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Introduction: The history of standardization relating to the activities of medical laboratories traces the development of quality system standards in the world, and their evolution. Content: In this study, we have included the key benchmarks that represent the stages of the quality system's evolution in recent decades. Accreditation of medical laboratories has become compulsory in most countries, regarding national or international standards. International acknowledgment of the effectiveness of the results delivered to the many stakeholders, particularly patients and prescribers, is conferred through the use of standards. Summary: The ISO 15189 standard represents the latest and most specific international standards for medical laboratories of all types. Outlook: More research is necessary to study if laboratory practices reflect the evolution of standards within the medical laboratory field.

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OBJECTIVES: This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly. RESULTS: The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard. CONCLUSIONS: All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality.

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OBJECTIVES: The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. METHODS: The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. RESULTS: Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. CONCLUSIONS: The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

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BACKGROUND: Satisfaction has become a key measure of quality and an important tool for improvement. Laboratories are increasingly required to regularly assess satisfaction of their customers. This study aimed to assess clinicians' satisfaction with laboratory services and associated factors at public health facilities. METHODS: A facility-based cross-sectional study was conducted in Northeast Ethiopia from May to June 2019. Eight hospitals and 24 health centres were first selected using a stratified sampling method, and a total of 224 randomly selected clinicians were included. Satisfaction with multiple aspects of laboratory services was assessed using a self-administered questionnaire, on a rating scale of 1 (very dissatisfied) to 5 points (very satisfied). Laboratory quality assessment was performed using WHO-AFRO's stepwise accreditation checklist. Multivariable logistic regression model was fitted to determine the association between independent variables and clinicians' overall satisfaction level using STATA ver14.1. A p-value < 0.05 was considered significant. RESULTS: Overall, 72.8% of the clinicians were satisfied. Lowest mean ratings were obtained for the helpfulness of the laboratory handbook (3.3), provision of STAT/urgent services (3.7), and adequacy of tests provided (3.8). The clinicians' timely receipt of results (AOR = 2.3, 95% CI = 1.1-5.0), notification of panic results (AOR = 2.5, 95% CI = 1.1-5.6), perceived quality/reliability of test results (AOR = 3.1, 95% CI = 1.5-6.3), and the laboratories' rate of concordant malaria microscopy results (AOR = 4.1, 95% CI = 1.8-9.3), were significantly associated with satisfaction. CONCLUSIONS: Nearly one-third of clinicians were not satisfied with the laboratory services. Laboratory managers should emphasize the timely communication of STAT/urgent and panic results, and the reliability of test results, to improve users' satisfaction and overall quality of care.

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Background: Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS. Aim: This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality. Methods: Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs. Results: Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services. Conclusion: Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.

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OBJECTIVES: Clinical laboratory results are required for critical medical decisions, underscoring the importance of quality results. As part of total quality management, external quality assessment (EQA) is a vital component to ensure laboratory accuracy. The goal of this survey was to evaluate the current status of global laboratory quality systems and assess the need for implementation, expansion, or harmonization of EQA programs (EQAP) for Clinical Chemistry and Laboratory Medicine. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC full and affiliate members (n=110) on laboratory quality practice. A total of 41 (37.3%) countries representing all IFCC regions except North America provided responses about EQA availability and practices. RESULTS: All 41 countries perform EQA, 38 reported that their laboratories had EQA policies and procedures, and 39 further act/evaluate unacceptable EQA results. 39 countries indicated they have international and/or national EQAP and 30 use alternative performance assessments. EQA frequency varied among countries. Generally, an EQAP provided the EQA materials (40/41) with four countries indicating that they did not have an EQAP in their country. CONCLUSIONS: Globally, most laboratories participate in an EQAP and have defined quality procedures for EQA. There remain gaps in EQA material availability and implementation of EQA as a part of a total laboratory quality system. This survey highlights the need for education, training, and harmonization and will guide efforts of the IFCC TF-GLQ in identifying areas for enhancing global laboratory quality practices.

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BACKGROUND: Laboratory- related musculoskeletal disorders (LMSDs) are injuries resulting from working in the laboratory. Biomedical scientists (BMSs) play an important role in any health care system. However, they are at high risk of exposure to the LMSDs. OBJECTIVE: This study aimed to estimate the prevalence and the associated risk factors of LMSDs among this group of healthcare professionals. METHODS: We conducted a cross-sectional survey using the Nordic Musculoskeletal Questionnaire to estimate the prevalence of the LMSDs among the BMSs. BMSs with occupational or non-occupational accidents that affected their musculoskeletal system were excluded from the study. A Chi-square test was performed to measure the significant association between different risk factors (age, gender, weight, height, nationality, specialty, educational level, nature of the job, and the number of experience years) and the prevalence of the LMSDs among the BMSs. RESULTS: The study included 83 BMSs. Females represented 63.9% and 36.1% were in the age group of 35- 44. The overall prevalence of the LMSDs was 77.1%. The most prevalent LMSDs were neck, shoulders, and lower back with 50.6%, 49.4%, and 43.4%, respectively. A total of 65.57% of BMSs had irregular symptoms of LMSDs. CONCLUSION: The study found that the prevalence of LMSDs among the BMSs was high. Good practice and training in ergonomics may minimize the prevalence of LMSDs among the BMSs.

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The importance of quality assurance (QA) and quality management (QM) in medical laboratories has been a topic in many political and public discussions, especially since the beginning of the SARS-CoV­2 pandemic. Uniform standards are required in order to create comparability not only among medical laboratories in Germany, but also across national borders. There are two leading systems in Germany: The Guideline of the German Medical Association (Rili-BÄK) and accreditation according to DIN EN ISO 15189.This article is intended to raise awareness of quality in medical laboratories to ensure patient safety through competent diagnostics on the patient. A literature search was carried out, including legal texts, standards, and further QM documents and publications. Furthermore, empirical values from representatives of various institutions are considered.A comprehensive QM system significantly supports work in medical laboratory diagnostics. Maintaining trust in the efficiency of medical laboratories and the facilities that support them is of great importance for the best possible care for the population. The additional effort associated with accreditation is justified with regard to patient safety but should not experience any additional bureaucracy.

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Background: Several safety-related accidents occur in the laboratories because of insufficient regulations, inappropriate implementation of safety measures, or unawareness attitude and practices toward safety precautions. Thus, establishment of efficient regulations and safe habits toward workplace safety is crucial to prevent or minimize such accidents. Here we investigate the levels of laboratory safety awareness among undergraduate medical science students and laboratory workers at major hospitals in Taif, Saudi Arabia. Methods: An anonymous cross-sectional survey was conducted on a random sample of 185 students and workers. The survey was categorized into five sections: (1) variable demographic items, (2) orientation around the warning signage of medical laboratory picograms, (3) assess participants' attitudes toward laboratory safety, (4) assess participants' safety awareness and practices in medical laboratories, and (5) assess participants' knowledge in dealing with emergency equipment and related procedures. Results: Data analyses indicate that workers are generally more aware of the key aspects of laboratory safety. Although students demonstrated moderate to good knowledge of major laboratory signage, there are some areas of deficiency, particularly regarding the use of fire extinguishers. Of interest is that female students are more familiar with laboratory signage than male students, although general laboratory safety awareness among students is poor. Students also showed poor awareness of certain critical aspects of safety practices and emergency procedures. Conclusion: The study data reveal inadequate awareness and knowledge of certain laboratory safety aspects among undergraduate students. Therefore, academic institutions should introduce effective safety regulations, education, and training to improve student safety.

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Covid-19 pandemic has affected global supply chains disrupting local inventory management. Multiple studies have shed light on the scarcity of personal protective equipment. Still, not much data was seen on how this crisis resulted in the disruption of other health care sectors. This paper studies how this crisis affected supply chains and inventory management on the laboratory commodities during the Covid-19 pandemic within Saudi Arabia. A cross-sectional qualitative study targeting laboratory personals and suppliers in Saudi Arabia is conducted to evaluate laboratory material inventory management. Our sample includes twelve hospitals and ten suppliers. The study revealed that the supply chain functions resilience was moderate to mildly affected during the pandemic. The higher effect in the supply chain functions was in the lead time (58%), followed by purchasing (33%), then the inventory (25 %). The actual lab supply was significantly affected in 2 hospitals only, moderately affected in 7 hospitals (58%), and mildly affected in 2 hospitals. The unavailability of reagents was the highest result of the disruption (50%) besides the price change and lack of alternatives. Almost (86 %) of suppliers reported that their service was partially affected in most supply chain functions although they claimed having reasonable resilience measures/processes to sustain their operations. The highest risk mitigation process were the backup supply, recovery plan, and emergency/disaster agreements coverage. Most than half of the organizations reported that they have mature resilience measures. This leads us to conclude that both laboratory and supplier inventory and supply chain management had reasonable resilience processes in Saudi Arabia. Those measures were clear in minimizing the disruption effects caused by the pandemic and having a moderate impact on the laboratory operations.

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Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.

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BACKGROUND: Job satisfaction is an important condition for staff retention in most healthcare Organizations. As a concept, job satisfaction is linked to motivation theory. Herzberg's two factor theory of motivation is used in this study to explore what motivational elements are associated with job satisfaction among medical laboratory professionals (MLPs) in Oman. METHODS: A mixed-method approach was adopted, and focus group discussions (FGDs) were used for data collection. The FGDs were conducted in the main hospitals in Oman. Data were analyzed by directed content analysis, and frequencies of statements related to factors were calculated for a comparison with the Herzberg theory. RESULTS: The following job dissatisfaction factors (hygiene) were identified: health and safety, heavy workload, salary, promotion, recognition and organizational policies. The satisfaction (motivators) were: relationships with co-workers, relationship with leaders, and professional development. CONCLUSIONS: The job dissatisfaction reported was resulted from the absence of hygiene factors and some of the motivators in accordance with Hertzberg's theory. Hospital managers need to address these factors, defined by Hertzberg, in order to improve motivation and job satisfaction.

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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.

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BACKGROUND: The aim is to determine the incidence rate of unintentional injuries and its associated factors and determine the pattern of these injuries among laboratory staff in three reference laboratories in Sana'a, Yemen. METHODS: A cross-sectional study was conducted among laboratory staff in the three reference laboratories in Sana'a, Yemen. A pretested structured questionnaire was used to collect data on the unintentional injuries during the past 12 months including the type of injury. RESULTS: A total of 93 technicians responded and filled the questionnaires. Of the 93 technicians, 51 (54.8%) technicians reported that they had been injured in the past 12 months. Of all injuries, 38% of technicians were caused by needle sticks, 21% by sharp materials other than needles, 15% by hot materials, 15% by exposure to chemicals, and 11% of them by other exposures. Only 18% of injuries were reported to safety officer in the laboratory. Those who had an experience of <5 years were more likely to experience injury in the past 12 months than those who had 5 years of experience or more (odds ratio = 8.3; 95% confidence interval: 2.2, 27.4; P < 0.005). CONCLUSIONS: About half of laboratory technicians in Yemen reported that they had been injured in the past 12 months, with the needle stick being the most common cause of injury. Therefore, there is a need for targeted interventions to laboratory technicians to increase their awareness on the risk of injuries in the laboratory. Bio-safety training among laboratory technicians deemed very necessary.

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INTRODUCTION: Despite the increasing interest in Occupational Safety and Health (OSH), seldom studies are available on OSH in medical laboratories from developing countries in general although a high number of injuries occur without proper documentation. It is estimated that every day 6,300 people die as a result of occupational accidents or work-related diseases resulting in over 2.3 million deaths per year. Medical laboratories handle a wide range of materials, potentially dangerous pathogenic agents and exposes health workers to numerous potential hazards. This study evaluated the status of OSH in medical laboratories in Kajiado County, Kenya. The objectives included establishment of biological, chemical and physical hazards; reviewing medical laboratories control measures; and enumerating factors hindering implementation of good practices in OSH. METHODS: This was a cross-sectional descriptive study research design. Observation check lists, interview schedules and structured questionnaires were used. The study was carried out in 108 medical laboratories among 204 sampled respondents. Data was analysed using statistical package for social science (SPSS) 20 software. RESULTS: The commonest type of hazards in medical laboratories include; bacteria (80%) for Biological hazards; handling un-labelled and un-marked chemicals (38.2%) for chemical hazards; and laboratory equipment's dangerously placed (49.5%) for Physical hazards. According to Pearson's Product Moment Correlation analysis, not-wearing personal protective equipment's was statistically associated with exposure to hazards. Individual control measures were statistically significant at 0.01 significance level. Only 65.1% of the factors influencing implementation of OSH in medical laboratories were identified. CONCLUSION: Training has the highest contribution to good OSH practices.

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A study on the generation rate and the composition of solid medical wastes (MW) produced by private medical microbiology laboratories (PMML) was conducted in Greece. The novelty of the work is that no such information exists in the literature for this type of laboratories worldwide. Seven laboratories were selected with capacities that ranged from 8 to 88 examinees per day. The study lasted 6months and daily recording of MW weights was done over 30days during that period. The rates were correlated to the number of examinees, examinations and personnel. Results indicated that on average 35% of the total MW was hazardous (infectious) medical wastes (IFMW). The IFMW generation rates ranged from 11.5 to 32.5g examinee-1 d-1 while an average value from all 7 labs was 19.6±9.6g examinee-1 d-1 or 2.27±1.11g examination-1 d-1. The average urban type medical waste generation rate was 44.2±32.5g examinee-1 d-1. Using basic regression modeling, it was shown that the number of examinees and examinations can be predictors of the IFMW generation, but not of the urban type MW generation. The number of examinations was a better predictor of the MW amounts than the number of examinees. Statistical comparison of the means of the 7PMML was done with standard ANOVA techniques after checking the normality of the data and after doing the appropriate transformations. Based on the results of this work, it is approximated that 580 tonnes of infectious MW are generated annually by the PMML in Greece.

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OBJECTIVE: The objective of this study was to highlight current status and importance of National External Quality Assurance Program Pakistan (NEQAPP). Study Design: Cross sectional study. PLACE AND DURATION OF STUDY: Department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology (AFIP) from August to October 2015. METHODS: The study data was extracted from electronic NEQAPP database. Results from 2014-2015 were evaluated for clinical chemistry, hematology, microbiology, and immunoassay programs. Frequencies of unsatisfactory results of individual analytes as well as of all the participating laboratories were calculated. RESULTS: Failure rate of newly enrolled laboratories were more as compared to those which were participating for the last two years. The percentages of unsatisfactory results of all laboratories were 19% and 15% in 2014 and 2015, respectively. Fifteen analytes were selected according to their increasing percentage of participation. Failure rate was highest for alkaline phosphatase (35%) followed by creatinine (22%) and urea (20%) in two years analysis. Performance of laboratories in each quarter was evaluated depending upon number of analytes in which they fail to pass. The major failures were due to clerical and technical errors as determined during data compilation of results. CONCLUSION: There is an increase in trend of participating in NEQAPP by health care laboratories which is a step towards laboratory quality management system in Pakistan. Nonetheless, there is a need for improving quality of laboratory results.

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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.

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The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

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The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

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