https://orcid.org/0000-0001-7761-3604
Figures
Abstract
Background
The effectiveness of Quality Management Systems (QMS) in public medical laboratories is crucial to ensure quality and reliable testing outcomes for quality healthcare. This research aims to achieve a minimum of 2 Stars WHO-AFRO rating at the external audit of ten public medical Laboratories within twelve months of intervention using improved documentation and institutionalization of robust QMS.
Method
A quasi-experimental design was used to assess QMS interventions in ten of 28 public secondary medical laboratories in Lagos State. These facilities were randomly selected using non-probability measures over 12 months from November 2022 to October 2023. The study measured resource allocation, conducted staff training for capacity building, and provided mentoring support. External audits were performed using the WHO-AFRO SLIPTA 2015 checklist, with a grading system from 0 to 5 stars. The data collected included baseline and post-intervention scores, analyzed using descriptive statistics and baseline compared with follow-up audit performance.
Result
The 12-month implementation of laboratory QMS in ten Lagos State’s public secondary health facilities revealed substantial progress. Nine Medical laboratories in the study had a baseline WHO-AFRO rating of 0 Star, while General Hospital Ikorodu had a baseline rating of 1 Star. Sixty percent of the medical laboratories demonstrated commendable QMS improvement and achieved 3 Stars WHO-AFRO rating each, while twenty percent of the medical laboratories attained 2-Stars each. However, the remaining twenty percent of the health facilities achieved minimal improvements, securing 1 Star WHO-AFRO rating each.
Conclusion
Overall, Eighty percent of the medical laboratories showed progress in QMS implementation in Lagos State. The study reveals that a Government-led QMS implementation drives a more sustainable culture of quality in medical laboratories and the twelve-month measure indicates the possibility to extend the QMS interventions to the remaining eighteen public medical laboratories in Lagos State.
Citation: Adaran T, Jenrola O, Jegede F, Ojo O, Bakare A, Omiyale O, et al. (2025) Quality Management Systems implementation in public medical laboratories; A sustainable approach to health system strengthening in Lagos State, Nigeria. PLoS One 20(6): e0319409. https://doi.org/10.1371/journal.pone.0319409
Editor: Chika Kingsley Onwuamah, Nigerian Institute of Medical Research, NIGERIA
Received: October 16, 2024; Accepted: February 1, 2025; Published: June 2, 2025
Copyright: © 2025 Adaran et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the manuscript and its Supporting Information files.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
Background
Medical Laboratory services is a critical component of the health care system generating data that help physicians make informed decisions. Errors from the Medical laboratory services could negatively impact patient health outcomes. Globally, Quality Management Systems (QMS) are crucial building blocks interconnected to minimize errors in medical laboratory services. Medical laboratories faced significant challenges to ensure test results’ quality, reliability, accuracy, and timeliness standards [1]. Implementing a QMS can help laboratories overcome these challenges by implementing with fidelity in the application of the twelve quality system essentials as composite building blocks that help fulfill predetermined quality objectives [2].
Lagos State, Nigeria’s vibrant metropolis ensures quality healthcare hinges on robust public laboratories. These laboratories serve as the frontline sentinels, providing accurate diagnoses, monitoring disease outbreaks, and supporting clinical decision-making [3]. However, the effectiveness of these crucial institutions can be hampered by inadequate quality management systems, leading to unreliable results, compromised patient care, and, ultimately, weakened health systems [1]. Implementing robust QMS in public medical laboratories is not merely a technical endeavour but a transformative force in strengthening healthcare infrastructure. Ojo et al. [4] state, “Quality management is at the heart of an effective health system and is essential for ensuring safe, effective, and patient-centred care.” Embedded within this statement lies the fundamental purpose of this research: to explore the institutionalization of QMS in public medical laboratories across Lagos State, proposing a sustainable and measurable approach that fosters health system strengthening over a period.
As Kleinman & Dougherty [5] emphasize, “Quality improvement in health care is not an event and not a destination but a journey,” this research embarks on that journey, striving to equip public medical laboratories in Lagos State with the tools and systems necessary to navigate the path towards healthcare excellence. In a measure to ensure an efficiently strengthened laboratory system, the Lagos State Ministry of Health (LSMOH), through funding support from the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) grant, put strategies in place to ensure the implementation of a sustainable laboratory quality management system for continuous improvement procedures and overall guidance to achieve a minimum of 2-STARS WHO-AFRO rating using SLIPTA checklist after twelve months. The QMS program includes a set of policies, procedures, and practices that monitor/control all steps of the medical laboratory service cycle that can affect laboratory results ranging from pre-analytic, analytic, and post-analytical phases [6].
In 2020, the Global Fund supported the mapping of medical laboratories, which identified 26 secondary public laboratories with poor QMS implementation, hence the need to channel resources to improve the quality of medical laboratory service. The general findings from these 26 Lagos State-owned secondary facilities include sparing knowledge of QMS, leading to a lack of commitment to implementation in the entire medical laboratory service. In contrast, some levels of implementation were identified only in the HIV-disease-specific donor-funded laboratories in the facilities. This significant gap has not factored in integrated service delivery for a holistic approach to quality medical laboratory services. This fragmented approach (support for only disease-specific labs) reveals the knowledge gap in the implementation and sustainability of systems through policy development that will ensure the commitment of facility management to quality system essentials [7]. Hence, there is a need for capacity building, continuous monitoring of compliance with standards and measures of compliance to ensure sustainability. Ensuring knowledge sharing among these facilities to institutionalize the culture of QMS for a strengthened medical laboratory service [8].
The major aim of this study is to measure the impact of the various QMS interventions geared towards building the capacity of the Laboratory staff in compliance with ISO 15189;2012 using the WHO-AFRO SLIPTA checklist for rating.
Methodology
Study design
This study adopted a Quasi-experimental design to assess the impact of QMS interventions in ten selected public secondary laboratories in Lagos State, Nigeria. The interventions aimed to strengthen laboratory systems and achieve a minimum 2-STARS WHO-AFRO rating within 12 months.
Study area
The study was conducted across ten public secondary medical laboratories in Lagos State, Nigeria. These laboratories were strategically selected based on their need for QMS improvement and minimal infrastructural upgrade requirements. Lagos State being a state in southwestern Nigeria that borders Ogun State to the East and North, it is both the most populous and smallest in area of the 36 states in Nigeria. Lagos State is known for its vibrant culture, bustling markets, and significant economic activities. The state is a key culture, education, and transportation hub for Nigeria and Sub-Saharan Africa. Lagos has recorded medical breakthroughs in combating Ebola and COVID-19 outbreaks. The state also has the highest literacy rate in Nigeria [9].
Population, sample frame and respondents
Lagos State has a total of twenty local government areas with 28 secondary health facilities. All of the 28 secondary health facilities were considered target population for this intervention, while 10 out of the secondary health facilities fit into the sample frame. The respondents comprised medical laboratory staff, laboratory managers, quality officers, safety officers and other personnel directly involved in laboratory operations across the ten selected facilities. The 10 supported facilities are:
- General Hospital Lagos
- General Hospital Ikorodu
- General Hospital Isolo
- General Hospital Gbagada
- General Hospital Onikan
- General Hospital Randle, Surulere
- General Hospital Epe
- General Hospital Badagry
- Mainland Hospital Yaba
- Lagos Island Maternity Hospital
Justification for the selection of 10 secondary health facilities
The ten facilities that met the inclusion criteria such as the availability of good laboratory infrastructure (building/location) within a hospital setting with minimal or no need for renovations, high patient in-flow, with a minimum of five technical staff to ensure adequate dedication to QMS implementation and concurrence of the hospital management to ensure commitment to QMS implementation were selected. The participating facilities received equal support during this research.
Ethical consideration
Ethical considerations are a crucial aspect of research that ensures the protection of human rights, dignity, and safety, as well as the integrity of scientific data [10].
Ethical considerations included adherence to standard protocols for conducting audits and training sessions. All interventions and data collection processes were conducted with the full approval by the Health Research and Ethics Committee of Lagos State University Teaching Hospital (LASUTH-HREC) for Lagos State Government following ethical guidelines.
Data collection, training of personnel, resources allocation, and support/ external audit
The data were collected from the scores obtained at audits conducted at the facilities using the SLIPTA checklist 2015 version tool, these facilities’ scores were obtained from the Resilient and Sustainable Systems for Health (RSSH) of the Directorate of Healthcare Planning, Research and Statistics (DHPRS) of the Lagos State Ministry of Health. Data collection took place from August 20th to September 20th 2024.
The review of the data covered the interventions conducted at implementation which are:
Training programs.
Various training sessions were conducted to enhance the capacity of laboratory staff in QMS implementation, Biosafety, biosecurity, ISO 15189: 2012 compliance, and internal audit processes. These sessions were both residential and non-residential, accommodating different aspects of QMS using different training approaches.
Resource allocation and support.
The provision of stationery and deployment of Laboratory Information Management Systems (LIMS) at the selected laboratories were part of the support mechanisms. There was the visit of selected Quality Officers from other disease-specific implementing laboratories to conduct a hand-holding session for the development of a draft of Quality Manual at the 10-supported facilities. Each facility was visited by a 2-man team to guide the focal officers in the facility to develop the draft documents. Furthermore, mentoring visits by QMS mentors were undertaken to assist in on-site hand-holding processes and document development.
External audits.
The interventions were audited using the WHO-AFRO SLIPTA checklist 2015, employing a team of two auditors over three days to conduct external audits in October 2023. This checklist contains 12 sections which assess Baseline scores were recorded in November 2022 to assess the progress and impact of the various interventions, in the following sections, Documents and Records, Management Reviews, Organization and Personnel, Client Management and Customer Service, Equipment, Evaluation and Audits, Purchasing and Inventory, Process Control, Information Management, Identification of Non-Conformities, Corrective and Preventive Actions, Occurrence/Incident Management and Process Improvement, and Facilities and Safety.
Data analysis
Descriptive statistics test was used to analyze the quantitative data from the WHO-AFRO SLIPTA checklist 2015 version for each facility at the external audits. The descriptive statistics presented outcomes as frequency tables, percentages, and bar charts. The statistical test performed a Pre-post analysis, comparing the change in SLIPTA baseline scores before and after the interventions, and WHO-AFRO ratings were tabulated, data cleaning was performed and assessed. This is to measure the impact of the interventions on laboratory ratings (Table 1).
The above table is the standard Audit rating for the measure of QMS using the SLIPTA Checklist 2015 edition to measure the compliance of the facilities with ISO 15189;2012 edition.
Results
The results from the external audit utilizing the WHO SLIPTA Checklist underscore significant strides made within the 12-month implementation period across the laboratories in Lagos State as shown in Table 2. Remarkably, several facilities demonstrated commendable advancements, with Lagos Island Maternity Hospital, Mainland Hospital Yaba, General Hospital Lagos, General Hospital Gbagada, General Hospital Onikan and General Hospital Ikorodu achieving a noteworthy 3 STARS each. These high-performing institutions showcased substantial adherence to quality management systems, marked by impressive score increments from their baseline assessments. However, while displaying moderate improvements, some facilities, such as General Hospital Isolo, and General Hospital Randle attained 2 STARS, signifying the need for further enhancements to reach higher rating tiers. Conversely, General Hospital Badagry and General Hospital Epe exhibited minimal improvements, securing 1 STAR each, highlighting the imperative for additional support and interventions to meet the required standards. This collective progress emphasizes the dedication to implementing and sustaining quality management systems, albeit underscoring the necessity for continued efforts and support, particularly for facilities requiring additional assistance, to ensure hospital management’s commitment to comprehensive quality enhancements across all public laboratories in Lagos State.
Fig 1 shows the 2023 QMS External Audit Outcome for Supported Sites, with SLIPTA scores out of 275. GH Gbagada achieved the highest external audit score of 229 while GH Epe recorded the highest baseline score of 157.
The external assessment reviewed the 12 sections of the audit checklist and the breakdown of scores per health facility is in the table 3:
The summary of findings of Non conformities across 10 medcial laboratories in lagos and recommedsations was assessed in Table 4.
Discussion
The primary purpose of the medical laboratory is to generate data that are accurate, precise, and useful for clinical decision-making by the physicians, contributing to improve patient outcomes and optimal management of patients. This can not be achieved without a well-functioning QMS within the laboratory. QMS is therefore essential for efficiency, ensuring quality results for patient care. Evaluating the laboratory through assessments is an effective method to ascertain its accuracy, reliability, and adherence to Good Clinical Laboratory Practices GCLP). The roles played by a medical laboratory are pivotal, as it promptly delivers quality, accurate, and reliable laboratory data to meet the requirements of physicians engaged in medical practice and patient health maintenance expected health outcomes [11]. Therefore, it is imperative to minimize the potential for errors and uphold the highest achievable quality standards in testing and results [12].
The findings of this study underscore the critical importance of implementing sustainable QMS in public medical laboratories within Lagos State. The study revealed substantial progress. Almost all the 10 medical laboratories in the study had a baseline rating of 0 stars, except General Hospital Ikorodu with a baseline rating of 1 star. Remarkably, a good proportion of the medical laboratories (60%) demonstrated commendable QMS improvement in Lagos Island Maternity Hospital, Mainland Hospital Yaba, General Hospital Lagos, General Hospital Gbagada, and General Hospital Ikorodu achieving an important milestone of 3 Stars each WHO-AFRO Rating. However, moderate improvements were observed in 20% of the medical laboratories (General Hospital Isolo and General Hospital Randle) that attained a 2-Stars WHO-AFRO Rating. The remaining 20% (General Hospital Badagry and General Hospital Epe) achieved minimal improvements, securing 1 Star each.
The comparison between the baseline scores recorded in November 2022 and the final scores obtained in October 2023 showcases the substantial strides made in the QMS implementation. Facilities that initially lacked stars due to lower baseline scores now boast significantly higher scores, signifying a positive shift in their adherence to quality standards – ISO 15189;2012. Notably, General Hospital Gbagada displayed a remarkable improvement, soaring from a baseline score of 106 (0 Star) to an impressive 229, attaining a 3-star rating within the study period.
Similar studies have been conducted in other countries, such as Uganda, where implementing a quality management system in public laboratories led to significant improvements in the quality of laboratory services [13]. Another study conducted in Nigeria showed improved WHO/AFRO ratings after the audit [14]. The study also found that implementing QMS in a public hospital improved patient outcomes and increased patient satisfaction [14]. These studies suggest implementation of QMS in public medical laboratories is a sustainable approach to strengthening health systems.
In contrast, a study in Oyo state, Nigeria, assessed the capacity of public secondary facility-based medical laboratories to conduct diagnostic tests for selected epidemic-prone diseases. Capacity was assessed on a 100-point scale in which scores were rated low. Diagnostic testing capacity for bacterial meningitis, cholera, and measles was “low” in all the laboratories. The reasons reported for laboratories not conducting diagnostic tests for the selected diseases included inadequate instruments, unavailable reagents, and clinicians’ failure to request those diagnostic tests [15]. Findings from another study in Ghana in which a QMS audit was performed, the laboratory audit showed an overall weak laboratory QMS (zero star rated) based on the WHO/AFRO laboratory strengthening checklist and rating [12].
The possible reasons for improvement in the laboratory quality management system in this study are a result of the Lagos State government’s driven approach to management commitment and evidenced sustainability for public medical laboratory facilities, unlike what is currently experienced in the country where implementation is largely driven by donor partners in disease-specific laboratories. Resource mobilization using government counterpart financing to build the capacity of laboratory staff is critical to support other donor funds and continuous monitoring of activities to ensure the Medical Directors of these facilities account for the various health system strengthening interventions.
The various trainings and rounds of mentorship provided by the SLMTA Nigeria team may have improved the skills and knowledge of the laboratory staff in understanding the standard, leading to better development of documents, adherence to standard operating procedures (SOPs) and overall quality management practices [16]. Also, regular internal and external audits may have helped identify areas for improvement in a laboratory’s quality management system. Addressing audit findings can drive continuous improvement [16]. The effectiveness of Quality Management Systems (QMS) significantly relies on the services provided by auditors and assessors who play a crucial role in maintaining and sustaining standards. In 2017, the CDC-Nigeria laboratory program, in partnership with the ASLM team, conducted ISO15189 training. This initiative aimed to enhance the capabilities of 24 auditors and SLMTA personnel within the country, enabling them to better assist laboratories in achieving higher service quality and adherence to international standards. Consequently, there is a pressing need to formulate comprehensive in-country auditing guidelines tailored explicitly for medical laboratories in Nigeria [16].
Another reason for the improvement in QMS of the laboratory system in this study could be attributed to various forms of technical support, including infrastructure upgrades, capacity building, improvement projects, follow-up visits, mentoring, and advocacy by the Lagos State Ministry Health team, the measurable quality improvement is likely a direct outcome of these efforts. Furthermore, the commitment demonstrated by the technical staff at the facilities, coupled with a certain degree of ownership and support from facility management, has also played a significant role in the program’s achievements [14].
Despite the advancements made in QMS within public secondary medical laboratories as indicated in this study, there is an ongoing need for improvement. Implementing QMS services is crucial to ensure the reliability and reproducibility of results. Raising awareness about the significance of laboratories adopting QMS and maintaining such a culture should be given high priority. It is also recommended to encourage more laboratories to participate in the WHO/AFRO SLMTA/SLIPTA program, seek experienced mentors, and pursue accreditation. These efforts will contribute to a well-organized and consistent workflow, uphold standards, deliver quality and competent services, and enhance customer satisfaction.
Limitations of the study
Limitations of this study stem from several factors. Firstly, a short intervention period of twelve months might not entirely reflect the long-term sustainability or overall impact of implemented quality management systems. Secondly, the absence of detailed discussion on resource constraints and external factors, like policy changes or staff turnover, raises concerns about potential unaccounted influences on the outcomes. Reliance on a single assessment tool, the WHO-AFRO SLIPTA checklist limits the depth of analysis. Thirdly, insufficient exploration of ethical considerations and human resource dynamics further constrains the study’s comprehensive understanding.
Conclusion
The GIZ Grant target for the measure of quality management systems was to attain a minimum of 2 stars within twelve months of implementation. The outcome of the ten laboratories revealed that six health facilities achieved 3 Stars, 2 of the facilities attained 2 stars, while two facilities showed a level of improvement to attain 1- Star. Hence, demonstrates a significant possibility to strengthen the culture of QMS for quality service delivery.
Acknowledgments
We acknowledge the support from the staff of the Directorate of Health Care Planning, Research and Statistics (DHCPRS) of the Lagos State Ministry of Health for adequate leadership. Our sincere appreciation to the unsung heroes in the ten selected public medical laboratories in Lagos State who immensely put in all the efforts through unrelenting service to produce quality results and the Medical Directors of the Hospitals who gave unflinching commitment to the implementation of the interventions.
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