The following needs to be worded in a way that is suitable for presenting as a report at a meeting. Report for NATA

IANZ was evaluated by APAC in March 2023 and there were two findings relevant to Healthcare. The first was that the Medical Testing Scopes of Accreditation did not list the component, parameter or characteristic tested in some disciplines. A new Scope format has been created that includes analytes and corresponding analysers used. The second finding involved a change in terminology used in reports. Assessment Reports will no longer distinguish between Major or Minor nonconformities. Laboratories will now have a timeframe of 3 months to resolve nonconformities, reduced from the previous 6-month period. However, nonconformities that pose a high risk to patients or staff will require clearance within 1 month or less. The section titled “Observations” has been replaced with “Comments.”

There are currently 60 laboratories accredited to ISO15189. In the last year several workplace drug testing laboratories have transferred from the 15189 programme to the 17025 programme. Three laboratories that only performed Covid testing have voluntarily withdrawn their accreditation to 15189. The accreditation of APS Histology has been temporarily suspended by IANZ due to ongoing issues concerning elevated formaldehyde levels and prolonged TATs. This is the largest Histology laboratory in the country.

In December 2022 IANZ relocated approximately 400m. The medical assessment team is delighted with their new open plan office layout. In addition to improved lighting and functional toilets, the new setup facilitates better communication with other teams, management, and IT.

A new set of KPIs is currently being developed. The draft version is undergoing feedback collection.
Proposed performance indicators:
(a)	85% of assigned assessments should be completed within 1 month of the due date. 
(b)	95% of assigned assessments should be conducted within 3 months of the due date.
(c)	95% of Reports should be issued within 10 working days after completing the on-site assessment.
(d)	95% of invoices should be issued within 15 working days following the last day of the assessment
(e)	95% of NCs should be resolved within 3 months following the assessment date.
(f)	95% of PMARs should be submitted within 7 working days of clearing NCs
(g)	95% of PMARs should be reviewed within 10 working days of submission.
The discussion on KPIs predominantly revolved around billable hours. However, instead of a billable hours KPI, we propose implementing a target range for billable hours to guide teams and establish a goal of staying within the “green range” throughout the year.

As from July 1st, 2024, all medical laboratory assessments will be conducted against ISO 15189:2022. Prior to that, laboratories have the option to choose between the 2012 or 2022 version for assessment. Currently, only four laboratories have taken up this option and are still in the process of transitioning.  Although these labs had multiple nonconformities with the Quality Management System (QMS) not meeting the new standard, the nature of these nonconformities was not expected to be problematic.

The Specific Criteria is being updated to align with ISO 15189:2022. A draft version has been distributed to all Quality Managers, Point of Care Testing (PoCT) managers, MT-PAC members, and Assessors for review and comment. Further updates to the Specific Criteria are anticipated as IANZ and clients transition to ISO 15189:2022.

The medical healthcare team has welcomed two new assessors, completing the team’s staffing requirements. The Medical Team is now fully staffed although one staff member has been on long-term sick leave.