It is a good idea to transition to implementing the POC test on a wider scale fairly soon after the pilot so that the experience from the pilot can be directly applied. The pilot will have explored all the important aspects of introducing a new test (policy aspects, advocacy and communications, engagement with stakeholders, test selection, testing algorithms, treatment, procurement and supply chain management, referral pathways, training, quality management, project management, monitoring and evaluation). The most important factors influencing scale-up will be the support and commitment of stakeholders.
Key questions to ask when planning for scale-up include:
- Who will be responsible for managing the scale up? Are the necessary governance measures in place to ensure this is well managed?
- What role will the technical working group play?
- How will it be funded?
- Does the design for scale up have clear objectives with a clear understanding of the expected health benefits?
- Has the pilot raised any concerns with implementation that need to be considered for scale-up? Have you thought about the risks involved in scaling up and how to address these risks?
- Are there any policy or regulatory changes that need to be in place before scale-up? Is there a need for advocacy?
- Can the POC test be integrated within the existing health structure? How will this be done?
- Will the POC test be used as part of a formal screening program? If the test is being introduced as a formal Screening Program, then it must have certain specific attributes (Note that these attributes are also useful to consider even if the POC test is not to be used in this way). For example, The Population Based Screening Framework of the Australian Population Health Development Principal Committee states that screening programs must:
|Respond to a recognised need||Have a clear definition of the program objectives & expected health benefits|
|Identify the population that will benefit from screening||Promote equity and access to screening for the entire target population|
|Have scientific evidence of screening program effectiveness||Ensure the overall benefits of screening outweigh the harm|
|Be cost-effective overall||Use cost-effective measures to encourage high coverage|
|Ensure informed choice, confidentiality and respect for autonomy||Have evidence-based guidelines & policies for assessment, diagnosis and support for people with a positive test result|
|Clearly define the screening pathway & screening interval||Have a referral system for management of any abnormalities found and for providing information about normal screening tests|
|Have adequate facilities available for having tests and interpreting them||Have adequate facilities for follow-up assessment, diagnosis, management and treatment|
|Integrate education, testing, clinical services and program management||Ensure availability of the organisation, infrastructure, facilities and workforce needed to deliver the screening program|
|Plan evaluation from the outset and ensure that program data are maintained so that evaluation & monitoring of the program can be performed regularly||Have an organised quality control program across the screening pathway to minimise potential risks of screening|
|Have adequate resources available to set up and maintain a database of health information collected for the program||Have a database of the target population that can invite people for initial screening, recall people for repeat screening, follow those with identified abnormalities, link with morbidity & mortality results, and monitor & evaluate the program and its impact|
- Is a procurement, distribution and stock management system in place and working to ensure test kits and relevant consumables are available in all testing sites?
- What monitoring needs to be in place to track the performance of the new STI POC test? Have you planned for periodic evaluations?
- How will quality be maintained (e.g. use of standard operating procedures, internal and external quality controls to monitor the performance of each test and the performance of testing processes and outcomes etc.)? Who will be responsible for this? What resources have been allocated? Are there performance standards for the test, people using the test and sites using the test?
- Can staff training to use the POC tests be integrated into existing health worker education and training?
- How will the views of the target population (and wider community) be heard and incorporated into implementation of the POC test? What role will they plan in monitoring or managing the program?