Regulation of ART. S.T.A.R.T. Melbourne, 19 th February, 2017
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1 S.T.A.R.T. Melbourne, 19 th February, 2017 Regulation of ART Phill Matson Fertility North, Joondalup, WA & Edith Cowan University, WA Chair, Reproductive Technology Accreditation Committee
2 Regulation of ART Local bodies Ethics committee Hospital medical board State Laws New South Wales, South Australia, Victoria, Western Australia Compliance with law Licences (eg storage and treatment in WA) Accreditation Conformance with defined minimum standards Principles Audit by third party Not a pass or fail Requires thought and informed decision-making by clinic Framework for daily functioning Quality management system Controlled documentation Opportunity for suggestions to improve service
3 Accreditation Schemes in ART RTAC (Reproductive Technology Accreditation Committee) - Mandatory for clinics offering assisted reproduction treatments - Compliance with NH&MRC Ethical Guidelines for ART
4 Accreditation Schemes in ART RTAC (Reproductive Technology Accreditation Committee) - Mandatory for clinics offering assisted reproduction treatments - Compliance with NH&MRC Ethical Guidelines for ART NATA (National Association of Testing Authorities) - Mandatory for laboratories claiming Medicare rebate, and performing inhouse diagnostic tests
5 Accreditation Schemes in ART RTAC (Reproductive Technology Accreditation Committee) - Mandatory for clinics offering assisted reproduction treatments - Compliance with NH&MRC Ethical Guidelines for ART NATA (National Association of Testing Authorities) - Mandatory for laboratories performing in-house diagnostic tests, and claiming Medicare rebate ISO Optional
6 Why have RTAC accreditation? Reasons Maintain standards Code of Practice NH&MRC Ethical Guidelines for ART Ensure mandatory submission of IVF and donor data - National Perinatal Epidemiology and Statistics Unit (NPESU) - Australian & New Zealand Assisted Reproduction Database (ANZARD) Enforcement Required by Medicare for patients - Mandatory for clinics offering assisted reproduction treatments - value $ $4400 Required by Health Insurance Commission (HIC) - For access to free ovulatory drugs - value around $3000
7 What is RTAC Reproductive Technology Accreditation Committee Subcommittee of Fertility Society of Australia - Chairperson - FSA secretariat - RTAC Committee
8 What is RTAC Reproductive Technology Accreditation Committee Subcommittee of Fertility Society of Australia - Chairperson - FSA secretariat - RTAC Committee Documents - RTAC Scheme Rules (2016) - ANZ RTAC Code of Practice (2015) - International RTAC COP (2014)
9 How does a clinic obtain RTAC accreditation? Make contact with a certifying body
10 How does a clinic obtain RTAC accreditation? But who accredits the Certifying Bodies? The Joint Accreditation System of Australia and New Zealand (JAS-ANZ)
11 How does a clinic obtain RTAC accreditation? Make contact with a certifying body Implement requirements of the Code of Practice - Establish a Quality Management System - Establish a treatment database that gathers data to allow mandatory reporting of de-identified data to ANZARD (Australia & New Zealand Assisted Reproduction Database) - Ensure that the clinic structure has appropriate personnel & structure - Establish a laboratory that meets the requirements of the Code of Practice - Medical Director signs a Deed of Agreement with the FSA **
12 How does a clinic obtain RTAC accreditation? Make contact with a certifying body Implement requirements of the Code of Practice Have the clinic inspected by the certifying body - 15 Critical Criteria All audited annually - 5 Good Practice Criteria One third audited annually over 3 years.
13 How does a clinic obtain RTAC accreditation? Make contact with a certifying body Implement requirements of the Code of Practice Have the clinic inspected by the certifying body - Address non-conformances outlined in any Corrective Action Requests
14 How does a clinic obtain RTAC accreditation? Make contact with a certifying body Implement requirements of the Code of Practice Have the clinic inspected by the certifying body - Address non-conformances outlined in any Corrective Action Requests RTAC Certificate RTAC Licence
15 What are NHMRC Ethical Guidelines? ART clinics must agree to compliance to obtain RTAC accreditation
16 What are NHMRC Ethical Guidelines? ART clinics must agree to compliance to obtain RTAC accreditation Prohibited Practices - Cloning - Research on embryos without a permit - Trading in gametes (eggs and sperm) and embryos - Use of frozen material posthumously without consent - Anonymity of genetic parents and siblings - Sex selection for non-medical reasons
17 % Mean Variances per Clinic Effectiveness of RTAC System % of Clinics with Critical Criteria Variances 90 Mean Critical Criteria Variances per Clinic Jul-Dec 2011 Jan-Jun 2012 Jul-Dec 2012 Jan-Jun 2013 Audit Period Jul-Dec 2011 Jan-Jun 2012 Jul-Dec 2012 Jan-Jun 2013 Audit Period
18 Why have NATA accreditation? Demonstrates compliance with ISO Field Application Document Required by Medicare for patients to claim Diagnostic Testing fees - Blood tests - Hormones - Infectious disease testing - Some genetic testing - Semen Analysis Some small labs do not bother Cost of accreditation exceeds Medicare revenue
19 How does a clinic obtain NATA accreditation? Make contact with NATA Implement requirements of the Field Application Document - Establish a Quality Management System - Establish documented methods - Establish internal quality control - Establish external quality assurance - Establish a system of internal audit
20 How does a clinic obtain NATA accreditation? Make contact with NATA Implement requirements of the Field Application Document - Establish a Quality Management System - Establish documented methods - Establish internal quality control - Establish external quality assurance - Establish a system of internal audit Have the laboratory inspected by NATA - NATA Officer plus Technical Expert
21 How does a clinic obtain NATA accreditation? Make contact with NATA Implement requirements of the Field Application Document - Establish a Quality Management System - Establish documented methods - Establish internal quality control - Establish external quality assurance - Establish a system of internal audit Have the laboratory inspected by NATA - NATA Officer plus Technical Expert NATA accreditation granted
22 Why have ISO 9001 accreditation? Optional level of accreditation to improve clinic function - More use in multi-campus clinics - Improves standardisation of procedures and quality across the clinic - Can be done by the Certifying Body during the RTAC clinic inspection
23 Why have ISO 9001 accreditation? Optional level of accreditation to improve clinic function - More use in multi-campus clinics - Improves standardisation of procedures and quality across the clinic - Can be done by the Certifying Body during the RTAC clinic inspection
24 Thank you
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