Criterion 2.1.7
Guidance for all providers

Governance bodies show evidence of:

understanding cultural risk and being able to implement practices mitigating risk for the population receiving the health and disability service
considering, and adopting where relevant, current national guidelines such as the Nursing Council of New Zealand’s (2011) Guidelines for Cultural Safety, the Treaty of Waitangi and Māori Health in Nursing Education and Practice and the Medical Council of New Zealand’s (2019) ‘Statement on cultural safety’.

Governance bodies apply an intersectional lens when addressing barriers to service provision.

Additional guidance

Public/private hospital

Governance bodies have an understanding of the social determinants of each region. This understanding links to strategic planning and the quality improvement cycle.
Universal proportionalism (the principle that those with the greatest need receive the greatest proportion of funding) is included in strategic planning.
Governance bodies make proactive funding decisions.

Birthing units

Governance bodies have an understanding of the social determinants of each region. This understanding links to strategic planning and the quality improvement cycle.
Universal proportionalism (the principle that those with the greatest need receive the greatest proportion of funding) is included in strategic planning.
Governance bodies make proactive funding decisions.

Hospice

Governance bodies have an understanding of the social determinants of each region. This understanding links to strategic planning and the quality improvement cycle.
Universal proportionalism (the principle that those with the greatest need receive the greatest proportion of funding) is included in strategic planning.
Governance bodies make proactive funding decisions.


Criterion 2.1.8
Guidance for all providers


Governance bodies collaborate with the community on business planning and service development.
Service providers consider demographics (for example, the ageing population) in planning.
Governance body membership includes expertise from people with lived experience.
Service providers and their governance bodies report to, and are accountable to, people receiving services. They have implemented systems to evidence this practice.
Service providers have internal advisory groups (or similar) of people who have lived experience of relevant services.
Service providers may use a variety of avenues to invite Māori members onto their Boards or, for smaller services, to provide executive leadership direction and advice. Before approaching a Māori organisation or Iwi, service providers should consider how they are going to ensure their relationship is maintained in such a way that is respectful and builds trust. Further guidance, including tools and resources, on working with Māori is provided on Te Arawhiti the Office for Māori-Crown Relations. Although this guidance refers to “the Crown”, many of the principles of engagement may be adapted to suit service provider context, such as this ‘Building Closer Partnerships with Māori” principle-based document.
Service providers should provide evidence of planning, developing, maintaining, and sustaining these partnerships.
Service providers are recommended to reach out to their local mana whenua or local Iwi and Māori communities, noting that not all Māori will identify with the local Iwi.
Relevant tools and resources include:

Te Kāhui Māngai (Directory of Iwi and Māori Organisations). Overseen by Te Puni Kokiri the Ministry of Māori Development. This directory of Iwi and Māori organisations may be searched alphabetically, by map, or by listed-region.


Māori Maps  -  Overseen by Te Potiki National Trust gathers the information for Māori Maps from public sources and marae community engagement. This resource helps to connect Māori descendants with their marae, and enable visitors to make appropriate contact with these centres of culture - in particular, linking Māori youth with their ancestral identity.
Your regional hospital will have a Māori Health unit or team. Contact them directly through your regional hospital contact (eg Quality & Risk Manager or relevant Portfolio Manager) and check whether they have any advice. They should also have advice on whether it would be appropriate or timely to connect with your regional Iwi-Māori Partnership Board.
Seek out specialist Māori advice and/or work with a Māori Te Tiriti analysis expert to provide advice on whether your organisation and it’s policies facilitate Te-Tiriti based service delivery.
Appoint a kaumātua role, this may include both providing advice and direction to the Board/CE, while also ensuring the cultural safety of Māori using or working in your service.


Developing partnerships takes time. Service providers should be able to demonstrate interim solutions to address Māori capability gaps whilst meaningful partnerships are developed.
Further guidance is provided in the first online Ngā Paerewa eLearning module , available for free on the LearnOnline platform.
Further guidance and examples of this in context will be provided in the second online Ngā Paerewa eLearning module, available in 2023.

Additional guidance

Abortion services

Where appropriate, service providers establish working relationships with youth-specific health services based in schools and the community.


Criterion 2.1.9
Guidance for all providers

Evidence shows meaningful tāngata whaikaha, Māori, whānau, and Te Tiriti partner representation.
Evidence shows representatives have time to make decisions. This evidence may include:

board member interviews
minutes
demonstration of the way the policy reflects the views of Māori representatives.

Criterion 2.1.10
Guidance for all providers

Evidence shows demonstrated expertise in Te Tiriti, health equity, and cultural safety, and that training of governance body members occurs.
There is an executive leader on the governance body who champions Māori health equity as an integral component of quality.
Useful tools include:

Ministry of Health (2014) Equity of Health Care for Māori: A framework
Medical Council of New Zealand and Te Ohu Rata O Aotearoa, the Māori Medical Practitioners Association (2019) ‘He Ara Hauora Māori: A pathway to Māori health equity’
New Zealand Medical Council (2019) ‘Statement on cultural safety’.


Criterion 2.1.11
Guidance for all providers

A clinical governance structure is in place that:

includes lived experience and Māori representation
may be multidisciplinary
looks to national guidance to support development, such as the Health Quality & Safety Commission’s (2017) Clinical Governance: Guidance for health and disability providers.

The clinical governance structure, depending on the size and setting, may be a part of the service provider’s governance body.

Section 2.2: Quality and risk
Criterion 2.2.1
Guidance for all providers

Service providers demonstrate evidence of:

discussion at executive meetings that review quality and risk indicators
checking progress on key performance indicators
presentation of dashboard data, including Māori health indicators that reflect whānau participation and Māori satisfaction with the service
feedback to health care and support workers and documented links to the governance body
people receiving services having input into the quality and risk management system
a record of outcomes and agreed actions
feedback to people receiving services about outcomes from the quality framework, including experience of care and service feedback from people.

Service providers have:

an annual plan that contains specific quality outcomes as advised by a quality agency such as the Health Quality & Safety Commission, and review it quarterly
an understanding of WorkSafe requirements for a ‘person conducting a business undertaking’
an executive presence in project lead roles with a clear link to new developments or initiatives
escalation mechanisms.

Additional guidance

Public/private hospital

Quality and business planning documents show evidence that service providers:

participate in partnership for mātauranga Māori
include the Accessibility Charter
understand the social determinants of each DHB region
understand that social determinants help inform quality improvement goals with the aim of improving health outcomes for the communities being served.


Birthing units

Quality and business planning documents show evidence that service providers:

participate in partnership for mātauranga Māori
include the Accessibility Charter
understand the social determinants of each DHB region
understand that social determinants help inform quality improvement goals with the aim of improving health outcomes for the communities being served.

Hospice

Quality and business planning documents show evidence that service providers:

participate in partnership for mātauranga Māori
include the Accessibility Charter
understand the social determinants of each DHB region
understand that social determinants help inform quality improvement goals with the aim of improving health outcomes for the communities being served.


Criterion 2.2.2
Guidance for all providers

Service providers take a risk-based approach in order to:

give people receiving services and their whānau leadership roles and influence in decision making at all levels of service provision
focus resources on ‘critical’ aspects
increase safety and legal conformity
address health and safety for people.

	See Australia New Zealand Standard on Risk Management AS/NZS ISO 31000:2009.
Service providers use quality domains (see below for a summary) in their quality framework that are:

safe, noting that cultural safety is part of the whole concept of safety for all people receiving health and disability services, ensuring engagement of Māori and Pacific peoples
timely
equitable, which includes equal access, equal experience of care, and equal outcomes of care
effective
efficient
people- and whānau-centred.

Service providers’ quality frameworks encompass:

systems thinking
leadership for improvement and positive change
quality improvement and patient safety knowledge
evidence-based improvement and innovation
teamwork and communication.

Service providers’ quality management systems include:

performance evaluation through monitoring, measurement, analysis, and evaluation
a programme of internal audit
a process for identifying and addressing corrective actions.

Service providers can refer to the Health Quality & Safety Commission quality domains, which are embedded into a framework that provides a structure to improve and enhance quality of care. This framework consists of four components:

consumer engagement and participation – enabling people and whānau as active members of the health team
clinical effectiveness – evidence-based decision making derived from research and people’s experience to focus improvement
quality improvement and patient safety – increasing the capabilities of everyone participating in the health workforce in quality and safety improvement appropriate to their role and sphere of work
engaged effective workforce – an engaged, effective workforce that works in partnership with people and actively participates in an ongoing process of self and peer review.


Additional guidance

Birthing units

Service providers have a maternity quality and safety programme.
See Ministry of Health (2011) New Zealand Maternity Standards: A set of standards to guide the planning, funding and monitoring of maternity services by the Ministry of Health and district health boards.


Criterion 2.2.3
Guidance for all providers

Service providers are involved in continuous quality improvement activity, planning, and reporting progress on actions.
Service providers can evidence:

improvement activity
informed data analysis, including quality safety markers
that quality and safety risk policies and procedures provide indicative time frames for corrective actions and reporting progress.

The executive team or clinical quality governance group assures and reports progress to the governance body.

Criterion 2.2.4
Guidance for all providers

Service providers use strategic planning to analyse strengths, challenges, opportunities, and threats (SCOT), or threats, opportunities, weaknesses, and strengths (TOWS), or similar. External risks could include national reviews and enquiries. Internal risks could include results from internal reviews, investigations, audit processes, and complaints processes.
A strategic planning technique includes input from health care and support workers and people receiving services.
Service providers undertake benchmarking against relevant health performance indicators.
Service providers include business continuity as part of their annual planning processes.
Service providers undertake an internal and external risk assessment within defined intervals, or in response to level of risk.
In considering internal and external risks, service providers seek feedback through several mechanisms, such as focus groups and surveys.
Service providers demonstrate that quality improvements are made and embedded into practice as a result of incidents, adverse events, complaints, and investigations, among other factors.

Additional guidance

Public/private hospital

Risk mitigation is a continual process that is assessed, reviewed, and updated within defined intervals.
Frequency of review is dependent on the level of risk posed to the service provider.

Birthing units

Birthing units and maternity services: see the New Zealand Maternity Clinical Indicators.

Hospice

Risk mitigation is a continual process that is assessed, reviewed, and updated within defined intervals.
Frequency of review is dependent on the level of risk posed to the service provider.


Criterion 2.2.5
Guidance for all providers

The purpose of the National Adverse Event Reporting Policy is to contribute to improved quality, safety, and experience of health and disability services through systems that:

are safe
are people- and whānau-centred
provide for early identification and review of adverse events
verify lessons are learnt
demonstrate public accountability and transparency.

The policy supports a national approach to reporting, reviewing, and learning from adverse events and near misses, and is based on the following six key principles. (For more information, see Health Quality & Safety Commission (2017) National Adverse Events Reporting Policy.)

Open communication

Affected people are offered immediate support and an appropriate apology.
Affected people are informed of process and time frames and have the ability to provide comment on the draft review and final report.
A contact person for whānau is provided and there is an agreed regular communication process regarding review progress, and progress with review recommendations once the review is complete.
People receive a copy of the final review report and are appropriately supported.

Consumer participation

People who have been involved in an adverse event will be offered the opportunity to share their story as part of the review process.
Review findings and recommendations will be shared with them.
Independent representatives who have experience using the health and disability service are involved in the review process.

Culturally appropriate review practice

Hui process is followed as appropriate.
Reports have language at a level suitable for all to understand; that is, free of health and disability related jargon.
Service providers demonstrate they use culturally appropriate practices such as restorative practice.


System changes

Service providers demonstrate reviews are focused on system learnings.
Lessons learnt are shared locally and with other providers.
Deidentified copies of adverse event reports are sent to the Health Quality & Safety Commission to support national learnings, and for sharing with others such as the Health and Disability Commissioner and Coronial Services.
Reports state how the implementation of recommendations will be measured.

Accountability

There is evidence of learning, improving safety, and reducing the possibility of adverse events recurring.
Service providers demonstrate that the outcomes of internal reviews are communicated to all parties in an accessible format and the style of feedback is suitable to the person receiving services.
Evidence shows that processes are in place to verify service providers implement and follow up recommendations; for example, providers have a recommendations action plan.
Adverse event review reports state who is the accountable person for the implementation and evaluation of the recommendations.

Reporting must be safe

Service providers identify the immediate actions taken to mitigate risk to people receiving services.
The review focuses on determining the underlying system failures, and not blaming or punishing individuals.
Service providers update and implement operating policies and procedures to reflect a ‘just and fair’ culture of adverse event reporting and management.
Service providers support health care and support workers throughout the investigation.
Service providers implement a health care and support worker support programme, which may include debriefing.
Service providers understand statutory and regulatory obligations in relation to essential notification reporting and notify the correct authority where required.


Where events involve a criminal act, substance abuse by a health care worker, a deliberate unsafe act, or deliberate harm, service providers manage them in a separate process, which may involve regulatory authorities.

Additional guidance

Fertility services

Fertility services follow the adverse event process that is outlined in the RTAC Code of Practice.

Criterion 2.2.6
Guidance for all providers

Essential notifications are those things that service providers must report.  They include, but are not limited to:

those outlined in legislation, such as Section 31 of the Health and Disability Services (Safety) Act, The Fire and Emergency New Zealand Act
those required through regulation by other agencies such as WorkSafe, Public Health for notifiable and communicable diseases, or Responsible Authorities.

Criterion 2.2.7
Guidance for all providers

Service providers undertake analysis of their health care and support workers’ competencies in the following, and will support workers with training and development in areas with any identified gaps:

te reo and tikanga Māori and ongoing learning
understanding and using Māori models of care, health, and wellbeing
having the capability to use cultural intervention practices and approaches to pae ora
collecting high-quality ethnicity data and understanding the rationale for doing so
working in partnership and participating with iwi and Māori organisations within and outside of the health sector to allow for better service integration, planning, and support for Māori and whānau.


Criterion 2.2.8
Guidance for all providers

Service providers establish policies, practices, and training that will support and require their health care and support workers to review at defined intervals their organisation’s practice through a health equity and quality lens.
This may include prioritised use of the Health Equity Assessment Tool (HEAT) or equivalent and appropriate equity tools and ethnicity data improvement tools, such as:

Signal L, Martin J, Cram F, et al (2008) The Health Equity Assessment Tool: A user's guide
Ministry of Health (2013) Primary Care Ethnicity Data Audit Toolkit
Ministry of Health (2014) Equity of Health Care for Māori: A framework.


Service providers collect the ethnicity data of people using their service and their workforce following HISO 10001:2017 Ethnicity Data Protocols. Service providers use this information to understand the differences in health and wellbeing outcomes and experience, and take targeted actions to improve services for Māori, Pacific peoples, tangata whaikaha (all disabled people), members of the rainbow community, and other groups of people traditionally underserved by the Aotearoa New Zealand health and disability system.
Service providers who engage with the primary care system may find the results of the Health Quality & Safety Commissions primary care patient experience survey a valuable resource to understand differences in experiences based on ethnicity. Answers are further reported by district hospital region, which may help service providers choosing what areas of experience to focus improvement projects on.
Hospital-level service provides may find the results of the Health Quality & Safety Commissions primary care patient experience survey a valuable resource to understand differences in experiences based on ethnicity. Answers are further reported by district hospital region, which may help service providers choosing what areas of experience to focus improvement projects on.
Service providers may find the results of the Health Quality & Safety Commissions Dashboard of Health System Quality a valuable resource to understand differences in health and wellbeing outcomes by ethnicity:. This data can inform quality improvement projects in a local area.
The Health Quality & Safety Commission publishes templates and tools to support quality improvement projects on topics they have researched. These tools and templates may be used to support your local quality improvement projects.
Further guidance and examples of this in context will be provided in the second online Ngā Paerewa eLearning module, available in 2023.

Section 2.3: Service management
Criterion 2.3.1
Guidance for all providers


Service providers’ documented rationale for providing culturally and clinically safe services and its implementation demonstrate:

the use of an acuity methodology to estimate health care and support workers’ requirements
how shortfalls in health care and support workers’ capacity and capability are managed
how health care and support workers’ numbers are adjusted to meet changes in people’s acuity
consideration of cultural safety for health care and support workers, Māori and whānau. This could include: cultural independent or group supervision; and working towards best practice tikanga guidelines
a link to the quality and risk management framework that meets the required needs for safe and appropriate levels of service
that rostered workforce levels meet contract requirements for those service providers holding a contract for service.

Service providers consider the impact of environmental factors such as the building footprint on health care and support workers.
In considering suitability of workforce levels, service providers compare the hours that employed health care and support workers work over and above their contracted hours. Where health care and support workers are exceeding predetermined safe hours, providers implement actions to mitigate potential risk to people receiving services.
Service providers consider mental health and addiction peer support for health care and support workers.
In determining a safe and effective workforce, service providers have health and safety policies in place that cover:

overtime
workforce levels appropriate to prevent assaults on health care and support workers and other incidents
health care and support worker retention.

Workforce engagement surveys may be implemented to receive feedback on levels and skill mix.

Additional guidance

Aged care

Service providers communicate with people receiving services when they are planning changes to staffing levels.

Home and community


Home and community

When support workers do not come to work, service providers inform the people affected of the change of support workers, wherever possible.
Service providers’ documented rationale includes:

the required qualifications and experience for different types of support
skill mix (for example, specifying number of registered nurses, enrolled nurses, health care and support workers at level 3 and level 4, and peer support workers)
adherence to pay equity legislation.


Residential disability

Service providers communicate with people receiving services when they are planning changes to staffing levels.
When support workers do not come to work, service providers inform the people affected of the change of support workers, wherever possible.

Residential mental health and alcohol and other drug

Service providers communicate with people receiving services when they are planning changes to staffing levels.
When support workers do not come to work, service providers inform the people affected of the change of support workers, wherever possible.
Service providers’ documented rationale includes:

the required qualifications and experience for different types of support
skill mix (for example, specifying number of registered nurses, enrolled nurses, health care and support workers at level 3 and level 4, and peer support workers)
adherence to pay equity legislation.

Public/private hospital

Service providers use the Midwifery Employee Representation and Advisory Service (MERAS) Safe Staffing Standards (PDF, 239 KB).
Service providers’ documented rationale includes:

the required qualifications and experience for different types of support
skill mix (for example, specifying number of registered nurses, enrolled nurses, health care and support workers at level 3 and level 4, and peer support workers)
adherence to pay equity legislation.


Birthing units

Service providers use the Midwifery Employee Representation and Advisory Service (MERAS) Safe Staffing Standards (PDF, 239 KB).

Criterion 2.3.2
Guidance for all providers

Service providers embed their organisational values and mission into the culture of the service they deliver.
Position descriptions reflect expected positive behaviours and values.
Descriptions of roles cover responsibilities and additional functions, such as holding a restraint portfolio or infection prevention portfolio.
Recruitment practices meet current best practice, including through actively recruiting and retaining Māori health care and support workers.
Service providers proactively support workers to work within their scope of practice and speciality practice.
Service providers support access to mandatory and other relevant training.
Service providers are aware of requirements in relevant legislation such as the Children’s Act 2014.
Those service providers holding contracts for services meet their contractual requirements.
Service providers support Māori health care and support workers with targeted cultural and professional development opportunities.
Service providers meet the training and qualification requirements in the Support Workers (Pay Equity) Settlements Act 2017.
Service providers who are providing dementia and aged residential specialised hospital services meet their contractual requirements.

Additional guidance

Home and community

Service providers consider suitability, such as how well someone’s personality or attitude coheres with people receiving services, as an integral factor in determining their service’s workforce.

Residential disability

Service providers consider suitability, such as how well someone’s personality or attitude coheres with people receiving services, as an integral factor in determining their service’s workforce.

Residential mental health and alcohol and other drug

Service providers verify Addiction Practitioners Association Aotearoa New Zealand qualifications where relevant.
Service providers consider suitability, such as how well someone’s personality or attitude coheres with people receiving services, as an integral factor in determining their service’s workforce.


Criterion 2.3.3
Guidance for all providers

Service providers consider:

the type of services they are providing and the acuity of people receiving services
contracts they hold and their specific requirements
developing a plan to enhance competencies that may be required when they extend their services. This plan should be linked to current business planning that would include the type of service, equipment required, the workforce, and people receiving services
surveying the workforce and community to determine new requirements
the cultural make-up of health care and support workers and people. This includes actively recruiting and retaining a Māori workforce.

Competency records for all health care and support workers are available. The frequency of competency checks will depend on the associated risk.
Service providers have a mechanism to determine the percentage of health care and support workers who have completed or maintained the required competency.
Service providers require health care and support workers to complete cultural competency training.
Service providers consider the cultural make-up of their workforce, which includes considering:

the percentage of Māori health care and support workers
people’s right to speak their own language
tikanga
connections to iwi, hapū, and whānau.

Additional guidance

Public/private hospital

Service providers incorporate cultural competence into continuing education. Part of this education involves developing an awareness of Māori health models and how they apply to Māori reproductive health. This includes the four domains of Te Whare Tapa Whā:

hauora hinengaro
hauora tinana
hauora wairua
hauora whānau.


Birthing units

Service providers incorporate cultural competence into continuing education. Part of this education involves developing an awareness of Māori health models and how they apply to Māori reproductive health. This includes the four domains of Te Whare Tapa Whā:

hauora hinengaro
hauora tinana
hauora wairua
hauora whānau.

Abortion services

Service providers incorporate cultural competence into continuing education. Part of this education involves developing an awareness of Māori health models and how they apply to Māori reproductive health. This includes the four domains of Te Whare Tapa Whā:

hauora hinengaro
hauora tinana
hauora wairua
hauora whānau.


Criterion 2.3.4
Guidance for all providers

Service providers establish a continuing education programme for the workforce.
Service providers have implemented policies and procedures that address the need for workers to be released from work for education and learning.
Service providers support Māori health care and support workers to meet cultural and professional development needs.
Māori health care and support workers are able to learn and work in a culturally safe work environment.
Māori health care and support workers have ready access to cultural advisors, mentors, kaumātua, kuia, tohunga, and matakite to support their own cultural and professional development.
Service providers follow professional cultural safety guidelines and training; for example, Nursing Council of New Zealand‘s (2011) Guidelines for Cultural Safety, the Treaty of Waitangi and Māori Health in Nursing Education and Practice, Midwifery Council of New Zealand’s (2011) ‘Statement on Cultural Competence for Midwives (PDF, 345 KB)’, and Medical Council of New Zealand’s (2019) ‘Statement on cultural safety’.
All health care and support workers attend mandatory training.
Service providers seek to embed cultural values in their mandatory training programmes.
Credentialling is in place for relevant professionals. See Ministry of Health (2010) The Credentialling Framework for New Zealand Health Professionals.
Service providers’ training plans include rights-based framework training and responsiveness training.
Service providers maintain a training register.

Additional guidance

Home and community


Additional guidance

Home and community

Service providers demonstrate a culture of ongoing professional development for health care and support workers.
Training is underpinned by the principles of Enabling Good Lives, is mana enhancing, and focuses on ‘what we are trying to achieve for people’.
Training includes:

community inclusion
strengths-based training
supported decision-making
substitute decision-making
principles of Enabling Good Lives
positive behaviour support
speaking up for the safety of the person receiving services and their whānau
cultural training
rainbow (LGBTI+) training
rights-based and responsiveness training
stigma and discrimination training
consumer rights training
Health and Disability Services Consumers’ Code of Rights training.

Training is open to whānau, as appropriate.
Evidence demonstrates service providers work with organisations that represent the views of people who use the service in developing a learning and development plan.
Training materials are in accessible formats.

Residential disability

Service providers demonstrate a culture of ongoing professional development for health care and support workers.
Training is underpinned by the principles of Enabling Good Lives, is mana enhancing, and focuses on ‘what we are trying to achieve for people’.
Training includes:

community inclusion
strengths-based training
supported decision-making
substitute decision-making
principles of Enabling Good Lives
positive behaviour support
speaking up for the safety of the person receiving services and their whānau
cultural training
rainbow (LGBTI+) training
rights-based and responsiveness training
stigma and discrimination training
consumer rights training
Health and Disability Services Consumers’ Code of Rights training.

Training is open to whānau, as appropriate.
Evidence demonstrates service providers work with organisations that represent the views of people who use the service in developing a learning and development plan.
Training materials are in accessible formats.

Residential mental health and alcohol and other drug


Residential mental health and alcohol and other drug

Service providers demonstrate a culture of ongoing professional development for health care and support workers.
Training is underpinned by the principles of Enabling Good Lives, is mana enhancing, and focuses on ‘what we are trying to achieve for people’.
Training includes:

community inclusion
strengths-based training
supported decision-making
substitute decision-making
principles of Enabling Good Lives
positive behaviour support
speaking up for the safety of the person receiving services and their whānau
cultural training
rainbow (LGBTI+) training
rights-based and responsiveness training
stigma and discrimination training
consumer rights training
Health and Disability Services Consumers’ Code of Rights training.

Training is open to whānau, as appropriate.
Evidence demonstrates service providers work with organisations that represent the views of people who use the service in developing a learning and development plan.
Training materials are in accessible formats.


Criterion 2.3.5
Guidance for all providers

Service providers provide education or training for health care or support workers whose colleagues may be people with lived experience working in the service.
Service providers provide supervision, debriefing, and peer support.
Health care and support workers receive training about involving people with lived experience in service delivery.

Criterion 2.3.6
Guidance for all providers

Service providers:

encourage health care and support workers (at individual and team levels) to participate in learning opportunities that provide them with the most recent literature on Māori health outcomes and disparities, health equity, and quality, and enable them to use this evidence and learn with their peers. For examples, see the website of the Māori Health Review
support the development of expertise in te reo Māori for all health care and support workers
support health care and support workers to build their own knowledge of how they can effectively provide health information for Māori.

	See Ministry of Health (2015) A Framework for Health Literacy.
Service providers give health care and support workers the opportunity to reflect on their own cultural assumptions about Māori, and how these might influence their capacity to provide high-quality care.

Criterion 2.3.7
Guidance for all providers

Service providers consider:

assigning professional development support for clinical guidelines and decision-making tools that are focused on achieving health equity for Māori
establishing opportunities to share knowledge within the organisation about initiatives that work toward achieving health equity for Māori.

Service providers provide or make equity training available to health care and support workers. This training should include how to:

see and identify inequities
manage inequities for Māori and other groups of people receiving services
identify differences between inequality and inequity
identify policies or service designs that increase inequities for vulnerable populations, including Māori and Pacific peoples.


Criterion 2.3.8
Guidance for all providers

Training, support, performance and competence of health care and support workers are related to legal obligations for a healthy work environment.
Service providers provide safe systems of work for health care and support workers (section 36, Health and Safety at Work Act 2015).

Criterion 2.3.9–2.3.14

Residential mental health and alcohol and other drug: Guidance

Criterion 2.3.9

Service providers could appoint a person receiving services to a position of ‘person with lived experience’ or ‘consumer advisor’ or similar.
People with lived experience of the service state that they are involved in important decisions about service delivery.

Criterion 2.3.10

Service providers recognise people with lived experience of the service and organisations or groups that represent the views of people receiving the service as a valued voice and act on their opinions where appropriate.
Position descriptions are clear and provide an appropriate level of responsibility and accountability to people with lived experience.
Service providers adequately resource planning, implementation, and evaluation of service activities to involve people with lived experience.

Criterion 2.3.11

Policies and procedures may include:

employing people with lived experience of the service, where practicable
services helping with education, training, and support for people with lived experience to maximise their participation in the service
training for service providers in working with people as advisors.

Advisors liaise with organisations, networks, or groups that represent the views of people receiving services.

Criterion 2.3.12

Service providers could appoint a whānau member to a position of ‘whānau advisor’ or similar.
Whānau state that they are involved in important decisions about service delivery.

Criterion 2.3.13


Criterion 2.3.13

Service providers seek advice from whānau advisory groups when developing terms of reference.
Roles and responsibilities are clearly outlined and include accountabilities, confidentiality, and conflicts of interest.

Criterion 2.3.14

Policies and procedures may include:

employing whānau where practicable
the service helping with education, training and support for whānau to maximise their participation in the service
training for service providers in working with whānau as advisors.

Advisors liaise with whānau groups or networks.

Te Whatu Ora mental health and addiction: Guidance

Criterion 2.3.9

Service providers could appoint a person receiving services to a position of ‘person with lived experience’ or ‘consumer advisor’ or similar.
People with lived experience of the service state that they are involved in important decisions about service delivery.

Criterion 2.3.10

Service providers recognise people with lived experience of the service and organisations or groups that represent the views of people receiving the service as a valued voice and act on their opinions where appropriate.
Position descriptions are clear and provide an appropriate level of responsibility and accountability to people with lived experience.
Service providers adequately resource planning, implementation, and evaluation of service activities to involve people with lived experience.

Criterion 2.3.11

Policies and procedures may include:

employing people with lived experience of the service, where practicable
services helping with education, training, and support for people with lived experience to maximise their participation in the service
training for service providers in working with people as advisors.

Advisors liaise with organisations, networks, or groups that represent the views of people receiving services.

Criterion 2.3.12


Criterion 2.3.12

Service providers could appoint a whānau member to a position of ‘whānau advisor’ or similar.
Whānau state that they are involved in important decisions about service delivery.

Criterion 2.3.13

Service providers seek advice from whānau advisory groups when developing terms of reference.
Roles and responsibilities are clearly outlined and include accountabilities, confidentiality, and conflicts of interest.

Criterion 2.3.14

Policies and procedures may include:

employing whānau where practicable
the service helping with education, training and support for whānau to maximise their participation in the service
training for service providers in working with whānau as advisors.

Advisors liaise with whānau groups or networks.


Section 2.4: Health care and support workers
Criterion 2.4.1
Guidance for all providers

Service providers have a documented and implemented recruitment procedure that includes interviewing, reference checking, worker safety checking, criminal record-checking, and providing an employment agreement that complies with relevant legislation. Relevant legislation may include the Children’s Act 2014.
Interview panels include Māori representation (across all roles; in particular, clinical midwifery, nursing, allied health, leadership, and medical).
See Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development‘, endorsed by National DHB Chief Executives and the Health Workforce Information Programme’s District Employed Workforce Quarterly Reports for Māori workforce data.
Service providers undertake criminal record-checking as part of their recruitment processes.
Service providers have transparent recruitment processes and practices that they disclose with applicants, where possible.
Where they use volunteers and bureau staff, service providers have an implemented policy around their recruitment, induction, and ongoing training.
Service providers have a policy of inclusion that promotes and supports equal opportunity with inclusive language, recruitment channels, and documentation.
Service providers’ employment procedures:

meet the vision and mission statement of the organisation
strive to reflect the communities they serve.


Additional guidance

Aged care

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.


Home and community

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.

People receiving services have a choice of the support workers who work in their home.
Service providers demonstrate that Māori health care and support workers are able to work in a manner that is safe for them.
A person with a disability from the service is an integral part of the recruitment process. Ideally the person is involved in recruiting their own support health care and support workers. These people are adequately trained and compensated for their skill and contribution to the recruitment process.
Where service providers are having difficulty recruiting health care and support workers, they have mitigation strategies in place to safeguard people receiving services.
Service providers inform people receiving services whether the criminal record-checking process is complete for new support workers involved in their care.

Residential disability


Residential disability

People receiving services have a choice of the support workers who work in their home.
Service providers demonstrate that Māori health care and support workers are able to work in a manner that is safe for them.
A person with a disability from the service is an integral part of the recruitment process. Ideally the person is involved in recruiting their own support health care and support workers. These people are adequately trained and compensated for their skill and contribution to the recruitment process.
Where service providers are having difficulty recruiting health care and support workers, they have mitigation strategies in place to safeguard people receiving services.

Residential mental health and alcohol and other drug

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.


Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.

People receiving services have a choice of the support workers who work in their home.
Service providers demonstrate that Māori health care and support workers are able to work in a manner that is safe for them.
A person with a disability from the service is an integral part of the recruitment process. Ideally the person is involved in recruiting their own support health care and support workers. These people are adequately trained and compensated for their skill and contribution to the recruitment process.
Where service providers are having difficulty recruiting health care and support workers, they have mitigation strategies in place to safeguard people receiving services.

Public/private hospital

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.

Service providers use the MERAS Safe Staffing Standards (PDF, 239 KB).

Birthing units


Birthing units

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.

Service providers use the MERAS Safe Staffing Standards (PDF, 239 KB).

Hospice

Service providers’ policies may include:

how they support the implementation of Te Tumu Whakarae (2019) ‘Te Mahi a Te Tumu Whakarae – Position statement on Māori workforce development’ and associated targets
Te Kuwatawata
exit interviews – either with a manager or with someone else nominated by the person or human resources
strategies that support recruitment of a workforce that reflects the communities they serve
volunteers
unregulated health care and support workers
alignment with the Employment Relations Act 2000
values-based recruitment
progression pathways determined for peer support roles.

Service providers demonstrate a commitment to:

succession planning
leadership and workforce development.


Criterion 2.4.2
Guidance for all providers

Evidence shows that service providers have:

an identified clinical lead who is responsible for clinical oversight and outcomes for the people receiving services
a clear and documented escalation pathway for health care and support workers in situations where no registered nurse is on duty
position description statements with equity statements about recruiting Māori health care and support workers and those who have competency in te reo Māori.

Service providers recognise cultural skills to support different models of care.
Service providers may adopt a skills framework.

Additional guidance

Fertility services

Service providers mitigate the risk of inexperience by using RTAC (key personnel) for sector guidance.

Criterion 2.4.3
Guidance for all providers

Service providers validate professional qualifications as part of the employment process and annually after employing each health care and support worker.

Additional guidance

Birthing units

National access agreement requires validation of the applicant or holder’s annual practising certificate and indemnity insurance (under section 88 of the New Zealand Public Health and Disability Act 2000).


Criterion 2.4.4
Guidance for all providers

Service providers demonstrate that their orientation and induction programmes incorporate te reo Māori, and actively promote it throughout the organisation and workforce.
Service providers demonstrate that the orientation and induction programmes cover their health care and support workers to provide a culturally safe environment to Māori.
Where they use volunteers, service providers have an implemented policy on their recruitment, induction, and ongoing training.
Where they use bureau staff, service providers have an implemented policy around the use of these staff and the competency requirements that bureau staff must meet before working for the service provider.

Additional guidance

Aged care

Service providers embed the principles of Enabling Good Lives in their orientation and induction processes.

Home and community

Service providers embed the principles of Enabling Good Lives in their orientation and induction processes.

Residential disability

Service providers embed the principles of Enabling Good Lives in their orientation and induction processes.

Residential mental health and alcohol and other drug

Service providers embed the principles of Enabling Good Lives in their orientation and induction processes.

Public/private hospital

Service providers embed the principles of Enabling Good Lives in their orientation and induction processes.

Criterion 2.4.5
Guidance for all providers

Service providers have a performance management policy.
File notes on health care and support workers may include:

health care and support worker interview
feedback from the person receiving services and their whānau
feedback from cultural supervisors, mentors, cultural advisors, and cultural expert
recommendations arising from events, such as letters of apology, training, or competency review.

Appropriately trained people complete performance reviews.
In the case of performance management, health care and support workers may have access to independent support.
Service providers undertake performance/goal-setting reviews at defined intervals.
Service providers use performance reviews to identify and support opportunities for professional development.
Professional development opportunities may include:

cultural pathways
organisational culture and expectations.


Criterion 2.4.6
Guidance for all providers

Service providers consider reporting workforce information at defined intervals by ethnicity. They organise data by roles, gender, and age range for meaningful analysis and interpretation.
Service providers consider reviewing ethnicity data of health care and support workers for quality, including completeness, annually. Service providers use ethnicity data improvement tools to improve quality – for example, the Ministry of Health’s (2013) Primary Care Ethnicity Data Audit Toolkit. If ethnicity data is not recorded for existing health care and support workers,  service providers need to collect it.
Service providers ensure the right people within their organisation have completed the freely available Online Ethnicity Data Training Course on Learn Online (note, you are required to create a login to access the course. It is free to do so.

Additional guidance

Public/private hospital

Service providers develop a mechanism to extract multiple ethnicity fields from data.
Service providers follow prescribed reporting processes.
Service providers refer to HISO 10001 2017: Ethnicity Data Protocols.
A workforce ethnicity audit is part of the internal audit programme.
Service providers meet whole-of-government standards for collecting disability data. See State Services Commission (2020) ‘Standards of workforce information for agencies in the state services (PDF, 280 KB)’ and Stats NZ (2017) ‘Improving New Zealand disability data’.

Birthing units

Service providers develop a mechanism to extract multiple ethnicity fields from data.
Service providers follow prescribed reporting processes.
Service providers refer to HISO 10001 2017: Ethnicity Data Protocols.
A workforce ethnicity audit is part of the internal audit programme.
Service providers meet whole-of-government standards for collecting disability data. See State Services Commission (2020) ‘Standards of workforce information for agencies in the state services (PDF, 280 KB)’ and Stats NZ (2017) ‘Improving New Zealand disability data’.


Hospice

Service providers develop a mechanism to extract multiple ethnicity fields from data.
Service providers follow prescribed reporting processes.
Service providers refer to HISO 10001 2017: Ethnicity Data Protocols.
A workforce ethnicity audit is part of the internal audit programme.
Service providers meet whole-of-government standards for collecting disability data. See State Services Commission (2020) ‘Standards of workforce information for agencies in the state services (PDF, 280 KB)’ and Stats NZ (2017) ‘Improving New Zealand disability data’.


Criterion 2.4.7
Guidance for all providers

Service providers have implemented policies related to a debriefing process following incidents.
If incidents occur, health care and support workers are actively supported and have access to independent support such as an employee assistance programme.
People are encouraged to make full use of available health and legal support.

Additional guidance

Aged care

Service providers access available resources to support the process of debrief and discussion, such as the New Zealand Nurses Organisation (2014) ‘Incident debriefing’ fact-sheet (PDF, 196 KB).

Residential mental health and alcohol and other drug

Health care and support workers have access to supervision.


Section 2.5: Information
Criterion 2.5.1
Guidance for all providers

Service providers meet whole-of-government standards for collecting disability data.
Service providers refer to: Office for Disability Issues (nd) Guidance on administrative data
Records are uniquely identifiable, legible, timely, signed, and dated, and include the name and designation of the service provider, following professional guidelines and sector standards.
Service providers write notes in partnership with the person, as much as possible.
Service providers only hold information about people that is relevant for safe support.
Sometimes the use of a person’s previous name can be psychologically harmful. Service providers record people’s preferred names and pronouns on documents related to the services they receive. Records of previous names people were known by are kept private. See Stats NZ standards and policies: Sex – Classification and Statistical Standard, Gender Identity – Classification and Statistical Standard, Data Protection and Use Policy.
People receiving services are able to request and review their records in accordance with privacy laws, and service providers give them their records in a format accessible to the person concerned.
Service providers have consent processes in place for data collection.
Service providers collect, record, and use ethnicity data in accordance with HISO 10001 2017: Ethnicity Data Protocols.
Service providers include an ethnicity audit as part of the internal audit programme, using a tool such as the ethnicity data auditing tool (EDAT).
Service providers explore person-centred methods of managing health records, such as:

personal health records as a web-based set of tools that allows people to access and coordinate their lifelong health information and make appropriate parts of it available to those who need it
an integrated and comprehensive view of health information, including information people communicate themselves, such as symptoms and medication use, information from doctors, such as diagnosis and test results, and pharmacy data.


Additional guidance

Fertility services

Service providers maintain appropriate levels of documentation and management of health records, according to relevant legislation and standards, including the New Zealand Standard on Health Records NZS 8153:2002. For information about the requirements of the New Zealand Connected Health Information Services, see Connected Health Information Services. Permanent records are kept of:

clinical and laboratory results of investigations undertaken
the outcome of every attempted fertilisation
every insemination
every embryo transfer
the fate of every embryo
conceptions arising from treatment involving in vitro sperm, eggs, or embryos.

Service providers collect information required by the HART Act on the donors of children conceived using donated gametes or embryos, including:

physical characteristics – name; gender; date, place and country of birth; height; eye and hair colour
ethnicity and any relevant cultural affiliation
for a Māori donor, whānau, hapū, and iwi, to the extent the donor is aware of these
family medical history
social history.


Residential mental health and alcohol and other drug

Service providers will write notes in collaboration with the person receiving services, unless there are good reasons not to.

Public/private hospital

Service providers will write notes in collaboration with the person receiving services, unless there are good reasons not to.

Birthing units

Service providers will write notes in collaboration with the person receiving services, unless there are good reasons not to.

Hospice

Service providers will write notes in collaboration with the person receiving services, unless there are good reasons not to.


Criterion 2.5.2
Guidance for all providers

The information management system complies with the:

New Zealand Public Health and Disability Act 2000
Health Act 1956
Health Information Privacy Code 1994
Privacy Act 2020
Official Information Act 1982
Cancer Registry Act 1993 and Cancer Registry Regulations 1994
Public Records Act 2005
Health (Retention of Health Information) Regulations 1996.


An overarching policy and related procedures govern a service provider’s information management system.
Service providers keep private information in a secure manner, ensuring it is unable to be publicly accessed or observed.
Service providers implement guidance relating to managing electronic information including social media, use of images, and emails. For one resource, see the Nursing Council of New Zealand’s (2019) Guideline: Social Media and the Nursing Profession: A guide to maintain professionalism online for nurses and nursing students (PDF, 490 KB).
Service providers follow the required procedures for the minimum duration of storage of people’s records, as regulated under the Health Information Functional Disposal Authorities (FDA) (Department of Inland Affairs – National Archives).
Service providers maintain high-quality, complete ethnicity data consistent with HISO 10001 2017: Ethnicity Data Protocols.
Service providers use ethnicity data audit tools such as the Ministry of Health’s (2013) Primary Care Ethnicity Data Audit Toolkit.
Service providers capture data on gender that goes beyond male and female options to include gender diverse people, with at least either a wide variety of culturally appropriate gender options or a write-in field for a gender that is not listed. See Stats NZ (2020) ‘Sex and gender identity statistical standards: Consultation’.
Service providers use optional data fields to recognise the identities of people from rainbow communities to support equitable and high-quality health and support outcomes for people from these communities.
Service providers use data fields to recognise iwi affiliation whakapapa.

Additional guidance

Fertility services


Additional guidance

Fertility services

The minimum duration of storage of people’s records is regulated under the Health Information Functional Disposal Authorities (FDA) (Department of Internal Affairs – National Archives). That minimum duration is:

10 years from the date of treatment not leading to the birth of a child
26 years from the date of treatment leading to the birth of a child (allowing for 20 years for the child to reach maturity, 3 years for ACC claims and 3 years for ACC appeals)
50 years for information about donors or children conceived using donor gametes or embryos, as described in the HART Act.


Public/private hospital

Service providers have a data use policy.
Local lead maternity carers can access service providers’ information management systems for information sharing.

Birthing units

Service providers have a data use policy.
Local lead maternity carers can access service providers’ information management systems for information sharing.

Criterion 2.5.3
Guidance for all providers

Service providers maintain active, updated, and archived records in a suitable order and condition so that they may be retrieved when required, and enable records to follow people when needed.
Service providers undertake procedures to test back-up records at defined intervals, and update their disaster recovery strategy and the business continuity plan as required.
As part of their internal audit programme, service providers regularly monitor their records as to the quality of the documentation and the effectiveness of the information management system.

Part 1: Our rights
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Part 3: Pathways to wellbeing

Page last updated: 01 March 2023

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HomeOur workRegulationCertification of health care servicesFor service providersReconfiguring services or building a new premises

Certification of health care services

Health and Disability Services (Safety) Act
Standards
For residents and families
For service providersAnnual service provider declaration
Notification for one hospital-level resident to be cared for in a rest home service area
Applying for certification
Designated auditing agencies
Notifying a change of clinical or facility manager
Notifying a change of governance
Notifying an incident under section 31
Reconfiguring services or building a new premises
Reporting on an ACC Notification of Harm
Residential disability provider surveillance

For designated auditing agencies
For Te Whatu Ora
Making a complaint
HealthCERT Bulletin
Publications

 Reconfiguring services or building a new premises


Health facilities must comply with the Health and Disability Services (Safety) Act 2001. For this reason, the Director-General of Health needs to be advised when reconfigurations are proposed to a certified premises or a new health premises is to be built.
Aged residential care, hospice, and maternity services must advise HealthCERT if planning is underway to:

change (add or remove) the number of beds
change (add or remove) a service
change the configuration of beds within the services offered
build a new facility or a new wing.

In these situations the provider must complete the Notification of reconfiguring services or building a new premises form (Word, 62 KB).
If you have a contract with Te Whatu Ora, please ensure that Te Whatu Ora's Portfolio Manager has been advised of the proposal. Please attach any emails or correspondence from Te Whatu Ora about the proposal.
When HealthCert receives the form it will determine:

the risk associated with the proposed change
if a partial provisional audit is required prior to occupancy.

Public and private surgical hospitals should complete the form at public hospitals and private surgical hospitals or directly contact HealthCERT.
This form is not needed for:

Public or private surgical hospitals making changes to services
residential disability services providers
buying or selling an aged residential care, hospice, private hospital or maternity service.

In these situations, the provider should email HealthCERT at [email protected] or call 0800 113 813.
Further information
If you have any questions, please contact HealthCERT on 0800 113 813.

Downloads

 Notification of reconfiguring services or building a new premises form (docx, 62 KB)

Page last updated: 05 December 2022

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Page last updated: 05 December 2022

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HomeOur workRegulationMedicines control

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Medicines Control is a regulatory team within the Ministry of Health (formerly situated in Medsafe) that oversees the local distribution chain of medicines and controlled drugs within New Zealand. The team issues licences and authorities, undertakes drug abuse containment activities and monitors compliance with legislation; in particular, the Medicines Act 1981, Medicines Regulations 1984, the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977. The Director-General of Health has delegated certain legislated powers and functions to Medicines Control.
The Team Leader of Medicine Control is designated Licensing Authority for all licences issued under the above legislation (except licences to manufacture and licences to pack medicines). For information relating to these two licences please refer to the Medsafe website.
Medicines Control Contacts


In this section

Controlled drugs

 Prescribing of controlled drugs is more tightly controlled than prescribing of other medicines, reflecting the need to restrict access to, and minimise the misuse of, controlled drugs.

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Drug abuse containment

 Drug abuse containment activities are carried out by Medicines Control staff in conjunction with two Medical Officers of Health who have wide powers under both the Misuse of Drugs Act 1975 and the Medicines Act 1981.

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Bringing medicines into New Zealand

 Information on bringing medicines, including controlled drugs, into New Zealand, and commercial importing and exporting

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Pharmacy licensing

 Information on applying for a licence to operate a pharmacy, new pharmacy premises, and the requirements for pharmacy ownership.

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Industrial hemp

 Information about the current regulations that apply to the use of industrial hemp for industry and as a food.

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Medicines control publications

 Publications relating to medicine control activities in New Zealand.

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 Medsafe
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is responsible for the regulation of medicines and medical devices in New Zealand, and the safe use of medicines.

Medsafe website

PHARMAC
The Pharmaceutical Management Agency of New Zealand (PHARMAC) works with the Ministry of Health (including Medsafe) and district health boards to provide affordable access to prescription medicines, and to promote the optimal use of medicines.

PHARMAC website

Related areas

 Medicines Act 1981

 Psychoactive substances regulation

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Popular guides & tools

 Medicines Care Guides For Residential Aged Care

Page last updated: 27 January 2023

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Therapeutic products regulatory regime | Ministry of Health NZ

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 Therapeutic products regulatory regime


We are working on a modern, comprehensive, cost effective regulatory regime for therapeutic products in New Zealand which will support consumer safety.On this page:

Therapeutic products

Therapeutic Products Bill
The aims of the Bill

Natural health products

About natural health products
The need to regulate natural health products
What the Bill means for natural health products

Common questions on the Bill
Relevant documents
Related information


Common questions on the Bill
Relevant documents
Related information

Therapeutic products
Therapeutic products include medicines, medical devices and natural health products. These products are used by New Zealanders in their daily lives, and in all parts of the health system.
While therapeutic products have many benefits there are risks if they are used inappropriately or not for their intended purpose. Ensuring the benefits of therapeutic products outweigh possible harm to consumers is important and why New Zealand needs a regulatory regime for all therapeutic products.
The current way New Zealand regulates therapeutic products does not always meet the needs of consumers, patients, manufacturers or exporters. The Ministry has been leading work on a new Therapeutic Products Bill to address these issues.
Therapeutic Products Bill
The Therapeutic Products Bill was introduced to Parliament on 30 November 2022 and has been referred to the Health Select Committee. Submissions on the Bill can be made via the New Zealand Parliament website. Submissions on the Bill close 11.59pm, Sunday 5 March 2023
The Bill has been more than a decade in the making. It is significant legislation which will update New Zealand’s regulatory regime (replacing the Medicines Act 1981 and Dietary Supplements Regulations 1985) to ensure it is fit for the future, and contributes to a strong, effective health and disability system.
The Bill takes on board sector feedback to consultation undertaken in recent years (e.g., the previous Natural Health and Supplementary Products Bill), the health and disability system reforms, new health technology changes and lessons from COVID-19.
The aims of the Bill

The purpose of the Bill is to protect, promote, and improve the health of all New Zealanders by providing for the:

acceptable safety, quality, and efficacy of medicines
acceptable safety, quality, and performance of medical devices
acceptable safety and quality of natural health products, and that any health benefit claims are supported by scientific or traditional evidence


It will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include medicines from general sale products like paracetamol to gene, cell and tissue therapies, and medical devices from tongue depressors to implantable pacemakers.
Both medical devices and gene, cell and tissue therapies are currently not fully regulated in New Zealand so the Bill seeks to address this. The regulation of clinical trials will also be made more robust.
The Bill provides a risk-proportionate approach. Pre-market controls will provide assurances that products are made to the proper standards, while in-market and post-market controls will enable a timely response if safety issues arise.
The regime will deliver a regulator that is independent, transparent, accountable, able to sustain regulatory capability and capacity, and is responsive and flexible.
Having flexible, risk-proportionate approval systems will also ensure New Zealand can access necessary life-saving medicines and respond to health emergencies, for example pandemics or natural disasters requiring a health response.
The new regime will align with international best practice and it will be future-proofed so that new and emerging health technologies can be regulated appropriately.


Natural health products
In 2021, Cabinet decided to regulate natural health products under the Therapeutic Products Bill.
The Bill is not intended to stop people buying natural health products, unless there is robust scientific evidence to justify restricting it (e.g., certain parts of a plant may be toxic while other parts are fine, or the concentration of a product is too risky at a certain level to be available for general sale).
In developing the new regime, Manatū Hauora has drawn on previous work on natural health products, which included several rounds of consultation and significant input from stakeholders. Stakeholder hui were also held in November 2022 with representatives from key organisations.
Contrary to some recent reports on social media, there is no list of prohibited ingredients in the current Bill, and no proposal to ban common herbs and spices used in cooking. The impact of the Bill on any particular natural health product/ingredient would be determined via secondary legislation, following consultation with stakeholders. See Q&A below for more information.
About natural health products
Natural health products support health and wellness, and are made from natural ingredients, or synthetic equivalents such as synthetic vitamins.
This includes herbal remedies (in the form of capsules, tonics, and skin creams), vitamin and mineral supplements, traditional Māori remedies, traditional Chinese medicine, homeopathic remedies, and some remedies based on animal products, such as deer velvet and fish oil capsules.
Supplemented foods, such as bread or juice fortified with vitamins and minerals, are generally not considered natural health products. They are regulated by the Ministry for Primary Industries. Read more on the regulation of supplemented foods.
The need to regulate natural health products


The need to regulate natural health products
It’s important people have the information they need to make informed decisions about the products they use, and have access to safe and high-quality products. Natural health products are not risk-free. They are generally lower risk products than medicines and higher risk than foods with similar ingredients.
Regulations can help ensure:


products contain safe ingredients at a safe dose
suitable quality manufacturing processes are in place to provide assurance that products are not contaminated
product information is clear on the use and recommended dose
health claims are based on evidence
products made in New Zealand and exported overseas meet international standards.

What the Bill means for natural health products
In 2021, Cabinet decided to regulate natural health products under the Therapeutic Products Bill. The Bill makes it clear that natural health products are a different product category to medicines and medical devices. This reflects that, while there are many similarities between product types, there are also distinct differences.
Having a single Bill will help clarify the interface with other legislation. Currently natural health products must comply with the relevant parts of the Food Act 2014, particularly the Dietary Supplements Regulations 1985; the Hazardous Substances and New Organisms Act 1996, particularly the Cosmetic Group Standard 2017; the Medicines Act 1981; and/or the Animal Products Act 1999. Consumer laws also apply (e.g. the Fair Trading Act 1986 and the Consumer Guarantees Act 1993).
The Bill includes:

a risk proportionate approach to the manufacture of natural health products
requirements that support exports, taking relevant international standards and practice into account, and meeting New Zealand’s international obligations
a definition for natural health products that differentiates them from food and medicines
the ability to make health benefit claims that can be supported by scientific evidence, or evidence of traditional use
labelling to support consumers to make informed choices about their own health and wellbeing
enforcement provisions that include the recall of products where necessary.

Common questions on the Therapeutic Products Bill
A number of people and organisations have contacted the Ministry with questions about the Bill, in particular the proposal to regulate natural health products.
Questions cover:


Prohibited/permitted NHP ingredients
Risk of harm of NHPs
Access to NHPs
Impact on costs
Rongoā/Te Tiriti
WHO report

Common questions on the Therapeutic Products Bill
Relevant documents
See these previously released decision documents:
Released 17 January 2023

Cabinet paper: Therapeutic Products Bill: Approval for introduction (PDF, 712KB)
Legislation Committee minute: Therapeutic Products Bill: Approval for introduction (PDF, 672KB)
Cabinet minute: Therapeutic Products Bill: Approval for introduction (PDF, 683KB)

Released 30 November 2022

Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 1
Regulatory Impact Statement: Therapeutic and Natural Health Products Regulation – Supplementary Analysis 2022 No 2
Cabinet paper: Pharmacy Ownership and Licensing (PDF, 663 KB)
Cabinet minute: Pharmacy Ownership and Licensing (PDF, 660 KB)
Regulatory Impact Statement: Pharmacy Ownership and Licensing
Cabinet paper: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 706 KB)
Cabinet minute: Crown Liability under the Therapeutic Products Bill and Other Offence and Penalty Matters (PDF, 652 KB)
Cabinet paper: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 854 KB)
Cabinet minute: Therapeutic Products and Natural Health Products Regulatory Scheme (PDF, 662 KB)

Released 17 March 2022

Cabinet paper: Regulating Natural Health Products (PDF, 306KB)
Cabinet minute: Regulating Natural Health Products (PDF, 144KB)
Regulatory Impact Statement: Regulating natural health products (PDF, 398KB)

Released 14 December 2018


Released 14 December 2018

Cabinet paper: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 191 KB)
Cabinet minute: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 128 KB)
Regulatory impact statement: Therapeutic Products Bill – Personal Import of Medicine by mail/courier (PDF, 56 KB), (Word, 40 KB)

Minutes from November 2015 and March 2016 Cabinet papers

Cabinet minute: Therapeutic Products Regulation Paper 1: Context and Overview (PDF, 144 KB)
Cabinet minute: Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (PDF, 141 KB)
Cabinet minute: Therapeutic Products Regulation: Further Policy Approvals (PDF, 150 KB)

Released 28 April 2016

Therapeutic Products Regulation Paper 1: Context and Overview (Word, 35 KB)
Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (Word, 157 KB)
Regulatory Impact Statement 1 (for Cabinet Papers 1 and 2) (Word, 130 KB)
Therapeutic Products Regulation Paper 3: Further Policy Approvals (Word, 46 KB)
Appendix 1 for Cabinet Paper 3: A3 (PowerPoint, 68 KB)
Regulatory Impact Statement 2 (for Cabinet Paper 3) (Word, 114 KB)

Related information

Medicines Act 1981, section 4
Guideline on the Regulation of Therapeutic Products in New Zealand
Overview of Therapeutic Product Regulation (PDF 395KB, 24 pages)


In this section

Common questions on the Therapeutic Products Bill

 A number of people and organisations have contacted the Ministry with questions about the Bill, in particular the proposal to regulate natural health products (NHPs).

 Read more

Subscribe to Therapeutic Products updates

 Subscribe to our email list to receive therapeutic and natural health product updates.

 Read more

 Contact us
If you would like updates on therapeutic and natural health products, you can subscribe to the newsletter and read previous editions of the newsletter.
If you would like more information or to get in touch with the team, please contact us at [email protected]
Related links
Common questions on the Therapeutic Products Bill

Page last updated: 15 February 2023

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This section provides information for certified providers who need to make an annual declaration.Certified providers are required to submit an annual declaration in any calendar year in which an audit related to certification does not occur.
Providers must complete the form attached to this page and submit it to their Designated Auditing Agency.
Further information
If you require any further information or advice please contact us.

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 Annual Service Provider Declaration Form (docx, 59 KB)

Page last updated: 11 December 2013

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