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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-


  1. Supporting the health and wellbeing of New Zealanders through standards and accreditation.

  2. 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

  3. Quality infrastructure – a brief overview Alex Kay Trade and International

  4. • 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

  5. Players and roles Image: teara.govt.nz

  6. 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

  7. 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

  8. My Wednesday morning with the QI Images: Te Ara and Wikipedia

  9. 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

  10. Kia ora – Thanks! Alex Kay SENIOR POLICY ADVISOR Trade and International Ministry of Business, Innovation & Employment Alex.Kay@mbie.govt.nz 10

  11. 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)

  12. Standards bodies

  13. 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

  14. Optics Assistive products for persons with disabilities Dentistry Infusions and injections Medical devices Surgery Equipment for transfusions Sterilization of healthcare products Health informatics Traditional Chinese medicine

  15. 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

  16. UN Sustainable Development Goals (SDG)

  17. NZ’s contribution internationally 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

  18. Contact Details Natalie Bowie Sector Engagement Lead 021 824412 natalie.bowie@mbie.govt.nz Aged Standards www.standards.govt.nz nzagedcataloguereview@mbie.govt.nz

  19. Thermo-, Sphygmomano-, Tono- What do all these meters measure? 13 November 2019

  20. "This image is taken from Blood pressure in general practice" by Medical Heritage Library, Inc. is licensed under CC BY-NC-SA 2.0

  21. Natalia’s Eye by Julian Carvajal CC BY 2.0

  22. Good Measurements Fit for purpose Value and uncertainty Achieved via Well defined quantity Reliable / suitable equipment Calibration of equipment Competency of users

  23. Thank you www.measurement.govt.nz

  24. Certification & Risk Health & Disability Sector Seminar 13 September 2019 Presented by Kathryn Lockyer

  25. Definition of Risk • a situation involving exposure to danger. • the possibility of something bad happening

  26. 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)

  27. Certification allows you to demonstrate your service meets requirements Certification is a tool to help mitigate Risk Certification can support regulation

  28. 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?

  29. Did you know that there are more than 1400 ISO standards that keep people healthy and safe?

  30. Thank you

  31. ACCREDITATION AND COMPETENCE

  32. 2019 Gallup Poll 84% Nurses 67% Medical Doctors 66% Pharmacists

  33. • Reliability • Expertise • Trustworthiness • Knowledge • Understanding • Empathy • Accuracy • Safety

  34. Provider s Public

  35. IANZ Primary accreditation • provider in healthcare Experience • All medical laboratories • Almost all radiology providers • Robust oversight of industry •

  36. Why? • Consistency in service provision • Technical competence • Reduction in errors • Reduction in risk • Safer services • Meet Government expectations

  37. Protecting the Health and Wealth of NZ

  38. Phil Barnes General Manager INTERNATIONAL ACCREDITATION NEW ZEALAND When Good Labs Go Bad: Standards, Accreditation & Politics be assured

  39. 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

  40. Blue Print for Perfection The Standard: ISO 15189  Quality  Front End Focus  Health & Safety  Ethics  IT 43 be assured

  41. Pathway to Perfection 1 st April 2003: NZ first in the world, Yay!!! Consequently: First non-conformity in the world, (Not so Yay) 44 be assured

  42. Highway to Hell? Casualties and Collateral  Tairawhiti DHB  Auckland DHB  Otago DHB  Northland DHB  Waikato DHB be assured

  43. A Tale of Two Cities ADHB s Jewel in the Crown and: J ust A nother P rivate P rovider for A uckland ? Letters from Australia: DML & LTA CCDHB: All’s well that ends well ? 46 be assured

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