supporting the health and wellbeing of new zealanders ... · standard title nzs 7106:1998...
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Supporting the health and wellbeing of New Zealanders through standards and
accreditation.
Agenda
1. Welcome and introduction
2. Brief presentations
o Quality infrastructure – a brief overview
o The value of standards
o Thermo- Sphygmomano- Tono–... What do all these meters measure?
o Certification and Risk
o Accreditation and Competence
3. Keynote address: When Good Labs Go Bad, Standards, Accreditation & Politics, Phil Barnes, General Manager, IANZ
4. Panel Discussion and Q&A, followed by afternoon tea
Quality infrastructure – a brief overview
Alex Kay Trade and International
• Standards, conformity assessment and metrology
• Also known as ‘Quality Infrastructure’ (QI)
• Covers: Standards development and management
Accreditation and conformity assessment
Measurement science and practice, and calibration
• QI present in most countries
Players and roles
Image: teara.govt.nz
QI – the end result is quality assurance
• Businesses use it to open markets, improve their sustainability, lift productivity or increase consumer confidence
• It provides information to consumers that helps them choose the goods or services that best fit their needs
• Government uses it as a tool for public outcomes
Regulatory use of QI
• Opportunities to improve relationship between regulatory schemes and the QI
Golden rules for rule-makers: Know the QI tools
Know the QI players
Ensure:
o Clear roles and responsibilities
o Appropriate level of regulatory control and oversight
Make rules relative to risks
Be internationally aware
My Wednesday morning with the QI
Images: Te Ara and Wikipedia
What’s new?
Plan for the conformance system (relevant to wider QI)
Designed to assist accreditation and conformity assessment bodies and other organisations, agencies and people involved in conformance
Addresses a range of current challenges and opportunities in conformance
o e.g. regulatory practice, visibility, coordination, technical workforce
Alex Kay SENIOR POLICY ADVISOR
Trade and International Ministry of Business, Innovation & Employment
Alex.Kay@mbie.govt.nz
10
Kia ora – Thanks!
Standards NZ – who we are
o Business Unit within MBIE
o Act of Parliament
Cost recovery model
International first
Board who sign off on committees and final standards
o Create, facilitate and project manage standards development
International (ISO, IEC)
Regional / Joint with Australia (AS/NZS)
National (NZS)
Standards bodies
Why health standards are important
Health standards help ensure that individuals and communities receive the quality of care they deserve.
Health standards:
• ensure consistency and efficiency by not having multiple specifications
• provide tools to assess and evaluate conformity and a solid technical base for health legislation
• ensure good-quality care and safe and reliable products and services
• Make it easier to compare health services, exchange information and safeguard the privacy of an individuals health
Dentistry
Infusions and injections
Optics
Medical devices
Assistive products for persons with disabilities
Sterilization of healthcare products
Equipment for transfusions
Surgery
Health informatics
Traditional Chinese medicine
Standard Title
NZS 7106:1998 Polyurethane condoms
SNZ HB 8134.5:2005 Health and Disability Sector Standards – Proposed Audit Workbook and Guidance for Residential
Services for People with Dementia
SNZ HB 8134.6:2006 Best Practice Guidance for Community Services for People with Dementia and Proposed Audit
Workbook
SNZ HB 8141:2004 Restraint Minimization and Safe Practice Audit Workbook
SNZ HB 8142:2001 Infection Control Audit Workbook
SNZ HB 8143:2002 National Mental Health Sector Standard Audit Workbook
SNZ HB 8152:2001 Sentinel Events Workbook
SNZ HB 8156:2003 Ambulance Service Sector Standard Assessment Workbook
SNZ HB 8181:2007 Fertility Services Audit Workbook
SNZ HB 8134.1:2001 Health and Disability Sector Standards (Residential) Audit Workbook
SNZ HB 8134.2:2001 Health and Disability Sector Standards (Hospital) Audit Workbook
SNZ HB 8134.3-2004 Health and Disability Sector Standards (Intellectual Disability) Audit Workbook
SNZ HB 8158:2004 Home and Community Support Sector Standard Audit Workbook
SNZ HB 8163:2005 Indicators for safe aged-care and dementia-care for consumers
SNZ HB 8171.1:2005 Allied health services sector Standard – Physiotherapy Services Audit Workbook
SNZ HB 8171.2:2005 Allied health services sector Standard – Chiropractic Services Audit Workbook
NZS 8164:2005 Day-stay surgery and procedures
NZS 8165:2005 Rooms/Office-based surgery and procedures
NZS 8171:2005 Allied health services sector Standard
SNZ HB 8134.4:2004 Health and Disability Sector Standards (Children and Young People) Audit Workbook
NZS 8151:2004 Accident and Medical Clinic Standard
NZS 8157:2003 Alcohol and Other Drug Treatment Sector Standard
NZS/ISO 15189:2007 Medical laboratories – Particular requirements for quality and competence
SNZ HB 8149:2001 Microbiological surveillance of flexible hollow endoscopes
UN Sustainable Development Goals (SDG)
ISO/TC 121 - Anaesthetic and respiratory equipment Breathing attachments and anaesthetic machines
Airways and related equipment
Respiratory devices and related equipment used for patient care ISO/TC 173/SC1 - Wheelchairs ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
NZ’s contribution internationally
Contact Details
Natalie Bowie Sector Engagement Lead
021 824412
natalie.bowie@mbie.govt.nz
Aged Standards www.standards.govt.nz
nzagedcataloguereview@mbie.govt.nz
Thermo-, Sphygmomano-, Tono-
What do all these meters measure?
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Good
Measurements Fit for purpose
Value and uncertainty
Achieved via
Well defined quantity
Reliable / suitable equipment
Calibration of equipment
Competency of users
Thank you
www.measurement.govt.nz
Certification & Risk Health & Disability Sector Seminar
13 September 2019
Presented by Kathryn Lockyer
Definition of Risk
• a situation involving exposure to danger.
• the possibility of something bad happening
Risk Based Thinking
• Inherent in a number of certification standards
• Provides a framework to identify potential areas of risk relevant to processes
• And, then steps to eliminate potential areas of concern, or address actual events to ensure they don’t occur
• Useful tools to help you understand risk
IS0 31000:2018 (Guidelines), IEC 31010:2019 (Risk assessment techniques)
Certification allows you to demonstrate your service meets requirements
Certification is a tool to help mitigate Risk
Certification can support regulation
In NZ certification activities covers the following areas:
• Aged Care
• Reproductive Technology
• Urgent care facilities
• Hospital care (Children’s health services, geriatric services, maternity services, medical services, mental health services or surgical services)
• Alcohol and Other Drug Treatments
• Home and Community Support Sector
• Day-stay surgery
What’s Next?
Did you know that there are more than 1400 ISO standards that keep people healthy and safe?
Thank you
ACCREDITATION AND
COMPETENCE
2019 Gallup Poll
84% Nurses
67% Medical Doctors
66% Pharmacists
• Reliability
• Expertise
• Trustworthiness
• Knowledge
• Understanding
• Empathy
• Accuracy
• Safety
Providers
Public
IANZ • Primary accreditation
provider in healthcare
• Experience
• All medical laboratories
• Almost all radiology providers
• Robust oversight of industry
Why? • Consistency in service
provision
• Technical competence
• Reduction in errors
• Reduction in risk
• Safer services
• Meet Government
expectations
Protecting the Health
and Wealth of NZ
be assured
Phil Barnes General Manager
INTERNATIONAL ACCREDITATION NEW ZEALAND
When Good Labs Go Bad: Standards, Accreditation & Politics
be assured
Political Context
Gisborne, Dr Bottrill and The Inquiry
Cloak of Secrecy: our business is not your business
New Zealand Labs – Good, Bad or Ugly?
Public
Private
‘The Schedule’
‘Mandatory’ Accreditation (if you can afford it)
be assured 43
Blue Print for Perfection
The Standard: ISO 15189 Quality
Front End Focus
Health & Safety
Ethics
IT
be assured 44
Pathway to Perfection
1st April 2003: NZ first in the world, Yay!!!
Consequently:
First non-conformity in the world, (Not so Yay)
be assured
Highway to Hell?
Casualties and Collateral Tairawhiti DHB
Auckland DHB
Otago DHB
Northland DHB
Waikato DHB
be assured 46
A Tale of Two Cities
ADHBs Jewel in the Crown
and:
Just Another Private Provider for Auckland? Letters from Australia: DML & LTA
CCDHB: All’s well that ends well ?
be assured
IANZ only Picks on the Little Guys…
Case1: Lab Minus
It all started so well…
But don’t come yet, we are not ready!
A really difficult easy decision –
Risk asymmetry
be assured
Case 2: Aussie Rules
Private War Rolls Royce or a Russian Tank?
LTA in Wonderland –
……………….or in No-man's-land?
Back to the drawing board – and the blueprint
be assured
Case 3: Capital Investment
Wellington SCL
History suggested high risk-
Where did it all go right?
be assured
New Role for IANZ?
Above the radar
In the line of fire
“We are not the compliance arm of the regulator”…are we?
Where to from here?
Panel Discussion
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