Changes to Human Pathology Assessments

15 December 2020

Human Pathology

At NATA, we understand that no two facilities are the same. That’s why we’re making changes to our Human Pathology assessment model to better align with the way our industry structures itself, as well as with NPAAC supervision arrangements.

From 1 January 2021, your facility will be assessed as a single governance structure, meaning that the NATA assessment will see laboratories the way they see themselves. There will be a focus on clinical governance and risk management across the organisation. Together, this will result in an assessment plan that is tailored to your facility, maximising the benefits to you.

The approach will involve a renewed focus on clinical governance and risk-management including at the highest level of the organisation. The role of the Designate Person will be explored and assessments of the main lab (GX) in your organisation will include a review of how supervision is managed across all labs in the network.

Jennifer EvansWhat does this mean for me?

We’ve been working with you for the last six months to understand your facility to ultimately make the transition smooth. This means that from your next assessment, you will be moved over to the revised assessment model. Extra visits in the initial stage of the assessment may be required in order to meet all regulatory and ILAC agreements, however these will not result in any further cost to you.

By now, your CC will have been in contact with you to confirm supervision arrangements as well as to go through your facility's individual assessment plan. No further action is required by you at this stage. If you have any further questions please see our FAQs below or contact your client coordinator directly.


FAQs

What are the changes and when will they apply?
Starting from 1 Jan 2021, NATA will be rolling out the revised Human Pathology assessment model. Your CC will be best placed to explain what to expect and when the new model will apply to you.

Will this change the way I prepare for assessments? How?
You may find the focus of the assessment changes to include clinical governance and risk particularly of the labs that your lab supervisors.

Why are you making this change?
The NPAAC supervision document became effective in August 2019. Laboratories have changed their structures in line with this document and the Revised assessment model reflects those changes. Additionally, advances in automation have made the running of labs more efficient and fool proof. NATA sees the need to change the focus of its assessments and will focus on governance and risk.

Why is this change being made now?
NATA has been working through the changes over the last year. We have worked on identifying lab structures and the supervision arrangements in place for each test in your laboratory’s scope of accreditation. Your assessment plans going forward should now have been discussed between you and your client coordinator. The next step is to simply start the new process.

What does it mean for me and my assessments moving forward?
This is a positive step forward for you and your facility as it will effectively mean a tailored approach to your assessment. The revised assessment model will be focusing more on Clinical governance and risk in line with the requirements of NPAAC. You will have been provided with an assessment plan for the roll out of the revised model for your organisation.

I’m in the middle of my assessment cycle. Will we continue on with the original process or will it now change to the new procedures?
Your Client coordinator should by now have been in touch with details of your revised assessment plan. If this hasn't happened, contact with your Client Coordinator to review your plans. The introduction of the plans still requires NATA to comply with the regulatory requirement so the commencement will be tailored to ensure those requirements are covered. Additionally there may be some more frequent visits which will be at no extra cost to the lab to ensure a smooth transition.

Will there be a change in my annual fees as a result of these changes?
As a result of these changes, fees will not increase.

I still don’t understand what this means for me. Can anyone help?
Speak to your Client Coordinator.