Poor supply chain management and stock-outs of point-of-care diagnostic tests in Upper East Region’s primary healthcare clinics, Ghana
Poor supply chain management and stock- outs of point-of-care diagnostic tests in Upper East Region's primary healthcare clinics, Ghana
Desmond KuupielID 0 1
Boikhutso Tlou 0 1
Vitalis Bawontuo 1
Paul K. DrainID 1
Tivani P. Mashamba-Thompson 0 1
0 Department of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal , Durban , South Africa , 2 Faculty of Health and Allied Sciences, Catholic University College of Ghana , Fiapre, Sunyani , Ghana , 3 International Clinical Research Centre, Department of Global Health, University of Washington, Seattle, Washington, United States of America, 4 Division of Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, United States of America, 5 Department of Epidemiology, University of Washington , Seattle, Washington , United States of America
1 Editor: Nei-yuan Hsiao, University of Cape Town Faculty of Health Sciences , SOUTH AFRICA
Several supply chain components are important to sustain point-of-care (POC) testing services in rural settings. To evaluate the availability of POC diagnostic tests in rural Ghana's primary healthcare (PHC) clinics, we conducted an audit of the supply chain management for POC diagnostic services in rural Upper East Region's (UER) PHC clinics, Ghana to determine the reasons/causes of POC tests deficiencies.
Funding: Funded by University of KwaZulu-Natal,
College of Health Sciences Research Scholarship.
The funders had no role in study design, data
collection and analysis, decision to publish, or
preparation of the manuscript.
Material and methods
We conducted a review of accessible POC diagnostics in 100 PHC clinics in UER, Ghana
from February to March 2018. We used a monitoring audit tool adopted from the World
Health Organization and Management Science for Health guidelines for supply chain
management of diagnostics for compliance. We determined a clinic?s compliance with the
stipulated guidelines, and a composite compliant score was defined as a percentage rating of 90
to 100%. We used univariate logistic regression analysis in Stata 14 to determine the level
of association between supply chain management and the audit variables.
Overall, the composite compliant score of supply chain management for existing POC tests
was at 81% (95%CI: 79%?82%). The mean compliance with distribution guidelines was at
93.8% (95%CI: 91.9%?95.6%) the highest score, whilst inventory management scored the
lowest, at 53.5% (95%CI: 49.5%?57.5%) compliance. Of the 13 districts in the region, the
results showed complete stock-out of blood glucose test in all selected PHC clinics in seven
(53.8%) districts, haemoglobin and hepatitis B virus test in three (23.1%), and urine protein
Competing interests: The authors have declared
that no competing interests exist.
Abbreviations: LMICs, Low- and middle income
countries; MSH, Management Science for Health;
PHC, Primary Healthcare; POC, Point-of-Care; UER,
Upper East Region; WHO, World Health
test in two (15.4%) districts. Based on our univariate logistics regression models, stock-out
of tests at the Regional Medical and District Health Directorates stores in the region, high
clinic attendance, lack of documentation of expiry date/expired tests, poor documentation
of inventory level, poor monitoring of monthly consumption level, and failure to document
unexplained losses of the various POC tests were significant predictors of complete test
stock-out in most of the clinics in the Upper East Region.
There is poor supply chain management of POC diagnostic tests in UER?s PHC clinics.
Improvement in inventory management and human resource capacity for POC testing is
critical to ensure accessibility and sustainability of POC diagnostic services in
resource-limited settings PHC clinics.
Diagnostics are an essential component to advance universal health coverage, address health
emergencies, and promote healthier populations [
]. However, several primary healthcare
(PHC) facilities lack sophisticated laboratory infrastructure and do not have the resources to
transport clinical specimens to central laboratories, where available, and point-of-care (POC)
diagnostics can provide a solution to this challenge [
]. The World Health Organization
(WHO) has pre-qualified some POC diagnostic technologies for use in resource-limited
settings to facilitate POC testing, disease management and prevention [
]. However, supply chain
management challenges may hamper the accessibility of these essential POC diagnostics and
possibly result in stock-outs, especially in low- and middle-income countries (LMIC) rural
clinics such as Ghana [
]. For instance, nearly 50% of clients did not have access to HIV and
syphilis testing in Guatemala partially due to test stock-outs ; almost half of the rapid
syphilis test (RST) implementation pilot sites and a third of rollout sites in Zambia reported test
]. In addition, stock-outs of RSTs were reported at various stages in Zambia in a
study aimed at assessing the impact of RSTs and treatment in pregnant women [
]. It is also
evident that stock-outs of various POC tests have been reported in primary healthcare facilities
in Mozambique [
], Uganda [
], and South Africa [
]. In Ghana, a study aimed at assessing
the accessibility of POC diagnostic services for antenatal care in rural primary PHC clinics,
revealed poor availability of POC tests [
], which is similar to what has been reported in rural
South Africa [
Adequate supply chain management prevents diagnostic test stock-outs and sustains POC
diagnostic services in rural health facilities [
]. Supply chain management has been defined
by various studies to include all activities leading to the production, selection, quantification,
negotiation, procurement, quality assurance, storage, inventory management, distribution and
redistribution of a service or product [
]. In this study, we define supply chain
management as events leading to the selection, distribution, storage and inventory management, as
well as human resource capacity, for POC testing in rural primary healthcare clinics. Strict
adherence to WHO quality-ASSURED (Affordability, Sensitivity, Specificity, User-friendly,
Rapid and robust, Equipment-free and Delivered) criteria for selection of POC diagnostics for
rural PHC clinics ensures accessibility of POC tests for rural populations and improves access
to healthcare [
]. Timely distribution of POC diagnostic tests, availability of adequate storage
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facilities, and ensured availability of the needed human resource capacity for POC diagnostics
management and testing is important to sustain POC testing [
5, 17, 19
]. We, therefore, sought
to audit the supply chain management for POC diagnostic tests in rural Upper East Region?s
(UER) PHC clinics, Ghana to determine the reasons for POC tests deficiencies.
Material and methods
This study was approved by the Navrongo Health Research Centre Institutional Review
Board/Ghana Health Service (approval number: NHRCIRB291) and the University of
KwaZulu-Natal Biomedical Research Ethics Committee (approval number: BE565/17). Permission
was obtained from the Upper East Regional Health Directorate prior to the conduct of this
study. All study participants also signed an informed consent prior to participating in the
This is a cross-sectional study, which involved an audit of the role of supply chain management
of POC diagnostic test accessibility in rural PHC clinics in the UER of Ghana. This current
study is a follow-up on a prior study involving 100 rural PHC clinics from all 13 districts
aimed at assessing the accessibility of POC diagnostic services for maternal health in rural
PHC clinics in the UER [
]. The findings of the previous study demonstrated low availability
of POC test (less than 5 tests for most of the clinics. Supply chain management was found to
be a major barrier hence; informing our decision to conduct this follow-up study to audit the
supply chain management for POC diagnostic tests to determine the reasons for POC tests
Study area and population
This study was conducted in the UER of Ghana. The region was chosen because it is the least
(21%) urbanized in Ghana with a maternal mortality ratio of 108/100000 live births [
]. It is
located in the north-eastern corner of Ghana, bordered by Burkina Faso to the north, Togo
and the Upper West Region to the east and west respectively, and the Northern Region to the
south. The region had 1188800 people in 2016 and is considered largely (79%) rural and
scattered in dispersed settlements [
]. The main source of income for the majority of the
population is farming. The region is divided into 13 administrative districts (Fig 1) and all were used
in this study.
This was a follow-up study to a prior study aimed at assessing the accessibility of POC
diagnostic services for maternal healthcare in rural health facilities in the UER, Ghana [
previous study used a multistage sampling strategy comprising stratified sampling, probability
proportionate to size and simple random sampling to select 100 rural PHC clinics with
representation from all the thirteen districts in the UER. All 100 PHC clinics were surveyed in this
Data collection procedure
This study was conducted from February to April 2018, using an audit tool adopted from
Management Science for Health (MSH) laboratory diagnostic supply chain management [
and WHO guidelines for selection of POC tests for rural PHC clinics [
]. The audit tool
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Fig 1. Map of Upper East Region showing the 13 administrative districts.
(S1 Table) was pre-tested in ten non-participating rural PHC clinics in the UER and adjusted
to suit the local context based on feedback from respondents. The audit tool consisted of a set
of questions, each aimed to assess the selection, inventory management, distribution, and
human resource capacity for POC testing in the selected PHC clinics. In order to ensure the
accuracy of the audit, the PHC clinics managers/supervisors were informed about the purpose
of the audit and the procedures that would be followed. Data on the selection of POC
diagnostics was obtained based on the WHO quality-ASSURED criteria for POC diagnostic selection
for rural PHC clinics [
]. Data on the distribution of POC diagnostics, POC diagnostics
storage and inventory management, and human resource capacity for POC testing were obtained
using the audit tool in order to investigate the supply chain management of POC diagnostic
tests of the selected rural PHC clinics. We also obtained data on stock levels of eight (8) POC
tests: HIV, malaria, syphilis, haemoglobin, urine protein/albumin, urine pregnancy, blood
glucose, and hepatitis B, in order to investigate deficiency and determine its relationship with
the supply chain management. These tests were the top eight POC tests in the majority of the
PHC clinics. These POC tests are also included in the first WHO essential list of diagnostics
for resource-limited settings [
]. Finally, we took data on the average clinic attendance per
month to facilitate the determination of the relationship between clinic attendance and POC
The primary outcome of this study included supply chain management and stock levels of
POC tests in all selected PHC clinics in the UER of Ghana. For supply chain management, one
point (100%) was allotted to each question if all the requirements for the question were fulfilled
for each of the components. A sum of the scores for each component was obtained to provide
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the overall percentage score. A score of 90 to 100% was considered ?compliant? supply chain
management, indicating strong, reliable, and satisfactory compliance with the stipulated
guidelines. A rating of less than 90% was considered ?non-compliant? supply chain
management, indicating unsatisfactory compliance of the clinic to the stipulated MSH and the WHO
guidelines. POC test stock-out was measured as either ?Yes? or ?No? of HIV test, malaria test,
syphilis test, haemoglobin test, urine protein/albumin test, urine pregnancy test, blood glucose
test, and hepatitis B test. That is, Yes = availability of test, and No = complete stock-out of
test. Clinic attendance was measured as: 0?100 patients/clients per month = low attendance
and > 100/month = high attendance. Data were analysed using Stata version 14. Frequencies,
means, standard deviation as well as 95% confidence intervals (CI) were calculated for all eight
POC tests audited. We used Univariate logistic regression to associate the independent
(reasons for test stock-outs) variables with the dependent variable (POC tests for HIV, malaria,
syphilis, haemoglobin, urine protein/albumin, urine pregnancy, blood glucose, and hepatitis B
test) and p<0.05 was reported.
Data from this study are the property of the University of KwaZulu-Natal and can be made
publicly available. All interested researchers/readers/persons who meet the criteria for access
to confidential data can access the dataset via Dr Tivani Mashamba-Thompson, the project
supervisor and the Academic Leader (Research) for the School of Nursing and Public Health
via this email address: . Data access may also be requested
from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) from
the following contacts: The Chairperson BIOMEDICAL RESEARCH ETHICS
ADMINISTRATION Research Office, Westville Campus, Govan Mbeki Building University of
KwaZulu-Natal P/Bag X54001, Durban, 4000 KwaZulu-Natal, South Africa Tel.: +27 31 260 4769
Fax: +27 31 260 4609 Email: .
Results and discussion
In 100 PHC clinics, 959 health professionals were found, with Community Health Nurses
being the majority (30%) and Dispensary Technicians/Assistants being the minority (2.4%).
Antenatal client census per month for a majority (75%) of the clinics was less than 100 (Range:
3?360). Of the eight POC tests audited in the region, the haemoglobin test was available in 26
clinics; blood glucose test in seven clinics; HIV test in 83 clinics; syphilis tests in 23 clinics;
hepatitis B in 21 clinics; malaria test in 97 clinics, urine pregnancy test in 91 clinics, and urine
protein/albumin test in 20 clinics.
Supply chain management of existing POC tests
Inventory management of existing POC tests
Inventory management at the PHC clinic in Ghana is the ultimate responsibility of the clinic
supervisor/manager unless otherwise, delegated to another staff within the clinic. All audited
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PHC clinics had personnel whose duties included managing POC tests. An updated list
of POC tests was available in 82% of the clinics; availability of storage space was 64%, and
availability of stock/bin cards was 85%. Additionally, monthly consumption level was
documented in 33% of the PHC clinics; with 44% documented inventory levels, and 26%
documented unexplained losses. Whilst few (16%) PHCs documented expiry dates of existing
POC test kits, a majority (81%) of the PHC clinics had inventory control forms/books.
Likewise, only 4% of the PHCs had set minimum and maximum stock levels to match with peak
consumption levels. Expired POC diagnostics (haemoglobin, syphilis, and HIV) were found
in 37% of the PHC clinics, of which only 16% had a compiled list of the expired POC
6 / 15
Selection of existing POC diagnostic tests
Although PHC clinic staff were not involved in the selection of POC tests but rather higher
authorities at the District, Regional, and National levels, our finding showed selected POC
tests for the clinics largely were in compliance with WHO quality ASSURED guideline. Our
findings showed existing POC diagnostics were affordable, enabled rapid testing and
treatment at the first visit, as well as requiring no refrigerated storage (robust) in all 100 PHC
clinics. 100% of the existing POC diagnostics were found to be suitable for screening pregnant
women and all other patients. On perceived sensitivity and specificity of the POC diagnostic
tests, 84% of the clinics said the existing POC diagnostics provided sensitive test results with
very few false-negatives, whilst 72% said existing POC diagnostics provided specific test results
with very few false-positive. Ninety-four percent (94%) of the existing POC diagnostics were
found to be user-friendly, and 77% were simple to perform and required minimal training
(equipment-free). The mean score for compliance with WHO guidelines for selection of POC
diagnostic tests for resource-limited settings such as PHC clinics was 91% (95%CI: 89%?93%).
Distribution of existing POC diagnostic tests
Distribution of POC tests to PHC clinics is the responsibility of the health authorities at the
Regional medical store and District Health Directorate upon request by the PHC clinics.
Timely distribution of POC diagnostic tests to PHC clinics, however, depended on the
availability of requested tests at the District Health Directorate or at the regional medical stores in
the UER. Of the 100 PHC clinics, 90% received POC diagnostic supplies within 24-hours of
requisition whenever the test was available either at the District Health Directorate or at the
regional medical stores. All 100 PHC clinics cross-checked requisitions against supply to
ensure that POC diagnostics supplied corresponded with the test kits requested, as well as
checked for differences. Ninety-seven percent (97%) of the PHCs asked the supply person to
note differences. A review of requisition books revealed that all differences were documented
in all 100 PHC clinics. Ninety-nine percent (99%) of the PHC clinics asked the supply person
to sign against the requisition supplied. Seventy-five percent (75%) of the PHC clinics
documented supplied POC diagnostics information into the ledger books and 96% kept requisition
forms/books in a safe place. The average score for compliance with distribution guidelines by
the PHC clinics was 93.8% (95%CI: 91.9?95.6%).
Human resource capacity for performing POC testing
Training of PHC clinic staffs to enable them to perform testing onsite is the ultimate duty of
the health authorities at the District and Regional level. This study results showed majority
(98%) of the PHC health professionals were trained in how to use existing POC diagnostics.
Standard operating procedures (SOPs) for performing POC tests were available in 81% of the
clinics. However, 24% of the clinics did have SOPs for safe disposal of used POC tests, and
neither did they have SOPs for reagent stock level management. The average score for compliance
with guidelines by the PHC clinics was 85.7% (95%CI: 81.8%?89.6%).
Stock levels of POC diagnostic tests
haemoglobin and hepatitis B virus tests in three (23.1%) districts. The study results
additionally, showed complete stock-out of urine protein test in all selected PHC clinics two (15.4%)
The results of the audited stock levels of HIV, malaria, syphilis, haemoglobin, urine
protein/albumin, urine pregnancy, blood glucose, and hepatitis B POC tests, showed that the
mean (plus or minus) standard deviation (SD) stock level of malaria tests in all 100 PHC clinics
was 189. 8 tests (SD = 188.8). Blood glucose test was revealed to be the least available in all 100
PHC clinics, with a mean stock level of 2.8 tests (SD = 10.6), as illustrated in Fig 2.
Causes/Reasons for complete stock-outs of POC diagnostic tests in PHC
Fig 2. Shows a bar chart of the mean variations in stock levels of POC tests audited in 100 PHC clinics in the Upper East Region.
consumption level, and documentation of minimum and maximum stock level (all p<0.05).
Stock level of HIV, malaria, and blood glucose tests were shown to be significantly associated
with only clinic attendance (all p<0.001), whilst syphilis test stock level was only significantly
associated with documentation of expiry date, documentation of monthly consumption
level, and documentation of minimum and maximum stock level (all p<0.001). Hepatitis B
stock level was also found to be significantly associated with only documentation of
unexplained losses (p = 0.011) and documentation of minimum and maximum stock level
(p<0.001). The results of the multivariate regression analysis further showed urine
pregnancy test stock level was only significantly associated documentation of minimum and
maximum stock level (p<0.001), and urine protein test dipsticks stock level was only
significantly associated with documentation of inventory level (p = 0.015), and documentation of
minimum and maximum stock level (p<0.001).
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We audited the supply chain management of POC diagnostics in rural PHC clinics in the UER
of Ghana. In this study, inadequate supply chain management of POC diagnostics was high,
and the combined compliance score was strong on distribution and selection of POC
diagnostics. POC diagnostics inventory management was revealed to be weak, followed by human
resource capacity for POC testing in the region. This audit also demonstrated stock-outs of
PLOS ONE | https://doi.org/10.1371/journal.pone.0211498
haemoglobin, blood glucose, syphilis, hepatitis B, and urine protein/albumin POC test kits in
the majority of the rural clinics. Lack of POC tests at the Regional/District Health Directorate
stores, inadequate inventory management, and high clinic attendance demonstrated
significant association with test stock-out in the PHC clinics.
Supply chain management challenges for POC diagnostics have been shown in other
studies within LMICs [
5, 15, 21?23
]. Hawkes et al. (2011), Jani et al. (2013), Tirinato et al. (2007)
and Palamontain et al. (2012), in their various studies, identified weaknesses in POC
diagnostics supply chain management that included human resources and training for POC testing
]. Weak supply chain management is very challenging to achieving cost-efficient
implementation of POC diagnostics [
]. It has been one of the major causes of poor stock levels
of POC tests in LMICs [
]. Additionally, poor supply chain management leads to downtime
of POC diagnostic device operating times [
]. It can potentially result either in stock-outs of
POC tests or in over-stocking of tests beyond PHC clinic consumption level which may expire
]. Ansbro et al. (2015) and Bonawitz et al.?s (2015) studies in Zambia demonstrated a high
level of syphilis POC test stock-outs at rollout sites, and at various stages of the implementation
for pregnant women, as well as at the evaluation stage [
]. Smith et al.?s (2015) study
conducted in Guatemala?s rural antenatal clinics also showed evidence of stock-outs of HIV,
syphilis, and hepatitis B virus POC tests . Dassah et al.?s (2018) study conducted in Ghana aimed
at exploring healthcare providers? experiences and challenges in antenatal syphilis screening
following the national rollout of rapid syphilis POC tests further reported frequent stock-outs
of syphilis and HIV tests in the health facilities [
]. Another example is Jaya et al.?s (2017)
audit in rural KwaZulu-Natal PHC clinics, which indicated that four out of 11 rural clinics
reported past experiences of HIV rapid test kit stock-outs [
]. Contrary to our findings, a
study by Hasselback et al. (2014) in Capo Delgado province in Mozambique revealed
substantially high levels of malaria POC test stock-outs in rural health facilities with increasing levels
of consumption in the region [
Studies have demonstrated reasons of POC test stock-outs to include
inadequate/underestimation of supply chain management during implementation [
6, 8, 7, 29
documentations and distribution systems [
]; lack of storage space [
]; and poor commodity
] which support these study findings. To address stock-outs of test POC tests
Peeling and Ronald (2009) recommended among other good supply-chain management,
effective training, and information systems [
]. Electronic connectivity such as the use of
dashboards to prevent stock-outs and also detect high consumption and low consumption clinics
to support redistribution of tests to prevent the expiration of tests has been suggested [
Tirinato et al. (2007) suggested the use of point-of-care inventory management system [
Practical training of health workers on how to perform POC tests and interpret of the results, stock
management, record keeping, and quality control have also been found to improve test
availability for use by rural health workers [
]. It is therefore imperative for Ghana to adopt an
electronic inventory management system, for PHC clinics alongside existing strategies and
ongoing activities such as the National Health Insurance Scheme, provision of equipment to
existing health facilities at all levels, building of Community-Based Planning and Services
(CHPS) compounds, and training and posting more health professions to help achieve
Universal Health Coverage.
The use of the WHO quality ASSURED criteria [
] and the MSH guidelines for diagnostic
supply chain management [
] has enabled us to adequately audit the supply chain
management for POC diagnostic services in rural PHC clinics in Ghana. Auditing the supply chain
management systems, especially in these rural health facilities, provides an opportunity to
streamline measures to ensure equity in the demand and supply of POC diagnostics [
study findings have contributed to gaining a better understanding of the POC diagnostic
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supply chain management in these clinics and revealed areas that require attention to improve
the accessibility of POC diagnostic services to patients. The findings have also provided
evidence-based information to help with planning and improving the access to these services in
rural health facilities. They are additionally useful in helping to plan and achieve universal
coverage as well as the health-related sustainable development goals. These findings may be
generalizable to other resource-limited settings.
There were several study limitations. We noticed that the supply of POC diagnostics to
PHC health facilities in Ghana depended on the availability of the tests at the national and
regional medical stores as well as at the district health directorate stores, which was not
considered in our study. We recommend a study to audit the availability, stock level, reasons for
stock-outs of tests at the District and Regional levels to ensure sustainability of POC testing
services in PHC clinics. We also realized that selection and procurement of POC diagnostics is
done at the national level and could be constrained by lack of funding and which may also
affect the availability of POC tests in rural health facilities. On the performance of the available
POC tests, we were limited to measure only the perceived sensitivity and specificity of the tests
since PHC health workers were more unlikely to have access to confirmatory testing results to
know the diagnostic accuracy of POC tests. Global development, procurement, and forecasting
may also play a larger role for POC diagnostics supply chains because the production lines for
new assays entering the market are mostly unable to meet the demand of rapid
recommendations that lead to rapid global uptake [
]. In view of this, we also recommend increased
development of POC diagnostics in LMICs in order to meet demand and supply. This study
did not investigate the root causes responsible for the poor inventory management although
the majority of the study respondents said they were trained on inventory management. We
recommend a study to unravel the root causes/reasons accounting for the poor inventory
management at the PHC clinics in the region in order to sustain POC testing services.
Accessibility to POC testing in rural PHC clinics is mostly limited and supply chain
management systems are mostly poor and unable to meet demand [
]. Improving supply chain
management, especially inventory management, and training of healthcare workers would sustain
accessibility of POC diagnostic services and may ultimately lead to sustained health system
]. We recommend regularly refresher training/workshops for PHC clinic staffs
responsible for POC diagnostic inventory management as well as their subordinates particularly,
new staffs. Documentation of minimum and maximum monthly consumption levels, inventory
levels, unexplained losses, expiry dates of existing POC tests ensure sufficient availability of POC
tests in rural health facilities [
]. We also recommend an electronic system of inventory
management to help detect PHC clinics with high and low consumption levels and to redistribute
POC tests to high consumption clinics in order to prevent test kits from expiring [
Although this study finding suggested the distribution of existing POC tests to be
adequately managed, documentation challenges by PHC staffs were revealed. We recommend
that the District/Regional health authorities should regularly organize refresher training for
PHC staff on documentation of test stock levels on site to aid forecasting demand to ensure
continued supply of the diagnostic tests to match consumption. We additionally recommend
the adoption of the proposed lean and agile supply chain management framework for POC
diagnostics in LMICs [
] to suit local contexts in order to ensure universal health coverage and
improve health outcomes in rural communities.
There is poor supply chain management of POC diagnostics in the Upper East Region?s rural
PHC clinics. The audit results have shown higher deficiencies in inventory management and
12 / 15
human resource capacity for POC diagnostic services in audited PHC clinics in rural UER.
Improving inventory management, training of healthcare workers, and provision of standard
operating procedures, alongside increased procurement of POC diagnostics is highly
recommended strengthening rural healthcare delivery and outcomes. Finally, supply chain
management strategies for POC diagnostics need to be well planned to ensure accessibility of POC
diagnostic services in rural resource-limited settings, which could ultimately lead to universal
S1 Table. Audit tool.
S1 Dataset. SCM data.xlsx.
S2 Table. Multivariate regression analysis output from Stata 14.
We are thankful to the University of KwaZulu-Natal for providing us with essential research
resources during the course of this study. The authors would like to thank the authorities of
the Upper East Regional Health Directorate, the District Health Management Teams, and all
the rural PHC managers for granting us permission to conduct this study. Finally, we would
like to thank the staff of the Department of Public Health Medicine, University of
KwaZuluNatal for their diverse support.
Conceptualization: Desmond Kuupiel, Tivani P. Mashamba-Thompson.
Data curation: Desmond Kuupiel.
Formal analysis: Desmond Kuupiel.
Investigation: Desmond Kuupiel.
Methodology: Desmond Kuupiel, Boikhutso Tlou.
Supervision: Vitalis Bawontuo, Tivani P. Mashamba-Thompson.
Validation: Boikhutso Tlou.
Writing ? original draft: Desmond Kuupiel.
Writing ? review & editing: Desmond Kuupiel, Vitalis Bawontuo, Paul K. Drain, Tivani P.
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1. World Health Organization. World Health Organization Model List of Essential In Vitro Diagnostics First edition ( 2018 ). Geneva: World Health Oraganization; 2018 2018.
2. Drain PK , Hyle EP , Noubary F , Freedberg KA , Wilson D , Bishai WR , et al. Diagnostic point-of-care tests in resource-limited settings . Lancet Infect Dis . 2014 ; 14 .
3. Pai NP , Vadnais C , Denkinger C , Engel N , Pai M . Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low- and middle-income countries . PLoS Med . 2012 ; 9 ( 9 ):e1001306. https:// doi.org/10.1371/journal.pmed. 1001306 PMID: 22973183
4. Majors CE , Smith CA , Natoli ME , Kundrod KA , Richards-Kortum R . Point-of-care diagnostics to improve maternal and neonatal health in low-resource settings . Lab Chip . 2017 ; 17 ( 20 ): 3351 - 87 . https://doi.org/ 10.1039/c7lc00374a PMID: 28832061
5. Kuupiel D , Bawontuo V , Mashamba-Thompson TP . Improving the Accessibility and Efficiency of Pointof-Care Diagnostics Services in Low- and Middle-Income Countries : Lean and Agile Supply Chain Management . Diagnostics . 2017 ; 7 ( 4 ): 58 .
6. Peeling RW . Diagnostics in a digital age: an opportunity to strengthen health systems and improve health outcomes . Int Health . 2015 ; 7 ( 6 ): 384 - 9 . https://doi.org/10.1093/inthealth/ihv062 PMID: 26553825
7. Smith A , Sabido? M , Camey E , Batres A , Casabona J . Lessons learned from integrating simultaneous triple point-of-care screening for syphilis, hepatitis B, and HIV in prenatal services through rural outreach teams in Guatemala . International Journal of Gynecology & Obstetrics . 2015 ; 130 , Supplement 1 : S70 - S2 .
8. Ansbro E ?M, Gill MM , Reynolds J , Shelley KD , Strasser S , Sripipatana T , et al. Introduction of syphilis point-of-care tests, from pilot study to national programme implementation in Zambia: a qualitative study of healthcare workers' perspectives on testing, training and quality assurance . PloS one . 2015 ; 10 ( 6 ):e0127728. https://doi.org/10.1371/journal.pone. 0127728 PMID: 26030741
9. Bonawitz RE , Duncan J , Hammond E , Hamomba L , Nambule J , Sambambi K , et al. Assessment of the impact of rapid syphilis tests on syphilis screening and treatment of pregnant women in Zambia . International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics . 2015 ; 130 Suppl 1 : S58 - 62 .
10. Hasselback L , Crawford J , Chaluco T , Rajagopal S , Prosser W , Watson N. Rapid diagnostic test supply chain and consumption study in Cabo Delgado, Mozambique: estimating stock shortages and identifying drivers of stock-outs . Malaria journal . 2014 ; 13 ( 1 ): 295 .
11. Kyabayinze DJ , Achan J , Nakanjako D , Mpeka B , Mawejje H , Mugizi R , et al. Parasite-based malaria diagnosis: Are Health Systems in Uganda equipped enough to implement the policy? BMC Public Health . 2012 ; 12 ( 1 ): 695 .
12. Jaya Z , Drain PK , Mashamba-Thompson TP . Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa . PloS one . 2017 ; 12 ( 8 ):e0183044. https://doi.org/10.1371/journal.pone. 0183044 PMID: 28829801
13. Kuupiel D , Tlou B , Bawontuo V , Mashamba-Thompson T , P., Accessibility of point-of-care diagnostics for maternal healthcare in lower health facilities in Northern Ghana: A cross-sectional survey. [A crosssectional survey] . In press 2018 .
14. Kuupiel D , Tlou B , Bawontuo V , Mashamba-Thompson TP . Accessibility of Point-of-Care Diagnostic Services for Maternal Health in Lower Healthcare Facilities in Northern Ghana: A Cross-Sectional Survey . Available at SSRN 3204717 . 2018 .
15. Engel N , Wachter K , Pai M , Gallarda J , Boehme C , Celentano I , et al. Addressing the challenges of diagnostics demand and supply: insights from an online global health discussion platform . BMJ Global Health . 2016 ; 1 ( 4 ):e000132. https://doi.org/10.1136/bmjgh-2016 -000132 PMID: 28588980
16. Pinna R , Carrus PP , Marras F. Emerging Trends in Healthcare Supply Chain Management-An Italian Experience . In: Tozan H , Erturk A , editors. Applications of Contemporary Management Approaches in Supply Chains . Rijeka: InTech; 2015 . p. Ch . 06 .
17. Embrey MA , Health MSf . MDS-3: Managing Access to Medicines and Health Technologies: Kumarian Press; 2012 .
18. Peeling RW , Mabey D , Herring A , Hook EW . Why do we need quality-assured diagnostic tests for sexually transmitted infections? Nature reviews Microbiology . 2006 ; 4 ( 12 ): S7 .
19. Fonjungo PN , Boeras DI , Zeh C , Alexander H , Parekh BS , Nkengasong JN . Access and Quality of HIVRelated Point-of-Care Diagnostic Testing in Global Health Programs . Clin Infect Dis . 2016 ; 62 ( 3 ): 369 - 74 . https://doi.org/10.1093/cid/civ866 PMID: 26423384
20. Ghana Statistical Service. 2010 Population & Housing Census: Summary Report of Final Results Accra: Ghana Statistical Service; 2012 [http://www.statsghana.gov.gh/docfiles/2010phc/Census2010_ Summary_report_of_final_results .pdf.
21. Mabey DC , Sollis KA , Kelly HA , Benzaken AS , Bitarakwate E , Changalucha J , et al. Point-of-care tests to strengthen health systems and save newborn lives: the case of syphilis . PLoS medicine . 2012 ; 9 ( 6 ): e1001233. https://doi.org/10.1371/journal.pmed. 1001233 PMID: 22719229
22. Sharma S , Crawley A . Strategies for overcoming challenges for decentralised diagnostics in resourcelimited and catastrophe settings . 2016 .
23. Peeling R . Bringing diagnostics to developing countries: an interview with Rosanna Peeling. Expert review of molecular diagnostics . 2015 ; 15 ( 9 ): 1107 - 10 . https://doi.org/10.1586/14737159. 2015 . 1081802 PMID: 26312948
24. Tirinato JA , Zelin MP , Gibson PA , Zaltsman L , Davis G . Point-of-care inventory management system and method . Google Patents; 2007 .
25. Palamountain KM , Baker J , Cowan EP , Essajee S , Mazzola LT , Metzler M , et al. Perspectives on introduction and implementation of new point-of-care diagnostic tests . Journal of Infectious Diseases . 2012 ; 205 ( suppl _2): S181 - S90 .
26. Hawkes S , Matin N , Broutet N , Low N. Effectiveness of interventions to improve screening for syphilis in pregnancy: a systematic review and meta-analysis . The Lancet infectious diseases . 2011 ; 11 ( 9 ): 684 - 91 . https://doi.org/10.1016/S1473- 3099 ( 11 ) 70104 - 9 PMID: 21683653
27. Jani IV . How point-of-care testing could drive innovation in global health . The New England journal of medicine . 2013 ; 368 ( 24 ): 2319 . https://doi.org/10.1056/NEJMsb1214197 PMID: 23758238
28. Schito M , Peter TF , Cavanaugh S , Piatek AS , Young GJ , Alexander H , et al. Opportunities and challenges for cost-efficient implementation of new point-of-care diagnostics for HIV and tuberculosis . Journal of Infectious Diseases . 2012 ; 205 ( suppl _2): S169 - S80 .
29. Peeling RW , Ronald A . Diagnostic challenges of sexually transmitted infections in resource-limited settings . Future microbiology . 2009 ; 4 ( 10 ): 1271 - 82 . https://doi.org/10.2217/fmb.09.100 PMID: 19995188
30. Thairu L , Katzenstein D , Israelski D. Operational challenges in delivering CD4 diagnostics in sub-Saharan Africa . AIDS Care . 2011 ; 23 ( 7 ): 814 - 21 . https://doi.org/10.1080/09540121. 2010 .541416 PMID: 21400312
31. Dassah ET , Adu-Sarkodie Y , Mayaud P. Rollout of rapid point of care tests for antenatal syphilis screening in Ghana: healthcare provider perspectives and experiences . BMC health services research . 2018 ; 18 ( 1 ): 130 . https://doi.org/10.1186/s12913-018-2935-y PMID: 29458363
32. UNAIDS. Countdown to ZERO: global plan towards the elimination of new HIV infections among children by 2015 and keeping their mother alive . UNAIDS; 2011 .
World Health Organization. Manual for procurement of diagnostics and related laboratory items and equipment: Diagnostics and Laboratory Technology . Geneva; 2013 .