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1. APAC Nonconformity Responses

a) The new Scope of Accreditation will list each analyte and the name of the analyser used.

b) Assessment Reports will no longer differentiate between Major or Minor nonconformities. Laboratories will now have 3 months to clear nonconformities (previously 6 months). However, nonconformities with a high risk to patients (or staff) will have a shorter clearance time of 1 month or less. Observations have been replaced by Comments.

2. New Labs

a) The Skin Institute had an Initial Assessment in 2022 and has now applied to progress with gaining accreditation. However, because it has not responded to the Nonconformities raised last year and will now need to be assessed against ISO15189:2022.

b) Orbis Diagnostics has expressed interest in gaining accreditation for Hepatitis and HIV Serology testing.

3. Suspension of Accreditation

APS Histology has been suspended due to ongoing issues with high formaldehyde levels and poor TATs. This is the largest Histology laboratory in the country.

4. Withdrawal of Accreditation

Two laboratories have voluntarily had their accreditation withdrawn. Both laboratories were only testing for Covid.

5. Internal Auditing Course

IANZ went onsite to Waikato hospital to deliver an Internal Auditing course in July 2023. The training was well received, and feedback was overwhelmingly positive.

6. Healthcare in the New Office

The medical assessment team is enjoying their new open plan office layout. Apart from having better lighting and functional toilets, it is now much easier to communicate with other teams, management, and IT especially.

7. Key Performance Indicators (KPIs)

A new set of KPIs is in the process of being developed. It is still in draft form while feedback is being sought.

Proposed performance indicators:
- 85% of assigned assessments are to be conducted within 1 month of the due date. An assessment due in May should be completed in May, but it can be completed any time between April and June and still meet this goal.
- 95% of assigned assessments are to be conducted within 3 months of the due date.
- 95% of Reports to be issued within 10 working days of completing the on-site assessment.
- 95% of Invoices to be issued no more than 15 working days after the last day of the assessment.
- 95% of Corrective Action Requests (CARs) to be cleared within 3 months of the assessment date.
- 95% of Post-Market Activity Reports (PMARs) to be submitted within 7 working days of CAR clearance completion.
- 95% of PMARs to be reviewed within 10 working days of being submitted.
- The whole discussion on KPIs largely revolved around billable hours. Instead of having a billable hours KPI, we are proposing a range for billable hours to guide teams and provide a goal to stay within the ‘green range’ for the year.

8. Transition to ISO 15189:2022

- All medical laboratory assessments from 1st July 2024 will be against ISO 15189:2022. Prior to that, laboratories can choose to be assessed against the 2012 or 2022 version.
- To date, only four laboratories are in the process of transitioning – Whangarei, Dargaville, Kaitaia, and Bay of Islands. There were multiple nonconformities where the Quality Management System (QMS) did not meet the new standard; however, addressing these issues is not expected to be problematic for these laboratories.

9. Specific Criteria for Accreditation

The Specific Criteria is in the process of being updated in line with ISO 15189:2022. A draft version has been sent to all Quality Managers, all Point of Care Testing (PoCT) managers, MT-PAC members, and each Assessor asking for comment. It is envisaged that as IANZ and the clients transition to ISO 15189:2022, the Specific Criteria will require further updates.

10. Staff

Two new assessors have joined the medical healthcare team, which is now fully staffed. One staff member has been off on long-term sick leave.