Bi-ennial Report
2012 - 2013
UK NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME
for Blood Transfusion Laboratory Practice
UK NEQAS (BTLP)
PO Box 133
Watford
WD18 0WP
©UK NEQAS (BTLP) 2014
Issued June 2014
INDEX
Page
Number
1
INTRODUCTION and SCOPE
1
2
STAFF
1
3
PARTICIPANTS
1-2
4
PERFORMANCE SUMMARIES
5
Exercises distributed
General information
12R1
12E2
12E3
12R4
12E5
12E6
12R7
12E8
12R9
12E10
13R1
13E2
13E3
13R4
13E5
13E6
13R7
13E8
13R9
13E10
ERROR RATES
3
4
5
5-6
6
6-7
7-8
8
9 - 10
10
10 - 11
11
11 - 14
14
15
15 - 16
16
17
17 - 18
18 - 19
19 - 20
20
20 - 21
6
LEARNING POINTS
22
7
SCHEME DEVELOPMENT AND QUALITY INDICATORS
23 - 25
8
QUESTIONNAIRES AND NON-SCORING ELEMENTS
26
9
TRENDS IN TECHNIQUES USED IN UK NEQAS EXERCISES
27 - 28
10
INFORMATION/EDUCATION/PUBLICATIONS/PRESENTATIONS
29 - 30
11
REFERENCES
30
12
FINANCIAL STATEMENT
30
13
APPENDICES
31 - 69
1
Steering Committee
31
2
Summary of UI submissions
32
3
UI ‘Rules’
33
4
ABO antibody titration pilot - annual report 2012-13
34 - 43
5
Pre-transfusion testing questionnaire 2012
44 - 48
6
Pre-transfusion testing questionnaire 2013
49 - 55
7
Emergency issue questionnaire 13R1
56 - 66
8
Data from anonymous questionnaire 2013
67
9
Meeting programme 2012
68
10
Meeting programme 2013
69
1.
INTRODUCTION AND SCOPE
UK NEQAS (BTLP) is hosted by West Herts Hospital NHS Trust and is located on the ground floor
of the Pathology Block at Watford General Hospital. It shares premises and administrative and
logistics staff with UK NEQAS (H). The UK NEQAS Unit is part of pathology within the Clinical
Support Directorate, and the legal oversight and working arrangements are described in a
Memorandum of Agreement with the Trust.
The Scheme is advised by and reports to the BTLP Steering Committee (see Appendix 1 for current
membership) and reports unsatisfactory performance to the National Quality Assurance Advisory
Panel for Haematology.
This report presents data for two calendar years: 2012 and 2013
2.
STAFF
Chair of the Steering Committee – Dr Peter Baker
Scheme Director - Dr Megan Rowley
Scheme Manager - Mrs Clare Milkins
Deputy Scheme Manager - Ms Jenny White
Senior BMS – Mr Arnold Mavurayi
Executive Assistant – Ms Isabella De-Rosa
Telephone: +44 (0) 1923 217933
Fax: +44 (0) 1923 217934
Email: [email protected]
Website: www.ukneqasbtlp.org
3.
PARTICIPANTS
The number of participants registered at December 2013 is shown in table 1.
participation by country is shown in table 2.
Overseas
Table 1 - Participation December 2013
Type of Participant
Number Registered
UK clinical (including Republic of Ireland and Channel Islands)
395
Overseas clinical
418
UK and overseas diagnostic companies
8
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Table 2 - Overseas Participation by Country (including non-clinical)
Country
No. Participants
Country
No. Participants
No. Participants
Australia
1
Macau
1
Belgium
2
Malawi
1
Chile
2
Malta
3
China
1
Mexico
1
Croatia
2
Netherlands
4
Cyprus
7
New Zealand
1
Denmark
33
Norway
5
Egypt
1
Oman
2
Estonia
2
Poland
1
Faroe Islands
1
Portugal
46
Finland
4
Romania
1
France
2
Saudi Arabia
1
Germany
1
Serbia
2
Gibraltar
1
Singapore
1
Greece
11
Slovenia
1
Greenland
1
Spain
2
Hong Kong
1
Sweden
3
Iceland
1
Switzerland
3
Israel
18
Sri Lanka
1
Italy
68
Tunisia
1
Kenya
1
Turkey
163
Kuwait
13
United Arab Emirates
2
Lebanon
1
USA
1
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4.
PERFORMANCE SUMMARIES
4.1
Table 3 – Summary of exercises distributed
Ex. Code
Distributed
Contents
Main aim
12R1
16 January
ABO/D, AS, ABID, XM,
PH
Detection of ABO and IgG antibodies in the
crossmatch; Fy phenotyping.
12E2
20 February
AS, ABID
Identification of antibody mixtures.
12E3
19 March
AS, ABID
Identification of an antibody mixture. Detection of a
weak antibody
12R4
16 April
ABO/D, AS, ABID, XM,
PH
D typing of a rr DAT positive sample. Antibody
identification with an enzyme non-specific antibody
present. Jk phenotyping.
12E5
14 May
AS, ABID
Identification of an antibody mixture that includes
an antibody of low clinical significance directed
against a low frequency antigen.
12E6
18 June
AS, ABID
Identification of an antibody with and without the
patient red cell phenotype provided.
12R7
16 July
ABO/D, AS, ABID, XM,
PH
Identification of an antibody mixture, including a
cold-reacting antibody, and detection in the
crossmatch. Pilot for DAT testing. Rh phenotyping.
12E8
17 September
AS, ABID
Identification
’standard’.
12R9
15 October
ABO/D, AS, ABID, XM,
PH
Identification of an antibody mixture; detection of
IgG antibodies in the crossmatch. Ss phenotyping.
12E10
19 November
AS, ABID
Identification of antibody mixtures.
13R1
21 January
ABO/D, AS, ABID plus
XM with in-house donor
cells
(latter
not
assessed)
Emergency scenario and dual population of D
pos/D neg.
13E2
18 February
AS, ABID
Detection of a weak antibody and Identification of
an antibody mixture.
13E3
18 March
AS, ABID
Identification of antibody mixtures.
13R4
15 April
ABO/D, AS, ABID, XM,
PH
D typing of a DVI sample. Assessment of intra-lab
consistency in crossmatching. Fy phenotyping.
13E5
13 May
AS, ABID
Detection of a weak antibody and identification of
an antibody mixture.
13E6
17 June
AS, ABID
Identification of antibody mixtures with mixed field
phenotypes
provided,
representing
recently
transfused patients.
13R7
15 July
ABO/D, AS, ABID, XM,
PH
Assessment of detection of incompatibility due to
ABO and anti-S; .Jk phenotyping.
13E8
16 September
AS, ABID
Identification of antibody mixtures.
13R9
14 October
ABO/D, AS, XM,
Sensitivity of the IAT crossmatch in an urgent
a
scenario, including anti-Wr .
13E10
18 November
AS, ABID
Detection of the NEQAS standard anti-D and
identification of an antibody mixture.
AS - Antibody Screen
XM - Crossmatch
ABID - Antibody Identification
PH – Red Cell Phenotyping
Q - Questionnaire
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of
an
antibody
mixture;
anti-D
4.2
General Information Relating to Exercise Summaries and material (4.3 - 4.12)
Data relates to UK clinical laboratories (including Republic of Ireland). Detailed results are not
shown for non-UK laboratories as this group is so large and disparate; however, the overall error
rates for UK and non-UK are shown in section 5.
Antibody titres quoted are those obtained in the UK NEQAS laboratory on the closing date, by
LISS tube IAT, against red cells bearing heterozygous expression of the relevant antigen, unless
otherwise stated.
Errors and return rates reported may include late results, and any amendments made following
appeals.
Each ‘patient’ whole blood sample comprises a pool of four or five donations, which may be
whole blood or red cells to which ABO compatible FFP and Alsever’s has been added.
Each ‘patient’ plasma sample comprises a pool of ABO compatible plasma, some of which
contain red cell antibodies.
Each ‘donor’ sample comprises a single red cell donation, diluted in modified Alsever’s solution to
a red cell concentration of 7-10%.
Preparation of the plasma pools and ‘donor’ samples is subcontracted to the NHS Blood and
Transplant Reagents Unit, although this material may also be prepared or further manipulated
within the UK NEQAS Unit.
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4.3
12R1
‘Patient’ 1: B D pos, inert
‘Patient’ 2: A D pos, anti-c (titre 16)
‘Patient’ 3: AB D pos, inert
‘Donor’ W: A D pos, R2R2, Fy(a+b+)
‘Donor’ Y: A D pos, R1R1, Fy(a+b-)
‘Donor’ Z: A D pos, R1r, Fy(a-b+)
Return rate: 98.8%.
Errors
ABO/D typing
 One D typing error during transcription to website.
Antibody Screening: no errors.
Antibody Identification:
 No ID errors.
 Four UI submissions – all unnecessary as non-exclusion of antibodies to low frequency/low
clinical significance antigens.
Crossmatching
 All detected the ABO incompatibilities.
 Two laboratories missed both incompatibilities due to anti-c:
o one used the whole blood samples by mistake
o one tested manually and could not identify a cause.
 Four laboratories transposed donor results during manual testing (n=3) or when transcribing
results from an automation printout to a worksheet (n=1), resulting in 4 missed
incompatibilities and 4 missed compatibilities.
 Two laboratories made transcription errors at web entry, resulting in one missed
incompatibility and one missed compatibility.
 One laboratory deselected donor Y for Patient 2.
Phenotyping (and interpretation of probable Rh genotype)
 One laboratory transposed donor results.
 Five others recorded 5 false positive and 2 false negative results.
4.4
12E2
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-E+Jkb (titre 16 and 8 respectively)
Anti-K+Jkb (titre 4 and 8 respectively)
Inert
Inert
Return rate: 99.2%
Transcription errors during web-entry
 One laboratory transposed results for all samples, reporting Patients 1 and 2 as 3 and 4, and
vice versa.
 One laboratory reported anti-Jka in place of anti-Jkb for both samples and another for Patient
1 only.
 Two laboratories reported anti-c ±E, instead of anti-E.
Other errors
Antibody Screening: No further errors
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Antibody Identification
 Two laboratories did not report the presence of anti-E, but said that they could not exclude it.
 Fourteen did not report the presence of anti-K:
o 7 laboratories reported that they were unable to exclude anti-K (but did not make a UI
submission)
o in 3 cases the anti-K was totally masked and the participants were unaware
o in 3 cases a positive reaction with a Jk(b-) K+ screen cell was overlooked
o one laboratory reported anti-Lua instead of anti-K where the Lu(a+) cell was also K+.
4.5
12E3
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Inert
Anti-c+Fya (titre 8 and 4)
Anti-Fya (titre 4)
Inert
Return rate: 99.5%.
Errors
Antibody screening:
 One false negative, probably due to data entry error.
 One false positive, with a weak positive reaction recorded.
Antibody identification – Patient 2 (no errors for Patient 3)
 One laboratory reported anti-c±E without recording the potential presence of anti-Fya.
 Three reported anti-e, presumably due to data entry error.
 Seventeen UI submissions were agreed.
 One UI submission was not agreed.
 Five reported anti-Fya as not being excluded but did not make UI submissions.
4.6
12R4
‘Patient’ 1: A D neg, DAT pos1, anti-S+ENS 2 (titre 4)
‘Patient’ 2: O D pos, Inert
‘Patient’ 3: AB D neg, inert
1
Red cells coated with anti-c
2
Enzyme non-specific
‘Donor’ W: O rr, Ss, Jk(a-b+)
‘Donor’ Y: O rr, Ss, Jk(a+b-)
‘Donor’ Z: O rr, SS, Jk(a+b+)
Return rate: 99.8%.
Performance monitoring
 D negative or UI were acceptable results for Patient 1.
 Anti-S or anti-S+ENS were acceptable results for Patient 1.
Transposition/transcription errors
 One laboratory transposed samples during manual testing causing two ABO and D errors.
 One laboratory transposed samples Y and Z, resulting in two incorrect Jkb types.
 Four laboratories made data entry errors onto the website, resulting in two false positive D
types and two missed incompatibilities.
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Other Errors
ABO/D typing
 One laboratory reported UI for P3, due to strong positive results in the reverse group. This
was probably due to the use of the separate plasma sample (provided for antibody screening
and crossmatching) instead of the whole blood sample for reverse grouping.
D typing of DAT positive sample
 One laboratory reported Patient 1 as D variant, having recorded a mixed field reaction with
the anti-D and the control reagent in BioVue, and negative reactions with tube; the
participant stated that D variant would not have been reported had this been a clinical
sample.
 A further 47 (12%) laboratories, representing 46% of BioVue users, recorded a positive
reaction with the anti-D reagent, and all but 2 also recorded a positive control. However, all
of these correctly made an interpretation of D negative or UI.
Antibody identification
 One laboratory reported a second specificity not actually present (anti-K)
 One missed the anti-S, reporting anti-E+ENS
 Two reported anti-S+UI:
o one made no UI submission
o one UI submission was not agreed.
 Seven UI submissions were agreed.
 The presence of the ENS antibody was recorded by 42% of laboratories.
Crossmatching:
 One laboratory ‘de-selected’ all three donors for Patient 3.
 One reported a false positive reaction by IAT.
Phenotyping:
 Four laboratories made five errors using manual techniques:
o one false positive was probably due to the use of an incorrect centrifuge speed
o 2 were probable misinterpretations or mis-recording of manual results
o one obtained only weakly positive reaction in a manual tube technique and reported
the unlikely result of Jk(a-b-).
Exercise Comments
Although 46% of BioVue users reported a false positive reaction with their anti-D reagent, only one
laboratory misinterpreted the D type of the rr DAT positive sample (coated with anti-c). Two
laboratories made the same interpretation error with a similar sample in 10R4 and ten made the
same error in 09R7.This suggests that the educational efforts of the Scheme and of Ortho Clinical
Diagnostics are having a positive effect.
4.7
12E5
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Inert
Anti-D (titre 4)
Inert
Anti-K+Cw (titre 4 for both)
Return rate: 98.0%.
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Performance monitoring
As there is no requirement to detect anti-Cw in the antibody screen or to exclude it when
undertaking antibody identification (where all positive reactions have been accounted for),
anti-K and anti-K+Cw were both acceptable results for Patient 4.
Errors
Antibody screening: no errors.
Antibody identification
Patient 2
 Six laboratories incorrectly reported anti-D+Cw.
 A further seven UI submissions were received from laboratories unable to exclude anti-Cw.
Patient 4
 Nine laboratories reported anti-K alone, but these were not classed as errors.
4.8
12E6
‘Patient’ 1:
Inert
‘Patient’ 2:
Anti-c (titre 4)*
‘Patient’ 3:
Inert
‘Patient’ 4:
Anti-c (titre 4)*
*These were prepared from the same pool – a red cell phenotype was provided for Patient 2 but not
Patient 4.
Return rate: 97.8%
Errors
Antibody screening: None.
Antibody identification
There were no errors in identification, however:
 Six participants reported anti-c+UI for both Patients 2 and 4, being unable to exclude
antibodies to low frequency and/or low clinical significance antigens.
 A further five had problems with Patient 4 (no phenotype provided):
o one could not exclude anti-Fya (excluded for Patient 2 based on phenotype provided)
o 4 were not prepared to submit an interpretation without a phenotype.
Exercise Comments
Theoretical red cell phenotypes were only provided for one of the two identical samples containing
anti-c, in order to assess the difference in antibody identification interpretation depending on
whether or not a phenotype is available to help in excluding additional specificities. The exercise
instructions stated that patients 3 and 4 had been recently transfused so phenotypes were
unavailable. The effect on interpretation of anti-c was minimal, with only one participant unable to
exclude anti-Fya in sample 4. However, a further 4 were not prepared to submit any interpretation,
despite the fact that this is a realistic clinical scenario. Discussion at a subsequent Steering
Committee meeting regarding future exercises, focussed on the scheme providing a phenotype
where many of the reactions are mixed field to reflect a recently transfused patient, rather than not
providing any phenotype at all.
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4.9
12R7
‘Patient’ 1: B D neg, DAT neg, inert
‘Patient’ 2: O D pos, DAT neg, anti-M+Fya (titre 8 and 4)
‘Patient’ 3: A D pos, inert, DAT 2+ positive*
*Cells coated with anti-c by the supplier
‘Donor’ W: O r’r, MN ,Fy(a-b+)
‘Donor’ Y: O R1r, NN, Fy(a+b+)
‘Donor’ Z: O R2R2, NN, Fy(a-b+)
Return rate: 99.0%
Performance monitoring
UI was an acceptable result for ABO and D typing for Patient 3. P1 (D negative) was withdrawn from
scoring for crossmatching because 28 laboratories in the UK and many overseas deselected the D
positive donors.
Transposition/transcription errors
 One laboratory transposed samples 1 and 2 during labelling resulting in ABO/D errors.
 One laboratory reported a false positive screen due to transcription error at data entry.
 Two laboratories transposed donors W and Z during web data entry.
 Three missed compatibilities due to probable transcription error.
 Eight laboratories reported incorrect Rh phenotypes, probably due to transcription error.
 One laboratory appeared to have transposed either samples or results causing phenotyping
errors.
Other errors
ABO/D typing
 One laboratory reported P1 as group A due to misinterpretation of the reactions in a manual
system.
 6% reported the ABO and D type as UI for the DAT positive sample and another 1%
reported group A but UI for the D type:
o all used BioVue and recorded a positive or mixed field reaction with the reagent
control.
Antibody Screening: none
Antibody Identification
 Four laboratories made ID errors:
o one reported anti-M only, being unaware of the anti-Fya, which was masked by the
anti-M
o one reported anti-S+Fya; having overlooked the possibility of anti-M, they selected
Fy(a-) S+ cells which were also M+, to ‘confirm’ the presence of anti-S
o one reported anti-K+Fya – in retrospect, positive reactions were noted with Fy(a-) Kcells
o one made a UI submission, which was not agreed
o 4 other UI submissions were agreed.
Crossmatching
 One laboratory missed both incompatibilities and one compatibility. This was not repeatable
and no cause has been established.
 A further ten laboratories recorded false positive reactions.
 Two laboratories deselected all three donors for Patient 3.
Phenotyping
 Twelve laboratories made errors, including 10 false positives for e typing.
 There were 11 sets of correct serological reactions with incorrect Rh shorthand
interpretations.
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Results of DAT testing
 62% returned a DAT result for Patient 1 and 63% for Patient 2; all reported these as D
negative.
 68% reported a result for P3:
o 5/276 (2%) recorded an incorrect result of DAT negative.
Exercise Comments
The results suggest that the positive DAT sample was stable, although there was no further
information available from the five laboratories who reported Patient 3 as D negative.
4.10 12E8
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-E+Fya (titre 4 for both)
Anti-D standard
Anti-D (titre 1)
Inert
Return rate: 99.5%
Antibody screening
 Two laboratories made errors:
o one false negative due to transcription error at web entry
o one, non-repeatable, false negative for P2 (Standard anti-D) using LISS tube
technique, cause unknown.
Antibody Identification
 Five laboratories made either transcription or data entry errors.
 Three laboratories reported an additional anti-Cw in samples 2 and 3.
 One UI submission (unable to exclude anti-CW) was agreed.
4.11 12R9
‘Patient’ 1 - A D negative, inert
‘Patient’ 2 - A D positive, anti-c+K (titre 16 and 32)
‘Patient’ 3 - B D positive, inert
‘Donor’ W – O rr, K-, S+s‘Donor’ Y – O rr, K+, S+s+
‘Donor’ Z – O rr, K+, S-s+
Return rate: 98.8%.
Transposition/transcription errors
 One laboratory transposed samples 2 and 3 during labelling, accounting for two incorrect
ABO groups.
 One laboratory reported all three donors as compatible with Patient 2; this was likely to be
due to web data entry error as the reaction grades recorded were correct.
 One laboratory transposed results for donors W and Z, resulting in two false positive and two
false negative phenotypes.
Other errors
ABO/D typing: none
Antibody Screening: none
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Antibody Identification
 Ten laboratories made incorrect or incomplete submissions:
o 2 reported anti-c+S due to misinterpretation, with one not taking the screening panel
results into account
o 7 could not exclude anti-K (or in one case also anti-c) but did not make UI
submissions
o one made a UI submission that was not agreed.
 Eleven made UI submissions which were agreed.
Crossmatching
 One laboratory deselected all three donors for Patients 1 and 3.
 One deselected donor W for Patient 3.
 Two recorded false positive reactions.
Phenotyping
 Four laboratories recorded two false positive and four false negative reactions.
 Fifty-three laboratories had no anti-S reagent and 66 no anti-s.
4.12 12E10
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-C+D (titre 16 for both)
Anti-E+Jkb (titre 8 and 16 respectively)
Inert
Inert
Return rate: 98.2%
Errors
Antibody screening: None
Antibody identification
 One laboratory transposed the results for Patients 1 and 2 whilst recording reactions onto
the panel sheets.
 One laboratory did not record the potential presence of anti-C.
 Seven laboratories reported anti-Jkb as a single specificity:
o 4 were aware that anti-E could not be excluded but did not make a UI submission
o 3 did not record the potential presence of anti-E.
 Three laboratories made UI submissions, two of which were agreed.
4.13 13R1
‘Patient’ 1: A D pos, inert
‘Patient’ 2: O D MF (50:50 D pos and D neg), inert
‘Patient’ 3: A D neg, anti-Jkb (titre 4)
Exercise format
This was an ‘emergency exercise’, with instructions to select donations from stock. Request forms
were provided, indicating that 2 units of red cells were required from stock within 10 minutes for
Patients 1 and 2 (young females), and requesting a group and screen for Patient 3, in an out-ofhours scenario. Emergency results were input into SurveyMonkey questionnaires and final results
were input through the usual web reporting systems and scored as usual for ABO/D, antibody
screening and antibody identification. Full details can be found in Appendix 7.
Return rate: 98.5%.
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Errors
ABO/D typing
 One laboratory reported Patient 2 as group A due to transcription error.
 Another laboratory reported Patient 1 as D variant based on an initial negative reaction with
a rapid anti-D reagent by tube; this was followed by a strong positive reaction by routine
testing and, due to the discrepancy, was ‘confirmed’ by using the original rapid reagent in a
non-validated tile technique and observing a weak positive reaction. On investigation postclosing it was noted that this reagent was not working properly.
 Group A UI was reported for Patient 3 by a laboratory that recorded a negative reaction with
two routine anti-D reagents but a weak positive with a confirmatory reagent.
 One laboratory recorded UI for P3 when the automation did not give a group.
Antibody Screening: One laboratory reported a false positive screen, due to data entry error.
Antibody Identification:
 Four laboratories reported anti-Jkb plus an additional specificity not actually present (C, K,
Lea, Kpa).
 One reported anti-Jka, presumably due to ticking the wrong box.
 Five made UI submissions (anti-Jkb + UI), four of which were agreed.
D typing of patient 2 (mixed field D positive/D negative)
The reaction grades and interpretations are summarised in table 4.
Table 4 – reaction grade with anti-D vs. interpretation of D type
Reaction grade
with anti-D
Includes a
MF
Includes a weak
1
positive
Strong positive
only
1
D UI
D positive
Interpretation
D variant
D negative
Total
122
35
6
1
164 (41%)
1
18
3
0
22 (6%)
0
207
2
0
207 (53%)
– but does not include a MF
It is notable that of the 41% who recorded a MF reaction, 25% of these made an interpretation of D
positive or D variant
A summary of the interpretations and technology used is shown in table 5 and the photographs in
figures 1 and 2 show the in-house results for the mixed field reaction with a DiaMed card and a
BioVue cassette, respectively.
Table 5 – detection of mixed field reaction vs. Technology used
Primary technique
Number users
% recorded MF for first anti-D
reagent
DiaMed
235
63%
BioVue
151
9%
Tube
170
32%
Grifols
46
63%
LPM (inc Capture)
42
24%
Other
29
24%
Solid phase (inc SS)
4
0%
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Figure 1 – mixed field reaction with DiaMed for 13R1
In house grouping (using recommended methods starting with 12.5 µL and 10 µL packed
cells)
Figure 2 – mixed field reaction with BioVue for 13R1
In house grouping results (using recommended methods starting with 1% and with 0.8% cell
suspensions)
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Exercise comments
 It was of concern that a female patient of child bearing potential with anomalous D typing
results and no clinical and/or transfusion history was reported as D positive or D variant by
25% of laboratories who reported the dual population of red cells.
The full report for the emergency testing part of the exercise is shown in Appendix 7.
4.14 13E2
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-c+K (anti-c titre: 4 vs r’r cells, anti-K titre 8)
Inert
Inert
Anti-c (titre 2 vs R2R2 cells – not detectable vs. r’r cells)
Return rate: 98.5%.
Transposition and transcription errors:
 One laboratory transposed the results for Patients 1 and 4 at data entry.
 Another reported anti-e+K, presumably due to ticking the wrong box.
Other errors
Antibody Screening: None.
Antibody Identification
Patient 1
 Seven laboratories reported anti-c plus an incorrect specificity:
o only one said they could not exclude anti-K.
 Two reported anti-c only:
o one did not mention anti-K
o one said anti-K could not be excluded but did not make a UI submission.
 Fourteen reported anti-c+UI:
o one recorded that anti-c could not be excluded but did not make a UI submission.
o 13 made UI submissions, 12 of which were agreed, with the majority being unable to
differentiate between anti-K and anti-Jka.
Patient 4
 Four laboratories reported anti-c plus an additional specificity not actually present.
 One made a UI submission which was agreed.
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4.15 13E3
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Inert
Anti-C+D (titre 16 and 8, respectively)
Inert
Anti-D+K (titre 16 and 4, respectively)
Return rate: 98.5%.
Errors
Antibody screening: None.
Antibody identification


One laboratory reported anti-D as a single specificity for Patient 2, with no mention of anti-C,
having overlooked a positive reaction with an r’r cell, positioned immediately after the 3 D+
cells on the identification panel.
Two laboratories reported anti-D as a single specificity for Patient 4, with no mention of antiK. Both had recorded a positive reaction with a D-K+ cell:
o one omitted to transcribe this reaction from the automated printout to the panel profile
sheet
o in the other case, it is likely that the interpretation was made on the basis of the
enzyme panel alone.
4.16 13R4
‘Patient’ 1: O D VI, inert
‘Patient’ 2: A D pos, anti-Jkb (titre 4)
‘Patient’ 3: B D pos, inert
‘Donor’ W: O rr, Jk(a+b+). Fy(a-b+)
‘Donor’ Y: same pool as donor W
‘Donor’ Z: same pool as donor W
Return rate: 98.0%.
Performance monitoring
Results of D negative, UI and D variant were accepted as correct for Patient 1.
D typing of the DVI patient
 Seven laboratories recorded a positive reaction with an anti-D reagent (five reference
laboratories and two non-reference laboratories). Five reported an interpretation of D variant,
one UI, and one D negative.
Transposition/transcription errors
 One laboratory transposed results for Patients 1 and 3 whilst transcribing data from an
analyser printout to data entry forms – this does not reflect their clinical practice.
 A second laboratory recorded a weak reaction between Patient 2 and all 3 donors, but made
an interpretation of compatible for Donor Y, presumably due to data entry error.
 A third laboratory reported one false positive crossmatch result, again probably due to data
entry error.
Other errors
Antibody screening: None.
Antibody identification
 Two laboratories reported an additional antibody not actually present (anti-K and anti-Kpa).
 Two UI submissions were agreed.
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Crossmatching
 332/347 (96%) of those who recorded reaction grades, recorded the same strength of
reaction against all three (identical) donors.
Phenotyping
 One laboratory recorded all 3 donors as Fy(a+b-), instead of Fy(a-b+).
Exercise Comments
It was notable that two non-reference laboratories in the UK used anti-D typing reagents that detect
DVI, which is outwith BCSH guidelines for routine patient testing 1. One of these made an
interpretation of D variant and the other UI.
4.17 13E5
‘Patient’ 1:
Inert
‘Patient’ 2:
Anti-s (titre 4)
‘Patient’ 3:
Anti-K+Fya (titre 32 and 2 respectively)*
‘Patient’ 4:
Inert
*This plasma contained a contaminating anti-Jka reacting weakly by enzyme IAT only. This was
confirmed by the supplier on retrospective testing of the individual donations. It was reported by 2
reference laboratories but did not affect the results submitted.
Return rate: 98.7%.
Errors
Antibody screening: None.
Antibody identification
Patient 2
 All laboratories reported the anti-s.
 Four reported an additional antibody not actually present (anti-C, -E, -N, -Jkb).
 Eight made UI submissions of which four were agreed.
 One reported anti-s+UI but did not make a UI submission.
Patient 4
 One laboratory reported anti-K+UI, but the UI submission was not agreed as anti-Fya could
be identified.
Exercise Comments
Several users of Immucor Capture reported non-specific reaction in Patient 2. The majority reported
anti-s following further testing by a different technique, but two reported anti-s+UI. UK NEQAS inhouse testing, using manual Capture, did not find any non-specific reactions.
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4.18 13E6
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-D+Jkb (titre 32 and 8 respectively)
Anti-E+Fya (titre 4 and 8 respectively) – phenotype MF for C, E, M, N, Leb, Jkb
Inert – phenotype mixed field (MF) for several antigens
Inert
Return rate 99.5%.
Errors
Antibody screening: None.
Antibody identification Patient 1
 One laboratory reported anti-E+Jkb due to misinterpretation and no systematic process for
exclusion.
 One laboratory reported anti-D, with anti-Jkb + other specificities as not excluded, but did not
make a UI submission.
 One UI submission was not agreed as the anti-Jkb could have been identified.
Antibody identification Patient 2 (MF E)
 Three laboratories reported anti-Fya alone:
o One was unable to exclude anti-E but did not make a UI submission
o 2 missed the anti-E which was masked.
 Neither used an enzyme panel, although had one available.
Outcome of providing patient phenotypes as mixed field
Participants had no problems excluding additional specificities, but a few contacted the scheme to
say they could not distinguish between allo- and auto-anti-E. Given that the result sheets do not
specify allo or autoantibodies, participants were advised to report the specificity regardless. The
‘patient’ auto result has since been added to the phenotype information provided for ‘E’ exercises.
4.19 13R7
‘Patient’ 1: B D pos, inert
‘Patient’ 2: O D pos, anti-S (titre 4)
‘Patient’ 3: AB D pos, inert
‘Donor’ W: O D pos, Ss, Jk(a-b+)
‘Donor’ Y: A D pos, ss, Jk(a+b-)
‘Donor’ Z: O D pos, SS Jk(a+b+)
Return rate 99.8%.
Transposition/transcription errors
 One laboratory reported Patient 2 as D negative due to transcription error at data entry on
website.
 Three laboratories reported Patient 2 vs. donor Z as compatible, two presumably due to data
entry error and the 3rd due to confirmed transcription error.
Other errors
ABO/D typing: None.
Antibody Screening: None.
Antibody identification
 Two laboratories reported anti-S plus a second specificity not actually present.
 Three UI submissions were not agreed as they were due to non-specific positive reactions in
Capture.
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Crossmatching
 Two laboratories missed the incompatibility between the anti-S and Donor W (Ss). Both
found it positive on repeat:
o one, using manual BioVue, suspected that the red cell concentration used was too
low (<0.8%)
o one, using automated DiaMed, found a stronger reaction on repeat with manual
testing.
 One laboratory deselected Donor Y for Patient 3.
Phenotyping
 Eight laboratories recorded three false positive and ten false negative results:
o two of these may have transposed results.

Forty laboratories did not have either reagent available, and a further seven had no anti-Jkb.
Exercise Comments
Outcome re Capture non-specific reactions in Patient 2 (anti-S)
Two Capture users phoned before the closing date about non-specific reactions in the sample
containing anti-S. They were requested to report in the same way as they would for a clinical
sample; both reported anti-S alone. It is not known if all Capture users found these non-specific
reactions. In-house testing using a manual Capture technique did not detect non-specific reactions.
Discussions with representatives from Immucor concluded that there are several differences
between the manual and automated techniques, including centrifugation, the order in which the
reagents are added, and the washing phase; however, it is unclear whether any of these variations
are the cause of the differences in reactions seen between UK NEQAS in-house manual testing and
automated testing by participants.
4.20 13E8
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-C+D (titre 16 and 8 respectively)
Anti-c+K (titre 2 and >32 respectively)
Inert
Inert
Return rate: 99.0%.
Errors
Antibody screening:
 One laboratory reported a false positive result, presumably due to data entry error.
Antibody ID:
 One laboratory did not record the presence of the anti-C in Patient 1, having overlooked the
positive reaction with an r’r cell, which was positioned directly following three D positive cells
on the identification panel.
 Two laboratories reported anti-c only in Patient 2:
o one reported that anti-K (and anti-Fya) could not be excluded but did not make a UI
submission (retrospective UI submission was not agreed as anti-Fya could be
excluded and anti-K identified)
o one did not record the presence of anti-K.
 One of three initial UI submissions was not agreed, as anti-c could have been identified.
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4.21 13R9
‘Patient’ 1 - A D pos, anti-Wra(titre 8)
‘Patient’ 2 - O D pos, anti-Jkb (titre 2)
‘Patient’ 3 - AB D neg, inert
‘Donor’ W – O D neg, Wr(a-), Jk(a-b+)
‘Donor’ Y – O D pos, Wr(a+), Jk(a+b+)
‘Donor’ Z – A D neg, Wr(a-), Jk(a+b-)
Return rate: 99.3%.
Aim: this exercise was designed to assess the sensitivity of the IAT crossmatch. In order to achieve
this and to prevent de-selection of antigen negative ‘donors’, the scenario was given where there is
insufficient time to identify antibodies or select antigen negative units, with instructions that a
serological crossmatch should be undertaken. Anti-Wra was selected as it is unlikely to be detected
in the antibody screen.
Problems with exercise and performance monitoring
 Several laboratories reported Donor Y as compatible with Patient 1, having ticked to say that
a serological crossmatch had been performed, but having not recorded any reaction grade
for the IAT. At least one of these had done a DRT crossmatch only, as they would do in
clinical practice. It was assumed that at least some of the other laboratories had done the
same. The instructions stated that a serological crossmatch should be done, but did not
specify an IAT crossmatch. Patient 1 was therefore withdrawn from scoring for
crossmatching. Patient 1 was also not scored for screening as detection of anti-Wra is
dependent on profile of screening cells.
 Contrary to the instructions, many laboratories de-selected donor Y for Patient 3 because of
the D ‘incompatibility’. Patient 3 was therefore withdrawn from scoring.
Errors
ABO/D typing
 One laboratory recorded weak anomalous reactions in the reverse groups for Patients 1 and
3 by automated DiaMed and was therefore unable to interpret the ABO groups. The same
reactions were seen on repeat and the cause remains unknown.
Antibody screening
 One laboratory tested the whole blood sample (supplied for grouping only) instead of the
separate plasma sample, so did not detect the anti-Jkb.
Crossmatching
 Twenty-two laboratories missed the incompatibility due to anti-Wra (not scored):
o 5 recorded a negative reaction by IAT (two due to donor cell transposition)
o one used ‘EI’
o 15 did not record a reaction for the IAT (it has been assumed they did not include an
IAT).
 Three laboratories missed the anti-Jkb against both donors W and Y:
o one was due to data entry error
o one had problems preparing the cell suspension for use on the Gelstation, but
obtained a positive reaction on repeat even with original cell suspension.
o one used a reduced incubation time in a manual DiaMed technique, but obtained a
positive reaction on repeat even with the non-standard 10 minute incubation time.
 Nine laboratories missed the anti-Jkb vs donor Y only:
o 7 used a BLISS addition technique (64% vs 27% of BioVue users overall)
o 2 used manual DiaMed with no cause established.
Exercise comments
Ortho Clinical Diagnostics (OCD) provide validated procedures for crossmatching by both
suspension and addition methods for manual and automated testing. However, OCD advised the
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Scheme that the suspension method using 0.8% red cell diluents has a higher sensitivity than the
addition method using 3-5% cells and BLISS.
4.22 13E10
‘Patient’ 1:
‘Patient’ 2:
‘Patient’ 3:
‘Patient’ 4:
Anti-D – UK NEQAS ‘standard’
Anti-K+Fya (titre both 4)
Inert
Inert
Return rate: 98.7%.
Errors
Antibody screening: No errors (100% detection of the ‘standard’ anti-D).
Antibody identification:
 Five laboratories reported the presence of an additional specificity in Patient 1 that was not
actually present (four anti-Cw; one anti-K).
 One laboratory misidentified Patient 2 as anti-C+Fya and did not record the potential
presence of anti-K.
 One laboratory reported anti-Fya only, with anti-K as not excluded, but they did not make a
UI submission.
Exercise comments
Analysis of the reaction grade by technique for the standard anti-D revealed that 51/364 (14%) of
laboratories appeared to have undertaken antibody screening more than once, i.e. they ticked two
different techniques, or the same technique but by both manual and automated methods. EQA
samples should be tested to the same level as equivalent clinical samples before results are
submitted, to ensure that EQA results reflect clinical practice.
5.
SUMMARY OF ERROR RATES
The error rate is based on the number of opportunities for error by all participants returning results.
Figures shown in brackets following the error rate for UK laboratories are the percentages known to
be due to transcription or transposition errors (Tx). This information is not available for non-UK
laboratories, as these participants are not contacted regarding errors made.
Tables 6 and 7 compare error rates over the last four years for UK and non-UK participants
respectively, where n = the number of tests distributed in each category, that were suitable for
scoring; e.g. there were 12 samples (suitable for scoring) distributed for ABO grouping during 2012,
but only 11 during 2013. The data for 2010 was for the financial year covering exercises 09R4 to
10E3; subsequently, data for each calendar year is displayed.
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Table 6 – Error Rates by Test
Test
ABO
2013
(13R1 – 13E10)
2012
(12R1 – 12E10)
2011
(11R1 – 11E10)
2010
(09R4 – 10E3)
n
error rate (%Tx)
n
error rate (%Tx)
n
error rate (%Tx)
n
error rate (%Tx)
11
0.11 (40%)
12
0.17 (88%)
12
0.26 (92%)
12
0.17 (78%)
12
0.46 (23%)
1
D
11
0.14 (50%)
12
0.17 (88%)
12
0.22 (91%)
False Neg Ab
Screen
16
0.02 (100%)
17
0.07 (80%)
21
0.11 (89%)
14
0.21 (21%)
False Pos Ab
Screen
19
0.04 (100%)
19
0.05 (75%)
15
0.10 (67%)
19
0.07 (83%)
ABID (single)
6
1.5 (34%)
8
0.5 (27%)
12
0.32 (36%)
6
0.4 (44%)
ABID (dual)
9
0.9% (7%)
9
1.8 (25%)
6
1.3 (29%)
7
3.7 (11%)
Missed
Incompatibility
10
0.54 (24%)
13
0.35 (78%)
17
1.3 (18%)
9
0.62 (62%)
Missed
Compatibility
11
0.05 (50%)
20
0.48 (18%)
14
0.32 (33%)
23
0.31 (50%)
False Pos
Phenotyping
5
0.5 (83%)
10
1.2 (24%)
11
0.31 (11%)
8
0.59 (58%)
False Neg
Phenotyping
7
0.77 (38%)
20
0.54 (44%)
13
0.36 (8%)
16
0.50 (44%)
1
1
Includes one or more DAT positive sample.
Table 7 - Non-UK error rates
Test
2013
(13R1 – 13E10)
2012
(12R1 – 12E10)
2011
(11R1 – 11E10)
2010
(09R4 – 10E3)
n
error rate
n
error rate
n
error rate
n
error rate
ABO
11
0.72
12
0.82
12
0.72
12
0.18
D
11
0.72
12
0.72
12
0.93
12
0.77
False Neg Ab
Screen
16
1.2
17
0.34
21
0.35
14
1.74
False Pos Ab
Screen
19
0.32
19
0.42
15
0.44
19
0.30
ABID (single)
6
3.8
8
2.01
12
1.2
6
1.5
ABID (dual)
9
3.5
9
7.38
6
2.0
7
7.0
Missed
Incompatibility
10
4.2
13
1.63
17
3.2
9
4.0
Missed
Compatibility
11
0.51
20
1.12
14
3.4
23
0.9
False Pos
Phenotyping
5
0.87
10
1.22
11
0.49
8
0.96
False Neg
Phenotyping
7
0.62
20
0.82
13
0.78
16
1.0
1
Includes one or more DAT positive sample.
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1
6.
LEARNING POINTS FROM EXERCISE RESULTS
Table 8 – Learning points
Issue
ABO/D Grouping
Making ABO/D
interpretations based on
mixed field reactions
Exercise(s)
Learning point
12R4
13R1
A mixed field D typing reaction might be due to a D negative patient being
transfused D positive blood, and no interpretation should be made until the
cause of the anomaly can be confirmed.
SHOT reports show that ABO grouping errors all occur in manual test systems
or during manual intervention in automated systems. Full automation should be
used where possible and where this is not possible, systems should be in place
to minimise the risk of error.
An interpretation of D positive should not be made on the basis of a weak
positive result with a single anti-D reagent where no patient details are provided.
BCSH guidelines recommend further investigation, with an interim interpretation
of D negative, for female patients of child bearing potential or any patient likely
to require regular transfusion.
Where a reagent control gives a positive reaction the test is invalidated
regardless of the strength of reaction relative to anti-D reagent(s), and no
interpretation should be made until the D status has been confirmed using
saline reacting monoclonal anti-D reagents.
Rapid grouping is particularly high risk as the testing and reporting is manual,
and the reagents may be infrequently used. The use of adequate controls is
essential.
12R7
Manual testing systems
Interpretation of D type
based on a weak reaction
with an anti-D reagent
13R1
Interpretation of D type in
the presence of a positive
reaction with a reagent
control
Adequate controls for
rapid grouping reagents
12R4
Antibody Identification
Recognition that an
additional specificity may
be masked in an antibody
mixture
Use of screening panel
results and phenotype
when interpreting ID
results
Positive reactions not
accounted for by the
specificity already
identified.
13R1
12E2; 12E3
12R7; 12E10
13E2; 13E6
13E8
12R9
When interpreting antibody identification results it is vital that the presence of
additional clinically significant antibodies is systematically excluded, and that all
positive reactions are accounted for before a final interpretation is made.
When interpreting antibody identification results all available information should
be taken into account, including patient phenotype, differential reaction by
technique, and results of all cells tested (including the screening panel).
12E2; 13E3
Where reactions in the screen and/or panel cannot be attributed to the
antibody(ies) already positively identified, it is essential to investigate the
potential presence of other antibodies (regardless of clinical significance), in
order to safely complete the antibody identification process. Accounting for all
reactions will cover the possibility of error in the initial identification, ensure that
all clinically significant antibodies are identified, and prevent unexpected
problems in crossmatching should the patient require transfusion.
Inclusion of an enzyme
13E6
An enzyme technique can be an invaluable part of the antibody identification
panel
process, particularly where there is a mixture of antibodies or where weak Rh or
Kidd antibodies require confirmation or need to be excluded.
Positively identifying
12E5; 12R7;
The specificity of an antibody should only be assigned when it is reactive with at
antibodies not actually
13R1; 13E2;
least two examples of reagent red cells carrying the antigen and non-reactive
present
13R4; 13E5;
with at least two examples of reagent red cells lacking the antigen. This rule
13R7; 13E10
applies independently to each antibody specificity potentially present in an
antibody mixture, including those considered of unlikely clinical significance.
Antibodies of low clinical
12R1; 12E5
Once all reactions in the identification and screening panel have been
significance and to low
12E8; 13E2
accounted for by the presence of antibodies already identified, there is no need
frequency antigens
13R4
to exclude antibodies of low clinical significance or those directed against low
frequency antigens.
Procedure for recording
12E10; 13E3
Interpretation and documentation of antibody identification results is an errorand interpreting ID results
prone manual process, and this should be considered when establishing
procedures for reporting antibody identification for both clinical and EQA
samples.
Phenotyping, crossmatching and general areas
Laboratory equipment should be regularly calibrated and maintained, to avoid
Equipment maintenance
12R4
suboptimal testing (in this case incorrect centrifugation speed).
Rare phenotypes
12R4
Where particularly rare phenotypes are found, tests should be repeated and
controls checks for validity.
Preparation of EQA
13R7
EQA samples should be appropriately prepared for use in the required test
samples for use
system. In this example, red cells in Alsever’s (7-10%) were used directly in an
automated system for crossmatching but were much too weak, and
consequently the antibody was not detected.
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7.
SCHEME DEVELOPMENT AND QUALITY INDICATORS
7.1 Accreditation
Unconditional CPA accreditation of the Scheme has been maintained with the most recent being in
July 2012. The Scheme will be inspected by UKAS to ISO17043 standards from 2014.
7.2 IT and communications
By December 2013, 99% of UK and 95% of non-UK laboratories had taken advantage of web-based
entry of results and receipt of reports. There were only four UK laboratories who were still returning
results on paper (compared with 13 in 2012). Following 2013/14 re-registration, we wrote to all UK
laboratories who were still receiving paper reports for either BTLP and/or FMH and encouraged
them to register for the web. The scheme no longer offers a paper-based service to new participants
and has decided to give notice in the 2014/15 re-registration newsletter that this option will no longer
be available to existing participants from April 2015.
Significant progress has been made with development of a new information website during 2013
and this will be launched in 2014.
7.3 UI Submissions
A total 134 UI submissions were received during this two year review period, 129 from the UK
(including Ireland) and five from outside of the UK. On review of the panel sheets and explanations,
the Scheme agreed with 112 submissions (84%) and disagreed with 22 (16%). Appendix 2 lists all
the UI submissions, and provides further details on the 22 where there was no agreement; the
current version of the ‘Rules’ are in appendix 3. This data will be continue to be reviewed.
7.4 ABO titration Pilot
The ABO titration pilot continued during 2012 and 2013. Participation increased by 10% during
2013, from 68 to 75 participants. All plasma samples were sent undiluted and covered a range of
titration values, including duplicates, and a replicate sample distributed in sequential exericses. The
results show a wide variation in practice, and a wide range of results within all techniques, including
the standard. The annual report for 2012/13 can be found in Appendix 4.
The scheme has been working with NIBSC to develop reference preparations for anti-A and anti-B
to support the programme, and the first part of the validation has been undertaken. WHO has
agreed the project, which allows for the reference preparations to be developed as international
standards.
7.5 Point of care D typing
In early 2012, the Scheme started a collaboration with one of the organisations providing a service
for termination of pregnancy, where women are given prophylactic anti-D based on results from a
commercial tile-based D typing kit at the client’s side in the clinic. Testing and recording of results is
all manual, and venous samples are taken following equivocal results and referred to a hospital
laboratory for confirmatory testing. 49 clinics registered in the scheme in April 2012, and there was a
15% increase in participation in 2013. During 2013, the scheme distributed two anomalous D types:
a 50:50 Dpos/Dneg mixed field and partial DVI.
7.6 Simulated whole blood samples
Simulated whole blood samples are currently under development. The aim is to reduce haemolysis
and allow the addition of the alloantibody to the whole blood sample for grouping and screening.
Following a review of previous experiments and observations, the first phase of the trial took place
in 2013, where testing was undertaken using anti-D. The next phase of the trial will take place in
early 2014, using different antibody specificities, and will include testing using automated
technologies, with the help of steering committee members.
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7.7 Direct Antiglobulin Test (DAT)
Plans to pilot EQA for the DAT have been postponed because the supplier of the material was
unable to meet our requirements. We are now working with a different supplier and hope to
undertake the pilot in 2014.
7.8 On-line competency assessment scheme
During the last two years, the Scheme has been developing a an on-line competency assessment
scheme, called TACT (Training, Assessment and Competency Tool). An IT company (Certus
Technology Associates Ltd) has been engaged to help deliver the core interactive web-based
scheme during 2014. TACT will generate transfusion scenarios that can be accessed 24/7/365. The
scenarios will challenge staff in a number of critical areas, e.g. sample and request acceptance,
ABO and RhD interpretation, antibody screen and identification, component selection and
compatibility processes. Selected, yet controlled random elements within the scenario generation
process, will help to enhance the participation experience by eliminating predictability. Laboratory
managers will have a constant link to the activities of their staff members within TACT and be able
to use the system to complement their own internal training and competency schemes. TACT will
incorporate ‘automatic’ assessment based on BCSH guidance and the opportunity for managers to
review scenarios with staff against local practices. Staff will be able to build a portfolio of activity
which will allocate them a current competency rating based on their performance in the different
categories being assessed. Activities attempted / completed within TACT may be used as CPD
evidence and be transferred across employing organisations when moving jobs. Currently, a
repository of scenarios is being created and the logistics of the automated assessment mechanism
is being configured for pilot testing in Spring 2014. Once launched, and in order to keep TACT at the
forefront of laboratory training and competency assessment activities, we intend to continually
develop and enhance TACT with subscriber uptake dictating the rate of that development.
7.9 Pilot Scheme for red cell genotyping
A pilot scheme for red cell genotyping is in the early stages of development and we are
collaborating with the International Blood Group Reference Laboratory and the Chair of the
International Society for Blood Transfusion Working Group on red cell genotyping. There were two
meetings in 2013, to discuss implementation and development of this pilot scheme. A pre-pilot
exercise, in collaboration with ISBT, is planned for April 2014, with a view to present the results at
the ISBT Congress in June.
7.10 scheme re-design

There are plans for further changes to scheme design which will follow the completion of the
simulated whole blood sample project and be based on the outcomes of the Scheme Design
Task Force meeting which took place in June 2013. Recommendations from the Task Force,
included the following:
o Assess serology and process separately.
o Distribute more samples which will give anomalous ABO/D results.
o Include age and gender with instructions at least some of the time.
o Change IT to default the interpretation to ‘compatible’ for a reaction grade of negative and
‘incompatible’ for a reaction grade of weak or strong positive, for crossmatching and
screening.
o Investigate ways to increase the volume of red cells distributed for crossmatching.
o Collect a wider range of reaction grades for screening and crossmatching - 0-5 rather than
weak/strong.
o Consider moving from 4 ‘R’ (full programme) + 6 ‘E’ (antibody screening and ID only)
exercises a year to 6 ‘R’ + additional theoretical exercises for antibody identification and
process.
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7.11 Key Performance Indicators
Targets and achievement rates for key performance indicators are shown in table 9.
Table 9 – Combined Key Performance Indicators for 2012 and 2013
Category
No. of
Events
Target
Exercise Distributions
20
On schedule
Target
Achievement
Rate
Actual
Achievement
Rate
100%
100%
90%
100%
1
Report Distributions
20
Within 6&8 days of C/D
(E&R exercises
respectively)
Complaints
23
Acknowledged within one
week; dealt with in 4
weeks
70%
100%
Make telephone contact
90%
84%
1,2
80%
100%
50%
58%
80%
100%
100%
(mean = 0.2%
3
USQ)
0%
(mean = 8.1%
3,5
USQ)
100%
(mean = 0.8%
3
USQ)
100%
(mean = 0.04%
UFT)
New Unsatisfactory
Performers
Borderline Performers
31
77
Within 5 days of C/D
Telephone or written
contact
Within 10 days of C/D
1,2
Reported Sample Quality –
Plasma
69
2% unsatisfactory
90% of
samples
Reported Sample Quality –
Whole Blood Samples
24
2% unsatisfactory
90% of
samples
Reported Sample Quality –
Red cells in Alsever’s
21
2% unsatisfactory
90% of
samples
Integrity of Samples
47,950
<0.5% unsuitable for
testing (UFT) per
exercise
90% (i.e. 9/10
exercises)
1
4
- C/D = Closing Date
- Of those contacted
3
- USQ = reported as Unsatisfactory Sample Quality
4
- KPI not met – 5 UPs were not phoned as it would not have been helpful
5
- KPI not met – within the UK and ROI, a target of 4% USQ would have been achieved in 100% of samples.
The current target is unrealistic and will be changed following further discussion. Work is being undertaken to
develop a simulated whole sample to address this issue. The whole blood samples are only used for ABO/D
typing in-house testing demonstrates that haemolysis does not affect the blood grouping results.
2
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8.
QUESTIONNAIRES AND NON-SCORING ELEMENTS
8.1 Standard Practice questionnaire
Annual standard practice questionnaires were distributed in 2012 and 2013. See Appendices 5 and
6 for reports.
8.2 Emergency Exercise
13R1 was an emergency scenario, where three ‘patient’ samples and request forms were distributed
for either crossmatch within 10-15 minutes (against donor units from the bank) or for group and
save. ABO/D grouping, antibody screening and antibody identification were assessed in the usual
way, but additional information was collected through SurveyMonkey and reported at a later date.
The report can be found in Appendix 7.
8.3 Anonymous questionnaire
An anonymous questionnaire was distributed to all participants at the annual meeting, with the
request that one person from each organisation complete and return the survey by the end of the
meeting. The questionnaire asked how the EQA exercises are undertaken, with respect to the level
of testing undertaken compared to clinical samples. It also asked about collaboration within and
outside networks, and how the reports are used. This followed a similar questionnaire several years
ago and was undertaken in light of the recent Pathology Quality Review. The results showed that
45% of respondents at least sometimes have more than one member of staff undertaking the
exercise prior to submission of results, and 35% use more than one technique. 13% admitted that
their submitted results are sometimes influenced by other laboratories, either within or outside of the
network. The data was reported to participants in the annual newsletter in February 2014 and the
relevant section is appended as Appendix 8.
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9.
TRENDS IN USE OF TECHNIQUES IN UK NEQAS EXERCISES
Data prior to 2008 are taken from one exercise in each year and therefore only include laboratories
returning results. Subsequent data are derived from questionnaires. Historically, questionnaire data
have shown that some participants use different or additional techniques for UK NEQAS samples
than for clinical samples.
Abbreviations used in figures 1
LPM – Liquid phase microplate
CAT – Column agglutination technology
Figure 1 – ABO/D typing technology
Figure 2 – IAT antibody screening technology
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Figure 3 - Use of enzyme techniques in antibody screening
Figure 4 - IAT crossmatching technology
Figure 5 – Means of establishing final compatibility
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10. INFORMATION, EDUCATION AND PUBLICATIONS/PRESENTATIONS
Education
Annual meeting November 2012: See appendix 9 for programme details.
Annual meeting November 2013: See appendix 10 for programme details.
MRCPath teaching
Publications
Scheme Publications

Abstract (Oral): Titration of IgG antibodies in pregnancy – a snapshot of performance and policy
in the UK. Vox Sang 2012, 103, Suppl 1. White J, Milkins C, Mavurayi A, Rowley M.

Abstract (Oral): Requirement for a Knowledge-based Competency Assessment Scheme
provided by UK NEQAS (BTLP). Transfusion Medicine 2012, 22, Suppl 1. White J, Chaffe B,
Milkins C, Rowley M. Transfusion Medicine 2011, 21, Suppl 1. White J, Milkins C, Rowley M.

Abstract (Poster): Requirement for a blood transfusion laboratory knowledge based competency
assessment scheme in the UK. Vox Sang 2013, 105, Suppl 1. White J, Chafffe W, Milkins C,
Rowley M.

Abstract (Poster): ‘Labelling of transfusion samples from unknown patients in emergency
situations’ Transfusion Medicine 2013, 23, Suppl 2. White J, Milkins C, Rowley M.

Grifols article: ‘Pre-transfusion testing and transfusion guidelines in the UK’ published in English
and Chinese (and now more recently in Japanese)

Letter to the Editor: ‘ No Progress in ABO Titre Measurement: Time to Aim for a Reference?
Transplantation - in press. Bentall A, Regan F, White J, Milkins C, Rowley M, Ball S, Briggs D.
Scheme Representations
UK NEQAS (BTLP) has been represented on, or associated with, the following committees and
organisations during the two year period:







BCSH Transfusion Task Force
BBTS Special Interest Group for Blood Bank Technology
Serious Hazards of Transfusion (SHOT) Working Expert Group and Steering Group
UK Transfusion Laboratory Collaborative (as a collaborator)
BGS Reading organising committee
RCPath - FRCPath examinations
BCSH guideline writing group for:
o Specification and use of IT systems in blood transfusion practice
o Pre-transfusion compatibility testing
o Use of anti-D Ig for the prevention of HDFN
o Blood grouping and antibody testing in pregnancy
Related Publications


SHOT annual report 2012, published 2013
BCSH Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories
(2012). Transfusion Medicine volume 23, issue 1, pages 3-35 February 2013, and at
www.bcshguidelines.com.
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Presentations/teaching
In addition to those already included in the publications section, Scheme staff made several
contributions through oral presentations and teaching to many different organizations.
11. REFERENCES

1 - BCSH Guidelines for pre-transfusion compatibility procedures in blood transfusion
laboratories (2012). Transfusion Medicine volume 23, issue 1, pages 3-35 February 2013, and at
www.bcshguidelines.com.
12. FINANCIAL STATEMENT
Income and Expenditure Summaries for the two-year period, April 2011 to March 2013 (to the
nearest £500)
Income:
£
Participant Type
UK Clinical Laboratories:
611,500
Non-UK Clinical Laboratories:
383,500
6,000
Non-Clinical Laboratories:
£1,001,000
Grand Total
Expenditure:
Category
£
Capital Expenditure
0
Salaries:
588,500
Revenue:
242,000
Overheads:
157500
13000
Education/R&D (inc. books meetings etc.)
£1,001,000
Grand Total
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Appendix 1
Composition of Steering Committee at December 2013
Dr Peter Baker (Chair), Royal Liverpool University Hospital
Mr Martin Maley, RCI, NHSBT, Newcastle
Mrs Anna Capps-Jenner, Ealing Hospital and TDL
Mr Ray Melanaphy, Northern Ireland BTS
Ms Catherine Almond, Kent & Canterbury Hospital
Dr Rekha Anand, NHSBT, Birmingham
Dr Mallika Sekhar, Royal Free NHS Foundation Trust
Vacancy
Mr Malcolm James (co-opted), NHSBT Reagents, Birmingham
Mrs Debbie Asher (Observer - NQAAP representative), Norfolk and Norwich University Hospital
Mrs Clare Milkins (Secretary), Scheme Manager, UK NEQAS
Dr Megan Rowley, Scheme Director, UK NEQAS
Ms Jenny White, Deputy Scheme Manager, UK NEQAS
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Appendix 2
Summary of Data for UI submissions January 12 to December 13
(UK and non-UK)
Table 1 – Details by exercise
Exercise
Antibodies
Code
12R1
c
12E2
K+Jkb
12E3
Fya+c
12R4
S + ENS
12E5
D; K+Cw
12E6
c
12R7
M+Fya
12E8
D
12R9
K+c
12E10
E+Jkb
13R1
Jkb
13E2
K+c; c
13R4
Jkb
13E5
K+Fya; s
13E6
D+Jkb
13R7
S
13E8
K+c
13E10
K+Fya
Total
No. UI
returns
5
5
20
8
12
17
7
2
12
5
5
15
2
9
2
3
4
1
134
No. agreed
5
4
19
7
12
17
5
2
11
4
4
14
2
4
0
0
2
0
112
No.
disagreed
0
1
1
1
0
0
2
0
1
1
1
1
0
5
2
3
2
1
22
Table 2 – Reasons for disagreeing with the UI submissions
Category
Could have identified the antibody with the IAT panel results submitted
False positive or false negative reactions recorded
Could have excluded additional antibody (ies) based on IAT results
submitted
Did not consider the presence of an antibody (actually present)
Total
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No.
submissions
11
6
3
2
22
Appendix 3
Acceptance of a result of UI for antibody identification
This process should only be used where antibodies of likely clinical significance cannot be fully
elucidated or excluded. N.B. UK NEQAS (BTLP) samples do not contain more than two
specificities, so if you have positively identified two specificities please do not make an UI
submission. The following rules apply:
a.
the following will incur penalties
 Misinterpretations contributed to by false negative or false positive reactions.
 If a specificity (actually present) is not entered as positively identified and we feel that it can be
identified based on two positive and two negative reactions (as stated in BCSH guidelines) by
whatever method is appropriate (e.g. IAT, OR enzymes in the case of Rh). This will be based on
a maximum of 2 antibodies being present. (N.B: Serological reactions obtained with the antibody
screening cells should be included in the interpretation).
 If a specificity not actually present is entered as positively identified.
 If a specificity is entered as ‘cannot be excluded’, but we feel that it can be excluded, either
because of one or more negative reactions with an appropriate antigen positive cell, or because
of one or more negative reactions by a particular method. For example, stating that an Rh
antibody cannot be excluded from an antibody mixture in the presence of a negative result with
an enzyme treated cell carrying the corresponding antigen would incur a penalty.
 If a specificity is entered as ‘cannot be excluded’, but the patient phenotype provided shows that
the patient is positive for the corresponding antigen.
 If a clinically significant antibody is not identified in the presence of an enzyme non-specific
antibody.
b.
the following will not incur penalties
 Being unable to exclude a specificity in line with BCSH guidelines. E.g. having no homozygous
cell available to exclude anti-Jka.
 Including a specificity (if actually present) even if the inclusion does not comply with BCSH
guidelines (e.g. only one r’r cell).
 If an antibody (actually present) is reacting with homozygous but not with heterozygous cells,
and is recorded as ‘cannot be excluded’ rather than as ‘positively identified’. However, this would
only apply if our in-house testing also found non-reactivity with heterozygous cells by the same
technique; otherwise, this would be classed as a false negative result.
c.
the following documentation is required for a UI submission to be considered
 The UI box should be marked in addition to any boxes for antibodies that you can confidently
identify.

The UI submission must include details of antibodies that cannot be positively identified, but
cannot be excluded, and your explanation of why identification cannot be confirmed.

Copies of all panel sheets showing the reactions recorded, (including those used for antibody
screening) must be returned with your exercise result sheet and marked with your PRN.
If supporting paperwork is not submitted, antibodies recorded as positively identified will
be considered as your result for performance monitoring purposes.
 Copies of all panel sheets showing the reactions recorded, (including those used for antibody
screening) must be returned with your exercise result sheet and marked with your PRN.

If supporting paperwork is not submitted, antibodies recorded as positively identified will be
considered as your result for performance monitoring purposes.
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Appendix 4
UK NEQAS (BTLP)
ABO titration pilot annual summary
2012 - 2013
Introduction
The UK NEQAS (BTLP) ABO titration pilot has been running since an exploratory pilot exercise in 2009
revealed a wide variation of methodology in use, the titration results obtained and their use in the ABO
incompatible (ABOi) transplant context. The main focus of the pilot is to look at ABO titration in
laboratories supporting ABOi transplant, and the 2012-13 pilot included 38 such laboratories with a further
31 laboratories performing ABO titration for other clinical reasons. Since 2010, results obtained with
‘standard’ indirect antiglobulin (IAT) and direct room temperature (DRT) techniques based on DiaMed (as
the most commonly used column agglutination technology) have been requested alongside those using
in-house techniques, in an attempt to allow a more direct comparison of results. In-house validation and
examination of participants’ results showed that using the Diluent 2 or CellStab as the red cell diluent did
not affect results, and the standard technique provided in 2012-13 allowed the use of either of these
diluents, in theory allowing more laboratories to submit results using the standard technique. The reports
issued for each 2012-13 pilot exercise summarised the medians by method, and included individual
results for each laboratory. This report provides a more detailed analysis of the results.
Exercise Summary 2012-13
Table 1 shows a summary of the exercises distributed in the 2012-13 cycle.
Table 1 – summary of ABO titration exercise material, participation and results 2012-13
12/13 ABOT1
12/13 ABOT2
12/13 ABOT3
12/13 ABOT4
Data
June 2012
September 2012
December 2012
March 2013
Number of participants
Return rate
69 (36 UK)
92.8%
49 DRT
48 IAT
42 DRT
2
31 IAT and 5 DTT
Group O
32 DRT, 256 IAT
Group O
32 DRT, 256 IAT
Group O
32 DRT
128 IAT
69 (37 UK)
91.3%
44 DRT
49 IAT
45 DRT
2
28 IAT and 6 DTT
Group O
64 DRT, 128 IAT
Group O
64 DRT, 256 IAT
Group B
32 DRT
32 IAT
68 (36 UK)
89.9%
48 DRT
50 IAT
38 DRT
2
21 IAT and 7 DTT
Group B
32 DRT, 16 IAT
Group O
64 DRT, 256 IAT
Group O
16 DRT
16 IAT
67 (37 UK)
89.6%
46 DRT
48 IAT
35 DRT
2
22 IAT and 7 DTT
Group O
256 DRT, 2048 IAT
Group O
64 DRT, 256 IAT
Group O
128 DRT
256 IAT
Cells provided for
titration
A1rr
A1rr
A1rr
A1rr
Replicate samples
P1 and P2 one pool
P2 same pool as
12/13 ABOT3/T4
Additional information
collected
Other reasons for
performing ABOT
Clinical use of results
P2 same pool as
12/13 ABOT2/T4
Clinical use of results
Screen for red cell
antibodies
P2 same pool as
12/13 ABOT2/T3
A subtyping
Clinical use of results
Survey renal Tp units
Number Std. results
Number in-house results
Plasma sample 1
1
Group and titre
Plasma sample 2
1
Group and titre
Plasma sample 3
1
Group and titre
1
2
Titres shown are median results obtained with the standard technique; DTT or equivalent
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Appendix 4
Examples of results by technology (including ‘standard’)
Figure 1 shows results of a low titre sample ABOT3 P3 to demonstrate the distribution of results using inhouse technologies by DRT, IAT and IAT using DTT-treated plasma, and the standard technique.
Figure 2 shows results of a high titre sample ABOT4 P1 to show the distribution of results using in-house
technologies by DRT, IAT and IAT using DTT-treated plasma, and the standard technique. The number in
each group is shown in brackets after the technology.
Figure 1: ABOT3 Patient 3
Technique
DRT Standard
DRT In-house Overall
DRT In-house DiaMed
DRT In-house BioVue
DRT In-house tube
DRT In-house Immucor
IAT Standard
IAT In-house Overall
IAT In-house DiaMed untreated
IAT In-house BioVue untreated
IAT In-house tube untreated
IAT In-house Immucor untreated
IAT DTT (or equivalent) overall
Anti-A titre median (range)
16 (8-64)
8 (4-64)
8 (8-32)
8 (4-16)
16 (4-64)
4 (4-8)
16 (8-32)
16 (4-128)
8 (8-32)
32 (16-128)
24 (8-32)
4 (4-8)
4 (0-8)
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Appendix 4
Figure 2: ABOT4 Patient 1
Technique
DRT Standard
DRT In-house Overall
DRT In-house DiaMed
DRT In-house BioVue
DRT In-house tube
DRT In-house Immucor
IAT Standard
IAT In-house Overall
IAT In-house DiaMed untreated
IAT In-house BioVue untreated
IAT In-house tube untreated
IAT In-house Immucor untreated
IAT DTT (or equivalent) overall
Anti-A titre median (range)
256 (64-512)
128 (32-1024)
128 (64-256)
384 (64-1028)
64 (32-512)
32 (32-32)
2048 (512-8192)
3048 (1000-32000)
4048 (2048-4096)
12288 (1024-32000)
1536 (1000-8192)
2096 (2096-2096)
512 (128-2048)
Difference between standard and media
2012/13
The IAT medians obtained for the 12 samples
distributed in 2012/13 using in-house techniques
(All in-house, BioVue, DiaMed, Tube, DTT) were
examined for distance from the corresponding IAT
median for the ‘standard technique’. Each was
assigned a score of 1 for each dilution above the
standard median and of -1 for each dilution below
the standard median. The cumulative scores are
Cumulative difference between standard medians and medians using ‘in-house’ (IH) techniques
Figure 3: Cumulative difference IH IAT medians vs. ‘standard’ IAT median
In figure 3, ‘0’ represents the
standard median.
As expected, the DDT
median was lower than the
median using the standard
technique which uses
untreated plasma.
The IAT BioVue median was
higher than that for the IAT
‘standard technique’
(DiaMed) in 11/12 (92%)
samples (data on each
samples was provided in
individual exercise reports
during 2012/13).
Replicate samples
Exercises 12ABOT2, 12ABOT3 and 12/13ABOT4 contained a replicate sample from a pool of plasma
that was frozen in aliquots, with one thawed for each exercise. Results from laboratories who
completed all three exercises using the same technology for each are included in Table 2, which
shows the number (%) of results obtained with each method that were the same for all three replicates,
and the number (%) where one or more result differed by one, two or more than two doubling dilutions.
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Appendix 4
Table 2 – reproducibility of titration result for the three replicate samples, by method
Method (number)
Same each time
Within 1 dilution Within 2 dilutions
Std DRT (33)
IH DRT (28)
IH DiaMed DRT (11)
IH Tube DRT (12)
Std IAT (38)
IH IAT (12)
1
IH IAT DTT (3)
1
5 (15%)
4 (14%)
2 (18%)
0 (0%)
16 (42%)
1 (8%)
0 (0%)
12 (36%)
15 (54%)
8 (73%)
6 (50%)
19 (50%)
7 (58%)
1 (33%)
13 (39%)
7 (25%)
1 (18%)
4 (33%)
3 (8%)
2 (17%)
1 (33%)
>2 dilutions apart
3 (9%)
2 (7%)
0 (0%)
2 (17%)
0 (0%)
2 (17%)
1 (33%)
2 DiaMed and 1 tube
Figure 4 shows the overall percentage of replicate results that did not differ by more than one dilution
over the three exercises 12/13 ABO T2, T3 and T4, by technology.
Figure 4: Replicate results within 1 doubling dilution, by technology
Exercise 12/13ABOT1 included two samples from the same pool (P1 and P2). Figures 5 and 6 show
the reproducibility of the DRT and IAT titration results by technology. In figure 5, in-house results of P1
are plotted vs. those for P2 (N.B. where multiple results occur at one point in the chart, these will be
overlaid). Figure 6 shows the difference between results for P1 vs. P2 in individual laboratories,
displayed by technology for DRT and IAT. Technologies with <5 results have not been included in
figures 5 and 6.
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Appendix 4
Figure 5: 12/13ABOT1 DRT and IAT in-house individual results P1 vs. P2 identified by technology
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Appendix 4
Figure 6: 12/13 ABOT1 DRT and IAT - difference P1 vs. P2 in individual laboratories by technology
Difference of results from method median (cumulative data for 1012/13)
All of the IAT results obtained for the 12 samples distributed in 2012/13 using in house techniques
(BioVue, DiaMed and Tube technology) and the standard technique were examined for distance from
the method median. Each result was assigned a score of 1 for each dilution above the median and of 1 for each dilution below the median. Where the median fell between two doubling dilutions the results
either side of were assigned a value of 0.5. The cumulative results by technology are displayed in
Figure 7 below, and Figure 8 shows all results together. The numbers for other in-house methods were
too small for anaylsis.
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Appendix 4
Figure 7: % IAT results at intervals from the IAT method median for each technology
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Appendix 4
Figure 8: % IAT results at intervals from the IAT method median all technologies
A subtyping
In 12/13 ABOT4, 49/60 laboratories undertook A1/A2 typing, including 30 that use these results to
support an ABOi solid organ transplant program. Three reported a result for ‘Patient’ Z only, and one of
these stated that they did not report on A subtypes other than A1, as their reagent identifies A1 but a
negative results does not confirm A2 (as opposed to any other A subgroup).
Two laboratories, both supporting ABOi solid organ transplant programmes, reported all three ‘patient’
samples as A1.
Red cell antibodies
In exercise 12/13 ABOT3, 21/32 laboratories that support ABOi solid organ transplant, stated that they
screen patients for red cell antibodies other than ABO:
8 at the time of each ABO titration
10 at admission to the transplant programme only
3 at the time each routine ‘group and screen’ sample is taken
One of these stated that the result of this screen would not be taken into account when selecting red
cells for ABO titration, and four said that they did not know. A further five laboratories stated that they
do not screen for red cell antibodies other than ABO, three did not know whether a red cell antibody
screen is performed, and three did not answer this question.
Clinical use of ABO titration results to support ABOi transplant
With exercise 12/13 ABOT4, a project was undertaken in collaboration with Dr Andrew Bentall
(University Hospitals Birmingham) to investigate how titration results are used in clinical practice. The
UK renal transplant centres routinely provided with titration results by participating laboratories were
contacted to find out whether the three ‘patients’ in exercise12/13 ABOT4 would be admitted to the
ABOi program and whether an ABOi transplant would take place, based on the titration results
obtained in this exercise.
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Appendix 4
14 UK centres (undertaking 359 transplants) participated. The median IAT titre at which clinicians
would accept patients onto the ABOi programme for treatment was 512 (range 128-4096). The median
target for acceptable titre at day of transplantation was 8 (range 2-16). The laboratories providing
results for these centres have a titre range differing by up to 5 dilutions based on UK NEQAS data;
using a reference technique across all the respective laboratories reduced variability to a maximum of
1 dilution from the median. Variation in local in-house titre results did not correlate with the titres
considered acceptable for inclusion in ABOi programmes1
Discussion
Titration techniques are likely to include manual steps in dilution and / or reading and therefore some
variation in replicate results is to be expected. However, it would be reasonable to expect results of
replicate samples to be within one doubling dilution.
IAT results appear to be more reproducible than DRT results. Overall, 62% of intra laboratory results
obtained by DRT and 86% by IAT (untreated plasma) were within one doubling dilution for the three
replicate samples distributed in 12/13 ABOT2, T3 and T4. Although it is not clear how technology
affects reproducibility, apart perhaps from the method for reading the titration endpoint, when this was
examined by technique, 92% of IAT results obtained using the standard technique were within one
doubling dilution cf. 66% in-house IAT results. The opposite was observed for the DRT, with 51%
standard DRT results being within one doubling dilution cf. 68% in-house DRT results.
Two replicate samples were distributed in exercise 12/13 ABOT1, and 95.5% results overall by DRT
and 98.8% by IAT were within one dilution, with 61% of IAT results and 72% DRT results being
identical for both samples. The proportion of results within one doubling dilution was higher than that
seen for the replicate samples sent over three exercises (12/13 ABOT2, T3 and T4). This might be
because fewer replicates (2 cf. 3) were compared, or because fewer variables impacted on results of
tests performed on the same day, e.g. they were less likely to have been undertaken by different
individuals.
Although the number of laboratories returning results of techniques using BioVue technology (and
other in-house techniques) was small, the BioVue IAT median was generally higher than that for other
techniques, and was higher than the IAT standard technique median for 11/12 (92%) samples issued
in 2012/13. This effect was also apparent when comparing the cumulative differences between the
standard and in-house method medians (see Figure 3).
When comparing the cumulative difference of each result from the median result for the individual
technology, a tighter range of results was obtained using the IAT standard technique than with a tube
technique (see Figures 7 and 8).
Conclusions
There is still considerable variation in results obtained between techniques, and the introduction of a
standard technique would facilitate the transfer of results and transplant protocols (i.e. acceptable
titration values for admission to ABOi renal transplant programs and suitability for transplant) across
centres.
Use of the standard technique appears to reduce the inter laboratory range of results, compared to
tube techniques. Where any single technology is used, reproducibility on the day is good within one
doubling dilution, but becomes more variable in a significant proportion of laboratories when replicate
samples are tested on separate occasions.
References
1
No progress in ABO titre measurement; time to aim for a reference?
Bentall, A. et al, Transplantation, Volume 97, Number 3, February 15, 2014.
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Appendix 4
Appendix Standard technique in use 2012-13
 Prepare dilutions of plasma in saline (PBS or NaCl) using a doubling dilution method.
Make the dilutions with a minimum volume of 200µl, using an automatic pipette. Use a
new tip to dispense each dilution.
 Prepare a 0.8 - 1% red cell suspension in CellStab (use ID-diluent 2 if CellStab is not
available).
LISS indirect antiglobulin test (IAT) using IgG cards
a) Add 50ul of cells suspended in CellStab to each microtube
b) Add 25ul of each plasma dilution to the corresponding microtube
c) Incubate at 37oC for 15’
d) Centrifuge 10’ in DiaMed centrifuge
Direct agglutination at room temperature (DRT) using NaCl cards
a) Add 50ul of cells suspended in CellStab to each microtube
b) Add 50ul of each plasma dilution to the corresponding microtube
c) Incubate at RT for 15’
d) Centrifuge 10’ in DiaMed centrifuge
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NQAAP Report for 2012
Appendix 5:
Pre-Transfusion Testing Questionnaire - UK and Republic of Ireland
Distributed with exercise 12R4 – April 2012
Introduction
The purpose of this questionnaire was to update basic information on routine pre-transfusion grouping
and antibody screening procedures, last gathered in January 2011. We will continue to update this
information on an annual basis.
Return rate
Responses were received from 305/409 (75%) laboratories, compared with 77% in 2011, 75% in 2009
and 86% in 2008. Seventeen respondents stated that their laboratory does not undertake routine pretransfusion testing, and five returned blank questionnaires. Data from 283 hospital transfusion
laboratories has been analysed; however, three of these did not complete any details in the testing
section.
Summary and trend data
Table 1 shows a summary of current data compared to historical data where available
Table 1 – Trends in routine pre-transfusion testing
1
Automation for ‘group and screen’
1
Used during core hours
2
Proportion of full automation used 24/7
Proportion of full automation interfaced to LIMS
Routine ABO/D Grouping
Liquid phase microplates
Column Agglutination Technology (CAT)
Omit reverse group on patients with historical groups
Omit reverse group on patients without historical group
D typing reagents
Single anti-D used once for patients with a historical group
Single anti-D once for patients with no historical group
Routinely include IAT for D typing on apparent D
negatives
Include and anti-CDE reagent
Routine method of establishing compatibility
Electronic issue
‘Immediate’ spin
IAT ( other technique(s))
IAT technology antibody screening
CAT
Solid Phase Microplate (SPMP)
IAT technology crossmatching
CAT
Tube
2012
n=283
2011
n=307
2009
n=332
2008
n=392
2002
n=446
81%
90%
98%
74%
84%
98%
73%
79%
96%
68%
82%
89%
41%
NDA
NDA
10%
86%
23%
<1%
13%
82%
24%
<1%
13%
80%
26%
<1%
14%
77%
25%
<1%
41%
33%
13%
1%
52%
28%
5%
52%
31%
6%
44%
22%
8%
45%
25%
6%
15%
5%
3%
3%
5%
1%
≥ 10%
54%
8%
38%
46%
8%
46%
46%
7%
47%
37%
8%
55%
10%
15%
75%
92%
8%
90%
10%
89%
8%
90%
9%
85%
4%
98%
2%
96%
2%
81%
7%
96%
3%
77%
3
17%
3%
Full automation from 2008 onwards cf. full or ‘semi’ automation in 2002
2009/11/12 data includes only those ‘always used out of hours’ whilst 2008 includes ‘used out of
hours’
3
2001 exercise data.
NDA = no data available
2
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3
NQAAP Report for 2012
Appendix 5:
Analysis of 2012 data
General information /automation
Workload (n=283)
Figure 1 shows the percentage of laboratories within workload categories based on the approximate
number of group and screens performed per year for 2012 (with previous years for comparison).
Figure 1
IT and automation
281/283 (99%) have an IT system for recording and reporting results of blood grouping tests.
The two laboratories with no IT system process <1000 groups and screens per annum.
Table 2 shows the LIMS used by the 276 laboratories answering this question. 75% use iSoft or
Clinisys. There were 23 other commercial IT suppliers reported, with none of these having more than
ten users.
Table 2 – LIMS used by number (%) of laboratories (where stated)
IT system
iSoft
Clinisys
Other*
Total
Number (%) of laboratories
108 (39%)
99 (36%)
69 (25%)
276 (100%)
* including two using in-house systems and two not stating an IT supplier
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Appendix 5:
Table 3 shows the use of automation for routine group and screens within core hours.
Table 3 – Number (%) laboratories using automation for group and screens during core hours
Testing
Full automated
Semi-automated (i.e. not walkaway)
No automation
Total
Number (%) of laboratories
228 (81%)
8 (3%)
47 (17%)
283 (100%)
During core hours, approximately 93% of group and screens are tested with full automation (taking the
number of group and screens performed by each laboratory to be the midpoint where the category is a
range, using 500 for the <1000 category and 30000 for the >25000 category). This does not take
account of urgent testing which may be undertaken manually in a laboratory with automation even
during core hours.
Table 4 shows the number (%) of laboratories with an interface between the automation and laboratory
information management system (LIMS).
Table 4 – Number (%) laboratories with automation – LIMS interface
Interface between automation
and LIMS
Bi-directional
Uni-directional
Not interfaced
Total
Number (%) with full
automation
147 (66%)
72 (32%)
5 (2%)
224* (100%)
Number (%) with semiautomated testing
0 (0%)
8 (100%)
0 (0%)
8 (100%)
*four laboratories using full automation did not answer this question
Testing outside core hours
268/282 (95%) stated that they undertake pre-transfusion testing outside core hours
o 221/268 (83%) have full automation and 220 stated how this is used for routine testing out
of hours:
198/220 (90%) always use the automation
17/220 (8%) sometimes use the automation
5/220 (2%) never use the automation, but it is possible that these only undertake
urgent testing out of hours.
Details of testing
ABO/D typing technology
Table 5 shows the number (%) of laboratories using each technology as their primary ABO/D typing
technique for patients with a previous group, and table 6 the percentage of each using full automation,
semi-automated systems and manual testing.
Table 5 – ABO/D typing techniques
Technology
DiaMed
BioVue
Liquid phase microplate
Solid phase
Grifols
Tube
All techniques
All laboratories
148 (53%)
89 (32%)
29 (10%)
1 (<1%)
2 (1%)
11 (4%)
280 (100%)
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Appendix 5:
Table 6 – Use of automation by technology
Technology
1
DiaMed (n=148)
BioVue (n=89)
Liquid phase microplate (n=29)
Solid phase (n=1)
Grifols (n=2)
Tube (n=11)
Full
automation
119 (81%)
82 (92%)
1
22 (76%)
1 (100%)
2 (100%)
N/A
Semiautomation
2 (1%)
0 (0%)
5 (17%)
0 (0%)
0 (0%)
N/A
Manual testing
27 (8%)
7 (8%)
2 (7%)
0 (0%)
0 (0%)
11 (100%)
all using Immucor automated systems
Use of automation for other tests
Table 7 shows the number (%) of the 236 laboratories with automation that use it for tests other than
‘group and screen’.
Table 7 – Use of automation by test
Test
Antibody ID
Crossmatching
Phenotyping
Number (%)
129 (55%)
67 (28%)
60 (25%)
Inclusion of a reverse group
64/277 (23%) omit the reverse group for patients with historical groups, however 5 of these
include a reverse group if there is only one historical group record.
1/277 (<1%), using a manual DiaMed technique, also omits the reverse group for new patients.
D typing
Table 8 shows the number (%) using one anti-D reagent once, or testing for D in duplicate, either with
different reagents or with one reagent twice, for patients with and without a historical group.
Table 8 – D typing protocol for patients with and without a previous group
D typing reagents
Patients with a historical group
Use a single anti-D reagent once
Test in duplicate
Total
147 (52%)
132 (48%)
279
Patients with no historical
group
77 (28%)
199 (72%)
276
Three of those using a single anti-D once for patients with no previous group, undertake
manual testing.
9/280 (3%) laboratories incorporate an anti-CDE reagent into routine testing:
o 7 for all patients
o 2 only for patients with no previous group
14/277 (5%) routinely confirm D negatives using an IAT anti-D reagent:
o 10 for all patients
o 4 only for patients with no previous group
IAT technology used for routine antibody screening and crossmatching
Table 9 shows the number (%) using each IAT technology for antibody screening and crossmatching.
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Appendix 5:
Table 9 - IAT technology used for antibody screening and crossmatching
Technique
Antibody
screening (n=279)
Crossmatching
(n=278)
IAT technology
Capture
Solid
RRS
Screen
BioVue
DiaMed
91 (33%)
163 (59%)
22 (8%)
80 (29%)
191 (69%)
1 (<1%)
Grifols
Tube
1 (<1%)
2 (<1%)
0 (0%)
0 (0%)
2 (<1%)
4 (1%)
Method for establishing final compatibility
151 (54%) use electronic issue (one during core hours only)
107 (38%) use an IAT crossmatch (with or without an immediate spin)
22 (8%) use an immediate spin crossmatch.
Electronic issue details
91/151 (60%) require two samples taken at separate times before a patient is eligible for
electronic issue
o Seven of these only require one sample if the patient groups as O.
Of those using EI as their primary method for establishing compatibility:
o 4/151 (3%) are using manual systems
o 3/151 (2%) are using semi-automated systems.
Use of an enzyme technique
12/280 (4%) routinely perform an antibody screen with enzyme treated cells.
251/280 (90%) have access to an enzyme panel for antibody identification.
Conclusions
The report issued in 2011 (11R1) included a full discussion. Most of the discussion points are still
pertinent and will not be repeated on an annual basis unless significant changes are apparent.
However, it is noted that:
Workload figures and decreasing EQA registrations viewed together suggest a trend towards
testing in fewer but larger laboratories.
Use of full automation for group and screen has increased (81% cf. 74% in 2011), and use of
automation 24/7 in laboratories that test out of hours has also risen (90% cf. 84% in 2011).
For the first time there are no laboratories performing routine antibody screening in tubes.
More than half (54%) of laboratories now use electronic issue as the routine method of
establishing compatibility.
The questionnaire data will continue to be collected and analysed on an annual basis.
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Appendix 6:
Pre-Transfusion Testing Questionnaire - UK and Republic of Ireland
Data collected February – June 2013
Introduction
The purpose of this questionnaire was to update basic information on routine pre-transfusion grouping
and antibody screening procedures, last gathered in April 2012. We will continue to update this
information on an annual basis.
Return rate
Responses were received from 289/400 (72%) laboratories, cf. 75% in 2012, 77% in 2011, 75% in 2009
and 86% in 2008. Eleven respondents stated that their laboratory does not undertake routine pretransfusion testing. Duplicate entries have been removed, with the most recent entry kept for inclusion in
the analysis. Data from 278 hospital transfusion laboratories has been analysed; however, two of these
did not complete any details in the testing section.
Summary and trend data
Table 1 shows a summary of current data compared to historical data where available
Trends in routine pre-transfusion testing
2013
n=278
2012
n=283
2011
n=307
2009
n=332
2008
n=392
Automation for ‘group and screen’
1
Used during core hours
84%
81%
74%
73%
68%
2
Proportion of full automation used 24/7
93%
90%
84%
79%
82%
Proportion of full automation interfaced to LIMS
98%
98%
98%
96%
89%
Routine ABO/D Grouping
Liquid phase microplates
10%
10%
13%
13%
14%
Column Agglutination Technology (CAT)
86%
86%
82%
80%
77%
Omit reverse group on patients with historical
22%
23%
24%
26%
25%
groups
Omit reverse group on patients without
0%
<1%
<1%
<1%
<1%
historical group
D typing reagents
Single anti-D used once for patients with a
53%
52%
52%
44%
45%
historical group
Single anti-D once for patients with no historical
31%
28%
31%
22%
25%
group
Routinely include IAT for D typing on apparent D
6%
5%
6%
8%
6%
negatives
Include and anti-CDE reagent
3%
3%
3%
5%
1%
Routine method of establishing compatibility
Electronic issue
55%
54%
46%
46%
37%
‘Immediate’ spin
7%
8%
8%
7%
8%
39%
38%
46%
47%
55%
IAT ( other technique(s))
IAT technology antibody screening
CAT
91%
92%
90%
89%
90%
Solid Phase Microplate (SPMP)
8%
8%
10%
8%
9%
IAT technology crossmatching
CAT
98%
98%
96%
81%
96%
Tube
1%
2%
2%
7%
3%
1
Full automation from 2008 onwards cf. full or ‘semi’ automation in 2002
2
2009/11/12 data includes only those ‘always used out of hours’ whilst 2008 includes ‘used out of hours’
3
2001 exercise data.
NDA = no data available
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2002
n=446
41%
NDA
NDA
41%
33%
13%
1%
15%
5%
3%
≥ 10%
10%
15%
75%
85%
4%
3
77%
3
17%
Appendix 6:
Analysis of 2013 data
General information /automation
Workload (n=278)
Figure 1 shows the percentage of laboratories within workload categories based on the approximate
number of group and screens performed per year for 2013 (with previous years for comparison).
Figure 1
27/47 (57%) of ROI laboratories test <5000 samples per year cf. 48/231 (21%) in the UK.
IT and automation
273/277 (98.6%) record and report results of blood grouping tests through a laboratory
information management system (LIMS).
Four laboratories stated that they do not report through a LIMS; two process <1000 groups and
screens per annum, and two process 1000-5000. However, in the last pre-transfusion
questionnaire in 2012, two of these four stated that they did report through a LIMS.
Table 2 shows the LIMS used by the 270 laboratories answering this question. 75% use iSoft or
Clinisys. There were 24 other commercial IT suppliers reported, with none of these having more than
ten users.
Table 2 – Details of LIMS used (where stated)
IT system
iSoft
Clinisys
Other*
Total
Number of laboratories
110 (41%)
92 (34%)
68 (25%)
270 (100%)
* including two using in-house systems
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Appendix 6:
Booking EQA samples into the LIMS
196/271 (72%) book EQA samples into the LIMS. The most common reasons cited for not doing so
are:
The format of the samples (not whole blood)
Problems with cumulative data for ‘NEQAS’ patient IDs (changing blood groups)
Interference with workload statistics and cluttering database
Problems booking into shared databases within Trusts
Custom and practice
Table 3 shows the use of automation for routine group and screens within core hours.
Table 3 –Use of automation for group and screens during core hours
Testing
Full automated
Semi-automated (i.e. not walkaway)
No automation
Total
Number of laboratories
231 (84%)
4 (1%)
41 (15%)
276 (100%)
During core hours, approximately 96% of group and screens are tested with full automation (taking the
number of group and screens performed by each laboratory to be the midpoint where the category is a
range, using 500 for the <1000 category and 30000 for the >25000 category). This does not take
account of urgent testing which may be undertaken manually in a laboratory with automation even
during core hours.
Table 4 shows the number and % of laboratories with an interface between the automation and
laboratory information management system (LIMS).
Table 4 – Automation – LIMS interface
Interface between automation
and LIMS
Bi-directional
Uni-directional
Not interfaced
Total
Number with full
automation
160 (69%)
67 (29%)
4 (2%)
231 (100%)
Number with semiautomated testing
0 (0%)
4 (100%)
0 (0%)
4 (100%)
Testing outside core hours
270/277 (97%) stated that they undertake pre-transfusion testing outside core hours
o 226/270 (84%) have full automation and stated whether it is used for testing out of hours:
210/226 (93%) always use the automation
13/226 (6%) sometimes use the automation
3/226 (1%) never use the automation
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Appendix 6:
Details of testing (n=276)
ABO/D typing technology
Table 5 shows the number and percentage of laboratories using each technology as their primary
ABO/D typing technique for patients with a previous group, and table 6 the percentage of each using
full automation, semi-automated systems or manual testing.
Table 5 – ABO/D typing techniques
Technology
DiaMed
BioVue
Liquid phase microplate
Grifols
Tube
All techniques
Number of laboratories
144 (52%)
84 (30%)
27 (10%)
8 (3%)
13 (5%)
276 (100%)
Table 6 – Use of automation by technology
Full
automation:
Number
121 (84%)
77 (92%)
1
25 (93%)
8 (100%)
N/A
Technology
1
DiaMed (n=144)
BioVue (n=84)
Liquid phase microplate (n=27)
Grifols (n=8)
Tube (n=13)
Semiautomation:
Number
2 (1%)
0 (0%)
2 (8%)
0 (0%)
N/A
Manual testing:
Number
21 (15%)
7 (8%)
0 (0%)
0 (0%)
13 (100%)
23 using solid phase automated systems
Use of automation for other tests
Table 7 shows the number and % of the 235 laboratories with automation that use it for tests other
than ‘group and screen’.
Table 7 – Use of automation by test
Test
Antibody ID
Crossmatching
Phenotyping
Number of laboratories
145 (62%)
76 (32%)
86 (37%)
Inclusion of a reverse group
61/272 (22%) omit the reverse group for patients with more than one historical group (all using
automation), however 7 of these include a reverse group if there is only one historical group
record.
All respondents perform a reverse group on patients with no historical group; however, 24
laboratories did not answer this question.
D typing
Table 8 shows the number and percentage using one anti-D reagent once, or testing for D in duplicate,
either with different reagents or with one reagent twice, for patients with and without a historical group.
Table 8 – D typing protocol for patients with and without a previous group
D typing protocol
Use a single anti-D reagent once
Test in duplicate
Total
Patients with a historical group:
Number
145 (53%)
128 (47%)
273
Patients with no historical group:
Number
83 (31%)
185 (69%)
268
Four of those using a single anti-D once for patients with no previous group, undertake manual
testing.
8/272 (3%) laboratories incorporate an anti-CDE reagent into routine testing:
o 7 for all patients
o 1 only for patients with no previous group
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Appendix 6:
17/269 (6%) routinely confirm D negatives using an IAT anti-D reagent:
o 12 for all patients
o 5 only for patients with no previous group
IAT technology used for routine antibody screening and crossmatching
Table 9 shows the number and percentage using each IAT technology for antibody screening and
crossmatching.
Table 9 - IAT technology used for antibody screening and crossmatching
Technique
1
Antibody
screening (n=275)
Crossmatching
(n=273)
IAT technology
Solid
Capture
Grifols
Screen
BioVue
DiaMed
84 (30%)
158 (58%)
22 (8%)
1 (<1%)
79 (29%)
179 (66%)
2 (1%)
0 (0%)
Tube
Other
8 (3%)
1 (<1%)
1(<1%)
9 (3%)
4 (1%)
0 (0%)
1
This laboratory uses DiaMed for crossmatching
Method for establishing final compatibility
151/275 (55%) use electronic issue (EI), including one using EI during core hours only.
106/275 (39%) use an IAT crossmatch (with or without an immediate spin)
18/275 (7%) use an immediate spin crossmatch.
Requirement for a second sample
Table 10 shows the number and % of laboratories requiring a group on two samples taken at separate
times (one group could be historical), before group specific blood is issued in a routine situation. This is
shown, both overall and depending on whether compatibility is established by EI or a serological
crossmatch.
Table 10 – Requirement for two samples by method of establishing compatibility
Electronic
issue:
Number
52 (35%)
2 (1%)
47 (31%)
50 (33%)
151 (100)%
Require second sample?
1
Yes, always
Yes, unless first sample is group O
No, but in process of implementing two sample policy
No
Total
Serological
crossmatch:
Number
18 (14%)
1 (1%)
52 (42%)
53 (43%)
124 (100%)
All
laboratories:
Number
70 (25%)
1
3 (1%)
99 (36%)
103 (37%)
275 (100%)
Two Scotland and one Northern Ireland
Testing of second sample
All of the 73 laboratories requesting a second sample perform an ABO forward group (with or without a
reverse group), 64 (88%) perform a D type and 65 (89%) an antibody screen. The combinations of
tests performed are detailed in Table 11.
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Appendix 6:
Table 11 – Details of testing on the second sample
Combination of tests on the second sample
Full ABO group, D type and antibody screen
ABO forward group, D type and antibody screen
Full ABO group and antibody screen
Full ABO group only
Full ABO group and D type
ABO forward group only
Total
Number of laboratories
43 (59%)
18 (24%)
4 (6%)
4 (6%)
3 (4%)
1 (1%)
73 (100%)
Table 12 shows the number of laboratories by country that use EI and automation, and the number that
either currently test a second sample before issuing group specific blood, or are in the process of
implementing a policy to do so.
Table 12 – Use of automation, EI and requirement for a second sample by country
Country
England (n=181)
Scotland (n=28)
Wales (n=12)
Northern Ireland (n=8)
Republic of Ireland (n=47)
Total
Use of automation:
Number
170 (94%)
22 (79%)
10 (83%)
7 (88%)
26 (55%)
236 (100%)
Electronic issue:
Number
126 (70%)
9 (32%)
10 (83%)
3 (38%)
3 (6%)
152 (100)%
Second sample:
Number
125 (69%)
15 (54%)
9 (75%)
5 (63%)
18 (38%)
173 (100%)
Use of an enzyme technique
13/274 (5%) routinely perform an antibody screen with enzyme treated cells
249/273 (91%) have access to an enzyme panel for antibody identification
Discussion
The report issued in 2011 (11R1) included a full discussion. Most of the discussion points are still
pertinent and will not be repeated on an annual basis unless significant changes are apparent.
However, it is noted that:
Workload figures and decreasing EQA registrations viewed together suggest a trend towards
testing in fewer but larger laboratories, at least in the UK.
Use of full automation for group and screen continues to rise (84% cf. 81% in 2012), as does
the use of automation 24/7 in laboratories that test out of hours (93% cf. 90% in 2012).
26% of laboratories request two samples taken at separate times for a group check (one group
could be historical), before group specific blood is issued in a routine situation, and a further
36% are in the process of implementing this policy.
More than half (55%) of laboratories now use electronic issue as the routine method of
establishing compatibility.
A higher proportion of those using EI request a second sample than those crossmatching
serologically (35% cf. 14%); however, the difference is less pronounced when those in the
process of implementing this policy are included.
The numbers using automation and EI, and requiring a second sample, varies by country within
the UK, and is considerably lower in the Republic of Ireland (where there is a higher proportion
of small laboratories) than in the UK.
EQA ‘requests’ are booked into the LIMS in 72% laboratories. This is desirable wherever possible, as it
allows the EQA samples to follow the same process as clinical samples and consequently makes the
EQA results more relevant to clinical practice. The format of the samples (i.e. they are not whole blood)
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Appendix 6:
was cited as a reason for not booking EQA samples to the LIMS, and whilst it is appreciated that the
sample format is not ideal, it does not appear to be a barrier to LIMS entry in the majority of
laboratories. In some cases there are additional obstacles to overcome, e.g. where there is a shared
database and / or there are problems with building up historical records for EQA ‘patients’. These
situations may require additional planning as to how the samples are allocated names and numbers for
entry to the LIMS.
The questionnaire data will continue to be collected and analysed on an annual basis
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Appendix 7
Emergency Issue Questionnaire
Distributed with exercise 13R1 – January 2013
UK and Republic of Ireland
Main aims
The aims of this ‘emergency exercise’ were to determine:
Testing undertaken where blood is required within 10-15 minutes
The type of blood issued to a young female in 10-15 minutes
Detection of a MF reaction in D typing
Effect of finding a MF reaction on type of red cells issued for transfusion
Testing undertaken on a sample for ‘group and screen’ outside of core hours
The level of retrospective testing undertaken both before and during the next session of core
hours
Specifications for ‘emergency’ group O negative units
Labelling of samples for ‘unknown’ patients
Material
A whole blood sample and a request form were provided for each of the patients listed below,
with instructions for completing the exercise in the emergency format. Blood was required
within 10-15 minutes for patients 1 and 2, and a group and save was requested for Patient 3.
Patient 1
Clinical details
Expected results
Amy Stake, female, age 39,
In theatre post ENT surgery, unexpected bleeding ++
Group A D positive, inert
Patient 2
Clinical details
Expected results
Anna Mergenci, female, age 33
Ectopic pregnancy, bleeding PV, for immediate surgery
Group O dual population D positive / D negative, inert
Patient 3
Clinical details
Expected results
Jim Slyp, male, age 63
Fractured femur following fall, for surgery in 60-90 minutes
Group A D negative, anti-Jkb
Two SurveyMonkey questionnaires were issued, one for Patients 1 and 2 and another for
Patient 3.
Return rate
The questionnaire was issued to 400 laboratories in the UK and ROI. Incomplete submissions
missing key information within a set of data for a patient have been excluded, as have duplicate
submissions. 365 (91%) returns were analysed for Patient 1, 362 (91%) for Patient 2, and 340
(85%) for Patient 3.
The numbers undertaking the exercise in an emergency scenario are shown in Table 1. As not
all respondents answered all questions, the totals in the analysis do not always equal the
number of returns.
Table 1: Testing by Patient
Questionnaire
Patient 1
Patient 2
Patient 3
Tested in ‘emergency’
scenario
Number (% of returns)
333 (91%)
330 (91%)
319 (94%)
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Not tested in ‘emergency’
scenario
Number (% of returns)
32 (9%)
32 (9%)
21 (6%)
Appendix 7
Table 2 shows the reasons given for not undertaking emergency testing.
Table 2: Reasons for not undertaking emergency testing
1
Reason for not testing in
emergency format
Reference laboratory
No emergency testing
Manufacturer / diagnostics company
Other
Total
Patients 1 and 2
Number
11
12
3
1
6
32
Patient 3
Number
11
2
2
2
6
18
Issuing O D negative blood, but not completing the exercise
Five would not perform G+S until next day and one would not perform a G+S at all given the clinical details for
Patient 3. These have been included in the analysis for Patient 3.
2
Data analysis
Decisions surrounding duplicate submissions:
Complete rather than incomplete submissions have been selected.
Submissions relating to ‘out of hours’ scenarios have been selected rather than those
for a ‘lone worker’ scenario.
If there was more than one complete set of data (either both lone worker or both out of
hours) then most the most recently submitted has been selected.
Edits to data:
Responses of Yes / No to whether testing was undertaken have been edited according
to whether corresponding result sections were completed.
Information in comment fields has been used to edit responses where relevant.
Results
Both Patient 1 and Patient 2 required blood within 10-15 minutes and not all questions on
testing were repeated for both patients. Therefore, some of the detail in the following section is
provided for Patient 1 only.
Data from Patient 3 has been reported separately, as the clinical scenario was different.
Of those testing Patients 1 and 2 in an emergency, 231 (70%) tested as ‘out of hours’, and 101
(30%) as ‘lone worker within core hours’, and one did not specify the scenario for testing. There
was no apparent difference between these two groups either in the testing undertaken within
10-15 minutes, or the specification of red cells selected, so they have been analysed together.
Patients 1 and 2 requiring blood within 10-15 minutes
ABO grouping undertaken within 10-15 minutes
296 and 293 (89%) participants recorded an ABO/D group within the 10-15 minutes, for
Patients 1 and 2 respectively. Further details of the extent of this testing are summarised in
Table 3.
Table 3: Testing undertaken within 15 minutes
Procedure
1
Performed 2 or >2 ABO forward groups (+/-reverse group)
1
Performed 2 or more D types
Patient 1
Number
162/296 (55%)
2
148/274 (54%)
Patient 2
Number
158/293 (54%)
3
136/261 (52%)
excludes 8 participants who only performed one ABO group – presumably these 8 used two anti-D reagents as
part of a single group
2
22 did not answer this part of the question
3
32 did not answer this part of the question
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Appendix 7
Patient 1 (Female aged 39, group A D positive, inert)
Details of ABO/D grouping within 10-15 minutes
255/296 (86%) considered one (or more) of the group(s) performed to be a ‘rapid’
group
135/162 (83%) performing two or >2 forward groups used a new aliquot for
subsequent group(s)
183/295 (62%) included a reagent control with their forward group(s)
248/296 (84%) performed a reverse group before issuing blood:
 213/248 (86%) tested as part of a full group
 35/248 (14%) tested by re-sampling at a different time to the forward
group
Table 4 shows the technologies used for ABO/D grouping within 10-15 minutes. The total
numbers include 80/294 (27%) laboratories which used more than one technology. Two
respondents did not state which technology was used.
Table 4: Technology used for ABO/D typing within 10-15 minutes (Patient 1)
Technology
Tube
DiaMed
BioVue
Slide / Tile
Microplate
Grifols
Other
Total number
206 (70%)
63 (21%)
61 (21%)
24 (8%)
17 (6%)
2 (1%)
2 (1%)
As a single technology
137 (46%)
25 (8%)
31 (10%)
9 (3%)
8 (3%)
2 (1%)
2 (1%)
ABO/D grouping results
294/296 (99.3%) laboratories reported group A D positive. One reported O D positive, based
on a single group by BioVue, and another reported A D variant based on two or more D types
by BioVue and tube (including a reagent control), using the same aliquot of red cells.
Red cells selected for transfusion
Table 5 shows the group of red cells selected for transfusion to Patient 1 within 10-15 minutes
vs. the ABO/D results reported.
Table 5: ABO/D reported vs. red cells selected for Patient 1 (A D Pos) within 10-15
minutes
ABO/D result
Red cells selected for transfusion
A D positive
A D negative
O D positive
O D negative
A D positive (294)
228
1
14
50
A D variant (1)
0
1
0
0
O D positive (1)
0
0
0
1
None (37)
0
0
0
37
1
Presumably data entry error as selected units were reported as compatible
88/333 (26%) selected O D negative blood
o 66/88 (75%) designated these as ‘flying squad’
327/333 (98%) specified that the units were K negative
Other specifications noted were:
17 Rh phenotyped blood (8 R1R1, 4 c negative, 4 E negative, 1 Rh matched)
13 high titre negative
10 CMV negative (as part of the specification for ‘flying squad’ blood)
1 Fy(a-)
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AB D positive
1
1
0
0
0
Appendix 7
Additional testing within 10-15 minutes
Table 6 shows the additional testing undertaken on Patient 1 within 10-15 minutes, by those
recording a group vs. those not recording a group within 10-15 minutes.
Table 6: Additional work undertaken by on Patient 1 within 15 minutes
1
Additional test / procedure
Group within 15 minutes
Number (n=296)
Immediate spin crossmatch
1
Check group of the donor units
91 (31%)
24 (8%)
No group within 15
minutes
Number (n=37)
1 (3%)
4 (11%)
20/28 in Republic of Ireland
Level of testing undertaken before issue of blood
Table 7 shows the level of ABO testing undertaken within 10-15 minutes (excluding those who
did not perform an ABO group) and the ABO group of red cells issued.
Table 7: Testing undertaken before issue of O group or group A blood
Level of testing on primary sample prior to blood issue in 15
minutes
1
2 forward groups performed on separate aliquots +/- other tests
(n=135)
1
1 forward group + ISXM and / or separate reverse group (n=64)
1
4
1 forward group , no separate reverse group or ISXM (n=96)
No reverse group or reagent control
Patient 1 (A D pos) - Number
Selecting
Selecting
group O
group A
(n=65)
(n=231)
18 (28%)
117 (51%)
15 (23%)
31 (48%)
10 (15%)
49 (21%)
2,3
65 (28%)
15 (6%)
Includes those performing two or more forward groups on the same aliquot of cells
Includes one selecting group AB presumably due to data entry error
3
nd
13 stated that would have requested a 2 sample before issue of red cells but it is not known whether the results
of testing this sample have been taken into account when testing the primary sample or selecting red cells.
4
ISXM = Immediate Spin crossmatch
2
Patient 2 (Female aged 33, group O dual population D positive / D negative (50:50), inert
Red cells selected for transfusion
All 37 laboratories not performing an ABO/D group within 10-15 minutes issued group O D
negative blood.
Table 8 shows the D grouping results of the 293 laboratories performing and recording an
ABO/D group for Patient 2 within 10-15 minutes vs. red cells selected for transfusion. 291
correctly recorded the ABO group as O, two did not record the result of their ABO group and
another recorded as result of group A.
Table 8: D groups recorded and blood selected for Patients 2 (O MF D) within 15 minutes
Group reported (number)
1
D positive (n=219)
D UI (n=60)
D variant (n=11)
D negative (n=3)
Total (n=293)
1
Selected O D positive units
Number
163 (74%)
6 (10%)
3 (28%)
1 (33%)
173 (59%)
– this includes one laboratory which reported group A
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Selected O D negative units
Number
56 (26%)
54 (90%)
8 (73%)
2 (67%)
120 (41%)
Appendix 7
56/60 of those reporting Patient 2 as UI D gave a reason:
49 dual population / mixed field reactions with anti-D reagent(s) (five issued D positive
blood)
6 weak or variable reactions (one issued D positive blood)
1 unspecified D typing anomaly (issued D negative blood).
Two laboratories reporting Patient 2 as D positive also commented on reactions with anti-D
reagent(s), with one noting a mixed field reaction (and going on to issue D positive blood), and
the other noting a weak reaction and issuing D negative blood.
The technology used by those noting a mixed field reaction with anti-D / dual population in
Patient 2 during testing within 10-15 minutes, is shown in Table 9. Table 10 shows the same
information, but based on the final results submitted for exercise 13R1 after all testing was
completed.
Table 9: Recording of a MF reaction vs. technology (testing in 10-15 minutes)
1
Technology
1
Tube
BioVue
DiaMed
Slide/tile
LPMP
Grifols
Other
Multiple
Number using
technology (n=293)
136 (46%)
30 (10%)
24 (8%)
11 (4%)
8 (3%)
2 (1%)
2 (1%)
80 (27%)
MF noted (n=50)
Number (% of labs using technology)
13 (10%)
3 (10%)
14 (58%)
1 (9%)
2 (25%)
1 (50%)
0 (0%)
16 (20%)
Used as single technology apart from ‘multiple’
Table 10: Recording of a MF reaction vs. technology (final result of all testing for
exercise 13R1)
1
Technology
1
2
Tube
BioVue
DiaMed
LPMP
Grifols
Multiple
2
Number using
technology (n=395)
53 (13%)
71 (18%)
116 (29%)
11 (3%)
9 (2%)
135 (34%)
MF recorded (n=164)
Number (% of those using the technology)
12 (23%)
9 (13%)
77 (66%)
1 (9%)
5 (56%)
60 (44%)
Used as single technology apart from ‘other / multiple’
with one or more anti-D reagent
Patients 1 and 2 Retrospective testing and actions
Table 11 shows details of testing undertaken and Table 12 actions that would be undertaken if
this were a real clinical situation, after the issue of blood (10-15 minutes), but before the next
session of ‘core’ hours. Table 13 details any retrospective testing undertaken during the next
session of core hours.
Table 11: Details of testing undertaken after issue at 15 minutes, but before next session
of core hours
Further testing
st
1
Additional ABO group on 1 sample
st
Additional D type on 1 sample
Antibody screen
Retrospective XM of units issued
Other testing
Patient 1 (n=333)
Number
244 (73%)
229 (69%)
321 (96%)
227 (68%)
1
7 (2%)
Patient 2 (n=330)
Number
244 (74%)
241 (73%)
314 (95%)
231 (70%)
1
10 (3%)
including patient phenotyping, a DAT on incompatible units, and testing for partial / weak D (patient 2 only)
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Appendix 7
Table 12: Details of actions that would be taken after issue at 15 minutes, but before
next session of core hours
Patient 1 (n=333)
Number (%)
12 (4%)
86 (26%)
58 (17%)
Further actions
Seek advice from other staff
Seek transfusion history
nd
Serological testing on 2 sample
Patient 2 (n=330)
Number (%)
25 (8%)
155 (47%)
78 (24%)
Table 13: Details of further testing during next session of core hours
Patient 1 (n=333)
Number (%)
255 (77%)
33 (10%)
21 (6%)
1
16 (5%)
13 (4%)
Further testing
1
No further testing
Group and antibody screen
Blood group (no screen)
Crossmatch on units issued
3
Other
Patient 2 (n=330)
Number (%)
204 (62%)
55 (17%)
91 (27%)
2
22 (7%)
40 (12%)
two reported one or more of the units as incompatible
one reported both units as incompatible
3
including checking of samples and /or interpretations and authorising of results (both patients); referring for D
typing, or resolving in-house, and 6 seeking transfusion history (patient 2 only)
2
Had additional units been requested two hours after the initial sample arrived, assuming that a
second (theoretical) sample gave the same results as the first sample, and with no further
information available,
99 laboratories would have issued a different group at 10-15 minutes and 2 hours, with details
shown in table 14:
Table 14: Change in selection D group between 15 minutes and 2 hours
Results of initial D group
D positive (n=219)
D UI (n=60)
D variant (n=11)
D negative (n=3)
No group performed (n=37)
Total (n=330)
Changed from issuing
D pos to D Neg
29 (13%)
2 (3%)
0 (0%)
0 (0%)
0 (0%)
31 (9%)
Changed from issuing
D neg to D pos
45 (21%)
3 (5%)
1 (9%)
2 (67%)
17 (46%)
68 (21%)
Patient 3 – Group and save (male aged 63)
Table 15 shows how the group and save sample was processed, and Table 16 the group and
screen results recorded within 60-90 minutes. One laboratory stated that they performed a
group and screen, but did not answer any further questions and this has been excluded from
the analysis.
Table 15: Processing of group and save sample within 60-90 minutes
1
Action within 60-90 minutes (n=325)
Group and screen (+/- other tests)
Rapid group and store sample for testing next day
No testing until next session of core hours
Number
315 (97%)
2 (1%)
1
8 (2%)
two booked in sample and checked labelling
Table 16: Group and screen results within 60-90 minutes
Group and screen result 60-90 minutes (n=315)
A D negative, antibody present
A D positive, antibody present
No group recorded, antibody screen positive
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Number
313 (99%)
1 (<1%)
1 (<1%)
Appendix 7
255/315 (81%) laboratories performed an automated group and screen within 60-90 minutes
and 59 (19%) a manual group and screen. The laboratory reporting an antibody screen without
an ABO group does not have automation.
Of the 60 not performing an automated group and screen:
41 do not have automation
6 do not use automation for urgent work
8 only use automation within core hours
1 only allows core transfusion staff to use automation
4 did not use automation for ‘EQA related’ reasons:
o
3 to assess manual testing
o
1 because the sample was haemolysed.
Patient 3 - Additional testing / actions
Tables 17 and 18 show additional testing and actions undertaken, either before 90 minutes or
after 90 minutes but before the next session of core hours. An entry of ‘no data’ indicates that
this information was not requested in the questionnaire.
Table 17: Additional testing within 60-90 minutes and after 90 minutes but before core
hours
Further testing
1
2
Antibody identification
Patient phenotype
Crossmatch
Number undertaking additional testing (n=315)
After 90 minutes but
Total
Within 60-90
before the next session
minutes
of core hours
1
291(92%)
9 (3%)
300 (95%)
2
119 (38%)
60 (19%)
179 (57%)
58 (18%)
6 (3%)
64 (20%)
A further 12 stated that they would refer for antibody identification
A further 48 stated that they would refer for antibody identification
Table 18: Actions that would have been taken within 60-90 minutes and after 90 minutes
but before core hours
1
Further actions
Within 90
minutes
Identify antigen negative units in stock
Order antigen negative blood from blood
service
Inform clinical team of potential delay
Try to ascertain transfusion history
Try to ascertain antibody history
Seek advice from another member of staff
Other
97 (31%)
1
Number (%)
After 90 minutes
but before core
hours
74 (23%)
179 (57%)
37 (12%)
286 (91%)
195 (62%)
190 (60%)
25 (8%)
7 (2%)
6 (2%)
No data
No data
No data
25 (8%)
Total
171 (54%)
216 (69%)
292 (93%)
195 (62%)
190 (60%)
25 (8%)
32 (10%)
70 of these would also try to identify antigen negative units in stock
Other actions included completing testing started in 60-90 minutes, obtaining a sample to refer,
contacting clinicians (to enquire about the patient’s potential blood requirement, to try postpone
the operation, or to update them on progress of the investigation), checking the patient’s
haemoglobin result, and checking stock levels.
One laboratory performing a group and screen, would not undertake any additional tests /
actions within 60-90 minutes, or before the next session of core hours.
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Appendix 7
General policy questions
Second sample requested
A second sample would have been requested for Patient 1 (group A D positive, inert) within 1015 minutes by 68/333 (20%) laboratories, and for Patient 3 (group A D negative, anti-Jkb) within
60-90 minutes by 112/315 (36%) participants.
Samples from ‘Unknown patients
Red cells of a different group would have been selected for Patient 1 (A D positive) by 46/333
(14%), if the sample had been from an ‘unknown’ patient.
Table 19 shows how samples from unknown patients are named, and Table 20 how they are
numbered. 32 respondents stated that these questions were not applicable to their case-mix,
and a further 31 did not specify whether the emergency numbers used were sequential or not.
Table 19: Naming systems for unknown patients (n=301)
Response
‘Unknown’ or equivalent
Fictional names using the radio alphabet, eg Tango Delta
Fictional names using a different system
Barcode system to provide additional ID and link patient sample
Number (%)
260 (86%)
10 (3%)
24 (8%)
7 (2%)
Table 20: Numbering systems for unknown patients (n=270)
Response
Sequential unique numbers
Non-sequential unique numbers
Barcode system to provide additional ID and link patient / sample
Number (%)
166 (61%)
97 (36%)
7 (3%)
Use of D positive blood for men and for women beyond childbearing age.
158/331 (48%) have a policy for issuing group O D positive red cells for men
148/327 (45%) have a policy for issuing group O D positive red cells for women not of
childbearing potential, defined as over:
o 45 years by 3 (2%)
o 50 years by 31 (21%)
o 55 years by 2 (1%)
o 60 years by 112 (76%)
Policy for selection of ‘emergency’ O D Negative blood
Table 21 shows the specification of group O D negative units selected as emergency ‘flying
squad’ blood.
Table 21: Emergency O D negative blood
Specification
D negative cde/cde (rr)
K negative
HbS negative
Irradiated
Other
Number
302 (92.1%)
331 (99%)
34 (10%)
3 (1%)
113 (34%)
The ‘other’ category included 83 selecting CMV negative units, 90 selecting units ABO high
titre (HT) negative, and 32 selecting both CMV and HT negative, for all or for specific groups of
patients.
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Appendix 7
Discussion and conclusions
Limitations of the data
The questionnaires asked whether or not a second sample would be requested at or before the
completion of testing at 15 minutes for Patients 1 and 2, and if yes, the participants were informed that
the test results were the same on the second sample. The questionnaire did not ask at what point this
second sample would have been tested, and this would presumably have depended at what point it
was received. 78 respondents stated that they would have undertaken testing of a second sample after
the 15 minutes but before the next session of core hours (including 19 who answered ‘no’ to the
question about whether a second sample would be requested). It is not clear how many of the 68
participants who said that they would have requested a second sample, took these results into account
when issuing blood at 15 minutes.
Issue of group specific blood within 10-15 minutes
A blood group was reported within 10-15 minutes by 89% of laboratories, with approximately 55%
undertaking a second cell group within the time; however, 16% of these performed the second test on
the same aliquot of cells as the first group, which would perpetuate any error in selection of the correct
specimen. This 16% includes six laboratories who stated that they would request a second sample
within the time-frame. If we assume that these six took the results of the second sample into account,
the figure using the same aliquot of red cells reduces to 12% - the same as was reported in a similar
exercise in 2010 (10R9).
Sixty five (20%) laboratories issued group A blood for Patient 1 (A D positive), having undertaken rapid
grouping on a single aliquot of cells and with no immediate spin crossmatch. This figure reduces to 52
(16%), taking into account those who stated they would request a second sample, using the same
assumption as above. BCSH guidelines recommend that following an emergency rapid group, a
second test to detect ABO incompatibility should be undertaken prior to release of group specific red
cells. This can be a repeat group (forward or reverse) or an immediate spin crossmatch, but it is
important to go back to the primary sample to avoid perpetuating any errors in sample identification in
the laboratory. Group confirmation on a second sample is clearly the safest course of action as it also
provides the opportunity to detect ‘wrong blood in tube’, but this may not always be possible, especially
in emergency situations.
Issue of group O D negative blood
In this exercise, 102 (31%) participants selected group O units for Patient 1 (88 O D negative and 14 O
D positive), and 33 (32%) of these had completed sufficient testing to meet the BCSH
recommendations for issue of group specific blood 1. Selection of group O blood in this circumstance,
is a local policy decision based on a risk assessment of emergency testing, with factors including the
frequency with which emergency testing is undertaken, differences in methodology between routine
and emergency testing, level of blood stocks, skill mix and case mix. The National Blood Transfusion
Committee recommends use of O D negative in emergency situations, only until the patient’s blood
group has been determined, with a limit of two units wherever possible 2. Eleven of the 33 stated that
they would have requested a second sample, but again it is not clear from the data whether this
influenced the selection of red cells.
Detection of dual population D positive/ D negative (50:50)
The overall detection rate of the mixed field reaction was only 17% and this varied considerably by the
technology used, ranging from 9-10% by tube, slide and BioVue users, to 58% by DiaMed users.
The overall detection rate was much higher in the final results submitted, reflecting the increased use
of DiaMed and multiple techniques undertaken when the results of emergency testing were combined
with the routine follow-up testing.
Issue of D positive blood to a young female patient with a dual population of D positive and D
negative red cells
Sixty laboratories reported UI for Patient 2 within 10-15 minutes, with 56 citing anomalous reactions vs.
anti-D. Six of these (10%) were amongst the 173 who selected D positive blood for Patient 2. More
participants said they would undertake additional D typing, seek advice from colleagues, refer to a
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Appendix 7
reference centre and seek a transfusion history for patient 2 than for patient 1, after the 15 minute and
during the next session of core hours. Where anomalous D typing results are obtained, females of
childbearing potential or patients who are likely to require long term transfusion should be treated as D
negative until a confirmed group has been assigned.1
Additional blood required for P2 after 2 hours
Had additional units been requested two hours after the initial sample arrived, assuming that a second
(theoretical) sample gave the same results as the first sample, and with no further information
available, 99 laboratories would have issued a different group at 2 hours from that issues at 10-15
minutes. Thirty-one switched from O D positive at 10-15 minutes to O D negative at two hours, and 68
vice versa. Those moving to issue D positive, were presumably doing so in line with policy on using the
patient’s own blood group once sufficient testing has been undertaken. Of those moving to D negative,
28 (90%) stated that they undertook additional D typing after the 15 minutes, and it may be that they
detected the mixed field reaction during this additional testing.
Group and screen P3
Fewer participants responded to the questionnaire for patient 3 than for Patients 1 and 2 (340 cf. 365
and 362). Of those who did submit results, the vast majority (97%) performed an automated group and
screen. Eight participants did no serological testing, although two booked the sample into the system,
and a further two performed a rapid group only. This sample contained anti-Jkb and there would have
been a delay in providing blood had testing been left until a request for blood had actually been
received. Of those who undertook a group and screen, 99% either performed antibody identification
during this session of work or referred the sample to a reference centre. 93% would have informed the
clinical team about the potential delay in provision of red cells should transfusion have been required,
and 60% would have tried to ascertain the patient’s antibody history. Communicating with the clinicians
about potential delays to transfusion, even when blood has not been requested, is a crucial part of the
service. Where feasible, an antibody history should be sought, as there may be a record of additional
specificities having been previously detected but no longer present. Utilisation of a regional or national
antibody database is desirable in this respect.
Of those with automation, 19 (7%) did not use it to test this sample out of hours: 15 of these stated that
they revert to manual testing outside core hours or for urgent work, or in one case where non-core
transfusion staff are lone working. SHOT reports demonstrate that ABO grouping errors all occur
during manual testing or manual intervention during automated testing 3, and the UK Transfusion
Collaborative recommends that all laboratories have full walk-away automation in place 24/7 4.
Specification for O Negative emergency ‘flying squad’ blood
99% specified that their emergency O D negative blood is K negative and 92% cde/cde (rr). 83 (25%)
participants stated that they use CMV negative if possible, but several stated that this was restricted to
obstetric and/or neonatal patients. Since 2012, SaBTO has recommended that CMV negative red cell
components are only required for intra-uterine transfusions, neonates, and elective transfusions during
pregnancy 5.
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Appendix 7
Use of D positive blood for men and for women beyond child-bearing potential
Less than half (48%) have a policy to give emergency O D positive red cells to men, and 45% to
women beyond child-bearing potential. The cut-off used to define child-bearing potential varies, with
the majority (76%) using 60 years of age. This cut-off also varies between different guidelines, with the
recent compatibility testing guidelines recommending 50 years of age 1.
Labelling of samples from unknown patient
The vast majority of hospitals label these samples as ‘unknown male’ or ‘unknown female’, rather than
assigning a fictional name. The majority also use sequential emergency numbers, which are far more
likely to be confused or transcribed incorrectly than if the numbers are non-sequential. This causes a
potential problem with patient identification when more than one unknown patient arrives in the
Emergency Room during the same period of time. The CMO’s National Blood Transfusion Committee
for England and North Wales 2006 6 and the BCSH Administration guidelines 7 urge caution with the
issue of consecutive emergency numbers that, because of their similarity, have the potential to cause
ID errors where there is more than one ‘unknown’ casualty involved.
References
1. BCSH (2012) guidelines for pre-transfusion compatibility procedures in blood transfsuion
laboratories.
http://www.bcshguidelines.com (accessed 2 August 2013)
2. NBTC: The appropriate use of group O RhD negative red cells
http://www.transfusionguidelines.org.uk/docs/pdfs/nbtc_bbt_o_neg_red_cells_recs_09_04.pdf:
(accessed 6 August 2013)
3.
SHOT reports, http://www.shotuk.org/shot-reports/ (accessed 6 August 2013)
4. UK Transfusion Laboratory Collaborative: Recommended minimum standards for hospital
transfusion laboratories Transfusion Medicine, 2009, 19, 156–158
5. Advisory Committee on the Safety of Blood, Tissues and Organs: Report of the SaBTO CMV
Steering Group. March 2012
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/215126/dh_132966.pdf
(accessed 30 July 2013)
6. National Blood Transfusion Committee (2006) Recommendations for Organisation of
Hospital Transfusion Services following July 2005 London Bombings.
http://www.transfusionguidelines.org.uk/Index.aspx?Publication=NTC&Section=27&pageid=7556
(accessed 31 July 2013)
7. BCSH (2009) Guidelines on the administration of blood components.
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Appendix 8
Data from anonymous questionnaire distributed at the
2013 Annual Participants’ Meeting in Manchester
The 2013 meeting was highly successful, with over 250 delegates
registered, and the feedback was excellent. We asked delegates to
complete an anonymous questionnaire (one from each hospital) designed
to collect information on how our EQA exercises and reports are used.
The results are shown in the pie charts to the right.
How do we treat EQA material?
The purpose of EQA is one of inter-laboratory comparison and in order
ensure that EQA reflects clinical practice, EQA samples should receive
the same level of testing that clinical samples receive. This means that
each sample should go through one or other analyser, rather than both,
and should not be tested by a second person unless this would happen
with a similar clinical sample. Clearly, EQA samples look different, and
these days clinical test results rarely require manual transcription onto
paper, although clinical results do sometimes require manual input into a
computer. EQA results may therefore require some additional checks
for transcription errors in critical areas prior to submission.
It’s good to see that the majority of laboratories do treat their EQA
samples in this way. However, the fact that up to 45% at least
sometimes undertake additional testing prior to submission of results,
suggests that there is a desire to use the samples to competency assess
staff and to EQA all analysers, and perhaps manual back-up techniques.
Additional analysers and techniques can be subject to EQA by
alternating the samples or exercises, or be assessed by IQC. 31% of
participants stated that they use leftover EQA material for IQC of
other methods or equipment after submission of results, and similarly
83% for competency assessment of staff. This is of course an
acceptable use of spare EQA material, although it is advisable to keep
sufficient material for re-testing after the closing date, in case of error
(additional samples are offered to laboratories who have made errors,
but it is useful to retest the original sample as well). We hope that our
new TACT competency assessment scheme will address the issue of
several members of staff undertaking the EQA to evidence competency.
How do we review the results?
CPA and ISO 15189 standards require that performance in EQA is
reviewed and communicated to staff, and 94% stated that they always
or sometimes do this. The BTLP web report now includes a PowerPoint
presentation which summarises the material, results, discussion and
learning points, with additional educational material where appropriate,
to aid in in-house discussions or at regional meetings. 47% of
respondents stated that they at least sometimes look at or use this,
whilst 7% were unaware of its existence. If you have any suggestions for
improving this tool, we would love to hear them.
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Appendix 9
Manchester Conference Centre and Hotel, Manchester
14 November 2012 – Man vs Machine
09.00
Coffee, Registration and Commercial Exhibition
09.55
Opening Remarks by Peter Baker (Chair UK NEQAS Steering Committee)
Session 1 10.00 to 11.30
Chair: Clare Milkins
Whose blood is it anyway?
10.00
Background to and data from the National Audit of Sampling labelling
Anne Varey, Transfusion Quality Coordinator, James Cook University Hospital
10.20
Two samples – what, when, why and how
Dr Jeannie Callum, Director of Transfusion Medicine, Sunnybrook Health Sciences Centre, Toronto,
Canada
11.05
Discussion
Coffee and exhibition 11.30 to 11.50
Session 2 11.50 to 12.50 Who’s got the remote control?
Chair: Steve Tucker
11.50
Remote authorisation of results – fact or fiction?
Stephan Bates, ex Laboratory Manager, Cheltenham & Gloucester
12.10
Tracking, trauma and traceability
Colin Barber, Transfusion Practitioner, The Royal London Hospital
12.30
UK NEQAS On-line Competency Assessment Scheme
Bill Chaffe, Senior EQA Scientist, UK NEQAS (BTLP)
Lunch and Exhibition 12.50 to 14.00
14.00
UK NEQAS update
Megan Rowley, Clare Milkins, Jenny White
Session 3 14.30 to 16.00
You are the weakest link!
Chair: Mallika Sekhar
14.30
The root cause of ‘human error’
Judy Langham, Principal Haemovigilance Specialist, MHRA
14.50
The psychology of distraction
Susy Churchill, Independent Psychological Consultant, Researcher and Trainer at Churchill Associates
15.30
The management of distraction in the laboratory
Richard Haggas, Quality Manager, Leeds Teaching Hospitals
15.45
Discussion and close 16.00
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Appendix 10
A New Transfusion Landscape: Down to Earth or Life on Mars?
Joint Meeting of UK NEQAS (BTLP) and the BBTS Blood Bank Technology SIG
20 November 2013, National Motorcycle Museum, Birmingham
Registration, refreshments and commercial exhibition from 09.00
10.00: Opening welcome, Dr Peter Baker, Chair UK NEQAS (BTLP) Steering Committee
10.05 - 12.00 Staffing the transfusion laboratory of the future: Chair: Dr Megan Rowley
10.05
BBTS vision of the future including the role of the consultant transfusion scientist
Mr Martin Bruce, BBTS President Elect
10.25
Human Issues in Healthcare Delivery'
Lieutenant Colonel Jim Storr PhD
10.55
The lone worker – staffing the out-of-hours service and the ‘spokes’
Ms Catherine Almond, Blood Transfusion Laboratory Manager, Kent and Canterbury
11.10
How will the rest of the transfusion team fit in?
Ms Liz Still, Consultant Transfusion Practitioner - BMI Healthcare
11.20
Competency assessment and training in a ‘virtual laboratory’
Mr Bill Chaffe, UK NEQAS, Mr Ian Bamsey and Dr Brian Lings, CERTUS
11.40
Discussion
12.00 to 13.15 Lunch and commercial exhibition
13.15 – 13.55 Incident management – CAPA and RCA Chair: Mr Steve Tucker
13.15
Interactive session using different laboratory and clinical based scenarios
Mr Richard Haggas and Mr Bill Chaffe
13.55 – 14.50 Implementation of the group-check sample Chair: Mrs Clare Milkins
13.55
14.10
14.25
Is it happening?
Yes - Ms Tracy Nevin, Transfusion Practitioner, Princess Alexandra Hospital, Harlow
No - Mr Graham Bellamy, Transfusion Laboratory Manager, Sheffield Children’s Hospital
Discussion
14.50 to 15.15 Tea/Coffee
15.15 – 16.15 D typing and FMH Chair: Mr Gordon Burgess
15.15
15.30
16.00
UK NEQAS performance monitoring for FMH and point of care testing for D typing
Dr Megan Rowley, UK NEQAS
Fetal D typing: where are we up to?
Dr Geoff Daniels, IBGRL
Discussion
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