SHEFFIELD CLINICAL IMMUNOLOGY AND
ALLERGY SERVICE
These constitute guidelines for the diagnosis/management of the condition stated, for use by immunology doctors
and nurses within the Sheffield Clinical Immunology and Allergy Service.
Clinical judgement supersedes these guidelines whenever necessary.
CLINICAL UNIT DOCUMENT
CIAU Quality Manual
Index No:
QM1
Name,
Version No:
Date
QM 1.03
Signed
Designation
Approved for local
use at this centre by:
Dr Egner/ Dr
Shrimpton/ Dr Sargur
Consultant
Immunologists
Date operational:
FEBRUARY 2014
Date for review:
FEBRUARY 2016
Filename:
QM 1.03 CIAU Quality Policy
Status:
Operational /Controlled
Location of copies on this site:
Copy 1: Immunology Office CIAU
Copy 2: Shared Drive Limited Access
Copy 3: Immunology Nursing Station
Copy 4: Intranet/Internet Sites
Reviewed, some changes made
Summary of changes compared to previous
version:
This is the third version
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 2 of 17
Date of issue FEBRUARY 2014
QUALITY MANUAL
This document, together with specified procedure manuals represents the Quality
Management System of the Department of Clinical Immunology and Allergy, Northern
General Hospital Sheffield. It has been compiled to meet the requirements of the UK
Primary Immunodeficiency Network (UK PIN) and other appropriate national and
international standards. All procedures specified herein are mandatory within the Department
of Clinical Immunology and Allergy.
EDITION No
3rd edition
DATE OF ISSUE
February 2014
REVIEW INTERVAL
Biannual
AUTHORISED BY
AUTHOR
Dr A Shrimpton
COPY
Master Copy
LOCATION OF COPIES
1 Clerical Office
2 Nursing Station CIAU
3 Intranet/Internet Sites
QUALITY MANUAL
QM 1.03 Expires February 2016
2
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 3 of 17
Date of issue FEBRUARY 2014
Document review history
Review date
Reviewed by
QUALITY MANUAL
QM 1.03 Expires February 2016
3
Signature
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 4 of 17
Date of issue FEBRUARY 2014
CONTENTS
QUALITY MANUAL................................................................................................... 2
1
GENERAL INFORMATION .......................................................................................................................... 5
1.1
1.2
2
TITLE OF DEPARTMENT
THE QUALITY MANUAL .............................................................................................................................. 6
QUALITY POLICY ......................................................................................................................................... 7
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES ..................................................................... 10
2.1
RELATIONSHIP TO THE HOST ORGANISATION ........................................................................................... 10
2.1
ORGANISATION AND RESPONSIBILITIES WITHIN THE IMMUNOLOGY AND ALLERGY
UNIT…………………………………………………………………………………………………
11
3.
ORGANISATION AND ADMINISTRATION……………………………………………………………..12
4.
PERSONNEL…………………………………………………………………………………………………13
5.
PREMISES AND ENVIRONMENT………………………………………………………………………..14
6.
CLINICAL CARE……………………………………………………………………………………………16
7
HOME THERAPY……………………………………………………………………………………………18
8.
AUDIT, EDUCATION AND MANAGEMENT……………………………………………………………20
QUALITY MANUAL
QM 1.03 Expires February 2016
4
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 5 of 17
Date of issue FEBRUARY 2014
1 GENERAL INFORMATION
1.1
Title of department
The Clinical immunology and Allergy Unit (CIAU) is part of Sheffield Teaching Hospitals NHS
Foundation Trust.
The postal address is:-
Clinical Immunology and Allergy Unit
Northern General Hospital
Sheffield Teaching Hospital NHS
Foundation Trust
Tel.: 0114 226 6963
Fax: 0114 226 9244
Sheffield S5 7AU
Information on the services provided and contact telephone numbers are available here, in a
series of publications, on our website and on the hospital intranet.
The CIAU is a dedicated stand alone unit within the Communicable Diseases and Specialised
Medicine Directorate and is located on the Northern General Hospital site of Sheffield Teaching
Hospitals NHS Foundation Trust.
It provides a regional wide service for adults with Primary Immune Deficiency (PID) and is
provided by the Immunology team covering Sheffield, Rotherham, Barnsley, Doncaster and
Chesterfield whose main services are described below.
Patients with, or under investigation for PID, in the regional catchment areas attend regular
specialist PID clinics held on CIAU. The current waiting time for new referrals in approximately
12 weeks, but urgent referrals will be overbooked and seen within 2 weeks. There is open
access during office hours for C1 inhibitor deficiency patients requiring urgent assessment and
treatment for acute symptoms. Transition clinics are twice a year in conjunction with the
paediatric service at Sheffield Children’s Hospital. Hospital based immunoglobulin infusions are
administered on CIAU and a home therapy service for immunoglobulin infusions is also offered.
The Home Therapy training programme utilises a competency-based programme. CIAU staff
are available for telephone advice from other multidisciplinary team members. Primary
immunodeficiency patients can also contact the medical and nursing staff directly for advice.
The CIAU also provides a service for patients with allergic diseases including outpatient
assessment, education and training, allergen challenges and desensitisation.
QUALITY MANUAL
QM 1.03 Expires February 2016
5
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 6 of 17
Date of issue FEBRUARY 2014
1.2
The Quality Manual
This Quality Manual describes the Quality Management System of the Clinical Immunology and
Allergy Unit. Throughout the text there are references to UK PIN standards (in brackets) and to
Procedures (indicated by square brackets), written in fulfilment of these standards.
This Quality Manual (A1 Quality Manual) fulfils two functions. It describes the Quality
Management System for the benefit of the Unit’s own management and staff, and it provides
information for users and for inspection/accreditation bodies.
The sections of the Quality Manual are arranged so that they equate with the UK PIN standards
(see table below). Under the title of each standard there is a brief description of the way in
which the Clinical Immunology and Allergy Unit seeks to comply with the particular standard
and references are given to appropriate procedures.
The sections of the standards should be seen to relate to each other in the following manner Section A describes the organisation and administration of the Clinical Service, Sections B & C
cover Staffing and Resources, Sections D & E cover clinical care for hospital and home therapy
and Section F covers audit, education and quality management. The quality management
system and the clinical processes are continually evaluated and quality assured (Section F).
The results feed back to maintain and where required, improve the quality management
process and to ensure that the needs and requirements of users are met.
Paragraph in the
Quality Manual
Section of UK PIN Standards
3
A Organization and administration
4
B Staffing
5
C Facilities
6
D Clinical Care
7
E Home Therapy
8
F Audit, education and management
QUALITY MANUAL
QM 1.03 Expires February 2016
6
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 7 of 17
Date of issue FEBRUARY 2014
2 QUALITY POLICY
The Quality Policy (A1 Quality policy) of the CIAU is given below and published as a separate
controlled document to be displayed within the Department.
CIAU Quality Policy
The Clinical Immunology and Allergy Unit (CIAU) at the Sheffield Teaching Hospitals
NHS Foundation Trust is committed to providing a first class clinical service for patients
with Immunological disorders in a professional and friendly manner.
Good clinical care and patient satisfaction are our priorities. We aim to treat each
patient holistically, taking into account their needs and wishes, and ensuring that they
have sufficient understanding of their conditions to enable them to effectively manage
their condition and to be involved in their care as an active participant.
The unit aims to incorporate best practice from all sources including Sheffield Teaching
Hospitals Trust Policies and Procedures, National Guidance and Best Practice
Statements from Professional Bodies.
The CIAU works in collaboration with the Trent Immunodeficiency Consortium (TRIAC)
to develop guidelines and improve and audit practice on a regional basis. TRIAC also
provides a forum for maintaining continuing professional development for nursing and
medical staff.
QUALITY MANUAL
QM 1.03 Expires February 2016
7
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 8 of 17
Date of issue FEBRUARY 2014
The Consultant Immunologists:
Dr W Egner
Consultant Immunologist
Dr A Shrimpton
Consultant Immunologist
Dr R Sargur
Consultant Immunologist
(Clinical Lead)
The Medical Team
Dr Melanie York
StR
Dr Shena Roper
General Practitioner with a special interest in Allergy
Dr Elizabeth Angier
General Practitioner with a special interest in Allergy
The Immunology Nursing Team:
Sister Fran Ashworth
Immunology Nurse Specialist band 7
Sister Tracy Brown
Immunology Nurse Specialist band 6
Staff Nurse Lisa Walsh
Staff Nurse
Staff Nurse Pamela Hudson
Staff Nurse
Staff Nurse Jayne Rendi
Staff Nurse
Staff Nurse Helen Goodright
Staff Nurse
Staff Nurse Deborah Hughes
Staff Nurse
Health Care Assistant: Lisa Seward
Health Care Assistant
The Administration and Secretarial Team
Kelle Scruton
Dr Egner’s Secretary
Hayley Rowan
Dr Shrimpton’s and Dr Sargur’s Secretary
Linsey Fielding
Clerical Officer
Tamsyn Johnson
Clerical Officer
Loren Kelsey
Clerical Officer
QUALITY MANUAL
QM 1.03 Expires February 2016
8
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 9 of 17
Date of issue FEBRUARY 2014
Outpatient Clinics
Monday All Day
Nurse Led Infusion Clinic
Monday Morning
Nurse led Home Therapy Training
Monday Afternoon
Nurse Led Telephone Follow-up Clinic
Tuesday Morning
Dr Egner’s Allergy Clinic
Tuesday Morning
Desensitization Clinic
Tuesday Afternoon
Dr Egner’s Immunology Clinic
Tuesday Afternoon
Nurse Led Allergy Clinic
Wednesday Morning
Dr Shrimpton’s Allergy Clinic
Wednesday Morning
Dr Roper’s Allergy Clinic
Wednesday Morning
Dr Angier’s Allergy Clinic
Wednesday Morning
Desensitization Clinic
Thursday Morning
Dr Roper’s Allergy Clinic (term time only)
Thursday Morning
Dr Sargur’s Immunology Clinic
Thursday Afternoon
Dr Sargur’s Allergy Clinic
Thursday All Day
Nurse led Home Therapy Training
Friday Morning
Dr Angier’s Allergy Clinic
Friday Morning
Dr Shrimpton’s Immunology Clinic
QUALITY MANUAL
QM 1.03 Expires February 2016
9
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 10 of 17
Date of issue FEBRUARY 2014
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
2.1
Relationship to the Host Organisation
The Clinical Immunology and Allergy Unit is part of Sheffield Teaching Hospital NHS
Foundation Trust. The organisational relationships within are shown at the end of this
document.
The Clinical Lead is managerially accountable to the Clinical Director of Communicable
Diseases and Specialised Medicine Directorate through to the Medical Director of the Trust.
The Senior Immunology Nurse specialist is accountable to the matron.
2.2 Organisation and Responsibilities within CIAU
The Clinical Service is led by 3 Consultant Clinical Immunologists, all on the Specialist Register
for Immunology. They are Dr William Egner, Dr Ravishankar Sargur and Dr Anna Shrimpton
who is also Clinical Lead. There is also one full-time Specialist Registrar. (B1 Professional
direction)
The Clinical Lead is accountable to the Clinical Director for Communicable Diseases and
Specialised Medicine (CDSM) Directorate. There are also operational links to the service
manager in respect of service development, financial governance and waiting list control. (A 1)
The Nursing team is accountable to the Matron for Immunology (shared with Metabolic Bone
Medicine and Palliative Care). The Immunology Nurse Specialist band 7 is Team Leader and
supervises the day-to-day running of the unit.
The CIAU Executive Committee (which includes CIAU Clinical Lead, Clinical Director for
CDSM, General Manager for CDSM, Matron, Service Manager, Directorate Accountant and
Nurse Director for CDSM) (A3, A4) meets monthly.
Multidisciplinary meetings (A3) take place weekly to discuss patient care and include a
management briefing. All members of CIAU plus Clinical Scientists are encouraged to attend
these meetings.
A communication diary and weekly meetings are held between the Specialist Nurses to
ensure seamless updates of patient and service information.
QUALITY MANUAL
QM 1.03 Expires February 2016
10
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 11 of 17
Date of issue FEBRUARY 2014
A CIAU subdirectorate meeting is held every 3 months. All members of CIAU plus Assistant
Service Manager, Matron and Governance team are invited to this meeting.
A service improvement meeting is held every other week which uses the clinical
microsystems approach to service improvement. All members of the CIAU team are invited to
this meeting which is facilitated by a member of the STH service improvement team. (F4)
An operational meeting is held between the Clinical Lead, Specialist Nurses and reception
team on a two weekly basis. (A3)
Organisation and Administration
A1 Organisation and management
The organisation and management of CIAU is detailed in section 3 of this quality manual
A2 Centre has sufficient caseload
CIAU manages patients predominantly in Sheffield, Rotherham, Barnsley, Doncaster and
Chesterfield. Referrals are received from all DGHs and outreach laboratory services are
provided in a number of hospitals. There are close links with the Paediatric Immunology
Service at the Sheffield Children’s Hospital. The Centre maintains a database of all PID
patients.
A3 The Centre has a defined management process
CIAU has regular minuted management meetings and participates in the CDSM Directorate’s
administrative structure with a defined Management structure.
A4 There is adequate funding and appropriate budgetary management for the Centre
Regular financial reports are received and discussed as appropriate at the monthly CIAU
executive meetings. Developments are agreed with the general manager for CDSM. There is
full budgeting for all staff, consumables and drugs.
QUALITY MANUAL
QM 1.03 Expires February 2016
11
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 12 of 17
Date of issue FEBRUARY 2014
3 PERSONNEL
B1 Professional direction - Consultants
Three consultants work within CIAU. All consultants are on the Specialist Register for
Immunology. All consultants have extensive experience of the clinical management of patients
with immunological and allergic disease and participate fully in the relevant CPD programmes
(F2).
B2 Staffing - Nurses
There are 2 full time Specialist Nurses (band 7 and band 6), five part time band 5 staff nurses
and a part-time band 2 health care assistant working in CIAU. Sister Ashworth, the Senior CNS
and Unit manager runs a Nurse led Allergy Clinic and a Telephone follow-up clinic weekly. IVIg,
SCIg and C1INH patients receive their infusions in a Nurse led clinical setting. The Nurses
participate fully in relevant CPD including Allergy and Primary Immunodeficiency (F2).
B3 Clinical Cover
The Department operates within Monday to Friday office hours. There is out-of-hours telephone
advice available from the Consultant Immunologists on an unofficial basis. Patients on Home
Therapy can obtain advice by contacting the Senior Immunology Nurse Specialist via long
range pager.
B4 Care of Children
Children under the age of 16 are not treated on CIAU. Any referrals are passed on
immediately to the paediatric consultants at Sheffield Children’s Hospital. Transition clinics are
held 6 monthly at alternate sites.
B5 Recognition for Postgraduate Training
The Clinical Immunology and Allergy Unit and Immunology laboratory are recognised for
training by JRCPTB.
4 PREMISES AND ENVIRONMENT
C1 Facilities for care
QUALITY MANUAL
QM 1.03 Expires February 2016
12
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 13 of 17
Date of issue FEBRUARY 2014
CIAU is a dedicated stand alone unit. All clinical work is undertaken in the unit. (C4).
C2 Support from other specialities
Patients with immunodeficiencies may present to a range of medical and surgical specialists as
well as to their own GPs. Links with other medical specialities are an integral part of the care
given. Named consultants in other medical specialties who will receive primary immune
deficiency referrals are documented in the TRIAC compendium. (D1).
C3 Diagnostic support
CIAU is fully supported by diagnostic services, all of which are CPA accredited. One
immunology laboratory exists in the Sheffield Teaching Hospitals NHS Foundation Trust.
Clinical Genetics is provided off site.
C4 Facilities for hospital-based treatment and for storage of drugs and plasma products
There are facilities for outpatient and day-case treatment on CIAU. Facilities within the unit are
available for the storage of drugs and plasma products as per the local Trust policies.
C5 Office space and Secretarial support
The offices for medical and secretarial staff are based predominantly on CIAU. There is one
large consultants’ office shared by Drs Sargur and Shrimpton, Dr Egner has his office in the
UKNEQAS building, next door to CIAU. There is also a consultant office in the laboratory
building. The StR, F2, GPs and secretaries share an open plan office. Secretarial services are
available to all grades of staff. The clerical staff undertakes clinic coordination and filing duties.
C6 Facilities for follow-up
In Sheffield, follow up appointments are available in all PID clinics. There are 5 consulting
rooms, a day case area and a waiting room. Phlebotomy is undertaken on the unit. No
separate facilities exist for training.
C7 Library and IT support
There are two Medical School Libraries, one located at the Northern General and one at the
Royal Hallamshire Hospital. Staff also have access to online search facilities and consultants
and the StR are able to access journals through the University ejournal database (MUSE). All
staff have access to computers with email facilities.
5 CLINICAL CARE
D1 Protocols for clinical use
QUALITY MANUAL
QM 1.03 Expires February 2016
13
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 14 of 17
Date of issue FEBRUARY 2014
A separate file of protocols is kept. Secretary Hayley Rowan, under supervision of the quality
manager (band 6 nursing post), is responsible for document control and maintains the Master
Copies. Authorised copies are issued as necessary. (D2, F5). Master and authorised copies
are monitored by the quality manager (D1, F5).
D2 Literature is available
Full literature is available to patients in the Unit. Use is made of on-line and web-based sources
of literature, which can be printed off as required for patients. A master pack of PID literature
is kept in the Department for reference.
D3 Regular monitoring is documented
Regular monitoring of all patients is undertaken and senior clinical staff review results. Action
is taken according to Departmental Policies and Protocols (D1, E7).
D4 Maintenance of patient database
The Clinical Immunology & Allergy Unit maintains a patient database.
D5 Referral guidance
Referral guidance is available on the hospital intranet/internet, giving details of staffing, clinics
and how to access the service.
D7 Patients’ Notes
In conformity with Trust Policies, one set of medical notes [which may have separate volumes
to store results] is used per patient at NGH. There is a separate set of notes at the Royal
Hallamshire Hospital. The Nurses keep a separate record of regular patients e.g. infusion
patients using the care pathways for PID patients. Notes in regular use are held by the
Secretary in the A&C office. The Trust has an electronic tracking system for notes.
D8 Specimens should be stored for look back
Specimens are stored from patients with PID, pre-treatment or on change of treatment in the
Immunology Laboratory with their consent. Samples are stored from other categories of
patients where appropriate. There is a laboratory SOP relating to storage of specimens.
QUALITY MANUAL
QM 1.03 Expires February 2016
14
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 15 of 17
Date of issue FEBRUARY 2014
D9 Risk assessment
All patients receiving Immunoglobulin or C1 Inhibitor concentrate replacement therapy have a
detailed assessment of the risks. This is discussed with patients and the risks and discussion
recorded in the handwritten clinical notes, backed up in the typed letter to the referring doctor
and GP. A Trust consent form is signed by the patient and consenting doctor or designated
Senior Nurse. Written information is given to patients and this is recorded in the case notes.
D10 Evidence for assent to treatment
Assent to treatment is usually obtained verbally and the fact recorded in the handwritten case
notes. In specific instances where high-risk procedures are to be undertaken (see above),
written consent will be obtained and placed in the notes (D9).
QUALITY MANUAL
QM 1.03 Expires February 2016
15
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 16 of 17
Date of issue FEBRUARY 2014
6 HOME THERAPY
E1 Facilities for home therapy
Patients are trained for home therapy in the day case area on CIAU.
E2 There are appropriate staff for the caseload of home therapy patients
The Senior Immunology Nurse Specialist takes prime responsibility for home therapy patients,
and delegates as appropriate to other nursing staff. (B2).
E3 Documentation
Home Therapy is organised according to nationally and locally agreed policies, including
shared care guidelines.
E4 Consent
Patient’s consent is recorded in the case notes. The responsible Consultant or Senior Nurse
liaises with the GP to obtain their consent and support.
E5 Training
The training for subcutaneous infusion is given over the course of 6–8 weeks of ongoing
therapy. The patient and relative(s) will complete the standard nationally agreed test paper at
the conclusion of the course. Further supervised treatments will be completed, until the Senior
Immunology Nurse Specialist or appointed deputy is satisfied that the patient is safe to selftreat unsupervised. A letter is provided to the patient and copied to the GP confirming this
from the responsible consultant. The Home Therapy programme is recognised locally and
regionally.
E6 Facilities for follow-up and monitoring
Follow-up in the home is undertaken and the Trust make up the mileage claimed. Outpatient
follow-up is arranged on the Clinical Immunology and Allergy Unit. Monitoring of progress is by
means of self-treatment logs, diaries and blood sampling, which are reviewed by senior clinical
and nursing staff as appropriate.
E7 Regular monitoring and reassessment
The Senior Immunology Nurse Specialist carries out reassessment and monitoring.
Competency reviews take place every 12-18 months, or sooner if required. This is recorded in
separate Home Therapy Evaluation case notes.
E8 Database of home therapy patients
The Nursing Staff maintain a database of home therapy patients (D5) and those infusing in
Outreach and Community Hospitals.
QUALITY MANUAL
QM 1.03 Expires February 2016
16
Clinical Immunology and Allergy Unit
533580396
Northern General Hospital Sheffield
Page 17 of 17
Date of issue FEBRUARY 2014
7 AUDIT, EDUCATION AND MANAGEMENT
F1 Evidence of internal and external audit
CIAU regularly undertakes internal audits and participates/organises regional and national
audits.
F2 Participation in CPD
Nursing and medical staff participate in relevant CPD, attending Regional, National and
European Society Meetings in PID, Allergy and Immunology.
F3 Appraisal
All staff are appraised annually, according to Trust Guidelines
F4 Meetings with patients
Patients’ views are also collected informally and through feedback surveys carried out at
regular intervals.
F5 Quality Manager
Band 6 nurse is the designated Quality Manager.
F6 National & Trust Policies
CIAU is compliant with all relevant policies affecting the operation of the Unit.
F7 Complaints policy
The Trust complaints procedure is applied
F8 Research
The Unit undertakes research in allergy and immunodeficiency. It has a good publication
record and staff are actively encouraged to present at National and International Meetings
QUALITY MANUAL
QM 1.03 Expires February 2016
17