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Immunology and Allergy Services in Scotland

APPENDIX V

DRAFT STANDARDS AND REQUIREMENTS FOR HOME IVIg THERAPY CENTRES

Organisation

1 A document should set out the scope and organisation of the Home Therapy Centre, including its managerial relationship within the hospital.

2 The Centre must have a sufficient caseload to maintain and develop requisite clinical skills.

3 A designated budget should be made available for the programme.
[Funding should include staff salaries and the capital and revenue consequences of Home Therapy, for example, provision of infusion pumps, travelling costs for home visits, etc. Soft funding will only allow conditional accreditation of the centre, unless there is written agreement that the Trust will take on the revenue consequences of the programme when the soft funding comes to an end].

Staffing

4 Each programme should be headed by an appropriately trained Consultant Immunologist.
[There needs to be evidence that the Consultant in Charge has received specific training in the management of antibody-deficient patients and the running of a Home Therapy programme by either pre- or post-appointment experience in a recognised (accredited) Home Therapy Centre].

5 There must be an appropriately trained nurse to run the programme.
[The appropriate seniority is Grade F and above. An ENB989 teaching certificate is an essential requirement. Experience and training either pre- or post-appointment in a recognised (accredited) centre is also required].

6 Appropriately skilled cover must be available at all times to give advice to patients and other doctors about Home Therapy and any problems that might arise.
[For single-handed consultants / nurses this may be provided by arrangement with a neighbouring centre in order to ensure cover during periods of annual or other leave].

Facilities

7 Appropriate facilities must exist for undertaking hospital-based infusions in the pre-home therapy phase.

8 Appropriate facilities must be made available for undertaking the training course over 1-2 days.

9 Medical and nursing staff must have appropriate office space and secretarial support to enable them to organise and run the programme.

10 Facilities must be made available for out-of-hours contact with a member of the Home Therapy Team.

11 Appropriate equipment must be made available. [This should include pumps, drip stands, resuscitation equipment, etc].

12 Appropriate arrangements must be in place for home visits and hospital-based follow-up.

The Programme

13 The training programme must be organised according to the nationally agreed guidelines and there must be a written local protocol.
[The organisation must conform to the agreed protocol which in turn must be approved by the Association of Clinical Pathologists, the Royal College of Pathologists and the Royal College of Physicians and be submitted to the Department of Health].

14 Information on IVIg therapy and the Home Therapy Programme must be made available to patients and general practitioners.

15 Documentation must be completed indicating the consent of the patient and the general practitioner and showing evidence of satisfactory completion of training.
[Ideally this should be kept in a Home Therapy file separate from the hospital case notes. Evidence of continuing compliance with criteria for inclusion in the programme is also required].

16 Patients and their partners must be given the necessary training and successful training must be documented by completion of a model test paper.

17 Regular monitoring of patients must be carried out with annual assessments of patient competencies. There must be evidence of clinical review, nursing review, and regular submission of logs and diaries. There must be documentary evidence of departmental policies.

18 All programmes must participate in the national Home Therapy Database Scheme and all patients must be registered with the UK and European Immunodeficiency Registers.

Audit and Education

19 There must be evidence of regular internal and external audit.
[This may take the form of a notes review, audit against internal documentation for re-assessments and follow-up, and participation in on-going audit].

20 All staff must participate in relevant programmes of continuing professional development, (CPD). [Documentary evidence of participation in regular CPD will be required].

Accreditation

21 Inspection must be undertaken by a Home Therapy Nurse and Consultant, selected by the Association of Clinical Pathologists, (ACP), together with a patient representative selected by the Primary Immunodeficiency Association, (PiA), all of whom must be from a different region.

22 Accreditation will be valid for 4 years but will lapse automatically if the Consultant in Charge vacates his / her post.

23 The accrediting body will be the Association of Clinical Pathologists, (ACP), and its Immunology Committee.

24 Details of accredited centres will be published and informatiuon will be made available to the Service, PCGs, the PiA and the Scottish Executive Health Department.

Adapted from the Immunology Committee of the Association of Clinical Pathologists, 1999.

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