25 November 2024
Chris Johnson
[FYI request #28680 email]
Tēnā koe Chris
Your request for official information, reference: HNZ00067737
Thank you for your email on 7 October 2024, asking Health New Zealand | Te Whatu Ora for the
information in relation to risk management under the Official Information Act 1982 (the Act). A copy
of your clarified request of 14 October 2024 is set out in appendix one.
Response
The following paragraphs provide you with contextual information in relation to your request.
Health NZ along with other agencies, such as the Ministry of Health | Manatū Hauora,
Pharmaceutical Management Agency (Pharmac), and the Health Quality and Safety Commission |
Te Tāhū Hauora, are responsible for ensuring public funding and services protect, promote and
improve the health of all New Zealanders (section 3 of the Pae Ora (Healthy Futures) Act 2022
(Pae Ora Act).
These agencies along with others are also responsible for considering or implementing policies
and procedures to ensure improved hauora outcomes for New Zealanders as well as identifying
and managing risk.
For more information about the role of these organisations in the health sector please refer to the
following web links:
• The Ministry of Health (the Ministry) is the government’s lead advisor on health priorities
and policies. The Ministry also regulate and monitor the health system.
o
www.health.govt.nz/
o
www.health.govt.nz/about-us/new-zealands-health-system/overview-and-statutory-
framework
o
www.health.govt.nz/system/files/2024-01/briefing-to-the_-incoming-minister-of-
health-part-b-black-box-watermarked.pdf
• Health Quality and Safety Commission:
www.hqsc.govt.nz/
• Pharmac:
www.pharmac.govt.nz/
• New Zealand Medicines and Medical Devices Safety Authority:
www.medsafe.govt.nz/
As you wil be aware, there are a number of different types of risks that Health NZ identifies and if
necessary, manages. The high level risks are presented on pages 53- 56 of Health NZ’s annual
report ‘Pūrongo-ā-tau – Annual Report 2022 – 2023’.
The Annual report can be found here:
•
www.tewhatuora.govt.nz/assets/Publications/Annual-Reports/Te-Whatu-Ora-HNZ-
Purongo-a-tau-Annual-Report-22-23.pdf
Primary and Secondary Legislation
Risks can be managed through a number of different types of interventions such as primary or
secondary legislation, for example the Public Finance Act 1989 (safeguarding and reporting on
Public Finance expenditure) and an Order in Council (section 3 of the Health Act 1956).
Committees, Panels and Boards
Commit ees, Expert Groups, and Boards play an important role in New Zealand’s health system
providing specialised expertise and advice to support policy development and risk management.
In addition, Health NZ has a number of expert groups who provide leadership in key health areas,
and advise on and monitor complex health care services in New Zealand
Information on the committees and groups can be found at the following web locations:
•
Health Committees and Boards: www.health.govt.nz/about-us/new-zealands-health-
system/health-system-roles-and-organisations/health-committees-and-boards
•
Health New Zealand Expert Groups: www.tewhatuora.govt.nz/corporate-information/about-
us/expert-groups
Standards and Guidelines
Standards developed and published by Health NZ set the minimum requirements which must be
met for health and wellbeing of patients, visitors, and staff. Guidelines set out the health sector
best practice for employees, practitioners, or service providers in the sector. Some of our
standards and guidelines are publicly available here:
• Standards
:https://www.tewhatuora.govt.nz/search?keywords=standards
• Guidelines:
https:/ www.tewhatuora.govt.nz/search?keywords=guidelines
As noted above there is a wide ambit of types of risks Health NZ needs to consider and types of
interventions to manage risk.
Your request for information, even though it has been clarified is very broad, and substantial
manual collation would be required to locate and prepare all documents within its scope. As such,
providing all of the information requested would ‘
impair efficient administration’ under section
16(2)(a) of the Act.
However, in addition to the contextual information provided above, we provided examples in
response to your request, under section 16(1)(e) of the Act. These are attached in
appendix two.
How to get in touch
If you have any questions, you can contact us at
[email address].
If you are not happy with this response, you have the right to make a complaint to the
Ombudsman. Information about how to do this is available at
www.ombudsman.parliament.nz or
by phoning 0800 802 602.
As this information may be of interest to other members of the public, Health NZ may proactively
release a copy of this response on our website. Al requester data, including your name and
contact details, wil be removed prior to release.
Nāku iti noa, nā
Danielle Coe
Manager (OIAs) – Government Services
Office of the Chief Executive
Appendix One: Clarified Request (14 October 2024)
OIA 1) Are there documented policies or procedures for assessing new information about a health
policy or practice in Health NZ, that would lead to a formal review of the evidence, and a potential
change in approach? Please provide the documents that describe this policy or procedure.
There may be many such documents - eg a procedure as a result of a decision by another regulatory
body (eg MedSafe), or a request/warning from a professional body, a warning on a product (tool or
certified technique/guideline), a Ministerial or Ministry of Health initiative (screening programme), or a
set of findings in the medical literature that flag that a safety issue or unintended consequence of a
practice needs attention, or surveil ance/epidemiological/ACC reporting identifies an issue, or a
concerned group from the public documents an issue.
OIA 2) Please identify all areas (including but not limited to the above) where Health NZ has an explicit
risk management strategy in place to monitor and respond to feedback and requests from key
stakeholders. For example, Health NZ may be able to provide a document from each of its senior
leadership team that describes how they manage the risks and safety feedback from their
stakeholders. There may also be a central dedicated Evaluation Unit that clinically assesses Health NZ
initiatives for effectiveness, and focuses warnings and alarms generated internally and externally. The
expected outcome of this is a list/table.
We asked: By “leadership team” did they mean Tier 2 Directors reporting to the Chief
Executive?
You replied: Yes
We asked if they are interested in a copy of the current risk management policy and framework.
You replied: Yes. For this request I am also happy for only the Risk Management
Policy/Framework/Registers in the Public Health part of Health NZ to be supplied - Eg screening
programmes, immunisation, medication via consumer products/services etc. - and only entries
related to community/clinical safety, and safety signals detected or raised with Health NZ and
what rating/mitigating actions are being taken.
OIA 3) Please provide al Job Titles that deal with emerging warnings and risks and group them within
the Health NZ organisational structure so that their role can be assessed in context and their leadership
team executive identified. Eg Public Health/Hospital/Primary Health/Stakeholder
Management/Executive. The expected outcome of this is a list/table.
We asked the requester to clarify what they mean by “emerging warnings and risks” as this request is
very broad and to specify particular areas, projects or initiatives they are wanting information about.
You replied: I am interested in topics related to Health and Disability services purchased/funded
by Health NZ. For example I am not interested in property management or supply chain
logistics issues/risks etc. I have provided a suggested rewording below. Please let me know if
this needs further refinement based on how Health NZ operates or is structured.
"OIA 3) Please provide all Job Titles that receive/detect/manage emerging warnings and risks
that may indicate a safety issue with a health and disability product or service supplied, funded
or mandated by Health NZ. Please group the Job Titles within the Health NZ organisational
structure so that their role can be assessed in context and their leadership team executive
identified. Eg Public Health/Hospital/Primary Health/Stakeholder Management/Executive. The
expected outcome of this is a list/table - which may include job titles such as - Data Scientist,
Epidemiologist, Contract Manager, Clinical Safety Officer, (Re)Evaluation Unit Manager,
General Manager of Breast Screening, Clinical Audit, Rest Home Auditor, MedSafe Liaison
Officer"
OIA 4) Please list the Criteria a suitably qualified Group from the Public would have to meet, in order for
Health NZ to commence a formal review into a scientifical y documented and quantified Issue of
Concern. To be clear:
- This Group from the Public would not have any commercial or regulatory relationship with Health NZ -
but might be entitled to use the services purchased or supplied by Health NZ or be self/privately
funded.
- The Issue of Concern would be regarding a substantial initiative by Health NZ - such as a Public
Health initiatives (eg a screening programme, vaccination - eg Thalidomide, forced medication of the
population through consumer products), medical practice (Cervical Screening at Greenlane Hosptial),
pharmaceuticals (eg ultimately leading to product recalls or severe limitation in the
indication). Therefore substantial impact, liability and potential embarrassment.
Appendix Two: Response
Item 1: Are there documented policies or procedures for assessing new information about a
health policy or practice in Health NZ, that would lead to a formal review of the evidence,
and a potential change in approach? Please provide the documents that describe this
policy or procedure.
As noted above the lead agency advising on health priorities and policies is the Ministry of Health.
However, Health New Zealand, other agencies, organisations are consulted or provide advice to
the Ministry for its consideration.
A review or assessment of information about health policies and procedures can be triggered in a
number of different ways. Such as, a review of trends within the national health datasets, Coroners
Reports, reviews of research papers and best practice guidelines issued overseas and in
Aotearoa, reviews of current health legislation, or direction from the Ministry or Government. An
example is the recent review of the Mental Health (Compulsory Assessment and Treatment) Act
1992 (Mental Health Act).
Information about the background to and the review process is available here:
www.health.govt.nz/publications/transforming-our-mental-health-law-a-public-discussion-
document. Members of the public have been essential to the process of both the preceding
Government’s Inquiry into Mental Health and Addiction and the public consultation (October 2019 –
January 2022) on repealing and replacing the Mental Health Act as part of the democratic process.
It was also recognised that a review the Mental Health Act would take some time. So, to ensure
that we improved peoples’ experiences under the current Mental Health Act, new guidelines were
released in the short to medium term.
The guidelines can be found here:
www.health.govt.nz/regulation-legislation/mental-health-and-
addiction/mental-health-act/guidelines-and-resources#mig
The guidelines and the review of the Mental Health Act have been supported by ongoing
monitoring and reporting of access to services, as well as reaching out to those with lived
experience. Links to the reports / data can be found here:
www.tewhatuora.govt.nz/health-
services-and-programmes/mental-health-and-addiction/mental-health-and-addiction-monitoring-
reporting-and-data.
Item 2: Please identify all areas (including but not limited to the above) where Health NZ
has an explicit risk management strategy in place to monitor and respond to feedback and
requests from key stakeholders. For example, Health NZ may be able to provide a
document from each of its senior leadership team that describes how they manage the risks
and safety feedback from their stakeholders. There may also be a central dedicated
Evaluation Unit that clinically assesses Health NZ initiatives for effectiveness, and focuses
warnings and alarms generated internally and externally. The expected outcome of this is
a list/table.
As noted above the number and types of risks are significant in an organisation of Health NZ’s size
and the work it does. Risk is managed depending on type, location and significance through
various levels of Health NZ.
Al employees (permanent, temporary and casual), medical officers, students, and other partners in
care, volunteers, contractors and consultants working for and on behalf of Te Whatu Ora are
required to manage risk.
Item 3: Please provide all Job Titles that receive/detect/manage emerging warnings and
risks that may indicate a safety issue with a health and disability product or service
supplied, funded or mandated by Health NZ. Please group the Job Titles within the Health
NZ organisational structure so that their role can be assessed in context and their
leadership team executive identified. Eg Public Health/Hospital/Primary Health/Stakeholder
Management/Executive. The expected outcome of this is a list/table - which may include
job titles such as - Data Scientist, Epidemiologist, Contract Manager, Clinical Safety Officer,
(Re)Evaluation Unit Manager, General Manager of Breast Screening, Clinical Audit, Rest
Home Auditor, MedSafe Liaison Officer"
Our overarching Risk Management Structure is set out below. The structure accounts for
the risk management at a national, regional, and district level.
•
The Te Whatu Ora Board / or its Commissioner/s are ultimately accountable
for the organisation’s risk management. The Board / Commissioner/s
provides independent oversight and direction to the Chief Executive and
Executive Leadership Team on organisational performance including risk
management.
•
Other Te Whatu Ora Board Sub-Committees that have oversight and provide
specialist advice and support on specific subject area risks and risk
management activities.
•
Clinical Governance arrangements that oversee clinical activities and quality
nationally and throughout the Te Whatu Ora regions and districts across the
motu and, as part of this role, review clinical patient safety risks to ensure
they are minimised and managed.
•
The Te Whatu Ora Executive Leadership Team that manages the
organisation’s strategic, change, enterprise and operational risks.
Item 4 Please list the Criteria a suitably qualified Group from the Public would have to meet, in
order for Health NZ to commence a formal review into a scientifically documented and
quantified Issue of Concern. To be clear:
- This Group from the Public would not have any commercial or regulatory relationship with
Health NZ - but might be entitled to use the services purchased or supplied by Health NZ or be
self/privately funded.
There is no list of criteria that a group from the public would need to meet in order to request a
Health NZ commence a review. However, this does not necessarily mean a review wil be initiated
following a request for a formal review. The information would need to be assessed for accuracy
and considered in the context of New Zealand’s population and health outcomes.
Please note a request for a review would need to go to the appropriate agency based on their
responsibilities under the relevant legislation.
