Regulation and governance for the implementation and management of point-of-care testing in Australia: a scoping review

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Publicado en:BMC Public Health vol. 25 (2025), p. 1
Autor principal: Prestedge, Jacqueline
Otros Autores: Kaufman, Claire, Williamson, Deborah A
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Springer Nature B.V.
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Acceso en línea:Citation/Abstract
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022 |a 1471-2458 
024 7 |a 10.1186/s12889-025-21894-2  |2 doi 
035 |a 3175401729 
045 2 |b d20250101  |b d20251231 
084 |a 58491  |2 nlm 
100 1 |a Prestedge, Jacqueline 
245 1 |a Regulation and governance for the implementation and management of point-of-care testing in Australia: a scoping review 
260 |b Springer Nature B.V.  |c 2025 
513 |a Journal Article 
520 3 |a BackgroundPoint-of-care testing (PoCT) is an increasingly important diagnostic tool in the healthcare system for accessible pathology testing in hospital, primary care, and community care settings. Clear regulation and governance models are important to ensure quality of PoCT results for patient care.MethodsThis review aimed to identify existing regulation and guidelines for management of PoCT and how this has been implemented within Australian healthcare services. We conducted a search of academic publications in PubMed and grey literature (national, state, and independent organisations) and other publicly available information from internet searches for governance of PoCT in Australia. Relevant data from these sources were extracted and narratively synthesised.ResultsForty-seven sources (17 studies from PubMed, 30 grey literature) were included in the final review. Of the grey literature sources, fifteen current PoCT governance documents comprising of six standards, five guidelines and four frameworks at the international, national and jurisdictional level were included with an increasing number of grey literature sources since the onset of the COVID-19 pandemic in 2020. The seventeen included research articles were categorised according to implementation barriers and facilitators with the themes of workforce, clinical governance, PoCT workflow, and cost. An understanding of the clinical and cultural context for PoCT was the most frequently reported facilitator of PoCT, while the most frequently reported barrier was related to inadequate data management.ConclusionThis review demonstrated limited and inconsistent sources on regulatory and governance models for implementing and managing PoCT in Australia. Identified PoCT programs showcased diverse implementation and governance models to support quality PoCT, with few reporting formal accreditation. Streamlined, practical regulation and governance for PoCT may increase adoption across healthcare settings while ensuring quality results and meeting the needs of patients and healthcare practitioners. 
651 4 |a Australia 
653 |a Health services 
653 |a Pandemics 
653 |a Health care access 
653 |a Primary care 
653 |a Certification 
653 |a Search engines 
653 |a Grey literature 
653 |a Guidelines 
653 |a COVID-19 
653 |a Models 
653 |a Quality of care 
653 |a Health care policy 
653 |a Accreditation 
653 |a Internet 
653 |a Health care 
653 |a Workflow 
653 |a Quality control 
653 |a Program implementation 
653 |a Medical laboratories 
653 |a Pathology 
653 |a COVID-19 diagnostic tests 
653 |a Community health care 
653 |a Point of care testing 
653 |a Data management 
653 |a Quality standards 
653 |a Jurisdiction 
653 |a Regulation 
653 |a Pharmacy 
653 |a Literature reviews 
653 |a FDA approval 
653 |a Documents 
653 |a Patients 
653 |a Management 
653 |a Governance 
653 |a Medical diagnosis 
653 |a Sociocultural factors 
653 |a Diagnostic tests 
653 |a Clinical governance 
653 |a Disorders 
653 |a Cultural factors 
653 |a Implementation 
653 |a Workforce 
653 |a Clinical standards 
653 |a Medical personnel 
653 |a Social 
700 1 |a Kaufman, Claire 
700 1 |a Williamson, Deborah A 
773 0 |t BMC Public Health  |g vol. 25 (2025), p. 1 
786 0 |d ProQuest  |t Health & Medical Collection 
856 4 1 |3 Citation/Abstract  |u https://www.proquest.com/docview/3175401729/abstract/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch 
856 4 0 |3 Full Text  |u https://www.proquest.com/docview/3175401729/fulltext/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch 
856 4 0 |3 Full Text - PDF  |u https://www.proquest.com/docview/3175401729/fulltextPDF/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch