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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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