1         References

The following documents are references to the Certification program:

·          Reproductive Technology Accreditation Committee: Code of Practice for Assisted Reproductive Technology Units

·          NZS 8181:2007, Fertility Services

·          ISO/IEC Guide 65: 1996 – General requirements for bodies operating product certification systems.

·          International Accreditation Forum, IAF GD5 - Guidance on the Application of ISO/IEC Guide 65:1996

·          ISO 19011:2002 – Guidelines for quality and/or environmental management systems auditing

These documents are available from a Standard organisation and/or www.fertilitysociety.com.au 

2         Overview

Reproductive Technology Accreditation Committee (RTAC) Scheme for the certification of Assisted Reproductive Technology (ART) Units against the Code of Practice for ART Units (COP) is aimed at providing confidence and assurance in the management and competence of organisations/facilities offering reproductive technology.

The Fertility Society of Australia (FSA) is the peak body for reproductive medicine in Australia and New Zealand.  RTAC is the committee of the FSA that developed the Code of Practice and manages the accreditation of ART units. 

The purpose of the RTAC Code of Practice is to set and maintain minimum standards for clinics or centres offering assisted reproductive technology (ART), and to encourage continuous improvement in the quality of care offered to people accessing fertility treatment in Australia and New Zealand.  

The Code of Practice has been benchmarked against the Core Standards for Safety and Quality in Healthcare, and provides a detailed specification covering the management system, process controls, service requirements and qualifications of key personnel.

In New-Zealand, compliance with NZ8181 is a requirement of the Ministry of Health.

3         Scope of the Scheme 

This Scheme details the requirements and procedures for the certification of ART units against the Code of Practice (CoP) or NZ8181. ART units holding a current RTAC Scheme certification issued by a JAS-ANZ accredited RTAC Scheme certification body (CB) like Global-Mark, will be eligible for RTAC licensing as an RTAC accredited ART unit(Not applicable to NZ).

The CoP (or NZ8181) is to be observed in units involved in the treatment of patients with ART including donated gametes or embryos.

Certain ART units in Australia and New Zealand have also been designated by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists as training units for the subspecialty of reproductive endocrinology and infertility. The additional requirements of those units are beyond the scope of the RTAC Scheme.

In Australia, the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 defines an accredited ART centre as a ‘person or body accredited to carry out assisted reproductive technology by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia’.  Under this Act, a person commits an offense (imprisonment for 5 years), if the person ‘intentionally uses, outside the body of a woman, a human embryo that is not an excess ART embryo; and the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre’. As a result, it is currently an offense in Australian Commonwealth law to use human embryos in any way without RTAC licensing. New Zealand has the HART Act 2004 which governs the delivery of ART services.

ART units must also comply with relevant legislation and regulations. In rewriting the CoP, RTAC has attempted to align it with the regulatory and legislative requirements. However, there may be differences in detail between this CoP, National Health and Medical Research Council (NHMRC) guidelines, and the legislation and associated regulations relevant to ART that have been proclaimed by various governments. In such cases, as a general rule, national legislation overrides state legislation, and state legislation overrides regulation / guidelines.

4         Definitions 

ANZARD:  Australian and New Zealand Assisted Reproduction Database

ANZICA:  Australian and New Zealand Infertility Counsellors Association

Appoint: When the Organisation employs, hires, contracts with, chooses, or arranges for a particular individual to provide a certain role.

ART:  Assisted Reproductive Technology

Artificial Insemination: The controlled and planned ART process by which sperm is introduced into the female genital tract with or without hormonal stimulation.

ART Unit: A facility with a laboratory collecting or preparing human gametes and/or embryos for therapeutic service, possibly across a range of sites of clinical activity. Where the collection of gametes/embryos takes place at a different site to the preparation, the two sites are considered to be a single Unit.

Audit: A systematic, independent examination and review to determine whether actual activities and results comply with planned arrangements.

Authority: The proper powers to carry out an action whether granted directly or delegated.

CoP: Code of Practice for ART Units (replaced by NZ8181 for NZ Clinics)

Certification: A third party assessment of the quality system of the service provider with respect to published quality system standards and any supplementary documentation required under the system (for example ISO 19011:2002).

Competent: Having the required ability, knowledge or authority.

CREI: Certificate of Reproductive Endocrinology and Infertility

Deed of Agreement: Signed agreement with the FSA to comply with the RTAC Code of Practice.  A new agreement is required annually.

Facility: The physical location, site or building within or from which the service is provided.

FNA: Fertility Nurses of Australasia

FSA: Fertility Society of Australia

Governance: Taking responsibility for the overall direction of the organisation, including determination of the purpose and goals of the service.

GM: Global-Mark

HIV: Human immunodeficiency virus

Integration: When the Organisation involves, assimilates, incorporates or amalgamates individuals into its day to day activities.

Management: Implementing the policy determined by the governing body and coordinating the day to day service activity which achieve the purpose and goals of the organisation.

Must: Where it is mandatory in every circumstance to perform the required task with no exception.

Organisation: An entity that is accountable for the delivery of services at one or more ART Units.

Ovulation Induction: The controlled and planned ART process whereby hormonal stimulation is employed to induce the process of ovulation.

Patient:  A user or participant in the service.

Policy: Overall intentions and directions of an organisation.

Procedure:  A specific way to carry out an activity.

Process: A set of interrelated or interactive activities which are planned and carried out under controlled conditions.

Quality Policy: Overall intentions and direction of an organisation related to quality as

formally expressed by top management.

Records: A description of the healthcare provided for an identifiable patient/donor. May be a single file, multiple files, hard copy or electronic and be held by an organisation, service provider or the patient/donor themselves.

Review: A formal process of updating, amending, or replanning that is based on evaluation of outcomes.

Risk: The chance of something happening which will have an adverse impact on objectives.

Risk management: The culture, processes and structures that are directed towards realizing potential opportunities whilst managing adverse effects.

Service provider: An individual who is responsible for providing the service either independently or on behalf of an organisation. This includes all staff and management who are employed, self employed, visiting, honorary, sessional, contracted or volunteer.

SIRT: Scientists in Reproductive Technology

Stakeholders: Person or group having an interest in the performance or success of an organisation.

Supervision: An activity that aims to enable the supervisee to achieve, sustain and develop a high quality practice through the means of focused support and development.

Therapeutic Service:  Service aimed at treating patients, such as IVF, IUI. It does not include diagnostic procedures e.g. semen analysis.

5         Specific Program Conditions

Changes to ART Unit:

These include the scope of treatment, key personnel, new or additional site.  The ART should notify Global-Mark in writing of any such changes.  Global-Mark reserves its right to conduct an appropriate audit to confirm compliance with the CoP (or NZ8181) is maintained.

Exceptional circumstances audit:

Should an exceptional circumstance arise concerning an ART unit or organisation and related to compliance with the CoP, the FSA Board retains the right, through RTAC, to require an ART unit to undergo an additional Primary or Surveillance audit conducted by a Global-Mark.

General provisions

If an explanation is required for the consistent application of this Scheme or reference standards, such explanatory requirements shall only be acceptable if approved and published by the RTAC TC.

Certification

RTAC is the organisation/authority who grants Certification.

Internal audit requirement

Certification shall not be granted to the ART unit until there is sufficient evidence to demonstrate that the arrangements for internal audit have been implemented, are effective and are being maintained, and one complete internal audit and review program covering all processes of the ART management system has been conducted.

Privacy

Patient names shall not be communicated with patient information outside of the ART unit, except where subject to written and specific patient consent.

Privacy Legislation requires the RETURN or DISPOSAL of any patient information supplied by the ART unit, or any personal staff information, such as training and competency records.  For the purpose of its reviews and assessment, Global-Mark generally only requires review of records not retention nor for the records to be taken off the ART site.

6         Certification process

6.1          Document review

The client must supply a copy of their System Documents for review (typically Policy Manual and System Procedures).  These will be returned fully (or destroyed if requested by the Client) by Global-Mark after the review is completed.

Once the documents have been reviewed a letter (based on doc review template) should be sent to Client and next step in the process can start.

6.2          Certification Review:

The initial audit (Certification review) of the organisation under the CoP (or NZ8181) must include the critical criteria and all sections of best practice criteria as applicable within each ART unit.

Newly established ART units will undertake the primary audit and be granted an RTAC licence prior to first gamete collection for therapeutic service.

6.3          Post Certification Reviews:

The organisation and all ART units shall be subjected to a surveillance audit at least once in each 12 month period.

Thee scope of these audits as applicable to each ART unit shall cover:

a.       all of the Critical Criteria; plus

b.       a minimum of one-third of the Good Practice Criteria such that all of the Good Practice criteria are covered at each unit during surveillance over each three year period.

Global-Mark shall then convey the findings and any recommendations to the ART unit. The ART unit shall respond to the findings, where applicable, within a required timeframe as prescribed above.

6.4          Reporting:

On completion of a review, Global-Mark shall, within 10 business days, provide a written report and recommendation(s) regarding the continuation of certification, and submit this report to RTAC for the purposes of considering the continuation of the RTAC Licence. The report must include all review findings/non-compliance issues and the corrective actions undertaken.

Reports shall also include the specific report information required by RTAC as detailed in Supplement 2.

For NZ8181, there is no liaison with RTAC, however the reports are uploaded onto the Ministry of Health web site. Certification decisions may also be communicated to the Ministry of Health. 

6.5          Dealing with Review findings:

Global-Mark shall then convey the findings and any recommendations to the organisation. The organisation shall respond to the findings, where applicable, within a required timeframe as present below:

·          Critical Criteria – agreed corrective action within a timeframe negotiated with GM based on the magnitude of the risk, up to a maximum of 30 days; evidence of compliance is required.

·          Good Practice Criteria – agreed corrective action within a timeframe negotiated with GM based on the magnitude of the risk, up to a maximum of 30 days; evidence of compliance, or a documented corrective action plan for correction to be reviewed at next audit, is required.

Any non-conformance related to a high risk activity must be corrected or addressed immediately. This includes but is not limited to:

1. Patient safety

2. Patient identification

3. Traceability

6.6          Transfers to GM

Clients seeking to transfer their certification to Global-Mark, need to supply a copy of their previous audit report(s), a valid and current JASANZ Accredited Certificate and complete a Client Agreement Form, however the following also applies:

Definition of a transfer

The transfer of certification is defined as the recognition of an existing and valid RTAC Scheme certification, granted by one JAS-ANZ accredited RTAC Scheme certification body, (hereinafter referred to as the “issuing CB”), by GM (hereinafter referred to as the “accepting CB”) for the purpose of issuing its own certification.

Minimum Requirements

Accreditation

Only RTAC Scheme certifications which are covered by a JAS-ANZ accredited RTAC Scheme certification shall be eligible for transfer.

Pre-Transfer Review

·          Global-Mark will completed a pre-transfer review, which may include a site visit.

Certification

Normally, only valid JAS-ANZ accredited RTAC Scheme certification should be transferred. In cases where the certification has been granted by a CB which has ceased trading or whose accreditation has expired, been suspended or withdrawn, GM may consider such a certification for transfer at its discretion.

Outstanding nonconformities should be closed out, if practical, with the issuing CB, before transfer. Otherwise they shall be closed out by GM.

If no further outstanding or potential problems are identified by the pre-transfer review, a certification may be issued following the normal decision making process.

Where doubt continues to exist, after the pre-transfer review, as to the adequacy of a current or previously held certification, the GM shall, depending upon the extent of doubt, either:

·          treat the applicant as a new client, OR

·          conduct an audit concentrating on identified problem areas.

7         What Documents/Records Are Needed To Understand This Program

In order to understand our Program you should also access and be aware of the following documents:

·            G-00: Welcome Pack

·            MSP-00: Introduction to our Management Systems

·            MSP-01: Nomenclature and Definitions

·            MSP-24 Appeals

Note: for NZ8181, there is no liaison with RTAC, however, the audit reports and findings are uploaded onto the Ministry of Health web site.

8         Schedule of fees for Assisted Reproductive Technology Units

8.1          Fees (fees exclude GST)

8.2          Conditions

·          Fees are in Australian Dollars, and GST is payable for Australian based clients.  Fee subject to yearly review.

·          This document should read in conjunction with the Welcome Pack, available on our web site: www.global-mark.com.au, which presents the full terms and conditions, certification rules and process, certification programs, and rules governing certification marks.

·          Travel cost and expenses: travel cost and expenses to and from the city where each team member or client manager is based will be charged at cost, unless directly organized by the client.  It is our aim to minimize travel expenses by forward planning, and whenever possible sharing travel with another client (s).

·          Travel time: Global-Mark does not charge for travel time.

·          Variations to scope of certification, or follow ups reviews fees if needed will be charged on the basis of $190 per hour plus GST (minimum 3 hours for Australian based clients)

·          The accreditation levy is charge per year per certificate.  Currently set at $110 per year, per program.

·          This document can be used as a Tax Invoice when making and paying an Application Fee (mentioned above).  Global-Mark Pty Ltd ABN is: 55 108 087 654

   Client Agreement Form

    Application to Reproductive Technology Accreditation Scheme

Your Company Undertakings

This is to confirm that our Company:

·          Wishes to apply for Certification with Global-Mark Pty Ltd.

·          Has read and agrees to comply with the procedures, processes, Terms and Conditions presented in Global-Mark’s document: Welcome Pack.

·          Agrees to pay its bills within 14 days from receipt of an invoice in line with the above mentioned Schedule of Fees, or Fee Proposal.

·          Agrees not to bring Global-Mark into disrepute and to continue to comply with the requirement of the standard to which it seeks or has certification and to provide full access to records, people, processes and systems to Global-Mark.

·          Commits to being truthful and transparent in its relationship with Global-Mark, and will advise Global-Mark should any circumstance arise which may affect compliance to the standard to which it seeks or has certification.

We are aware that the above mentioned documents are available at www.global-mark.com.au and are subject to change by Global-Mark.

We have read, understood and agree with the Fee Proposal or Schedule of Fees

Your Company Details

Your Company People

Declaration and Signature

I am authorised by the Company applying for Certification to sign this form, and to commit the Company to the Terms and Conditions of the Agreement with Global-Mark Pty Ltd.

Signature:________________________ Name of Signatory:__________________________ Date:______________