Monday, June 24, 2024

PCR testing delay review released

The Ministry of Health has today published an external review into delays in PCR testing processing during the early stages of New Zealand’s COVID-19 Omicron outbreak.

Director-General of Health, Dr Ashley Bloomfield said he welcomed the review and its recommendations.

“I’d also like to reassure all New Zealanders that all practical steps were taken to address these issues at the time, including sending more than 9,000 tests to Australia for processing, rolling out rapid antigen tests, and increasing lab capacity,” he said.

As of 1 March, a third of people with delayed test results had already been re-tested and the full backlog of tests were all processed by mid-March, the Ministry confirmed.

In response to the testing delays, Dr Bloomfield also commissioned Allen and Clarke to undertake a review of the circumstances that led to the delays, including forecasting of testing capacity in the lead-up to the Omicron outbreak.

This review has now found four areas contributed to the issues, including laboratory capacity; planning; reporting; and organisational design. It makes a number of recommendations for improvements.

“As we have been throughout the pandemic, we are committed to learning from this experience, and work is well underway to implement the recommendations. The Ministry’s response to this report is also being published today,” said Dr Bloomfield.

He said that by mid-February, Omicron had caused a rapid increase in demand on PCR testing and positivity rates among those tested, resulting in a reduction in pooling of testing that impacted capacity.

Lab staffing was affected by prolonged pressure at the time; some workers testing positive for COVID-19; limits caused by international test reagent availability; distribution and logistics issues.

“These issues arose at a time that the health system was responding rapidly on many fronts to the highly transmissible Omicron variant and the emerging evidence about how it impacted our capacity and resources, including our labs,” said Dr Bloomfield.

Since March 2020, laboratories across the motu have processed more than 7 million PCR tests to support the public health response.

“That’s a mammoth effort – and I want to personally thank laboratory staff across the motu for their ongoing commitment to the health of all New Zealanders.”

“I want to emphasise that this is not the fault of our labs – these staff have been doing phenomenal work throughout the pandemic, and similar issues have faced labs overseas during an Omicron outbreak.

“Overall, New Zealand has done comparatively well in responding to Omicron and this is reflected in hospitalisation and mortality figures. Part of that success is down to the immense work of our lab staff,” the Director-General said.

The review also examined the Ministry’s role in the circumstances that led to delays and identified some processes that led to inconsistencies in reporting of testing capacity. Changes are already being made to address these gaps, said Dr Bloomfield.

“It’s clear from the review’s finding that, we could – and should – have done better on measuring and communicating lab capacity at that time.” 

“When I became aware of these inconsistencies, I informed Ministers and worked with our testing team to ensure we could provide a more consistent and accurate picture of capacity that carefully considered the impact of Omicron.”

This includes an updated Testing Plan that, alongside the latest COVID-19 modelling, will ensure we have a clearer picture of our lab capacity and enhance our ability to respond to future outbreaks, he said.

“We have already strengthened testing expertise within the Ministry, and, alongside Health New Zealand, we are working with the laboratory network and DHBs to ensure testing continues to support New Zealand’s COVID-19 response as it evolves.

“These improvements are being embedded and built upon as responsibility for testing and supply now transitions to Health New Zealand,” said Dr Bloomfield.

The Allen and Clarke PCR Testing Rapid Review can be found here.

Below are the review’s recommendations and the Ministry of Health’s response to them:

1. Recommendation: Review the resourcing model of the COVID-19 Testing and Supply Group to address any capacity deficits and enable the Group to manage current workload and transition away from operation surge settings.

Ministry response: The Ministry will work to strengthen capability and capacity within the Testing Team to ensure the right mix of skills is obtained to support the implementation of the Updated Testing Plan.

2. Recommendation: Develop a clear Testing Plan that determines the role of PCR testing and other modalities going forward, as well as providing clarity about the roles and expectations of the laboratories.

Ministry response:  The Ministry has updated the Testing and COVID-19 Surveillance Plans based on ‘most likely’ COVID-19 scenarios for consideration by Cabinet. The updates were informed by modelling from COVID-19 Modelling Aotearoa and recent experiences in overseas jurisdictions.

The Testing team is developing service implementation plan(s) ensuring the testing requirements for the Updated Testing Plan are met. This will include testing service requirements and specifications for both collection and testing providers.

3. Recommendation: As part of the strategic planning (recommendation 2), address how COVID-19 testing transitions into a business-as-usual laboratory testing regime.

Ministry response: The Ministry agrees that a new operating model is required as we transition from the current state to a business-as-usual laboratory testing regime and is developing a new Operating Model and a new Commissioning Model. 

The development of the new Commissioning Model will bring clarity to:

  • What we are commissioning and how different types of testing (ie non-COVID-19) can be integrated into the model 
  • Baseline and surge capacity requirements
  • Stakeholder engagement.

4. Recommendation: Determine the level of standing PCR testing infrastructure required for future variants or pathogens and where this infrastructure should be maintained as part of the strategic planning (refer to recommendations 2 and 3). In the absence of guidance from the Ministry, some laboratories have signalled they may need to reduce their PCR capacity, including mothballing equipment and reducing staff.

Ministry response: The Updated Testing Plan and new Commissioning Model will enable the Ministry to engage with the DHB and laboratory sector around contractual arrangements to enable them to make informed decisions about the level of PCR infrastructure needed to plan for in the medium term, particularly as we enter the first winter with fewer border restrictions.

The assumptions from all COVID-19 service plans will inform service delivery requirements, the level of NAAT testing capacity and where it is needed.

5. Recommendation: Review the approach to contracting laboratory services to facilitate greater transparency and national coordination in a pandemic. The health systems reforms and transition to new entities (Health NZ, Māori Health Authority, and the Public Health Agency), provides an opportunity to consider how laboratory testing can be better used for surveillance and public health outcomes as part of any review of laboratory services.

Ministry response: The Ministry is working through a procurement process to procure COVID-19 testing services with laboratory providers for 1 July. This will involve:

  • Determining baseline and surge capacity requirements
  • Revise the funding model
  • Market analysis and stakeholder engagement in the process

The Ministry is also developing a new contracting model that will establish Service Level Agreements for contracting laboratory services with key performance and reporting metrics. The Service Level Agreements will cover pricing, minimum specified standards, capacity, consistent performance metrics and a monitoring framework.

6. Recommendation: Consider greater interoperability of information technology platforms so that the data that is generated from laboratory testing can be better used for surveillance and public health outcomes as part of any review of laboratory services.

Ministry response: The Ministry will undertake a gap assessment of current and future end-to-end IT interoperability requirements from test order to reporting of results. This will analyse the current IT state region by region including orders/collections, testing, and reporting.

Once the gap assessment is completed consistent standards and reporting requirements for testing services will be incorporated into all service level agreement contracts.

The Ministry will also catalogue all data sources and methods of collection to map end to end data and information flows.

7. Recommendation: Consider how the Ministry and Health NZ can achieve more integrated ways of operating with laboratories when planning for managing the ongoing testing requirements of COVID-19, and in planning undertaken for future pandemic readiness.

Ministry response: The Ministry agrees and will develop a new contracting model with laboratories that includes:

  • Service level agreements with clear performance metrics and reporting
  • Defined communication pathways
  • Clear roles and responsibilities.

The Ministry agrees with the need to improve transparency of decision making and have timely input from laboratory stakeholders in relation to service design for the Testing response.

8. Recommendation: Ensure there are clear, formal governance arrangements in place between the Ministry and/or Health NZ and laboratories that enable sufficient centralised planning and management of testing in Aotearoa New Zealand’s pandemic approach.

Ministry response: The Ministry will review the governance arrangements with Health NZ and the laboratory sector. The Ministry intends taking a sector stewardship approach to the new governance arrangements, treating the laboratory network as a system. Clear terms of reference, roles and responsibilities and accountabilities will be established for the sector reference groups the Ministry engages with.

9. Recommendation: Consider options to strengthen the Chief Testing Adviser position and shape the role so that the Ministry and/or Health NZ is able to better leverage their subject matter expertise and insights across testing planning, modelling and reporting.

Ministry response: The Ministry will review how work priorities are identified for the Chief Testing Advisor to maximise subject matter expertise across the Science, Surveillance and Insights and Testing and Supply work programme.

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