Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
1.
Blood Bank refrigerator
mapping data provided for
Main Theatre fridge showed
breach of stated
requirement. No nonconformity had been raised.
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
N
Asr
A.6.3
D.1.2h
JC
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
2.
The records of departmental
management meetings do
not include target dates to
ensure that actions are
completed in an agreed and
appropriate timescale.
N
A1.5
CT
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
1 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
3.
1365
03/12/2012
to
06/12/2012
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Prof. G Smith
Clause
Finding
Classification
The departmental training
policy (HAPOL 051 v 4.01)
states that following initial
competency assessment
periodic reassessment is not
required apart from in certain
circumstances, i.e. a period
for reassessment has not
been defined. However in
practice the competency
matrices (summaries) are
reviewed every six months
but the record of what was
reviewed and when is
incomplete. In addition initial
competency records for longserving staff are incomplete,
and some tasks are not
included (e.g. referral)
N
Document Name:
Author:
Owner:
Mr. J Connolly
Asr
A6.3
B6.2h
B9.3
CT
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
2 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
4.
1365
03/12/2012
to
06/12/2012
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Finding
Classification
A large number of noncontrolled working
instructions were in-use (also
raised previously at SV
29/11/2010). In addition
version discrepancies
between footers and front
pages were detected in a
number of documents.
N
Asr
A8.1
All
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Please note clearance
evidence should include
rigorous document control
audit to demonstrate full
compliance
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
3 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
5.
1365
03/12/2012
to
06/12/2012
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Prof. G Smith
Clause
Finding
Classification
The Haematology-specific
records of the last AMR
comprise only of the CPA
Executive Summary which
describes how the
components of the QMS are
reviewed but does not
include an actual review of
the outcomes of:- user
satisfaction & complaints,
internal audit of the QMS and
examination processes,
status of preventive,
corrective & improvement
actions, and quality
indicators.
N
Document Name:
Author:
Owner:
Mr. J Connolly
Asr
A11.1
b-e
gh
CT
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
4 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
6.
7.
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
A number of staff rotate
through Immunology and
also participate in the shift,
OOH & weekend rotas for
Haematology. This means
that Immunology is short
staffed due to these rotas.
This has the potential to
cause service issues:
NEQAS error (LKM1)
attributed to lack of
experienced staff available
for checking by second
person.
N
There are insufficient
phlebotomy staff at the
Gloucester site to meet the
demands of the service. The
service has been reduced in
some areas leading to
adverse incident reports.
N
Asr
B 2.1
SC/SP
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
B2.1
F3.1a
MP
Added Standard F3.1a
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
5 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Finding
Classification
Asr
8.
There is only one
receptionist in the OPD
Phlebotomy area at
Gloucester to deal with
patients, make appointments
for treatment, answer the
telephone and answer
queries from many visitors
who are unsure of hospital
departments. The telephone
had to be left unanswered
whilst the receptionist was
attending to these problems.
X
MP
Remove from report – not
managed by Pathology
9.
Records of CPD and some
training events are held only
by the individual so the
laboratory management does
not hold a full staff record.
N
CT
Added Standard B9.5
B6.2g
B9.5
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
N/A
Mrs. M Popeck
CPA Response
N/A
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
6 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
10. The Specimen reception
manager had not been
competency assessed for the
work she performed and had
limited opportunity for her
professional development
and further education.
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
N
Asr
B9.1b
B9.3
F3.1a
MP
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Added Standard F3.1a
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
11. The main theatre blood
fridge is located in an
inappropriate position. The
room has poor circulation
and is over-heating. The
compressor on the fridge is
working too hard to maintain
temperature. This will reduce
lifespan of equipment and
increase risk of failure
Document Name:
Author:
Owner:
O
C1.2a
D1.1
JC
Classification lowered to
Observation
Removed Standard D1.4
Added Standard D1.1
Laboratory management to
note finding
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
7 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Prof. G Smith
Clause
Classification
12. Lack of space in Blood
Transfusion laboratory
results in incompatible
activities taking place in the
same work area (e.g.
booking in blood products in
the analyser processing
area)
N
13. There is insufficient space for
patient recovery facilities in
the phlebotomy area at
Cheltenham
O
14. There is insufficient storage
space in the phlebotomy
area in Cheltenham for
reagents/stock.
O
Document Name:
Author:
Owner:
Mr. J Connolly
Asr
C.1.2.c
JC
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
C3.1b
MP
Classification lowered to
Observation
Laboratory Management to
note finding
C4.1f
MP
Classification lowered to
Observation
Laboratory management to
note finding
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
8 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
15. HazTabs in the spillage kit in
Immunophenotyping
Laboratory out of date (Exp:
7/2011).
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
Asr
N
C5.3f
GS
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
16. The procedure ‘BTSOP 044
Maintenance & alarm testing
Stroud’ requires clarity for
staff on action to be taken in
event of failure of equipment
& returning blood to fridge if
not required immediately
N
D1.2h
JC
Removed Standard D3.2d
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
9 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
17. BTS Request form is not
time stamped on receipt in
Blood Bank and no audit of
times to ensure delay
acceptable.
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
N
Asr
E5.1c
JC
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
18. The SOP for Autoimmune
profile contains photographs
of ANA staining on Hep2 for
reference even though the
analysis is carried out on
mouse LKS slides.
N
F2.1j
SC
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
19. There are many GP clinics
performing INR tests locally
but there is no evidence of
the comparison of results or
quality assurance of these
tests. (Note: these clinics nor
tests are not managed by the
laboratory)
Document Name:
Author:
Owner:
X
MP
Removed from report not
part of the assessment
N/A
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
N/A
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
10 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
Asr
Hospital:
CPA Decision
20. The GRH Laboratory
definition of the
“Measurement of
Uncertainty” does not take
into account external factors
which could influence the
quality of results. However
evidence was seen that
these factors are considered.
O
F3.3
GS
Laboratory management to
note finding
21. BTS telephone of urgent
results / blood product not
recorded on phone pad or
consistently recorded in
LIMS phone-browser.
N
G.3.1f
A6.3
JC
Added Standard A6.3
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
11 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
22. The report does not contain
information about the type of
specimen or highlighting of
abnormal results for ANA.
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
N
Asr
G2.3
dg
SC
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
23. Coeliac testing reports do not
include gluten dietary advice,
nor reference to established
guidelines for follow-up.
N
G5.1
SP
Part of finding removed
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
12 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
24. Audit of the department’s
examination processes are
appropriately scheduled,
however the areas to be
audited are not planned in
advance but selected on an
ad-hoc basis. This means
that the schedule does not
ensure that the full scope of
the department’s repertoire is
included in the audit cycle.
N
25. The results of internal audit
are not consistently
communicated to staff
(similar finding raised
previously at SV
29/11/2010).
N
Asr
H4.2a
CT
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
H4.4
H6.5
H1.2
CT
Added Standard H1.2
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
13 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Finding
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Prof. G Smith
Clause
Classification
26. Although some examples
were found there is
insufficient evidence that the
monitoring of corrective
action for effectiveness is
embedded in the quality
improvement process (also
raised previously at SV
29/11/2010)
N
27. Although some NC data is
reviewed for trends, not all
sources of NC are included
and records of review are not
consistently kept (similar
finding raised previously at
SV 29/11/2010).
N
Asr
H6.2d
CT
Hospital:
CPA Decision
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Summary of root cause, corrective
action and evidence submitted by
laboratory to clear finding
Mrs. M Popeck
CPA Response
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
H7.1g
CT
Interim Accreditation
To maintain accreditation
finding to be cleared within 12
weeks from date of visit
Expiry date:
25 Feb 2013
INSTRUCTIONS FOR SUBMITTING CLEARANCE EVIDENCE
Please complete the Summary column of the above table and submit this form as a Word document with clearance evidence. Evidence should be
submitted as soon as possible and NO LATER THAN FOUR WEEKS BEFORE THE EXPIRY DATE. Please submit evidence to clear all findings at the
same time and send electronically to office@cpa-uk.co.uk with the Regional Assessor copied in.
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
14 of 15
23 February 2012
3.00
Clinical Pathology
Accreditation (UK) Ltd
CPA Ref No(s):
Date of Visit:
1365
03/12/2012
to
06/12/2012
Clearance Review Form - Main Visit
Department:
Dept of Haematology & Blood Transfusion
Assessors:
RA-Cathy Tate
Mr. J Connolly
Hospital:
Prof. G Smith
Gloucestershire Hospitals NHS FT
Mr.S Conlan
Dr. S Pereirera
Mrs. M Popeck
PLEASE ENSURE THE EVIDENCE FOR EACH FINDING IS CLEARLY IDENTIFIED e.g. via clearly annotating files with finding number, embedding
evidence within the clearance review form, or via submitting one email per finding.
Document Name:
Author:
Owner:
MV-Ncor Obs
Regional Assessment Managers
Regional Assessment Managers
Page
Date
Version
Key: Asr = Assessor, App = Applicant, Rep = Representative
15 of 15
23 February 2012
3.00