Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

Background Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. Objectives The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. Method An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.


Introduction
The burden of tuberculosis in Africa remains high. The World Health Organization (WHO) reported 1 342 000 tuberculosis cases in the region in 2014; 28% of the global caseload. The region suffers from the highest per-capita burden; 281 cases per 100 000 population, more than double the global average. Despite meeting the Millennium Development Goal target of a falling tuberculosis incidence rate, the African region failed to meet the targets for 50% reduction in tuberculosis prevalence and mortality. Furthermore, the attainment of these targets varied among countries, with 40 countries achieving the Millennium Development Goal tuberculosis incidence target and only 18 countries achieving the 50% reduction in tuberculosis mortality target. Rates of multi-drug resistant tuberculosis vary across the continent, with average rates of 2.1% (0.5-3.7) among new cases and 11% (6.7-16) among previously-treated cases. 1 High-quality laboratory services are an essential component of all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. 2,3 However enabling access to quality tuberculosis diagnostic services for populations in need is a major challenge in low-resource settings. The End TB Strategy calls for universal access to drug susceptibility testing (DST). 4 However, the WHO reported that only 6.4% of new bacteriologicallyconfirmed tuberculosis cases and 33% of previously-treated cases received DST in 2014. 1 Laboratory services on the continent are known to suffer many challenges, including poor infrastructure, inadequate human resource capacity, and weak underlying health systems. 3 Background: Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care.
Objectives: The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region.
Method: An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region.
Results: A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation.

Conclusion:
Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa
Read online: A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing. A weak QMS may result in laboratory errors that can lead to both over-and under-diagnosis of tuberculosis, interruptions in service, and delayed reporting of results, leading to a negative impact on patient care. Failure to meet minimum safety standards may put laboratory workers, patients and the community at risk. 8 Such requirements can only be consistently met by concerted efforts to develop and maintain quality management systems within the tuberculosis laboratories. Accreditation is a formal process of recognition that appropriate and sufficient quality systems have been implemented. Accredited laboratories are recognised as meeting certain quality standards and having the necessary technical processes in place, as well as administrative systems needed to ensure quality results. Evidence from various high-and low-income settings 8,9,10,11 demonstrates that the implementation of QMS and accreditation leads to a measurable improvement in the quality of services and increased patient safety due to a reduction in laboratory errors.
National Tuberculosis Reference Laboratories (NTRLs) play a critical role in ensuring quality tuberculosis diagnostic services throughout the whole diagnostic testing network, conducting advanced testing (such as liquid culture, first-and second-line DST), supervision of peripheral laboratories, external quality assurance, and conducting drug surveillance surveys and operational research. Quality improvement of NTRLs is a critical first step in building strong diagnostic networks to deliver quality laboratory services for patient care.
Accreditation of NTRLs was a specific goal in the Global Plan to Stop TB (2006. 12  There are a number of key resources available to assist tuberculosis laboratories in developing and maintaining a QMS, which are reviewed in the Global Laboratory Initiative's (GLI) recently-published Guide for Providing Technical Support to TB Laboratories in Low-and Middle-income Countries. 13 Adherence to the ISO 15189:2012 international standard (www.iso.org) is used by regulating authorities and accreditation bodies for recognising the competence of medical laboratories. The WHO's Laboratory Quality Management System provides a comprehensive overview of laboratory QMS and comes in the form of a modular training package and manual. 14 GLI developed an online tuberculosis-specific tool to assist laboratories with accreditation preparedness (www.gliquality.org). SLIPTA is a stepwise monitoring and auditing framework developed by the WHO Regional Office for Africa, based on ISO 15189. Assessment using the SLIPTA checklist is scored and rated on a scale of one to five stars, with five stars being considered an indicator of readiness for international accreditation. Strengthening Laboratory Management Toward Accreditation (SLMTA) is a structured quality improvement programme, which teaches laboratory managers how to implement practical QMS in resourcelimited settings (www.slmta.org). The programme includes a series of workshops and work-based improvement projects supported by site visits and mentoring, and impact of the programme is measured using the SLIPTA checklist. 15 The Foundation for Innovative New Diagnostics found has developed a tuberculosis-specific version of SLMTA (TB-SLMTA), including a harmonised checklist based on SLIPTA and the GLI tool. 16 GLI Africa, a partnership focused on strengthening tuberculosis diagnostic networks in the African Region, 17 has established a programme aimed at supporting quality improvement and accreditation of NTRLs on the continent. As a first step in this initiative, a survey was developed to determine the current status of implementation of QMS at NTRLs, and the knowledge and use of various tools to assist in accreditation preparedness.

Survey development and dissemination
The aim of the survey was to gather baseline data on NTRL status regarding QMS and accreditation, to inform planning for support to countries working towards accreditation.

Survey questions
The survey consisted of questions in several key areas: (a) familiarity with various tools and approaches that can be used when implementing a QMS; (b) progress with implementing QMS in their laboratory; (c) data from internal or external QMS assessments; (d) programmes and partners supporting strengthening of QMS in their laboratory; and (e) challenges faced in strengthening QMS. Survey questions and possible responses are provided in full in Table 1.

Data management
Data from the online survey were managed via the WHO extranet data system. Survey responses were exported from the WHO system in .csv format, and data analysis was conducted in Microsoft Excel (2013 version; Microsoft, Redmond, Washington, United States).

Results
Responses were received from all 47 WHO African Region member states. A total of 49 responses from NTRLs were received; one per country except for Zimbabwe and Nigeria where each has two NTRLs which responded individually. All responses were submitted via the online survey tool.
Ten laboratories reported actively implementing the GLI tool; two of which had already achieved accreditation and one laboratory was close to achieving accreditation at the time of the survey. Four additional laboratories reported partially implementing the GLI tool, all of which had been audited in 2013 or 2014 and received two, three, three and four SLIPTA stars levels. Twenty-one countries reported having a SLIPTA focal point appointed within the Ministry of Health.
All laboratories that reported using the GLI tool also reported having staff trained on SLMTA or TB-SLMTA. Two laboratories who reported actively implementing GLI and TB-SLMTA were from WHO SRLs that were already accredited but whose staff received TB-SLMTA training to build capacity for providing QMS support to other countries in the region.  Figure 2).

Audits
Eighteen NTRLs (36.7%) reported having had an audit conducted using the SLIPTA checklist. The date of the most recent audit and the audit score are shown in Figure 3. It was not documented whether these audits were internal or external and, if external, the identity of the auditing body. An additional four laboratories reported having planned audits that had not yet been conducted.

External quality assurance
A total of 98.0% (48/49) of the NTRLs reported participation in at least one EQA programme, with 46 of these 48 sites Italy (12%) (Figure 4). The most common form of support provided by SRLs was provision of EQA panels, technical support, training and supervision visits.

Barriers to implementation of a quality management system
Of those laboratories not actively implementing QMS, the reasons for not having done so a QMS in their laboratory are shown in Figure 5. A lack of training, poor staff motivation, lack of an accreditation programme and insufficient on-site supervision were cited as the major reasons for nonimplementation of a QMS. Interestingly, lack of funds was the lowest-rated response among the options provided in answer to this question. However, when laboratories were asked a separate question about the barriers to implementing QMS, lack of funds was cited as one of the main reasons. Furthermore, only 28.6% of respondees reported that they had included a budget and workplan for laboratory accreditation in their strategic plans or Global Fund concept notes.

Recommendations
Although the majority of laboratories had knowledge of QMS tools, and almost half reported receiving SLMTA training or using the GLI tool, only a third of the laboratories reported having conducted an audit, an essential first step in establishing a baseline and developing an action plan to address recommendations and corrective actions resulting from the audit. Furthermore, responses from a number of countries suggested that there may be some confusion between the different tools mentioned in the survey. Since this survey did not provide a detailed measure of QMS implementation in individual laboratories and only a small proportion of laboratories were able to provide audit data, a full audit of laboratories using the SLIPTA checklist is an urgent priority in order to develop a detailed action plan and budget for achieving accreditation. It is also recommended     that information on accreditation is disseminated to countries in the region explaining the process of accreditation, the tools available and an implementation roadmap is provided to assist countries with planning. Additionally, a regional database of suitably-qualified organisations and individuals who are able to provide technical assistance to countries for accreditation should be developed.
Participation in EQA for acid-fast bacilli smear microscopy was very high, with 95.8% of NTRLs participating in an EQA scheme. However, EQA for other diagnostic techniques was less frequently conducted, with 60.4% of NTRLs not participating in first-line DST EQA and very low participation in EQA for second-line DST and molecular methods. It is not known what proportion of the NTRLs conduct secondline DST, and therefore the low participation in EQA may, in some cases, reflect the fact the second-line DST is not currently conducted in the country. The same may apply to the low enrolment of NTRLs in molecular testing. Furthermore, the extent to which NTRLs perform EQA of laboratories within their network was not reported; it is these laboratories that conduct the majority of microscopy testing for patient care.
Participation in EQA for all NTRLs should be urgently expanded for all diagnostic technologies performed. This can be achieved by expanding access to EQA programmes through the SRL network or other recognised providers.  The majority of countries reported a formal agreement with an SRL. However, capturing of detailed information on the extent of support and to what extent the SRL is fulfilling the country's need for technical support was outside the scope of the current survey. Establishment of formal relationships between the nine countries not currently supported by SRLs should be prioritised. Provision of EQA panels for all diagnostic technologies to all supported countries should be an essential component of the support provided by the SRL network or via other providers.
There was a disparity in QMS implementation and accreditation between Anglophone and non-Anglophone countries on the continent. This is anticipated to be due to the greater availability of tools and support in Anglophone countries in the region. Translation of any training materials or tools found to be lacking should be performed as an urgent priority, as well as building greater capacity for technical support in Francophone and Lusophone countries.
A lack of planning and budgeting were highlighted as major gaps, with almost three quarters of laboratories not having included plans for accreditation in their strategic planning processes. GLI Africa can play a role in providing guidance on planning and budgeting for accreditation, as well as advocating for the importance of quality improvement and accreditation as being key contributors toward countries meeting sustainable development goals for health. An assessment of country capacity and availability of partners and donors to support countries in planning, funding and implementing accreditation programmes should be conducted. Laboratories need to elicit senior management support within the Ministry of Health and include funding for quality improvement and accreditation of tuberculosis laboratories in their country strategic plans. 18 Equally, donors need to allocate adequate funding for quality improvement and accreditation programmes. To ensure local political commitment, as well as continued and adequate donor funding, need more evidence on the benefit of accreditation. Such evidence should focus on the patient impact of improved quality and specifically the benefit of accreditation per se as opposed to quality improvement in the absence of accreditation, as well as including a costing and cost-benefit analysis.

Limitations
The scope of this survey was to obtain a general overview of the knowledge and status of QMS among NTRLs on the continent, and not to provide detailed information about particular laboratories. Therefore, a clear indication as to the status of QMS implementation in individual laboratories was not possible as approximately two-thirds of laboratories had not been assessed using a recognised QMS checklist.
This survey focused on NTRLs and did not determine the status of QMS and progress toward accreditation for other laboratories in the network. In most countries, it would be anticipated that the NTRL is likely to be the most advanced in terms of QMS. It would be important to obtain information on the status of QMS in other laboratories, particularly those performing culture, DST and line-probe assay.
The survey was administered in three main lingua franca used in the African Region; namely, English, French and Portuguese. However, the WHO recognises other languages, including Spanish, as being the official language used in Equatorial Guinea. There were some conflicting responses given to several questions, implying that the questions were not clearly understood by all respondents. Finally, this survey was conducted among the 47 WHO African Region member states and not the 54 countries comprising the whole