Vaccinator Training Course Standards Version Date Comments Version 6.0 January 2015 3 yearly review Authorised by the IMAC Education Review Group Page 1 of 17 Date revised: January 2015 Contents Introduction ............................................................................................................................................ 3 Resources ................................................................................................................................................ 4 Course objective ..................................................................................................................................... 5 Vaccinator training courses (VTC) ........................................................................................................... 5 Prerequisites ........................................................................................................................................... 5 Assessment procedures .......................................................................................................................... 5 Unit timing .............................................................................................................................................. 6 Model programme .................................................................................................................................. 7 Unit 1: Vaccine preventable diseases ..................................................................................................... 8 Unit 2: Legislation, approval and authorisation...................................................................................... 9 Unit 3: The immune system .................................................................................................................. 10 Unit 4: The National Immunisation Schedule ....................................................................................... 11 Unit 5: Composition of vaccines ........................................................................................................... 12 Unit 6: Vaccine safety ........................................................................................................................... 13 Unit 7: Storage and handling of vaccines.............................................................................................. 14 Unit 8: Informed consent and immunisation conversations ................................................................ 15 Unit 9: Vaccine administration ............................................................................................................. 16 Unit 10: Improving immunisation coverage ......................................................................................... 17 Page 2 of 17 Date revised: January 2015 Introduction These standards set the minimum education requirements which underpin safe vaccination practice in New Zealand; to ensure equity and consistency of course delivery nationally. Vaccinator training courses are designed for health professionals to have the appropriate competencies to vaccinate safely within their scope of practice. The courses are in line with the: Immunisation Standards for Vaccinators and Guidelines for organisations offering immunisation service, in the appendices of the current Immunisation Handbook (Ministry of Health - MoH) Authorisation of Vaccinators and criteria for Pharmacist vaccinators administering vaccines in the appendices of the current Immunisation Handbook o Maintaining authorisation vaccinator status or approved vaccinator status is the responsibility of the individual o Approval of authorised vaccinators is the responsibility of the regional Medical Officers of Health (MOHs) and requirements are in the current Immunisation Handbook o Pharmacist Vaccinators administering specific reclassified vaccines are approved by completing the Ministry of Health process outlined in the current Immunisation Handbook o N.B Vaccinators who are not prescribers, pharmacists, or authorised vaccinators may only administer vaccines on a prescription or standing order o Maintaining scope of practice is the responsibility of the individual practitioner and their employer; issues should be addressed with the appropriate regulating body The Vaccinator Training Course covers the vaccines on the New Zealand National Immunisation Schedule and consists of: Theory (16 hours minimum). Flexible learning option with 12 hours self study and four hours tutorial is available Open book assessment of a minimum one hour duration consisting of a combination of multiple choice and short answers (80% pass rate is required) Open book assessment can be oral at the Regional Immunisation Advisor/National Manager's discretion Page 3 of 17 Date revised: January 2015 Resources websites MoH coded resources cited can be ordered from www.healthed.govt.nz Other MoH resources available from www.health.govt.nz IMAC resources cited available from www.immune.org.nz Medsafe datasheets available from www.medsafe.govt.nz CARM resources available from nzphvc.otago.ac.nz Brighton Collaboration resources available from www.brightoncollaboration.org Health and Disability Commissioner website resources available from www.hdc.org.nz Guidelines for nurses on administration of medicines available at www.nzno.org.nz © No part of these standards may be reproduced without the written permission of the copyright owner Disclaimer: The Immunisation Advisory Centre has taken all reasonable steps to ensure that information contained is reliable and accurate; it accepts no liability or responsibility for any acts of omissions, done or omitted in reliance in whole or in part, on the information. This publication is intended to support education sessions provided at Vaccinator Training Courses and should be used in conjunction with other evidence based immunisation publications. The Immunisation Advisory Centre takes no responsibility for the manner in which this information is subsequently used. Page 4 of 17 Date revised: January 2015 Course objective To provide participants with the knowledge and skills required to provide quality, safe and effective delivery of vaccines on the National Immunisation Schedule and to meet the minimum legal requirements for vaccinators. Vaccinator training courses (VTC) Vaccinator training course flexible learning – includes pre-reading, 12 hours self study, a four hour tutorial and an open book assessment Vaccinator training course two day – includes pre-reading, two study days and an open book assessment Prerequisites Current health professional practicing certificate (APC) Pre-reading of the current Immunisation Handbook o Introduction o General immunisation principles o Processes for safe immunisation o Vaccination questions and concerns o Immunisation of special groups o All appendices Assessment procedures Course assessment Assessment is by combination open book assessment lasting a minimum of one hour. Pass mark is 80%. The current Immunisation Handbook may be used to assist participants; however, not all answers will be found in this source but will have been covered during the course. Re-sits as required are possible. Open book assessment is to be completed ideally within 5 working days, contact Education Administrator if exception required Clinical Assessment On completion of the vaccinator training course it is recommended that all participants demonstrate clinical competency through a clinical assessment. A qualified assessor (nominated by the Medical Officer of Health) will undertake this and the participant is responsible for negotiating this. A copy of the completed clinical assessment is will be a requirement for the Medical Officer of Health when applying for vaccinator authorisation or for pharmacist vaccinators to complete their process. Participants are responsible for negotiating a mutually convenient time with the assessor. The assessor will complete the clinical assessment, usually in the clinical environment, for a minimum of Page 5 of 17 Date revised: January 2015 two persons separate vaccination events, as relevant to the vaccinator area of practice. For early childhood vaccinators at least one will be a child 15 months of age or younger. The assessment will be based on the Standards for Vaccinators found in the appendices of the current Immunisation Handbook (MoH). The clinical assessment form is located in “Appendix One” of the Vaccinator Training Manual. It is suggested that the participants familiarise themselves with this document prior to their clinical assessment. Unit timing Unit Topic Minimum timings 1 Vaccine preventable diseases 60 minutes 2 Legislation, approval, and authorisation 15 minutes 3 The immune system 60 minutes 4 The National Immunisation Schedule 45 minutes 5 Composition of vaccines 60 minutes 6 Vaccine safety 75 minutes 7 Storage and handling of vaccines 45 minutes 8 Informed consent and immunisation conversations 60 minutes 9 Vaccine administration 120 minutes 10 Improving immunisation coverage 60 minutes Page 6 of 17 Date revised: January 2015 Model programme Day One Unit 08:30 Introduction and housekeeping 08:45 Vaccine preventable diseases (including VPD video - 10 minutes) 10:00 Break 10:15 The immune response (including Cold War DVD) 3 11:30 National Immunisation Schedule (including MOH DVD) 4 12:30 Lunch 13:15 Composition of vaccines 5 14:15 Legislation, approval, and authorisation 2 14:30 Catch-ups 10 15:00 Break 15:15 Catch-ups continue 16:30 Questions and answers / Clinical myths DVD 16:30 Close Day Two 1 10 Unit 08.30 Review and recap/questions/activity/evaluations 08.45 Improving Immunisation coverage 10 09:30 Storage and handling of vaccines 7 10.15 Break 10:30 Vaccine safety 6 11:45 Improving immunisation coverage 10 12:30 Lunch 13:15 Vaccine administration 15:15 Break 15:15 Informed consent and immunisation conversation 16:15 Open book assessment preparation, evaluations 16:30 Close 9 8 Page 7 of 17 Date revised: January 2015 Unit 1: Vaccine preventable diseases Purpose To provide an overview of vaccine preventable diseases, associated complications, long term outcomes, and the impact of vaccines historically. Learning outcomes At the end of this session attendees will be able to: Describe briefly the global burden of disease due to vaccine preventable diseases and the impact of immunisation Outline briefly the disease process, potential complications and long-term outcome for each vaccine preventable disease on the current National Immunisation Schedule Identify the process to notify vaccine preventable diseases Identify appropriate resources about vaccine preventable diseases to provide to vaccinees or parents/caregivers Access further information about each disease when required Course content should include Global burden of disease History of vaccines and vaccination Epidemiology, modes of transmission and clinical features of each of the vaccine preventable diseases on the national immunisation schedule Introduction to the concept of coverage Notification of vaccine preventable diseases How to access recommended resources Resources Refer to resource website list at beginning of document Childhood Immunisations booklet MoH code HE1323 Immunise your children on time pamphlet MoH code HE1327 Infectious Disease MoH code HE1215 Meningococcal Diseases causes meningitis MoH code HE2417 Vaccine preventable diseases DVD if available Medical Officer of Health, or Communicable Disease specialist if available Current Immunisation Handbook (MoH) Page 8 of 17 Date revised: January 2015 Unit 2: Legislation, approval and authorisation Purpose To provide an overview of legislation, regulation and authorisation for immunisation practice. Learning outcomes At the end of this session attendees will be able to: Identify the limitations and requirements for non prescribers who are not authorised or pharmacist vaccinators Describe initial authorisation, re-authorisation as a vaccinator and the process for pharmacists administering vaccines Define the legal role and responsibilities of an authorised/approved vaccinator as covered in the Medicines Regulation 1984 Practice according to the Immunisation Standards Identify the acts and regulations which govern immunisation practice Course content should include The need to administer vaccines under prescription or standing orders if not authorised/approved Authorisation of vaccinators and criteria for pharmacist vaccinators administering vaccines as per current Immunisation Handbook (MoH) The process required at the local level to apply for authorisation, and re-authorisation The current Immunisation Standards and their relevance to immunisation best practice for vaccinators Legislation relevant to vaccinators, including: o Health (Immunisation) Regulations 1995 o Medicines Regulations 1984 o Health Act 1956 o Health and Disability Services Act 1993 o Health Practitioners Competency Assurance Act 2003 Resources Refer to resource website list at beginning of document Local process, and forms required for application as an authorised vaccinator Contact details for Medical Officer of Health, and local immunisation coordinator/facilitator Current Immunisation Handbook (MoH) Ministry of Health requirements for standing orders Page 9 of 17 Date revised: January 2015 Unit 3: The immune system Purpose To provide a review of the function of the immune system, and response to vaccines. Learning outcomes At the end of this session attendees will be able to: Describe the structure of the immune system Describe how the nonspecific responses prevent infection Describe briefly the specific immune response to a vaccine antigen and the generation of immune memory Differentiate cellular and humoral immune response Differentiate passive and active immunity Relate the infant immune response to the timing of the vaccination schedule Differentiate primary and secondary immune response Describe herd immunity and explain its role for individuals and population health List factors that affect the immune response to vaccines Course content should include Cell mediated and antibody mediated immunity, soluble mediators, antibodies and antigens The immune response to a vaccine including primary and secondary antibody responses The physiology of active immunity The physiology of passive immunity Rationale for the use of conjugated vaccines in infants The concept of herd immunity for the community Duration of immunity following disease and vaccination Access to resources discuss the immune response with parents and care givers Resources Refer to resource website list at beginning of document Current Immunisation Handbook (MoH) The Body Story, cold war DVD Page 10 of 17 Date revised: January 2015 Unit 4: The National Immunisation Schedule Purpose To provide an outline of the vaccines on the New Zealand National Immunisation Schedule and immunisation of special groups. Learning outcomes At the end of this session attendees will be able to: Outline the current National Immunisation Schedule Identify the recommended timing/spacing of National Immunisation Schedule vaccines Describe the length of immunity provided by different vaccines Describe the immunisation of special groups and high risk populations Differentiate between a standard and a catch-up when implementing the National Immunisation Schedule Course content should include The current New Zealand National Immunisation Schedule and purpose Spacing of vaccines Strategies for control of each disease and the pattern of disease Effectiveness of vaccines at different ages How to modify or adapt the schedule to encompass variations e.g. child, adolescent, or adult immigrants, parents selectively vaccinating Publicly funded and privately funded vaccines Duration of immunity Use of the current Immunisation Handbook (MoH) Resources available locally and nationally to consult about immunisation issues Resources Refer to resource website list at beginning of document New Zealand National Immunisation Schedule poster MoH code HE1221 Hepatitis B Information For Health Professionals MoH code HE1401 IMAC National Immunisation Schedule card IMAC Guidelines for Tetanus Prone Wounds current flow chart Current Immunisation Handbook (MoH) Page 11 of 17 Date revised: January 2015 Unit 5: Composition of vaccines Purpose To provide an outline of the types of vaccines on the New Zealand National Immunisation Schedule including composition and regulation for vaccine safety. Learning outcomes At the end of this session attendees will be able to: Describe the process of vaccine regulation and the role of Medsafe Outline the types and classification of vaccines on the NZ National Immunisation Schedule Describe the manufacture process of vaccines Discuss the function of vaccines components Identify current resources on vaccine ingredients Course content should include Vaccine types and classifications Vaccine manufacture; including the cell lines used, recombinant, polysaccharide, and conjugate vaccines Use of, and rationale for vaccine components Current resources on efficacy, reactogenicity, specific contraindications, presentations and dosage of vaccines Resources to assist discussions with parents/patients/caregivers Resources Refer to resource website list at beginning of document IMAC Vaccine ingredients factsheet Vaccine data sheets from the Medsafe website IMAC vaccine composition game (optional) Expired/compromised vaccine samples Current Immunisation Handbook (MoH) Page 12 of 17 Date revised: January 2015 Unit 6: Vaccine safety Purpose To provide an overview of prevention strategies, management of an adverse event following immunisation (AEFI), and reporting for global vaccine pharmacovigilance. Learning outcomes At the end of this session attendees will be able to: Minimise the risks of adverse reaction due to vaccination by assessing for true contraindications Describe common expected responses to National Immunisation Schedule vaccines Differentiate between adverse event and adverse reaction Differentiate between anaphylaxis, faint, hypotonic-hyporesponsive episode (HHE), and other hypersensitivities Identify, manage and report an AEFI Describe the emergency management of anaphylaxis Outline the equipment required for emergency response Discuss how vaccine safety can be misconstrued and appropriate responses to address this Discuss the contribution to global vaccine pharmacovigilance of reporting to the Centre for Adverse Reactions Monitoring (CARM) Course content should include 2012 WHO classification of AEFIs Essential components of a pre vaccination check to reduce the risk of an AEFI Contraindications to specific vaccines Differentiation between anaphylaxis, HHE, faint and other hypersensitivities The equipment required in managing a serious event and regular checking of this The process to manage a serious event The process for documenting and reporting AEFIs to CARM The Brighton Collaboration’s role in global vaccine pharmacovigilance The role of active and passive surveillance in vaccine safety Resources Refer to resource website list at beginning of document IMAC Vaccine safety factsheet CARM reporting form Current Immunisation Handbook (MoH) Page 13 of 17 Date revised: January 2015 Unit 7: Storage and handling of vaccines Purpose To outline the standards for the correct storage and transport of vaccines, along with provider evidence demonstrating this. Learning outcomes At the end of this session attendees will be able to: Describe the key elements of the cold chain Describe and assess the requirements for the correct storage of vaccines in any vaccination site Assess that vaccine storage/transportation meets cold chain accreditation standards at their site Discuss vaccines vulnerable to light, hot or cold thermal insult Identify an appropriate process for vaccines when cold chain breaches occur Describe the essential role of electronic loggers Outline the correct procedure for receiving and accepting a vaccine supply Outline the process for management of National Cold Chain Accreditation monitors received by a provider Outline monthly, six monthly, and annual refrigerator maintenance Course content should include Medicines Regulations 1984 ‘Vaccine Storage and Distribution National Standards 2012’(MoH) Cold chain information in the current Immunisation Handbook (MoH) Actions required when vaccines have been compromised Cold chain accreditation process and the requirements for providers of immunisations National cold chain audit and the process required when a card is received Correct process for transporting vaccines in a chilly bin Resources Refer to resource website list at beginning of document National Guidelines Vaccine Storage and Distribution 2012(MoH) Annual Cold Chain Management Guide (MoH) Practical guide and equipment for packing a chilly bin Current Immunisation Handbook (MoH) Page 14 of 17 Date revised: January 2015 Unit 8: Informed consent and immunisation conversations Purpose To outline the process for informed consent and introduce strategies to enhance immunisation conversations. Learning outcomes At the end of this session attendees will be able to: Describe the informed consent process Identify barriers to informed consent and immunisation and discuss strategies to address these Demonstrate acknowledgement of concerns about immunisation respectfully Provide adequate communication for parents/caregivers/vaccinees in regard to the benefits and risks of vaccination appropriate to their individual need Evaluate own skills to further develop communication competence Prepare for questions about common immunisation concerns by extending own knowledge Identify resources to support effective communication conversations Document the informed choice and consent process Course content should include Barriers to consent Myths and misconceptions to immunisation Legal requirements for consent Care of the Children Act 2004 Resources for facts about common immunisation concerns: vaccine safety, multiple injections, how vaccines work, vaccine misconceptions, natural immunity versus vaccine immunity, why vaccines are necessary Strategies to address immunisation issues and support immunisation decision- making respectfully and appropriately Resources Refer to resource website list at beginning of document Childhood Immunisation MoH code HE1323 After your child is vaccinated MoH code HE1504 Immunisation certificate MoH code HE7013 Health and Disability Commissioner website resources Immunisation audience research Current Immunisation Handbook (MoH) Myths and realities: responding to arguments against vaccination. A guide for providers. Australian Government Page 15 of 17 Date revised: January 2015 Unit 9: Vaccine administration Purpose To promote administration of vaccinations on the NZ National Immunisation Schedule according to best practice standards. Learning outcomes At the end of this session attendees will be able to: Describe the provision of a suitable environment for vaccination Demonstrate appropriate pre-vaccination clinical assessment List true contraindication for all vaccines and specific contraindications Demonstrate evidence based medication checking procedure Identify the correct route, site, and positioning of limbs for all vaccines for different age groups Ensure that vaccines, resources and emergency equipment are accessible and checked Correct disposal of vaccines and associated equipment Documentation Course content should include Preparation for administering vaccinations Assessment of a potential vaccinee prior to vaccination Location and rationale of injection site(s) and choice of needle gauge(s) and length(s) Factors that contribute to optimal vaccine delivery Safe and appropriate restraint and distraction techniques for children of various ages Safe and appropriate disposal of vaccines and associated equipment Post vaccination information Documentation of vaccination event Resources Refer to resource website list at beginning of document The National Immunisation Schedule card MoH code HE1308 Appropriate post-immunisation advice leaflets Immunisation certificate code HE7013 Immunisation Record MoH code HE1309 Expired/compromised vaccine samples, needles and syringes Infant doll for demonstration/practical session Current Immunisation Handbook (MoH) IMAC Best practice strategies factsheet Guidelines for nurses on administration of medicines Page 16 of 17 Date revised: January 2015 Unit 10: Improving immunisation coverage Purpose To outline a range of strategies to achieve and maintain immunisation targets to prevent vaccine preventable disease. Learning outcomes At the end of this session attendees will be able to: Obtain and utilise resources to confidently and appropriately communicate with parents and caregivers about immunisation Utilise the newborn enrolment tool to ensure on time 6 week immunisations Utilise the National Immunisation Register (NIR) and the provider’s patient management system (PMS) to assist in improving immunisation coverage within their practice Describe the importance of the national target for immunisation Discuss how to optimise opportunistic immunisation in their practice Adhere to only using true contraindications to immunisation Outline the principles for planning catch-up schedules Describe the local referral process and role of Outreach Immunisation Service (OIS) Describe quality data entry for their PMS, and subsequent transfer to NIR, to ensure accurate immunisation coverage figures Course content should include Presentation of immunisation resources and how to obtain them. Include Health and Disability Code of Rights. The National Immunisation Register (preferably by local NIR administrator) - basic rules on PMS data entry and referral processes and how to contact NIR administrator How to plan and manage catch-up schedules Resources Refer to resource website list at beginning of document Local NIR PMS troubleshooting guide if available Local NIR and Datamart coverage reports if available Current Immunisation Handbook (MoH) Page 17 of 17 Date revised: January 2015