Page 7 - FSANZ Autumn 21 Volume 95 Amended

Audits resume with new scheme rules
Auditing of IVF units under the Reproductive Technology Accreditation Committee’s Code of Practice (COP) resumed on 1 January 2021 after being postponed and subsequently suspended last year because of the COVID-19 pandemic.
Because of the deferral, operating licences for units were extended for 12 months pending the resumption of audits by certifying bodies.
RTAC Chair, Chris Copeland, said while the pandemic was still creating challenges for units, each is trying to cope with a “new normal.”
He said the resumption of the audit program on 1 January followed extensive consultation with each of the certifying bodies.
The following information outlining the process has been forwarded to all units regarding the auditing of the RTAC COP in the COVID environment.
The auditing process will continue to be managed by the certifying bodies in a similar manner to that conducted before the COVID shutdown.
Although it is the stated aim of RTAC to return to onsite auditing of all units, this may not be possible for some units – especially those located outside of Australia – for several years to come.”
The following arrangements are now in place:
Remote audits performed by video conferencing will replace on-site audits where an on-site audit cannot be performed due to government enforced COVID restrictions. If an on-site audit is feasible, then this is the method of audit that should be applied.
Assisted reproductive technology units must be available to participate in either a remote or on-site audit as circumstances dictate. If an audit is not possible then the licence may be renewed by RTAC, but only after consultation with the certifying body.
Each certifying body will manage the day-to-day operation of a remote audit as they do for on-site audits. The COP will be audited according to the same schedule and an audit under either method will be equivalent and employ the same vigour.
The certifying body will assess the increased risk associated with the remote audit and any increased risk will be detailed within the audit report and will form part of the recommendations of the audit. This may include a subsequent on-site audit as determined by the certifying body and allowed within COVID restrictions.
The intention is for audits in 2021 and 2022 to catch up on those audits suspended in 2020 and units will need to negotiate with their certifying body on the most appropriate way to achieve this outcome.
Each unit will need to communicate with their certifying body regarding the method of audit.
Chris Copeland
If a remote audit is required, each unit must ensure that the information technology infrastructure needed to be in place for the remote audit has been tested.
This policy will be reviewed six monthly or more frequently as circumstances around COVID evolve.
Scheme Rules
The RTAC Scheme Rules define the requirements for bodies providing audit and certification to the Australian and New Zealand COP and the international COP.
The FSANZ Board and the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) have approved revised Scheme Rules that are presented on the FSANZ website www. fertilitysociety.com.au
The new Scheme Rules require each assisted reproductive technology unit to be audited at least once in every three-year cycle by at least two auditors – one of which is the lead auditor and the other a technical expert (TE).
The TE does not have to be a qualified auditor, but must have different qualifications to the lead auditor.
Professional groups have been asked to provide a list of potential TEs and submit these to the certifying bodies via the secretariat. The certifying body will propose a TE and negotiate with the ART unit.
If the ART unit refuses all TE nominations, the audit will not proceed and the licence will lapse and require renewal.
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