Appendix 3: Immunisation standards for vaccinators and Guidelines for organisations offering immunisation services
The ‘Immunisation standards for vaccinators’ (see section A3.3) are quality levels all vaccinators should achieve to ensure they can competently deliver safe and effective immunisation services.
The ‘Immunisation standards for vaccinators’ and the ‘Guidelines for organisations offering immunisation services’ (see section A3.4) apply to the delivery of all National Immunisation Schedule vaccines and any other vaccines authorised by a medical officer of health or the Director-General of Health.
All vaccinators and immunisation providers offering privately purchased vaccines must also adhere to the ‘Immunisation standards’ and ‘Guidelines for organisations offering immunisation services’.
The Schedule aims to protect children and adults against 13 serious vaccine-preventable diseases and offers publicly funded immunisation to individuals at risk of hepatitis A, inﬂuenza, varicella, tuberculosis, meningococcal and/or pneumococcal disease.
Note: the term ‘vaccinator’ used throughout these standards applies to both registered nurse vaccinators and pharmacist vaccinators.
A3.2 HDC Code of Health and Disability Services Consumers’ Rights Regulation 1996Top
It is expected that all organisations and providers offering immunisation services practise in accordance with the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996. The Regulations establish the rights of consumers, and the obligations and duties of providers to comply with the Code of Rights made pursuant to the Health and Disability Commissioner Act 1994.
The obligation under the Regulations is to take ‘reasonable actions in the circumstances to give effect to the rights, and comply with the duties’ in the Code of Rights. The Code of Rights is as follows.
Right 1: Right to be treated with respect Right 2: Right to freedom from discrimination, coercion, harassment and exploitation Right 3: Right to dignity and independence Right 4: Right to services of an appropriate standard Right 5: Right to effective communication Right 6: Right to be fully informed Right 7: Right to make an informed choice and give informed consent Right 8: Right to support Right 9: Rights in respect of teaching or research Right 10: Right to complain
For more detailed information on the Code of Health and Disability Services Consumers’ Rights, refer to the Health and Disability Commissioner’s website (www.hdc.org.nz).
Standard 1: The vaccinator is competent in all aspects of the immunisation technique and has the appropriate knowledge and skills for the task
Required characteristics of the vaccinator
1.1 The vaccinator completes an appropriate training programme approved by the Ministry of Health. If a vaccinator is working as an authorised vaccinator they should have a current authorisation certiﬁcate from a medical ofﬁcer of health or the Director-General of Health.
1.2 An approved pharmacist vaccinator completes a vaccinator training programme approved by the Ministry of Health and a clinical assessment, and vaccinates in accordance with the specific vaccine’s gazetted medicines classification.1
1.3 The authorised vaccinator provides a summary of their immunisation practice over the preceding 12 months. Pharmacist vaccinators need to maintain a summary2 of their immunisation practice over the preceding 12 months.
1.4 The vaccinator remains current with developments in immunisation theory, practice and policy. Every two years the vaccinator undertakes specific Ministry of Health-approved education updates (minimum of four hours), either by attending an education course or by completing an online course.
1.5 The vaccinator understands the importance of effective vaccine cold chain management and contributes to the practice/clinic achieving and maintaining Cold Chain Accreditation (CCA).3
1.6 The vaccinator ensures all the vaccines they administer have been stored at the recommended temperature range of +2oC to +8oC at all times.
1.7 The vaccinator is able to respond to and manage vaccine reactions, including anaphylaxis, and can perform resuscitation if necessary. The vaccinator is familiar with the adverse events reporting process to the Centre for Adverse Reactions Monitoring (CARM), and is aware of the process to submit an adverse event report.
1.8 The vaccinator is able to deal with spillages (blood or vaccine), and the safe disposal of needles, syringes and vaccines.4
1.9 The vaccinator effectively communicates immunisation information to families and individuals in a culturally competent way and provides evidence-based balanced information to enable informed decision-making.
1.10 The vaccinator has had specific National Immunisation Register (NIR) education and training to enable them to check a child’s immunisation records (or request this information if they do not have access to the NIR), administer the correct vaccines and provide follow-up services.
1.11 The vaccinator has had training in the correct use of their practice management system or school-based immunisation system or the NIR manual forms to enable them to correctly enter an individual’s information on the NIR (if applicable).
1.12 The vaccinator maintains linkages with other providers associated with immunisation delivery; for example, immunisation coordinators, outreach immunisation providers and their local DHB NIR team.
Standard 2: The vaccinator obtains informed consent to immunise
Required characteristics of the vaccinator
2.1 Evidence-based information about the disease and vaccines must be given to individuals/parents/guardians to enable them to make an informed choice and give informed consent.
2.2 The vaccinator communicates in a form, language and manner that enables the individual/parent/guardian to understand the information provided. Communication should be supported by evidence-based health education material.
2.3 The vaccinator allows time to answer questions and obtains feedback indicating that the individual/parent/guardian understands which vaccine is being recommended and why.
2.4 The vaccinator informs the individual/parent/guardian about the NIR, including information on the use and disclosure of the information held on the NIR, how the information is stored and that all vaccinations given will be recorded on the National NIR (if applicable) unless the individual/parent/guardian chooses to opt off the NIR. (Note: some school-based immunisation programmes will collect an individual’s information on the NIR; if this is the case, information about the NIR will be contained on the consent form.)
2.5 Consent does not need to be given in writing (except for school-based immunisation programmes and BCG vaccination), but the vaccinator should keep a written summary of the discussion as well as a record that verbal consent was obtained.
2.6 The vaccinator obtains consent for each immunisation episode and records that the individual/parent/guardian has been made aware of the beneﬁts and risks of the disease and the vaccine in order to make an informed choice about immunisation and the immunisation programme, including the NIR.5 (Note: for school immunisation programmes, written consent must be given when the parent/guardian will not be present at the immunisation.)
2.7 If the individual/parent/guardian chooses to opt off the collection of their or their child’s information on the NIR, the vaccinator informs them that they/their child can still be immunised but the information will not be sent to the NIR. The vaccinator also must inform the individual/parent/guardian what they need to do to opt off, what information will be retained by the NIR, why this information is retained, and that they can reconsider their decision at any time in the future.
2.8 If the individual/parent/guardian declines to be immunised/to immunise their child, the vaccinator provides information about keeping themselves and others healthy. The vaccinator should advise the individual/parent/guardian that they can reconsider their decision at any time in the future.
Standard 3: The vaccinator provides safe immunisation
Required characteristics of the vaccinator and immunisation setting
3.1 The venue provides for privacy and is appropriate for the individual/parent/guardian. Facilities are available for assessment and management of adverse events, including anaphylaxis.6
3.2 If the venue is a non-clinical setting (eg, in a home, workplace or school) then a minimum of two immunisation team members should be present for vaccination; at least one must be an authorised vaccinator and both must be trained in basic emergency techniques, including resuscitation and anaphylaxis.
3.3 The vaccinator holds a current CPR certificate7 consistent with their practice, education and assessed competence as a vaccinator.
3.4 The vaccinator can treat adverse events following immunisation (AEFIs), including anaphylaxis, and has a contingency plan for seeking emergency assistance.
3.5 Because of the potential for anaphylactic reactions, vaccinees (with their parents/guardians if applicable) are required to remain under observation for a minimum of 20 minutes after immunisation.
3.6 The vaccinator ensures continuity of the cold chain and follows the practice/clinic cold chain management policy. The vaccinator ensures the practice/clinic achieves Cold Chain Accreditation.8
3.7 Before vaccinating, the vaccinator:
determines the current health of the vaccinee and the possible immunosuppression status of contacts9
ascertains the date of the last immunisation to ensure doses are spaced correctly (if applicable)
enquires about any reactions following previous vaccine doses
3.8 The vaccinator uses clean techniques in the preparation and administration of all vaccines,11 visually checks the vaccine, checks expiry date, reconstitutes vaccines with the diluent supplied (as appropriate) and uses vaccines within the recommended period after reconstitution.
3.9 The vaccinator provides verbal and written information that is evidence based and follows best practice principles about care after immunisation, including management of expected vaccine responses and accessing advice and medical attention, if required, during ofﬁce and after ofﬁce hours.12
3.10 The vaccinator is recommended to carry indemnity insurance for their personal/professional protection.
Standard 4: The vaccinator documents information on the vaccine(s) administered, and maintains patient conﬁdentiality
Required characteristics of the vaccinator
4.1 The vaccinator documents the individual’s personal details, including: National Health Index number (NHI), name, date of birth, ethnicity, address, contact telephone number, next of kin details and general practitioner (if the vaccinator is not the usual primary care provider).
4.2 Having chosen the appropriate immunisation schedule, the vaccinator documents the following details:
date vaccine administered
vaccine type and number in the series
batch number and expiry date
injection site (eg, ‘right deltoid’ not ‘upper arm’)
that the patient was observed for 20 minutes post-vaccination
if the vaccine was given by a non-standard route (the reasons must be well documented)
the immunisation event in the child’s Well Child Tamariki Ora My HealthBook (if applicable)
the date for the next immunisation in the child’s Well Child Tamariki Ora My HealthBook (if applicable)
advice and resources given.
4.3 The vaccinator ensures the immunisation information is sent to the NIR (ie, electronically or manually) where applicable, unless the individual/parent/guardian has opted off the collection of their/their child’s immunisation information on the NIR.
4.4 The vaccinator ensures the Immunisation Certiﬁcate is accurately completed following the 15-month and 4-year immunisation events.
4.5 When an individual is registered on the NIR, all associated providers are notiﬁed that an immunisation event has occurred. If the practice/clinic is not the usual primary care provider, and if the individual/parent/guardian consents, then the individual’s general practitioner or other primary care provider is informed by the vaccinator within five working days of giving the vaccine.
4.6 The vaccinator ensures the Immunisation Beneﬁt Claim is accurately completed and submitted, including the correct NHI number (if applicable).
4.7 All clinical documentation is appropriately managed and stored to maintain conﬁdentiality, and is made available to the individual/parent/guardian on request.
Standard 5: The vaccinator administers all vaccine doses for which the vaccinee is due at each visit and only follows true contraindications
Required characteristics of the vaccinator
5.1 If informed consent is obtained, the vaccinator adheres to the National Immunisation Schedule and delivers all the immunisations recommended for that visit, unless the individual/parent/guardian does not consent to this.
5.2 When catch-up immunisation is required, this is planned with the minimum number of visits/injections and in conjunction with the individual/parent/guardian.
5.3 A dose of vaccine is deferred or avoided only when contraindicated or the individual/parent/guardian has chosen to defer/avoid it. The reason for deferral or avoidance must be well documented.13
Standard 6: The vaccinator reports adverse events following immunisation promptly, accurately and completely
Required characteristics of the vaccinator
6.1 All serious or unexpected adverse events following immunisation are reported by the vaccinator to the Medical Assessor, Centre for Adverse Reactions Monitoring (CARM),14 and to the individual’s general practitioner (if the vaccinator is another person). If the individual/parent/guardian does not consent to being identiﬁed, the report should be made without personal identiﬁcation.
6.2 The vaccinator informs the individual/parent/guardian that if an adverse event occurs, they can also report it to CARM.
6.3 When a CARM report is received, the vaccinator informs the DHB NIR Administrator (completes an NIR4 form) so that the adverse event code can be recorded on the NIR.
6.4 The vaccinator seeks specialist (eg, general practitioner, paediatrician, infectious diseases physician or medical ofﬁcer of health) opinion if uncertain about the safety of further doses and referral is made to secondary care if required.
6.5 The vaccinator ensures the adverse event, and any subsequent decisions relating to the event, are effectively communicated to the individual/parent/guardian and clearly documented in the child’s Well Child Tamariki Ora My Health Book (if applicable)and in the patient records and appropriate follow-up is carried out.
A3.4 Guidelines for organisations storing vaccines and/or offering immunisation servicesTop
These guidelines apply to all organisations who store vaccines and/or offer immunisation services, including (but not limited to) general practices, public health units, community pharmacies, travel clinics, occupational health clinics, emergency medical services, research units and hospital wards/clinics/departments/pharmacies.
The organisation that employs vaccinators to offer immunisation services has links to primary health care and to Well Child Tamariki Ora providers
Childhood immunisation is delivered, not in isolation, but as an integrated part of Well Child Tamariki Ora activities through primary health care.
If possible, at the time of immunisation, the organisation undertakes other health promotion and/or disease prevention activities as applicable, such as the Well Child National Schedule or Care Plus.
Immunisation events, childhood and adult, are well communicated to other health services linked to the individual (eg, primary health care, outreach immunisation services, pharmacies, occupational health).
The organisation achieves high immunisation coverage of its population
The organisation has an effective, secure, NHI-based system for recording and reporting immunisations and identifying individuals requiring immunisation.
Respecting the individual’s/parent’s/guardian’s rights to make an informed choice, the organisation takes all steps to ensure that an individual’s immunisation schedule commences on time and that subsequent events are administered on the due date.
The organisation has electronic linkage to the NIR for registration and immunisation event notiﬁcation, and uses the NIR to assist with follow-up. If electronic linking is not available, manual processes must be used.
The organisation has a robust reminder (pre-call) system which encourages the delivery of on-time immunisation and timely follow-up for overdue immunisation.
The organisation has an effective communication strategy to target high-needs population groups.
Attendance at the practice/organisation is used as an opportunity to remind individuals/parents/guardians of the importance of immunisation, and, if appropriate, to check and offer to bring up to date the individual’s immunisation status.
Those who do not respond to recall and who have not declined to take part are appropriately and routinely referred to the outreach immunisation service, as per local protocol.
The organisation supports vaccinators and NIR administrators
The organisation has comprehensive immunisation-related policies based on best practice, informed consent, the vaccination process and management of adverse events.
The organisation uses a pharmaceutical refrigerator to store vaccines, has a vaccine cold chain policy in place and achieves cold chain accreditation15 for all areas within the organisation storing vaccines.
The organisation provides training and support workers (eg, kaiawhina, community health workers) for vaccinators working in the community.
The organisation supports the need for vaccinators to have access to ongoing education and training on all aspects of immunisation at least every two years and when there are changes to the Schedule.
The organisation provides ongoing training and support specific to the NIR, practice management systems and/or the school-based vaccination system (if applicable).
The service is readily available, with no barriers to access
No fee is charged to the individual/guardian for the immunisations that are on the Schedule or high-risk programmes (or for completing the child’s Immunisation Certiﬁcate), except for an administration fee for the tetanus-diphtheria boosters at ages 45 and 65 years.
Non-resident children are eligible to receive funded Schedule vaccines, and providers may claim the immunisation benefit for these children. Further information on eligibility can be found on the Ministry of Health website.
Immunisations are provided at all times when the organisation or service is open.
Immunisations are provided without the need for an appointment.
The organisation is culturally appropriate (ie, all health workers are assessed as culturally competent, reflect the populations they serve and offer a range of health information resources16 in different languages).
2The summary should include type of immunisation practice as a vaccinator (eg, general practice, occupational health, pharmacy etc); types of vaccinations given (eg, intramuscular, subcutaneous, intradermal); and other responsibilities related to immunisation (eg, cold chain-designated person etc).