Important Notice
If you have ISO9001, a delay in your scheduled audit may be permissible, however we are suggesting that our clients undertake their ISO9001 audits remotely.
New Zealand clients have been afforded an extension on NZ8181 until the 30/9/2020, with a MOH review in July.
What does the suspension policy mean for our licence?
Under this policy, all audits have been postponed until 2021 and licences have been automatically extended for 12 months. If your licence expired on 30th June 2020 it will now expire on 30th June 2021. There are some exceptions to this policy which will be dealt with on an individual basis.
Do I need to do anything about extending the licence?
No, all licenses will be automatically extended and you will be sent a new certificate before your existing licence was due to expire. However, this will take time to process. If your licence is about to expire please send a polite request to the FSA secretariat in regards to expediting your licence renewal. Your patience with this process is appreciated.
Do I need to inform my Certifying Body (CB) of the licence extension?
No, however, it would be courteous to keep in contact with them.
Does this mean the Code of Practice has been suspended?
No, the Code of Practice (COP) remains in force and the unit is required to abide by all the criteria detailed in the COP and the policies and procedures contained in the unit’s quality manuals. In particular close attention must be paid to providing adequate staff and that staff are adequately supervised (Section 1.4, Critical Criterion 2), should the unit be providing services albeit in a reduced way.
What does hibernation mean for our unit?
Hibernation is a term that has entered the COVID-19 vocabulary and its meaning varies among different people and organisations. From an RTAC perspective, a unit entering hibernation has closed temporarily and is not presently providing treatment to patients on its licensed premises. The unit in hibernation must continue to monitor any stored embryos, sperm or eggs. It must ensure that cryo tanks are monitored and are physically checked according to the policies and procedures laid out in that unit’s manuals (Section 1.7.2 of the COP).
What happens if the unit doesn’t reopen, i.e. it permanently closes?
Unfortunately, some units may close permanently as a result of the COVID-19 medical emergency. Section 1.7.2 of the COP covers the specific responsibilities of the unit in these circumstances. Arrangements must be made with another unit for the care and responsibility for any cryo stored embryos, eggs and sperm. Also, all records about patient treatments and donor records are to be handed over to another clinic for management.
Will new licences be issued?
No new licences will be issued until the crisis has been officially declared as over. If you are in the middle of relocating then this may need to be postponed, however, contact your CB and discuss your plans.
Our unit wants to continue the existing patient cycles using a different hospital or daycare centre. How do we obtain a licence to do this?
This will depend. You must contact your CB and discuss your plans. The CB will then contact RTAC with a recommendation and a new temporary licence may be issued.
Are units still required to report adverse events?Yes, the COP has not been suspended and each unit must report all adverse events that occur as required in the COP.
What will be reviewed at my next audit in 2021?
For those units not assessed in 2020, good practice criteria will need to include both what was scheduled for 2020 as well as what is scheduled for 2021. This may necessitate extra time on site for those units and this will need to be agreed with your CB at the time of the audit.
Hibernation Checklist
The checklist below has been developed for those units contemplating placing their clinics in “hibernation”for the duration of the crisis. A link to the “Coronavirus Business Owners Guide” has also been provided which may be useful.
We would like to thank you for your patience whilst we work through this unusual environment together. As always Global-Mark will provide you with our highest level of services, and keep you informed with the most up-to-date information on certification.
Please don’t hesitate to contact me if you need further support or have any concerns email me on donna.close@global-mark.com.au.
Client Manager & RTAC Program Manager
