Quality Of Laboratory Services Research Articles

A review on quality management system in laboratory testing

A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Continuous improvement of laboratory quality service is vital to ensure accuracy, reliability, and timeliness of laboratory results. Implementation of the quality management system is an effective way of monitoring and assuring laboratory quality service. Various standards and regulations outline specific requirements for implementing a Quality Management System (QMS) in a laboratory environment, such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493. These standards provide guidelines and criteria for laboratory processes, including testing, calibration, documentation, personnel competency, and overall quality control. This article will discuss the applicable standards and legislation, the 12 essential elements of laboratory QMS, and the role of QMS software in a laboratory environment. The objective of this study is to assess the impact of laboratory quality management system implementation on improving quality laboratory service.

Navigating Quality Assessment Hurdles in Clinical Laboratory Services: A Comprehensive Review in Resource-Limited Settings.

External quality assessment is the process of evaluating the performance of a laboratory and the competence of professionals. Participation in EQA and standardizing the quality of laboratory services are a mandatory requirements for accreditation. This review is aimed at identifying and discussing challenges that hinder the effective implementation of an EQA program in countries with resource limited setting. To obtain abundant information, articles were identified by searching the literature publishedin English using the National Library of Medicine, PubMed, Science Direct and AMC digital library databases. The articles identified in the references were manually searched and included. After the article was identified, it was imported to Endnote version 8.1 and exported to Microsoft Word for citation. Based on this review, the major identified challenges that hinder the implementation of an EQA program include the high cost of control materials, malfunction and lack of maintenance for equipment failure and breakdown, a knowledge gap among laboratory professionals, noncommutability of control samples, and difficulty in assigning target values. In addition, failing to participate in EQA and failing to take corrective action are the major challenges identified. As a result, applying to an EQA program in resource-limited counties was highly challenging. To attain high performance in the laboratory and to provide quality laboratory service for patient care, the EQA supplier and the user laboratory must pay attention to these issues and take appropriate corrective actions for ongoing quality improvement and accreditation.

SIX SIGMA METRICS: INDICATOR OF QUALITY ASSURANCE FOR CLINICAL BIOCHEMSITRY

Introduction: In present scenario Quality is the important aspect of laboratory practices. Mostly internal and external quality control are utilized to maintain quality in laboratory. Quality assurance of laboratory services is the need of present time in health care which require Quality Planning, Quality Control (QC), Quality Assessment (QA) and Quality Improvement . Aims & Objectives: 1. To quantify the defects and errors in analytical phase of laboratory testing by sigma metrics and to represent the calculated sigma value. 2. Application of six sigma test in laboratory with the IQC and EQAS to maintain quality laboratory services. Methodology: Study was conducted at Clinical Biochemistry Laboratory, GMC Akola. We run IQC samples on daily basis and EQAS samples are running on monthly basis. Retrospectively we utilized data of IQC and EQAS from January to October 2023 for 16 Biochemical Analytes. Sigma metrics for each parameter was calculated. Result: The sigma metrics for IQC indicated that 1 out of 16 analytes qualified six sigma quality performance. Of these 15 analytes performance with sigma metrics was beteween three and six. We found different sigma value like more than6 for only HDL cholesterol and more than 3 for Amylase, Total Bilirunbin, Creatinine, Cholesterol, Glucose, Phosphorus, total Protein , SGPT , TG, UA, Urea, SGOT, which is among the acceptable range of performance. Conclusion: In our study sigma value was highest for HDL cholesterol and other 15 analytes show sigma value between 3 to 6 which is acceptable range. Sigma analysis is a continuous procedure and by taking the help of method decision chart we can improve on decision on making in clinical chemistry laboratory regarding optimising QC procedure.

Literatur Review : Implementasi Manajemen Mutu Dan Kualitas Layanan Di Unit Laboratorium

This comprehensive review synthesizes findings from various journals on the management of quality and service in laboratory units within the healthcare context. The synthesis reveals the importance of service quality and its impact on patient satisfaction and service effectiveness. Key findings include the positive influence of service quality dimensions such as reliability, physical evidence, and friendliness on patient satisfaction. Additionally, the interconnection between service quality and adherence to health standards and regulations is emphasized, underlining the significance of compliance for service improvement. External factors, such as government regulations and health policies, are identified as potential influencers of service quality, adding complexity to quality management. Practical implications for healthcare policies and practices are highlighted, suggesting improvements in human resource training, service processes, and infrastructure. Recommendations include strengthening human resource training through regular and ongoing programs, optimizing service processes by thorough workflow evaluations, and ensuring strict compliance with health standards. Furthermore, the integration of technological innovations is proposed as a progressive step toward enhancing service efficiency and result accuracy. The implementation of laboratory information systems, modern equipment, and related applications is suggested to advance service quality. The establishment of a regular monitoring and evaluation system, including internal audits, routine performance reviews, and patient feedback collection, is crucial for continuous improvement. Collaboration with external entities, such as health oversight agencies and laboratory professional associations, is advocated for robust guidance and support. Encouraging research and innovation in quality management and laboratory service is recommended to enhance understanding of new technology applications, quality maintenance strategies, and policy impact evaluation. By implementing these suggestions, laboratory units are expected to continually enhance service quality and ensure optimal patient satisfaction.

Comparison of quality results between semi-autoanalyzer and autoanalyzer: A retrospective study conducted in a tertiary care center (Rural India)

Introduction and Aim: In India, the primary health centres, urban health centres and privatized small-scale laboratories use basic laboratory services like point of care testing (POCT) and quantitative results obtained from semi-auto analysers for diagnosis and treatment. Our objectives were to analyse biochemical parameters in the autoanalyzer and the semi-autoanalyzer and to compare the test performance of analysed biochemical parameters in the semi-autoanalyzer and autoanalyzer. Materials and Methods: One hundred samples (10 patient samples and 90 internal quality control values), tested for 15 biochemical parameters were retrospectively studied. They were processed with the same reagent, methodology and environmental conditions in autoanalyzer Mindray BS 390 and semi-autoanalyzer KLS BA 200. Statistical analysis was carried out using independent student t test, Pearson correlation, Bias percent and Bland-Altman plot analysis Results: Our study showed strong positive correlation for the 15 biochemical parameters between semi-autoanalyzer and autoanalyzer except for calcium, which showed moderate positive correlation (r=0.879). Bias % were all in acceptable limits except for SGOT and Albumin. Bland Altman analysis for ALP and Triglycerides also showed high variability between the two measurements with a mean difference of -6.23 and 4.48 respectively. Conclusion: The test performance of biochemical parameters measured in the semi-auto analyser and fully automatic analyser were highly related and comparable, with a significant positive correlation. Semi-auto analysers could be an efficient alternative in peripheral setups to provide quality laboratory services. During the breakdown of any autoanalyzer, the semi-autoanalyzer acts as backup for analysing routine chemistry tests in some laboratories.

Pengembangan Desain Laboratorium Zakat dan Wakaf pada Jurusan Manajemen Zakat dan Wakaf (Studi Kasus Laboratorium POZAWA / Pondok Zakat dan Wakaf Jurusan Manajemen Zakat dan Wakaf FEBI UIN Prof. K.H. Saifuddin Zuhri Purwokerto

The laboratory is a means and a place to support learning activities related to measurement, testing, developing understanding and skills, as well as innovation in accordance with the disciplines and fields of work that exist in universities. Laboratory of Pondok Zakat and Waqf (Lab. POZAWA) FEBI UIN Prof. K.H. Saifuddin Zuhri Purwokerto plays an important role in strengthening student competencies. So it needs to be developed so that it becomes a quality laboratory with high competitiveness and becomes a reference laboratory in the development of Zakat and Waqf Management at the national level. The method used in this research is the analytical-descriptive method, to describe a factual and actual phenomenon, event or event as it was at the time the research was conducted. The results of this study conveyed that the development of the Pondok Zakat and Waqf Laboratory Design (POZAWA Laboratory) was carried out through 6 (six) efforts, including: 1). Procurement of laboratory equipment for complete facilities in the laboratory room, 2). Procurement of laboratory assistants and technicians, 3). Foster Village Development, 4). Development of extension studios (PODCAST or radio) as information channels, 5). Improving the quantity and quality of laboratory services, 6). Creating a laboratory web site. Apart from that, efforts were also made to map fields of cultivation or business and to make strategic alternative decisions

A comparative evaluation of six sigma metrics and quality goal index ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during lockdown in a NABL accredited central laboratory

Introduction and Aim: Sigma represents Standard Deviation (SD) which indicates the degree of variation in a process, where the higher sigma value implies that less likely the laboratory reports false test results. Using a newer parameter called Quality Goal Index (QGI) we can find the reason behind the lower sigma value. Our study aimed to compare the six-sigma metric and QGI ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during the first lockdown. Methodology: A retrospective study was used to compare the six-sigma metric and QGI ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during the first lockdown for the selected ten analytes from 1st of January 2020 to 30th of June 2020 from the clinical biochemistry section of Yenepoya Medical College Hospital, Deralakatte, Mangalore. Results: The sigma metrics from January to March (level 1) indicated that urea, TSH, beta-HCG fell short of meeting Six Sigma quality performance and from April to June, glucose, creatinine, urea and ALT had metrics less than 3 at both the Internal Quality Control levels. QGI ratio indicated that from January to March, the problem was imprecision for urea, TSH and beta-HCG (QGI < 0.8). From April to June, urea and creatinine showed imprecision, glucose and ALT showed inaccuracy, urea and ALT showed both imprecision and inaccuracy. Conclusion: This study highlights the necessity for stringent Internal Quality Control and External Quality Assurance monitoring even during the lockdown period of the pandemic. By implementing six sigma and finding QGI ratio, quality of laboratory services can be improved immensely.

Internists' Satisfaction with Clinical Laboratories Services of Basra City: A Pilot Study

Background: The quality of laboratory services is a very important tool for patient care. Medical decisions in diagnosing disease and providing appropriate treatment mainly depends on the results of laboratory tests jointly with the clinical examination and interview. So this study was conducted to assess the confidence of internists in laboratory services and to analyze the strengths and limitations imposed on these services. Method: A cross sectional study was conducted among 53 respondent internists from government and private sector laboratories in Basra Governorate from 1st of April to 30th of May 2022. This study included doctors specialized in internal medicine in private and public hospitals and clinics. A structured, self-administered questionnaire was used, which consisted of a 2-5 point Likert scale questions with 22 survey principles and two main sections: personal information and data on services provided by laboratories. All participants were informed of the contents of the questionnaire form and gave consent. The collected data were fed to a database made through IBM SPSS statistics for Windows, version 24 to obtain statistical analyzes. After securing validity, reliability analysis was carried out and Alpha Cronbach (0.732) was considered reliable. The average score for each item on the scale was calculated, and an overall degree of physicians' confidence in laboratory services was calculated. Results: Respondents' mean age was 50.62 years and the mean experience years was 20. Most of the respondents were male internists nearly half of them held a doctorate or the Arab/Iraqi board for medical specializations' degrees. The average general-confidence of participants was 58.5%. Nearly half of the internists were satisfied with the laboratory services provided by government hospitals in Basra Governorate. However, there are some services that need attention. For the private sector, mostly (84.9%) of participants preferred private sector laboratories. Conclusion: All the doctors who were included in the study were convinced with services provided by the private sector laboratories, and relationships between internal medicine specialists and laboratory staff were good, which may have a positive impact on the provision of services.

External Quality Assessment (EQA) of Laboratory Tuberculosis Diagnosis in Lagos State, Nigeria: A Three-Year Review

The low detection of tuberculosis cases is a big problem in Nigeria. The rate of accurate diagnosis while ensuring the quality of TB treatment monitoring tool – AFB, with a 90% Pass grade system among the testing laboratories requires to be monitored. Therefore, this study evaluated the external quality assessment (EQA) of TB diagnosis to satisfy laboratory quality requirements in Lagos, Nigeria. This study was conducted using data from 132 laboratories in Lagos, examining 3years retrospective EQA reports from 2019 to 2021. A structured data abstraction chart was employed to extract EQA data from the STBLCP database, while a trained supervisor checked for completeness, clarity, and consistency of data. IBM-SPSS version 28.0 was used for data analysis. The external assessment report showed an improved TB Laboratory diagnostic performance in the 2nd quarter of 2019 and 2020, but a decline was noticed in the 3rd and the 4th quarters. There was an increase in the overall laboratory performance from 94.4% in 2019 to 96.1% in 2020. A significant proportion (79.2%) of the slides assessed in 2019 passed external assessment tests (had a concordant score of 90 and above). However, the performance was significantly better in 2020 (84.2%) and 2021 (88.2%). Laboratories should be upgraded to a world-standard level, and staff should be well-trained, with periodic competency assessments to make reliable diagnoses, while ensuring all testing laboratories are enrolled in EQA program for the measure of quality laboratory services and consistency in service delivery. Keywords: Assessment, Diagnosis, External, Laboratory, Tuberculosis, Quality.

Post-graduate training in Laboratory Medicine: Potential to fill a crucial gap in Indian healthcare system

Quality Laboratory services with a widespread reach is the core of a healthcare system of the country. Diagnostic services at all levels requires technical expertise of different laboratory specialists. However the presence of all specialist together in one setup is always not possible due to limited number of trained manpower. Even today, diagnostic laboratory services remain unsupervised. To void this gap, All India Institute of Medical Sciences (AIIMS) New Delhi, in 1988, opened up the patient-centric department of Laboratory Medicine with a centralised specimen collection centre and a core laboratory performing the majority of the routine laboratory investigations, offering a one-window solution to both patients and clinicians. In 1997, a three-year postgraduate Masters degree (MD) in Laboratory Medicine was started. This medical specialty encompasses the art of test selection, test operation, and test interpretation to manage patients. It aligns with the recent technological advancement of automation and advanced instrumentation that are breaking boundaries of the traditional medical laboratories of pathology, biochemistry, and microbiology. This postgraduate model ensures that the laboratory services are accessible, affordable, and available to both patients and clinicians without compromising quality care. Laboratory Medicine is emerging as an answer to one of the several inadequacies and pitfalls of the Indian health system.

The link between accreditation and quality laboratory services: public versus private laboratories in South Africa

The link between accreditation and quality laboratory services: public versus private laboratories in South Africa

RELATIONSHIP OF ORGANIZATIONAL RESOURCES TO PRE-ANALYTIC ERRORS IN BANDUNG CITY PUSKESMAS LABORATORY

Background. Lack of awareness about the role of laboratory services in many developing countries causes a lack of resources which is the main factor that affects the poor quality of laboratory services. Quality control aims to reduce or minimize errors that occur in the laboratory. The laboratory error ranged from 0.012-0.6%. Errors that occur in the pre-analytic stage are the largest, reaching 60-70% of the total laboratory errors. Pre-analytical error data from one of the Puskesmas laboratories in Bandung is 4.7%.
 Destination. To find out the description of organizational resources, description of pre-analytical errors and to determine the relationship of organizational resources to pre-analytical errors in the Bandung City Health Center Laboratory.
 Method. This research is a correlation analytic research. The research subjects were laboratory officers at the Bandung City Health Center Laboratory as many as 20 respondents. The resource variable was measured using a questionnaire and the pre-analytic error variable was derived from secondary data.
 Results. The results of this study indicate that the organizational resources at the Bandung City Health Center Laboratory are 65% quite good, 30% good and 5% not good. Pre-analytical errors in the Bandung City Health Center Laboratory, as much as 20% did not have pre-analytic errors, as many as 80% had pre-analytical errors. There is no relationship between organizational resources and pre-analytic errors in the Bandung City Health Center Laboratory (Sig. 2-tailed 0.422).
 Conclusion. Most (65%) of Bandung City Health Center Laboratories have good organizational resources. Pre-analytical errors in the Bandung City Health Center Laboratory varied between 0.10-27.03%. There is no relationship between organizational resource variables and pre-analytic errors in the Bandung City Health Center Laboratory.

Statistical Investigation of High Culture Contamination Rates in Mycobacteriology Laboratory.

BackgroundCulture of Mycobacterium tuberculosis remains the gold standard in mycobacteriology laboratories, constrained by the very high risk of contamination; therefore, contamination rate is an important key performance indicator (KPI) for laboratory monitoring and evaluation processes.AimThis study aimed to investigate the factors that contribute to elevated contamination rates in the Sudan National Tuberculosis Reference Laboratory.MethodA laboratory-based retrospective study was applied; a TB culture register-book was carefully reviewed and data from 2 January 2019 to 31 December 2019 were entered, cleaned, and analyzed using IBM SPSS 20. A multivariate logistic regression model was performed to examine two dependent variables, the massive contamination, and the single tube contamination against predictors of reason for cultivation, type of specimen, experiment team, and the quarter of cultivation.ResultsIt has been found that in 2019 contamination rates were frequently higher; the highest rates were recorded in January and November, 28.2 and 25.2%, respectively. August is an exception with an accepted contamination rate of 4.6%. Of 1,149 specimens requested for culture, 945 (82.2%) samples were eligible to be included in multivariate logistic regression analysis. The team conducting the experiment was significantly associated with a high single tube contamination p value 0.007; adjusted odds ratio AOR 3.570 (1.415–9.005). The correlation between the single tube contamination and the massive contamination is significant; p value 0.01.ConclusionThe study concludes that high culture contamination is the greatest risk to the quality of laboratory service and can end in either the loss of specimens or delay in the decisions of initiating patient treatment. In addition, the low quality or incompleteness of data increases the uncertainty and undermines the measurement of key performance indicators.

The Process of Establishing and Managing a Laboratory Diagnostic Network in the COVID-19 Pandemic in Iran

The COVID-19 pandemic caused by the newly emerged coronavirus was first detected in China in December 2019 and rapidly spread worldwide. The rapid spread of the disease urged all countries involved, in accordance with their capacities, take the necessary measures to diagnose and manage the disease. The first patient was diagnosed with COVID-19 in Iran in February 2020. Considering the significant role of the laboratory services in detection and management of the disease, planning and programming to provide access to these services was considered as a top priority for healthcare system in Iran. Adopting all existing laboratory capacities and providing necessary infrastructures for expanding COVID-19 laboratory diagnostics, resulted in the establishment of a nationwide network of COVID-19 molecular diagnostic laboratories within the shortest possible time. In addition to expanding the capacity of laboratory services, improving the laboratory network’s performance have been taken into serious consideration. Despite the strict sanctions, the COVID-19 molecular diagnostic laboratories scaled up to more than 430 laboratories currently (September 2021), mostly are operating in the private sector. With considerable efforts, COVID-19 molecular laboratory network was established to provide nationwide diagnostic services. Considering the capacity for the SARS-CoV-2 Rapid Antigen test, we can now perform more than 100,000 COVID-19 diagnostic tests per day. However, due to the ongoing pandemic and in accordance with the requirements of the health system, it is necessary to plan and carry out more COVID-19 diagnostic tests. This study aimed to introduce the process of establishing the COVID-19 laboratory diagnostic network to manage the COVID-19 pandemic in Iran.

Preparedness of district clinical laboratories towards ISO 15189: 2012 accreditation scheme in Lake Zone, Tanzania (a descriptive cross-sectional study)

Introductiondiagnosis, prevention, and surveillance of diseases relies on high quality laboratory services. However, accessibility and availability of the quality laboratory services among healthcare facilities remains a serious challenge among sub-Saharan African countries. This study investigated the preparedness of district clinical laboratories for ISO 15189: 2012 accreditation scheme using Stepwise Laboratory Quality Improvement Process towards Accreditation (SLIPTA) checklistin Lake Zone, Tanzania.Methodsthis descriptive cross-sectional study was conducted from September 2018 to August 2019 among clinical laboratories at district hospitals and council designated hospitals in Lake Zone regions of Tanzania. Data were collected using the verified WHO-SLIPTA checklist. In each laboratory, either the laboratory manager, quality officer or safety officer was interviewed.Resultsa total of 10 health laboratories affiliated to 6 districts and 4 councils designated hospitals were enrolled. Six laboratory managers and four quality officers were interviewed. Six (60%) and 4 (40%) laboratories were under government ownership and private ownership, respectively. The majority (70%, n=7) of medical district laboratories in Lake Zone-Tanzania were not registered for WHO-SLIPTA.Conclusionabout two third of district and council designated hospital laboratories in Lake zone are not registered for WHO-SLIPTA indicating unpreparedness towards ISO 15189: 2012 accreditation.

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

BackgroundThe 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.MethodsWe 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.ResultsThe 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).ConclusionsHIV, 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.

Comparison of Selected Clinical Chemistry Assay Results by two Analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus.

Comparison of assay results is very important for having a comparable backup analyzer to provide a quality laboratory service without interruption. Even though, several factors affect assay results by different instruments, little or no data is available regarding assay results comparison between Cobas 6000 (c501) and Cobas integra 400 plus in the study area. Thus, the present study was aimed to compare assay results of two fully auto-mated clinical chemistry analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus at the National Clinical Chemistry Reference Laboratory of Ethiopian Public Health Institute, Addis Ababa, Ethiopia. The assay results for the 20 selected clinical chemistry parameters were obtained from 52 randomly selected samples on Cobas 6000 (c501) and Cobas integra 400 plus. Statistical analysis was done using Med-Calc software. The 2019 CLIA proposed acceptance limits for proficiency testing were used to check bias or difference obtained from correlation and regression analysis. Assay results comparison revealed almost perfect data correlations among all selected clinical chemistry parameters: Albumin, ALP, ALT, Alpha-amylase (AMYL), AST, Direct bilirubin, Total bilirubin, Total cholesterol, Creatine kinase, Creatine kinase MB-subunit, Creatinine, GGT, Glucose, HDLC4, LDH, Phosphate, Total Protein, Triglycerides, Uric acid, and Urea, on both analyzers with coefficient of determination (R2) ranging from 98.9% to 99.99% and coefficient of correlation (r) ranging from 99.4% to 100%, depicting the precision and reliability of assay results, standardization, and system equivalency. Moreover, the calculated bias/difference is lower than both CLIA total allowable error and CLIA allowable error. In summary, regression/correlation analysis and calculated bias or difference revealed almost equivalent data representation of both analyzers as per the CLIA standard, thus showing that both fully automated analyzers are standardized and properly calibrated to be used simultaneously and inter-changeably as the main and back up analyzers for selected clinical chemistry parameters analyzed at the clinical chemistry reference laboratory.

The Impact of Laboratory Quality Management System Implementation on Quality Laboratory Service Delivery in Health Center Laboratories of Oromia Region, Ethiopia

The Impact of Laboratory Quality Management System Implementation on Quality Laboratory Service Delivery in Health Center Laboratories of Oromia Region, Ethiopia

Improving laboratory quality and capacity through leadership and management training: Lessons from Zambia 2016–2018

BackgroundCompetent leadership and management are imperative for delivering quality laboratory services; however, few laboratory managers receive job-specific training in organisational management and leadership.ObjectiveTo develop and evaluate participants’ competencies in organisational leadership and management as measured through learner and laboratory quality improvement assessments.MethodsThis professional development programme employed a mentored, blended learning approach, utilising in-person didactic and online training, with the practical application of a capstone project in the laboratories. Programme impact was evaluated through a series of pre- and post-laboartory assessments using the Stepwise Laboratory Improvement Process Towards Accreditation checklist, as well as learner-competency assessments through online quizzes and discussions.ResultsFrom 2016 to 2018, 31 managers and quality officers from 16 individual laboratories graduated from the programme having completed capstone projects addressing areas in the entire laboratory testing process. Laboratories increased their compliance with the International Organization for Standardization 15189 standard and all but two laboratories significantly increased their accreditation scores. Two laboratories gained three stars, two laboratories gained two stars, and five laboratories gained one star. Five laboratories subsequently achieved International Organization for Standardization 15189 accreditation in 2019.ConclusionThis programme taught leadership theory to laboratory managers and allowed them to implement leadership and management practices in the laboratory setting. Programmes such as this complement existing laboratory quality management training programmes such as Strengthening Laboratory Management Toward Accreditation.

Situation analysis of medical laboratories in primary health centres

Background: This study was conducted with the objective to assess the medical laboratories attached with primary health centres (PHCs) focusing on the current needs, gaps and to understand the utilization pattern of the laboratory services. There are hardly any relevant studies that are known to have investigated the functioning of laboratories attached with PHCs based on quality of service they are providing.Methods: This study was a cross sectional study based on observations and assessment made at 33 randomly selected medical laboratories attached with PHCs in Ahmedabad district, Gujarat. Checklist adapted from National Quality Assurance Standards (NQAS) and Indian Public Health Standards (IPHS) were used as a tool for data collection.Results: Though all the laboratories have been found to be functioning effectively based on the indicators in this study, some of the laboratories were not performing basic important tests like rapid plasma reagin (RPR) (18%) and hepatitis B surface antigen (HbSAg) (21%). None of the laboratories attached to the PHCs under study performed Widal test. There was very low utilization of urinary pregnancy test (UPT) (1.81%) in the first quarter of the year.Conclusions: Although most of the indicators reflect satisfactory performance of the laboratories, there exists certain gaps and needs that are essential in provision of quality laboratory services in the primary level of health care. The laboratory information management system (LIMS) was the major issue in the laboratories.