Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
Please return to:
Clinical Pathology Accreditation (UK) Ltd.
21-47 High Street
Feltham
Middlesex
TW13 4UN
Tel: (020) 8917 8400
Fax: (020) 8917 8500
e-mail: office@cpa-uk.co.uk
www.cpa-uk.co.uk
Registered in England & Wales No. 2675095
Clinical Pathology Accreditation (UK) Ltd is a wholly owned subsidiary of the United Kingdom Accreditation Service
©Copyright CPA 2012 All rights reserved. No part of this document may be reproduced or utilized in any
form without permission in writing from the publisher.
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
Annual Registration
CPA Ref. No.
Full completion and submission of this form according to the schedule
provided by CPA is a requirement for maintenance of CPA status
Instructions for completing the Annual Registration Form
1.
Please fill in the reference number in the header section
2.
The applicant must sign and date the form.
3.
ALL SECTIONS OF THIS FORM MUST BE COMPLETED INCLUDING
YES/NO/NOT APPLICABLE SECTIONS
4.
It is preferred that this form, and any attachments, are completed and submitted
electronically (electronic signatures and/or scanned documents are acceptable).
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
SECTION A:
Annual Registration
CPA Ref. No.
DEPARTMENTAL IDENTITY
Department
Organisation
Hospital
Road
City
County
Postcode
Tel Number
Fax Number
Website
APPLICANT CONTACTS
Head of Department
Signature and Date
Tel Number
Email
OWNING INSTITUTION
Chief
Executive/Manager
Organisation
Hospital
Road
City
County
Postcode
Email
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
LEGAL ENTITY
Is the Legal Entity the same as the Owning Institution?
YES
NO
If NO please complete details below
Chief
Executive/Manager
Organisation
Hospital
Road
City
County
Postcode
Email
Correspondence is normally sent to the Head of Department; at least one alternative
contact should be provided with the agreement of the Head of Department (e.g. Quality
Manager, Laboratory Manager). Please provide details.
Name and position
Tel Number
Email
Name and position
Tel Number
Email
Name and position
Tel Number
Email
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
SITES/SERVICES MANAGED BY THE LABORATORY
Have there been any changes to sites/premises since the last Annual
Registration/Application form submitted
If YES please detail below
YES
NO
In order for CPA to assess the full extent of the service delivered and managed by the
laboratory we require the address of all sites and information on the services provided at
each site including main sites, satellite sites, hot labs, blood fridge, blood banks,
mortuaries, phlebotomy, body stores, clinical material/record storage facilities.
Address
Department
Organisation
Hospital
Road
City
County
Postcode
Services: Tick the appropriate box(es) for the above site
Main Lab
Satellite Lab
Phlebotomy
Other (please specify)
Hot Lab
(PLEASE DUPLICATE THE ADDRESS/SERVICES FOR EACH SITE)
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
BLOOD FRIDGES MANAGED BY THE LABORATORY
Is the laboratory responsible for the management of blood fridges?
YES
NO
If yes, please complete additional Blood Fridges appendix 3 (separate
form in Excel Format available on the website www.cpa-uk.co.uk)
PHLEBOTOMY
Is phlebotomy managed by Pathology/Laboratory Services?
If YES please specify management arrangements below
YES
NO
MORTUARY AND POST-MORTEM FACILITIES MANAGED BY THE LABORATORY
Is the laboratory responsible for the management of Mortuary or PostMortem facilities?
YES
NO
If yes, please complete additional Mortuary appendix 4 (separate form
in Excel Format available on the website www.cpa-uk.co.uk )
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
SECTION B
WORKLOAD and REPERTOIRE
Have there been any significant changes to workload (+/- 10%) since
the last Annual Registration/Application form submitted
If YES please detail below
Have there been any changes to repertoire since the last Annual
Registration/Application form submitted
If YES please detail below
Have there been any changes to equipment since the last Annual
Registration/Application form submitted
If YES please detail below or attach information
Document Name:
Author:
Approved:
CPA Ref. No.
Annual Registration
AF-LAB-AnnReg
Louise Davison
Phil Shread
Page
Date
Version
YES
NO
YES
NO
YES
NO
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Clinical Pathology
Accreditation (UK) Ltd
Annual Registration
CPA Ref. No.
WORKLOAD:
Total
Units
Last 12 months figures for the laboratory
% of work from general practice
REPERTOIRE:
Details of the laboratory's repertoire are required to give a clear indication of the range of
services. If accreditation is awarded, it will relate only to the service in operation at the
time of the assessment. Any services developed subsequently will not be implicitly
approved without re-application to CPA. Please list the services provided with an
indication of the frequency of testing and annual totals. Indicate any services referred to
other laboratories.
If preferred this information can be submitted on a separate spreadsheet.
If you have declared more than one laboratory site then please provide
workload/repertoire details for each site.
For Histopathology applications please include total numbers of specimen requests,
blocks and slides.
For Cytology applications please include total numbers of gynaecological and nongynaecological requests and provide copies of your most recent statutory Cytology
returns.
For Gynaecological Cytology applications please give numbers of LBC prepared and
screened on-site, LBC prepared and screened off-site and LBC prepared off-site and
screened on-site
Please group tests under headings for each test group declared on the following
page for example:Test grouping
Frequency
of Tests
Workload
per annum
In house
2,000
1,500
Referred out
Tests
Haematology
Ferritin
Document Name:
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Approved:
Monthly
AF-LAB-AnnReg
Louise Davison
Phil Shread
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500
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Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
GUIDANCE ON TEST GROUPING
Tick the groups you are including in the in-house repertoire list.
Blood Transfusion
Clinical Biochemistry
Cytology: Gynae
Cytology: Non-Gynae
Genetics- Cytogenetics
Genetics- Molecular
Haematology
Histocompatibility & Immunogenetics
Histopathology
Immunology
Microbiology
Molecular Diagnostics
Mycology
Neuropathology
Semen Analysis: Post vasectomy only
Semen Analysis: Fertility service
Specialist Endocrinology
Specialist Paediatric Metabolic Biochemistry
Specialist Toxicology
Virology
ANDROLOGY
HFEA registered?
YES
NO
Please access the HFEA website for information on assays covered by the licence.
CPA does not assess this repertoire.
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
CPA Ref. No.
Annual Registration
SCREENING PROGRAMMES
Do you provide a service for NHSCSP?
Do you provide a service for the UK Newborn
Screening Programmes?
If YES please detail below
YES
NO
YES
NO
EXTERNAL QUALITY ASSESSMENT PARTICIPATION
Please detail below or attach a list of all the EQA Schemes in which you
participate
Has the laboratory been identified as having unsatisfactory
performance in the last 12 months?
If YES please detail below or attach information
Have there been any changes with regard to EQA participation since
the last Annual Registration/Application form submitted
If YES please list below
Has the laboratory been involved in any other accreditation
programmes?
If YES please list details below
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
Page
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YES
NO
YES
NO
YES
NO
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Clinical Pathology
Accreditation (UK) Ltd
SECTION C:
Annual Registration
CPA Ref. No.
STAFFING and ESTABLISHMENT
Staffing Numbers
*CPA recognise that the traditional protected titles may not be used in all laboratories.
If you find it more appropriate please provide the Agenda for Change grades on a
separate list/spreadsheet. PLEASE COMPLETE ALL COLUMNS
* Staff
Funded
Staff Currently Vacancies in
Establishment
In Post WTE
WTE
WTE
A: Medical Staff
Consultant
Specialist Registrar or University
equivalent
Senior House Officers
Other Medical Staff
B: Clinical Scientists
Grade C or equivalent
Grade B or equivalent
Grade A or equivalent
C: Biomedical Scientists
Senior Manager / BMS 4
Advanced Practitioner
BMS 3
BMS 2
BMS 1
Trainee BMS
D: Other Laboratory Staff
MLA
Cytology Screeners
Associate Practitioner
Trainee Cytology Screeners
PM Technicians
MTOs
ATOs
Secretarial / Clerical
Phlebotomists
Document Name:
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Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
Have there been any key changes with regard to
staffing/establishment since the last Annual Registration/Application
form submitted?
If YES please detail below
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
CPA Ref. No.
Annual Registration
Page
Date
Version
YES
NO
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Clinical Pathology
Accreditation (UK) Ltd
SECTION D:
CPA Ref. No.
Annual Registration
STANDARDS FOR ACCREDITATION
Please refer to the CPA Accreditation Standards Document and tick the appropriate box
indicating conformance with each standard.
Standard
Yes
No
Not
Applicable
Standard
A1
D1
A2
D2
A3
D3
A4
E1
A5
E2
A6
E3
A7
E4
A8
E5
A9
E6
A10
F1
A11
F2
B1
F3
B2
G1
B3
G2
B4
G3
B5
G4
B6
G5
B7
H1
B8
H2
B9
H3
C1
H4
C2
H5
C3
H6
C4
H7
Yes
No
Not
Applicable
C5
If you have answered NO / NOT APPLICABLE to any of the above, please include/attach
a full explanation.
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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Clinical Pathology
Accreditation (UK) Ltd
SECTION E:
CPA Ref. No.
Annual Registration
SUMMARY OF ANNUAL MANAGEMENT REVIEW
DATE OF REVIEW
a) reports from managerial and supervisory personnel
b) assessment of user satisfaction and complaints (H2)
c) internal audit of quality management system (H3)
d) internal audit of examination processes (H4)
e) external quality assessment reports (H5)
f) reports of assessments by outside bodies
g) status of preventive, corrective and improvement actions (H6)
h) quality indicators that monitor the laboratory’s contribution to patient care
i) major changes in organisation and management, resource (including staffing) or process
j) follow up of previous management reviews.
Review of Quality Policy
Review of Quality Objectives
Document Name:
Author:
Approved:
AF-LAB-AnnReg
Louise Davison
Phil Shread
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