ACCREDITATION

Accreditation as a fertility clinic is mandatory for all Australian fertility clinics which offer IVF and related services. Additionally, all professionals involved in providing fertility services such as doctors, nurses, scientists and counsellors who provide ART services are regulated by the Fertility Society of Australia (FSA). The accreditation or certification process has been designed to provide quality and consistency of ART services in Australia.

In contrast, clinics offering just insemination or holistic treatments are not required to seek accreditation and are therefore not held to the same standards. Furthermore, the staff of holistic centres or other non-medical clinics are not required to be members of a professional society.

The FSA regulates fertility clinics providing ART services through the Code of Practice. A subcommittee of the FSA, the Reproductive Technology Accreditation Committee (RTAC) administers the Code of Practice and it applies to individual practitioners, patients and clinics as a whole.

This Code of Practice is the oldest code of practice in existence for ART and provides a framework for accreditation. Like many other regulatory frameworks, the Code of Practice is based upon the International Organisation for Standardization (ISO) principles. The most common ISO is ISO 9001 which is held by a lot of businesses in Australia and around the world.

Embodied in the Code of Practice is a requirement to follow the NHMRC ethical guidelines. This ensures that patients receive a consistent and ethical service that meets the majority of needs. The Code of Practice is reviewed every 3 years so that it remains relevant to current practice and laws and the last review was in October 2017.

RTAC has the overall responsibility for the Code of Practice but any changes must be approved by the board of the FSA before being incorporated into it. Accreditation of a fertility clinic requires initial certification of a new fertility clinic and then full recertification each three years, with review of specific critical criteria annually. An example of how RTAC regulates fertility clinics and research laboratories is that as a result of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Research Amendment Act, 2006, it is an offence in Commonwealth law to use human embryos in any way without RTAC licensing.

Although RTAC administers the Code of Practice it does not perform accreditations on fertility clinics. External, independent certification bodies perform the accreditation process. A certification body must itself be approved and certified by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) (Reference: http://www.jas-anz.org/).

NATA (National Association of Testing Authorities)

Most of the full service fertility clinics hold NATA accreditation as pathology laboratories. NATA accreditation is a Commonwealth requirement if Medicare benefits are to be claimed for semen tests or blood hormone tests outside those included in the Medicare 13200 item number for IVF treatment. (See Fees>Medicare section for further information on item number 13200.)

If a fertility clinic has chosen not to apply for NATA accreditation as a pathology provider for a particular test then patients will be unable to claim Medicare rebates for that test. In this case patients may be referred to an external laboratory for that testing.

The standard is ISO-15189:2012 and all pathology laboratories in Australia must comply with this standard. The accreditation is carried out by the independent certification body NATA (National Association of Testing Authorities). Audits are carried out annually whereby not all aspects are inspected each year, but are inspected over a 3 year period. This standard is quite rigorous and enforces a minimum standard of quality on the results provided by the laboratory.

References

Commonwealth of Australia. Prohibition of Human Cloning for Reproduction and the Regulation of Human Research Amendment Act, 2006, (2006). Canberra.

Fertility Society of Australia » RTAC. (2017). Retrieved from https://www.fertilitysociety.com.au/rtac/

infertility | Definition of infertility in English by Oxford Dictionaries. (2018). Retrieved from https://en.oxforddictionaries.com/definition/infertility

ISO. (2012). ISO 15189:2012 Medical Laboratories – Requirements for quality and competence (38th ed.). Geneva.

ISO 9001 Quality management. (2018). Retrieved from https://www.iso.org/iso-9001-quality-management.html

JAS ANZ. (2018). Retrieved from http://www.jas-anz.com.au/

National Health and Medical Research Council. (2017). Ethical guidelines on the use of assisted reproductive technology in clinical practice and research. Canberra.