Critical success factors for Vietnamese laboratories striving to implement quality management systems.

Accurate laboratory reporting is crucial to patient diagnosis and treatment. This study identified critical success factors (CSF) for implementing a laboratory quality management system (QMS). This descriptive research used qualitative and quantitative methods to collect and analyze data from laboratory managers and staff employed in Vietnamese hospital laboratories implementing a QMS. The top five CSFs identified were: (1) staff QMS knowledge, (2) manager leadership, (3) staff commitment, (4) mentorship, and (5) hospital administration support. Identifying CSFs is critical to successful planning and implementation of QMS.

Laboratory medicine in Africa since 2008: then, now, and the future.

The Maputo Declaration of 2008 advocated for commitment from global stakeholders and national governments to prioritise support and harmonisation of laboratory systems through development of comprehensive national laboratory strategies and policies in sub-Saharan Africa. As a result, HIV laboratory medicine in Africa has undergone a transformation, and substantial improvements have been made in diagnostic services, networks, and institutions, including the development of a competent workforce, introduction of point-of-care diagnostics, and innovative quality improvement programmes that saw more than 1100 laboratories enrolled and 44 accredited to international standards. These improved HIV laboratories can now be used to combat emerging continental and global health threats in the decades to come. For instance, the unprecedented Ebola virus disease outbreak in west Africa exposed the severe weaknesses in the overall national health systems in affected countries. It is now possible to build robust health-care systems in Africa and to combat emerging continental and global health threats in the future. In this Personal View, we aim to describe the remarkable transformation that has occurred in laboratory medicine to combat HIV/AIDS and improve global health in sub-Saharan Africa since 2008.

The SLMTA programme: Transforming the laboratory landscape in developing countries.

BACKGROUND: Efficient and reliable laboratory services are essential to effective and well-functioning health systems. Laboratory managers play a critical role in ensuring the quality and timeliness of these services. However, few laboratory management programmes focus on the competencies required for the daily operations of a laboratory in resource-limited settings. This report provides a detailed description of an innovative laboratory management training tool called Strengthening Laboratory Management Toward Accreditation (SLMTA) and highlights some challenges, achievements and lessons learned during the first five years of implementation (2009-2013) in developing countries. PROGRAMME: SLMTA is a competency-based programme that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training programme spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization's Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training programme. CONCLUSION: Within five years, SLMTA had been implemented in 617 laboratories in 47 countries, transforming the laboratory landscape in developing countries. To our knowledge, SLMTA is the first programme that makes an explicit connection between the performance of specific management behaviours and routines and ISO 15189 requirements. Because of this close relationship, SLMTA is uniquely positioned to help laboratories seek accreditation to ISO 15189.

Laboratory system strengthening and quality improvement in Ethiopia.

BACKGROUND: In 2010, a National Laboratory Strategic Plan was set forth in Ethiopia to strengthen laboratory quality systems and set the stage for laboratory accreditation. As a result, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was initiated in 45 Ethiopian laboratories. OBJECTIVES: This article discusses the implementation of the programme, the findings from the evaluation process and key challenges. METHODS: The 45 laboratories were divided into two consecutive cohorts and staff from each laboratory participated in SLMTA training and improvement projects. The average amount of supportive supervision conducted in the laboratories was 68 hours for cohort I and two hours for cohort II. Baseline and exit audits were conducted in 44 of the laboratories and percent compliance was determined using a checklist with scores divided into zero- to five-star rating levels. RESULTS: Improvements, ranging from < 1 to 51 percentage points, were noted in 42 laboratories, whilst decreases were recorded in two. The average scores at the baseline and exit audits were 40% and 58% for cohort I (p < 0.01); and 42% and 53% for cohort II (p < 0.01), respectively. The p-value for difference between cohorts was 0.07. At the exit audit, 61% of the first and 48% of the second cohort laboratories achieved an increase in star rating. Poor awareness, lack of harmonisation with other facility activities and the absence of a quality manual were challenges identified. CONCLUSION: Improvements resulting from SLMTA implementation are encouraging. Continuous advocacy at all levels of the health system is needed to ensure involvement of stakeholders and integration with other improvement initiatives and routine activities.

Training-of-trainers: A strategy to build country capacity for SLMTA expansion and sustainability.

BACKGROUND: The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme uses a training-of-trainers (TOT) model to build capacity for programme scale-up. The TOT strategy is designed to maximise utilisation of its graduates whilst minimising inconsistencies and ensuring high programme quality during global expansion. OBJECTIVES: To describe the SLMTA TOT programme approach. METHODS: The two-week training, led by carefully selected and trained master trainers, enables effective and authentic implementation of the curriculum by its graduates. The teachback methodology used allows participants to practise teaching the curriculum whilst learning its content. A trainer's toolkit provides all the materials necessary for teaching and must be followed faithfully during training. Two surveys were conducted to assess the effectiveness of the TOT strategy: one sent to 316 TOT graduates in 25 countries and the other sent to the programme leaders in 10 countries. RESULTS: By the end of 2013, 433 SLMTA trainers had been trained who, in turn, taught more than 1900 people to implement SLMTA in 617 laboratories in 47 countries. Ninety-seven percent of the 433 TOT graduates and 87% of the 38 master trainers are based in developing countries. Ninety-two per cent of the graduates have been utilised at least once in programme implementation and, as of August 2013, 87% of them were still actively involved in programme activities. Ninety-seven per cent of the graduates stated that the TOT workshop prepared them well for training or other programme tasks. CONCLUSION: The SLMTA TOT strategy is effective in building local capacity for global programme expansion whilst maintaining programme quality.

Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems.

BACKGROUND: The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme is a large-scale effort to improve the quality of laboratories in resource-limited countries. OBJECTIVES: This study sought to evaluate the first four years (2010-2013) of SLMTA implementation. METHODS: Country-level data were submitted by SLMTA programme leads and compiled globally. Performance was measured before (baseline) and after (exit) SLMTA implementation using an audit checklist which results in a percentage score and a rating of zero to five stars. Some laboratories continued to monitor performance in post-exit surveillance audits. We evaluated score improvements using two-tailed t-tests for equal variances and estimated the number of tests performed by SLMTA laboratories based on star level. RESULTS: SLMTA was implemented in 617 laboratories in 47 countries in Africa, the Caribbean, Latin America and Southeast Asia. At the baseline audit, the laboratories scored an average of 39% on the checklist and 84% of them were rated below one star. As of December 2013, 302 laboratories had completed the SLMTA programme; mean checklist scores increased from 39% at baseline to 64% at exit (p < 0.001) over an average 16-month programme duration. Ninety-two laboratories conducted a surveillance audit at a median of 11 months after their exit audit; 62% further increased their performance. Six SLMTA laboratories have achieved accreditation status. In total, the 617 SLMTA laboratories conduct an estimated 111 million tests annually. Only 16% of these tests were conducted by laboratories with at least one star at baseline, which increased to 68% of tests after SLMTA training. Thus, approximately 23 million tests are conducted annually by laboratories previously at zero stars that now have one to five stars; this number is projected to increase to 58 million when currently-enrolled laboratories complete the programme. CONCLUSION: SLMTA has transformed the laboratory landscape in resource-limited countries worldwide and has the potential to make a substantial and sustainable impact on the quality of laboratory testing and patient care.

Building local human resources to implement SLMTA with limited donor funding: The Ghana experience.

BACKGROUND: In 2009, Ghana adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme in order to improve laboratory quality. The programme was implemented successfully with limited donor funding and local human resources. OBJECTIVES: To demonstrate how Ghana, which received very limited PEPFAR funding, was able to achieve marked quality improvement using local human resources. METHOD: Local partners led the SLMTA implementation and local mentors were embedded in each laboratory. An in-country training-of-trainers workshop was conducted in order to increase the pool of local SLMTA implementers. Three laboratory cohorts were enrolled in SLMTA in 2011, 2012 and 2013. Participants from each cohort attended in a series of three workshops interspersed with improvement projects and mentorship. Supplemental training on internal audit was provided. Baseline, exit and follow-up audits were conducted using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. In November 2013, four laboratories underwent official SLIPTA audits by the African Society for Laboratory Medicine (ASLM). RESULTS: The local SLMTA team successfully implemented three cohorts of SLMTA in 15 laboratories. Seven out of the nine laboratories that underwent follow-up audits have reached at least one star. Three out of the four laboratories that underwent official ASLM audits were awarded four stars. Patient satisfaction increased from 25% to 70% and sample rejection rates decreased from 32% to 10%. On average, $40 000 was spent per laboratory to cover mentors' salaries, SLMTA training and improvement project support. CONCLUSION: Building in-country capacity through local partners is a sustainable model for improving service quality in resource-constrained countries such as Ghana. Such models promote country ownership, capacity building and the use of local human resources for the expansion of SLMTA.

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique's SLMTA story.

BACKGROUND: Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH) laboratory structure. OBJECTIVE: This article outlines the steps followed to establish a national framework for quality improvement and embedding the SLMTA programme within existing MOH laboratory systems. METHODS: The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and seven from partner organisations) conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist), workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. RESULTS: The six laboratories demonstrated substantial improvement in audit scores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. CONCLUSION: Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that country leadership, ownership and institutionalisation can set the stage for programme success and sustainability.

A comprehensive review of the SLMTA literature part 1: Content analysis and future priorities.

BACKGROUND: Since its introduction in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has been implemented widely throughout Africa, as well as in the Caribbean, Central and South America, and Southeast Asia. OBJECTIVE: We compiled results from local, national and global studies to provide a broad view of the programme and identify directions for the future. The review consists of two companion papers; this paper focuses on content analysis, examining various thematic components of the SLMTA programme and future priorities. METHODS: A systematic literature search identified 28 published articles about implementing the SLMTA programme. Results for various components of the SLMTA programme were reviewed and summarised. RESULTS: Local and national studies provide substantial information on previous experiences with quality management systems; variations on SLMTA implementation; building human resource capacity for trainers, mentors and auditors; the benefits and effectiveness of various types of mentorship; the importance of management buy-in to ensure country ownership; the need to instill a culture of quality in the laboratory; success factors and challenges; and future directions for the programme. CONCLUSIONS: Local, national and global results suggest that the SLMTA programme has been overwhelmingly successful in transforming laboratory quality management. There is an urgent need to move forward in four strategic directions: progression (continued improvement in SLMTA laboratories), saturation (additional laboratories within countries that have implemented SLMTA), expansion (implementation in additional countries), and extension (adapting SLMTA for implementation beyond the laboratory), to lead to transformation of overall health systems and patient care.

A comprehensive review of the SLMTA literature part 2: Measuring success.

BACKGROUND: Since its introduction in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has been implemented in 617 laboratories in 47 countries. OBJECTIVE: We completed a systematic review of the published literature on SLMTA. The review consists of two companion papers; this article examines quantitative evidence presented in the publications along with a meta-analysis of selected results. METHODS: We identified 28 published articles with data from SLMTA implementation. The SLMTA programme was evaluated through audits based on a standard checklist, which is divided into 12 sections corresponding to the 12 Quality System Essentials (QSEs). Several basic service delivery indicators reported by programmes were also examined. Results for various components of the programme were reviewed and summarised; a meta-analysis of QSE results grouped by the three stages of the quality cycle was conducted for 126 laboratories in 12 countries. RESULTS: Global programme data show improved quality in SLMTA laboratories in every country, with average improvements on audit scores of 25 percentage points. Meta-analysis identified Improvement Management as the weakest stage, with internal audit (8%) and occurrence management (16%) showing the lowest scores. Studies documented 19% - 95% reductions in turn-around times, 69% - 93% reductions in specimen rejection rates, 76% - 81% increases in clinician satisfaction rates, 67% - 85% improvements in external quality assessment results, 50% - 66% decreases in nonconformities and 67% increases in staff punctuality. CONCLUSIONS: The wide array of results reported provides a comprehensive picture of the SLMTA programme overall, suggesting a substantive impact on provision of quality laboratory services and patient care. These comprehensive results establish a solid data-driven foundation for program improvement and further expansion.

Ensuring the quality of HIV rapid testing in resource-poor countries using a systematic approach to training.

HIV rapid testing is a key tool in the fight against the HIV/AIDS epidemic; it enables the rapid expansion of prevention and treatment programs in resource-limited countries. Meeting the goals of these programs means that millions of people will need testing annually. Accuracy and reliability of these tests are critical to the success of these programs. Given the enormous number of rapid tests that are performed each year, even a low error rate of 0.5% applied to 100 million people will result in 500,000 erroneous results. Ensuring the quality of HIV rapid testing presents unique challenges in that testing is often performed in various settings by personnel without formal laboratory training. This article describes the development and implementation of a generic HIV rapid test training package using a systems approach in an effort to standardize training and ensure the quality of rapid tests. It also highlights achievements from Uganda, Haiti, and Botswana.

Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation.

The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed to promote immediate, measurable improvement in laboratories of developing countries. The laboratory management framework, a tool that prescribes managerial job tasks, forms the basis of the hands-on, activity-based curriculum. SLMTA is implemented through multiple workshops with intervening site visits to support improvement projects. To evaluate the effectiveness of SLMTA, the laboratory accreditation checklist was developed and subsequently adopted by the World Health Organization Regional Office for Africa (WHO AFRO). The SLMTA program and the implementation model were validated through a pilot in Uganda. SLMTA yielded observable, measurable results in the laboratories and improved patient flow and turnaround time in a laboratory simulation. The laboratory staff members were empowered to improve their own laboratories by using existing resources, communicate with clinicians and hospital administrators, and advocate for system strengthening. The SLMTA program supports laboratories by improving management and building preparedness for accreditation.