic tests for
malaria detection. It is operated in collaboration with UK NEQAS
Parasitology and is offered to UK NEQAS Haematology participants registered
for the Blood Films scheme.

Analytes
o Detection of species specific malarial antigen in blood

Scheme design
Participants may register more than one kit method but must identify the results
generated from each kit registered.
Two specimens of lysed whole blood containing recombinant malarial antigen
are distributed 4 times a year, with each distribution of Blood Films for
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Parasite Identification. Results are returned as positive or negative for different
malaria infections, depending on the kit.
The scheme is monitored for participation and analytical performance. Shadow
scoring is in place during 2014.
NOTE
UK NEQAS General Haematology subcontracts the preparation of survey
material for the Blood Films for Parasite Identification (PA) and the Rapid
Diagnostic Testing for Malaria (RD) schemes to the Hospital for Tropical
Diseases, London.
Digital Morphology (DM surveys)
The Digital Morphology Scheme provides the opportunity for individual
practitioners to maintain and develop morphology and interpretive skills for the
purpose of continuing professional development (CPD). Participants can
register as individuals or a laboratory manager can register a group of staff.
Laboratory managers register participation in this scheme with their other UK
NEQAS (H) registrations. Individuals may register directly on the Digital
Morphology web pages (accessed via www.ukneqash.org) and pay securely
using PayPal.
This interpretive scheme offers the following benefits to participants:







Teaching, training and self-assessment
Maintenance of competency
High quality images
Same image viewed by all
State of the art virtual microscope software
Wide variety of cases
Secure on-line registration and participation
Each case comprises a virtual microscope slide, with brief patient history and
blood results. 6 cases are offered each year.
Participants examine the large scale, stitched digital slide with the assistance of
virtual microscope software, select the relevant morphological features and
offer a diagnosis. Each case also includes a small number of follow up
questions.
Results are submitted through a secure on-line account and participants receive
immediate feedback via case annotations. Final results and feedback are
provided at the close of the case, when participants can add their own reflective
comments and download a participation certificate.
The scheme is credited for Continuing Professional Development with the
Institute for Biomedical Science (IBMS) and the creditation code is printed on
each certificate.
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HAEMOGLOBINOPATHY SURVEYS
Abnormal Haemoglobins, Hb A2, Hb F and Hb S (AH
surveys)

Purpose
This scheme is designed to assess the performance of non-molecular detection
techniques in the screening and diagnostic testing for the haemoglobinopathies,
using liquid blood specimens.
There are 3 options for participation:
Option 1: Sickle screening only (SS specimens), for participants who perform
sickle solubility testing or other similar technique only.
Option 2: Full participation (SS and AH specimens), for participants who
undertake haemoglobin variant detection and identification (adult specimens),
fraction quantification and interpretation. Full participation includes the sickle
screening only option.
Option 3: Full participation plus the liquid capillary specimens for newborn
haemoglobinopathy screening option (SS, AH and LN specimens) for
participants who undertake the diagnostic testing of newborn infants’
specimens for haemoglobin variants in addition to testing adult specimens.
Participants may register for any or all of the analytes offered; the tariff of fees
varies according to the option selected.

Analytes and units
Units
o
o
o
o
o
o

Sickle screening test (SS specimens)
Hb variant identification: adult (AH) specimens
Hb variant identification: liquid newborn
(LN) specimens
Quantification of Hb A2, Hb F and Hb S (AH)
Assessment of Hb A2 and Hb F in terms
of the participant’s reference range (AH)
Interpretation of results (AH and LN)
% total Hb
Scheme design
There are 6 distributions per year of each option. Sickle screening only
participants receive 3 specimens in each survey for sickle screening (SS
specimens). Full participants receive the specimens for sickle screening, plus
an additional 3 specimens (AH specimens) for Hb variant identification using
all available methods, including sickle screening, fraction quantification and
interpretation. The specimens are prepared by UK NEQAS (H), and are
accompanied by background details of full blood count, age, gender, ethnic
group and clinical condition. The survey material is treated with antibiotics but
is not fixed. Participants registered for the liquid capillary newborn specimens
(LN) receive an additional 6 specimens per year for haemoglobin variant
identification and interpretation.
Participants are monitored for participation, sickle solubility test, Hb A 2
measurement and Hb S measurement. Fraction identification (AH or LN
specimens), Hb F quantification and interpretation of results are performance
assessed but there is no numerical performance score provided at present.
Where applicable, performance monitoring is based on the laboratory standards
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published by the National Sickle and Thalassaemia Screening Programme in
England.
Newborn Sickle Screening (NH Surveys) using dried blood
spots

Purpose
This scheme is designed to performance assess the screening of dried blood
spot cards for clinically significant variant haemoglobins by laboratories that
offer newborn sickle screening, either as a primary testing or a confirmatory
testing site.

Analytes
o Identification of sickle haemoglobin and other clinically significant
variant haemoglobins
o Interpretation of results obtained

Scheme design
12 distributions are made per year on a monthly basis. Each distribution
contains 3 dried blood spot newborn screening cards prepared from EDTA
anti-coagulated umbilical cord blood (36 specimens per year). The specimens
are suitable for screening by high performance liquid chromatography (HPLC),
isoelectric focusing (IEF), capillary electrophoresis (CE) and tandem mass
spectrometry (TMS).
Performance is scored for participation, fraction identification and
interpretation. The performance monitoring is based on the laboratory
standards published by the National Sickle and Thalassaemia Screening
Programme in England.
DNA for Haemoglobinopathies (DN Surveys) *

Purpose
This scheme is designed to performance assess the mutational analysis for
thalassaemia, with occasional samples for the identification of variant
haemoglobins, and the interpretation of the results obtained in context of the
patient’s clinical background and other haematology. It is suitable for
specialist laboratories that offer molecular haemoglobinopathy testing as part
of their diagnostic repertoire.

Analytes
o Mutational analysis for alpha and beta thalassaemia, with occasional
specimens for variant haemoglobins
o Interpretation of results obtained
o Recommendations for follow up
o Annotation of results making the correct use of the HGVS
nomenclature system

Scheme design
Three distributions, each containing 2 specimens, are made per year (6
specimens in total). Survey material is supplied as DNA in TE buffer and is
suitable for all molecular haemoglobinopathy techniques. Each specimen is
supplied with clinical case details, gender, ethnic background and haematology
results.
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Participants may register for full participation or for alpha or beta thalassaemia
mutational testing only, at a reduced fee. All receive the same samples.
Participants are monitored for participation and analytical performance.
Analytical performance is against a model answer defined by a panel of the
scheme’s expert advisors and shadow scoring is in operation during 2014.
OTHER SPECIALIST HAEMATOLOGY SURVEYS
Red Cell Enzymes (G6 surveys)

Purpose
This scheme monitors the screening and/or quantitative assay of red cell
enzymes. These surveys are currently restricted to Glucose-6-phosphate
dehydrogenase (G6PD) specimens only.

Analytes and units
G6PD
o Qualitative screening test
o Quantitative assay
o Assessment of quantitation in terms
of the participant’s reference range

Units
IU/gHb
Scheme design
Six distributions of 2 specimens each are made per year. The specimens are
prepared by UK NEQAS (H) from human whole blood and animal whole
blood. The survey material is treated with antibiotics but is not fixed, and is
dispensed using the same method as for full blood count specimens. The
survey material is suitable for most recognised methods currently available,
although variable results have been reported with screening methods based on
dye decolourisation. For this reason, this method is not actively performance
assessed.
Participants may register for the screening test or the quantitative assay or both.
The same fee is charged in all cases. Performance is scored for participation,
screening and quantitative assay.
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PILOT SCHEMES
Before a new scheme is recognised as a full scheme, it is operated on a pilot
basis. These schemes may or may not be charged for depending upon the
degree of development and the availability of alternative sources of funding.
Pilot schemes are not formally performance assessed and out of consensus
performance is reported to the participant only, for information.
UK NEQAS (H) offers pilot schemes in development for:

Nucleated red blood cell count

Erythrocyte sedimentation rate
EXPERIMENTAL TRIALS
Experimental trials to identify specific sources of error or to test new materials
and assay procedures may also be distributed. These experimental trials are
distributed as additional, free of charge, surveys usually in the same mailing as
the normal surveys. Individual laboratory performance is NOT assessed in
these trials.
Participants may be invited to take part in studies as part of larger projects.
Participation in these studies is always voluntary.
Some trials may involve the use of questionnaires. Where possible, these are
distributed electronically, usually to the main laboratory contact. Again,
participation is voluntary.
UK NEQAS (H) greatly appreciates the effort and support of participants in
any development work.
EDUCATIONAL SCHEMES
Post analytical Haematology
This pilot interpretative scheme is not being offered during 2014 – 15.
Parasitology Teaching
The Parasitology Teaching day is offered in conjunction with the UK NEQAS
Parasitology Scheme.
The day covers all aspects of blood parasite
identification and each participant receives a teaching manual and set of
teaching slides to keep. The participant fee covers up to two members of staff.
Teaching sessions are offered at a variety of locations throughout the UK and
Republic of Ireland during the year. Once registered, you will be offered a
place at the geographical location closest to your organisation.
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REGISTRATION AND RE-REGISTRATION
All prospective, individual participants registering directly in the Scheme
receive the following, either electronically or by post:





An introductory letter or email
A copy of this Handbook
A registration form
A table of fees for the current UK financial year
(1st April to 31st March)
An annual schedule of distribution dates
(1st April to 31st March)
Where requested, the Scheme office will supply a formal quotation for the
services required.
Completion of the registration form indicates that the prospective participant
agrees to abide by the terms and conditions of registration with the scheme, and
that any UK participant supplying a direct or indirect clinical service agrees to
abide by the Joint Working Group on Quality Assessment’s Conditions of
Participation.
Participants are requested to provide contact details for a named laboratory
contact (main contact) to whom the specimens will be sent, a named consultant
or quality manager contact to whom correspondence concerning performance
will be sent and an invoicing contact. The laboratory contact must supply a
functioning email address as much of the Scheme’s operation is conducted
electronically. The participant may register additional contacts, who will be
able to submit results and access reports online.
A new participant is included in the next available distribution, as long as the
registration form is received at least three weeks before the distribution date
and subject to the availability of survey material. We will inform you
immediately if there is likely to be any delay to commencement of your
participation.
Following receipt of the completed registration form, an invoice is issued to the
participant’s finance address. The invoice total is calculated pro rata to the
number of distributions remaining for the current financial year
(April - March). First class postal delivery in the UK for survey packages is
included in the fee; any additional carriage or postage costs will be added to the
invoice plus a printing, postage and packing fee for non-web report return for
web-based schemes. The scheme will charge for additional services (e.g.
inclusion of cold packs) that are not covered by the standard fee.
The Scheme reserves the right not to confirm registration of a participant until
an official purchase order number or payment has been received. Once the
administration has been completed, the laboratory will be issued with a
Participant Reference Number (PRN) and will be informed of the date of the
first distribution.
The Scheme will register multiple sites and analysers, subject to the conditions
listed in the Surveys Offered section. In general, the Scheme will register as
many instruments, providing an analyser generated, numerical result, as the
participant requires under the same participation. Only one submission is
allowed for elements of a scheme involving interpretation or diagnosis. Thus
for the Abnormal Haemoglobins scheme, multiple analysers may be registered
for fraction quantification but only one submission per participant can be made
for haemoglobin variant identification and interpretation of results.
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The specimens for all instruments registered under the same PRN will be sent
to a single named laboratory contact and have the same named consultant and
finance contact. Where instruments are under the same PRN but on different
sites, the participant must be able to process the specimens through all the
analysers and return results by the closing date. Each analyser registered is
given a unique identifier, comprising the PRN with a letter suffix.
The Scheme operates a one analyser, one identifier policy and requires a serial
number to be supplied with each analyser registered. When an analyser is
replaced, a new analyser identifier is issued for the replacement analyser. The
only exception to this arrangement is for some point of care testing sites, where
the analysers are regularly exchanged.
The Scheme will issue a certificate of registration on request.
The arrangements for registration through one of our recognised distribution
agents may differ, depending upon the agent. The services provided by UK
NEQAS (H) are the same for all participants.
Annual re-registration
Between January and March of each year, participants that register directly are
contacted and asked to confirm their re-registration details for the following
financial year online, and to provide a purchase order number, which is used to
raise an invoice in April or May.
Changes to registered information
Alterations to your registered details, including changes in instrument or
method details, should be sent to us in writing, either by letter, fax or email,
signed or sent by one of the named contacts, the head of the laboratory or
laboratory manager. You may notify us of a change at short notice by
telephone, but we will ask you to confirm in writing as soon as possible.
We request that 3 weeks’ notice is given for changes to registered details to be
effective, i.e. changes sent by the end of the first week in the month will take
effect from the distribution for the following month. We regret that we cannot
guarantee to process changes to registered details notified on your results return
page or results sheet, as this delays data entry and may be overlooked due to
the volume of data to be processed.
Please inform us of any changes to your registered details immediately. Delay
may result in inappropriate data analysis and adverse performance assessment.
Cancellation or suspension of participation
Please notify the Scheme office in writing (by letter, fax or email) if you wish
to cancel your participation in any survey, giving at least three weeks’ notice
before the next distribution date for the survey. Services cancelled without this
notice period will be charged for. The Scheme may apply an administration
charge, equivalent to one quarter’s registration fee, for deregistration in the
second half of the participation year.
UK laboratories are asked to supply a reason for deregistration from any part of
the Scheme’s services. Deregistration by UK laboratories is summarised to the
National Quality Assessment Advisory Panel for Haematology on a quarterly
basis. Deregistration by a UK participant with performance problems is
notified to the NQAAP immediately.
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You may suspend your participation in any survey temporarily if your
laboratory is not offering the test as a clinical service for any reason or your
analyser is out of service, providing that you notify us in writing, including by
email or fax.
The Scheme will cancel the registration of any participating laboratory that
fails to pay the appropriate charges. Any UK laboratory under the remit of the
Joint Working Group on Quality Assessment will be notified to the NQAAP
for Haematology in the event that services are cancelled due to non-payment of
subscription fees.
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INFORMATION FOR SUCCESSFUL PARTICIPATION
Annual Distribution Schedule
Regular participation is essential to gain maximum benefit from registration.
All participants are sent an annual distribution schedule(s) with their reregistration form, which lets you know when to expect specimen packages.
This schedule lists the date and content for each distribution in the following
registration year (April – March). The participation schedules are available to
download if additional copies are needed.
UK Delivery
Survey packages are sent by first class post within the UK. If you do not
receive your package within 2 days of the survey distribution date, please
contact the Scheme office as soon as possible and also check your
organisation’s internal post room or delivery service. If your survey specimens
are frequently delayed please contact the Scheme to discuss the problem.
Within the UK, Royal Mail Special Delivery can be used for a small additional
charge.
Survey package
Your survey package will contain the following:




Specimens for the surveys you are registered for
Instruction sheet(s)
Summary information for the safe handling of survey material
(Control of Substances Hazardous to Health (COSHH) information)
Results sheet(s) for participants not registered for web return
Please check your survey package upon receipt and notify the Scheme office as
soon as possible of any missing specimens or documents, or broken, leaking or
unlabelled specimens. We will dispatch replacements immediately and will
allow you additional time to return your results, if possible.
Survey instruction sheets
Separate instruction sheets are provided for each of the surveys for which you
are registered. It is important to read the instruction sheet as the information
may change from survey to survey. The survey instruction sheets all follow the
same pattern and consist of six sections; see the example in Appendix 2.






Section one describes the contents of the distribution package; this
information is common to all the instruction sheets in the
distribution.
Section two refers to the relevant information for COSHH. Detailed
COSHH information is contained in the standard COSHH
information sheet included in each survey package.
Section three describes the intended use of the survey specimens.
Section four describes the survey and gives any specific information
that may be required for the handling and analysis of the specimens,
e.g. patient data, method codes.
Section five details how to return the results to UK NEQAS (H).
Section six gives information on the next distribution.
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Specimens and specimen handling
To give a true assessment of performance in a laboratory, EQA specimens
should be treated in the same way as patients’ samples. We appreciate that this
is not possible in some cases because of the type of survey material but we ask
participants to avoid repeat testing, unless this would be done for patients’
material. Collusion between participants is strongly discouraged. Any
suspicion of collusion, if confirmed, will be reported to the NQAAP for
Haematology.
Some survey specimens (e.g. Abnormal Haemoglobins) are produced from
single blood donations and are therefore limited in volume. In this case it is
not possible to send the volume that you would receive for a patient’s
specimen. Please contact the Scheme if you use a manual method that requires
a larger volume than contained in one standard specimen, as it may be possible
to dispatch an additional specimen with your survey package, subject to
availability of survey material.
Repeat specimens are generally available throughout the survey period to
replace specimens received in an unsatisfactory condition (i.e. broken, leaking,
unlabelled, haemolysed or clotted) and to replace those accidentally damaged
or misplaced in the laboratory. Please contact the Scheme office as soon as
you realise you need repeat specimens. Specimens may be neither available
nor suitable for analysis after the survey has closed.
Specimens, or what remains of them, should be retained until the report of the
survey is received, in case of any query.
The materials distributed are provided as specimens for the sole purpose of
enabling external quality assessment of laboratory performance during the
current distribution. They do not constitute in vitro medical diagnostic devices
(IVDs), and are not suitable for any other purpose.
Although all our product pools are screened for microbial contamination and
individual human donations are screened for HIV I/II antibodies, HCV
antibodies and for HBsAg, they should be handled and disposed of as clinical
waste.
Returning results
Web Results Service
Web entry is available for the majority of established schemes. Once
registered as a Web User, you will be sent an email with your logon
information, containing:

your Participant Reference Number (Laboratory Code)

a five digit number (Identity)

a seven character password
Participants may register as many members of staff as they wish to access the
data entry and reports service. Each member of staff will need their own logon
information.
Instructions for using the Web Results Service are available to download from
the documents section of our website (www.ukneqash.org).
Participants who experience problems returning results using the Web Results
Service should contact the Scheme office for advice.
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Where a participant is registered for web entry for one survey type, they will be
expected to use web entry for all surveys for which it is available.
Non-web results
An additional fee is charged to participants who do not use web entry for
schemes where it is available. This is a single, annual fee and it covers the
additional costs to the Scheme of manual data entry, printing, packing and
posting of paper reports. This fee is not applicable to the return of results by
fax for reasons beyond the control of the participant, e.g. the return of late
results or due to the non-availability of the web service.
Results should be returned by fax, as posted results often arrive after the
closing date. The UK NEQAS (H) fax number (+44 (0)1923 217879), and the
survey closing date, are shown on every result sheet.
When sending results by fax it is good practice to send a fax header sheet
giving details of the sender, including your PRN, a contact fax number and the
total number of sheets to be expected. We will contact you if we receive
incomplete or illegible results.
If you fax results, please do not post them as well.
You should keep a copy of the results sheet(s) submitted and the fax
confirmation, in case of queries.
Scheme Units
The units used by the Scheme are shown in the Surveys Offered section of this
handbook. Results in other units are not accepted and their use may result in
an adverse performance assessment.
Late returns
If you are unable to return your results by the closing date, you may submit
them late. Web users should contact the Scheme for a results sheet or may use
a results sheet available for download from the data entry website. If you use a
download form, make sure you enter your participant reference number.
When you return results late, the first report you receive may not show your
results. A second ‘late’ report, showing your results, will be generated before
the next survey is processed. Unless we have agreed to accept your results late
without penalty, you will receive a non-participation score (see Performance
Monitoring).
In general, results will not be accepted if the specimens have been analysed
after the report has been issued, although this does not apply if the participant
can show that the raw data is captured directly from the analyser.
Some survey material is unsuitable for analysis after the closing date and the
Scheme may not accept results in these circumstances. You are advised to
contact the Scheme before analysing specimens after the closing date.
The Scheme reserves the right to reject results submitted after the subsequent
survey has been dispatched, regardless of the analysis date, unless this is
necessary to correct an error made by the Scheme.
Amendment of results
You may amend your results at any time up to the survey closing date. If you
have saved but not submitted your results online, you can amend them without
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assistance. If you have submitted your results, you can ask the Scheme to reset
your data entry screens to allow you to make an alteration.
Participants may occasionally incur a performance penalty that is caused by the
necessity to report EQA results in a different format or manner from that used
for patients’ samples. In these circumstances, the Scheme will modify results
after the closing date, provided the participant can provide evidence that the
specimens had been correctly analysed up to the point where they were
reported. A typical example would be a transcription error in the data entry of
full blood count results, where patients’ results are reported directly via a
LIMS. In this case, a copy of the instrument printout, showing that the samples
were analysed correctly before the survey closing date, would be sufficient
evidence. The Scheme reserves the right not to correct results if a participant
asks for this action regularly. Results are only amended after the closing date
with the agreement of the Scheme Organiser or Data Manager.
The Scheme will not amend results that arise from specimen transposition or
where the correct identification and manual transcription of results is an
integral part of the procedure, e.g. for molecular testing.
The Scheme will amend results at any time to correct an adverse score incurred
because of an error by the Scheme.
Result sheets and data entry screens
Results sheets and data entry screens vary with the tests, but a standard layout
has been used as far as possible. Results sheets are not supplied to registered
web users, although a results document for internal use may be downloaded
from the data entry website for most schemes.
Additional information may be requested for some tests, including details of
the method used, an assessment of results submitted in terms of the normal
reference range in use in the laboratory, or an interpretation of the results.
Specific directions will be included in Section 4 of the instruction sheet for the
survey.
Survey closing and return of reports
The closing dates for surveys are set to accommodate the stability of the survey
material and the requirement of the majority of participants to receive a report
as soon as possible after submission of results. They may not be convenient to
all participants on all occasions, especially for some of the non-FBC surveys.
If you have problems in returning results by the closing date, please contact the
Scheme office.
The closing date for each survey is published on the survey instruction sheet.
We make every effort to return reports quickly once a survey has closed;
however, some reports depend on expert comment from external scheme
advisors. These reports may take a little longer.
Newborn sickle screening reports are issued 7 days after survey closing but
may be delayed if we are awaiting repeat testing results or late results from
participants.
We aim to return the reports for specialist surveys, such as DNA for
Haemoglobinopathies, Blood Component Quality Monitoring and pilot
schemes, within 4 weeks of the survey closing.
Opting for web operation, where available, removes additional delays resulting
from postal delivery of reports.
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SURVEY DATA ANALYSIS
Target value
Individual results are assessed against a target value.
For categorical data, the target value is the consensus result returned by
participants, unless there is a known ‘true’ value, e.g. the identification of a
parasite species by PCR. The Scheme has acceptance criteria for the % of
participants that must be in agreement with the consensus target or the ‘true’
value for the specimen to be used for scoring.
The consensus value for numerical data may be either a trimmed mean or
median or, where appropriate, the method trimmed mean or median. The
survey data is also used to produce the standard deviation (SD) and coefficient
of variation (CV%).
Statistical processing of numerical data
Statistical analysis is performed on all the results submitted for each test to give
the all methods statistics. Results may then be divided into groups and reanalysed to give appropriate method group and in some cases sub-method
group statistics.
Each parameter is classified independently; this allows for greater flexibility in
regrouping as new equipment becomes available.

Using the trimmed mean as consensus value
Depending on the data, transformation (e.g. logs) may be used. As the mean
(M) may be unduly affected by the presence of outlier results, symmetrical
trimming of the data set is employed to remove any potential outliers. Ten
percent trimming (five percent from each end of the data) is employed at
present. An SD is calculated using Downton’s method for estimation of the
SD, which compensates for the data removed by trimming.
In an effort to smooth out the effects of the variability of the dispersion of the
data from survey to survey, an historical SD (HSD) is used. This HSD is the
pooled SD of each specimen from the last six months.

Using the median as consensus value
Where the distribution of the data is problematical, the statistical techniques of
Tukey are used to estimate the location and spread of the distribution of results
to give:




Median (M)
Estimated standard deviation (SD)
Number of observations (N)
Coefficient of variation (CV)
The reason for using the median rather than the mean is twofold:


It is not dependent on the shape of the distribution
It is much less affected by the outlying values
The spread of the central 50% of the population between the quartiles is related
to a normal Gaussian distribution to give the estimated standard deviation.
This in turn is used to determine the coefficient of variation.
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Deviation index
The distance of each result from the median (or mean) expressed in standard
deviation units is known as the Deviation Index (DI) and is used to indicate
individual performance in one survey.
DI =
where:

R
M
SD
R-M
SD
= Laboratory result
= Median or Mean
= Standard deviation
Interpretation of Deviation Index for FBC parameters
From the equation above, the DI may be either a positive or negative number.
The table below gives a guide to interpretation of the DI. This has been
adapted from ISO13528:2005.
DI
< -3.0
-3.0 – -2.0
-2.0 – -1.0
-1.0 – -0.5
-0.5 – 0.5
0.5 – 1.0
1.0 – 2.0
2.0 – 3.0
>3.0
Interpretation
Serious problem requiring investigation
Check calibration, check instrumentation
Satisfactory – borderline
Good
Excellent
Good
Satisfactory – borderline
Check calibration, check instrumentation
Serious problem requiring investigation
PERFORMANCE SCORING
The purpose of EQA is to provide an objective, long term, retrospective
assessment of laboratory performance and to improve performance through
education. Individual laboratory performance in all surveys is assessed against
the consensus result for the survey and a scoring system is used to help achieve
this.
The Scheme employs expert statistical advice for the development and review
of performance scoring. All performance scoring is approved by the Steering
Committee or relevant Scientific Advisory Group and the NQAAP before
implementation. Any scoring system in development or awaiting this approval
is operated on a shadow basis, for information only.
The performance scoring system was developed in conjunction with the
UK NEQAS (H) Steering Committee and NQAAP for Haematology. It
consists of two parts: a non-participation score and an analytical performance
score. The non-participation score is applied to all survey types; the analytical
performance score was first introduced in the Blood Count, Reticulocyte and
ADLC surveys, and has now been adapted for use in most other
UK NEQAS (H) surveys.
For both non-participation and analytical performance, a score is allocated or
calculated for performance, as explained below. For those analytes that do not
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currently have an analytical performance score, a laboratory receives an outlier
letter if their result is out of consensus. The number of outlier letters sent to a
laboratory for any survey type is monitored.
Group performance of instruments and methods
The specimens used by UK NEQAS (H) for automated cell counting are
usually stabilised in some way. This stabilised material may respond
differently depending on the instruments/methods and reagent systems used.
There may, therefore, be performance differences between the various methods
and instruments; which do not reflect behaviour with the usual clinical blood
specimens. Group statistics are therefore used to monitor performance, where
appropriate. The instrument groups used for FBC are shown in table 3; those
for other survey types are available on request. Instrument grouping is
dynamic and the most up to date list is available from the Scheme Office.
Table 3. Instrument groups for Full Blood Count
Group Name
Instrument
Abbott Cell-Dyn 3000 Series
Abbott Cell-Dyn 3500, Abbott Cell-Dyn 3700
Abbott Cell-Dyn 3200 & Ruby
Abbott Cell-Dyn 3200, Abbott Cell Dyn Ruby
Abbott Cell-Dyn 4000 &
Sapphire
Abbott Cell-Dyn 4000, Abbott Cell-Dyn Sapphire
Beckman Coulter LH Series
Beckman Coulter GenS, Beckman Coulter LH500,
Beckman Coulter LH750, Beckman Coulter LH755,
Beckman Coulter LH780, Beckman Coulter StkS
Beckman Coulter T Series
Beckman Coulter Ac•T 10, Beckman Coulter HMX,
Beckman Coulter Ac•T Diff, Beckman Coulter Ac•T 8,
Beckman Coulter Max M
Beckman Coulter UniCel DxH
800
Beckman Coulter UniCel DxH 600
Beckman Coulter UniCel DxH 800
Horiba Instruments
Horiba ABX Micros 60, Horiba ABX Micros CRP
Horiba ABX Pentra Series
Horiba ABX Pentra 60, Horiba ABX Pentra 80,
Horiba ABX Pentra 120, Horiba ABX Pentra DF 120,
Horiba ABX Pentra DX 120, Horiba ABX Pentra DX
Nexus, Beckman Coulter Ac•T 5 Diff
Siemens ADVIA 120
Siemens ADVIA 120, Siemens ADVIA 2120,
Siemens ADVIA 2120i
Sysmex K Series
Sysmex K1000, Sysmex K4500, Sysmex KX21,
Sysmex XP-300
Sysmex pocH-100i
Sysmex pocH-100i
Sysmex X – Class
Sysmex XE2100, Sysmex XE2100D, Sysmex XE2100L,
Sysmex XE5000, Sysmex XN-1000, Sysmex XN-2000,
Sysmex XN-9000
Sysmex XT Series
Sysmex XS_500i, Sysmex XS800i, Sysmex XS1000i,
Sysmex XT1800i, Sysmex XT2000i, Sysmex XT4000i
Miscellaneous
Instruments with insufficient numbers registered to form
an instrument class.
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UK NEQAS (H) requires a minimum of 20 instruments registered to form an
instrument group for statistical analysis. Where there are insufficient users of a
methodology registered to form a group, the all methods statistics are used.
Instrument grouping is decided by an evidence based process, using advice
from the instrument manufacturers, expert users from the Steering Committee
and Scientific Advisory Groups and evaluation of UK NEQAS (H) data. A
request to amend instrument grouping may be made by UK NEQAS (H) staff,
the instrument manufacturer, a Scheme advisor, a participant or other
stakeholder to the Scheme Organiser or Data Manager. Changes to instrument
grouping are ratified by the appropriate SAG and reported to the NQAAP.
Non-participation Score
Participation in any survey will be given a nil score and a late or non-return a
score of 50. The total for the most recent three surveys will then give the nonparticipation score. Thus, two late or non-returns out of three surveys will
generate a score of 100, which is considered Persistent Unsatisfactory
Performance (PUP). A single non return is considered unsatisfactory
performance (UP).
Analytical Performance Score
For numerical data, this is a running score derived from the results for the most
recent six specimens for which results have been returned. The running
analytical performance score for each parameter is calculated from the group
deviation indices of the six specimens. The calculation of the analytical
performance score is shown in more detail below.
For categorical data, the analytical performance score is derived from the sum
of the adverse scores allocated for different errors. These are presented as a
look up table of scores for correct and incorrect returns. The score for an
individual distribution is the sum of the scores incurred in that distribution; this
may then be truncated and carried forward for summation across 3 surveys to
give the running analytical performance score. This truncation avoids a single
error, e.g. transposition, having an undue impact on the cumulative analytical
performance score.
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Calculation of Analytical Performance Score
The full blood count data is used as an example:
1.
Group Deviation Indices are calculated using the formula:
DI =
R=
M=
SD =
2.
3.
4.
5.
R-M
SD
laboratory result
trimmed mean for each specimen in each instrument class
and survey
trimmed SD in each instrument class estimated by pooling
the SD values for all specimens in a six-month period where
all results have been subject to logarithmic transformation
before analysis
The absolute value of the group deviation index is taken (ignoring
the sign) and any values >3.5, are rounded down to 3.5. This is to
avoid a very high DI value, e.g. due to a transcription or
transposition error, having an excessive effect on the calculations.
The resulting group deviation indices for the two specimens over
three surveys are then added together and the total multiplied by
multiplication factor. For the FBC survey, this multiplier is six.
Different multipliers may be used in different schemes (see below).
In the event of non-participation, earlier data will be used in the
calculation.
This approach, i.e. rounding down to 3.5 and multiplying the total of
the group deviation indices by a multiplier, has been chosen, by
experiment, so that the action point for review of performance is
indicated by a score of ≥100. For FBC, this means that an average
absolute group deviation index, after any rounding down, of ≥ 2.8
will produce a score of ≥ 100, i.e. (2.8+2.8+2.8+2.8+2.8+2.8) x 6 =
100.8.
Example 1 Deviation indices were obtained as follows for an FBC
parameter:
Survey
1
2
3
Specimen 1
-0.64
0.00
-1.89
Specimen 2
+1.85
+1.13
+0.64
The score is calculated by ignoring the sign, rounding any value
> 3.5 down to 3.5 and multiplying the total by 6.
Score = (0.64 + 1.85 + 0.00 + 1.13 + 1.89 + 0.64) x 6 = 37
i.e. Satisfactory performance
Example 2 Deviation indices were obtained as follows for another FBC
parameter:
Survey
1
2
3
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-7.05
+2.89
-2.64
31
Specimen 2
+2.80
+4.11
+2.05
for General Haematology: Handbook
The score is calculated by ignoring the sign, rounding any value
> 3.5 down to 3.5 and multiplying the total by 6.
Score = (3.50 + 2.80 + 2.89 + 3.50 + 2.64 + 2.05) x 6 = 104
i.e. Unsatisfactory Performance
The analytical performance score for numerical parameters in other surveys is
calculated according to the same principles. The truncation and the multiplier
constants may be modified according to the survey and the number of
specimens included in the calculation altered.
Where possible, the
performance score is calculated over a rolling time window of 3 surveys or 6
specimens.
The current multiplier values used in different survey types are:

FBC / Hb only / ADLC / Retics:
6

Hb A2 / Hb S:
9

G6PD quantification
10
The multiplier may be varied according to advice from the Scheme’s statistical
and scientific advisors. Any change will be notified to participants.
Continuing assessment in the laboratory
A plot of the cumulative analytical performance score is shown in each report.
To obtain full benefit from the Scheme, participants are encouraged to monitor
their own performance. For each parameter, a plot of DI as + or - for all
specimens in each survey should highlight trends in a readily discernible way.
The overall trend of performance and any differences in performance between
the specimens in a survey can be identified. In general, wide variation between
specimens is likely to be due to a random error.
EQA provides a means for self-assessment by the participant who is
encouraged to contact the Scheme to discuss problems. Wherever possible, we
will supply additional material for checking instrument calibration and
identifying factors responsible for performance errors. When requesting
additional material, however, participants should remember that the Scheme
survey material is a scarce resource and has a limited shelf life.
PERFORMANCE MONITORING: KEY PRINCIPLES
All participants (UK and International)
All participants receive a participation score for all surveys. A participation
score of ≥100 for participation is regarded as persistent unsatisfactory
performance, as it demonstrates non or late return of results for 2 of 3
consecutive surveys.
Where an analytical performance score is calculated, as described in the scheme
design, it is shown in the participant’s individual report. Where there is no
analytical performance score, the target or expected result and the participant’s
result is shown in the report.
All scoring systems for numerical data are based on the longitudinal
assessment of how far an individual participant’s results are from the target
value for a parameter and aim to give a long-term, retrospective picture of
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laboratory performance. Within UK NEQAS Haematology, the deviation
index (DI) is used to determine the distance from the target value for
quantitative data.
Look up tables are used to determine the score for categorical data.
The UK NEQAS Haematology performance algorithms have been developed
with a cut off of 100 as the point at which action is taken on analytical
performance for quantitative tests. For non-quantitative tests, an initial
notification of unsatisfactory performance may be sent for error(s) in a single
survey.
At the conclusion of each distribution, the performance of all participants is
filtered to identify those with performance scores in the following order:






Numbers of participants with scores ≥100 for participation
Numbers of participants with analytical performance scores ≥100 for
quantitative schemes
Number of participants with one or more errors in the survey for
categorical schemes
Numbers of participants within the UK within these groups
Numbers of participants within the UK within these groups and
providing a direct or indirect clinical service
Number of participants within the UK within these groups providing a
direct or indirect clinical service, with a raised analytical performance
score in 2 of 3 consecutive surveys, which may indicate Persistent
Unsatisfactory Performance (PUP).
Every 3 months (or less), participants are reviewed in each survey for the total
number of PUP/UP problems in the preceding 12 months. Occasionally, there
may be participants with a performance score that has not triggered review by the
Scheme Director by the standard route above but still require action, e.g. several
one-off incidents in a year.
Although scores are reported to all participants on their survey reports, only UK
clinical participants are actively reviewed by the Scheme Director.
UK Participants
In addition to the performance scores outlined above, UK participants are also
monitored for the following Unsatisfactory Performance (UP) indicators, which
are regarded as outlier results that might indicate unsatisfactory performance:



PA: failure to identify P. falciparum, % parasitaemia outside +/- 3
standard deviations of the median parasitaemia value.
AH: assessment of Hb A2 and Hb F results in terms of the participant’s
normal reference range, followed up if it would lead to a clinically
incorrect action.
Any incorrect SCT (sickle screening test) or failure to note the presence
of a variant Hb on fraction identification may be followed up with a
request to re-test the survey specimens before the report is issued. This
is regarded as an UP (unsatisfactory performance) issue.
The definitions below are used across all the General Haematology schemes.
The application of the actions listed will take into account any applicable
confounding factors.
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
Unsatisfactory Performance (UP)
This describes a participant with a single instance in a rolling time window
where their performance has breached the agreed performance criteria.
For UK NEQAS (H) the rolling time window is usually 6 specimens
containing that parameter for quantitative assays, or 3 consecutive surveys
for qualitative parameters and non-participation. Examples of this would
be:



The first occasion on which the analytical performance score for a
quantitave assay passes the 100 action limit
Reporting a clinically incorrect qualitative result, e.g. an incorrect
sickle screening test or clinically incorrect haemoglobin variant
identification
Failing to return results or returning results after the closing date
in any survey where there is national or professional agreement
that a 100% return rate is necessary
Action taken (UK participants): the participant receives a standard
letter from the Scheme Director alerting them to the error. The
laboratory is asked to contact the Scheme Organiser with any further
information and help is offered at this point if required. There is no
penalty for non-response, although if the problem persists in
subsequent surveys a lack of response is taken into account in
deciding the next actions.

Persistent Unsatisfactory Performance
This term is used when a participant has a second UP occurrence for the
same parameter in a rolling time window. Within the UK NEQAS
Abnormal Haemoglobins scheme, examples of this would be:




An analytical performance score for a quantitative assay above
the 100 action limit on 2 occasions within the period covered by
the most recent 6 specimens containing that parameter
Reporting an incorrect qualitative result for the same parameter in
2 out of 3 consecutive surveys
Failing to return results or returning results after the closing date
in 2 out of 3 consecutive surveys
Any other instance that gives the Scheme Director cause for
concern, e.g.
o An UP for analytical performance followed by a nonreturn of results
o A laboratory with clinically significant UP incidents in 2
different parameters within 3 surveys
o An UP for analytical performance that would have put a
patient’s health and wellbeing at risk, had the same error
occurred with a patient’s specimen
Action taken (UK participants): the participant receives a letter
from the Scheme Director reminding them that they need to take
action and warning them that they risk reporting to the NQAAP. If no
response is received to this letter, the Scheme Organiser will contact
the participant directly to ensure that the letter has been received and
understood.
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
Unresolved PUP
This term is used for a laboratory that incurs a third occurrence of
unsatisfactory performance within the rolling time window following a
second performance letter. Examples of this would be:
 The performance score for a parameter remaining above 100 and
failing to fall, with unsatisfactory DI values, within the rolling
time window
 A second letter for 2 different parameters within 3 surveys
 A non- return PUP letter following a second letter for analytical
performance
 A third instance of failure to return results within the rolling time
window following the second letter
Action taken (UK participants): In this instance, the Scheme Organiser
contacts the laboratory to inform them that their performance has failed to
improve. If not already received, the laboratory is asked to supply details
of any reasons for the performance problem and corrective actions that
have been taken. The Scheme Organiser prepares an Exception Report
with copies of all performance records, correspondence and details of
telephone conversations. The information is reviewed and the participant
is contacted to discuss the problem. The identity of the laboratory may be
disclosed to the NQAAP at this point, in line with Joint Working Group on
Quality Assessment (JWG) terms of participation.

Criteria for reporting to NQAAP
The National Quality Assessment Advisory Panel asks the Scheme to provide
the following information:




A quarterly anonymous summary of the number of UP, PUP and
unresolved PUPs
The disclosure of the identity of any participating laboratory that
breaches the JWG and NQAAP Terms and Conditions of participation
The disclosure of the identity of any laboratory that is classified as an
unresolved PUP and has not taken any effective corrective action to
reduce their performance score
The disclosure of the identity of any laboratory that, in the opinion of
the Scheme Director, demonstrates clinically hazardous performance,
including attempting to conceal performance problems
Action taken (UK participants): The course of action taken by the
NQAAP is determined by the NQAAP Chairman after consultation with
other NQAAP members and, if necessary, colleagues on the Joint Working
Group on Quality Assessment.
AH and NH Participants in English NHS Trusts
Laboratories in this category that are reported to the NQAAP for AH, NH or
DN performance will be reported to the Manager of the NHS Sickle and
Thalassaemia Screening Programme at the same time, provided they have
given their approval for this action.
The Scheme makes a twice yearly summary report to the NHS Sickle and
Thalassaemia Screening Programme on the performance of participants in
the AH, NH and DN schemes.
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This report includes:
 Summary of the number of distributions sent out in the time period
and number of specimens in total
 Number of screening laboratories reporting results
 Analytical methods used in the time period
 Number of laboratories not returning results within deadline and
receiving an adverse non-participation score
 Number of laboratories receiving letters for performance issues
during the period
 Action taken and comments for those laboratories having analytical
performance scores ≥100
 Additional information for Newborn Sickle Screening Laboratories
only:
o Number of laboratories reporting a single ‘out of
consensus’ result in the time period and receiving an
adverse score (analytical performance UPs)
o Reasons for ‘out of consensus’ results (if known)
o Number of inappropriate interpretations (interpretive
performance UPs)
The performance of antenatal and newborn screening laboratories in England
that receive an analytical or participation letter in the AH, NH or DN schemes, or
for MCH in the FB scheme (antenatal screening laboratories), will be disclosed
to the NHS Sickle and Thalassaemia Screening Programme Manager with the
six-monthly performance report, provided the participant has given their
approval for this action.
Confounding Factors
All performance is reviewed in the light of known confounding factors that may
influence the EQA results obtained.
Performance monitoring is not an exact process. Scoring is, however, a long
established means of screening out laboratories that require additional scrutiny
and is a comparator by which the performance of a large number of participants
can be examined in a timely and cost effective manner.
The following factors are taken into account when interpreting the performance
score of an individual laboratory:



The determination of the target value may be difficult where there is
no higher order reference material or method. Within Haematology,
target values are generally determined from the consensus trimmed
mean (either all method or method specific) of participants’ results.
The consensus all methods mean will be skewed by the instrument or
method that has the greatest number in the data set.
Survey material, although prepared to be as similar to patients’
samples as possible, may perform differently from clinical material
with different technologies (‘matrix effect’). Where this is recognised
as significant, there may be a need to group methods based on similar
technology together, so that there is a like for like comparison.
The frequency of the challenge for any single parameter in a series of
EQA distributions will affect how rapidly the score responds to
corrective action. Within General Haematology, the performance
score for any parameter is calculated from the most recent 6
specimens that contained that parameter for assay. This will mean
that a laboratory’s score will remain above 100 for several consecutive
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




distributions, even though adequate corrective action has been taken,
if they have not had sufficient challenges for the score to respond.
The difficulty of the challenge: testing at the level of clinical decision
making or for rare conditions will produce worse performance scores
than testing, for example, in the middle of the normal reference range.
UK NEQAS is increasingly targeting this clinical decision range.
Where performance overall is very good, a performance score beyond
the action limit may be technically undesirable but may not reflect a
clinically significant problem.
Where performance overall is very poor, a performance score within
the action limit may not be a guarantee that the result produced would
not be a matter of clinical concern.
A single, clinically significant, error may not push the performance
score beyond the action limit. For this reason EQA schemes may use
other means, such as assessment of results for action, in the
interpretation of performance.
Since it is impossible to write guidelines to cover every eventuality,
the Scheme Director retains the discretionary authority to contact any
laboratory whose performance gives cause for concern in his
professional judgement.
Withholding performance letters
On occasion, a performance letter to a participant may be withheld. The
following list gives examples of the circumstances in which letters may be
withheld (this list is not exhaustive):








Where the participant does not provide a direct or indirect clinical
diagnostic service, e.g. manufacturers, pharmaceutical companies,
university departments
Where the participant is located outside the UK
Where the participant has informed the scheme that their instrument or
method is not in operation
Where an instrument is in operation but is not in clinical service, e.g.
the service / instrument is being set up, under evaluation or under
repair
Where there is a recognised performance problem for a parameter,
relating to the manner in which the UK NEQAS (H) survey material
functions on a particular instrument technology
Where there have been insufficient challenges for the parameter for
the score to have resolved. In this case, the following must be true:
o The score must be falling
o The DI value(s) for specimens tested since the first UP letter
must be satisfactory
o The participant must have responded to the earlier UP letter,
indicating that they are aware of the situation and have taken
action
Where there is an identified performance problem, which has been
reported to the NQAAP. The NQAAP is informed directly of
performance
Where the participant has made a formal complaint to the Steering
Committee or NQAAP Chairman to dispute the performance score
issued by the Scheme. This requires prompt action from the Steering
Committee or NQAAP Chairman to resolve the dispute
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Withdrawal of results or specimens from scoring
The results from individual participants, groups of participants, individual
survey material pools or whole distributions may be withdrawn from scoring, if
they fail to meet established acceptability criteria. The decision to withdraw a
parameter from scoring is taken by the Scheme Organiser / Director and Data
Manager. Participants will be notified as soon as the decision is made.
Equivalence with other terms
Different EQA schemes utilise different terminology. The equivalence of the
terms, as far as possible, is outlined below:
 Poor performance is generally used in the same way as unsatisfactory
performance.
 Outwith or out of consensus is any result that is beyond the
performance limits compared to the consensus target value. In
general, this will be the same as poor or unsatisfactory performance.
However, it is possible for the out of consensus result to be correct,
even though other participants do not agree with it.
 Hazardous performance is a single error that is of sufficient clinical
impact that it could put a patient's health and wellbeing at risk if the
error had been made with a patient's sample. This equates to a single
UP occurrence with potentially serious consequences.
SURVEY REPORTS
Individual reports, showing participant’s results as well as the statistical
analysis of the survey, are produced for all survey types. The report includes
the participant’s participation and analytical performance scores, if applicable.
In addition to survey reports, the Scheme may issue supplementary and
experimental trial reports. These are not performance assessed and give
summary statistics and relevant comments only.
Web users A Portable Document Format (PDF) copy of the report for each
survey is posted to the same web server used for data entry. Reports on the
web server are protected by the same level of security as that used for entering
of results. Registered web users are informed by email of the availability of the
report on the web server.
Non-web users Two copies of the report for each survey are distributed.
One is sent to the named laboratory contact and the second to the named
consultant contact. Participants should ensure that their reports are retained
and are available to staff. Duplicate copies of reports can be printed if
necessary; the Scheme reserves the right to charge for this service.
Example: Blood Count Survey Reports
This report is described in some detail below as it contains elements that are
used in other individual reports. An example of the Blood Count survey report
is shown in Appendix 4. The Scheme can supply pdf examples of other types
of survey reports upon request.
The Blood Count report is on three pages. At the top of each page is the survey
type, the distribution number and date, PRN and page number. The pages
contain the following information:
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
Page one shows the overall performance for that instrument. The
analytical performance score for each analyte over the previous ten
surveys is printed in graphical form. The non-participation score is
printed in the top right-hand corner of the page under the heading
lines and the survey contents in the top left-hand corner.

Pages two and three show the data analysis for specimens one and
two respectively. A description of the specimen is given at the top
left-hand corner of the page, under the heading lines, and a summary
of specimen quality in the top right hand corner. Each of these pages
shows up to eight boxes with the analysis for each registered
parameter. Each box contains a graphical representation of the
distribution of the data, both the all method data and the instrument
group (shown shaded). A small arrow above the graph indicates
your position in the distribution. Beside this graph is shown the
following information:
o
o
o
o
o
o
o
Your Instrument:
Your result:
Target value:
DI:
CV%:
N:
N (trimmed):
o
Perf. Score:
The registered instrument type
The result submitted
The Group Trimmed Mean,
Deviation Index
Group Geometric Coefficient of Variation,
Total number of data points in the group
Trimmed number of data points used to
calculate the mean
Analytical Performance Score for that
parameter
Use of reports
Reports are copyright and may not be copied, distributed, published or used for
publicity and promotion in any form without the written consent of the Scheme
Director on each and every occasion, though the participant may share
performance data with individual clients (e.g. GPs, clinicians, pharmaceutical
companies) without consultation.
Amended reports
The Scheme may reissue reports following amendment of data or correction of
an error noted after the original report was distributed. The original and
amended report can be differentiated from the issue date and time printed on
the report. Where the reports have been reissued for all participants or a whole
group of participants, the reason is stated on the report.
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INTERNATIONAL PARTICIPANTS
Most UK NEQAS (H) survey types are open to international (non-UK)
laboratories and the Scheme has over 500 participants from outside the UK.
This section of the Handbook contains information that is applicable to
international laboratories only; otherwise the service supplied to international
participants is as described for UK laboratories.
Cost of participation
The costs for international laboratories are based on the UK prices, which are
reviewed each year. Additional fees to cover extra postage or courier delivery
costs will be charged, as will any additional bank charges that are incurred.
Fees are payable by all participants and we do not offer any services free of
charge.
You will be advised of the current fees when you apply for participation and
when you renew your participation each year. If you start your participation
part way through the year, you will only pay for the remaining distributions in
that year.
Fees are quoted exclusive of VAT. If you are located within the European
Community (EC), you will be advised as to the correct procedure to comply
with EC tax law when you apply for participation.
Fees may be paid in pounds sterling (£) (GBP), US dollars ($) or Euros (€)
(primarily for EC member states).
Registration
International laboratories participate in UK NEQAS (H) either directly as an
individual laboratory or via a recognised distribution agent, if one is available
in the country or region. There is no difference in the service provided by
UK NEQAS (H), but the additional services provided by the distribution agent
(e.g. translation or delivery services) may vary and are not within our control.
Registration procedures for international participants are slightly different from
those for UK laboratories and you will be advised of this when you apply.
Scheme Language
All scheme paperwork and reports are written in English. Some distribution
agents offer translation services for key documents.
Specimen Delivery
International participants receive the same specimens as those distributed in the
UK. Tracked and signed for delivery may be adequate for destinations in the
Republic of Ireland and some other European Community countries. For other
destinations, delivery by courier is essential, to ensure a timely delivery and to
preserve the integrity of the specimens.
Closing dates and return of results
The closing date for international participants is the same as that for UK
laboratories and most international participants return their results in time.
Late returns will always be processed and a delayed report distributed,
provided the specimen remains viable on the date of analysis and the target
results have not been reported to participants. Participation penalties are
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usually waived for international participants returning results within 48 hours
of the closing date.
Reports and Performance Monitoring
International participants receive the same reports as UK laboratories.
However, the criteria for the Persistent Unsatisfactory Performance criteria
approved by the NQAAP do not apply, and performance scores (both analytical
and participation) are reported for information only.
Confidentiality
Conditions of confidentiality are maintained but, by written agreement with the
participant laboratory, arrangements can be made to provide data direct to a
national or other relevant body for performance monitoring purposes. Web
entry access details may be made available to a distribution agent responsible
for the registration of a participant, with the participant’s permission. This is
solely for the purpose of assisting the participant with access to the data entry
and report web pages. The distribution agent is required to keep the
participant’s details and performance information confidential.
DISTRIBUTION AGENTS
UK NEQAS (H) uses the services of a number of recognised distribution
agents for the distribution of EQA services outside the UK. There are many
advantages to this for the participant; in particular, the agent acts as a point of
contact in the region, may offer translation services or assistance with
interpretation of documents and the agent may act as a central delivery point,
reducing the impact of courier costs.
A participant who registers through a distribution agent is the customer of that
agent and is responsible for payment of their subscription fees directly to the
agent, in their local currency. The agent has the right to refuse registration to a
participant who does not pay their fees and will advise UK NEQAS (H) to
cease dispatch of EQA services.
The fees charged by a distribution agent for UK NEQAS (H) services will be
inclusive of charges for any additional services provided by the agent and
therefore cannot be compared directly to the UK price list.
A UK NEQAS (H) distribution agent is expected to abide by the UK NEQAS
(H) terms and conditions for agents, which are available from the Scheme
Office.
In general, UK NEQAS (H) prefers to work with just one agent in an individual
country or region and attempts to use the same agents as other UK NEQAS
centres.
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WHO COLLABORATING CENTRE FOR QUALITY
ASSURANCE IN HAEMATOLOGY
UK NEQAS (H) is the World Health Organisation (WHO) Collaborating
Centre for Quality Assurance in Haematology. The Centre organises a separate
International EQA Scheme in Haematology, on behalf of the WHO. This
scheme is designed for laboratories in the developing world using basic
laboratory techniques, and consists of six distributions a year for a limited
range of tests. Participants are recommended and sponsored by the WHO,
although a small number of private fee paying laboratories are accepted. Full
details are available from the UK NEQAS (H) office.
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OVERSIGHT OF EQA IN THE UK
There is a strong regulatory framework within the UK that governs the operation of
EQA schemes, and the Scheme both informs and receives information from a
number of relevant organisations. These regulatory and informative links are
illustrated in Figure 1.
Figure 1: Relationships between the various bodies concerned with EQA in the UK
Key:
BCSH
MHRA
NQAAP
JWG
CPA (EQA)
UKAS
British Committee for Standardisation in Haematology
Medicines and Healthcare products Regulatory Agency
National Quality Assessment Advisory Panel (Haematology)
Joint Working Group on Quality Assessment
Clinical Pathology Accreditation (EQA) Ltd
UK Accreditation Service
UK NEQAS (H) Steering Committee
All UK NEQAS Schemes are supported by advice from an appropriate UK NEQAS
Steering Committee. Membership of the Steering Committee is ratified by and
accountable to the UK NEQAS Executive Committee, which provides the terms of
reference for individual UK NEQAS Steering Committee and Scientific Advisory
Groups.
The Steering Committee Chair is independent of UK NEQAS operational interests,
and membership includes appropriate experts, participants and advisors. They sit in
their own right and not as representatives of any professional or other group.
However, they may fulfil an invaluable liaison function with such groups.
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UK NEQAS (H) operates with the advice of an over-arching Steering Committee
and three Scientific Advisory Groups (SAGs): the General Haematology SAG, the
Morphology SAG and the Special Haematology SAG. The Steering Committee
and SAGs have representatives from participants, the professions and observers
from the NQAAP, in addition to expert scientific and clinical advisors. Their
purpose is to advise the Scheme Director and Organiser on scientific, technical and
organisational matters.
Steering Committees and SAGs do not consider the performance of individual
participating laboratories, except in advising on performance criteria or where
performance may indicate a failure in the operation of the Scheme (and even in
such cases the laboratories will not be identifiable).
The members of the Steering Committee for General Haematology (Correct at April
2014) are:
Professor A Copplestone (Chair),
Combined Laboratories,
Derriford Hospital,
Derriford Road,
Plymouth, PL6 8DH
Mr I Mellors
Haematology Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle on Tyne, NE1 4LP
Dr J Ardern
Dept of Laboratory Medicine,
Manchester Royal Infirmary,
Oxford Road,
Manchester, M13 9WL
Dr B J Wild,
c/o UK NEQAS (H),
PO Box 14,
Watford, WD18 0FJ
Dr J Burthem
Dept of Laboratory Medicine,
Manchester Royal Infirmary,
Oxford Road,
Manchester, M13 9WL
Professor K Hyde
(Scheme Director),
UK NEQAS (H),
P O Box 14,
Watford, WD18 0FJ
Dr P Carrington
Trafford General Hospital
Moorside Road
Davyhulme
Manchester, M41 5SL
Mr Neil Porter
c/o UK NEQAS (H),
PO Box 14,
Watford, WD18 0FJ
Mr P McTaggart
UK NEQAS (H) Data Manager
UK NEQAS (H),
P O Box 14,
Watford, WD18 0FJ
Ms K Sandler (lay representative)
C/o RCPath Lay Representatives
Committee
Royal College of Pathologists
London, SW1Y 5AF
Mrs B J De la Salle (Secretary),
UK NEQAS (H),
P O Box 14,
Watford, WD18 0FJ
Ms I De-Rosa (Recorder)
UK NEQAS (H),
P O Box 14,
Watford, WD18 0FJ
Phone: 01923 217878
NQAAP representatives are invited to attend the Steering Committee and SAGs as
observers and receive all papers.
The Directors and Organisers of other UK NEQAS Schemes, members of the UK
NEQAS Executive and the President of UK NEQAS may attend the Steering
Committee or SAG meetings as observers, upon request.
The Chairs of the SAGs are:



Morphology SAG:
General Haematology SAG:
Special Haematology SAG
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National Quality Assessment Advisory Panel (NQAAP)
The National Quality Assessment Advisory Panels (NQAAPs) are professional
groups with executive responsibility for maintaining satisfactory standards of
analytical and interpretative work in UK laboratories, whether in the private or in
the public sector, in which investigations are performed for the detection, diagnosis
and management of disease in humans. The Royal College of Pathologists, the
Institute of Biomedical Science, the Association of Clinical Biochemists and other
appropriate professional bodies each nominate one member, who normally serves
for four years. The Panels are discipline specific and receive reports from the
relevant UK NEQAS and other approved EQA schemes. The Chairperson of each
Panel reports to the Joint Working Group (JWG) on Quality Assessment, a
committee of the Royal College of Pathologists (RCPath).
UK NEQAS (H) reports to the NQAAP for Haematology. The Director gives
regular reports to the Panel on the Scheme’s activities and the overall performance
of UK laboratories. The Director also brings to the attention of the Panel Chairman
any UK laboratory whose analytical and/or participation performance is judged
unsatisfactory by criteria approved by the Panel. The identity of the laboratory is
disclosed to the Panel Chairman who will share this information with other relevant
Panel members.
The Haematology Panel consists of the following members at the time of
publication (April 2014):
Chairman
Dr Richard Soutar
Consultant Haematologist
Department of Haematology
Gartnavel General Hospital
21 Shelly Road
Glasgow G12 0XL
E-mail: [email protected]
Members
Mrs C Whittington
Dr Y Sorour
Mrs L Shipway
Dr P Harrison
Mrs D Asher
Joint Working Group on Quality Assessment (JWG)
The JWG comprises representatives of the professional bodies associated with
laboratory medicine. It has a professional ‘watchdog’ role and is a committee of the
Royal College of Pathologists.
All UK participants agree to the Conditions of Participation produced by the Joint
Working Group on Quality Assessment when they sign their registration or reregistration forms. The most recent JWG Conditions of Participation are available
from the JWG website using the following link:
http://www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/J/Joi
nt_Working_Group_Conditions_of_Participation_August10.pdf
The JWG consists of the Chairs of the NQAAPs and representatives of professional
bodies and other stakeholders with an interest in the quality of laboratory
investigations.
The JWG Chairman (2014) is Dr David James.
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State of the art reports (BCSH & MHRA)
State of the art reports, including concerns about the performance of in-vitro
diagnostic devices, are made to the British Committee for Standardization in
Haematology (BCSH) and, when relevant, to the Medicines and Healthcare
products Regulatory Agency (MHRA).
Consultation with manufacturers
The performance of individual participants is never discussed with instrument
manufacturers, without the participant’s express permission.
Instrument and kit manufacturers are consulted with respect to instrument grouping
for performance assessment, advice on how UK NEQAS (H) specimens should be
analysed and in the event that particular trends in performance are observed in
Scheme data with different in-vitro diagnostic devices.
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APPENDIX 1: DEFINITION OF MATERIALS
There has been considerable confusion with various types of material used in
standardization and quality control. The following definitions are slightly modified
from those of the International Committee for Standardization in Haematology
(ICSH) and are relevant to haematological practice:
Reference Standard: A substance or device one or more properties of which are
sufficiently well established to be used for the calibration of an apparatus, the
assessment of a measurement method or for assigning values to a material. Where
possible it must be based on or be traceable to exactly defined physical or chemical
measurement. International reference materials (or preparations) of this type may
also be termed International Standards. These are not intended to be used in
laboratory working procedures but serve as materials with which national standards
and calibrators can be controlled and diagnostic products can be verified and
evaluated. Such international standards should only be made available to national
authorities.
Calibrator: A substance, or device, which is based on a Reference Standard and is
used to calibrate, graduate or adjust a measurement.
Calibration: Adjustment of instrument bias or assigning of a bias conversion
factor to obtain accurate measurements. Accuracy over the operational range must
be established by appropriate use of reference methods, reference materials, and/or
calibrators.
Control Material: A substance, or device used in routine practice for checking the
precision of a method and/or instrument.
Survey Material Specimens: Specimens provided by a quality assessment scheme
to multiple laboratories for analysis, and subsequent provision of target value(s), as
derived from measurements by reference laboratories and/or by statistical analysis
of the results obtained by participants in the scheme.
Experimental Trial Specimens: Specimens distributed to multiple laboratories in
experimental trials. They have not yet been established as suitable for assessment
surveys.
Definitive Method: A method which after exhaustive investigation is found to
have no known source of inaccuracy or ambiguity.
In vitro diagnostic medical device (IVD)
For the purposes of this document we are using the definition of an IVD as stated in
the In Vitro Diagnostic Medical Device Regulations (Statutory Instrument 2000 No
1315 ISBN 0110992601):
“in vitro diagnostic medical device means a medical device which
(a) is a reagent, reagent product, calibrator, control material, kit, instrument,
apparatus, equipment, or system, whether used alone or in combination; and
(b) is intended by the manufacturer to be used in vitro for the examination of
specimens including blood and tissue donations, derived from the human body,
solely or principally for the purpose of providing information (i) concerning a physiological or pathological state,
(ii) concerning a congenital abnormality,
(iii) to determine the safety and compatibility of donations, including blood and
tissue donations, with potential recipients, or
(iv) to monitor therapeutic measures,
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and includes a specimen receptacle but not a product for general laboratory use,
unless that product, in view of its characteristics, is specifically intended by its
manufacturer to be used for in vitro diagnostic examination.”
Reference Method: A clearly and exactly described technique for a particular
determination which provides sufficiently accurate and precise laboratory data for it
to be used to assess the validity of other laboratory methods for this determination.
The accuracy of the reference method must be established in comparison with a
definitive method where one exists. An international reference method is one
established by a competent international authority.
Reference Reagent: A reagent which has defined and clearly described properties.
It is used with a reference method or procedure and, when appropriate, in
conjunction with an international standard.
Selected Method: A procedure, the reliability of which has been validated by a
collaborative study and which is recommended by a competent authority for routine
use in laboratory analysis having been selected on the grounds of its accuracy and
precision, the intended scope of the test, economy of labour and materials, and ease
of operation.
Diagnostic Kit: A package containing reagents and/or other material and a method
protocol designed for reliable performance of a specified analysis or analyses.
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APPENDIX 2: EXAMPLE INSTRUCTION SHEET
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APPENDIX 3: EXAMPLE RESULT SHEET
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APPENDIX 4: EXAMPLE REPORT
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Version 6.0 – April 2014
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