Equitable access to full blood examination testing at the point of care in remote primary health

The SPOCTrial is a multi-component intervention that introduces a new model of care for sepsis detection. The nine intervention components are detailed below. 1. POC FBE Testing System, Connectivity and Consumables The core component of the SPOCTrial intervention is the inclusion of a POC FBE test within the Primary Health Care Sepsis Pathway(s). To enable this test, the PixCell HemoScreen™ POC FBE device and associated equipment will be installed within a suitable location at each participating health centre during the transition month. The POC FBE testing system, including connectivity and consumables consists of: • 1x PixCell HemoScreen POC FBE device. • 1x Citizen printer. • 1x barcode scanner (optional). • 1x Dell OptiPlex Micro. • MediTrac and Atellica® Connect POC Insights software (Siemens Healthcare Pty Ltd). • 1x 4G data SIM and dongle. • CBC cartridges. • CBC samplers. • HemoCups. The POC FBE testing system will be available for health care professionals to use with clients as needed throughout the transition and intervention phases. 2. Introductory Education and Site Assessment Each participating health centre will receive an introductory education session covering the SPOCTrial protocol and intervention, the Primary Health Care Adult and Paediatric Sepsis Pathways, the CARPA Standard Treatment Manual’s early recognition of sepsis acute assessment protocol, how POC FBE tests fit within these, and a demonstration of POC FBE testing system. The session (~1 hr) will be delivered by the SPOCTrial PixCell Operations and Clinical Support Team member(s) to Site Principal Investigator (PI), Primary Health Centre Managers (PHCM) and other relevant health centre and health organisation staff (to be determined locally). Each health centre will receive at least one session during the transition period, or within 4 weeks prior and can be repeated as many times as requested by the PHCM, Site PI or local PixCell Champion during the transition and intervention phases. This session will be interactive and allow participants to ask questions to ensure they have a good understanding of the SPOCTrial intervention and to identify any local issues which may impact implementation. Frequently asked questions will be noted and used to improve future education sessions. During the transition period, a site assessment will be conducted by SPOCTrial PixCell Operations and Clinical Support Team member(s) with the PHCM, local PixCell Champion, Site PI or delegate(s). The site assessment will cover local context, identify the PixCell Champion(s), appropriate physical locations for POC FBE test system and consumables, consumable delivery options, and local barriers to the SPOCTrial. 3. Sepsis and Primary Health Care Sepsis Pathways and Guidelines To ensure all participating health care professionals understand how to identify sepsis, have knowledge of sepsis management and familiarity with the Primary Health Care Sepsis Pathway(s), and CARPA Standard Treatment Manual, they will be required to complete the self-guided ‘Early Sepsis Recognition and Management’ eLearning course administered through the NT Remote Locum Program, or equivalent. 4. POC FBE Testing Resource Package During the transition period, each health centre will receive a folder containing hardcopies of resource to support POC FBE testing. Softcopy resources will be made available on the SPOCTrial website. The resource package includes: • SPOCTrial Handbook (guidelines and requirements of POC FBE testing, training and competency certification and quality management). • Quick reference posters (laminated set also available in A3 or A4 sizes). • Quality management forms. • Troubleshooting guides. • Normal reference intervals for client tests. • Client and quality result interpretation guides. The resources will be updated as necessary by the SPOCTrial PixCell Operations and Clinical Support Team during the intervention phase, and additional site-specific resources can be developed if requested by health centres. A form for the manual recording of client POC FBE test results in electronic health records (eHR) will be provided by the SPOCTrial PixCell Operations and Clinical Support Team to the administering organisation of each participating health centre. The template contains mandatory required data fields, but additional fields can be added to meet the local needs of each organisation. 5.PixCell POC FBE Testing Operator Training and Competency Assessment Each health professional will need to complete mandatory training and achieve competency certification at least every 12-months. Upon certification of operator competency, each health care professional will receive a unique operator ID providing them access to the PixCell HemoScreen device and POC FBE testing. Training will be available via a self-guided eLearning course, or via an equivalent trainer-guided videoconference or face-to-face session. Competency assessment will include knowledge assessments (available via eLearning course or hardcopy) and a skills check involving quality control tests, which can be self- or trainer-guided (videoconference or face-to-face). Health care professionals can complete training as individuals or in small groups during the transition period, or at any time during the intervention phase. Initial operator training and competency assessment will take approximately 1.5 hours to complete and subsequent re-certifications approximately 1 hour. The eLearning course and competency assessments will cover: • How the FBE test fits within the sepsis pathways. • Technical specifications of the HemoScreen™ POC FBE testing device, associated consumables and accessories • Sample collection requirements. • Client testing process. • How to accurately record test results. • Result interpretation. • Quality management materials, activities and procedures (quality control [QC] and external quality assurance [EQA] testing, maintenance). • Biosafety considerations. • Common sources of error and risk mitigation strategies. • Troubleshooting. • Available support and clinical governance systems and resources. • Operator roles and responsibilities. • Clinical uses of POC FBE test outside of sepsis. 6. Quality Management Framework A quality management framework is essential to monitoring and managing the quality of POC FBE testing and ensuring client safety. The following materials and resources will be provided by the by the SPOCTrial PixCell Operations and Clinical Support Team in the transition period and throughout the intervention phase: • QC kits. • EQA program. • Device maintenance requirements. • Annual quality testing schedule. • Forms for recording quality management activities (can be tailored to each site). • QC targets and limits. • QC troubleshooting guides. • Site-specific forms and resources (as requested). • Clinical and Quality Advisory Group. The SPOCTrial PixCell Operations and Clinical Support Team and the Clinical and Quality Advisory Group will oversee quality management with the following tasks: • Record and monitor quality testing, device maintenance, operator competency, errors and flagged results using Atellica® Connect POC Insights software. • Coordinate supply of QC kits and EQA materials to health centres throughout the transition and intervention phases. • Supply quality testing schedule, forms and resources to health centres throughout the transition and intervention phases. • Regularly communicate with health centres and PixCell Champions to manage mandatory completion of QC and EQA testing according to schedule (monthly QC tests, four EQA testing events per annum) throughout the intervention phase. • Regularly communicate with Clinical and Quality Advisory Group to manage quality and safety issues. The Clinical and Quality Advisory Group will provide clinical oversight of POC FBE testing as per the NPAAC Requirements for Point of Care Testing (2nd Edition 2021). 7. SPOCTrial PixCell Operations and Clinical Support Team (external facilitators) Due to remoteness and the transient workforce in the remote primary health care setting, facilitation of POC testing is most efficiently achieved by external facilitators. 8. Ongoing Education and Engagement To promote acceptability, adoption, effectiveness, reach and sustainability of the SPOCTrial intervention, several optional materials will be offered in a range of formats to facilitate ongoing education and engagement throughout the intervention phase. These optional materials will be developed by the SPOCTrial PixCell Operations and Clinical Support Team and delivered to certified PixCell operators, relevant medical officers and other relevant health centre/organisation staff. 9. PixCell Champion (internal facilitator) A local health care professional with current PixCell operator certification will be nominated by each health centre to fulfil the role of PixCell Champion. PixCell Champions will: • Assist with local orientation of relevant staff to the POC FBE testing system. • Liaise with SPOCTrial PixCell Operations and Clinical Support Team to coordinate local POC FBE quality management activities including QC and EQA testing and device maintenance activities (i.e. software updates, cleaning, consumable orders and deliveries). • Liaise with SPOCTrial PixCell Operations and Clinical Support Team to resolve local issues with PixCell device, quality management, operator training. • Advocate for the SPOCTrial at the health centre.