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CLINICAL IMMUNOLOGY AND ALLERGY SERVICE3.1 Relationship to the Host OrganisationThe Clinical Immunology and Allergy Unit is part of Sheffield Teaching Hospital NHSFoundation Trust. The organisational relationships within are shown at the end of thisdocument.The Clinical Lead is managerially accountable to the Deputy Clinical Director (and ClinicalDirector) of Communicable Diseases and Specialised Medicine Directorate through to theMedical Director of the Trust. The Senior Immunology Nurse specialist is accountable to thematron.3.2 Organisation and Responsibilities within CIAUThe Clinical Service is led by 4 Consultant Clinical Immunologists, all on the Specialist Registerfor Immunology. They are Professor William Egner, Dr Ravishankar Sargur, Dr Anna Shrimptonand Dr Dilani Arnold. There are two StR posts and one rotating F2. (B1)The Clinical Lead is accountable to the Deputy Clinical Director (and Clinical Director) forCommunicable Diseases and Specialised Medicine (CDSM) Directorate. There are alsooperational links to the service manager in respect of service development, financialgovernance and waiting list control. (A1)The Nursing team is accountable to the Matron. The Immunology Nurse Specialist band 7 isTeam Leader and supervises the day-to-day running of the unit.The CIAU Executive Committee (which includes CIAU Clinical Lead, Deputy Clinical Directorfor CDSM, Operations Director for CDSM, Matron, Service Manager, Directorate Accountantand Nurse Director for CDSM) (A3, A4) meets monthly.Multidisciplinary meetings (A3) take place weekly to discuss patient care and include amanagement briefing. All members of CIAU plus Clinical Scientists are encouraged to attendthese meetings. A communication diary and weekly meetings are held between theSpecialist Nurses to ensure seamless updates of patient and service information.A CIAU subdirectorate meeting is held every 3 months. All members of CIAU plus ServiceManager, Matron and Governance team are invited to this meeting.QM 1.05 Immunology Service Description - Expires March 202111

CLINICAL IMMUNOLOGY AND ALLERGY SERVICEA service improvement meeting is held on alternate weeks. Previously this has used theclinical microsystems approach to service improvement. All members of the CIAU team areinvited 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, matron, service manager, specialistNurses and clerical team leader on a four weekly basis. (A3)A1 There is a document describing the scope and organisation of the primaryimmunodeficiency service, including its managerial relationship within the hospitalThe organisation and management of CIAU is detailed in this service descriptionA2 The service has sufficient caseload and appropriate staffing to maintain and developrequisite clinical skillsCIAU predominantly sees patients from Sheffield, Rotherham, Barnsley, Doncaster andChesterfield. Referrals are received from all DGHs. All clinics are held on CIAU. Outreachlaboratory services are provided in a number of hospitals. There are close links with thePaediatric Immunology Service at the Sheffield Children’s Hospital, with regular paediatric/adultMDTs. The Centre has a database of all PID patients. The current waiting time for newreferrals is approximately 12-16 weeks, but urgent referrals will be overbooked and seen within2 weeks.A3 The service should have a clearly defined management process relating to theprimary immunodeficiency service. This should include evidence of regular, minutedmanagement meetings.CIAU has regular minuted management meetings and participates in the CDSM Directorate’sadministrative structure with a defined Management structure.A4 There is appropriate budgetary management of the primary immunodeficiencyservice provided by the serviceRegular financial reports are received and discussed as appropriate at the monthly CIAUexecutive meetings. Developments are agreed with the operations director for CDSM. Thereis full budgeting for all staff, consumables and drugs.QM 1.05 Immunology Service Description - Expires March 202112

CLINICAL IMMUNOLOGY AND ALLERGY SERVICE4 STAFFINGB1 There is an appropriately trained consultant clinical immunologist in charge of theserviceFour Consultants work within CIAU. All Consultants are on the Specialist Register forImmunology. All Consultants have extensive experience of the clinical management of patientswith immunological and allergic disease and participate fully in the relevant CPD programmes(F2).B2 There are appropriately trained senior nurses to provide nursing care and run thehome treatment programmes, who must be registered with the NMCThere are 3 full time Specialist Nurses (one band 7 and two band 6), home therapy coordinator (3 days a week, band 6), band 5 staff nurses and a part-time band 2 health careassistant working in CIAU. Sister Rowley is the unit manager and there is a Nurse led AllergyClinic and a Telephone follow-up clinic weekly. IVIg, SCIg and C1INH patients receive theirinfusions in a Nurse led clinical setting. The Nurses participate in relevant CPD includingAllergy and Primary Immunodeficiency (F2).B3 There is appropriately skilled medical cover available to offer advice to patients orother healthcare professional involved in the care of patients with primaryimmunodeficiencyThe Department operates within Monday to Friday office hours. There is out-of-hours telephoneadvice available from the Consultant Immunologists on an unofficial basis via STH switchboard.Patients on Home Therapy can obtain advice by contacting the Senior Immunology NurseSpecialist via NGH switchboard on 0114 24343, bleep 2918 NGH 8.30-5.30 only.B4 Services involved in postgraduate medical training must provide a suitableenvironment and experience for the training in primary immunodeficiency, and berecognised and approved by appropriate UK authorities.The Clinical Immunology and Allergy Unit and Immunology laboratory are recognised fortraining by JRCPTB.QM 1.05 Immunology Service Description - Expires March 202113

CLINICAL IMMUNOLOGY AND ALLERGY SERVICE5 FACILITIESC1 Hospital-based outpatient, day case and inpatient facilities must be adequate for theneeds of the serviceCIAU is a dedicated stand-alone unit. All clinical work is undertaken in the unit. Patientfeedback is sought regularlyC2 The service has appropriate support from other clinical specialitiesPatients with immunodeficiencies may present to a range of medical and surgical specialists aswell as to their own GPs. Links with other medical specialities are an integral part of the caregiven. Named consultants in other medical specialties who will receive primary immunedeficiency referrals are documented in the TRIAC compendium. A monthly joint respiratory andImmunology clinic (JRIC) is held on CIAU. The medical team works closely with other medicalspecialties (both within STH and DGHs) and GPs communicating by email, telephone andletter. Patient specific MDTs are also arranged when necessary.C3 The service has adequate and readily accessible support from diagnostic servicesfor the management of primary immunodeficiencyCIAU is fully supported by diagnostic services. The immunology laboratory at SheffieldTeaching Hospitals NHS Foundation Trust is UKAS accredited. Clinical Genetics is provided offsite. Radiology can be viewed via PACS and reports are available on ICE.C4 There are appropriate storage facilities for drugs and immunoglobulin productsThere are facilities for outpatient and day-case treatment on CIAU. An outline business case forexpansion of CIAU has recently been approved. Facilities within the unit are available for thestorage of drugs and immunoglobulin products as per the local Trust policies.C5 Nursing and medical staff have adequate office space and administrative support toenable them to organise and run the service effectivelyThe offices for medical and secretarial staff are based predominantly on CIAU. There is onelarge consultants’ office shared by Drs Sargur, Shrimpton and Arnold. Prof Egner has his officein the UKNEQAS building, next door to CIAU. There is also a Consultant office in the laboratorybuilding. The StRs, F2, GPs and secretaries share an open plan office. Secretarial services areavailable to all grades of staff. The clerical staff undertake clinic coordination and filing duties.C6 There are satisfactory library and IT arrangements to support the serviceThere are two Medical School Libraries, one located at the Northern General and one at theRoyal Hallamshire Hospital. Staff also have access to online search facilities and Consultantsand the StRs are able to access journals through the University ejournal database (MUSE). Allstaff have access to computers with email facilities.QM 1.05 Immunology Service Description - Expires March 202114

CLINICAL IMMUNOLOGY AND ALLERGY SERVICE6 CLINICAL CARED1 There must be protocols in place relevant to the management of all primaryimmunodeficiencies catered for in the serviceA separate file of protocols is kept. Secretary Hayley Rowan is responsible for documentcontrol and maintains the Master Copies. Authorised copies are issued as necessary. (D2, F5).D2 There must be written literature on primary immunodeficiencies and their treatmentavailable for both patients and healthcare workersPatient Information Leaflets are available to patients in the Unit. Use is made of on-line andweb-based sources of literature, which can be printed off as required for patients. CIAU specificpatient information leaflets are reviewed regularly. There is an ongoing plan to transfer these tothe STH PIL system, Interlagos.D3 Regular monitoring arrangements for all patients with primary immunodeficienciesare appropriate and are documentedRegular monitoring of all patients is undertaken and senior clinical staff review results. Actionis taken according to Departmental Policies and Protocols (D1, E7). Annual reviews and 6monthly checks are undertaken on all patients receiving immunoglobulin replacement withdiscretion to see patients more frequently if required. Blood results are checked daily accordingto the CIAU Paperless Reporting SOP.D4 The service must maintain a database of patients with primary immunodeficiencyThe Clinical Immunology & Allergy Unit has a patient database. The national immunoglobulindatabase is updated regularly. CIAU also contributes to the UKPIN database.D5 Patients’ Notes must be properly maintained in accordance with local hospitalpoliciesIn conformity with Trust Policies, one set of medical notes [which may have separate volumesto store results] is used per patient at NGH. There is a separate set of notes at the RoyalHallamshire Hospital. The Trust has an electronic tracking system for notes. Some patient casenotes have been transferred onto EDMS which can be accessed via the Trust intranet. TheTrust are developing an electronic patient record, Lorenzo.QM 1.05 Immunology Service Description - Expires March 202115

CLINICAL IMMUNOLOGY AND ALLERGY SERVICED6 There should be robust mechanisms for recording details of blood products used inpatient management and for storage and archiving of appropriate specimens formonitoring and review purposesSpecimens are stored from patients with PID, pre-treatment or on change of treatment in theImmunology Laboratory with their consent. Samples are stored from other categories ofpatients where appropriate. There is a laboratory SOP relating to storage of specimens. Bloodproducts given to patients are recorded in line with STH policy. National Immunoglobulindatabase is completed for each patient receiving immunoglobulin replacement.D7 There should be evidence that the risks and benefits of treatment have beenconsidered and discussed with every patient with primary immunodeficiencyAll patients receiving Immunoglobulin or C1 Inhibitor concentrate replacement therapy have adetailed assessment of the risks. This is discussed with patients and the risks and discussionrecorded in the handwritten clinical notes, backed up in the typed letter to the referring doctorand GP. Written information is given to patients and this is recorded in the case notes. Thedecision to start Immunoglobulin replacement therapy is taken by the MDT. Response totreatment and need for ongoing treatment is also critically reviewed at each patient follow upappointment.D8 There should be evidence that every PID patient has given consent to treatment andhas received appropriate, relevant background and specific informationA Trust consent form is signed by the patient and consenting doctor or designatedSenior Nurse. Consent to treatment is taken prior to the first dose of Immunoglobulin orC1 inhibitor according to STH guidelines and recorded on STH consent form. Ongoingconsent to treatment is recorded at annual reviews.QM 1.05 Immunology Service Description - Expires March 202116

CLINICAL IMMUNOLOGY AND ALLERGY SERVICE7 HOME THERAPYE1 There are adequate facilities and equipment available for undertaking home therapytrainingPatients are trained for home therapy in the day case area on CIAU.E2 There should be a home therapy caseload sufficient to maintain knowledge andexpertise, and appropriate numbers of trained and experienced staff to provide adequatehome therapy training and supportThe Senior Immunology Nurse Specialist takes prime responsibility for home therapy patients,and delegates as appropriate to other nursing staff. (B2).E3 The home therapy training programme is organised in line with existing nationallyagreed guidelinesHome Therapy is organised according to nationally and locally agreed policies, includingshared care guidelines.E4 There is documentation which indicates the consent of the patient for hometreatmentPatient’s consent is recorded in the case notes. The responsible Consultant or Senior Nurseliaises with the GP to obtain their consent and support.E5 Patients and partners/carers are given necessary training: successful training isdocumented and signed by the trainer, patient and, if appropriate, infusion partnerThe training for subcutaneous infusion is given over the course of 6–8 weeks of ongoingtherapy. The patient and relative(s) will complete the standard nationally agreed test paper atthe conclusion of the course. Further supervised treatments will be completed, until the SeniorImmunology 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 thisfrom the responsible consultant. The Home Therapy programme is recognised locally andregionally.E6 There are appropriate resources for home visits and facilities for hospital basedfollow-up. Regular monitoring of all home therapy patients is documented, with regularassessments of patient and carer competencies for hose on home treatmentprogrammesFollow-up in the home is undertaken and the Trust make up the mileage claimed. Outpatientfollow-up is arranged on the Clinical Immunology and Allergy Unit. Monitoring of progress is bymeans of self-treatment logs, diaries and blood sampling, which are reviewed by senior clinicaland nursing staff as appropriate. The Senior Immunology Nurse Specialist carries outQM 1.05 Immunology Service Description - Expires March 202117

CLINICAL IMMUNOLOGY AND ALLERGY SERVICEreassessment and monitoring. Competency reviews take place every 12-18 months, or soonerif required. This is recorded in Home Therapy Evaluation case notes.E7 The service must maintain a database of home therapy patientsThe Nursing Staff maintain a database of home therapy patients (D5) and those infusing inOutreach and Community Hospitals.QM 1.05 Immunology Service Description - Expires March 202118

CLINICAL IMMUNOLOGY AND ALLERGY SERVICE8 AUDIT, EDUCATION AND MANAGEMENTF1 There is evidence of regular audit (internal and external)CIAU regularly undertakes internal audits and participates/organises regional and nationalaudits. Regular user satisfaction surveys are undertaken.F2 Staff participate fully in relevant programmes of continuing professional developmentNursing and medical staff participate in relevant CPD, attending Regional, National andEuropean Society Meetings in PID, Allergy and Immunology.F3 Regular performance appraisal of all staff shall be undertakenAll staff are appraised annually, according to Trust GuidelinesF4 The service should review (with patient participation) the quality of service which itprovidesPatient representative meetings are held. CIAU is currently reviewing the format of thesemeetings. Patients’ views are also collected informally and through feedback surveys carriedout at regular intervals.F5 There should be evidence of a managed approach in the service to quality issues anda written quality policy for the serviceThis service description and the quality policy contained within it, in addition to the evidencesubmitted for QPIDS accreditation are evidence of the managed approach in the service toquality issues.F6 All service protocols must be subject to document controlSecretary Ms Hayley Rowan, is responsible for document control. Local patient informationleaflets are in the process of being transferred to the Interlagos, the STH PIL control system.QM 1.05 Immunology Service Description - Expires March 202119

Organogram of Managerial Relationships within CIAU15/03/2019

Friday Morning Dr Arnold's Allergy Clinic Friday Morning Dr Shrimpton's Immunology Clinic. CLINICAL IMMUNOLOGY AND ALLERGY SERVICE QM 1.05 Immunology Service Description - Expires March 2021 11 3.1 Relationship to the Host Organisation The Clinical Immunology and Allergy Unit is part of Sheffield Teaching Hospital NHS .