HOSPITAL BLOOD BANK COMPLIANCE REPORT

FOR REPORTING PERIOD 1ST APRIL 2018 to 31ST MARCH 2019

*Please refer to the 2019 Hospital Blood Bank Compliance Report Guidance Notes on the MHRA website before completing this report template*

Section A General Information

1 Hospital name (Full name) A1 A1, $K$3 A1, A3, A5, A7, A8, A9, A11, A12, A13, A14, A15, A16, A17, A18, A19, A19.1,
2 Trust / Private Healthcare Organisation Name (as per official
website and where applicable)
3 Address line 1: A3 A3, $K$5
4 Address line 2:
5 Town/city: A5 A5, $K$7
6 County:
7 Post Code A7 A7, $K$9
8 Contact name A8 A8, $K$10
9 Telephone A9 A9, $K$11
10 Fax
11 Email A11 A11, $K$13
Number of blood components issued each year (units): (please
indicate if 0 [zero])
12 Red cells A12 A12, $K$15
13 Fresh Frozen Plasma / cryoprecipitate (total combined) A13 A13, $K$16
14 Platelets A14 A14, $K$17
15 Other A15 A15, $K$18
16 Autogolous pre-deposit components A16 A16, $K$19
17 Number of group and save samples A17 A17, $K$20
18 Are transfusion services at the above site provided by an A18 A18, $K$21
external contractor, or another Hospital site?
19 Does the Trust have more than one transfusion laboratory? A19 A19, $K$22
If response to A19 was 'Yes':
19.1 For Trusts or other legal entities with more than one transfusion A19.1 A19.1, $K$24
laboratory (including satellite laboratories, even if under a
common managerial structure), please confirm that a separate
Compliance Report has been submitted for each laboratory
location

Section B Activities Undertaken

1 Do you undertake any of the following activities:

1.1 Collection of whole blood (including pre-deposit autologous B1.1 B1.1, $K$29 B1.1, B1.2, B1.3, B1.4, B1.5, B1.6, B1.7, B1.8, B1.9,
units)
1.2 Apheresis collection of blood components for transfusion B1.2 B1.2, $K$30
(including granulocytes)
1.3 Storage of blood and blood components B1.3 B1.3, $K$31
1.4 Pre-transfusion testing (patient ABO/Rh grouping, antibody B1.4 B1.4, $K$32
screen, crossmatch etc)
1.5 Donor Testing (e.g. donation ABO/Rh grouping, viral markers B1.5 B1.5, $K$33
etc.)
1.6 Preparation of irradiated blood components B1.6 B1.6, $K$34
1.7 Preparation of washed blood components B1.7 B1.7, $K$35 Yes
1.8 Pooling components (e.g. cryoprecipitate) B1.8 B1.8, $K$36 No
1.9 Thawing frozen components B1.9 B1.9, $K$37
1.10 Are pre transfusion testing activities routinely performed by an P
off-site (remote) laboratory? If yes please provide details in
Section S below

Section C Previous Compliance Reports

1 Date of previous submission of Compliance Report: C1 C1, $K$44 C1, C3.6,

2 Reference to the BCR Assessment Confirmation Letter issued
from last Compliance Report. HOSPITAL BLOOD BANK
COMPLIANCE REPORT: XXXXXX/XXXXXX
3 Since the previous Compliance Report submission, have
3.6 you…..
How many significant changes have you had in TOTAL? C3.6 C3.6, $K$54

Section D MHRA Inspection History

1 Has the transfusion laboratory named in Section A - General D1 D1, $K$66 D1, D1.1, D2, D2.1, D2.2, D2.3,
Information been previously inspected by MHRA?
If response to D1 was 'Yes'
1.1 What was the date of inspection? (if more than 1 previous D1.1 D1.1 D1.1, $K$68
inspection, please provide the date of the most recent)
2 Has a transfusion laboratory within the same legal entity been D2 D2, $K$69
inspected by MHRA? (if more than 1 site in the legal entity has
been inspected, please provide information relating to the most
recent inspection).
If response to D2 was 'Yes'
2.1 What was the Laboratory name? D2.1 D2.1 D2.1, $K$71
2.2 What was the inspection date: D2.2 D2.2 D2.2, $K$72
 2.3 At the time of inspection, did the inspected site operate to the D2.3 D2.3 D2.3, $K$73
same working systems and procedures as the site listed in
Section A - General Information?

Section E Key personnel

1 Name of Transfusion Laboratory Manager E1 E1, $K$77 E1, E2, E3, E4, E6, E7.1, E7.2, E7.3, E7.4,
2 Full address E2 E2, $K$78
3 Post Code E3 E3, $K$79
4 Telephone E4 E4, $K$80
5 Fax
6 Email E6 E6, $K$82
7 How many staff do you have within the transfusion laboratory
during core working hours (Please give full time equivalents and
indicate 0 [zero] where applicable)?
7.1 Senior BMS/BMS E7.1 E7.1, $K$84
7.2 MLA E7.2 E7.2, $K$85
7.3 Other E7.3 E7.3, $K$86
7.4 Does the site have on-going staffing issues that are impacting E7.4 E7.4, $K$87
on the laboratory workload, training, or QMS tasks? If so,
please indicate the level of understaffing as a decimal fraction
(i.e. if 20% understaffing, enter 0.20). If not please enter "0"
(zero)

Section F Training

1 Does the transfusion laboratory have a documented training F1 F1, $K$91 F1, F2, F3, F4, F4.1, F4.2, F5, F5.1, F5.2, F6, F7, F7.1, F8, F9, F9.1, F9.2, F9.3, F10, F11, F11.1, F12, F13,
system?
2 Are relevant training areas for each staff job function identified F2 F2, $K$92
(e.g. in a plan or matrix), to ensure that all required training is
provided?
3 Does staff training include key quality system procedures (e.g. F3 F3, $K$93
deviations and recall) as well as pre-transfusion testing activity?

4 Does the transfusion laboratory have a documented, on-going F4 F4, $K$94

competency assessment system?
If response to F4 was 'Yes', please answer 4.1 to 4.2
4.1 Does on going competency assessment rely solely on external F4.1 F4.1 F4.1, $K$96
QC exercises (e.g. NEQAS/WASPS)?
4.2 Are staff who have been absent for an extended period (i.e. F4.2 F4.2 F4.2, $K$99
greater than 3 months) required to demonstrate their
competency on return to the laboratory?
5 Have all staff who may be called to work in the transfusion F5 F5, $K$100
laboratory (including out of hours cover) been trained and
assessed according to the systems mentioned above in
questions 1 to 4?

If response to question F5 was 'Some staff', please answer the following:

What is the percentage of ALL staff who have:
5.1 Completed training? F5.1 F5.1 F5.1, $K$103
5.2 Completed Assessment? F5.2 F5.2 F5.2, $K$104
6 Are staff in training under full supervision until documented F6 F6, $K$105
competency is attained?
7 For personnel who may be classified as "lone workers" in the F7 F7, $K$107
laboratory e.g. out of hours or night shift, is there a requirement
for them to have completed training and be competent on key
quality system procedures (e.g. deviaiton and recall)?

If response to F7 was 'Yes'

7.1 What is the frequency of competency assessment against the F7.1 F7.1 F7.1, $K$109
program performed prior to allowing personnel to perform "lone
worker" activities?
8 Is there a system for initial training in the principles of Good F8 F8, $K$112
Practice, in line with the requirements listed in Commission
Directive 2005/62/EC?
9 Is there a system for update training of staff in the principles of F9 F9, $K$113
Good Practice, in line with the requirements listed in
Commission Directive 2005/62/EC?
If response to F9 was 'Yes'
9.1 What is the frequency of update training (in months)? F9.1 F9.1 F9.1, $K$115
Please indicate the percentage of staff who were trained in the
principles of Good Practice during the calendar years of:
(please indicate if 0 [zero])
9.2 2017 F9.2 F9.2 F9.2, $K$117
9.3 2018 F9.3 F9.3 F9.3, $K$118
10 Please indicate the percentage of staff who have not received F10 F10, $K$119
any specific training in Good Practice (please indicate if 0
[zero]).
11 Is there a documented training programme for staff (e.g. F11 F11, $K$120
porters, nurses, ODAs) responsible for the distribution of blood
components from the transfusion laboratory (or satellite storage
fridges) to clinical areas?
If response to question F11 was 'Yes'
11.1 What percentage of these staff have been trained and currently F11.1 F11.1 F11.1, $K$122
assessed as competent in this task?
12 What is the frequency (in months) of re-certification for blood F12 F12, $K$123
collection?
 13 Are untrained staff prevented from the collection and distribution F F13 F13, $K$125
of blood?

Section G Quality Management System

1 Which person is accountable for overall quality within the Blood

Bank (including Quality Systems, preparation and control of
documentation, equipment, and compliance to the requirements
of the Blood Safety and Quality Regulations 2005)?

1.1 Name G1.1 G1.1, $K$130 G1.1, G1.2, G1.3, G1.4, G1.5, G1.6, G1.7,
1.2 Title G1.2 G1.2, $K$131
1.3 Please provide the length of employment in the Quality G1.3 G1.3, $K$132
Management role. If this is performed as part of a multi-
functional position, please indicate the time specifically assigned
to this role. (Free text response required. For example: '10
years in post, 0.25 whole time equivalent')
1.4 Have the personnel with overall responsibility for quality within G1.4 G1.4, $K$133
the transfusion laboratory read and understood Regulations 9,
10, 11, 12, 14, 15, 17 & 22 of the Blood Safety and Quality
Regulations, and the Good Practice Guide?
1.5 Is staff adherence to laboratory procedures assessed? G1.5 G1.5, $K$134
1.6 Is the content of laboratory and quality system procedures G1.6 G1.6, $K$137
assessed to ensure that it meets the requirements of the Blood
Safety and Quality Regulations and Good Practice?
1.7 Are effective senior and executive level oversight mechanisms G1.7 G1.7, $K$139
in place to assure compliance of the Quality Management
System (e.g. overdue deviations, CAPA, change controls,
documentation, etc)

Section H Procedures in place for quality assurance within the

transfusion laboratory – Corrective and Preventative Action
(CAPA)

1 Is there a formal reporting and investigation system in place to

report and investigate the following:
1.1 errors? H1.1 H1.1, $K$144 H1.1, H1.2, H1.3, H2, H3, H4, H5, H5.1, H5.2.1, H5.2.2, H5.2.3, H5.2.4, H6, H7, H8, H9, H10,
1.2 adverse events? H1.2 H1.2, $K$145
1.3 unplanned procedural deviations? H1.3 H1.3, $K$146
2 Are staff who are not involved in the operation of the transfusion H2 H2, $K$147
laboratory able to alter the content of incident reports, change
risk ratings or close reports without the involvement of senior
transfusion staff?
3 Is the incident system (including Trust Incident system) fully H3 H3, $K$148
visible to the transfusion laboratory senior staff, to enable
review of trends?
4 Are incident reports tracked by staff reporting to the transfusion H4 H4, $K$149
function, to ensure timely completion of the investigation?

5 Does the incident / adverse event / deviation procedure specify H5 H5, $K$150
an expected timescale for investigation and closure of
investigations?
If response to question H5 was 'Yes'
5.1 What is the timescale (in days)? H5.1 H5.1 H5.1, $K$152
5.2 Please give number of investigations (as of 1st December 2018)
that remained ‘open’ and exceeded the expected closure date
by: (please indicate if 0 [zero])
5.2.1 Up to 1 month H5.2.1 H5.2.1 H5.2.1, $K$154
5.2.2 1-3 months H5.2.2 H5.2.2 H5.2.2, $K$155
5.2.3 3-6 months H5.2.3 H5.2.3 H5.2.3, $K$156
5.2.4 greater than 6 months H5.2.4 H5.2.4 H5.2.4, $K$157
6 Is there an immediate (within 1 working day) assessment of a H6 H6, $K$158
reported incident / adverse event / deviation, to determine
whether any urgent (i.e. prior to completion of investigation)
actions may be required to safeguard patient safety?
7 Does the incident system in use ensure the reporting and H7 H7, $K$159
investigation of non-clinical incidents (e.g. calibration failure,
storage temperature excursions)?
8 Is the effectiveness of Corrective Action, Preventative Action H8 H8, $K$160
(CAPA) assessed formally at an identified period after
implementation?
9 Does the Incident system ensure the consideration of H9 H9, $K$163
component recall and notification to SABRE if necessary?
10 Are records of incident investigations formally reviewed before H10 H10, $K$164
final closure to confirm that the recorded details are clear and
fully explain the incident, root cause identified, risk impact
assessment performed, actions taken and conclusions?

Section I Procedures in place for quality assurance within the

transfusion laboratory – Component recall

1 Is there a system to recall / retrieve blood components after I1 I1, $K$168 I1, I1.1, I1.2, I1.3, I1.4,
release from the transfusion laboratory?
If response to question I1 was 'Yes'
 1.1 Does the system consider recall / retrieval following information I1.1 I1.1 I1.1, $K$170
obtained from external sources (e.g. the UK Blood Services)

1.2 Does the system consider recall / retrieval following information I1.2 I1.2 I1.2, $K$171
involving multiple units (e.g. recall of reagents from the
suppliers).
1.3 Does the system consider internal sources (e.g. laboratory I1.3 I1.3 I1.3, $K$172
errors or incidents)?
1.4 Has the effectiveness of the recall system been verified for all I1.4 I1.4 I1.4, $K$173
potential sources (e.g. by performing ‘mock’ recalls as a paper
exercise)?

Section J Procedures in place for quality assurance within the

transfusion laboratory – Reporting Serious Adverse Events
(SAE) and Serious Adverse Reactions (SAR):

1 Who is responsible for recording Serious Adverse Events and J1 J1, $K$178 J1, J2, J3, J5,
Serious Adverse Reactions in the MHRA’s internet based
system (SABRE)?
2 Please provide your SABRE registration number OR if there is J2 J2 J2, $K$179 J2
no intention to register with SABRE please provide details of
alternative reporting arrangements:
3 Is this SABRE registration for a group of hospitals within a J3 J3, $K$180
single legal entity, or a single site registration:
5 Are records relating to Serious Adverse Events and Reactions J5 J5, $K$187
retained for at least 15 years?

Section L Procedures in place for quality assurance within the

transfusion laboratory – Self Inspection (internal audit)

1 Is there a documented Self Inspection (internal audit) L1 L1, $K$199 L1, L1.1, L1.2, L1.3, L1.4, L1.5, L1.6.1, L1.6.2, L1.6.3, L1.6.4, L1.7,
programme in place?
If response to question L1 was 'Yes'
1.1 How frequently is transfusion assessed through self-inspection? L1.1 L1.1 L1.1, $K$201
(e.g. monthly, bi-monthly, annually)
1.2 On the basis of the current self inspection programme, what L1.2 L1.2 L1.2, $K$202
period of time (in months) is required to assess all transfusion
laboratory activities?
1.3 How many transfusion-related self-inspection audits were L1.3 L1.3 L1.3, $K$203
planned for the calendar year 2018?
1.4 How many were actually performed? L1.4 L1.4 L1.4, $K$204
1.5 In relation to the audits performed, how many exceeded their L1.5 L1.5 L1.5, $K$205
planned date by more than 3 months?
1.6 Please give the number of transfusion audit non-conformances
(as of 1st December 2018) that remained ‘open’ and exceeded
their assigned closure date by: (if no non-conformances please
indicate 0 [zero])
1.6.1 up to 1 month L1.6.1 L1.6.1 L1.6.1, $K$207
1.6.2 greater than 1 month and less than 3 L1.6.2 L1.6.2 L1.6.2, $K$208
1.6.3 greater than 3 months and less than 6 L1.6.3 L1.6.3 L1.6.3, $K$209
1.6.4 greater than 6 months L1.6.4 L1.6.4 L1.6.4, $K$210
1.7 Are standards used for self inspection reviewed to ensure that L1.7 L1.7, $K$211
transfusion laboratory and quality system procedures are
assessed against the requirements of the Blood Safety and
Quality Regulations, and the Good Practice Guide?

Section M Procedures in place for quality assurance within the

transfusion laboratory – Equipment maintenance and
calibration

1 Is there a planned preventative maintenance and calibration M1 M1, $K$217 M1, M2.1, M2.1.1, M2.1.2, M2.1.3, M2.1.4, M2.2, M2.2.1, M2.2.2, M2.2.3, M2.2.4, M2.3, M2.3.1, M2.3.2, M2.3.3, M2.3.4, M3, M4, M4.1, M4.2, M4.3, M5,
programme in place for all key items of laboratory equipment
which is monitored for compliance?
2 Section to detail the controlled temperature storage conditions,
including max/min (oC) ‘action’ alarm limits applied to fridges,
freezers and platelet incubators (this should include laboratory
equipment and satellite storage equipment which is under the
control of the transfusion laboratory)

2.1 Do you have a blood fridge on-site? M2.1 M2.1, $K$219

If response to question M2.1 was 'Yes'
2.1.1 MIN temperature alarm limit? M2.1.1 M2.1.1 M2.1.1, $K$221
2.1.2 MAX temperature alarm limit? M2.1.2 M2.1.2 M2.1.2, $K$222
2.1.3 Alarm delay (minutes)? M2.1.3 M2.1.3 M2.1.3, $K$223
2.1.4 Measurement of temperature: simulated core or air probe? M2.1.4 M2.1.4, $K$224
2.2 Do you have a platelet incubator on-site? M2.2 M2.2, $K$225
If response to question M2.2 was 'Yes'
2.2.1 MIN temperature alarm limit? M2.2.1 M2.2.1 M2.2.1, $K$227
2.2.2 MAX temperature alarm limit? M2.2.2 M2.2.2 M2.2.2, $K$228
2.2.3 Alarm delay (minutes)? M2.2.3 M2.2.3 M2.2.3, $K$229
2.2.4 Measurement of temperature: simulated core or air probe? M2.2.4 M2.2.4, $K$230
2.3 Do you have a plasma freezer on-site? M2.3 M2.3, $K$231
If response to question M2.3 was 'Yes'
2.3.1 MIN temperature alarm limit (if no lower limit please state: M2.3.1 M2.3.1 M2.3.1, $K$233
-100)?
2.3.2 MAX temperature alarm limit? M2.3.2 M2.3.2 M2.3.2, $K$234
 2.3.3 Alarm delay (minutes)? M2.3.3 M2.3.3 M2.3.3, $K$235
2.3.4 Measurement of temperature: simulated core or air probe? M2.3.4 M2.3.4, $K$236
3 Does the transfusion laboratory have access to all equipment M3 M3, $K$240
maintenance records?
4 Are maintenance and calibration reports reviewed? M4 M4, $K$241
If response to question M4 was 'Yes'
4.1 Is scope of maintenance / calibration performed included in this M4.1 M4.1 M4.1, $K$243
review?
4.2 Is the impact of maintenance / calibration findings on previous M4.2 M4.2 M4.2, $K$244
equipment use (e.g. if a fault was found by the engineer)
included in this review?
4.3 Is approval to return equipment to use included in this review? M4.3 M4.3 M4.3, $K$245

5 Is the traceability of engineer equipment to national standards M5 M5, $K$247

ensured (e.g. by obtaining a copy of, or reference to, the
calibration status of the engineer test equipment)?

Section N Procedures in place for quality assurance within the

transfusion laboratory – Qualification, validation and
change control

(The equipment qualification system should include a control of

the User Requirement Specifications, Design Qualification,
Installation Qualification, Operational Qualification and
Performance Qualification, pre-defined acceptance criteria for
each phase of work, and approval of results)

1 Is there an SOP in use that describes the system for N1 N1, $K$252 N1, N1.1, N1.2.1, N1.2.2, N1.2.3, N1.2.4, N1.2.5, N2, N3, N3.1, N3.2, N4, N6, N7, N7.2, N7.2.1, N7.2.1.1, N7.2.1.2, N7.2.2, N8, N8.1.1, N8.1.2, N8.1.3, N8.1.4, N8.2, N8.3,
qualification (validation) of equipment?
If response to N1 was 'Yes':
1.1 Does this SOP meet the requirements of 1.2.10, 1.2.11, 4.3 and N1.1 N1.1 N1.1, $K$254
4.7 of the Good Practice Guide?
1.2 Are the following key areas of equipment qualification
addressed by this SOP:
1.2.1 Description of critical functions to be tested, and the testing N1.2.1 N1.2.1 N1.2.1, $K$256
methods to be used to verify these functions?
1.2.2 Pre-defined acceptance criteria for the tests to be performed? N1.2.2 N1.2.2 N1.2.2, $K$257
1.2.3 Recording of results obtained in a report? N1.2.3 N1.2.3 N1.2.3, $K$258
1.2.4 Investigation of anomalies or non-conformances identified N1.2.4 N1.2.4 N1.2.4, $K$259
during testing?
1.2.5 Formal, documented approval of completed qualification work N1.2.5 N1.2.5 N1.2.5, $K$260
prior to use of the equipment?
2 Have all critical items of equipment which may impact upon N2 N2, $K$261
patient safety and blood component quality been identified and
validated?
3 Is there a process of periodic review of equipment qualification, N3 N3, $K$262
to verify that they are still operating in a valid manner?

If response to N3 was 'Yes':

3.1 When was this review last performed for the laboratory LIMS N3.1 N3.1 N3.1, $K$264
system? (Please enter a date)
3.2 When is the LIMS system review next due? N3.2 N3.2 N3.2, $K$265
4 Have qualification reports/data for each item of laboratory N4 N4, $K$266
equipment / IT system been reviewed to ensure compliance (in
terms of report content, data integrity, acceptance criteria, tests
performed etc) with current requirements in the Good Practice
Guide?
6 Are reagent controls (e.g. for grouping and screening) run on N6 N6, $K$270
each day of use?
7 Are all blood components monitored for compliance to the 30 N7 N7, $K$273
minute transportation time outside of temperature control, with
those components which have exceeded the 30 minute period
being excluded from return into available stock and use?

If N7 answered ‘No’ or ‘Some (dependent on location)’, please answer N7.2

7.2 If blood components are transported to remote areas where N7.2 N7.2 N7.2, $K$277
transportation time exceeds 30 minutes, has the transportation
system (e.g. transit box) been validated to demonstrate its
ability to consistently maintain blood at a temperature which
maintains the integrity and quality of the component?

If N7.2 answered ‘Yes’, please answer N7.2.1. If ‘No’, please go to N8

7.2.1 Does the laboratory use a documented transit box loading N7.2.1 N7.2.1 N7.2.1, $K$279
configuration (position of blood components and temperature
packs), to ensure compliance with validated conditions?
If N7.2.1 answered 'Yes', please answer N7.2.1.1, N7.2.1.2 and
N7.2.2. If 'No', please go to N8
What were the acceptance criteria used during the validation
study?
7.2.1.1 Temperature MIN? N7.2.1.1 N7.2.1.1 N7.2.1.1, $K$282
7.2.1.2 Temperature MAX? N7.2.1.2 N7.2.1.2 N7.2.1.2, $K$283
7.2.2 Maximum duration of transit assessed by validation (hours)? N7.2.2 N7.2.2 N7.2.2, $K$284
When was the last validation or if seasonal validation?
 8 Is there a documented system in place which is compliant with N8 N8, $K$285
1.2.12 and 4.6 of the Good Practice Guide, that describes the
system for change control? (This should demonstrate
assessment and management of the impact of any procedural
or equipment changes on the validation status of existing
processes, and to ensure that training and documentation is
available prior to the implementation of a change).

If response to N8 was 'Yes':

8.1 Does this system control changes to:
8.1.1 Documentation (SOPs and records)? N8.1.1 N8.1.1 N8.1.1, $K$288
8.1.2 Equipment? N8.1.2 N8.1.2 N8.1.2, $K$289
8.1.3 Facilities? N8.1.3 N8.1.3 N8.1.3, $K$290
8.1.4 Reagents and testing processes? N8.1.4 N8.1.4 N8.1.4, $K$291
8.2 Are changes implemented prior to the completion and approval N8.2 N8.2 N8.2, $K$292
of documents, training and validation?
8.3 How many change control reports / requests were raised during N8.3 N8.3 N8.3, $K$293
the reporting year 1st April 2018 to 31st March 2019?

Section O Computerised systems and Data Management

1 Does the laboratory use a transfusion IT system to record pre- O1 O1, $K$297 O1, O1.1, O1.2, O1.3, O1.4, O1.4.1, O2, O2.1, O2.3, O2.4, O2.5, O2.6, O3, O3.1, O3.2, O4,
transfusion testing results, special transfusion requirements
(e.g. irradiated blood) and available blood component
inventory?
If response to O1 was 'Yes':
1.1 What is the system name? O1.1 O1.1 O1.1, $K$299
1.2 Has the function of this IT system been validated, and O1.2 O1.2 O1.2, $K$300
revalidated after each system upgrade to confirm the correct
function of all critical system controls (e.g. correct interpretation
of blood groups, electronic issue etc)?
1.3 Have IT system interfaces to automated equipment (e.g. blood O1.3 O1.3 O1.3, $K$301
analysers) been validated?
1.4 Is data relating to IT system configuration and patient records O1.4 O1.4 O1.4, $K$302
‘backed up’?
If response to O1.4 was 'Yes':
1.4.1 Has work been performed to ensure that the back-up data O1.4.1 O1.4.1 O1.4.1, $K$304
enables a full system recovery?
2 Does the transfusion laboratory (or another department acting O2 O2, $K$305
on behalf of the transfusion laboratory) periodically check
patient databases for apparent duplicate patient records?
If response to O2 was 'Yes':
2.1 Are duplicate records merged, linked or is no action taken? O2.1 O2.1 O2.1, $K$307
If records are 'Merged' or 'Linked' please answer questions O2.3 to O2.6, then
go to question O3
2.3 Is there a documented procedure to describe the process for O2.3 O2.3 O2.3, $K$311
merging or linking patient records?
2.4 Are patient records, which have been identified as possible O2.4 O2.4 O2.4, $K$312
duplicate entries on the hospital's patient administration system
(hospital number), verified by transfusion staff prior to
performing any merging or linking of the records?
2.5 Are merged / linked transfusion records independently checked O2.5 O2.5 O2.5, $K$313
or audited?
2.6 Are records of any merging or linking retained, to enable re- O2.6 O2.6 O2.6, $K$314
instatement of the original patient records in the event of query
or error?
3 Does the transfusion laboratory operate a legacy (previous) O3 O3, $K$315
laboratory IT system in addition to the current IT system, which
contains historical information necessary for patient safety (e.g.
antibody identification, special transfusion requirements)?

If response to O3 was 'Yes':

3.1 Is the information retained by the legacy system accessed via O3.1 O3.1 O3.1, $K$317
the current laboratory IT system, or manually?
3.2 Is there an SOP to describe the use of the legacy system in O3.2 O3.2 O3.2, $K$318
order to search for historical patient information?
4 Is a Service Level Agreement in place with the current O4 O4, $K$319
laboratory LIMS service provider?

Section P Pre-transfusion testing

1 Have the reagents used for pre-transfusion testing been P1 P1, $K$323 P1, P2, P3, P3.1, P3.2, P3.3, P3.4, P3.4.1, P3.4.3, P3.4.4, P, P3.6, P3.7, P4, P4.1, P4.2, P4.3,
reviewed to ensure that they are CE marked for their intended
purpose?
2 Are the reagents used in full compliance with the manufacturers P2 P2, $K$324
instructions?
3 Does the laboratory named in section A use an 'Electronic Issue' P3 P3, $K$325
process to issue blood components for named patients without
serological compatibility testing (cross match)?
If response to P3 was 'Yes' please answer P3.1 to P3.6
3.1 Does the laboratory information management system (LIMS) P3.1 P3.1 P3.1, $K$327
meet the requirements of the BSH and the MHRA guidance for
electronic issue*?
*[https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil
e/449059/MHRA_Guidance_on_Electronic_Issue_new_logo.pdf]

3.2 How is the eligibility of a patient assessed when determining P3.2 P3.2 P3.2, $K$328
suitability for electronic issue?
 3.3 Are all aspects of the BSH electronic issue eligibility criteria* P3.3 P3.3 P3.3, $K$329
applied? *[reference BSH guidelines: The specification and use of
information technology (IT) systems in blood transfusion practice, 2006]

3.4 Does the laboratory use automated analysers to determine P3.4 P3.4 P3.4, $K$332
patient blood group and antibody screen?
If response to P3.4 was 'Yes', please answer 3.4.1 to 3.4.4
3.4.1 Is the automated equipment routinely used whenever testing is P3.4.1 P3.4.1 P3.4.1, $K$334
performed to enable electronic issue?
3.4.2 Are "quality control" (QC) tests performed on the analyser in P3.4.2
accordance with the manufacturers specification?
3.4.3 Are patient samples permitted to be run concurrent with the QC P3.4.3 P3.4.3 P3.4.3, $K$336
test?
3.4.4 How are pre-transfusion test results transferred to the LIMS P3.4.4 P3.4.4 P3.4.4, $K$337
from the automated analyser?
3.5 How are pre-transfusion test results transferred to the LIMS P P P, $K$341
following manual testing?
3.6 Are first time samples (first sample from a previously unknown P3.6 P3.6, $K$344
patient) tested for forward and reverse ABO group?
3.7 What approach is used to test subsequent samples for ABO P3.7 P3.7, $K$345
Group?
4 Does the laboratory named in Section A support a 'remote P4 P4, $K$348
electronic release' process at one or more locations remote
from the laboratory? (e.g. clinic areas on the same site storing
'stock' blood, or other hospital sites)
If response to P4 was 'Yes'
4.1 Does the remote site supplying the blood component for patient P4.1 P4.1 P4.1, $K$350
use have access to the LIMS system of the testing laboratory?

4.2 Which site determines patient suitability for Electronic issue? P4.2 P4.2 P4.2, $K$351
4.3 After determination of patient suitability for Electronic Issue, P4.3 P4.3 P4.3, $K$352
which site selects the components for transfusion?

Section Q Description of system in place for traceability of blood

components

1 How are the primary traceability records retained? (If the same Q1 Q1, $K$358 Q1, Q2, Q3, Q4, Q6, Q7, Q8, Q9,
information is stored by two different systems, i.e. paper records
and computer records, the primary record is used in the case of
discrepancy
2 What is the minimum time of traceability record retention (in Q2 Q2, $K$359
years)?
3 Are 100% of issued blood components verified for presence of Q3 Q3, $K$360
traceability information, or is the verification performed on a
sampling basis?
4 Are issued blood components whose final fate has not been Q4 Q4, $K$365
positively confirmed, automatically assigned a ‘transfused’ fate
that cannot be distinguished from those units with a confirmed
fate?
Please provide the traceability success rate (i.e. positive
verification of final disposition) for each of the quarterly time
periods identified below. (Please provide in % [to two decimal
places] and indicate if 0 [zero] %).

6 01 Apr 2018 to 30 Jun 2018 Q6 Q6, $K$368

7 01 Jul 2018 to 30 Sep 2018 Q7 Q7, $K$369
8 01 Oct 2018 to 31 Dec 2018 Q8 Q8, $K$370
9 01 Jan 2019 to 31 Mar 2019 Q9 Q9, $K$371

Section R Distribution of blood components

1 Do you supply blood components or services to off site locations R1 R1, $K$379
or other organisations (e.g. community hospitals, hospices and
satellite units)?

If response to R1 was 'Yes', please provide details of all other organisations to which you
supply blood components or services (e.g. community hospitals, hospices and satellite
units). If the organisation supplied is classified as facility (see guidance notes), please
advise each of these to submit a facility declaration form.

2 Organisation #1
1.1 Name R1.1 R1.1 R1.1, $K$382
1.2 Full address R1.2 R1, R1.1,
1.3 Post Code R1.3
1.4 Contact name R1.4
1.5 Telephone R1.5
1.6 Fax R1.6
1.7 Email R1.7
Please indicate if any of the following are provided:
1.8 Patient ABO / Rh Group / Antibody screen/ID
1.9 Crossmatching
1.10 SABRE reporting
1.11 Maintenance and calibration
1.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
1.13 Traceability records
1.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
 1.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
2 Organisation #2
2.1 Name R2.1
2.2 Full address R2.2
2.3 Post Code R2.3
2.4 Contact name R2.4
2.5 Telephone R2.5
2.6 Fax
2.7 Email R2.7
Please indicate if any of the following are provided:
2.8 Patient ABO / Rh Group / Antibody screen/ID
2.9 Crossmatching
2.10 SABRE reporting
2.11 Maintenance and calibration
2.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
2.13 Traceability records
2.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
2.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
3 Organisation #3
3.1 Name R3.1
3.2 Full address R3.2
3.3 Post Code R3.3
3.4 Contact name R3.4
3.5 Telephone R3.5
3.6 Fax
3.7 Email R3.7
Please indicate if any of the following are provided:
3.8 Patient ABO / Rh Group / Antibody screen/ID
3.9 Crossmatching
3.10 SABRE reporting
3.11 Maintenance and calibration
3.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
3.13 Traceability records
3.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
3.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
4 Organisation #4
4.1 Name R4.1
4.2 Full address R4.2
4.3 Post Code R4.3
4.4 Contact name R4.4
4.5 Telephone R4.5
4.6 Fax
4.7 Email R4.7
Please indicate if any of the following are provided:
4.8 Patient ABO / Rh Group / Antibody screen/ID
4.9 Crossmatching
4.10 SABRE reporting
4.11 Maintenance and calibration
4.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
4.13 Traceability records
4.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
4.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
5 Organisation #5
5.1 Name R5.1
5.2 Full address R5.2
5.3 Post Code R5.3
5.4 Contact name R5.4
5.5 Telephone R5.5
5.6 Fax
5.7 Email R5.7
Please indicate if any of the following are provided:
5.8 Patient ABO / Rh Group / Antibody screen/ID
5.9 Crossmatching
5.10 SABRE reporting
5.11 Maintenance and calibration
5.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
5.13 Traceability records
5.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
5.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
6 Organisation #6
6.1 Name R6.1
6.2 Full address R6.2
6.3 Post Code R6.3
6.4 Contact name R6.4
6.5 Telephone R6.5
6.6 Fax
6.7 Email R6.7
 Please indicate if any of the following are provided:
6.8 Patient ABO / Rh Group / Antibody screen/ID
6.9 Crossmatching
6.10 SABRE reporting
6.11 Maintenance and calibration
6.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
6.13 Traceability records
6.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
6.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
7 Organisation #7
7.1 Name R7.1
7.2 Full address R7.2
7.3 Post Code R7.3
7.4 Contact name R7.4
7.5 Telephone R7.5
7.6 Fax
7.7 Email R7.7
Please indicate if any of the following are provided:
7.8 Patient ABO / Rh Group / Antibody screen/ID
7.9 Crossmatching
7.10 SABRE reporting
7.11 Maintenance and calibration
7.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
7.13 Traceability records
7.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
7.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
8 Organisation #8
8.1 Name R8.1
8.2 Full address R8.2
8.3 Post Code R8.3
8.4 Contact name R8.4
8.5 Telephone R8.5
8.6 Fax
8.7 Email R8.7
Please indicate if any of the following are provided:
8.8 Patient ABO / Rh Group / Antibody screen/ID
8.9 Crossmatching
8.10 SABRE reporting
8.11 Maintenance and calibration
8.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
8.13 Traceability records
8.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
8.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
9 Organisation #9
9.1 Name R9.1
9.2 Full address R9.2
9.3 Post Code R9.3
9.4 Contact name R9.4
9.5 Telephone R9.5
9.6 Fax
9.7 Email R9.7
Please indicate if any of the following are provided:
9.8 Patient ABO / Rh Group / Antibody screen/ID
9.9 Crossmatching
9.10 SABRE reporting
9.11 Maintenance and calibration
9.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
9.13 Traceability records
9.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
9.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?
10 Organisation #10
10.1 Name R10.1
10.2 Full address R10.2
10.3 Post Code R10.3
10.4 Contact name R10.4
10.5 Telephone R10.5
10.6 Fax
10.7 Email R10.7
Please indicate if any of the following are provided:
10.8 Patient ABO / Rh Group / Antibody screen/ID
10.9 Crossmatching
10.10 SABRE reporting
10.11 Maintenance and calibration
10.12 Does the supplied site have a fridge, freezer or platelet
incubator for the storage of blood components?
10.13 Traceability records
 10.14 Is there a service level agreement / technical agreement in
place to describe the responsibility for these functions?
10.15 Is this site in the same legal entity (e.g. NHS Trust) as the
supplying Blood Bank?

Section S Work contracted to third parties

1 Do you contract any pre transfusion testing, compatibility testing S1 S1, $K$554 S1, S2.1,
or antibody identification to outside laboratories?
If response to S1 was 'Yes' please provide details of all contractors:
2 Contractor #1 (if applicable)
2.1 Name S2.1 S2.1 S2.1, $K$557

2.2 Full address S2.2

2.3 Post Code S2.3

3 Contractor #2 (if applicable)
3.1 Name S3.1

3.2 Full address S3.2

3.3 Post Code S3.3

4 Contractor #3 (if applicable)
4.1 Name S4.1

4.2 Full address S4.2

4.3 Post Code S4.3

Section T Corrective Action Commitments from Blood Compliance Report for reporting year 01 April 2017 to 31
March 2018 (April 2018 submission)

Please indicate any corrective actions commitments given in the previous compliance report submission which have not yet been completed
Previous compliance report Proposed action and completion date Reason for not completing the action
question number

Section U Proposed corrective actions / Remarks

Report question number Proposed action Anticipated completion date

reference (e.g. N20.2)
Please answer all applicable questions before submitting this form to the MHRA. The following table shows questions that have not been answered:

Click in this cell to refesh

table

Section A A1, A3, A5, A7, A8, A9, A11, A12, A13, A14, A15, A16, A17, A18, A19, A19.1,
Section B B1.1, B1.2, B1.3, B1.4, B1.5, B1.6, B1.7, B1.8, B1.9,
Section C C1, C3.6,
Section D D1, D1.1, D2, D2.1, D2.2, D2.3,
Section E E1, E2, E3, E4, E6, E7.1, E7.2, E7.3, E7.4,
Section F F1, F2, F3, F4, F4.1, F4.2, F5, F5.1, F5.2, F6, F7, F7.1, F8, F9, F9.1, F9.2, F9.3, F10, F11, F11.1, F12, F13,
Section G G1.1, G1.2, G1.3, G1.4, G1.5, G1.6, G1.7,
Section H H1.1, H1.2, H1.3, H2, H3, H4, H5, H5.1, H5.2.1, H5.2.2, H5.2.3, H5.2.4, H6, H7, H8, H9, H10,
Section I I1, I1.1, I1.2, I1.3, I1.4,
Section J J1, J2, J3, J5,
Section L L1, L1.1, L1.2, L1.3, L1.4, L1.5, L1.6.1, L1.6.2, L1.6.3, L1.6.4, L1.7,
M1, M2.1, M2.1.1, M2.1.2, M2.1.3, M2.1.4, M2.2, M2.2.1, M2.2.2, M2.2.3, M2.2.4, M2.3, M2.3.1, M2.3.2, M2.3.3, M2.3.4, M3, M4, M4.1, M4.2,
Section M
M4.3, M5,
N1, N1.1, N1.2.1, N1.2.2, N1.2.3, N1.2.4, N1.2.5, N2, N3, N3.1, N3.2, N4, N6, N7, N7.2, N7.2.1, N7.2.1.1, N7.2.1.2, N7.2.2, N8, N8.1.1, N8.1.2,
Section N
N8.1.3, N8.1.4, N8.2, N8.3,
Section O O1, O1.1, O1.2, O1.3, O1.4, O1.4.1, O2, O2.1, O2.3, O2.4, O2.5, O2.6, O3, O3.1, O3.2, O4,

Section P P1, P2, P3, P3.1, P3.2, P3.3, P3.4, P3.4.1, P3.4.3, P3.4.4, P, P3.6, P3.7, P4, P4.1, P4.2, P4.3,

Section Q Q1, Q2, Q3, Q4, Q6, Q7, Q8, Q9,

Section R R1, R1.1,

Section S S1, S2.1,

Section T Text based answers - please check manually
Section U Text based answers - please check manually

When all questions have been answered:

*** Please save this form and email to: [email protected] ***

*** Please ensure that the declaration form has been completed and submitted with the BCR to MHRA by email to:
[email protected] ***