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

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.

Impact of accreditation on health care services performance in Kiryandongo district, Uganda: a longitudinal study.

BACKGROUND: The COVID-19 pandemic has emphasised the need for quality laboratory services worldwide. There is renewed focus to strengthen country capacities and laboratories to effectively respond to public health emergencies and patient outcomes. Uganda launched the accreditation program for public health facilities in 2016 with sixteen laboratories. As of June 2021, twenty-three public laboratories have attained ISO 15189:2012 accreditation status. Despite the tremendous achievements of accrediting laboratories in Uganda, laboratory services still face challenges like stock out of commodities and limited testing scopes. We conducted this study to evaluate the impact of accreditation on health care services performance in Kiryandongo district, Uganda. METHODS: We conducted a longitudinal study from January 1, 2020- April 30, 2021 at ten health facilities in Kiryandongo district. We collected health care services performance data from the MoH dhis-2 on selected indicators for HIV, TB, Malaria, Laboratory, Maternal & child health and dhis-2 reporting. We used Generalized Estimating Equations to estimate the impact of accreditation on health care services performance at the different health facilities. RESULTS: The odds at the accredited facility in comparison to the non-accredited public facilities were; 14% higher for ART enrolment (OR = 1.14, 95% CI: 1.04-1.25), 9% lower for determine testing kits stock out (OR = 0.91, 95% CI: 0.85-0.97), 28% higher for TB case diagnosis (OR = 1.28, 95% CI: 1.10-1.49), 19% higher for TB case enrolment (OR = 1.19, 95% CI: 1.04-1.36), 104% higher for maternity admissions (OR = 2.04, 95% CI: 1.60-2.59), 63% higher for maternity deliveries (OR = 1.63, 95% CI: 1.39-1.90) and 17% higher for reporting hmis 10:01 data to dhis-2 (OR = 1.17, 95% CI: 1.04-1.31). The odds at the accredited facility in comparison to the non-accredited PNFP facilities were; 26% higher for ART enrolment (OR = 1.26, 95% CI: 1.17-1.36), 33% higher for TB case diagnosis (OR = 1.33, 95% CI: 1.15-1.55), 24% higher for TB case enrolment (OR = 1.24, 95% CI: 1.09-1.42), 136% higher for maternity admissions (OR = 2.36, 95% CI: 1.89-2.94), 76% higher for maternity deliveries (OR = 1.76, 95% CI: 1.51-2.04) and 2% higher for reporting of hmis-10:01 data to dhis-2 (OR = 1.02, 95% CI: 1.01-1.03). CONCLUSIONS: HIV, TB, laboratory, MCH, and reporting to dhis-2 selected indicators were positively impacted by accreditation. This impact translated into increased health care services performance at the accredited facility as compared to the non-accredited facilities.

Quality and resilience of clinical laboratories in Rwanda: a need for sustainable strategies.

BACKGROUND: Quality healthcare is a global priority, reliant on robust health systems for evidence-based medicine. Clinical laboratories are the backbone of quality healthcare facilitating diagnostics, treatment, patient monitoring, and disease surveillance. Their effectiveness depends on sustainable delivery of accurate test results. Although the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme has enhanced laboratory quality in low-income countries, the long-term sustainability of this improvement remains uncertain. OBJECTIVE: To explore the sustainability of quality performance in clinical laboratories in Rwanda following the conclusion of SLMTA. METHODS: A quasi-experimental design was adopted, involving 47 laboratories divided into three groups with distinct interventions. While one group received continuous mentorship and annual assessments (group two), interventions for the other groups (groups one and three) ceased following the conclusion of SLMTA. SLMTA experts collected data for 10 years through assessments using WHO's StepwiseLaboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. Descriptive and t-test analyses were conducted for statistical evaluation. RESULTS: Improvements in quality were noted between baseline and exit assessments across all laboratory groups (mean baseline: 35.3%, exit: 65.8%, p < 0.001). However, groups one and three experienced performance declines following SLMTA phase-out (mean group one: 64.6% in reference to 85.8%, p = 0.01; mean group three: 57.3% in reference to 64.7%, p < 0.001). In contrast, group two continued to enhance performance even years later (mean: 86.6%compared to 70.6%, p = 0.03). CONCLUSION: A coordinated implementation of quality improvement plan that enables regular laboratory assessments to pinpoint and address the quality gaps is essential for sustaining quality services in clinical laboratories.

Main findings: We found that continuous laboratory quality improvement was achieved by laboratories that kept up with regular follow-ups, as opposed to those which phased out these followups prematurely.Added knowledge: This study has affirmed the necessity of maintaining mentorship and conducting regular quality assessments until requisite quality routines are established to sustain laboratory quality services.Global health impact for policy and action: These findings emphasise the significance of instituting a laboratory quality plan, with regular assessments, as policy directives to uphold and enhance quality standards, which benefits both local and global communities, given the pivotal role of laboratories in patient treatment, disease prevention, and surveillance.

Accreditation of a molecular HIV diagnostic laboratory following the Strengthening Laboratory Management Towards Accreditation (SLMTA)-Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach in Kenya: an implementation science study.

Introduction: accreditation is the most effective approach to ensure the quality of services. Laboratory performance can be evaluated using the World Health Organization (WHO)-SLIPTA checklist, which checks a laboratory´s compliance with ISO 15189 on a five-star score scale and improved using the SLMTA approach. Compliance is assessed by an external body and can result in accreditation. In this paper, we describe the steps taken by the Kenya Medical Research Institute (KEMRI) HIV Laboratory, Alupe, a resource-limited public entity, towards accreditation, and discuss the lessons learned. Methods: the laboratory adopted a SLMTA-SLIPTA approach that included targeted mentorship, on-site workshops, and training. Mentorship-based interventions were used to establish a robust quality management system. Targeted mentorship, on-site workshops, and training were conducted between September 2015 and July 2016. Audits used the SLIPTA checklist to detect gaps in 12 quality system essentials. Performance indicators including turnaround time, external quality assurance, sample rejection rates, and corrective actions were tracked. An external assessment by the national accreditation body was conducted between September 2016 and November 2016. Results: training and mentorship-based interventions were successfully conducted. Quality management systems aligned with ISO 15189 were established. Baseline, midterm, and exit audits yielded scores of 47%, 75%, and 94% respectively. Early infant diagnosis external quality assurance scores were 100% in 2014-2016, while average viral load scores were at 60%, 70% and 90% during the same period. Turnaround time from September 2015 surpassed the 80% target. Accreditation was awarded in March 2017. Conclusion: the SLMTA-SLIPTA approach is suitable for quality improvement in resource-limited laboratories.

Implementing an intensified mentorship approach towards accelerated medical laboratory accreditation in 10 counties in Kenya.

Background: Despite Kenya's roll-out of the Strengthening Laboratory Management Towards Accreditation programme in 2010, most laboratories had not made significant or tangible improvements towards accreditation by 2016. In April 2016, the University of Maryland, Baltimore enrolled 27 facilities in the standard Strengthening Laboratory Management Towards Accreditation programme. Objective: This study aimed to describe and evaluate the implementation of an intensified mentorship strategy on laboratory accreditation. Methods: In October 2017, the University of Maryland, Baltimore implemented intensive mentorship in 27 hospital laboratories in Nairobi, Kiambu, Meru, Embu, Muranga, Nyeri, Laikipia, Nyandarua, Tharaka-Nithi, and Kirinyaga counties in Kenya. Laboratories were paired with competent mentors whose skills were matched to facility gaps. Baseline and follow-up assessments were done between April 2016 and March 2019 using the World Health Organization's Stepwise Laboratory Quality Improvement Process Towards Accreditation Checklist and overall scores of the 12 Quality System Essentials and star ratings (from zero to five, based on scores) used to evaluate the effectiveness of the intensified mentorship. Results: In September 2017, 14 laboratories scored zero stars, three scored one star, eight scored two stars, one scored three stars, and one laboratory was accredited. By March 2019, eight laboratories were accredited, five scored four stars, 10 scored three stars, three scored two stars, and only one scored one star. The average score change with the intensified approach was 81.5 versus 53.9 for the standard approach. Conclusion: The intensified mentorship strategy resulted in fast-tracked progress towards laboratory accreditation and can be adopted in similar resource-limited settings.

Enhancing accreditation outcomes for medical laboratories on the Strengthening Laboratory Management Toward Accreditation programme in Kenya via a rapid results initiative.

Background: Since 2010, Kenya has used SLIPTA to prepare and improve quality management systems in medical laboratories to achieve ISO 15189 accreditation. However, less than 10% of enrolled laboratories had done so in the initial seven years of SLMTA implementation. Objective: We described Kenya's experience in accelerating medical laboratories on SLMTA to attain ISO 15189 accreditation. Methods: From March 2017 to July 2017, an aggressive top-down approach through high-level management stakeholder engagement for buy-in, needs-based expedited SLIPTA mentorship and on-site support as a rapid results initiative (RRI) was implemented in 39 laboratories whose quality improvement process had stagnated for 2-7 years. In July 2017, SLIPTA baseline and exit audit average scores on quality essential elements were compared to assess performance. Results: After RRI, laboratories achieving greater than a 2-star SLMTA rating increased significantly from 15 (38%) at baseline to 33 (85%) (p < 0.001). Overall, 34/39 (87%) laboratories received ISO 15189 accreditation within two years of RRI, leading to a 330% increase in the number of accredited laboratories in Kenya. The most improved of the 12 quality system essentials were Equipment Management (mean increase 95% CI: 5.31 ± 1.89) and Facilities and Biosafety (mean increase [95% CI: 4.05 ± 1.78]) (both: p < 0.0001). Information Management and Corrective Action Management remained the most challenging to improve, despite RRI interventions. Conclusion: High-level advocacy and targeted mentorship through RRI dramatically improved laboratory accreditation in Kenya. Similar approaches of strengthening SLIPTA implementation could improve SLMTA outcomes in other countries with similar challenges.

From benchmarking to best practices: Lessons from the laboratory quality improvement programme at the military teaching hospital in Cotonou, Benin.

BACKGROUND: In 2015, the Army Teaching Hospital-University Teaching Hospital (HIA-CHU [Hôpital D'instruction des Armées de Cotonou Centre Hospitalier et Universitaire]) laboratory in Benin launched a quality improvement programme in alignment with the World Health Organization Regional Office for Africa's Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA). Among the sub-Saharan African laboratories that have used SLIPTA, few have been francophone countries, and fewer have belonged to a military health system. The purpose of this article was to outline the strategy, implementation, outcomes and military-specific challenges of the HIA-CHU laboratory quality improvement programme from 2015 to 2018. INTERVENTION: The strategy for the quality improvement programme included: external baseline SLIPTA evaluation, creation of work plan based on SLIPTA results, execution of improvement projects guided by work plan, assurance of accountability via regular meetings, training of personnel to improve personnel competencies, development of external stakeholder relationships for sustainability and external follow-up post-SLIPTA evaluation. LESSONS LEARNT: Over a period of 3 years, the HIA-CHU laboratory improved its SLIPTA score by 29% through a quality improvement process guided by work plan implementation, quality management system documentation, introduction of new proficiency testing and internal quality control programmes, and enhancement of personnel competencies in technical and quality management through training. RECOMMENDATIONS: The programme has yielded achievements, but consistent improvement efforts are necessary to address programme challenges and ensure continual increases in SLIPTA scores. Despite successes, military-specific challenges such as the high mobility of personnel have hindered programme progress. The authors recommend that further implementation research data be shared from programmes using SLIPTA in under-represented settings such as military health systems.

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015.

BACKGROUND: In 2011 the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) was launched, aimed at strengthening the quality and competence of African clinical, public health and reference laboratories. We reviewed the first version of the SLIPTA checklist in 2011. The continued development and publication of a new version of the International Organization for Standardization (ISO) 15189 standard demands a renewed review. OBJECTIVE: This study aimed to determine the suitability of SLIPTA in guiding laboratories towards ISO 15189:2012 compliance and accreditation and provide recommendations for further SLIPTA improvement. METHODS: The study was conducted between September 2018 and April 2019. Coverage of ISO 15189:2012 by SLIPTA checklist version 2:2015 was determined and the point distribution of the scoring system over the different sections of the SLIPTA checklist was re-investigated. These findings were compared with the review of the first version of the SLIPTA checklist (based on ISO 15189:2007) and with findings published on SLIPTA implementation and roll-out. RESULTS: The coverage of ISO 15189 by the SLIPTA checklist has increased, even though ISO 15189:012 is more extensive than ISO 15189:2007. The point distribution is still skewed towards sections related to quality planning rather than quality control and improvement. Although to date 314 laboratories have been assessed, barriers for laboratories to participate in SLIPTA are high. Sustainability of SLIPTA results is insufficiently studied. CONCLUSION: SLIPTA checklist version 2:2015 has improved compared to earlier versions. We recommend increasing accessibility for laboratories to participate and increasing guidance for ISO-based quality management system implementation.

Clinical Referral Laboratories in Rwanda.

OBJECTIVES: We investigated the quality system performance in Rwandan referral laboratories to determine their progress toward accreditation. METHODS: We conducted audits across five laboratories in 2017, using the Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist. Laboratories were scored based on the World Health Organization grading scale (0-5 stars scale) and compared with earlier audits. RESULTS: Between 2012 and 2017, only one laboratory progressed (from four to five stars). Four of the five laboratories decreased to one (three laboratories) and zero (one laboratory) stars from four and three stars. Management reviews, evaluation, audits, documents, records, and identification of nonconformities showed a low performance. CONCLUSIONS: Four of five laboratories are not moving toward accreditation. However, this target is still achievable by energizing responsibilities of stakeholders and monitoring and evaluation. This would be possible because of the ability that laboratories showed in earlier audits, coupled with existing health policy that enables sustainable quality health care in Rwanda.

Strengthening Laboratory Management Toward Accreditation, A Model Program for Pathology Laboratory Improvement.

The Strengthening Laboratory Management Toward Accreditation (SLMTA) program and subsequent Stepwise Laboratory Quality Improvement Process Toward Accreditation (SLIPTA) checklist were a response to the need for high-quality laboratories to combat the human immunodeficiency virus (HIV) epidemic and provide patients with the highest-quality care. The two tools work together to create a culture of quality in laboratories and allow the identification of gaps. The ultimate goal for any laboratory is to achieve a standard benchmark for quality and these programs have been highly successful in initially affecting the HIV epidemic but continuously improving laboratory quality across all diseases.

Rapid Ascent From Zero Quality to International Organization for Standardization Accreditation: A Case Study of Hai Duong Preventive Medicine Center in Vietnam, 2012-2013.

OBJECTIVES: In 2012, the Vietnam Ministry of Health sought to improve the quality of health laboratories by introducing international quality standards. METHODS: Strengthening Laboratory Management Toward Accreditation (SLMTA), a year-long, structured, quality improvement curriculum (including projects and mentorship) was piloted in 12 laboratories. Progress was measured using a standardized audit tool (Stepwise Laboratory Quality Improvement Process Towards Accreditation). RESULTS: All 12 pilot laboratories (a mix of hospital and public health) demonstrated improvement; median scores rose from 44% to 78% compliance. The public health laboratory in Hai Duong Province entered the program with the lowest score of the group (28%) yet concluded with the highest score (86%). Five months after the completion of the program, without any additional external support, they were accredited. Laboratory management/staff describe factors key to their success: support from the facility senior management, how-to guidance provided by SLMTA, support from the site mentor, and strong commitment of laboratory staff. CONCLUSIONS: Hai Duong preventive medical center is one of only a handful of laboratories to reach accreditation after participation in SLMTA and the only laboratory to do so without additional support. Due to the success seen in Hai Duong and other pilot laboratories, Vietnam has expanded the use of SLMTA.

Assessing the outcome of Strengthening Laboratory Management Towards Accreditation (SLMTA) on laboratory quality management system in city government of Addis Ababa, Ethiopia.

INTRODUCTION: Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The aim of this study is to assess the outcome of SLMTA on laboratory quality management system in Addis Ababa, Ethiopia. METHODS: The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. The study was conducted in Addis Ababa city government and the data was collected from February 'April 2014 and data was entered in to EPI-data version 3.1 and was analyzed by SPSS version 20. RESULTS: The assessment finding indicate that there was a significant improvement in average scores (141.4; range of 65-196, 95%CI=86.275-115.5, p=0.000) at final with 3 laboratories become 3 star, 6 laboratories were at 2 star, 11 were 1 star. Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2.5 times more likely to get good success in the final score(AOR=2.501, 95% CI=1.109-4.602) than which did not get it. CONCLUSION: At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance. Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories.

The status of medical laboratory towards of AFRO-WHO accreditation process in government and private health facilities in Addis Ababa, Ethiopia.

INTRODUCTION: The World Health Organization Regional Office for Africa (WHO AFRO) introduces a step wise incremental accreditation approach to improving quality of laboratory and it is a new initiative in Ethiopia and activities are performed for implementation of accreditation program. METHODS: Descriptive cross sectional study was conducted in 30 laboratory facilities including 6 laboratory sections to determine their status towards of accreditation using WHO AFRO accreditation checklist and 213 laboratory professionals were interviewed to assess their knowledge on quality system essentials and accreditation in Addis Ababa Ethiopia. RESULTS: Out of 30 laboratory facilities 1 private laboratory scored 156 (62%) points, which is the minimum required point for WHO accreditation and the least score was 32 (12.8%) points from government laboratory. The assessment finding from each section indicate that 2 Clinical chemistry (55.2% & 62.8%), 2 Hematology (55.2% & 62.8%), 2 Serology (55.2% & 62.8%), 2 Microbiology (55.2% & 62.4%), 1 Parasitology (62.8%) & 1 Urinalysis (61.6%) sections scored the minimum required point for WHO accreditation. The average score for government laboratories was 78.2 (31.2%) points, of these 6 laboratories were under accreditation process with 106.2 (42.5%) average score, while the private laboratories had 71.2 (28.5%) average score. Of 213 respondents 197 (92.5%) professionals had a knowledge on quality system essentials whereas 155 (72.8%) respondents on accreditation. CONCLUSION: Although majority of the laboratory professionals had knowledge on quality system and accreditation, laboratories professionals were not able to practice the quality system properly and most of the laboratories had poor status towards the WHO accreditation process. Thus government as well as stakeholders should integrate accreditation program into planning and health policy.

Laboratory quality improvement in Tanzania.

OBJECTIVES: The article describes the implementation and improvement in the first groups of medical laboratories in Tanzania selected to participate in the training program on Strengthening Laboratory Management Toward Accreditation (SLMTA). METHODS: As in many other African nations, the selected improvement plan consisted of formalized hands-on training (SLMTA) that teaches the tasks and skills of laboratory management and provides the tools for implementation of best laboratory practice. Implementation of the improvements learned during training was verified before and after SLMTA with the World Health Organization African Region Stepwise Laboratory Improvement Process Towards Accreditation checklist. RESULTS: During a 4-year period, the selected laboratories described in this article demonstrated improvement with a range of 2% to 203% (cohort I) and 12% to 243% (cohort II) over baseline scores. CONCLUSIONS: The article describes the progress made in Tanzania's first cohorts, the obstacles encountered, and the lessons learned during the pilot and subsequent implementations.