Availability, stock levels and usage of In-vitro diagnostics in the Bono region, Ghana: A cross-sectional study

Background Point-of-care (POC) diagnostic tests play essential roles in diagnosis, surveillance, and disease management in health settings. Nevertheless, implementation challenges may hamper POC test accessibility. This study evaluated the availability and stock levels of the World Health Organization (WHO) prequalified existing in-vitro diagnostics (IVDs) for use in health facilities without laboratories. Aim To evaluate the availability, stock levels, and usage of POC diagnostic tests. Setting Bono Region, Ghana. Methods This cross-sectional survey involved 102 randomly selected Community Health-based and Planning Services (CHPS), 12 district health depots, and a regional medical depot. Using a survey tool, data were collected on clinic staffing, availability and stock levels of tests, and funding sources. STATA 17 was employed for data analysis. Results Majority (37.3%) of the respondents were community health nurses, with 4.4 mean years of work experience and 38 working hours per week. Of the 18 existing WHO prequalified POC tests for use at facilities without laboratories, 10 (56%), 2 (11%) and 0 (0%) were found at CHPS, regional, and district depots, respectively. Majority (183 out of 301) stock levels were low. Of the 10 available tests found, 7 scored 111 (36%) of ‘high use’. Supply chain management compliance was 5 (31%) out of 16. All CHPS received government funding with 25.5% of them receiving additional donor or internally generated funding. Conclusion This study found poor supply chain management compliance, and low availability of POC tests in the Bono Region of Ghana. Contribution The study outlines POC tests availability and usage in low-resourced setting.


Introduction
Ghana, like other lower-and middle-income countries (LMICs), is faced with a double burden of communicable and non-communicable diseases. 1Despite this double burden of communicable and non-communicable diseases, the healthcare system is fragile and most of its health indicators are still far from reaching the target set by the United Nations Sustainable Development Goals (SDGs). 2,3,4For instance, maternal mortality is 310 per 100 000 live births, about 500% higher than the SDGs 2030 target of less than 70 per 100 000 live births, and neonatal mortality is 25 per 1000 live births. 5,6,7,8In light of this, Ghana is making efforts to extend healthcare services closer to the people through the establishment of Community-based Health and Planning Services (CHPS) at community level, and clinics and health centres at sub-district levels with a varied package of services including point-of-care (POC) diagnostic testing. 9,10,11,12,13,14,15,16,17,18,19,20int-of-care diagnostic testing offers the healthcare professional the opportunity to administer diagnostic tests close to the patient and receive quick results. 21,22,23,24,25,26,27,28Point-of-care tests are medical devices, designed to meet the World Health Organization (WHO) ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end user) Background: Point-of-care (POC) diagnostic tests play essential roles in diagnosis, surveillance, and disease management in health settings.Nevertheless, implementation challenges may hamper POC test accessibility.This study evaluated the availability and stock levels of the World Health Organization (WHO) prequalified existing in-vitro diagnostics (IVDs) for use in health facilities without laboratories.quality standard. 12,27,29,30,31,32,33,34,35,36,37,38,39The introduction of the WHO Model List of an Essential In-Vitro Diagnostic (EDL) has been a remarkable strategy to reach and speed up a life-saving diagnosis, informing treatment and referral decisions and eliminating symptomatic treatment, particularly in health facilities without laboratories. 28,40,41,42he WHO EDL is additionally contributing to improving access to healthcare services and health outcomes in resourcelimited settings. 42Notwithstanding the enormous benefits of POC testing services especially in healthcare facilities without laboratories, many challenges impede their successful implementation. 9,28For example, supply chain bottlenecks continue to hamper a sustainable stock level of POC diagnostics in low-resourced healthcare facilities. 43,44,45oreover, POC diagnostic testing service implementation is bedevilled with funding challenges. 46There is a need to evaluate accessibility to POC testing services in resourcelimited settings especially during this post-coronavirus disease 2019 (COVID-19) era to identify innovative solutions for sustaining POC testing services at health facilities without resourced laboratories in LMICs including Ghana.
In Ghana, little is known about POC diagnosis service provision at healthcare facilities without laboratories.Prior studies that evaluated the availability of POC testing in Ghana focused on Northern Ghana.Kuupiel et al. assessed the accessibility of pregnancy-related POC diagnostic services, 9 as well as the supply chain management and stock levels of POC tests in the Upper East Region of Ghana. 47ard et al. also investigated the availability and pricing of laboratory testing in the Northern Region to identify gaps regarding the WHO's Essential Diagnostics List. 16Therefore, this study evaluated the availability and stock level of POC diagnostic tests at health facilities without laboratories (CHPS facilities) in the Bono Region of Ghana highlighting the healthcare providers' experience and competencies, POC diagnostic test availability, stock levels, frequency of POC test usage, supply chain management, and funding.The authors hope the evidence provided by this study will inform the decisions of stakeholders such as healthcare professionals, the Government of Ghana (GOG), donors, POC diagnostic test manufacturers, and non-governmental organisations in health towards improving and bridging the POC testing accessibility gap.

Study area
The study was conducted in the Bono Region -one of the 16 regions of Ghana.The region was chosen because it is one of the newly created regions with few hospitals.The region has 12 administrative districts as shown in Figure 1.Sunyani is the regional capital.Each administrative district has a health depot, with 1 regional depot located in the regional capital, Sunyani, serving the 12 districts.The region lies in the mid-west of Ghana and shares local boundaries with the Bono East Region to the East, Savanna Region to the North, Ahafo Region, and the Western North Regions to the South.Internationally, the Bono Region shares a boundary with La Cote d'Ivoire to the West.The region covers about 11 481 sq.km area of land with a population of 1 208 965 with 49.4% male and 50.6% female. 48The region has 461 healthcare facilities including 306 CHPS, 50 clinics, 63 health centres, 21 maternity homes, 1 polyclinic, 2 psychiatry clinics, 1 regional hospital, 5 private hospitals, 5 Christian health hospitals, and 7 government hospitals. 49

Study design and study population
This is a cross-sectional quantitative study involving health facilities without laboratories (CHPS facilities), stores at the district health directorates, and the regional medical stores in the Bono Region of Ghana.The list of 306 CHPS which render POC diagnostic testing services in primary health care (PHC) facilities without laboratories, 12 stores at the health directorates, and 1 regional medical depot were obtained from the Bono Regional Health Directorate.

Sampling
A list of 306 CHPS offering POC diagnostic testing services was stratified into 12 strata with each stratum representing one of the 12 administrative districts in the Bono Region.Using proportional sampling, 33% of the population from each stratum was selected.The use of proportional sampling allowed to obtain an accurate representative sample from each district.Finally, a simple random sampling technique was used to draw the total number of respondents from each stratum where all the names of facilities in each stratum (district) were written on pieces of paper, and the total number was selected from the stratum.
Additionally, all 13 depots were sampled through a census.This type of sampling helped extract data on all the depots in the population and avoided sampling errors for the study because there was a small population of depots.

Sample size
Because a larger sample size will enable to have greater precision, 33% of CHPS, and all the district and regional health depots were selected.The formula where n is the total sample size 1/3 × 306 = 102, where N is the total number of CHPS (N = 306), Ni is the number of CHPS in a district, and ni is the sample size taken from a district and n/N will be constant for every district.Therefore, n/N = 102/306 = 1/3 (Table 1).Hence, 102 CHPS, 12 district depots, and 1 regional depot were recruited for the survey.A total of 115 respondents including 3 physician assistants, 15 midwives, 17 general nurses, 38 community health nurses, 26 health assistants, 3 mental health officers, 12 district health depot managers, and 1 regional depot manager participated in the study.

Data collection
Data were collected from June to July 2022 using the survey tool adopted by Kuupiel et al. 9 The tool was pretested in 12 non-participating CHPS in the Bono Region and all necessary adjustments were made based on respondents' feedback.For all participating CHPS, data were collected on human resource capacity (staffing); category of staff, and their competencies with the POC diagnostic test usage.Data were also taken on the availability and stock level of WHO in-vitro diagnostics (IVDs) for use in community settings and health facilities without laboratories from the district and regional depots, and the participated CHPS.The authors again collected data on the frequency of POC usage.Moreover, data were collected on inventory management variables such as bin cards, and control forms availability to determine compliance.Lastly, the authors collected data on funding to obtain the CHPS's source of funding.

Outcome measures
The primary outcomes of the study included the availability and stock levels of POC tests at the CHPS, districts and regional depots, and sources of funding for POC tests in the Bono Region.The secondary outcomes of this study were

Ethical considerations
This study received ethical approval from the Ghana Health Service Ethics Review Committee with approval number, GHS-ERC:018/03/22 and the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) with approval number, BREC/00004499/2022.The study obtained a gatekeeper permit from the Bono Regional Health Directorate, Sunyani, Ghana.All study participants agreed to participate by signing informed consent before the study.

Availability, stock level,and reasons for nonavailability of point-of-care diagnostics at district health directorate stores
The district depots recorded 100% non-availability of the existing POC diagnostic tests recommended by the WHO.

Human resource performance and inventory management for the available point-of-care diagnostic tests at Community Health-based and Planning Services
Table 5 shows the compliance of CHPS to supply chain management guidelines in the Bono Region of Ghana.The study showed the CHPS had 5 (31%) out of 16 variables complying with supply chain management.Majority (92%) of users were trained on the existing POC diagnostic tests usage.Of the 102 CHPS surveyed, 80% had available standard operating procedure (SOPP) for stock (reagents) level management.However, the study found 24.5% and 23% of CHPS without approved written SOPP, and without SOPP for the safe disposal of existing POC tests respectively.
The majority (93%) of CHPS had computerised or manually recorded inventory, and 93% available document inventory levels for diagnostic POC tests.Again, 90% of the CHPS had basic records cards, as well as 90% had available monthly consumption records.All other inventory management activities scored less than 90% with as low as 59% of CHPS having expired POC tests including HIV1/2 antibodies, and anti-TP HIV1/2.Out of the 59%, majority (58%) of them had no compiled list of expired POC tests.The findings from the district and regional depots also demonstrated that 33.3% of the tests were not to be used at PHC facilities.However, only Plasmodium spp.antigen and HIV1/2 antibodies (11.1%) were supplied and available at the regional depot while all the remaining tests are accessible from the open market.These findings are a wake-up call for quality improvement of POC diagnostic testing services in rural healthcare facilities towards health system strengthening and SDG 3.8 achievement of universal health coverage. 16,52,53though POC tests like blood typing, albumin, bilirubin, ketone, Hep C, WBL, CD4 count and qualitative HIV were claimed as not testing sites for the CHPS, their impact of nonavailability still holds.For instance, simple monitoring of antiretroviral therapy response for people living with HIV and/or AIDS will require referral to a higher-level facility for medications.Infants needing diagnosis of HIV infection will also face the same referral coupled with geographical accessibility challenges such as transport costs and its associated risks.Again, the non-availability of these tests means disease screening or monitoring ranging from blood grouping and rhesus factor type identification, kidney, liver, HCV, etc. disease investigation will require extra cost and time for the patient.This implies that out-of-pocket payment will be imposed on patients.Furthermore, CHPS facilities' permission to purchase tests from the open market can expose them to corruption and result in expensive healthcare costs for innocent patients.

Source of funding
The results from the current study fully support the finding of a similar POC diagnostic testing survey in the Northern Region of Ghana. 16Wand et al.'s study equally revealed the low availability of POC diagnostic tests in the rural clinics of Northern Ghana. 16Their study further asserts and adds that plasmodium spp.antigen, HIV and HCG were the most used POC tests. 16  ensure healthy lives for all.It states that 'the report provides information for evidence-based decision-making to ensure the health and wellbeing of persons in Ghana and monitor progress towards the nation's development goals'. 6untry prioritisation and level development of the WHOrecommended EDL are vital to help the accessibility of POC testing in the low-resource settings in Ghana. 39The low availability of POC diagnostic tests demonstrated in this study could affect Ghana's pursuit to achieve SDG 3 55 of ensuring healthy lives and promoting well-being at all ages as well as advancing universal health coverage. 56

FIGURE 1 :
FIGURE 1: Map of Bono Region showing the 12 administrative districts.

FIGURE 2 :
FIGURE 2: Distribution of source and period of funding of the 102 primary healthcare facilities surveyed.

TABLE 1 : Distribution of sampled Community Health-based and Planning Services in this study. Name of district No. of CHPS (facilities without laboratories) Sample size
-99 and 1-49 was determined as high, average and low stock levels, respectively.Responses on the frequency of POC tests usage were analysed as: 'more than once per day'; 'daily' 'weekly' 'monthly' and 'once per year or less' where POC tests are highly used, mostly used, fairly used, rarely used and does not used, respectively.A total of 90% -100% was regarded as 'compliant' to supply chain management, demonstrating reliable and acceptable compliance with the specified guideline.A score less than 90% was regarded as 'non-compliant' to supply chain management, demonstrating unacceptable compliance of the CHPS to the specified guidelines.Data were processed in Microsoft Excel and exported into STATA statistical software of version 17 for all analyses.All processed data were grouped into frequencies, standard deviation (s.d.), and means with 95% confidence intervals for the responses.

Table 2a ,
Table 2b and Table2cshows the characteristics of the selected CHPS and the respondents in this survey.The study recorded a 100% response rate from the staff in the selected CHPS facilities in the Bono Region.A total of 698 healthcare professionals were found in all 102 CHPS facilities.
and 37.76 ± 0.272 (95% CI: 37.23-38.30),respectively.Of the total 102 respondents from selected CHPS facilities, the largest proportion (38 = 37.3%) were community health nurses (nurse assistant preventive), and the least (3 = 2.9%) were Physician Assistants and Mental Health Officers.At the district and regional depots, 89 and 64 workers were found, respectively.All 12 district depot managers and 1 regional depot manager took part in the study.Availability,

TABLE 2a :
Category of the 102 Community Health-Based and Planning Services surveyed in the Bono Region.

TABLE 2c :
Category of the 102 Community Health-Based and Planning Services surveyed in the Bono Region.

TABLE 2b :
Category of the 102 Community Health-Based and Planning Services surveyed in the Bono Region.It was reported that supplies were only made by the Regional Medical Stores through Ghana Integrated Logistics Management Information System.However, the districts are authorised to approve the CHPS facilities managers for collection of the programme logistics (HIV1/2 antibodies, and Plasmodium ssp.antigen), and to purchase from the open market where the test is allowed to be used at the site. Availability,

Table 3
shows the availability, and stock level of POC diagnostic tests at the 102 CHPS facilities surveyed in the Bono Region of Ghana.Out of the 18 existing IVDs prequalified by the WHO to be used at health facilities without laboratories, 10 (56%) were available.The majority (93.1%) of the CHPS reported low (≤6 tests) availability of POC diagnostic tests, and 6.9% of the CHPS reported average(6-12 tests).The average number of POC tests available in the CHPS was 3 tests ± 2 (95% CI: 2.6-3.3).

TABLE 3 :
Distribution of available point-of-care diagnostic tests, and stock levels for all Health-Based and Planning Services surveyed in the 12 districts (N = 102).

TABLE 3
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TABLE 3 (
Continues...): Distribution of available point-of-care diagnostic tests, and stock levels for all Health-Based and Planning Services surveyed in the 12 districts (N = 102).

Table 4
shows the frequency of POC diagnostic tests used for all tests found in the study.The largest proportion, that is, 111 (36%) of the CHPS reported 'highly used' (more than once per day) for 7 out of the 10 available POC diagnostic tests: Glucose, Hb, UTS, HCG, Hep.B, HIV1/2 antibodies and Plasmodium spp.antigen.Out of the 111 responses of 'more than once per day' from the various tests' usage, Plasmodium spp.antigen recorded the majority, 66 (59.4%) while Hb recorded the least 0.9%.No POC test was recorded using 'used once per year'.

TABLE 4 :
Distribution of frequency of usage of the available point-of-care tests found.

TABLE 5 :
Human resource performance, and compliance of community healthbased and planning services to supply chain management guidelines in the Bono Region (N = 102).
94rtin et al.'s study also reported the complexity of POC testing implementation in the LMICs.54Similarly,Kuupieletal.'s study reported low availability of POC diagnostic tests in Northern Ghana.9Nonetheless,HCG,Hb and Hep B POC tests availability in Kuupiel et al. was higher than in the current study.9Thecurrent study envisaged the important information on the accessibility of the WHO EDL in the PHC facilities within the resource- The 2021 Population and Housing Census report provides a guide to stakeholders with the policy development aim to In this regard, it is important to provide available POC diagnostic tests to render accessible and effective POC diagnostics tests in a low-resource setting.To ensure a realistic availability of POC diagnostic testing in a resourcelimited setting, physical accessibility, distance and travel time are crucial elements while adequate funding is necessary.The authors would, therefore, recommend a spatial study to assess POC testing accessibility particularly on the physical distance, and travel time to the nearest healthcare facility.Further studies could also evaluate the barriers/challenges, and potential solutions to POC testing accessibility in resource-limited settings, to ensure effective implementation of POC testing.Despite the limitations, this study is the first to assess the WHO model list of essential in vitro diagnostics in CHPS facilities in the Bono Region of Ghana.The study revealed low accessibility of POC diagnostic tests in the region because of poor availability and has ascertained the need to improve access to POC tests.Again, implementing POC tests such as Blood Typing, Albumin, Bilirubin, Ketone, Hep C, WBL, CD4 Count and Qualitative HIV will help eliminate some accessibility barriers.The availability of POC tests is the key barrier to the effective implementation of POC diagnostic testing in the low-resource settings of the Bono Region.The authors, therefore, encourage all major stakeholders including the GOG, Ministry of Finance, Ministry of Health, Ghana Health Service, donors and non-governmental organisations to help provide adequate funds as startup capital, procurement and supply of the needed POC tests in PHC facilities in the region.The authors recommend the WHO EDL as a standard for measuring the geographic access to POC tests with limited availability in the region.The authors again recommend a spatial study to evaluate the physical accessibility of POC tests in the PHC facilities in the region.