S.T.A.R.T.S.T.A.R.T.Sydney, May 29, 2016Sydney, May 29, 2016

Regulation of ARTRegulation of ART

S.T.A.R.T.S.T.A.R.T.Sydney, May 29, 2016Sydney, May 29, 2016

Regulation of ARTRegulation of ART

Keith HarrisonKeith Harrison

Chairman, Reproductive Technology Accreditation CommitteeChairman, Reproductive Technology Accreditation Committee

Accreditation Schemes in ARTAccreditation Schemes in ART

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments

In Australia, the Prohibition of Human Cloning for Reproduction and theRegulation of Human Embryo Research Amendment Act 2006 defines anaccredited ART centre as a ‘person or body accredited to carry out assistedreproductive technology by the Reproductive Technology AccreditationCommittee of the Fertility Society of Australia’. Under this Act, a personcommits an offence (imprisonment for 5 years), if the person ‘intentionally uses,outside the body of a woman, a human embryo that is not an excess ARTembryo; and the use is not for a purpose relating to the assisted reproductivetechnology treatment of a woman carried out by an accredited ART centre’.As a result, it is currently an offence in Australian Commonwealth law to usehuman embryos in any way without RTAC licensing.

-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments

In Australia, the Prohibition of Human Cloning for Reproduction and theRegulation of Human Embryo Research Amendment Act 2006 defines anaccredited ART centre as a ‘person or body accredited to carry out assistedreproductive technology by the Reproductive Technology AccreditationCommittee of the Fertility Society of Australia’. Under this Act, a personcommits an offence (imprisonment for 5 years), if the person ‘intentionally uses,outside the body of a woman, a human embryo that is not an excess ARTembryo; and the use is not for a purpose relating to the assisted reproductivetechnology treatment of a woman carried out by an accredited ART centre’.As a result, it is currently an offence in Australian Commonwealth law to usehuman embryos in any way without RTAC licensing.

-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

Accreditation Schemes in ARTAccreditation Schemes in ART

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

Accreditation Schemes in ARTAccreditation Schemes in ART

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

State Legislative Registration BodiesState Legislative Registration Bodies

-- New South Wales, Victoria, Western AustraliaNew South Wales, Victoria, Western Australia

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

State Legislative Registration BodiesState Legislative Registration Bodies

-- New South Wales, Victoria, Western AustraliaNew South Wales, Victoria, Western Australia

Accreditation Schemes in ARTAccreditation Schemes in ART

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

State Legislative BodiesState Legislative Bodies

-- New South Wales, Victoria, Western AustraliaNew South Wales, Victoria, Western Australia

ISO 9001ISO 9001

-- OptionalOptional

RTAC (Reproductive Technology Accreditation Committee)RTAC (Reproductive Technology Accreditation Committee)

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

NATA (National Association of Testing Authorities)NATA (National Association of Testing Authorities)

-- Mandatory for laboratories performing diagnostic testsMandatory for laboratories performing diagnostic tests

State Legislative BodiesState Legislative Bodies

-- New South Wales, Victoria, Western AustraliaNew South Wales, Victoria, Western Australia

ISO 9001ISO 9001

-- OptionalOptional

Why have RTAC accreditation?Why have RTAC accreditation?

Required by Medicare for patientsRequired by Medicare for patients

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- value $2900value $2900 -- $4400$4400-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

No Longer Required by Health Insurance Commission (HIC)No Longer Required by Health Insurance Commission (HIC)

-- For access to free ovulatory drugsFor access to free ovulatory drugs-- value around $3000value around $3000

Required by Medicare for patientsRequired by Medicare for patients

-- Mandatory for clinics offering assisted reproduction treatmentsMandatory for clinics offering assisted reproduction treatments-- value $2900value $2900 -- $4400$4400-- Compliance with NH&MRC Ethical Guidelines for ARTCompliance with NH&MRC Ethical Guidelines for ART

No Longer Required by Health Insurance Commission (HIC)No Longer Required by Health Insurance Commission (HIC)

-- For access to free ovulatory drugsFor access to free ovulatory drugs-- value around $3000value around $3000

What is RTACWhat is RTAC

Reproductive Technology Accreditation CommitteeReproductive Technology Accreditation Committee

Subcommittee of Fertility Society of AustraliaSubcommittee of Fertility Society of Australia

-- Honorary chairpersonHonorary chairperson-- FSA secretariatFSA secretariat-- RTAC Technical CommitteeRTAC Technical Committee

Reproductive Technology Accreditation CommitteeReproductive Technology Accreditation Committee

Subcommittee of Fertility Society of AustraliaSubcommittee of Fertility Society of Australia

-- Honorary chairpersonHonorary chairperson-- FSA secretariatFSA secretariat-- RTAC Technical CommitteeRTAC Technical Committee

What is RTACWhat is RTAC

Reproductive Technology Accreditation CommitteeReproductive Technology Accreditation Committee

Subcommittee of Fertility Society of AustraliaSubcommittee of Fertility Society of Australia

-- Honorary chairpersonHonorary chairperson-- FSA secretariatFSA secretariat-- RTAC CommitteeRTAC Committee

DocumentsDocuments

-- RTAC Code of PracticeRTAC Code of Practice-- RTAC Scheme RulesRTAC Scheme Rules

Reproductive Technology Accreditation CommitteeReproductive Technology Accreditation Committee

Subcommittee of Fertility Society of AustraliaSubcommittee of Fertility Society of Australia

-- Honorary chairpersonHonorary chairperson-- FSA secretariatFSA secretariat-- RTAC CommitteeRTAC Committee

DocumentsDocuments

-- RTAC Code of PracticeRTAC Code of Practice-- RTAC Scheme RulesRTAC Scheme Rules

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

-- Establish aEstablish a Quality Management SystemQuality Management System

-- Establish a treatment database that gathers data to allow mandatoryEstablish a treatment database that gathers data to allow mandatoryreporting of dereporting of de--identified data to ANZARD (Australia & New Zealandidentified data to ANZARD (Australia & New ZealandAssisted Reproduction Database)Assisted Reproduction Database)

-- Ensure that the clinic structure has appropriate personnel & structureEnsure that the clinic structure has appropriate personnel & structure

-- Establish a laboratory that meets the requirements of the Code ofEstablish a laboratory that meets the requirements of the Code ofPracticePractice

-- Medical Director signs a Deed of Agreement with the FSAMedical Director signs a Deed of Agreement with the FSA

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

-- Establish aEstablish a Quality Management SystemQuality Management System

-- Establish a treatment database that gathers data to allow mandatoryEstablish a treatment database that gathers data to allow mandatoryreporting of dereporting of de--identified data to ANZARD (Australia & New Zealandidentified data to ANZARD (Australia & New ZealandAssisted Reproduction Database)Assisted Reproduction Database)

-- Ensure that the clinic structure has appropriate personnel & structureEnsure that the clinic structure has appropriate personnel & structure

-- Establish a laboratory that meets the requirements of the Code ofEstablish a laboratory that meets the requirements of the Code ofPracticePractice

-- Medical Director signs a Deed of Agreement with the FSAMedical Director signs a Deed of Agreement with the FSA

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- 14 Critical Criteria14 Critical CriteriaAll audited annuallyAll audited annually

-- 16 Good Practice Criteria16 Good Practice CriteriaOne third audited annually overOne third audited annually over3 years.3 years.

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- 14 Critical Criteria14 Critical CriteriaAll audited annuallyAll audited annually

-- 16 Good Practice Criteria16 Good Practice CriteriaOne third audited annually overOne third audited annually over3 years.3 years.

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- Address nonAddress non--conformances outlined in any Corrective Action Requestsconformances outlined in any Corrective Action Requests

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- Address nonAddress non--conformances outlined in any Corrective Action Requestsconformances outlined in any Corrective Action Requests

How does a clinic obtain RTAC accreditation?How does a clinic obtain RTAC accreditation?

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- Address nonAddress non--conformances outlined in any Corrective Action Requestsconformances outlined in any Corrective Action Requests

RTAC CertificateRTAC Certificate RTACRTAC LicenceLicence

Make contact with a certifying bodyMake contact with a certifying body

Implement requirements of the Code of PracticeImplement requirements of the Code of Practice

Have the clinic inspected by the certifying bodyHave the clinic inspected by the certifying body

-- Address nonAddress non--conformances outlined in any Corrective Action Requestsconformances outlined in any Corrective Action Requests

RTAC CertificateRTAC Certificate RTACRTAC LicenceLicence

What are NHMRC Ethical Guidelines?What are NHMRC Ethical Guidelines?

ART clinics must agree to compliance to obtain RTAC accreditationART clinics must agree to compliance to obtain RTAC accreditation

What are NHMRC Ethical Guidelines?What are NHMRC Ethical Guidelines?

ART clinics must agree to compliance to obtain RTAC accreditationART clinics must agree to compliance to obtain RTAC accreditation

Prohibited PracticesProhibited Practices

-- CloningCloning

-- Research on embryos without a permitResearch on embryos without a permit

-- Trading in gametes (eggs and sperm) and embryosTrading in gametes (eggs and sperm) and embryos

-- Use of frozen material posthumously without consentUse of frozen material posthumously without consent

-- Anonymity of genetic parents and siblingsAnonymity of genetic parents and siblings

-- Sex selection for nonSex selection for non--medical reasonsmedical reasons

ART clinics must agree to compliance to obtain RTAC accreditationART clinics must agree to compliance to obtain RTAC accreditation

Prohibited PracticesProhibited Practices

-- CloningCloning

-- Research on embryos without a permitResearch on embryos without a permit

-- Trading in gametes (eggs and sperm) and embryosTrading in gametes (eggs and sperm) and embryos

-- Use of frozen material posthumously without consentUse of frozen material posthumously without consent

-- Anonymity of genetic parents and siblingsAnonymity of genetic parents and siblings

-- Sex selection for nonSex selection for non--medical reasonsmedical reasons

Quality Management SystemQuality Management System

Required by most accreditation systems.Required by most accreditation systems.

A quality management system provides the integration ofA quality management system provides the integration of

-- organizational structureorganizational structure-- processesprocesses-- proceduresprocedures-- resourcesresources

to fulfill a quality policy and thus meet the needs andto fulfill a quality policy and thus meet the needs andrequirements of the users (patients, management & staff)requirements of the users (patients, management & staff)

Required by most accreditation systems.Required by most accreditation systems.

A quality management system provides the integration ofA quality management system provides the integration of

-- organizational structureorganizational structure-- processesprocesses-- proceduresprocedures-- resourcesresources

to fulfill a quality policy and thus meet the needs andto fulfill a quality policy and thus meet the needs andrequirements of the users (patients, management & staff)requirements of the users (patients, management & staff)

Quality Management SystemQuality Management System

Required by most accreditation systems.Required by most accreditation systems.

A quality management system provides the integration ofA quality management system provides the integration of

-- organizational structureorganizational structure-- processesprocesses-- proceduresprocedures-- resourcesresources

to fulfill a quality policy and thus meet the needs and requirements of theto fulfill a quality policy and thus meet the needs and requirements of theusers (patients, management & staff)users (patients, management & staff)

If it isn’t documented, it didn’t happen or it doesn’t exist.If it isn’t documented, it didn’t happen or it doesn’t exist.

Required by most accreditation systems.Required by most accreditation systems.

A quality management system provides the integration ofA quality management system provides the integration of

-- organizational structureorganizational structure-- processesprocesses-- proceduresprocedures-- resourcesresources

to fulfill a quality policy and thus meet the needs and requirements of theto fulfill a quality policy and thus meet the needs and requirements of theusers (patients, management & staff)users (patients, management & staff)

If it isn’t documented, it didn’t happen or it doesn’t exist.If it isn’t documented, it didn’t happen or it doesn’t exist.

Effectiveness of RTAC SystemEffectiveness of RTAC System

70

80

90

% of Clinics with Critical Criteria Variances

1.6

1.8

Mea

nVa

rianc

espe

r Clin

ic

Mean Critical Criteria Variances per Clinic

0

10

20

30

40

50

60

70

Jul-Dec 2011 Jan-Jun 2012 Jul-Dec 2012 Jan-Jun 2013

%

Audit Period

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

Jul-Dec 2011 Jan-Jun 2012 Jul-Dec 2012 Jan-Jun 2013

Mea

nVa

rianc

espe

r Clin

ic

Audit Period

Why have NATA accreditation?Why have NATA accreditation?

Required by Medicare for patients to claim Diagnostic Testing feesRequired by Medicare for patients to claim Diagnostic Testing fees

-- Blood testsBlood tests-- HormonesHormones-- Infectious disease testingInfectious disease testing-- Some genetic testingSome genetic testing

-- Semen AnalysisSemen Analysis

Required by TGA from July 1, 2017 for all diagnostic testing,Required by TGA from July 1, 2017 for all diagnostic testing,whether Medicare items or not.whether Medicare items or not.

Required by Medicare for patients to claim Diagnostic Testing feesRequired by Medicare for patients to claim Diagnostic Testing fees

-- Blood testsBlood tests-- HormonesHormones-- Infectious disease testingInfectious disease testing-- Some genetic testingSome genetic testing

-- Semen AnalysisSemen Analysis

Required by TGA from July 1, 2017 for all diagnostic testing,Required by TGA from July 1, 2017 for all diagnostic testing,whether Medicare items or not.whether Medicare items or not.

How does a clinic obtain NATA accreditation?How does a clinic obtain NATA accreditation?

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

How does a clinic obtain NATA accreditation?How does a clinic obtain NATA accreditation?

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

Have the laboratory inspected by NATAHave the laboratory inspected by NATA

-- NATA Officer plus Technical ExpertNATA Officer plus Technical Expert

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

Have the laboratory inspected by NATAHave the laboratory inspected by NATA

-- NATA Officer plus Technical ExpertNATA Officer plus Technical Expert

How does a clinic obtain NATA accreditation?How does a clinic obtain NATA accreditation?

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

Have the laboratory inspected by NATAHave the laboratory inspected by NATA

-- NATA Officer plus Technical ExpertNATA Officer plus Technical Expert

NATA accreditation grantedNATA accreditation granted

Make contact with NATAMake contact with NATA

Implement requirements of the Field Application DocumentImplement requirements of the Field Application Document

-- Establish a Quality Management SystemEstablish a Quality Management System-- Establish documented methodsEstablish documented methods-- Establish internal quality controlEstablish internal quality control-- Establish external quality assuranceEstablish external quality assurance-- Establish a system of internal auditEstablish a system of internal audit

Have the laboratory inspected by NATAHave the laboratory inspected by NATA

-- NATA Officer plus Technical ExpertNATA Officer plus Technical Expert

NATA accreditation grantedNATA accreditation granted

Why have ISO 9001 accreditation?Why have ISO 9001 accreditation?

Optional level of accreditation to improveOptional level of accreditation to improve clinic functionclinic function

-- More use in multiMore use in multi--campus clinicscampus clinics-- ImprovesImproves standardisationstandardisation of procedures and quality across the clinicof procedures and quality across the clinic

-- Can be done by the Certifying Body during the RTAC clinic inspectionCan be done by the Certifying Body during the RTAC clinic inspection

Optional level of accreditation to improveOptional level of accreditation to improve clinic functionclinic function

-- More use in multiMore use in multi--campus clinicscampus clinics-- ImprovesImproves standardisationstandardisation of procedures and quality across the clinicof procedures and quality across the clinic

-- Can be done by the Certifying Body during the RTAC clinic inspectionCan be done by the Certifying Body during the RTAC clinic inspection

Why have ISO 9001 accreditation?Why have ISO 9001 accreditation?

Optional level of accreditation to improve clinic functionOptional level of accreditation to improve clinic function

-- More use in multiMore use in multi--campus clinicscampus clinics-- ImprovesImproves standardisationstandardisation of procedures and quality across the clinicof procedures and quality across the clinic

-- Can be done by the Certifying Body during the RTAC clinic inspectionCan be done by the Certifying Body during the RTAC clinic inspection

Optional level of accreditation to improve clinic functionOptional level of accreditation to improve clinic function

-- More use in multiMore use in multi--campus clinicscampus clinics-- ImprovesImproves standardisationstandardisation of procedures and quality across the clinicof procedures and quality across the clinic

-- Can be done by the Certifying Body during the RTAC clinic inspectionCan be done by the Certifying Body during the RTAC clinic inspection

RTAC International Code of PracticeRTAC International Code of Practice

Thank youThank you