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Clin Chem Lab Med 2023; 61(6): 1015–1024

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

Assessment of laboratory capacity in conflict-


affected low-resource settings using two World
Health Organization laboratory assessment tools
https://doi.org/10.1515/cclm-2022-1203 star rating. In Gaza, two laboratories had a 3-star SLIPTA
Received November 23, 2022; accepted January 16, 2023; rating, one had a 2-star rating and two had a 1-star rating.
published online January 27, 2023 Conclusions: Laboratory systems in conflict-affected LMICs
have significant gaps. Implementating improvement strate-
Abstract
gies in such settings may be especially challenging.
Objectives: Laboratory diagnostic services are essential to Keywords: conflict; diagnostic services; laboratory diag-
drive evidence-based treatment decisions, manage out- nosis; low-resource.
breaks, 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-
Introduction
affected LMICs to understand gaps and opportunities for
Accurate and timely diagnosis is essential to quality
improving laboratory capacity.
healthcare, including disease screening, patient manage-
Methods: The World Health Organization Laboratory
ment, outbreak prevention, and generation of population-
Assessment Tool Facility Questionnaire (WHO Laboratory
level healthcare data to inform public health interventions
Tool) and Stepwise Laboratory Improvement Process
[1, 2]. However, many low- and middle-income countries
Towards Accreditation (SLIPTA) checklist were used to
(LMICs) lack sufficient laboratory diagnostic capacity, with
assess five laboratories in Eastern Democratic Republic of
significant deficiencies in essential infrastructure, supplies
the Congo (DRC) and five in Gaza, Palestine. Total scores
and equipment, skilled personnel, quality management
and percentage outcomes by indicator were calculated.
systems and information management, representing chal-
Results: Average WHO Laboratory Tool score across all
lenges to access to quality-assured laboratory services [2–4].
facilities was 41% (range 32–50%) in DRC and 78% (range
Additional burdens are placed on laboratory systems in
72–84%) in Gaza. Lowest scoring indicators in DRC were
conflict-affected and fragile settings due to safety and secu-
Biorisk management (13%, range 8–21%), Documentation
rity risks, damaged and temporary infrastructure, and
(14%, range 6–21%), and in Gaza, were Facilities (59%,
fragmented supply chains resulting from blockades as well
range 46–75%) and Documentation (60%, range 44–76%).
as population displacement (including laboratory work-
Highest scoring indicators in DRC were Facilities (70%,
force) [5–7]. The recent Lancet Commission on diagnostics
range 45–83%) and Data and Information Management
highlighted a need to address the diagnostic requirements of
(61%, range 38–80%), and in Gaza were Data Information
populations living in fragile and conflict situations [7].
and Management (96%) and Public Health Function (91%,
Emergency health interventions in conflict-affected
range 88–94%). In DRC, no laboratory achieved a SLIPTA
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
*Corresponding author: Beatrice N. Vetter, PhD, FIND, Campus Biotech,
9 Chemin des Mines, 1202 Geneva, Switzerland, of supportive tests including microbiology and antimicro-
E-mail: beatrice.vetter@finddx.org bial susceptibility testing to guide antibiotic use and detect
Jessica Markby, FIND, Geneva, Switzerland biomarkers for sepsis, and clinical chemistry tests for kid-
Monika Gygax, Catherine Savoy, Yves Giebens, Sanja Janjanin ney and liver function. Sexual violence is frequently
and Felicity Machoka, International Committee of the Red Cross, Geneva,
increased in conflict-affected areas, thus testing services
Switzerland
Justin Kinziagu Mawina, Ministère de la Santé Publique, Kinshasa,
for sexually-transmitted and blood-borne infections, such
Democratic Republic of the Congo as human immunodeficiency virus (HIV) and hepatitis C virus
Sahar M.M. Ghanem, Ministry of Health, Gaza, Palestine (HCV), as well as for obstetrics, are important. Additionally,
Open Access. © 2023 the author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License.
1016 Markby et al.: Assessment of laboratory services in conflict-affected settings

management of infectious disease outbreaks in displaced and Gaza are both contexts affected by intermittent episodes of armed
communities with poor hygiene and overcrowding requires conflict. Five laboratories from each country were included for assess-
ments: one primary healthcare, three secondary healthcare and one
the ability to test for a range of different pathogens, particu-
tertiary healthcare laboratory in DRC, and three hospital laboratories,
larly water-borne pathogens. one primary healthcare and one public health laboratory in Gaza (Ta-
Improving the quality of laboratory services has a pos- ble 1). The public health laboratory in Gaza only performs environ-
itive impact on accuracy of test results and timely result mental testing. Laboratories were selected based on recommendations
delivery, strengthening overall patient care. However, from Ministries of Health in each country and on priority areas ac-
cording to local ICRC operations and therefore may not be representa-
improving laboratory quality in low-resource settings can be
tive of all laboratories in the settings.
challenging due to logistical and resource constraints. Lab-
oratory quality standards for such settings are critical to
guarantee the minimum acceptable level of quality [8]. The Assessment procedures
first key step towards quality improvement is a situational
analysis and comprehensive assessment to better under- The WHO Laboratory Tool and SLIPTA checklist assessments were
stand the gaps and required interventions. Various tools that 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
have been developed to guide assessment of laboratories in
procedure consisted of: sighting, collection and review of applicable
low-resource settings can be adapted for use in conflict-
documentation; a facility tour including assessing layout, activities,
affected settings. The World Health Organization (WHO) staffing and organization of the facilities and sighting of equipment,
Laboratory Assessment Tool (WHO Laboratory Tool) is reagents, storage and testing areas; interviews with key stakeholders
designed to collect objective data to enable national decision- (laboratory director; quality, biosafety and data management personnel
makers and stakeholders to more accurately plan and in charge; key lab personnel).
Assessors were experienced, fully trained on the tools and sup-
implement laboratory capacity strengthening activities [9].
ported by local field staff to assist with translation; in Gaza, the assessor
It assesses objective elements that contribute to the capacity, was also supported by a laboratory biomedical engineer. Assessors were
performance, and quality of laboratory services, including not SLIPTA certified. Ethics committee approval was not required, as the
the availability of diagnostic tests. The WHO Stepwise Lab- project was not related to either human or animals use. Local authorities
oratory Improvement Process Towards Accreditation provided permissions to visit and assess the selected laboratories. No
further legal authorization was required for this work.
(SLIPTA) checklist was developed to assess the level of pre-
The WHO Laboratory Tool Facility Questionnaire covers 11 key
paredness to achieve ISO 15189 standards for medical labo-
indicators of good laboratory practice: Organization and Management;
ratories [10]. It focuses on processes that allow a laboratory Documents; Specimen Collection, Handling and Transport; Data and
to operate according to best-practice standards. As these two Information Management; Consumables and Reagents; Equipment;
tools assess different angles of laboratory capacity and Testing; Facilities; Human Resources; Biorisk Management; Public
operation, they are considered to be largely complementary. Health Function [9]. Each indicator has a number of sub-sections con-
taining in total over 330 questions that require responses. For 10 of the 11
The aim of this project was to assess laboratory capacity
indicators, responses are converted into weighted scores (yes = 1 point;
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 Table : List of project sites.
diagnostic services in these settings.
Democratic Republic of Congo Gaza
To our knowledge, this is the first report to assess service
readiness in conflict-affected LMICs and the findings repre- Laboratory Province Healthcare
sent a valuable baseline for the improvement of laboratory level
services in such settings based on the identified gaps. Ndosho Hospital/ North Primary Indonesian Hospital
Bethesda Hospital Kivu Laboratory
Centre
Heal Africa Hospital North Secondary Nasser Hospital
Materials and methods Kivu Laboratory
Centre d’Analyse North Secondary Shifa Hospital Labora-
Project settings Biomédicale de Kivu tory and Shifa Histopa-
Référence thology Laboratory
Panzi Foundation South Secondary Remal Primary Health-
The project was conducted by the International Committee of the Red Hospital Kivu care Clinic Laboratory
Cross (ICRC) and FIND, the global alliance for diagnostics. The project Hôpital Provincial South Tertiary Public Health Laboratory
was carried out in two conflict-affected settings in which the ICRC is General Référence Kivu
operational: the Democratic Republic of the Congo (Eastern DRC; North de Bukavu (HPGRB)
and South Kivu provinces), and the Gaza Strip, Palestine. Eastern DRC
Markby et al.: Assessment of laboratory services in conflict-affected settings 1017

partial = 0.5 points; no = 0 points; non-applicable = excluded from the 45–83%]), Data and Information Management (average score
calculation). These scores are used to derive percentage outcomes 61% [range 38–80%]) and Specimen Collection, Handling and
overall and for each indicator. The Testing indicator, which is designed
Transport (average score 56% [range 54–58%]). The lowest
to capture the number of diagnostic tests of each discipline and type
performed in each facility per month, is unscored. scoring indicators were Biorisk Management (average score
The SLIPTA checklist covers 12 indicators of laboratory operation: 13% [range 8–21%]) and Documentation (average score 14%
Documents and Records; Management Review and Management [range 6–21%]). Human Resources and Equipment also had
Responsibilities; Organization and Personnel; Client Management and low scores (both 30%, ranges 15–50% and 28–42%, respec-
Customer Service; Equipment; Evaluations and Audits; Purchasing and
tively) (Figure 1).
Inventory; Process Control; Information Management; Identification
Responses to the testing indicator showed that in DRC
of Non-Conformities, Corrective and Preventive Actions; Occurrence
Management and Process Improvement; Facilities and Biosafety [10]. the two most common test disciplines across all five lab-
The checklist has 115 questions, 41 of which have several sub-elements. oratories were clinical chemistry (at 19–47% of the total
Each question has a maximum pre-defined score based on relative test portfolio per laboratory) and haematology/haemo-
importance or complexity (2, 3 or 5 points). SLITPA scoring requires all stasis (at 11–39%) (Figure 2). This was followed by para-
sub-elements of a question to be present (scored as ‘yes’) in order to
sitology (at 4–15%), bacterial serology (at 2–14%) and
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 bacteriology (at 2–14%) for tests conducted in all five
reduced to 1 point; if all sub-elements are absent (scored as ‘no’), the laboratories. Viral serology, virology (except serology),
final score is 0 points. For this assessment, we employed a modified serology/immunoassay (non-pathogen), transfusion med-
SLITPA scoring to enable more granular evaluation of the presence or icine, histopathology and cytology were not conducted in
absence of sub-elements in questions. The response to each sub-
all laboratories, with histopathology and cytology testing
element was scored individually (yes = 1 point, partial = 0.5 points and
only being conducted to a very limited extent in two lab-
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 oratories (at 0.1–0.5% of the total test portfolio). Poly-
(n) of sub-elements and maximum score (MS) achievable for this merase chain reaction (PCR) testing for the viral
question; i.e. FS = pts(SE)/n(SE) × MS. pathogens HIV, hepatitis B virus (HBV), HCV and human
The overall SLIPTA star rating was allocated based on total score papillomavirus (HPV) was rarely performed in these lab-
across all indicators as follows: 1 star: 151–177 points (55–64%); 2 stars:
oratories, as was tuberculosis (TB) susceptibility testing
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 and antimicrobial susceptibility testing (data on file). Only
maximum score). one laboratory performed PCR testing for COVID-19. Cancer
screening, for example for markers such as complement C3
and C4, carcinoembryonic antigen, prostate-specific anti-
Outcomes
gen, or M proteins, was also infrequent.
In Gaza, the average WHO Laboratory Tool score
Outcome measures included WHO Laboratory Tool scores (total and per
indicator), as well as number of tests available (by test discipline and across all facilities was 78% (range 72–84%) (Figure 3).
type), and SLIPTA scores by indicator and star ratings based on total Highest scoring indicators were Data and Information
modified SLIPTA score. Management (all laboratories scored 96%), Public Health
Function (average score 91% [range 88–94%]), and Spec-
Statistical analysis imen Collection, Handling and Transport (all laboratories
scored 84%). The Human Resources indicator (all labora-
WHO Laboratory Tool scores (total and per indicator) are presented as tories scored 80%) and Consumables and Reagents indica-
percentages of maximum score achieved by each laboratory and the tor (average score 79% [range 69–87%]) also scored highly.
average percentage for each country. SLIPTA scores are presented The lowest scoring indicators were Facilities (average score
separately for each laboratory, as star ratings and as percentages of 59% [range 46–75%]), Documentation (average score 60%
maximum score achieved for each indicator. [range 44–76%]) and Biorisk Management (average score
69% [range 59–90%]), although there was substantial
variation across laboratories.
Results Responses to the testing indicator showed that the most
common test disciplines were clinical chemistry (at 47–76%
WHO Laboratory Tool scoring outcomes of the total test portfolio per laboratory), haematology/
haemostasis (at 9–28%) and bacteriology (including anti-
In DRC, the average WHO Laboratory Tool score across all microbial resistance testing) (at 5–11%) (Figure 4). Viral
assessed facilities was 41% (range 32–50%). The highest serology, transfusion medicine testing and bacterial
scoring indicators were Facilities (average score 70% [range serology was also performed in all laboratories, albeit to
1018 Markby et al.: Assessment of laboratory services in conflict-affected settings

DRC
Centre
Ndosho Heal Africa d’Analyse Bukavu Panzi Average
1 - OrganizaƟon and management 20% 67% 26% 66% 29% 42%
External communica on 0% 31% 31% 69% 19% 30%
Internal comm and structure 21% 93% 0% 100% 29% 49%
Budget 50% 100% 80% 50% 60% 68%
Licensing/supervision/accredita on 0% 0% 0% 25% 0% 5%
2 - Documents 6% 14% 11% 21% 19% 14%
Document control 0% 25% 25% 25% 0% 15%
Quality procedures 8% 15% 12% 19% 27% 16%
Biosafety 0% 0% 0% 25% 0% 5%
3 - Specimen collecƟon, handling and transport 54% 57% 57% 53% 58% 56%
Specimen collec on 52% 59% 58% 64% 71% 61%
Specimen handling 85% 85% 85% 73% 60% 78%
Specimen referral/transport 17% 17% 17% 0% 17% 13%
4 - Data and informaƟon management 38% 60% 73% 80% 55% 61%
Test results and reports 29% 64% 72% 80% 60% 61%
Data analysis and stats 100% 100% 100% 100% 100% 100%
Data security, confiden ality 0% 30% 60% 70% 0% 32%
5 - Consumables and reagents 40% 54% 39% 50% 45% 45%
Procurement 38% 63% 38% 63% 50% 50%
Inventory and storage 39% 41% 37% 41% 24% 36%
Use 50% 50% 30% 40% 50% 44%
Expired reagents 0% 100% 100% 100% 100% 80%
6 - Equipment 19% 42% 31% 28% 31% 30%
Equipment inventory 73% 48% 57% 85% 72% 67%
Equipment, maintenance and calibra on 9% 41% 26% 18% 24% 24%
8 - FaciliƟes 45% 82% 71% 83% 70% 70%
Infrastructure 50% 100% 83% 67% 67% 73%
Work condi ons 44% 80% 70% 85% 70% 70%
9 - Human Resources 30% 50% 20% 35% 15% 30%
Staff number 10% 100% 100% 100% 50% 90%
Qualifica ons 30% 30% 20% 50% 20% 30%
Con nuous educa on 13% 63% 0% 0% 0% 15%
10 - Biorisk management 10% 14% 8% 21% 11% 13%
Biorisk management policy 0% 0% 0% 67% 0% 13%
Biorisk assess and control 0% 0% 0% 0% 0% 0%
Implementa on and opera on 12% 17% 9% 20% 14% 14%
11 – Public Health FuncƟon 56% 58% 33% 56% 53% 51%
Surveillance and response 83% 75% 17% 67% 67% 62%
Specimens 60% 80% 80% 80% 80% 76%
Repor ng 29% 29% 14% 29% 21% 24%
Average 32% 50% 37% 49% 39% 41%

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


Markby et al.: Assessment of laboratory services in conflict-affected settings 1019

100% Other

Serology/immunoassay (non-
90% pathogen)

Transfusion medicine

80%
Cytology

Histopathology
70%
Parasitology
% monthly test per discipline

60% Virology (except serology)

Viral serology

50% Bacteriology (except serology)

Bacterial serology
40%
Haematology and haemostasis

30% Clinical chemistry

20%

10%

0%
Ndosho Heal Centre Bukavu Panzi
Africa d’Analyse

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.

varying degrees. The least common tests performed were (average 49% of the maximum score [range 33–55%]),
mycology, cytology, toxicology, histopathology and parasi- Facilities and Biosafety (average 36% [range 22–45%]),
tology (all below 0.5%). Although no viral PCR tests for HIV, Process Control (average 36% [range 29–45%]), Information
HCV, HBV or COVID-19, or susceptibility tests for TB, were Management (average 32% [range 17–54%]), and Organiza-
carried out at the five laboratories included in the project tion and Personnel (average 30% [range 13–45%]). A score of
(data on file), samples could be referred to a central referral zero was observed at four of five sites for the following
laboratory for these tests. No specific viral PCR tests for indicators: Management Review and Responsibilities, Client
HPV, viral serology tests for rubella, bacterial serology tests Management and Customer Service, Evaluations and Audits,
for salmonella (including Widal test for typhoid) or strep- Identification of Non-Conformities, Corrective and Preven-
tococcus, or parasitology tests for toxoplasmosis, were tive Actions, and Occurrence Management and Process
conducted (data on file). Screening for cancer and immu- Improvement.
nological disorders (i.e. rheumatoid factor or immuno- In Gaza, two laboratories had a 3-star SLIPTA rating, one
globulins) was limited. 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, Correc-
SLIPTA checklist tive and Preventive Actions (average 83% of maximum score
[range 70–90%]), Occurrence Management and Process
In DRC, no laboratory achieved a score sufficient for a star Improvement (average 82% [range 75–83%]), and Purchasing
rating (average score 65 [range 48–91]) (Figure 5). Highest and Inventory (average 75% [range 57–96%]). The lowest
performing indicators were Purchasing and Inventory scores were in Facilities and Biosafety (average 59%
1020 Markby et al.: Assessment of laboratory services in conflict-affected settings

Gaza
Public
Indonesian Nasser Shifa Remal Health Average
1 - OrganizaƟon and management 76% 76% 76% 76% 76% 76%
External communica on 75% 75% 75% 75% 75% 75%
Internal comm and structure 100% 100% 100% 100% 100% 100%
Budget 50% 50% 50% 50% 50% 50%
Licensing/supervision/accredita on 75% 75% 75% 75% 75% 75%
2 - Documents 61% 76% 59% 44% 61% 60%
Document control 70% 78% 63% 50% 70% 66%
Quality procedures 55% 71% 55% 41% 59% 56%
Biosafety 72% 100% 72% 53% 58% 71%
3 - Specimen collecƟon, handling and transport 84% 84% 84% 84% 84% 84%
Specimen collec on 99% 99% 99% 99% 100% 99%
Specimen handling 50% 100% 100% 100% 100% 100%
Specimen referral/transport 90% 90% 90% 90% 90% 90%
4 - Data and informaƟon management 96% 96% 96% 96% 96% 96%
Test results and reports 99% 99% 99% 99% 100% 99%
Data analysis and stats 100% 100% 100% 100% 100% 100%
Data security, confiden ality 90% 90% 90% 90% 90% 90%
5 - Consumables and reagents 83% 87% 83% 69% 72% 79%
Procurement 88% 88% 88% 75% 88% 85%
Inventory and storage 93% 94% 93% 73% 73% 86%
Use 70% 80% 70% 50% 50% 64%
Expired reagents 83% 83% 83% 83% 83% 83%
6 - Equipment 77% 82% 74% 67% 69% 74%
Equipment inventory 93% 93% 77% 77% 93% 87%
Equipment, maintenance and calibra on 74% 79% 74% 65% 65% 71%
8 - FaciliƟes 46% 75% 50% 55% 68% 74%
Infrastructure 50% 100% 50% 50% 75% 65%
Work condi ons 45% 73% 50% 56% 67% 58%
9 - Human Resources 80% 80% 80% 80% 80% 80%
Staff number 100% 100% 100% 100% 100% 100%
Qualifica ons 100% 100% 100% 100% 100% 100%
Con nuous educa on 50% 50% 50% 50% 50% 50%
10 - Biorisk management 71% 90% 65% 59% 62% 69%
Biorisk management policy 67% 100% 67% 67% 67% 73%
Biorisk assess and control 100% 100% 50% 50% 50% 70%
Implementa on and opera on 68% 88% 67% 59% 63% 69%
11 – Public Health FuncƟon 94% 94% 94% 88% 88% 91%
Surveillance and response 100% 100% 100% 100% 100% 100%
Specimens 80% 80% 80% 60% 63% 73%
Repor ng 100% 100% 100% 100% 100% 100%
Average 77% 84% 76% 72% 76% 77%

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


Markby et al.: Assessment of laboratory services in conflict-affected settings 1021

100%
Other

Serology/immunoassay (non-pathogen)
90%
Transfusion medicine

Toxicology
80%
Cytology

70% Histopathology
% monthly test per discipline

Mycology

60% Parasitology

Virology (except serology)


50%
Viral serology

Bacteriology (except serology)


40%
Bacterial serology

30% Haematology and haemostasis

Clinical chemistry

20% Water tes ng

Food tes ng (microbiology)


10% Food tes ng (chemicals and others)

Environmental tes ng (air, soil)


0%
Indonesia Nasser Shifa Remal Public
Health

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.

[range 41–80%]) and Evaluations and Audits (average 59% several laboratories failing to achieve a star rating [11–13].
[range 50–86%]). In Pakistan, deficiencies in biorisk management were
identified using a modified version of the WHO Laboratory
Tool [14].
Discussion There remains an overarching need for funding and
capacity building to support implementation of specific
This systematic assessment of laboratory capacity in two strategies to address the gaps observed in this project in
conflict-affected low-resource settings identified a number conflict-affected settings. For example, improvements to
of major gaps in laboratory infrastructure, processes, qual- biorisk management could be made through procurement
ity, and availability of diagnostic tests. To our knowledge, of safety equipment, development of laboratory safety
this is the first report to specifically assess service readiness training programmes and appointment of safety officers.
in LMICs that are conflict-affected, thus these findings Improvements to equipment could be achieved through
represent a valuable baseline for the improvement of labo- comprehensive equipment maintenance plans and training
ratory services in such settings based on the identified gaps. programmes for biomedical engineers. However, these
Consistent with our findings, previous assessments of strategies would incur substantial ongoing costs and
laboratory quality standards using SLIPTA in Southwestern require commitment from local stakeholders. In Gaza, the
Uganda, Nigeria and Ethiopia reported gaps in documen- majority of laboratory equipment is provided by interna-
tation, standard operating procedures, quality audit tional donors, which can lead to redundancies, as well as
schemes, internal audits, incidence management, external challenges in terms of servicing and obtaining parts and
quality assurance, and laboratory infrastructure, with technical support [7]. Other challenges associated with
1022 Markby et al.: Assessment of laboratory services in conflict-affected settings

DRC
Centre
Ndosho Heal Africa d’Analyse Bukavu Panzi
Score % of Score % of Score % of Score % of Score % of Max
max max max max max score
1 – Document and Records 2 7% 5 16% 3 11% 4 15% 1 4% 28
2 – Management Review and Management Responsibili es 0 0% 0 0% 0 0% 4 29% 0 0% 14
3 – Organiza on and Personnel 7 33% 8 35% 3 13% 10 45% 5 25% 22
4 – Client Management and Customer Service 0 0% 0 0% 0 0% 5 50% 0 0% 10
5 – Equipment 2 6% 10 27% 7 19% 5 15% 5 15% 35
6 – Evalua ons and Audits 0 0% 0 0% 0 0% 5 33% 0 0% 15
7 – Purchasing Inventory 13 55% 13 55% 8 33% 11 46% 13 54% 24
8 – Process Control 10 31% 13 40% 9 29% 14 45% 11 34% 32
9 – Informa on Management 4 17% 4 18% 9 42% 11 54% 6 27% 21
10 – Iden fica on of Non Conformi es, CAPAs 0 0% 4 19% 0 0% 0 0% 0 0% 19
11 – Occurrence Management and Process Improvement 0 0% 0 0% 0 0% 3 25% 0 0% 12
12 – Facili es and Biosafety 10 22% 19 45% 14 32% 18 41% 17 39% 43
Grand Total 48 75 52 91 58 275
SLIPTA star raƟng 0 star 0 star 0 star 0 star 0 star

AccreditaƟon readiness <55% <55% <55% <55% <55%

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

Gaza

Indonesian Nasser Shifa Remal Public Health


Score % of Score % of Score % of Score % of Score % of Max
max max max max max score
1 – Document and Records 25 88% 21 74% 17 60% 15 53% 25 89% 28
2 – Management Review and Management Responsibili es 9 62% 9 62% 9 62% 9 62% 12 87% 14
3 – Organiza on and Personnel 17 77% 18 82% 16 72% 16 72% 16 72% 22
4 – Client Management and Customer Service 6 60% 8 80% 6 60% 6 60% 8 80% 10
5 – Equipment 29 82% 24 69% 21 60% 18 51% 26 73% 35
6 – Evalua ons and Audits 8 50% 13 86% 8 50% 8 50% 9 58% 15
7 – Purchasing Inventory 21 87% 19 79% 14 58% 14 57% 23 96% 24
8 – Process Control 23 72% 24 75% 23 72% 21 67% 29 89% 32
9 – Informa on Management 15 72% 14 67% 14 67% 14 67% 17 83% 21
10 – Iden fica on of Non Conformi es, CAPAs 15 78% 17 90% 17 90% 17 90% 13 70% 19
11 – Occurrence Management and Process Improvement 10 83% 10 83% 10 83% 10 83% 9 75% 12
12 – Facili es and Biosafety 25 59% 34 80% 22 52% 18 41% 27 63% 43
Grand Total 201 211 176 165 213
SLIPTA star raƟng 2 stars 3 stars 1 star 1 star 3 stars

AccreditaƟon readiness 65 – 74% 75– 84% 55– 64% 55–64% 75– 84%

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

donated equipment include equipment that is incomplete way to introduce improvements. Such harmonization may
or beyond normal end of service, limited availability of need to take into consideration strengthening of supply
qualified staff for installation, inconsistent power supply chains and logistics systems, as duplication in equipment
leading to frequent breakdowns, and difficulties obtaining is currently a strategy to mitigate supply gaps that occur
software updates [7]. Strategies for harmonization of due to local restrictions on importation or irregular
laboratory equipment may therefore be a cost-efficient deliveries.
Markby et al.: Assessment of laboratory services in conflict-affected settings 1023

Development of new infrastructure is particularly laboratories in DRC, highlighting a need for wider testing for
associated with significant costs, thus funding for infra- disease surveillance.
structure improvements may be best used to upgrade Based on the findings from this project, a number of
existing facilities through renovations, extensions and interventions are planned to support the improvement of
remodelling. In the laboratories participating in this proj- the quality at sites involved in the assessments. These
ect, many buildings were old, damaged by ongoing conflict, include implementation of the SLMTA framework, diag-
or temporary in nature. Space was often inadequate for the nostic network optimization activities, and development
workload, with crowding of benches, refrigeration and and implementation of National Essential Diagnostic Lists
storage space. Ventilation was inadequate and electrical (nEDLs). SLMTA is designed to teach laboratory personnel
wiring was in poor condition. Many of these findings are how to implement practical QMS in resource-limited set-
consistent with inadequacies in physical laboratory infra- tings [21], and has been shown to transform the quality
structure observed across LMICs [1]. Damage associated of laboratories across different countries, facilitating
with shelling, a constant feature in many conflict-affected reductions in turnaround times, specimen rejection rates
countries, further exacerbates infrastructure-related and nonconformities, and improvements in external
challenges in such settings. quality assessments and clinician satisfaction [22, 23].
Laboratories in DRC scored poorly on human resources This project was limited by the small number of labo-
and personnel indicators, while this was a strength in Gaza. ratories included from each country (n=5), therefore the
Although the number of staff employed in the DRC labora- results may not be generalizable to the overall situation in
tories was appropriate in most of the participating labora- DRC and Gaza, or indeed to other conflict-affected settings.
tories, they were insufficiently qualified, and options for Furthermore, laboratory selection was guided by local
continuing education were extremely limited. A standard- Ministries of Health in collaboration with the ICRC in order
ized training curriculum at the national level is needed, to select the most representative or operationally impor-
incorporating ongoing in-service training. However, efforts tant facilities; this meant that no detailed facility mapping
to implement training programmes would require consis- was performed. Additionally, while the assessors were
tent funding to ensure sustainability, particularly given the trained and experienced, they were not SLIPTA certified,
higher salary requirements for qualified personnel. This and bias due to variability in assigning scores cannot be
may be challenging for LMICs that have healthcare budgets excluded. The modified SLIPTA scoring used in this study
based on cost recovery. Human resources related gaps are could have potentially resulted in a higher score for ques-
known barriers to access to laboratory services in LMICs [1], tions where some sub-elements were not fully met. Thus,
but are likely to be intensified in conflict-affected settings the SLIPTA outcomes only provide an indication of the
due to population displacement. extent to which the laboratories meet the required stan-
Gaps were noted in the test menus of laboratories in dards and are accreditation ready.
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
Conclusions
required improvement. Given the high frequency of injuries
Laboratory systems in conflict-affected, low-resource set-
caused by weaponry and need for surgical procedures in
tings have a number of major gaps and weaknesses. Imple-
conflict-affected areas, microbiology services are essential
mentation of strategies to improve laboratory services in
to humanitarian operations. In conflict-affected settings,
conflict-affected LMICs may be especially challenging, thus
access to imaging technologies critical for the care of people
particular attention to such settings is required in order to
with trauma or cancer is also likely to be limited, leaving
achieve equity in access to quality care.
healthcare workers with limited options for diagnosis of
these patients. Additionally, due to national prioritization of
other programmes in the context of global funding initia- Acknowledgments: The authors express their gratitude to
tives, PCR testing in the five DRC laboratories was limited for the following people or groups: staff at the laboratories in
HIV, HBV, HCV, HPV and TB, all of which represent public Gaza and DRC assessed as part of this report; laboratory
health challenges in the country [16–20]. A wider assessment assessors Rodrigo Acosta Zermeno (ICRC), Ryan Ruiz (FIND)
is needed to evaluate whether national capacity for these and Hanesh Fru Chi (FIND); Gaza in-country staff Wafa
tests across other laboratories in DRC requires improve- Elshawa and Akram Kahlout; ICRC headquarter project su-
ment. Testing for COVID-19 was limited to one of the five pervisor Stephanie Cristin; Project management assistance
1024 Markby et al.: Assessment of laboratory services in conflict-affected settings

Nella Renton (FIND). Medical writing assistance and edito- 70874/WHO_HSE_GCR_LYO_2012.2_eng.pdf?sequence=3&isAllowed=y


rial support, under the direction of the authors, was pro- [Accessed 10 Feb 2022].
10. World Health Organization Regional Office for Africa (WHO AFRO).
vided by Rachel Wright, PhD (FIND), according to Good
WHO guide for the stepwise laboratory improvement process towards
Publication Practice guidelines. accreditation (SLIPTA) in the African Region (with checklist). Available
Research funding: This project was funded by the ICRC from: https://www.afro.who.int/publications/who-guide-stepwise-
through a grant from Roche Diagnostics. laboratory-improvement-process-towards-accreditation-slipta-african
Author contributions: All authors have accepted [Accessed 10 Feb 2022].
11. Taremwa IM, Ampaire L, Iramiot J, Muhwezi O, Matte A, Itabangi H,
responsibility for the entire content of this manuscript
et al. Assessment of three medical and research laboratories using
and approved its submission.
WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long
Competing interests: BV and JM declare that they are way to go. Pan Afr Med J 2017;28:129.
employed by FIND. All other authors have no competing 12. Mbah H, Ojo E, Ameh J, Musuluma H, Negedu-Momoh OR, Jegede F,
interests to declare. et al. Piloting laboratory quality system management in six health
Informed consent: Not applicable. Informed consent was facilities in Nigeria. PLoS One 2014;9:e116185.
13. Desalegn DM, Taddese BD, Yemanebrhane N, Getahun MS, Kitila KT,
not required, as the project did not recruit participants.
Dinku TT, et al. Medical laboratory accreditation in a resource-limited
Ethical approval: Not applicable. Ethics approval was not district health centre laboratory, Addis Ababa, Ethiopia. Afr J Lab Med
required, as the project was not related to either human or 2019;8:793.
animal use. 14. Muhammad J, Sarwar S, Khan T, Qasmi SA, Ikram A, Ahmad G, et al. A
cross-sectional survey to assess biorisk management system in
research and diagnostic laboratories in Khyber Pakhtunkhwa, Pakistan.
Front Public Health 2021;9:766162.
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