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BY 4.0 license Open Access Published by De Gruyter January 27, 2023

Assessment of laboratory capacity in conflict-affected low-resource settings using two World Health Organization laboratory assessment tools

  • Jessica Markby , Monika Gygax , Catherine Savoy , Yves Giebens , Sanja Janjanin , Felicity Machoka , Justin Kinziagu Mawina , Sahar M.M. Ghanem and Beatrice Natalie Vetter EMAIL logo

Abstract

Objectives

Laboratory diagnostic services are essential to drive evidence-based treatment decisions, manage outbreaks, and provide population-level data. Many low- and middle-income countries (LMICs) lack sufficient diagnostic capacity, often further exacerbated in conflict-affected areas. This project assessed laboratory services in conflict-affected LMICs to understand gaps and opportunities for improving laboratory capacity.

Methods

The World Health Organization Laboratory Assessment Tool Facility Questionnaire (WHO Laboratory Tool) and Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist were used to assess five laboratories in Eastern Democratic Republic of the Congo (DRC) and five in Gaza, Palestine. Total scores and percentage outcomes by indicator were calculated.

Results

Average WHO Laboratory Tool score across all facilities was 41% (range 32–50%) in DRC and 78% (range 72–84%) in Gaza. Lowest scoring indicators in DRC were Biorisk management (13%, range 8–21%), Documentation (14%, range 6–21%), and in Gaza, were Facilities (59%, range 46–75%) and Documentation (60%, range 44–76%). Highest scoring indicators in DRC were Facilities (70%, range 45–83%) and Data and Information Management (61%, range 38–80%), and in Gaza were Data Information and Management (96%) and Public Health Function (91%, range 88–94%). In DRC, no laboratory achieved a SLIPTA star rating. In Gaza, two laboratories had a 3-star SLIPTA rating, one had a 2-star rating and two had a 1-star rating.

Conclusions

Laboratory systems in conflict-affected LMICs have significant gaps. Implementating improvement strategies in such settings may be especially challenging.

Introduction

Accurate and timely diagnosis is essential to quality healthcare, including disease screening, patient management, outbreak prevention, and generation of population-level healthcare data to inform public health interventions [1, 2]. However, many low- and middle-income countries (LMICs) lack sufficient laboratory diagnostic capacity, with significant deficiencies in essential infrastructure, supplies and equipment, skilled personnel, quality management systems and information management, representing challenges to access to quality-assured laboratory services [2], [3], [4]. Additional burdens are placed on laboratory systems in conflict-affected and fragile settings due to safety and security risks, damaged and temporary infrastructure, and fragmented supply chains resulting from blockades as well as population displacement (including laboratory workforce) [5], [6], [7]. The recent Lancet Commission on diagnostics highlighted a need to address the diagnostic requirements of populations living in fragile and conflict situations [7].

Emergency health interventions in conflict-affected settings depend upon fast, accurate and reliable laboratory test results. A key clinical priority in such settings is surgery for conflict-associated trauma, which can require a range of supportive tests including microbiology and antimicrobial susceptibility testing to guide antibiotic use and detect biomarkers for sepsis, and clinical chemistry tests for kidney and liver function. Sexual violence is frequently increased in conflict-affected areas, thus testing services for sexually-transmitted and blood-borne infections, such as human immunodeficiency virus (HIV) and hepatitis C virus (HCV), as well as for obstetrics, are important. Additionally, management of infectious disease outbreaks in displaced communities with poor hygiene and overcrowding requires the ability to test for a range of different pathogens, particularly water-borne pathogens.

Improving the quality of laboratory services has a positive impact on accuracy of test results and timely result delivery, strengthening overall patient care. However, improving laboratory quality in low-resource settings can be challenging due to logistical and resource constraints. Laboratory quality standards for such settings are critical to guarantee the minimum acceptable level of quality [8]. The first key step towards quality improvement is a situational analysis and comprehensive assessment to better understand the gaps and required interventions. Various tools that have been developed to guide assessment of laboratories in low-resource settings can be adapted for use in conflict-affected settings. The World Health Organization (WHO) Laboratory Assessment Tool (WHO Laboratory Tool) is designed to collect objective data to enable national decision-makers and stakeholders to more accurately plan and implement laboratory capacity strengthening activities [9]. It assesses objective elements that contribute to the capacity, performance, and quality of laboratory services, including the availability of diagnostic tests. The WHO Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist was developed to assess the level of preparedness to achieve ISO 15189 standards for medical laboratories [10]. It focuses on processes that allow a laboratory to operate according to best-practice standards. As these two tools assess different angles of laboratory capacity and operation, they are considered to be largely complementary.

The aim of this project was to assess laboratory capacity across a range of laboratories in two conflict-affected LMICs, using both the WHO Laboratory Tool and SLIPTA checklist, to define gaps and develop plans to improve laboratory diagnostic services in these settings.

To our knowledge, this is the first report to assess service readiness in conflict-affected LMICs and the findings represent a valuable baseline for the improvement of laboratory services in such settings based on the identified gaps.

Materials and methods

Project settings

The project was conducted by the International Committee of the Red Cross (ICRC) and FIND, the global alliance for diagnostics. The project was carried out in two conflict-affected settings in which the ICRC is operational: the Democratic Republic of the Congo (Eastern DRC; North and South Kivu provinces), and the Gaza Strip, Palestine. Eastern DRC and Gaza are both contexts affected by intermittent episodes of armed conflict. Five laboratories from each country were included for assessments: one primary healthcare, three secondary healthcare and one tertiary healthcare laboratory in DRC, and three hospital laboratories, one primary healthcare and one public health laboratory in Gaza (Table 1). The public health laboratory in Gaza only performs environmental testing. Laboratories were selected based on recommendations from Ministries of Health in each country and on priority areas according to local ICRC operations and therefore may not be representative of all laboratories in the settings.

Table 1:

List of project sites.

Democratic Republic of Congo Gaza
Laboratory Province Healthcare level
Ndosho Hospital/Bethesda Hospital Centre North Kivu Primary Indonesian Hospital Laboratory
Heal Africa Hospital North Kivu Secondary Nasser Hospital Laboratory
Centre d’Analyse Biomédicale de Référence North Kivu Secondary Shifa Hospital Laboratory and Shifa Histopathology Laboratory
Panzi Foundation Hospital South Kivu Secondary Remal Primary Healthcare Clinic Laboratory
Hôpital Provincial General Référence de Bukavu (HPGRB) South Kivu Tertiary Public Health Laboratory

Assessment procedures

The WHO Laboratory Tool and SLIPTA checklist assessments were performed over periods of three weeks in each setting (from 3rd to 27th August 2021 in DRC and 4th to 29th July 2021 in Gaza). The assessment procedure consisted of: sighting, collection and review of applicable documentation; a facility tour including assessing layout, activities, staffing and organization of the facilities and sighting of equipment, reagents, storage and testing areas; interviews with key stakeholders (laboratory director; quality, biosafety and data management personnel in charge; key lab personnel).

Assessors were experienced, fully trained on the tools and supported by local field staff to assist with translation; in Gaza, the assessor was also supported by a laboratory biomedical engineer. Assessors were not SLIPTA certified. Ethics committee approval was not required, as the project was not related to either human or animals use. Local authorities provided permissions to visit and assess the selected laboratories. No further legal authorization was required for this work.

The WHO Laboratory Tool Facility Questionnaire covers 11 key indicators of good laboratory practice: Organization and Management; Documents; Specimen Collection, Handling and Transport; Data and Information Management; Consumables and Reagents; Equipment; Testing; Facilities; Human Resources; Biorisk Management; Public Health Function [9]. Each indicator has a number of sub-sections containing in total over 330 questions that require responses. For 10 of the 11 indicators, responses are converted into weighted scores (yes = 1 point; partial = 0.5 points; no = 0 points; non-applicable = excluded from the calculation). These scores are used to derive percentage outcomes overall and for each indicator. The Testing indicator, which is designed to capture the number of diagnostic tests of each discipline and type performed in each facility per month, is unscored.

The SLIPTA checklist covers 12 indicators of laboratory operation: Documents and Records; Management Review and Management Responsibilities; Organization and Personnel; Client Management and Customer Service; Equipment; Evaluations and Audits; Purchasing and Inventory; Process Control; Information Management; Identification of Non-Conformities, Corrective and Preventive Actions; Occurrence Management and Process Improvement; Facilities and Biosafety [10]. The checklist has 115 questions, 41 of which have several sub-elements. Each question has a maximum pre-defined score based on relative importance or complexity (2, 3 or 5 points). SLITPA scoring requires all sub-elements of a question to be present (scored as ‘yes’) in order to achieve the maximum score for the question. If one sub-element is not present (scored as ‘partial’ or ‘no’), the final score for this question is reduced to 1 point; if all sub-elements are absent (scored as ‘no’), the final score is 0 points. For this assessment, we employed a modified SLITPA scoring to enable more granular evaluation of the presence or absence of sub-elements in questions. The response to each sub-element was scored individually (yes = 1 point, partial = 0.5 points and no = 0 points) and the final score (FS) for the questions was the sum of points (pts) of all sub-elements (SE) in proportion to the total number (n) of sub-elements and maximum score (MS) achievable for this question; i.e. FS = pts(SE)/n(SE) × MS.

The overall SLIPTA star rating was allocated based on total score across all indicators as follows: 1 star: 151–177 points (55–64%); 2 stars: 178–205 points (65–74%), 3 stars: 206–232 points (75–84%); 4 stars: 233–260 points (85–94%); 5 stars: 262–275 points (95–100%; 275 is the maximum score).

Outcomes

Outcome measures included WHO Laboratory Tool scores (total and per indicator), as well as number of tests available (by test discipline and type), and SLIPTA scores by indicator and star ratings based on total modified SLIPTA score.

Statistical analysis

WHO Laboratory Tool scores (total and per indicator) are presented as percentages of maximum score achieved by each laboratory and the average percentage for each country. SLIPTA scores are presented separately for each laboratory, as star ratings and as percentages of maximum score achieved for each indicator.

Results

WHO Laboratory Tool scoring outcomes

In DRC, the average WHO Laboratory Tool score across all assessed facilities was 41% (range 32–50%). The highest scoring indicators were Facilities (average score 70% [range 45–83%]), Data and Information Management (average score 61% [range 38–80%]) and Specimen Collection, Handling and Transport (average score 56% [range 54–58%]). The lowest scoring indicators were Biorisk Management (average score 13% [range 8–21%]) and Documentation (average score 14% [range 6–21%]). Human Resources and Equipment also had low scores (both 30%, ranges 15–50% and 28–42%, respectively) (Figure 1).

Figure 1: 
WHO Laboratory Tool Facility Questionnaire scores in DRC.
Figure 1:

WHO Laboratory Tool Facility Questionnaire scores in DRC.

Responses to the testing indicator showed that in DRC the two most common test disciplines across all five laboratories were clinical chemistry (at 19–47% of the total test portfolio per laboratory) and haematology/haemostasis (at 11–39%) (Figure 2). This was followed by parasitology (at 4–15%), bacterial serology (at 2–14%) and bacteriology (at 2–14%) for tests conducted in all five laboratories. Viral serology, virology (except serology), serology/immunoassay (non-pathogen), transfusion medicine, histopathology and cytology were not conducted in all laboratories, with histopathology and cytology testing only being conducted to a very limited extent in two laboratories (at 0.1–0.5% of the total test portfolio). Polymerase chain reaction (PCR) testing for the viral pathogens HIV, hepatitis B virus (HBV), HCV and human papillomavirus (HPV) was rarely performed in these laboratories, as was tuberculosis (TB) susceptibility testing and antimicrobial susceptibility testing (data on file). Only one laboratory performed PCR testing for COVID-19. Cancer screening, for example for markers such as complement C3 and C4, carcinoembryonic antigen, prostate-specific antigen, or M proteins, was also infrequent.

Figure 2: 
Percentage of tests per month by discipline and site in DRC. Other includes occult blood and protein electrophoresis tests for cancer, spermogramme tests and urine sedimentation tests.
Figure 2:

Percentage of tests per month by discipline and site in DRC. Other includes occult blood and protein electrophoresis tests for cancer, spermogramme tests and urine sedimentation tests.

In Gaza, the average WHO Laboratory Tool score across all facilities was 78% (range 72–84%) (Figure 3). Highest scoring indicators were Data and Information Management (all laboratories scored 96%), Public Health Function (average score 91% [range 88–94%]), and Specimen Collection, Handling and Transport (all laboratories scored 84%). The Human Resources indicator (all laboratories scored 80%) and Consumables and Reagents indicator (average score 79% [range 69–87%]) also scored highly. The lowest scoring indicators were Facilities (average score 59% [range 46–75%]), Documentation (average score 60% [range 44–76%]) and Biorisk Management (average score 69% [range 59–90%]), although there was substantial variation across laboratories.

Figure 3: 
WHO Laboratory Tool Facility Questionnaire scores in Gaza.
Figure 3:

WHO Laboratory Tool Facility Questionnaire scores in Gaza.

Responses to the testing indicator showed that the most common test disciplines were clinical chemistry (at 47–76% of the total test portfolio per laboratory), haematology/haemostasis (at 9–28%) and bacteriology (including antimicrobial resistance testing) (at 5–11%) (Figure 4). Viral serology, transfusion medicine testing and bacterial serology was also performed in all laboratories, albeit to varying degrees. The least common tests performed were mycology, cytology, toxicology, histopathology and parasitology (all below 0.5%). Although no viral PCR tests for HIV, HCV, HBV or COVID-19, or susceptibility tests for TB, were carried out at the five laboratories included in the project (data on file), samples could be referred to a central referral laboratory for these tests. No specific viral PCR tests for HPV, viral serology tests for rubella, bacterial serology tests for salmonella (including Widal test for typhoid) or streptococcus, or parasitology tests for toxoplasmosis, were conducted (data on file). Screening for cancer and immunological disorders (i.e. rheumatoid factor or immunoglobulins) was limited.

Figure 4: 
Percentage of tests per month by discipline and site in Gaza. Other includes occult blood and protein electrophoresis tests for cancer, spermogramme tests and urine sedimentation tests.
Figure 4:

Percentage of tests per month by discipline and site in Gaza. Other includes occult blood and protein electrophoresis tests for cancer, spermogramme tests and urine sedimentation tests.

SLIPTA checklist

In DRC, no laboratory achieved a score sufficient for a star rating (average score 65 [range 48–91]) (Figure 5). Highest performing indicators were Purchasing and Inventory (average 49% of the maximum score [range 33–55%]), Facilities and Biosafety (average 36% [range 22–45%]), Process Control (average 36% [range 29–45%]), Information Management (average 32% [range 17–54%]), and Organization and Personnel (average 30% [range 13–45%]). A score of zero was observed at four of five sites for the following indicators: Management Review and Responsibilities, Client Management and Customer Service, Evaluations and Audits, Identification of Non-Conformities, Corrective and Preventive Actions, and Occurrence Management and Process Improvement.

Figure 5: 
SLIPTA checklist scores in DRC. CAPAs, corrective and preventive actions.
Figure 5:

SLIPTA checklist scores in DRC. CAPAs, corrective and preventive actions.

In Gaza, two laboratories had a 3-star SLIPTA rating, one had a 2-star rating and two had a 1-star rating (average total scores 193 [range 165–213]) (Figure 6). The highest performing indicators were Identification of Non-Conformities, Corrective and Preventive Actions (average 83% of maximum score [range 70–90%]), Occurrence Management and Process Improvement (average 82% [range 75–83%]), and Purchasing and Inventory (average 75% [range 57–96%]). The lowest scores were in Facilities and Biosafety (average 59% [range 41–80%]) and Evaluations and Audits (average 59% [range 50–86%]).

Figure 6: 
SLIPTA checklist scores in Gaza. CAPAs, corrective and preventive actions.
Figure 6:

SLIPTA checklist scores in Gaza. CAPAs, corrective and preventive actions.

Discussion

This systematic assessment of laboratory capacity in two conflict-affected low-resource settings identified a number of major gaps in laboratory infrastructure, processes, quality, and availability of diagnostic tests. To our knowledge, this is the first report to specifically assess service readiness in LMICs that are conflict-affected, thus these findings represent a valuable baseline for the improvement of laboratory services in such settings based on the identified gaps.

Consistent with our findings, previous assessments of laboratory quality standards using SLIPTA in Southwestern Uganda, Nigeria and Ethiopia reported gaps in documentation, standard operating procedures, quality audit schemes, internal audits, incidence management, external quality assurance, and laboratory infrastructure, with several laboratories failing to achieve a star rating [11], [12], [13]. In Pakistan, deficiencies in biorisk management were identified using a modified version of the WHO Laboratory Tool [14].

There remains an overarching need for funding and capacity building to support implementation of specific strategies to address the gaps observed in this project in conflict-affected settings. For example, improvements to biorisk management could be made through procurement of safety equipment, development of laboratory safety training programmes and appointment of safety officers. Improvements to equipment could be achieved through comprehensive equipment maintenance plans and training programmes for biomedical engineers. However, these strategies would incur substantial ongoing costs and require commitment from local stakeholders. In Gaza, the majority of laboratory equipment is provided by international donors, which can lead to redundancies, as well as challenges in terms of servicing and obtaining parts and technical support [7]. Other challenges associated with donated equipment include equipment that is incomplete or beyond normal end of service, limited availability of qualified staff for installation, inconsistent power supply leading to frequent breakdowns, and difficulties obtaining software updates [7]. Strategies for harmonization of laboratory equipment may therefore be a cost-efficient way to introduce improvements. Such harmonization may need to take into consideration strengthening of supply chains and logistics systems, as duplication in equipment is currently a strategy to mitigate supply gaps that occur due to local restrictions on importation or irregular deliveries.

Development of new infrastructure is particularly associated with significant costs, thus funding for infrastructure improvements may be best used to upgrade existing facilities through renovations, extensions and remodelling. In the laboratories participating in this project, many buildings were old, damaged by ongoing conflict, or temporary in nature. Space was often inadequate for the workload, with crowding of benches, refrigeration and storage space. Ventilation was inadequate and electrical wiring was in poor condition. Many of these findings are consistent with inadequacies in physical laboratory infrastructure observed across LMICs [1]. Damage associated with shelling, a constant feature in many conflict-affected countries, further exacerbates infrastructure-related challenges in such settings.

Laboratories in DRC scored poorly on human resources and personnel indicators, while this was a strength in Gaza. Although the number of staff employed in the DRC laboratories was appropriate in most of the participating laboratories, they were insufficiently qualified, and options for continuing education were extremely limited. A standardized training curriculum at the national level is needed, incorporating ongoing in-service training. However, efforts to implement training programmes would require consistent funding to ensure sustainability, particularly given the higher salary requirements for qualified personnel. This may be challenging for LMICs that have healthcare budgets based on cost recovery. Human resources related gaps are known barriers to access to laboratory services in LMICs [1], but are likely to be intensified in conflict-affected settings due to population displacement.

Gaps were noted in the test menus of laboratories in both countries. A need for improved histopathology and cytology capacity was identified among all facilities assessed, which is of particular importance given high cancer fatality rates in LMICs [15]. Microbiology testing capacity in DRC also required improvement. Given the high frequency of injuries caused by weaponry and need for surgical procedures in conflict-affected areas, microbiology services are essential to humanitarian operations. In conflict-affected settings, access to imaging technologies critical for the care of people with trauma or cancer is also likely to be limited, leaving healthcare workers with limited options for diagnosis of these patients. Additionally, due to national prioritization of other programmes in the context of global funding initiatives, PCR testing in the five DRC laboratories was limited for HIV, HBV, HCV, HPV and TB, all of which represent public health challenges in the country [16], [17], [18], [19], [20]. A wider assessment is needed to evaluate whether national capacity for these tests across other laboratories in DRC requires improvement. Testing for COVID-19 was limited to one of the five laboratories in DRC, highlighting a need for wider testing for disease surveillance.

Based on the findings from this project, a number of interventions are planned to support the improvement of the quality at sites involved in the assessments. These include implementation of the SLMTA framework, diagnostic network optimization activities, and development and implementation of National Essential Diagnostic Lists (nEDLs). SLMTA is designed to teach laboratory personnel how to implement practical QMS in resource-limited settings [21], and has been shown to transform the quality of laboratories across different countries, facilitating reductions in turnaround times, specimen rejection rates and nonconformities, and improvements in external quality assessments and clinician satisfaction [22, 23].

This project was limited by the small number of laboratories included from each country (n=5), therefore the results may not be generalizable to the overall situation in DRC and Gaza, or indeed to other conflict-affected settings. Furthermore, laboratory selection was guided by local Ministries of Health in collaboration with the ICRC in order to select the most representative or operationally important facilities; this meant that no detailed facility mapping was performed. Additionally, while the assessors were trained and experienced, they were not SLIPTA certified, and bias due to variability in assigning scores cannot be excluded. The modified SLIPTA scoring used in this study could have potentially resulted in a higher score for questions where some sub-elements were not fully met. Thus, the SLIPTA outcomes only provide an indication of the extent to which the laboratories meet the required standards and are accreditation ready.

Conclusions

Laboratory systems in conflict-affected, low-resource settings have a number of major gaps and weaknesses. Implementation of strategies to improve laboratory services in conflict-affected LMICs may be especially challenging, thus particular attention to such settings is required in order to achieve equity in access to quality care.


Corresponding author: Beatrice N. Vetter, PhD, FIND, Campus Biotech, 9 Chemin des Mines, 1202 Geneva, Switzerland, E-mail:

Funding source: International Committee of the Red Cross

Acknowledgments

The authors express their gratitude to the following people or groups: staff at the laboratories in Gaza and DRC assessed as part of this report; laboratory assessors Rodrigo Acosta Zermeno (ICRC), Ryan Ruiz (FIND) and Hanesh Fru Chi (FIND); Gaza in-country staff Wafa Elshawa and Akram Kahlout; ICRC headquarter project supervisor Stephanie Cristin; Project management assistance Nella Renton (FIND). Medical writing assistance and editorial support, under the direction of the authors, was provided by Rachel Wright, PhD (FIND), according to Good Publication Practice guidelines.

  1. Research funding: This project was funded by the ICRC through a grant from Roche Diagnostics.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: BV and JM declare that they are employed by FIND. All other authors have no competing interests to declare.

  4. Informed consent: Not applicable. Informed consent was not required, as the project did not recruit participants.

  5. Ethical approval: Not applicable. Ethics approval was not required, as the project was not related to either human or animal use.

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Received: 2022-11-23
Accepted: 2023-01-16
Published Online: 2023-01-27
Published in Print: 2023-05-25

© 2023 the author(s), published by De Gruyter, Berlin/Boston

This work is licensed under the Creative Commons Attribution 4.0 International License.

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