Northern General Hospital Sheffield / Page 1 of 17
Date of issue FEBRUARY 2014
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 ManualIndex No: / QM1 / Version No: / QM 1.03
Name,
Designation / Date / Signed
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
Summary of changes compared to previous version: / Reviewed, some changes made
This is the third version
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
Document review history
Review date / Reviewed by / Signature
CONTENTS
QUALITY MANUAL
1GENERAL INFORMATION
1.1Title of Department
1.2The Quality Manual
2QUALITY POLICY
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
2.1Relationship to the Host Organisation
2.1 ORGANISATION AND RESPONSIBILITIES WITHIN THE IMMUNOLOGY ANDALLERGYUNIT………………………………………………………………………………………………… 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
1GENERAL INFORMATION
1.1Title 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 HospitalSheffield Teaching Hospital NHS Foundation Trust
Sheffield S5 7AU / Tel.: 0114 226 6963
Fax: 0114 226 9244
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 withinthe Communicable Diseases and Specialised Medicine Directorate andis located onthe NorthernGeneralHospitalsite 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 catchmentareas attend regularspecialist 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 yearin conjunctionwith thepaediatric 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.
1.2The 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 theQuality 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
2Quality 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.
The Consultant Immunologists:
Dr W Egner Consultant Immunologist
Dr A ShrimptonConsultant Immunologist(Clinical Lead)
Dr R SargurConsultant Immunologist
The Medical Team
Dr Melanie York StRDr 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 7Sister 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 SecretaryHayley Rowan Dr Shrimpton’s and Dr Sargur’s Secretary
Linsey Fielding Clerical Officer
Tamsyn Johnson Clerical Officer
Loren Kelsey Clerical Officer
Outpatient Clinics
Monday All Day / Nurse Led Infusion ClinicMonday 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
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
2.1Relationship to the Host Organisation
The Clinical Immunology and AllergyUnitis part of Sheffield Teaching Hospital NHSFoundation 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, allon the Specialist Register for Immunology. They are Dr William Egner,Dr Ravishankar Sargurand 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 governanceand 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 areheld between the Specialist Nurses to ensure seamless updates of patient and service information.
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.
Aservice 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 patientspredominantly inSheffield, Rotherham, Barnsley, Doncaster and Chesterfield. Referrals are received from all DGHs and outreach laboratoryservices 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 CDSMDirectorate’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.
3PersoNnel
B1 Professional direction - Consultants
Three consultantswork 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 timeSpecialistNurses (band 7 and band 6), five part time band 5 staff nurses and a part-time band 2 health care assistant working in CIAU. SisterAshworth, the Senior CNS and Unit manager runs a Nurse led Allergy Clinic and aTelephone 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 laboratoryare recognised for training by JRCPTB.
4Premises and environment
C1 Facilities for care
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 onCIAU. 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
InSheffield,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 atthe RoyalHallamshireHospital.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.
5Clinical Care
D1 Protocols for clinical use
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
TheClinical Immunology & Allergy Unit maintains a patient database.
D5Referral 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 RoyalHallamshireHospital. 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 Laboratorywith their consent. Samples are stored from other categories of patients where appropriate.There is a laboratory SOP relating to storage of specimens.
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).
6Home 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