PROCEDURE FOR IMMUNISATION

Issue History Issue Version Purpose of Issue/Description of Change Planned Review Date One To promote the safe administration of vaccines 2014 Named Responsible Officer:- Approved by Date Medicines Governance Pharmacist Quality, Patient Experience and Risk Group May 2012 Section:- Medicines Management MMSOP12 Target Audience Healthcare Professionals who advise or administer Immunisations to children or adults UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM THE TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION

CONTROL RECORD Title Procedure for Immunisation Purpose Support Staff when undertaking the required clinical procedure Author Quality and Governance Service (QGS) Equality Assessment Integrated into procedure Yes No Subject Experts A Nugent and L Knight Document Librarian QGS Groups consulted with :- Medicines Management Group Infection Control Approved 10/04/12 Date formally approved by Quality, Patient Experience and Risk Group 1 st May 2012 Method of distribution Email Intranet Archived Date Location:- S Drive QGS Access Via QGS VERSION CONTROL RECORD Version Number Author Status Changes / Comments Version 1 A Nugent L Knight N To reflect National and Trust immunisation standards for best practice Status New / Revised / Trust Change 2/13

PROCEDURE FOR IMMUNIS ATION INT R ODUCT ION This procedure outlines the principles for safe administration of vaccines. Immunisation programmes are one of the most successful public health measures and it is important that professionals provide a rationale outlining the benefits of vaccinations. In addition to this procedure, staff must also refer to the: Immunisation Against Infectious Disease (Green Book) refer to most current chapters on the web site as chapters are frequently updated http://www.dh.gov.uk/greenbook http://www.travax.nhs.uk/ UK Guidance on Best Practice in Vaccine Administration 2001 http://www.rcn.org.uk/ data/assets/pdf_file/0010/78562/001981.pdf TARGET GROUP All nurses and clinical staff trained to immunise or advise on immunisation. T R AINING All clinical staff are required to attend Essential Learning training, which includes anaphylaxis and basic life support every two years as outlined in the Trust Mandatory Training Matrix HEALTH VISITING SERVICE See additional training requirements in the Service Training Matrix, which is monitored via annual appraisal by line managers COMMUNITY NURSING See additional training requirements in the Service Training Matrix, which is monitored via annual appraisal by line managers PRACTICE NURSING Immunisation training for specific staff groups will be specified in the Service Training Matrix, which is monitored via annual appraisal by line managers 3/13

UNPLANNED CARE NURSES Unplanned care nurses are authorised under Patient Group Direction to administer a tetanus containing vaccine for tetanus prone wounds. See additional training requirements in the Service Training Matrix, which is monitored via annual appraisal by line managers FLU CHAMPIONS Nominated registered nurses within Wirral Community NHS Trust will assist Occupational Health Department to immunise Wirral Community NHS Trust front line staff during the annual flu campaign. Flu champions will attend an in house yearly update on influenza immunization as identified under Nominated Clinical roles in the relevant Service Training Matrix AUTHORISATION AND PAT IE NT G R OUP DIR E C T IONS (PGDS ) It is important that nurses are legally covered to administer vaccines, which are Prescription Only Medicines (POMs). There are two ways in which nurses can be legally covered to administer vaccines: 1. A nurse may administer a vaccine if he/she has a written instruction for the specific vaccine which includes the patient s name and route of administration, this is known as a Patient Specific Direction (PSD) and must be signed and dated by a qualified and registered prescriber. 2. A nurse may administer a vaccine to a patient, if there is an authorised Patient Group Direction for the specific vaccine. The nurse must have signed the PGD and agreed to only administer the vaccine in accordance with the PGD. The PGDs are approved by the Trust and all nurses must read and sign them individually. In addition the nurse s line manager must countersign the PGD to acknowledge that the nurse has the required competencies and authorisation to work within the PGD. Heads of Service are required to keep records of all nurses authorised to work under PGDs according to the Trust s Safe Handling and Administration of Medicines Policy and Clinical Protocol for the Development of PGDs Staff must have a copy of the relevant PGD with them, when administering the vaccines. This is essential to be able to check that the patient fulfills the inclusion criteria and is not excluded as outlined in individual PGDs. 4/13

RELATED POLICIES Please refer to relevant Trust policies and procedures CONSENT Refer to Trust Consent Policy for further information and guidance. Specifically for children: All parents/ legal guardians sign their intent to participate in the National Immunisation Programme following the birth of their child or on moving into Wirral. All parents/ legal guardians will be given Department of Health information leaflets on the National Childhood Immunisation Programme, the importance of vaccination and management of potential side effects. Verbal consent must be obtained from a person with parental responsibility, or the child being immunised, if they are Fraser Competent at each immunisation visit. If the immuniser is not satisfied that informed and understood consent has been given, the immunisation should be deferred (Refer to Clinical Protocol for Clarification of Parental Responsibility) PROCESSES FOR CHILDHOOD IMMUNISATIONS Scheduled Appointment System for Children All Wirral children will be allocated appointments generated and coordinated through Wirral Information Services for Child Health (WISCH) as per local Trust agreement For Children s Immunisation The following documents are required: Have a copy of the Generated Appointment list - scheduled immunisation list from the Genesis Team Child Health Department. CH12 Form should be completed for unscheduled immunisations given on the day or changes to consent for listed scheduled vaccinations and forward to Genesis Team at Child Health. A copy of the Health Protection Agency (HPA) Vaccination of individuals with Uncertain or Incomplete immunisation status accessed from http://www.hpa.org.uk/webc/hpawebfile/hpaweb_c/1194947406156 Access to patient notes (either computerised, Lloyd George notes, or community patient records) 5/13

Personal Child Health Records (Red book) are also required to record the vaccination and confirm any previous vaccination where relevant. For children who have come from outside the UK they may have an equivalent record which would also be acceptable. R E STR AINING CHILDR E N AND YOUNG PE OPLE Restraint is, by definition, applied without child s consent. However, safe parental restraint reduces the risk of needle stick injury to the child. Safe restraint means immobilisation by using limited force. It may be a method of helping children, in order to safely manage a painful procedure (RCN, 2010). This method of holding children may be used if necessary during the immunisation procedure with informed and understood parental consent. This predominately applies to the three to four year old children. Health Professionals must not hold the child in a safe position; this must be done by the parent or person with parental responsibility with guidance from staff. Clinical judgment on what advice to give parents will always be on a case by case basis, the child s welfare and safety will always be paramount. PROCEDURE FOR IMMUNIS AT ION EQUIPMENT Vaccine supply including the manufacturer s information leaflet Patient Documentation as listed above Copy of PGD or PSD Point of Use Disposal System (POUDS) tray Cotton wool Micro pore tape or plasters Yellow lidded Sharps container Selection of syringes 1ml or 2ml (single use only) Selection of needles (single use only) Green 21 gauge 38 mm long - use for drawing up of vaccine medication only (single use only) Orange 25 gauge 25 mm long or blue 23 gauge- 25mm long use to administer vaccines (single use only) refer to the Trust procedure for Administration of Medicines via the Intramuscular Route or the Subcutaneous Route for full details 16mm long, only to be used on pre-term or very small infants (single use only) FOR ADULTS AND CHILDREN Activity Verbally confirm the identity of the patient by asking for their full name and date of birth. If the patient is unable to confirm, check identity with family/carer In case of a child, check accompanying adult has Rationale To avoid mistaken identity To comply with Trust consent policy 6/13

parental responsibility Introduce yourself as a staff member and any colleagues involved at the contact At all times wear identity badge which includes name status and designation Check if any allergies Provide a safe and suitable environment and have appropriate equipment available Ensure the correct required vaccines are available and cold chain has been maintained Ensure a current Patient Group Direction (PGD) is in place to cover the specific vaccine to be administered or Patient Specific Direction (PSD) is written Staff must have a copy of the PGD with them when administering the vaccine If in a clinical setting, check the computer system to ensure patient has not previously been vaccinated and sufficient time has lapsed since previous immunisation When immunising children also check the Red Book or equivalent for details of previous immunisation Confirm that the patient or where appropriate carer understands what vaccination(s) are to be given and is aware of possible adverse drug reactions, including how to recognise the symptoms of anaphylaxis If administering the vaccine under PGD check that all the conditions of the PGD are fully met If administering the vaccine under a PSD, ensure the PSD gives full details on vaccine, dose, route, site of injection and includes the date prescribed, the prescribers signature and if administering to a child, the child s date of birth Decontaminate hands prior to procedure Risk assess use of Personal Protective To promote mutual respect and put the patient at their ease To reduce risk of adverse event To help reduce any potential errors during administration of vaccines Vaccines to be stored in accordance with manufacturer s guidance and vaccines transported under cold chain conditions at all times Vaccine supplies delivered to practices will be stored immediately on receipt to maintain cold chain To comply with legislation To comply with legislation To ensure patient does not receive inappropriate immunisations To gain informed and valid consent The onset of anaphylaxis can be delayed and it is essential that urgent medical care is sought as soon as possible To ensure the patient fulfils the inclusion criteria and is not excluded from any of the exclusion criteria To ensure the PSD includes sufficient information To reduce the risk of transfer of transient micro-organisms on the healthcare workers hands 7/13

Equipment on an individual patient basis Check vaccine is in date before administration. If required reconstitute vaccine according to the manufacturer s instructions ensuring the vaccine is thoroughly dissolved in the diluent before administration. Vaccines should not be drawn up in advance of an immunisation session. Inspect the vaccine ensuring it is clear from particulate matter and is the correct colour according to the manufacturer s information leaflet If the skin is clean, no further cleaning is necessary. Only visibly dirty skin needs to be washed with soap and water. Administer the vaccine in accordance with the PGD or PSD; also refer to the manufacturer s information leaflet and the Trust procedure for administration of medication via the intramuscular and subcutaneous route. Record the following : batch number and expiry date manufacturer specific name of vaccine administered route and site(s) used including clear description of which injection was administered in each site, especially where two injections were administered in the same limb dose administered date immunisation(s) were given name, signature and designation of immuniser The preferred site for intramuscular immunisation is usually the deltoid area of the upper arm or in children under one the anterolateral aspect of the thigh To ensure the vaccine is not date expired To ensure reconstituted vaccine is thoroughly mixed To ensure vaccines are not administered if they are shown to be not fit for purpose There is evidence that disinfecting the skin makes no difference to the incidence of bacterial complications of injections. Batch number and name of manufacturer is essential for tracking of any relevant problems Injection site avoids major nerves and blood vessels. Most vaccines are administered via the intramuscular route as this route is less likely to cause local reactions. Patients with bleeding disorders may have their immunisation via deep subcutaneous route. Refer to individual specific PGDs or summary of product characteristics for more details. If more than one vaccination is given, record To reduce the risk of bleeding To enable identification of vaccine 8/13

each site used, preferably in a different limb. If more than one injection is to be given in the same limb, they should be administered at least 2.5cm apart. Document clearly the site at which each injection is given. Dispose of sharps and any other clinical waste in line with Trust Policy If worn, remove and dispose of Personal Protective Equipment in line with Trust policy Decontaminate hands following procedure Discuss possible adverse effects and management of symptoms and record in health records If symptoms persist advise the patient to contact General Practitioner or Health Professional for advice Recipients of the vaccine should be observed for immediate adverse drug reactions, including observation for any signs of anaphylaxis as identified in the Trust s Procedure for Managing an Anaphylactic Emergency. Record information as per PGD instructions in patient s records/vaccination record form available on the Trust intranet site If attending a care home, ensure a record of the administration is also recorded on the Care Home s Medicines Administration Record regarding any localised reaction To reduce risk of inoculation injury and ensure safe management of healthcare waste To prevent cross infection and environmental contamination To reduce the risk of transfer of transient micro-organisms on the healthcare worker s hands To promote self care of minor adverse effects. Prolonged symptoms may need to be reported via the Yellow Card reporting system There is no evidence to support the practice of keeping patients under longer observation in the clinic or home environment To comply with Trust record keeping standards To ensure staff at the care home are aware patient has been immunised. ADDITIONAL INFORMATION WHEN IMMUNISING CHILDREN Complete scheduled immunisation list checking all details are correct:- child s full name date of birth address date of immunisation to be given and immunisations given to date vaccine scheduled is due NHS Number if available To ensure that the right children receive the correct vaccine and to ensure that consent to vaccines due is unchanged Any discrepancy in details of vaccines due detailed on scheduled immunisation list contact Child Health Genesis Team to check records 9/13

Check all of above with the patient s records and related documents Confirm child s name, date of birth, parent/guardian contact details and telephone number on each visit for immunisation. Confirm that the parents/guardian understands what immunisations are due. If any of the immunisations are questioned or declined check the immunisation history to date and check the record is correct Complete scheduled immunisation list and return to Genesis Team, Child Health If administering an unscheduled vaccine complete a CH12 Form and return to Genesis Team Child Health To identify any changes needed to update records To gain informed and valid consent To promote the benefits of gaining immunity, whilst not unduly pressuring the parents/guardian. Genesis Team record all immunisations given Record in Personal Child Health Record for under 5year olds ADDITIONAL INFORMATION WHEN IMMUNISING TRUST STAFF Record information as per PGD instructions in vaccination record form available from Occupational Health Ensure staff member has letter to give to General Practitioner To comply with Trust record keeping standards To ensure the General Practitioner is aware staff member has been vaccinated. ANAPHYLAXIS PRECAUTIONS Adrenaline (epinephrine) 1mg in 1ml ampoules must be available at each immunisation session. The expiry date of the adrenaline must be checked prior to immunising. (Refer to Trust Procedure for Managing Anaphylactic Emergency; also note adrenaline must remain in original manufacturer s packaging) PARENTS WHO DECLINE IMMUNIS AT ION If parents decline any of the immunisations due, explore the reasons why and offer further information and advice on risks and benefits of protecting against disease. Whilst, parents/guardians should not be unduly pressured, they need to be given sufficient information to make an informed decision. When two parents do not agree on vaccines to be 10/13

given, advice should be sought from the line manager, in some cases legal advice may be required. If parents decline immunisation, the immuniser should completed CH12 form to advise the Genesis Team at Child Health of any change in consent to scheduled immunisations. Record no consent to immunisation in child notes (computerized, Lloyd George notes or Trust records) and Personal Child Health Record. Offer any additional information to ensure the parent/guardian is making an informed choice, direct them to other sources of immunisation information i.e. Department of Health web site: www.immunisation.nhs.uk or alternatively refer to the Wirral University Teaching Hospital Trust Immunisation Lead at Child Health Department. Children who fail to attend should be followed up and another appointment offered. Re-call system is managed by the Genesis Team. R E P OR T ING OF VAC C INE INDUCE D ADVE R SE EFFECTS ADVICE FOR IMMUNIS E R S All suspected vaccine-induced adverse effects should be reported via the Yellow Card scheme. When submitting a Yellow Card, the vaccine brand name and batch number should be provided. Provide information on the nature, timing and severity of the suspected adverse reaction. For further guidance refer to Medicines and Healthcare Products Regulatory Agency s website: www.mhra.gov.uk Yellow Card reports can be submitted electronically Home - Yellow Card Scheme - MHRA Clinical incidents and near misses must be reported via The Trust s Incident Reporting System DEFECTIVE VACCINES AND B AT C H P R OB L E MS This may include errors in packaging, labels or leaflets or other product faults, such as particulate contamination of a vaccine. If you suspect that a vaccine is defective, do not use the product but contact Defective Medicines Report Centre (DMRC) of the MHRA via web site www.mhra.gov.uk For further information Health Professionals should refer to updated Chapter 8 of The Green Book Vaccine Safety and Adverse Events Following Immunisation for details of what information is required when submitting reports on suspected defective medicinal products Clinical incidents and near misses must be reported via The Trust s Incident Reporting System 11/13

SAFEGUARDING ADULTS AND CHILDREN In any situation where staff have concerns that the patient may be a vulnerable adult or a child in need or at risk, they need to follow the Trust s Safeguarding Policies and discuss with their line manager and document any outcomes. Advice can be sought from the Safeguarding Team. INCIDENT REPORTING Clinical incidents and near misses must be reported via The Trust s Incident Reporting System. REFERRALS Any referrals to health professionals, therapists or other specialist services must be followed up and all professional advice or guidance documented in the patient s health records. WHERE TO GET ADVICE FROM (this list is not exhaustive) Consultant Community Paediatrician (Wirral University Teaching Hospital) Line Manager Genesis Team, Child Health General Practitioner Medicines Governance Pharmacist For medicines advice contact the North West Medicines Information Centre this is an NHS funded resource for all doctors, nurses and allied health professionals 8.30-5.00pm Mon Friday 0151 794 8117 EQUALITY ASSESSMENT During the development of this procedure the Trust has considered the clinical needs of each protected characteristic (age, disability, gender, gender reassignment, pregnancy and maternity, race, religion or belief, sexual orientation). There is no evidence of exclusion of these named groups. If staff become aware of any clinical exclusions that impact on the delivery of care a Trust Incident form would need to be completed and an appropriate action plan put in place. REFERENCES Green Book Immunisation against infectious disease (2006) Department of Health. Updates are available at www.dh.gov.uk/greenbook The Vaccine Administration Taskforce (2001) UK guidance on best practice in vaccine administration. London: Shire Hall Communications 12/13

Royal College of Nursing, (2010) Restrictive physical intervention and therapeutic holding for children and young people Clinical Protocol for Clarification of Parental Responsibility Procedure for Managing an Anaphylactic Emergency Clinical Protocol for Development and Implementation of Patient Group Directions Consent Policy Managing the Quality of Health Records Policy Safe Handling and Administration of Medicines Policy Procedure for the Administration of Medication via the Intramuscular Route or the Subcutaneous Route Basic Life Support Procedures BIBLIOGRAPHY British National Formulary (BNF) always use most current version as changes every six months www.bnf.org BNF for Children www.bnfc.org Health Protection Agency (2005) National Minimum Standards for Immunisation Training Health Protection Agency website http://www.hpa.org.uk Resuscitation Council (2010) Resuscitation Guidelines http://www.resus.org.uk/pages/medimain.htm 13/13