Facilitators and barriers to in vitro diagnostics implementation in resource-limited settings: A scoping review

Background The World Health Organization (WHO) developed the model list of essential in vitro diagnostics (EDL) to guide countries to develop and update point-of-care (POC) per their disease priorities. The EDL includes POC diagnostic tests for use in health facilities without laboratories; however, their implementation might face several challenges in low- and middle-income countries (LMICs). Aim To identify facilitators and barriers to POC testing service implementations in the primary health care facilities in the LMICs. Setting Low- and middle-income countries. Methods This scoping review was guided by Arksey and O’Malley’s methodological framework. A comprehensive keyword search for literature was conducted in Google Scholar, EBSCOhost, PubMed, Web of Science and ScienceDirect using the Boolean terms (‘AND’ and ‘OR’), as well as Medical Subject Headings. The study considered published articles in the English language from 2016 to 2021 and was limited to qualitative, quantitative and mixed-method studies. Two reviewers independently screened the articles at the abstract and full-text screening phases guided by the eligibility criteria. Data were analysed qualitatively and quantitatively. Results Of the 57 studies identified through literature searches, 16 met this study’s eligibility criteria. Of the 16 studies, 7 reported on both facilitators and barriers; and the remainder reported on only barriers to POC test implementation such as inadequate funding, insufficient human resource, stigmatisation, et cetera. Conclusion The study demonstrated a wide research gap in facilitators and barriers, especially in the general POC diagnostic test for use in health facilities without laboratories in the LMICs. Extensive research in POC testing service is recommended to improve service delivery. Contribution This study’s findings contribute to a few works of literature on existing evidence of POC testing.


Introduction
guidance to countries on methods to develop, update and prioritise the IVDs. 8 The WHO's EDL provides a range of tests for general and disease-specific IVDs mostly in pointof-care (POC) form for use in healthcare facilities with or without laboratories. 8 Tier 1 facilities refer to primary care settings with healthcare professionals but no trained laboratory personnel, self-testing or low resource settings. 8,9,10,11,12 Point-of-care diagnostics refer to advanced technological-based medical devices for testing, screening and monitoring diseases in services near patients or clients. 13,14 Point-of-care diagnostics have shown to be a useful tool for improving disease diagnosis and treatment globally. 15,16 Evidence showed POC testing has improved antenatal HIV screening in sub-Sahara Africa. 3 In resourcelimited settings, POC technologies have become reliable and very important by providing healthcare providers with the easiest, most convenient and most accurate way of decision-making on diagnosis and treatment. 3,14,17,18,19,20,21,22,23 The quality of POC for limited-resource settings according to the WHO should be designed to meet the following benchmarks: affordable, sensitive, specific, user-friendly, rapid or robust, equipment-free, and delivered to those who need it (ASSURED). 8,24,25,26,27 Despite the benefits derived from POC testing, there are challenges with its implementation, which hinder accessibility for many patients in the LMICs. 28,29 Implementation and sustainability of POC testing in resource-limited settings are feasible when potential barriers are addressed. 30 Barriers to POC testing implementation may include challenges making POC testing service implementation difficult. Examples of these include low availability, low stock levels, procurement issues, poor supply chain management, funding, human resource capacity and many others. 21,24,27,31,32,33 Facilitators of POC testing are motivators or factors which contribute to POC testing implementation. For instance, effective regulations on quality and training enable the successful implementation of POC testing in healthcare facilities. 34 A wide research gap in the general POC test for use in a health facility without laboratories suggests presumptive treatment and poor health outcomes in many LMICs. Therefore, the need to investigate the barriers and facilitators of POC test implementation of general POC diagnostic testing services is of utmost importance.

Methods
We adopted Arksey and O'Malley's framework as a guide to conduct this scoping review. The preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews checklist were used to report this study. 35

Identifying the research question
The research question for this study was: To date, what evidence exists on facilitators and barriers to implementation of the WHO EDL for use in tier one healthcare facilities in LMICs? Table 1 shows the framework (population, content and context [PCC]) used to determine the suitability of the review question.

Literature search
With a date limitation of 2016-2021, we searched five electronic databases (Google Scholar, Academic Search Complete via EBSCOhost, PubMed, Web of Science and ScienceDirect) for relevant studies (Appendix 1). We used a combination of the following keywords: 'facilitator', OR 'enablers' AND 'barriers' AND 'point-of-care testing services', AND 'point-of-care diagnostics services', AND 'in vitro diagnostics', AND 'implementation', AND 'lower-andmiddle income countries' OR 'LMICs'. Medical subject headings were applied in the search strategy. Limitations on language and study design were removed.

Eligibility criteria
Articles published only in the English language were included subject to the eligibility criteria. Such articles also had to be written in at least one of the LMICs on facilitators and barriers and focus on either POC testing services or in vitro diagnostics in primary health care (PHC) facilities. This review was limited to primary study designs (qualitative, quantitative and mixed-methods study). We excluded all articles published before the year 2016.

Study selection
The databases' search and the title screening were conducted using the eligibility criteria. A clean library was shared with the review team after all duplicates were removed. Two authors independently screened abstracts and full articles using tools pilot-tested by the review team. The review team discussed all discrepancies that arose at the abstract screening stage between these two authors until a consensus was reached. Then, the last two authors addressed the discrepancies during the full-text screening phase.

Charting the data
We extracted the following: author and publication year, the country where the study was conducted, study design, study

Collating and summarising the results
Thematic analysis was conducted following the data extraction. The data were collated into themes and a summary of the study outcomes was reported in a narrative form.

Ethical considerations
This article followed all ethical standards for research without direct contact with human or animal subjects.

Results
Of the 72 eligible articles obtained from the databases search, 16 duplicates were removed. Out of the remaining 57 articles screened, 32 were excluded at the abstract screening stage. A further 25 articles were removed during the full-text screening phase. Finally, 16 articles remained for data extraction and analysis. The reasons for exclusion following the full-text screening were the following: five were review papers 24,38,39,40,41 ; two were conducted in high-income countries 42,43 ; one article focused on a POC test not included in the WHO EDL 44 ; and one reported on a POC test for health facilities with laboratories 45 ( Figure 1).

Characteristics of the included studies
Out of the 16 included articles for this study, five (31%) reported from South Africa, 46 27,46,48,54 ; and approximately 6% (n = 1) each was a mixed-method 55 and an experimental study 49 (Table 2).

Study findings
Of the 16 included studies, 7 studies reported on both facilitators and barriers to POC testing implementation. 47,51,52,55,56,59 The remaining 9 reported on different challenges with POC testing implementation (Table 3). 4

Point-of-care test for use in health facilities without laboratories
Of the 16 included studies, only two studies reported on five types of general POC tests: blood typing, haemoglobin, urinalysis, glucose and urine pregnancy test among the numerous general IVDs for use in health facilities without laboratories. 27,54 Six types of disease-specific IVDs were documented by 10 studies, 27,46,47,50,51,52,53,56,57,59 and one study did not specify the type of IVD 47 See (Figure 2).

Barriers to point-of-care test implementation
Although some barriers were country-specific, other countries in the included studies reported similar barriers. Human resource issues, such as the increased workload of healthcare professionals 46  documented the absence of a POC testing curriculum as well as the lack of training and continuous professional development for healthcare workers as some of the implementation challenges. Although workflow disruption and increased administrative burden should have been seen as common barriers to POC testing implementation, these were reported by Van Hecke et al. 48   has a strong bearing on the improvement and strengthening of the healthcare system in diagnosis, monitoring and treatment. Though studies were found in 27 LMICs, evidence was found from only six studies with regards to facilitators, which include coordination, adequate supply of consumables, refresher training programmes, enhanced patients' motivation, provider enthusiasm and expertise, political environment and high acceptability. Notwithstanding, included studies revealed that low availability of POC tests concern about confidentiality, policy guidelines, inadequate funding to support staff training, poor supply chain management, poor communication, lack of staff involvement and leadership participation in POC management programmes, and absence of continuous professional development were major barriers to POC testing services implementation in the rural areas. Again, out of the 18 existing POC diagnostic tests recommended by the WHO for use in health facilities without laboratories, no studies were found on POC tests such as CD4 cell enumeration, ketones, albumin, bilirubin and white blood lactate.

Implication for practice
The study findings imply that all rural areas in the LMICs have various challenges impeding POC testing implementation and its sustainability, which render quality of care below standard.  The low availability of POC tests might have contributed to poor accessibility in the resource-limited settings in LMICs. This challenge may also result in referrals and the distraction of workflow. Thus, patients travel from their local communities to bigger facilities for some POC tests not available in their healthcare setting. It also implies more spending because of travel costs and sometimes additional costs on healthcare aside subjecting patients to more risk on the travel route. Moreover, low availability will imply that presumptive treatment, wrongful diagnosis and poor health outcomes will be high. Again, barriers such as the absence of training of staff and lack of staff involvement in POC management programmes may deny healthcare providers the professional skills in counseling and handling confidential information. Conversely, patients' trust in health workers on confidential matters will be jeopardised. Human resource challenges might have resulted from inadequate funding to support the training of staff, which, consequently, might have contributed to a high workload of staff, poor supply chain management and an increase in administrative burden. We, therefore, recommend further studies to evaluate potential solutions to address the barriers to the POC diagnostic test implementation in resourcelimited settings towards optimising the well-being of the individual and achieving SDG 3.8 (universal health coverage).

Implication for research
The study shows limited primary research investigating the WHO EDL and POC test services in the LMICs. A sustainable POC test service will enhance accurate diagnosis and the improved well-being of individuals. Therefore, more primary research focusing on POC test implementation is recommended to explore the various facilitators of POC testing that increase service accessibility, especially in remote areas. We also recommend enhanced research to understand the challenges to POC testing implementation, particularly in the POC tests such as CD4 cell enumeration, albumin, ketones, bilirubin and white blood lactate, and thereby find potential solutions to those barriers.

Conclusion
The study presented limited evidence of publication on the implementation of the general POC test for use in a resourcelimited setting in the LMICs. It shows a research gap in general POC diagnostic tests for using health facilities without laboratories in the LMICs. Low availability of POC tests, funding and inadequate human resources remain as barriers to POC testing service implementation. It is, therefore, necessary to scale up POC testing service, particularly across rural areas of LMICs towards improving the service delivery.