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					         UK PIN HOME THERAPY GUIDELINES                                                Page 1 of 20




                           UK PRIMARY IMMUNODEFICIENCY NETWORK
             This document represents the consensus of the PIN Guideline Writing Group.
                       Local variations to these Guidelines may have been made.
    These Guidelines are for the management of home therapy for use by the Patient, Parent, Infusion
                       Partner, Immunologist and Immunology Specialist Nurses.
                  Clinical judgement supersedes the Guidelines wherever necessary.




Title                                                 Home Therapy Guidelines


Document No                                           21.08


Version No                                            8


Date original posted                                  July 2005


Date approved by PIN Writing Group                    To be approved


Date approved by PIN Steering Group                   To be approved


Date for review                                       September 2008


Withdrawal date                                       June 2009


Replaces version No                                   7


Filename                                              21.08 Home Immunoglobulin Therapy Training


Status                                                Draft, in consultation




                           Check this document is that latest version in use!

                       A list of current Guidelines is available at www.ukpin.org.uk




                                            HOME THERAPY
         UK PIN HOME THERAPY GUIDELINES                                            Page 2 of 20

CONTENTS

Page 1      Introduction

Pages 2-5   UK PIN Standard Training Programme

            1.1 staff
            1.2 assessment of patients
            1.3 risk assessment
            1.4 legal aspects
            1.5 shared care/contractual issues
            1.6 criteria for home therapy
            1.7 training a patient and infusion partner for home therapy
            1.8 intravenous therapy/subcutaneous therapy
            1.9 documentation
            1.10 prescribing treatment and organisation of home therapy supplies
            1.11 follow-up care

 Page 18.   References

            APPENDICES

            Appendix 1:   Pre-course Letter to GP
            Appendix 2:   Patient Consent Form
            Appendix 3:   Intravenous Home Therapy Programme Assessment Form
            Appendix 4:   Subcutaneous Home Therapy Programme Assessment Form
            Appendix 5:   Post Course Letter to GP
            Appendix 6:   Letter to Patient Following Completion of IV Training
                           Programme
            Appendix 7:   Letter to Parent/Legal Guardian Following Completion of
                           IV Training Programme
            Appendix 8:   Letter to Patient Following Completion of Sub-Cut Programme
            Appendix 9.   Letter to Parent/Legal Guardian Following Completion of
                           Sub-Cut Programme
 Page 19    Patient Assessment : Home Therapy (Intravenous)
 Page 20    Patient Assessment : Home Therapy (Subcutaneous)




                                         HOME THERAPY
INTRODUCTION


Patients who have been diagnosed as having primary antibody deficiency require regular replacement
therapy with immunoglobulin.        There are two routes currently available for administration of
immunoglobulin at home. Intravenous and subcutaneous preparations are given regularly and safely at
home. Not everyone is suitable for home therapy, but for those who meet the inclusion criteria and
express an interest to self-infuse, there are training programmes available. Each patient is carefully
assessed before being accepted on to a training programme. The programme addresses all aspects of
immunoglobulin therapy, including the necessary documentation for home infusion.

The Consensus Document relating to the management of antibody deficiency includes self-administration
and the aims of management of primary antibody deficiencies. It states that patients should receive
formal training at a recognised centre and should be reviewed by a Clinical Immunologist every 3-12
months according to local guidelines to assess progress and to detect possible complications (Chapel
1994).

Advantages of Home Therapy

Infusion in hospital requires a designated day case area. The infusion is usually initiated by an
Immunology Specialist Nurse or a nurse under their supervision.

Therapy at home minimises the use of the hospital and reduces the need for medical and nursing
supervision. In addition to the financial savings, home therapy is more convenient. It prevents time
wasted by patients waiting in hospital, time missed from work or school as well as travelling time. It gives
the patient greater autonomy and independence and more personal control over his/her condition
(Cochrane 1994, Henderson 2003).

Quality of life issues have been extensively researched and demonstrated the positive outcomes of Home
Therapy. (Gardulf, Noclay, Math 2004).

In cases of children under 16 years the advantages of home therapy will include family dynamics being
continued as normal as possible assuring the child has minimal interruption with education and
recreational activities (Russell 2002).




                                                     3
1.   How to establish a Home Therapy Training Programme

     1.1   Staff

           The Immunology Specialist Nurse should be a member of the RCN Immunology and
           Allergy Nurse Group. He/she must be competent in the administration of intravenous
           medication. He/she must have a teaching and assessing certificate or equivalent and if
           setting up a new programme have observed a home therapy training course at an
           established centre.

           A new Centre developing home therapy should initially be under the supervision of an
           established (ideally UK PIN registered or accredited) Home Therapy Centre (UK PIN
           Accreditation Standards). The Immunology Specialist Nurse is responsible for training the
           participants in all aspects of immunoglobulin infusion therapy and for arranging and
           liaising with home delivery companies.

     1.2   Assessment of patients

           The Immunology Specialist Nurse and Consultant Immunologist responsible for the
           assessment of the patient prior to gaining access onto the home therapy training
           programme. The team will liaise with the patient’s General Practitioner (GP) prior to the
           course to obtain an agreement for shared care (Appendix 1). The nurse is responsible for
           teaching the patient all aspects of immunology therapy, adverse reactions and the
           appropriate management of such reactions. Assessment of competence on completion of
           training must be undertaken.

     1.3   Risk Assessment

           The Consultant Clinical Immunologist/Immunology Specialist Nurse should also discuss
           the relative risks of transmissible diseases and arrange the regular medical follow-up of
           the patient in conjunction with other specialists as necessary.

              Regular patient/partner competencies assessment (frequency decided by centre on
               an individual patient basis).
              Audit of compliance to programme/continued need for home therapy/treatment ie.
               blood sampling/infusion records and clinic attendance (frequency decided by centre)
              Clinical review (frequency decided by centre).

     1.4   Legal Aspects

           To meet legal requirements, the immunology team is responsible for the provision of
           written evidence of consent and confirming the home therapy participants competence.
           Liaison with the patient's GPs and their community team is, therefore, essential.

           It is recommended to have the home therapy programme approved locally by the risk
           assessment team and local Medical Committee or equivalent for the centre. This
           information can then be available when approaching the patient's GP.      Written
           confirmation is forwarded to the patient and their GP acknowledging successful
           completion of the course.

     1.5   Shared Care/Contractual Issues

           Shared care is preferable for treatment at home. Although some GPs continue to
           prescribe in some areas, contracts are normally set with individual Primary Care Trusts
           (PCTs). Most General Practitioners welcome the chance to extend their knowledge of
           lifelong treatments. The contribution of the Royal College of General Practitioners to the
           Consensus document on the 'Diagnosis and management of patients with primary
           antibody deficiencies', has emphasised this (Chapel 1994).

           Each training centre should consult with their General Manager or Business Development
           Teams and Contracts Department (according to local arrangements) regarding
           contractual issues, initiating home treatment and prescribing of the immunoglobulin
                                               4
          product, as systems vary from one PCT to another. Specific shared care protocols and
          guidelines have been drawn up in some Regions to facilitate the process.

          Difficulties may be encountered in the securing of funding for home therapy. However, it
          is not advisable to allow patients to commence home therapy until secure funding has
          been established.

1.6       Criteria for Home Therapy

          a.      The patient should have been stabilised on treatment in the hospital setting for at
                  least 4-6 months without adverse reactions.
          b.      Patients on IVIG must have good venous access.
          c.      The patient and infusion partner should be motivated to carry out home therapy.
          d.      The patient and infusion partner must be trained to administer immunoglobulin by
                  the specialist nursing staff.
          e.      The patient must agree verbally and in writing to complete infusion logs, forward
                  regular blood samples for monitoring, and attend for hospital review as often as
                  required.
          f.      The patient's infusion partner must agree verbally and in writing to stay for the
                  duration of the home infusions and be available for regular assessment. Should
                  the partner change, a replacement infusion partner must be trained.
          g.      Funding for home therapy must be arranged as per departmental policy.
          h.      The general practitioner must be informed before and after the training period.
          i.      The patient must have a telephone for access to the emergency services in the
                  unlikely event of an adverse reaction.

1.7       Training a patient and partner for home therapy

          a.      Using the above assessment, patients and infusion partners will be trained in the
                  skills outlined in 1.8.
          b.      Assessment will be documented and agreed using department assessment tools.
          c.      Both patient and infusion partner must achieve the assessment competencies at
                  the end of the training period.
          d.      Training may be withdrawn at any stage if the patient criteria for entry change.
          e.      The patient and infusion partner may withdraw from the training at any time.
          f.      Arrangements for home delivery will be made with the appropriate delivery
                  company.

 1.8      INTRAVENOUS THERAPY                                 SUBCUTANEOUS THERAPY

 Team working between infusion partners                 Team working between infusion partners

      Principles of venepuncture                        Principles of subcutaneous infusion
      Potential venepuncture problems                   Site selection
      Vein selection, vein care, increasing vein        Site care
       prominence/site care                              Care and maintenance of MS16 Graseby
      Venepuncture practice                              infusion pump or equivalent
      Blood sampling - lgG, LFT, others                 Practice of safe needle insertion and
       as required                                        removal
      Infusion dose and rate                            Blood sampling -
      Record keeping                                     LgG, LFT, others as required
      Adverse reactions                                 Infusion dose and rate
      Potential risk of transmissible diseases          Record keeping
       (according to local/UK guidelines)                Adverse reactions
      Self infusion                                     Potential risk of transmissible diseases
      Review of procedures                               (according to local guidelines)
      Assessment of competencies                        Self infusion
      Questions and answers                             Review of procedures
      Reflection                                        Assessment of competencies
                                                         Questions and answers
                                                         Reflection

        Please refer to Manufacturers Immunology Home Therapy Manual
                                               5
1.9    Documentation

       All documentation should be filed in nursing or medical notes and include:

          Copies of Consent Form
          Details of drug therapy
          Evidence of successful training (completed assessment of competencies).
          Infusion records with immunoglobulin lot numbers
          Results of blood tests and relevant action taken
          Copies of letters about home therapy to the GP
          Copies of correspondence with home delivery company
          Copy of completed home therapy registration form

1.10   Prescribing Treatment and organisation of Home Therapy Supplies

       Each centre will have its own system for prescribing immunoglobulin and supplying the product
       and equipment to the patient's home.

       Supplies for immunoglobulin infusions at home include the immunoglobulin product and the
       ancillary items required for intravenous or subcutaneous infusion. This includes the supply of
       sterile needles, swabs, giving sets, infusion for intravenous immunoglobulin and a syringe driver
       for subcutaneous immunoglobulin. In addition there needs to be an appropriate means of safe
       disposal of contaminated equipment once the infusion is completed. Blood sampling equipment
       for monitoring both serum immunoglobulin levels and liver function tests is also required.

       Supplies may be provided by a community pharmacy service eg. Clinovia, Calea. Some hospital
       pharmacies may wish to fulfil this role since they may already supply other groups of patients at
       home.

1.11   Follow-up care

       The need for multidisciplinary team (MDT) care is emphasised in the Consensus document
       (Chapel 1994). Shared care between immunologists and local physicians or paediatricians and
       other specialities may be necessary, especially if the patient lives a distance from the immunology
       centre.

       Infection records and/or diaries may be used to monitor infections and treatments. Patients
       whose condition is stable should be followed up by the consultant/specialist nurse more frequently
       for the first year and every 6-12 months thereafter (according to local guidelines). Those with
       uncontrolled disease may need to be seen more frequently.

       The patients' infusion skills and knowledge, and their infusion logs/symptom diaries, should be
       monitored by the Immunology Specialist Nurse.




                                                   6
                                                                                             Appendix 1




PRE-COURSE LETTER TO GP


Dear Dr [Name of GP]

Re: Home Therapy Training

[Patient's name] has been having regular infusions for the past [number] months and has not suffered any
side effects. [Patient's name] has tolerated the infusions well and both [Patient's name] and [partner]
(infusion partner) are very keen to undertake the infusions at home.

You may be aware the immunology team run a Home Therapy Training Programme where we teach the
patients and partners all aspects of preparing and administering the infusion. The recognition and
management of adverse reactions are discussed in depth within the training programme. Reactions to
immunoglobulin are, however, extremely rare.

In order to proceed with this successful programme and maintain [patient's name] quality of life we would
request your continuing support. This shared care arrangement should not significantly increase your
workload.

Please find enclosed:

   Shared care protocol/interface document
   Home therapy patient information leaflets
   Primary Immunodeficiency Association etc.

If you require any further information or wish to discuss matters further, please do not hesitate to contact
us.

Yours sincerely




Consultant and/or Immunology Specialist Nurse




                                                     7
                                                                                           Appendix 2

PATIENT CONSENT FORM


For the safety of the patient it is important that he/she/parent/legal guardian agrees to comply with the
training programme and follow up care.

For Intravenous/Subcutaneous Immunoglobulin

Please complete a. or b. as appropriate

a.      I would like to attend the Home Therapy Training Course for self-
        administration of intravenous/subcutaneous immunoglobulin at [place of training]
        on [date].

b.      I would like to attend the Home Therapy Training Course for my son/daughter
        [patient's name] to receive intravenous/subcutaneous immunoglobulin at [place of training]
        on [date].

I understand this will involve attending a training programme and I will hope to be able to give my
own/child's infusion, if I feel confident to do so.

I have read the information concerning intravenous/subcutaneous infusions and I agree to carry out the
infusions as I have been trained. I will record the necessary infusion details. All aspects of adverse
reactions have been discussed and how to deal with them if/as necessary.

I agree to visit my hospital for regular follow-up appointments.

I understand immunoglobulin is a blood product and potential risks of blood borne infectious diseases has
been explained to me. I am aware that a blood sample will be stored regularly to look back for transmitted
organisms in the future should this be necessary.

Patient’s name   ________________________________

Signature        ________________________________

Date             ________________________________

Assistant to be trained

Name             ________________________________

Address          ________________________________
                 ________________________________
                 ________________________________

Telephone No: ________________________________

Relationship
to Patient       ________________________________

Date             ________________________________




                                                      8
                                                                                            Appendix 3

INTRAVENOUS HOME THERAPY TRAINING PROGRAMME
ASSESSMENT FORM


Name: ________________________________ Date: _________________

Circle the answer most appropriate; (T) True, (F) False or (U) Unsure

1.      T       F       U       I.V. Therapy means injecting medicine into an artery.
2.      T       F       U       The tourniquet should be tight enough to congest blood
                                flow through the veins, but not the arteries.
3.      T       F       U       Very small air bubbles will not do harm if they enter the
                                circulatory system
4.      T       F       U       Only sterile materials should enter the cardiovascular
                                system.

Place an 'X' before each correct answer. There may be more than one correct answer for each question


5.     If another person is pricked with your needle, you should
         a.     _____ Apply ice.
         b.     _____ Apply a plaster
         c.     _____ Thoroughly wash the area
         d.     _____ Report it to the Home Therapy Doctor/Nurse
         e.     _____ Ignore it

6.     If the needle is accidentally touched, you should
         a.      _____ Use a different needle
         b.      _____ Continue to use the same needle
         c.      _____ Wash it with soap and water
         d.      _____ Wash it with alcohol
         e.      _____ Call the Doctor/Nurse

7.      If you experience a headache during your infusion, you should
        a.       _____ Take Paracetamol
        b.       _____ Stop the infusion immediately
        c.       _____ Speed up the infusion rate
        d.       _____ Slow down the infusion rate
        e.       _____ Do nothing

8.      The butterfly needle/cannula should be
        a.      _____ inserted into an artery in the arm
        b.      _____ pointing away from the heart
        c.      _____ inserted into the arm or hand vein
        d.      _____ taped down before the infusion
        e.      _____ almost parallel to the skin on entry

9.      Used needles should be
        a.     _____ thrown away in a rubbish bag
        b.     _____ put into a sharps tin
        c.     _____ cleaned with alcohol and reused
        d.     _____ bent with a pair of pliers
        e.     _____ not sure




                                                    9
10.         List 3 things that you should always check about the immunoglobulin
            a.       _________________________________________________
            b.       _________________________________________________
            c.       _________________________________________________

Place the letter from Column B in the box for Column A which best describes it

Column A                                   Column B

11. [   ]   Veins                          a.   Washed with soap and water
12. [   ]   Sterile                        b.   Carry blood to the heart
13. [   ]   Tissue swelling                c.   Inflammation of the liver
14. [   ]   Arteries                       d.   Fever and itching skin
15. [   ]   Hepatitis                      e.   When infusion material enters tissues around a
                                                vein
                                           f.   Carry blood away from the heart
                                           g.   Totally free of bacteria

Answer the following questions in your own words

16. List 3 ways a needle may be contaminated
    a. _________________________________________
    b. _________________________________________
    c. _________________________________________

17. When should you NOT do an infusion?
    a. _________________________________________
    b. _________________________________________
    c. _________________________________________

18. What can you do to make a vein easier to find?
    ____________________________________________
    ____________________________________________
    ____________________________________________

19. Why should used I.V. equipment be disposed of carefully?
    ______________________________________________
    ______________________________________________
    ______________________________________________

20. What should you do if the infusion suddenly stops dripping?
    _________________________________________________
    _________________________________________________

21. Why is the rate of infusion important?
    _________________________________________________
    _________________________________________________
    _________________________________________________

22. What are the advantages of home rather than hospital administered
    infusions?
      __________________________________________________
      __________________________________________________
      __________________________________________________

Test paper reviewed with patient/infusion partner on

………………………………………………… (date)

Signed …………………………………………nurse

Signed ……………………………………………patient/infusion partner (delete as appropriate)
                                                       10
                                                                              Appendix 4


SUBCUTANEOUS HOME THERAPY TRAINING PROGRAMME
ASSESSMENT FORM


1. What must you check on the pump prior to the infusion?
   _____________________________________________________
   _____________________________________________________

2. Why do you prime the infusion set?
   _____________________________________________________
   _____________________________________________________

3. How do you check the needle is not in a blood vessel?
   _____________________________________________________
   _____________________________________________________

4. If another person is pricked with your needle, you should
   a. ____ Apply ice
   b. ____ Apply a plaster
   c. ____ Thoroughly wash the area
   d. ____ Report it to the Home Therapy Doctor/Nurse
   e. ____ Ignore it

5. If the needle is accidentally touched, you should
   a. ____ Use a different needle
   b. ____ Continue to use the same needle
   c. ____ Wash it with soap and water
   d. ____ Wash it with alcohol
   e. ____ Call the Doctor/Nurse

6. The needle should be
   a. ____ inserted into the thigh or abdomen
   b. ____ at an angle of 45-90º on entry
   c. ____ inserted into the arm or hand
   d. ____ taped down before the infusion
   e. ____ at an angle of 90º on entry

7. Used needles should be
   a. ____ thrown away in a rubbish bag
   b. ____ put into a sharps tin
   c. ____ cleaned with alcohol and reused
   d. ____ bent with a pair of pliers
   e. ____ not sure

8. List three things that you should always check about the immunoglobulin
   a. ________________________________________________________
   b. ________________________________________________________
   c. ________________________________________________________

9. Why should used equipment be disposed of carefully?
   ___________________________________________________________
   ___________________________________________________________
   ___________________________________________________________

10. What you should do if the pump bleeps and the infusion is not finished?
    ___________________________________________________________
    ___________________________________________________________
    ___________________________________________________________

                                                       11
11. Why is the rate of infusion important?
    ___________________________________________________________
    ___________________________________________________________
    ___________________________________________________________

12. What are the advantages of home rather than hospital administered infusions?
    ___________________________________________________________
    ___________________________________________________________
    ___________________________________________________________




Test paper reviewed with patient/infusion partner on


………………………………………………… (date)

Signed …………………………………………nurse

Signed ……………………………………………patient/infusion partner (delete as appropriate)




                                                       12
                                                                                              Appendix 5

POST COURSE LETTER TO GP
to adapt for intravenous or subcutaneous treatment




Dear Dr [Name of GP]

Re:

[Patient's name and infusion partner's name] have successfully undergone Home Therapy training and
their [type] infusion technique is satisfactory. [Patient's name and infusion partner's name] has given
[number] infusions under supervision [Patient's name and infusion partner's name] and is competent and
confident about self-infusion and they have been instructed about adverse reactions and their treatment.
Reactions are more common when a patient has an untreated bacterial infection, although adverse
reactions are rare. In the unlikely event of a reaction, and if you are called, injectable hydrocortisone and
antihistamines may be considered.

Please report any adverse reactions to
Dr [name] Cons. Immunologist/Immunology Specialist Nurse
Telephone No:

We plan to see [patient's name] for follow-up at regular intervals; thus we will be continuing to share the
clinical responsibility with you. Please find enclosed an adverse reaction information form. Thank you for
your ongoing help and support with [patient's name]'s infusions; if you have any queries please do not
hesitate to contact us.

Yours sincerely




Consultant                                        Immunology Specialist Nurse




                                                     13
                                                                                          Appendix 6


LETTER TO PATIENT FOLLOWING COMPLETION OF INTRAVENOUS
TRAINING PROGRAMME FOR PATIENT'S OWN RECORDS



  Dear [Patient's name]

  Re: Intravenous Immunoglobulin Home Therapy Training Programme

  We were delighted that you were able to attend the home therapy training course at [place of training]
  on [date].

  During the course you received instruction in the preparation of immunoglobulin, priming of an infusion
  set, the practice of venepuncture and all aspects of intravenous infusions. We also discussed in detail
  side effects and adverse reactions to immunoglobulin replacement therapy and the appropriate
  treatment of such reactions. We covered relative risks of transmissible diseases in relation to
  intravenous treatment as well as therapy by other routes.

  We discussed with you in some detail the practical aspects of your infusions and with whom you were
  to make arrangements in order to provide medical cover at the relevant times.

  At the end of the course you gave your own infusion uneventfully. You have now given several
  infusions under clinical supervision and you are considered appropriately trained to give infusions in
  your own home, or on holiday should this be necessary.

  Yours sincerely




  Consultant Immunologist             Immunology Specialist Nurse

  cc. GP




                                                  14
                                                                                          Appendix 7


LETTER TO PARENT/LEGAL GUARDIAN FOLLOWING COMPLETION OF
INTRAVENOUS TRAINING PROGRAMME FOR PATIENT'S OWN RECORDS



  Dear [Name of parent/legal guardian]

  Re: Intravenous Immunoglobulin Home Therapy Training Programme

  We were delighted that you were able to attend the home therapy training course at [place of training]
  on [date].

  During the course you received instruction in the preparation of immunoglobulin, priming of an infusion
  set, the practice of venepuncture and all aspects of intravenous infusions. We also discussed in detail
  side effects and adverse reactions to immunoglobulin replacement therapy and the appropriate
  treatment of such reactions. We covered relative risks of transmissible diseases in relation to
  intravenous treatment as well as therapy by other routes.

  We discussed with you in some detail the practical aspects of your child's infusions and with whom
  you were to make arrangements in order to provide medical cover at the relevant times.

  At the end of the course you gave your child's infusion uneventfully. You have now given several
  infusions under clinical supervision and you are considered appropriately trained to give infusions to
  your child in your own home, or on holiday should this be necessary.

  Yours sincerely




  Consultant Immunologist             Immunology Specialist Nurse

  cc. GP




                                                  15
                                                                                            Appendix 8


LETTER FOR SUBCUTANEOUS TRAINING FOR PATIENT'S OWN RECORDS



Dear [Patient's name]


Re: Subcutaneous Immunoglobulin Home Therapy Training

We were delighted that you were able to attend for home therapy training at [place of training] and
on [date].

During the training you received instruction in the drawing up the immunoglobulin, priming an infusion set
and administering the immunoglobulin via the syringe driver. We also discussed in detail side effects and
adverse reactions to immunoglobulin replacement therapy and the appropriate treatment of such
reactions. We covered relative risks of transmissible diseases in relation to subcutaneous treatment.

We were able to discuss with you in some detail the practical aspects of your infusions and with whom you
were to make arrangements in order to provide medical cover at the relevant times.

You have now given several infusions under clinical supervision and you are considered appropriately
trained to give these infusions in your own home, or on holiday should this be necessary.

Yours sincerely




Consultant Immunologist                                  Immunology Specialist Nurse

cc.     GP




                                                    16
                                                                                           Appendix 9


LETTER FOR SUBCUTANEOUS TRAINING FOR PATIENT'S OWN RECORDS



Dear [Name of parent/legal guardian]

Re: Subcutaneous Immunoglobulin Home Therapy Training

We were delighted that you were able to attend for home therapy training at [place of training] on [date]
During the training you received instruction in the drawing up the immunoglobulin, priming an infusion set
and administering the immunoglobulin via the syringe driver. We also discussed in detail side effects and
adverse reactions to immunoglobulin replacement therapy and the appropriate treatment of such
reactions. We covered relative risks of transmissible diseases in relation to subcutaneous treatment.

We were able to discuss with you in some detail the practical aspects of your child's infusions and with
whom you were to make arrangements in order to provide medical cover at the relevant times.

You have now given several infusions under clinical supervision and you are considered appropriately
trained to give these infusions to your child in your own home, or on holiday should this be necessary.

Yours sincerely




Consultant Immunologist                                 Immunology Specialist Nurse

cc.     GP




                                                   17
Authors

Fran Ashworth
Sheila Cochrane
Teresa Green
Lucia Russell
On behalf of UK PIN Writing Group

The authors would like to thank Nicky Brennan (Oxford) who compiled the original guidelines for
home therapy self infusion (1989).


References:

Ashworth FM et al (unpublished)             A Patient's Journey from Hospital to Home (unpublished)

Brennan VM et al (2003)                     Prospective audit of adverse reactions occurring in
                                            459 primary antibody deficient patients receiving
                                            intravenous immunoglobulin
                                            Clinical Experimental Immunology 133, 247-251

Brennan, VM et al (1995)                    Surveillance of adverse reactions in patients self infusing
                                            intravenous immunoglobulin at home
                                            Journal of Clinical Immunology 15:116-9

Chapel HM (1994)                            Consensus on diagnosis and management of primary
                                            antibody diseases
                                            British Medical Journal 308, 581-585

Cochrane S (1994)                           A mark of approval. Patient satisfaction with an IV self
                                            infusion teaching programme
                                            Professional Nurse November 106-111

Henderson K (2003)                          Training and support to enable home immunoglobulin
                                            therapy
                                            Nursing Times Vol 99 No 45

Ross C, Burton J, and                       Formative Assessment tool for home IVIG therapy
Salome-Bentley N (2005)                     training. Immunotherapeutics Quarterley 2005: 4(1): 4-5

Russell L (2002)                            The psychological benefits of an ongoing home
                                            Immunoglobulin therapy programme caring for young
                                            children with primary immunodeficiencies

                                            Tenth meeting of European Society for
                                            Immunodeficiencies ESID, Weimar, Germany 17-20
                                            October (Abstracts)

Gardulf A, Nocolay U, Math D (2004)         Children and adults with primary antibody deficiencies
                                            gain quality of life by subcutaneous IgG self-infusions at
                                            home
                                            Journal of Allergy and Clinical Immunology 114(4) 936-
                                            942




                                               18
There are various assessment tools for Home Therapy training. See example of an assessment tool below utilised by Oxford Home Therapy Training Centre.
                                                     PATIENT ASSESSMENT HOME THERAPY (INTRAVENOUS)
Patient:                       Introductory Training Date:
Partner:
                                                                                                           Skill Levels
                                      Date                    Date                   Date                        Date                  Date                   Date                   Date
Relationship:
                                Patient    Partner     Patient     Patient    Partner        Patient       Partner    Patient    Patient    Partner    Patient      Partner   Partner   Partner
Checking product


Product reconstitution

Equipment assembly

Pooling (if required)

Priming

Venepuncture

Blood sampling

Infusion monitoring

Equipment disposal

Record-keeping

Team-working

Adverse reactions

Patient/partner initials

                                                                                        Skill Levels
                                       Level A : Proficient                                                                                 Level B : Competent
   Performance is smooth, confident and efficient                                                          Performance is safe and accurate with good dexterity
   The practitioner can adapt within the clinical setting to changing circumstances                        Indirect supervision is required
   The practitioner can practice without supervision but knows his/her limits and when to                  Knowledge of underlying theory is evident
    obtain advice
   There is integration of theory and practice
                                 Level C : Advanced Beginner                                                                                  Level D : Novice
   Performance is slow, but is coordinated accurate and increasing in confidence                           Performance is slow, awkward, uncoordinated and lacking in confidence
   Continual supervision is required                                                                       Continual supervision is required
   Knowledge of underlying theory is demonstrated                                                          Knowledge of underlying theory requires significant prompting

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There are various assessment tools for Home Therapy training. See example of an assessment tool below utilised by Oxford Home Therapy Training Centre.

                                               PATIENT ASSESSMENT : HOME THERAPY TRAINING (SUBCUTANEOUS)
Patient:                              Introductory Training Date:
Partner:
                                                                                                                    Skill Levels
                                            Date               Date              Date               Date              Date              Date               Date              Date            Date
Relationship:


Product reconstitution

Equipment assembly

Pooling (if required)

Priming

Venepuncture

Blood sampling

Infusion monitoring

Equipment disposal

Record-keeping

Team-working

Adverse reactions

Patient/partner initials

                                                                                                  Skill Levels
                                             Level A : Proficient                                                                                      Level B : Competent
   Performance is smooth, confident and efficient                                                                  Performance is safe and accurate with good dexterity
   The practitioner can adapt within the clinical setting to changing circumstances                                Indirect supervision is required
   The practitioner can practice without supervision but knows his/her limits and when to obtain advice            Knowledge of underlying theory is evident
   There is integration of theory and practice
                                       Level C : Advanced Beginner                                                                                       Level D : Novice
   Performance is slow, but is coordinated accurate and increasing in confidence                                   Performance is slow, awkward, uncoordinated and lacking in confidence
   Continual supervision is required                                                                               Continual supervision is required
   Knowledge of underlying theory is demonstrated                                                                  Knowledge of underlying theory requires significant prompting




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