Examining 7 years of implementing quality management systems in medical laboratories in sub‐Saharan Africa

Abstract

Background

Achievement of ISO15189 accreditation demonstrates competency of a laboratory to conduct testing. Three programmes were developed to facilitate achievement of accreditation in low‐ and middle‐income countries: Strengthening Laboratory Management Towards Accreditation (SLMTA), Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) and Laboratory Quality Stepwise Implementation (LQSI).

Objective

To determine the level of accreditation and associated barriers and facilitators among medical laboratories in the WHO‐AFRO region by 2020.

Methods

A desk review of SLIPTA and SLMTA databases was conducted to identify ISO15189‐accredited medical laboratories between January 2013 and December 2020. Data on access to the LQSI tool were extracted from the WHO database. Facility and country characteristics were collected for analysis as possible enablers of accreditation. The chi‐square test was used to analyse differences with level of significance set at <0.05.

Results

A total of 668 laboratories achieved accreditation by 2020 representing a 75% increase from the number in 2013. Accredited laboratories were mainly in South Africa (n = 396; 55%) and Kenya (n = 106; 16%), two countries with national accreditation bodies. About 16.9% (n = 113) of the accredited laboratories were registered for the SLIPTA programme and 26.6% (n = 178) for SLMTA. Approximately 58,217 LQSI users were registered by December 2020. Countries with a higher UHC index for access to HIV care and treatment, higher WHO JEE scores for laboratory networks, a larger number of registered LQSI users, with national laboratory policy/strategic plans and PEPFAR‐priority countries were more likely to have an accredited laboratory. Of the 475 laboratories engaged in the SLIPTA programme, 154 attained ≥4 SLIPTA stars (ready to apply for accreditation) and 113 achieved ISO 15189 accreditation, with 96 enrolled into the SLMTA programme. Lower‐tier laboratories were less likely to achieve accreditation than higher‐tier laboratories (7.7% vs. 30%) (p < 0.001). The probability of achieving ISO 15189 accreditation (19%) was highest during the first 24 months after enrolment into the SLIPTA programme.

Conclusion

To sustainably anchor quality improvement initiatives at facility level, national approaches including access to a national accreditation authority, adoption of national quality standards and regulatory frameworks are required.

INTRODUCTION

Medical and public health laboratories are an essential and fundamental part of the health care system and play a critical role in disease diagnosis, monitoring, and treatment as well as in outbreak detection and response [1]. In the absence of laboratory services, patient management relies on syndromic diagnosis, which may be inaccurate due to the non‐specific nature of symptoms. Misdiagnosis leads to irrational use of medicines, unnecessary hospital admissions and poor patient and public health outcomes [2, 3]. Since 2010, the implementation of a quality management system (QMS) was identified as an effective entry point to strengthen overall laboratory services in resource limited settings (RLS) of Africa [4, 5]. Quality refers to meeting pre‐defined standards associated with improved accuracy, reliability and timeliness of test results reported from laboratories, while QMS refers to the coordinated activities to plan, direct and control an organisation to meet quality objectives [6]. The international standard for the quality and competency of medical laboratories is the International Organisation for Standardisation's ISO 15189 [7]. Laboratory accreditation is a binary pass/fail system providing the evidence and formal recognition that a laboratory is competent to carry out specific tasks (i.e., medical testing) according to international quality standards [8, 9]. Accreditation covers both the implementation of QMS and the technical competence to carry out laboratory testing within the scope of accreditation (e.g., HIV virology or serology tests). From a public health and clinical perspective, the recognition that a laboratory complies with quality standards is anticipated to translate into reliable and reproducible laboratory test results for adequate patient management and positive clinical outcomes.

In Africa, the implementation of QMS in general and the achievement of ISO 15189 accreditation specifically carries several challenges related to the generally low technical capacity and resources available at facility level. Many laboratories lack the basic human resource, infrastructure and organisational capacity needed to ensure that QMS implementation effectively translates into technical competence and accreditation, and contributes to positive public health and clinical outcomes [10]. To mitigate these challenges, WHO in collaboration with Ministries of Health and other stakeholders adopted a phased approach to QMS implementation [11]. One of the initiatives is the Strengthening Laboratory Management Towards Accreditation (SLMTA), launched in 2009, a structured quality improvement programme that teaches laboratory managers and quality officers how to implement a practical QMS in RLS, using available resources [12, 13]. SLMTA is based on a series of workshops, and work‐based improvement projects supported by site visits and mentoring. The programme is implemented globally and aims immediate and measurable improvement [12, 13].

A second initiative is the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, based on ISO 15189 and the 12 Quality System Essentials of the Clinical and Laboratory Standards Institute (CLSI) developed by the WHO Regional Office for Africa (WHO‐AFRO) [14, 15]. The SLIPTA checklist is used to benchmark a laboratory's stepwise progress towards ISO 15189 conformance [14, 15]. SLIPTA recognises quality improvement by the award of a certificate based on zero‐to‐five‐star level through an Independent Advisory Group [3, 14, 15]. According to the WHO‐AFRO SLIPTA guidelines, SLIPTA‐audited laboratories must close any gaps to advance to a higher star level until they attain 4 or 5 stars and are prepared to submit an application for international accreditation. However, accreditation preparedness can be attained from a lower star level depending on resources and dedication. [16, 17]. SLIPTA certificates are not designed to recognise technical competence for any test. SLIPTA certificates rather cover the quality implementation of the laboratory, thus guaranteeing continuous improvement throughout the laboratory. In 2012, ASLM was tasked with the ambitious goal of enrolling 2500 laboratories into the SLIPTA programme, and to ensure that 250 public laboratories would achieve international accreditation by the year 2020. This target was considered by global health stakeholders to be sufficient to create a significant clinical and public health impact, especially in HIV and tuberculosis control programmes supported by the United States President's Emergency Plan for AIDS Relief (PEPFAR) [18].

In the WHO‐AFRO region, SLIPTA and SLMTA are designed to be implemented as complementary programmes at country level (through a national SLIPTA focal point and Ministry of Health commitment for resources) and facility level (with facility management committing resources and staff). The SLMTA programme uses the SLIPTA checklist to identify gaps and benchmark progress while the laboratory management are equipped with the ability to implement quality management systems through SLMTA to improve their performance on the SLIPTA scale and eventually achieve formal accreditation status [16].

The Laboratory Quality Management System (LQMS) training tool kit and the Laboratory Quality Stepwise Implementation Tool (LQSI) developed by the WHO provide additional ‘program‐independent’ resources to laboratory facilities implementing a QMS [8, 9].

This paper reviews the progress of QMS implementation and the achievement of ISO 15189 accreditation in medical laboratories in the WHO‐AFRO region from the launch of the SLIPTA programme in 2012 to the 2020 milestone. Here, we evaluate the overall contribution of QMS implementation tools to achieving ISO 15189 accreditation, with a special focus on the outcomes of SLIPTA against its initial targets. The coverage, barriers, and facilitating factors to accreditation across national tiered laboratory networks are discussed within the perspective of country advancements towards achieving the targets of Universal Health Coverage (UHC) and requirements of International Health Regulations (IHR). In addition, we present the perspective of ASLM on the way forward to scale‐up systems for supporting quality laboratory testing throughout national laboratory networks and to ensure the impact of QMS on public health and patient outcomes.

METHODS

Study design

A desk review of ASLM (https://aslm.org/resource/gmap/), SLMTA, WHO and publicly available databases of accrediting bodies was conducted by the authors between 1st and 15th December 2020 to identify medical laboratories in the WHO‐AFRO region who had achieved ISO 15189 accreditation between January 2013 and December 2020. Additionally, data on access to the LQSI tool in sub‐Saharan Africa were extracted from the WHO database.

Accrediting bodies

All accreditation bodies affiliated to the African Accreditation Cooperation (AFRAC) were included in the analysis, as well as accreditation bodies outside Africa and affiliated with the International Laboratory Accreditation Council (ILAC) and reported to have delivered certificates to laboratories enrolled in the SLIPTA programme between 2013 and 2020. Affiliation to ILAC recognises that the accreditation bodies operate in accordance with ISO 17011, a standard that specifies the requirements for the competence, consistent operation, and impartiality of accreditation bodies [19, 20]. Affiliation to AFRAC ensures the Mutual Recognition Arrangement, enabling African accreditation bodies to deliver certificates within and across African borders.

AFRAC membership is designated as full, associate and stakeholder status, with membership status based on how much the accreditation bodies' established systems and operations meet the requirements of AFRAC and ILAC [20, 21]. Websites of these accreditation bodies can be consulted to confirm the identity of laboratories achieving ISO 15189 accreditation, as well as the scope of accreditation. The cost of accreditation is borne by each agency as per the requirements of the ISO 17011.

Participating laboratories

Laboratories achieving ISO 15189 accreditation

The list and scope of valid ISO 15189 accreditation was retrieved from the respective websites of the accrediting bodies between the 1st and the 15th of December 2020. In some instances, single laboratory facilities had more than one test in their scope of accreditation. Facility and country characteristics were collected to be further analysed as possible enablers of accreditation. The characteristics collected for laboratories included information on the awarding accreditation body, geographic region, as well as past or current participation in the SLIPTA programme. Laboratory participation in the SLMTA programme and the number of registered LQSI users in the country were also included as other characteristics.

A laboratory was considered engaged in SLIPTA if it had received at least one baseline audit conducted by certified ASLM SLIPTA auditors and assigned a formal star recognition between 2013 and 2020. As per initial guidance, the participation of a facility in the SLIPTA programme is for a maximum of 6 years. During this period, the facility commits to devote resources for advancing QMS towards international accreditation. The characteristics of SLIPTA laboratories, such as affiliation and tier level, as well as outcomes of baseline and follow‐up audits, were collected from stored information submitted as part of laboratories' original request to ASLM. Laboratories enrolled in SLIPTA commit to report whether and when they achieve international accreditation, regardless of any follow up SLIPTA audit.

Numbers of laboratories that engaged and completed the SLMTA programme by 15th December 2020 were collected from the SLMTA database [22]. A laboratory was considered to have completed the SLMTA programme if they had completed the SLMTA workshop series.

Country characteristics

Information collected from countries in the WHO‐AFRO region with and without at least one accredited laboratory comprised health expenses per capita [23, 24], selected indicators of the Joint External Evaluation (JEE) tool measuring the preparedness of the national laboratory network, availability and implementation of a national laboratory quality standard and selected indicators of HIV and tuberculosis care coverage [25].

Additional country information such as the existence of a directorate of laboratory at the ministry of health, the availability of national laboratory policies and strategic plans in the country, was gathered from MoH websites, or through ASLM networks and databases. Numbers of registered LQSI users per country between 26th February 2014 and 15 December 2020 were determined from WHO databases in compliance with WHO's data use and sharing policy [26].

Statistical analysis

The characteristics of all laboratories achieving ISO15189 accreditation were summarised as percentages. The results were disaggregated to show all laboratories versus non‐South African laboratories to correct for the significantly higher number of accredited South African laboratories.

To determine country factors contributing to laboratory accreditation, the 49 African countries from the WHO‐AFRO region were grouped into two: those with at least one accredited laboratory and those with none. Using secondary data available in WHO website [24, 25, 26], we tested for association of accreditation with the joint external evaluation (JEE) scores using the chi‐square test and compared mean UHC service coverage for different indices using ANOVA.

SLIPTA laboratories were categorised into two groups: laboratories ever achieving four and five stars (i.e., ready to apply for formal ISO accreditation per SLIPTA requirements) or accreditation and those achieving less than four stars. The laboratory characteristics included in the analysis were the laboratory tier level, affiliation, baseline SLIPTA score, number of follow‐up SLIPTA audits and the increase in SLIPTA scores between baseline and the most recent audit. Differences between the characteristics of the two groups of laboratories were determined using the chi‐square test. The cumulative probability of ever achieving four and five stars or accreditation was calculated at 24, 48 and 72 months with 95% confidence intervals. The level of significance was set at α < 0.05. The statistical analysis was performed using SPSS statistical software version 22.0 (SPSS Inc., Chicago, IL, USA).

Ethical considerations

The study did not involve human subjects and did not disclose the identity of laboratories achieving accreditation or participating in the SLIPTA programme; therefore, no ethical consent or approval was required.

RESULTS

Accreditation bodies delivering ISO 15189 accreditation to medical laboratories in the WHO‐AFRO region in 2020

Ten accreditation bodies were identified with full (N = 2), associate (N = 7) or stakeholder (N = 1) membership with AFRAC (Table 1). Central Africa was the only region with no AFRAC‐affiliated accreditation body. In addition, seven accreditation bodies affiliated to ILAC and based in Canada, the United States, France, Portugal, and Egypt were reported to have accredited at least one of the laboratories from the WHO‐AFRO region enrolled in SLIPTA and were included in the analysis. The largest providers of accreditation were the South African National Accreditation System (SANAS), followed by the Kenya National Accreditation Service (KENAS) collectively accounting for 81% of the 668 ISO 15189 accredited facilities recorded from 2013 to 2020. The cost of accreditation varied from 1500 to 9000 USD for initial accreditation depending on the accreditation body.

TABLE 1.

List of laboratory accreditation bodies by their ILAC affiliation status and number of accredited laboratories in the WHO‐AFRO region (data accessed from their website between 1st December and 15th December 2020)

No	ACCREDITING BODIES	N (%)	Country	ILAC membership	AFRAC membership
1	Ethiopian National Accreditation Office (ENAO)	26 (3.9%)	Ethiopia	MRA Signatory	Arrangement Members
2	Kenya Accreditation Service (KENAS)	122 (18.3%)	Kenya	MRA Signatory	Arrangement Members
3	Mauritius Accreditation Service (MAURITAS)	6 (0.9%)	Mauritius	MRA Signatory	Arrangement Members
4	Southern African Development Community Accreditation Services (SADCAS)	48 (7.2%)	Botswana	MRA Signatory	Arrangement Members
5	South African National Accreditation System (SANAS)	420 (62.9%)	South Africa	MRA Signatory	Arrangement Members
6	Nigeria National Accreditation System (NiNAS)	1 (0.1%)	Nigeria	Associate	Full Members
7	Système Ouest Africain d'Accréditation (SOAC)	18 (2.7%)	Cote d'Ivoire	Associate	Full Members
8	Medical Laboratory Science Council of Nigeria (MLSCN Accreditation Service)	6 (0.9%)	Nigeria	Affiliate	Stakeholder
9	College of American Pathologists (CAP)	12 (1.8%)	USA	Affiliate	N/A
10	Egyptian Accreditation Council (EGAC)	1 (0.1%)	Egypt	MRA Signatory	Arrangement Member
11	Institute for Quality Management in Healthcare (IQMH)	1 (0.1%)	Canada	MRA Signatory	N/A
12	Joint Commission International (JCI)	1 (0.1%)	USA	N/A	N/A
13	Comite Francais d'Accreditation (COFRAC)	3 (0.4%)	France	MRA Signatory	N/A
14	Instituto Portugues de Acreditacao (IPAC)	3 (0.4%)	Portugal	MRA Signatory	N/A

Characteristics of laboratories of the WHO‐AFRO region, registered for ISO 15189 accreditation in 2020 under AFRAC

Of the 668 laboratories awarded ISO 15189 accreditation, the majority were from South Africa (396 [55%]) followed by Kenya (106 [16%]) (Table 2). Overall, Central Africa accounted for less than 1% of all accredited laboratories. Achieving accreditation through a national body (87.1% of all laboratories accredited through SANAS and KENAS representing the lion's share) occurred approximately 10 times more often than through a regional body (9.9%). Only 3% of all accreditations (N = 20) were delivered by an institution overseas.

TABLE 2.

Characteristics of of laboratories with valid ISO 15189 accreditation as of December 2020 in the WHO‐AFRO region

Characteristic	All laboratories (N = 668)	Laboratories excluding South Africa (N = 299)
Geographical Scope of Accreditation body
National accreditation body	582 (87.1%)	214 (71.6%)
Regional accreditation body	66 (9.9%)	65 (21.7%)
Accreditation body overseas	20 (3.0%)	20 (6.7%)
Laboratory ever engaged in SLIPTA	113 (16.9%)	91 (30.4%)
Laboratory ever engaged in SLMTA	178 (26.6%)	158 (52.8%)
Regions of WHO‐AFRO (number of laboratories)
Central Africa	4 (0.6%)	4 (1.3%)
East Africa	208 (31.1%)	208 (69.6%)
South Africa	418 (62.6%)	49 (16.4%)
West Africa	38 (5.7%)	38 (12.7%)

Among all laboratories, the tests and services most frequently registered for accreditation were haematology (66.8%), chemistry (58.1%), histopathology (56.6%), microbiology (42.7%) and serology‐immunology (41.3%) (Table 3). In the 299 non‐South African laboratories, chemistry (24%) and histopathology (14.7%) were a less popular scope for accreditation than in the South African laboratories. Twenty‐two South African and 91 non‐South African laboratories (16.9% of all laboratories) were recorded in the SLIPTA database (Table 2). The proportion of laboratories registered in the SLMTA database was slightly higher, accounting for 26.6% of all accredited laboratories and 52.5% of non‐South African laboratories.

TABLE 3.

Testing scope of laboratories with valid ISO 15189 accreditation as of December 2020 in the WHO‐AFRO region

Testing scope	All laboratories (N = 668)	Laboratories excluding South Africa (N = 299)
Haematology	446 (66.8%)	132 (44.1%)
Chemistry	388 (58.1%)	72 (24.1%)
Microbiology	285 (42.7%)	127 (42.5%)
Histo‐pathology (specialised tests)	378 (56.6%)	44 (14.7%)
Immuno‐serology	276 (41.3%)	129 (43.1%)
Biochemistry	64 (9.6%)	64 (21.4%)
Parasitology	64 (9.6%)	64 (21.4%)
Molecular	45 (6.7%)	33 (11.0%)
Virology	27 (4.0%)	16 (5.4%)
Tuberculosis laboratory	27 (4.0%)	6 (5.4%)
Mycology	9 (1.3%)	1 (0.3%)

Characteristics of WHO‐AFRO countries with at least one accredited laboratory

Countries with at least one accredited laboratory had a significantly higher UHC service coverage index (49.3% vs. 43.5%: p = 0.039), and better access to HIV treatment (72.9 vs. 54.9%; p = 0.01) than those without an accredited laboratory (Table 4). Countries with at least one accredited laboratory had significantly higher JEE scores (>3) referring to at least a developed capacity for laboratory testing for detection of priority diseases (D 1.1), an effective national diagnostic network (D 1.3) and a laboratory quality system (D1.4). Countries with at least one accredited laboratory were more likely to be a PEPFAR priority country [27], have an accredited body in‐country, have a larger number of registered LQSI users and have a national laboratory policy and/or strategic plan in place. The level of health expenditure in a country was not significantly associated with the presence of at least one accredited laboratory in a country (Table 4).

TABLE 4.

Characteristics of countries with and without at least one ISO 15189 accredited laboratory as of December 2020 in the WHO‐AFRO region.

Characteristic	Country without an accredited laboratory (n = 25)	Country has at least one accredited laboratory	Total number of countries (n = 49)	p‐Value
Mean UHC service coverage index (SDG 3.8.1) (95% CI)	44.0 (39.4, 48.6)	49.3 (45.8, 52.8)	46.8 (43.9, 49.7)	0.055
Mean UHC service coverage sub‐index on infectious diseases (95% CI)	45.8 (39.0, 52.6)	52.6 (48.0, 57.2)	49.2 (45.1, 53.3)	0.092
Mean UHC service coverage sub‐index on service capacity and access (95% CI)	26.2 (18.8, 33.5)	31.4 (23.5, 39.3)	28.8 (23.5, 34.0)	0.317
Mean tuberculosis treatment coverage (95% CI)	52.8 (43.2, 62.4)	58.3 (53.0, 63.5)	55.5 (50.2, 60.8)	0.305
Mean HIV antiretroviral treatment estimates (95% CI)	56.7 (46.3, 67.2)	72.1 (66.0, 82.2)	65.8 (59.0, 72.6)	0.008
Mean current health expenditure (CHE) per capita in US$. (95% CI)	105.2 (30.7, 179.8)	146.3 (62.8, 229.8)	125.8 (71.7, 179.9)	0.451
JEE score D1.1. laboratory testing for priority diseases
Score 1	5 (22.7%)	0 (0.0%)	5 (11.1%)	0.003
Score 2	6 (27.3%)	1 (4.3%)	7 (15.6%)
Score 3	5 (22.7%)	6 (26.1%)	11 (24.4%)
Score 4	6 (27.3%)	15 (65.2%)	21 (46.7%)
Score 5	0 (0.0%)	1 (4.3%)	1 (2.2%)
JEE score D12: specimen referral and transport system
Score 1	9 (40.9%)	4 (17.4%)	13 (28.9%)	0.106
Score 2	5 (22.7%)	7 (30.4%)	12 (26.7%)
Score 3	6 (27.3%)	6 (26.1%)	12 (26.7%)
Score 4	1 (4.5%)	6 (26.1%)	7 (15.6%)
Score 5	1 (4.5%)	0 (0%)	1 (2.2%)
JEE score D.1.3 National diagnostic network
Score 1	5 (22.7%)	0 (0%)	5 (11.1%)	0.002
Score 2	11 (50.0%)	7 (30.4%)	18 (40.0%)
Score 3	6 (27.3%)	16 (69.6%)	22 (48.9%)
Score 4	0 (0.0%)	0 (0.0%)	0 (0.0%)
Score 5	0 (0.0%)	0 (0.0%)	0 (0.0%)
JEE score D1.4 laboratory quality system
Score 1	10 (45.5%)	2 (8.7%)	12 (26.7%)	0.001
Score 2	11 (50.0%)	9 (39.1%)	20 (44.4%)
Score 3	1 (4.5%)	10 (43.5%)	11 (24.4%)
Score 4	0 (0.0%)	2 (8.7%)	2 (4.4%)
Score 5	0 (0.0%)	0 (0.0%)	0 (0.0%)
PEPFAR priority country	1 (4.5%)	10 (43.5%)	11 (24.4%)	0.02
Country with accreditation body	0 (0%)	7 (30.4%)	7 (15.6%)	0.01
Country has a national laboratory policy and/or strategic plan	12 (54.5%)	21 (91.3%)	33 (73.3%)	0.005
Mean LQSI users in the country	149.5 (87.2, 211.8)	1689.0 (750.0, 2628.1)	936.4 (418.3, 1454.4)	0.002

Note: Bold value indicates p < 0.05.

Characteristics of laboratories engaged in the SLIPTA programme

A total of 475 laboratories were engaged in the SLIPTA programme between January 2013 and December 2020. Of those, 154 (32.4%) reached ≥4 SLIPTA stars and/or ISO 15189 accreditation by 2020 (Table 5). Laboratories at tier 1, i.e., at primary healthcare setting, were less likely to achieve the minimum 4‐star milestone than laboratories at higher tier levels (7.7% versus more than 30% for all other tier levels).

TABLE 5.

Comparison between laboratories achieving versus those not achieving >4 stars or ISO‐15189 accreditation between 2013 and 2020

Characteristics	Never reached 4 stars (N = 321)	Reached ≥4 stars or accreditation (N = 154)	Total	p‐Value
Tier level
Tier 1	60 (92.3%)	5 (7.7%)	65	<0.001
Tier 2	133 (69.3%)	59 (30.7%)	192
Tier 3	84 (54.5%)	70 (45.5%)	154
Tier 4	32 (62.7%)	19 (37.3%)	51
Not defined	12 (92.3%)	1 (7.8%)	13
Affiliation
Government	282 (66.5%)	142 (33.5%)	424	0.373
Military	10 (71.4%)	4 (28.6%)	14
Private for non‐profit	8 (66.7%)	4 (33.3%)	12
Private for profit	9 (75.0%)	3 (25.0%)	12
Not defined	12 (92.3%)	1 (7.8%)	13
Laboratory is registered in SLMTA	15 (15.6%)	81 (84.4%)	96	<0.001
Baseline SLIPTA score
<2 stars	128 (86.5%)	20 (13.5%)	148	<0.001
2 to 3 stars	192 (70.8%)	79 (29.2%)	271
≥4 Stars	1 (1.8%)	55 (98.2%)	56
Number of follow up SLIPTA audit(s)
None	280 (69.8%)	121 (30.2%)	401	0.051
Once	34 (55.7%)	27 (44.3%)	61
Twice	7 (53.8%)	6 (46.2%)	13
Increase of SLIPTA score between baseline and most recent audit
Increased	22 (45.7%)	25 (4.3%)	46	0.031
Star level stable or decreases	20 (71.4%)	8 (28.6%)	28

While most laboratories engaged in SLIPTA were government facilities, all types of affiliations appeared to have a comparable likelihood to achieve ≥4 SLIPTA stars or ISO 15189 accreditation. Laboratories enrolled into the SLMTA programme were more than five times likelier to achieve ≥4 stars, or ISO 15189 accreditation. Only 13% of laboratories with fewer than 2 stars and 29% of laboratories scoring 2 to 3 stars at the baseline audit achieved ≥4 stars, or ISO 15189 accreditation during the observation period.

Outcome of the SLIPTA programme among participating laboratories

Among the 475 laboratories that underwent SLIPTA baseline audits since 2013, 38 were followed up for 72 months (8%), 149 for 48 months (31%) and 268 for 24 months (56.4%) (Figure 1). Twenty laboratories (4.2%) had not yet reached 24 months in the programme by December 2020. The majority of the 74 follow‐up audits happened at the 48‐month time point (21% at 48‐month vs. 10% at month 24, and 8% at month 72). The largest number of ISO 15189 accreditations (19.4%) was achieved during the first 12 months of enrolment into the SLIPTA programme (Figure 1).

FIGURE 1.

Outcomes of ever achieving ≥4 stars or accreditation over time for 475 laboratories enrolled into the SLIPTA program from 2013 to 2020. [Correction added on 23 December 2022 after first online publication: Figure 1 was previously missing and now has been added in this version]

DISCUSSION

This report highlights that the number of ISO 15189‐accredited laboratories increased by 75% in the WHO‐AFRO region from 2013 to 2020, including a more than sevenfold increase among non‐South African laboratories [28]. Access to a national accreditation body was associated with higher numbers of accredited laboratories in South Africa and Kenya, but not in other countries such as Ethiopia and Nigeria. This suggest that while establishing a national accreditation body demonstrates a political will to advance accreditation in a country, this alone might not be enough to enhance achievement of a substantial number of accredited laboratories within a country. Additional operational mechanisms are needed to enable QMS implementation at a national scale. For example, in Kenya, the Ministry of Health has defined a goal to have all national and regional level public laboratories accredited to the ISO15189 standard [29], providing the impetus (and the resources) to accelerate laboratory accreditation. For South Africa, a national health insurance bill was formulated that mandates procurement of health services from accredited providers. This has been referenced in the NHLS strategic plan 2020 to 2025 [30]. Another critical ingredient that may push the agenda of accreditation forward in Kenya and South Africa is the establishment of national quality standards and regulatory frameworks enforcing the registration and licensing of medical laboratories and adequate QMS infrastructure, perhaps representing a more effective driver for the robust uptake of ISO 15189 accreditation than in other countries with national accreditation body, similar per capita health expenditure and UHC coverage [28, 29].

Of the 45 WHO‐AFRO countries with available JEE assessments data, only Rwanda and Namibia demonstrated a developed capacity for laboratory quality management system (indicator D1.4) while contributing only marginally to the overall number of internationally ISO accredited laboratories in 2020. Instead, Rwanda and Namibia report the existence of a national laboratory licensing system, which is based on mandatory compliance to national quality requirements for all laboratories. The situation in Rwanda and Namibia underscores that impacting public health and global security relies on systems to expand QMS across entire national laboratory networks, including but not limited to the accreditation of individual facilities. Higher JEE scores for laboratory quality, laboratory network and laboratory diagnostics of priority diseases, and higher UHC index for HIV treatment coverage were associated with at least one accredited laboratory in the country. Those associations suggest that a national policy framework, higher level of epidemic response preparedness and robust disease programmes might be important enablers of accreditation.

The 475 laboratories engaged in SLIPTA since 2013 indicate that on average, 60 facilities were audited and supported by the SLIPTA secretariat each year. While this outcome may seem modest regarding the original target of 2500 enrolled laboratories by 2020, it still represents a commendable accomplishment, especially in light of declining programmatic funding and the continued lack of the necessary policies, resources, and infrastructure in the majority of countries to support the implementation of QMS. The minority of SLIPTA laboratories who entered the programme with an already advanced QMS were the most likely to achieve accreditation within 12 months of enrolment, corroborating the notion that pre‐existing dedicated resources and institutional support are critical to achieving accreditation.

One in five accredited laboratories outside South Africa in 2020 formally participating in SLIPTA or SLMTA illustrates a healthy uptake of QMS implementation programmes and tools. However, a substantial number of laboratories achieved accreditation without using SLIPTA or SLMTA at all, or by using them informally. This could suggest a lack of awareness about the formal processes of SLMTA and SLIPTA and/or the complementarity of the programmes, thereby suggesting missed opportunities for structured QMS implementation. Alternatively, the design of the SLIPTA and SLMTA programmes, which is based on formal collaboration with Ministries of Health, might constitute a barrier to uptake for private laboratories, previously reported to constitute the bulk of accreditation seekers [28, 29]. SLMTA and SLIPTA do not deliberately target non‐government laboratories (otherwise more likely to seek and achieve accreditation), with the latter possibly having no other option than using the programmes ‘under the radar’. Unofficial utilisation of SLIPTA and SLMTA fails to benefit the facilities and complicates the tracking and improvement of QMS advancement strategies in the region. Equally, while the thousands of LQSI registered users in countries with accredited laboratories is impressive, the relative contribution of LQSI to QMS implementation is difficult to assess, given the lack of data connecting individual users with their affiliated laboratories.

The data from this study warrant a better understanding of the barriers and facilitating factors for successful accreditation. While enrolment into SLIPTA, SLMTA programmes and LQSI tool is relatively easy, initial requirements for sufficient infrastructure, resources, knowledge, expertise and commitment of laboratory management and staff are often left out from national policy, regulatory and operational frameworks. The resulting lack of implementation and/or enforcement of those requirements might subsequently become a critical gap for the advancement in QMS and achievement of accreditation. Other shortcomings can be attributed to the design of the programmes themselves. For instance, a critical review of SLIPTA shows that first, some of the ISO 15189 requirements (such as documenting a full management review annually, participation in External Quality Assessment [EQA] programmes for all tests and the validation and verification of all equipment and methods before use) are difficult to implement at lower‐tier levels, where financial and human resources are scarce [31]. Lower‐tier laboratories might therefore be disadvantaged, as suggested by the high proportion of low SLIPTA scores and attrition in this category of facilities. Secondly, technical requirements for specific disciplines (haematology, chemistry, bacteriology etc.), necessary for ISO 15189 accreditation, are not part of the SLIPTA implementation and certification process. This prompted the development of additional implementation tools such as the AMR and TB scorecards developed by FIND and the US CDC in collaboration with ASLM that focus on building the technical capacity for bacteriology testing as part of a QMS implementation approach [32, 33].

Beyond facility‐associated factors, larger contextual determinant may contribute to the poor QMS and accreditation outcomes in the region. Internal programmatic reviews conducted by the ASLM secretariat indicate that the worrisomely high attrition rate of laboratories enrolled in the SLIPTA programme may include the lack of country commitment to QMS implementation beyond the mere designation of the SLIPTA focal point at the MoH, as previously reported [3]. Laboratory QMS often remains a secondary objective in many countries of the WHO‐AFRO region, with no national resources committed and quality activities being often supported solely through bilateral aid, such as the PEPFAR programme. The resources and infrastructure required to support continuous quality improvement and effective QMS in laboratory facilities can only be sustained through national laboratory policies and strategic plans that include clear quality objectives and a supporting operational plan and budget for implementation and maintenance.

Conclusions and recommendation

This report highlights that the increased number of accredited laboratories in the WHO AFRO region is an impressive achievement, but remains below the level required to cover the quality needs of the national laboratory networks and the scope of diagnostics (covering all priority diseases and testing at the point of care) in support of achieving universal health coverage and International Health Regulation targets. Ensuring adequate quality of testing at national and continental scale requires redefining quality programmes, tools and resources beyond the remit of individual facilities. We recommend that national approaches to QMS be promoted as a way to durably anchor quality improvement activities at facility level. ASLM and Africa CDC recently developed the national laboratory quality framework as a useful guide to countries in establishing national laboratory quality policies, strategic plans and infrastructures allowing the entire national laboratory and diagnostic network to come on board of QMS [34]. The framework includes considerations for national quality standard, accreditation infrastructure, and quality system requirements applicable to each tier of the laboratory network, among others. Secondly, there is a need to reconsider/restructure the SLIPTA, SLMTA and LQSI programmes to make them more accessible, better comprehended and more user‐friendly to promote their use by countries including the private sector, while ensuring sufficiently stringent application that does not compromise QMS credentials. Consolidating the use of additional tools addressing specific technical aspect of diagnostics, such as the AMR or the TB scorecard [32, 33] as part of the SLIPTA and SLMTA programme is warranted. If implemented, those recommendations have the potential to transform the QMS and accreditation of the continent and to contribute to improved patient and public health outcomes.

FUNDING INFORMATION

This work was supported by PEPFAR (grant no. CDC‐RFA‐GH12‐1201 and PAC/20190912/03), the Fleming Fund (grant no. 4408‐20‐1‐FFRG‐and 4408‐19‐2‐FF55‐RGR2‐EQA) and the Bill and Melinda Gates Foundation (grant no. INV‐003603).

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