keith harrison - reproductive technology accreditation committee

Standards and Accreditation of ART in Australia

Keith Harrison

• History of IVF

• Legislation and Guidelines applying to ART clinics

• History of ART Accreditation and Licensing

• RTAC Code of Practice and Technical Bulletins

• Effectiveness of the RTAC Accreditation System

• Comparative Cost of the RTAC Accreditation System

History of IVF

1973 Monash Melbourne - miscarriage

1975 Steptoe & Edwards – Oldham (UK) - ectopic preg.

History of IVF



1978 Oldham (UK) - Louise Brown

History of IVF




1980 Melbourne (Monash / RWH) - Candice Reed

History of IVF





1981 Norfolk Virginia (USA) - Elizabeth Carr

1982 Sweden

France - Amandine

Germany - Oliver

Austria - Zlatan

History of IVF





1981 Norfolk Virginia (USA) - Elizabeth Carr

1982 Sweden

France - Amandine

Germany - Oliver

Austria - Zlatan

Now 1 in 100 babies result from ART

200,000 babies in Australia & NZ since 1980

12,875 babies in Australia in 2014

There is an ART baby in every classroom in Australia

IVF Today

Accreditation in ART Clinics in Australia

In early 1980s the Commonwealth Joint Parliamentary Committee of Public Accounts identified:

- Variable quality in Pathology testing

- Evidence of over-servicing in Pathology

- Evidence of medical fraud in Pathology

In response the RCPA entered into an agreement with NATA to develop an inspection and accreditation system from 1983 and it was made mandatory by Federal parliament with inspections beginning in 1985.

An International Standard plus standards created by National Pathology Accreditation Advisory Council (NPAAC)

Required an underlying Quality Management System

International Standards used by NATA

Australian IVF Births and Associated State Legislation

First IVF Babies Victoria 1980Western Australia 1982New South Wales 1983South Australia 1983Queensland 1984


IVF Babies Victoria 1980Western Australia 1982New South Wales 1983South Australia 1983Queensland 1984

State Legislation Victoria 1984 enacted 1988 Standards & Register

1995 ITA – licensing body – for a time accompanied RTAC2008 enacted 2009/10 VARTA – Regulatory with inspection powers

Queensland 1984 Demack report – recommended legislation - not enacted

South Australia 1988 Act plus SA Council on Reproductive Technology established2010 Amendment Act - SACRT abolished

Western Australia 1991 Act enacted 1993 RTC – licensing body – for a time accompanied RTAC

New South Wales 2007 Act – commenced 2010


IVF Babies Victoria 1980Western Australia 1982New South Wales 1983South Australia 1983Queensland 1984

State Legislation Victoria 1984 enacted 1988 Standards & Register1995 ITA – licensing body – for a time accompanied RTAC2008 enacted 2009/10 VARTA – Regulatory with inspection powers

Queensland 1984 Demack report – recommended legislation - not enacted

South Australia 1988 Act plus SA Council on Reproductive Technology established2010 Amendment Act - SACRT abolished

Western Australia 1991 Act enacted 1993 RTC – licensing body – for a time accompanied RTAC

New South Wales 2007 Act – commenced 2010

Federal Legislation & Guidelines2002 Research Involving Human Embryos Act 2002 - NHMRC Embryo Research Licensing Committee2002 Prohibition of Human Cloning for Reproduction Act 20022004 NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice

Australian State Surrogacy Legislation

1974 / 2008 Victoria - Status of Children Act (1974) & definitions in Assisted Reproductive

Treatment Act (2008)

1988 Queensland – complete ban

1994 Australian Capital Territory

2007 / 2010 New South Wales

2008 Western Australia

2009 / 2015 South Australia

2010 Queensland

2012 Tasmania

National ART Clinic Accreditation & Licensing

Australia

1986 Fertility Society of Australia (est. 1982) established standards for the conduct of ART

1987 Fertility Society of Australia established the Reproductive Technology Accreditation Committee (RTAC)- Peer review inspection, accreditation and licensing body- A license required for access to PBS-supplied gonadotrophins- Regularly reviewed Guidelines- Inspection team: Clinician, scientist, nurse, counsellor, consumer

1992 RTAC revised the Guidelines into a Code of Practice- Mandatory treatment cycle data submitted to ANZARD database

2008 RTAC Code of Practice totally restructured- Underpinned by a Quality Management System- Inspections by professional Certifying Bodies certified by JAS-ANZ- Rules for inspection developed in conjunction with JAS-ANZ- Code of Practice reviewed triennially involving all interested parties

2014 - International Version of the Code of Practice

United Kingdom

1991 Human Fertilisation & Embryology Authority – Inspection and licensing body

France

1994 Standards, clinic licensing, and embryo licensing legislation passed

RTAC Code of Practice – Critical Criteria

Critical Criteria

1. Compliance2. Key Personnel3. Complaints Management4. Adverse Events5. Identification and Traceability6. Medication Management7. Multiple Pregnancy8. Ovarian Hyperstimulation Syndrome9. Emergency Care10. Data Monitoring11. Data Reporting12. Donor and Surrogacy Requirements13. Management of Infection Risk14. Informed Consent15. Medical Management

Audited annually.

RTAC Code of Practice - Good Practice Criteria

1. Quality Management System

1.1 Quality Management Policy1.2 Management Review1.3 Integration of Personnel & Services1.4 Internal Communications1.5 Document Control System1.6 Records Management1.7 Personnel & Training1.8 Competency of Personnel1.9 Buildings & Facilities1.10 Risk Management1.11 Key Supplier Management1.12 Auditing

2. Patient Information3. Reproductive Health of Infertility Patients4. Cryostorage of Gametes and Embryos5. Stakeholder Feedback

Audited over a three-year cycle.

HFEA Code of Practice Requirement for a QMS

RTAC Code of Practice – Technical Bulletins

From time to time RTAC will become aware of issues, questions or comments where it may consider assisting units enhance the quality of their service to patients. A Technical Bulletin is an educational communication to all units, and Bodies certifying units to the RTAC Code of Practice, offering advice and guidance. It is not enforceable.

RTAC Technical Bulletin 1 Mar 2009 Closure of an ART Unit

RTAC Technical Bulletin 2 Jul 2009 Obtaining Donor Sperm Outside Australia and New Zealand

RTAC Technical Bulletin 3 May 2011 Donor Issues

RTAC Technical Bulletin 4 Sep 2012 Patient and Sample Identification

RTAC Technical Bulletin 5 Feb 2015 Serious Notifiable Adverse Events

RTAC Technical Bulletin 6 May 2015 Public Information, Communication & Advertising

RTAC Technical Bulletin 7 Public Information, Communication & Advertising - Australian Clinics

RTAC Technical Bulletin 8 Jun 2016 Donation of Gametes and Embryos

RTAC Code of Practice – Triennial Review

Reviewed every three years.

Ad hoc modifications occasionally made and enforceable within three months.

Technical Bulletins reviewed for incorporation into the Code of Practice.

Code of Practice Review Partners:

- Individual clinics and members of the Fertility Society of Australia

- Certifying Bodies and JAS-ANZ

- Department of Health – federal and state

- Relevant Medical Colleges

- State supervisory bodies

- Consumer organisations

Effectiveness of the RTAC Accreditation System (1)

Review the outcomes of all accreditation inspections of 87 Australian & New Zealand clinics for the six-month periods:

- July – December 2011

- January – June 2012

- July – December 2012

- January – June 2013

all being within the period of currency of a single review of the Code of Practice and over a year after its introduction.

Most clinics would have had two inspections over this two-year period.


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Critical Criteria variances found in recent times are predominantly documentation issues.


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% of Clinics with Good Practice Criteria Variances


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Calendar 201572 clinic audits


1.1 Quality Management Policy 31.2 Management Review -1.3 Integration of Personnel & Services -1.4 Internal Communications 21.5 Document Control System 31.6 Records Management 11.7 Personnel & Training 31.8 Competency of Personnel 21.9 Buildings & Facilities 101.10 Risk Management 31.11 Key Supplier Management -1.12 Auditing 2


Calendar 201572 clinic audits


1.1 Quality Management Policy 31.2 Management Review -1.3 Integration of Personnel & Services -1.4 Internal Communications 21.5 Document Control System 31.6 Records Management 1 Lack of equipment validation1.7 Personnel & Training 31.8 Competency of Personnel 2 Incomplete maintenance x 31.9 Buildings & Facilities 101.10 Risk Management 3 Instrument monitoring records x 51.11 Key Supplier Management -1.12 Auditing 2 Inconsistent use of air filtration

Effectiveness of the RTAC Accreditation System - Summary

• The RTAC accreditation system in Australia and New Zealand has contributed to steady improvement in standards achieved.

• Findings now are largely of negligible patient risk, being mostly documentation issues.

• The stable incidence of Good Practice Criteria findings reflects the true nature of quality management systems. The bar for performance is steadily raised by the Certifying Bodies seeking continual improvement in the quest for maximal risk management and treatment outcomes for infertile couples.

• There is evidence that, during a period of improving ART success rates, the implementation of this scheme has progressively reduced the risk of adverse outcomes.

Comparative Cost of the RTAC Accreditation System

RTAC – Australia & New Zealand

• 70 Clinics in 2015

• RTAC Chair, part time secretary, FSA Board

• Two certifying Bodies with 5 lead auditors

• FSA Levy $2000 / clinic

• Certifying Body Fee $3000 / clinic

• Total Cost $350,000

• Cost per clinic $5000

Comparative Cost of the RTAC Accreditation System

RTAC – Australia & New Zealand

• 70 Clinics in 2015

• RTAC Chair, part time secretary, FSA Board

• Two certifying Bodies with 5 lead auditors

• FSA Levy $2000 / clinic

• Certifying Body Fee $3000 / clinic

• Total Cost $350,000

• Cost per clinic $5000

HFEA – United Kingdom

• 140 Clinics in 1915/16

• 70 staff

• 12 members of Authority. 7 committees.

• Expenditure £5,146,000

• 80% from fees charged to clinics

• Cost per clinic £36,750 ($59,100)

Acknowledgments

The Late Professor Geoffrey Driscoll

Professor Douglas Saunders

Dr. Ian Pike

Dr. John Peek

Dr. Phill Matson

Kim O’Dea

keith harrison - reproductive technology accreditation committee

Healthcare