Abstract:A quality management system (QMS) plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Additionally, external quality assurance or assessment (EQA) programs offer multiple benefits to laboratories: method validation, comparing of results w… Show more
“…The self-awareness of healthcare workers and the strengthening of biosafety training, aimed at risk assessments and quality control, will affect the reduction of the level of exposure to potential hazards ( 21 ). In this way, they influence the development of awareness of personal responsibility for the level of exposure within the laboratory ( 22 ). The study by Hailu HA et al concluded that by good organization of work through the subjects’ basic knowledge of accreditation, standard operating procedures, we can influence the subjects’ awareness and reduce the level of exposure to dangers in laboratories ( 23 ).…”
Background: A laboratory professional concerned with the quality of work in medical-biochemical laboratories ensures the accuracy and precision of laboratory analyses through the implementation of international and European guidelines for working with hazardous substances, through the availability and implementation of Standard Operating Procedures (SOPs). Laboratory hazards that affect the concentration and safety of workers arise from laboratory deficiencies such as: lack of preventive measures, knowledge and skills implemented through SOPs and good laboratory practice. Biophysical hazards in medical laboratories are manifested by needles and sharp objects, infectious materials, noise, vibration, radiation, poor air quality, temperature inversions. Objective: The aim of the research was to raise awareness of the quality of work in medical-biochemical laboratories in order to ensure the safety of workers. Methods: A cross-sectional questionnaire-based study was conducted among 100 laboratory proffesionals from Bosnia and Herzegovina (BiH) and Croatia. The research was conducted over a period of three months. Results: A higher percentage of exposure to infectious agents and needles and sharp objects was found among respondents from BiH compared to CRO (p=0.018 and p=0.001, respectively). We found that respondents employed in accredited laboratories are aware of exposure to hazards in a high percentage related to infectious agents, toxins (p=0.0012 and p=0.0046, respectively). A significant statistical difference was found between respondents with BiH and respondents with CRO in terms of knowledge of accreditation standards of medical-biochemical laboratories (p=0.0155). Respondents who have standard operating procedures available are aware of the hazards of infectious agents (p=0.0001), toxins (p=0.0466), needles and sharp objects (p=0.0052), noise (p=0.0030), vibration (p=0.0007) and extreme temperatures (p=0.0014). Conclusion: Efficient implementation and continuous compliance with the ISO 15189: 2018 standard requires constant commitment and active participation of laboratory staff. Laboratories must have standard operating procedures in place and actively monitor their use.
“…The self-awareness of healthcare workers and the strengthening of biosafety training, aimed at risk assessments and quality control, will affect the reduction of the level of exposure to potential hazards ( 21 ). In this way, they influence the development of awareness of personal responsibility for the level of exposure within the laboratory ( 22 ). The study by Hailu HA et al concluded that by good organization of work through the subjects’ basic knowledge of accreditation, standard operating procedures, we can influence the subjects’ awareness and reduce the level of exposure to dangers in laboratories ( 23 ).…”
Background: A laboratory professional concerned with the quality of work in medical-biochemical laboratories ensures the accuracy and precision of laboratory analyses through the implementation of international and European guidelines for working with hazardous substances, through the availability and implementation of Standard Operating Procedures (SOPs). Laboratory hazards that affect the concentration and safety of workers arise from laboratory deficiencies such as: lack of preventive measures, knowledge and skills implemented through SOPs and good laboratory practice. Biophysical hazards in medical laboratories are manifested by needles and sharp objects, infectious materials, noise, vibration, radiation, poor air quality, temperature inversions. Objective: The aim of the research was to raise awareness of the quality of work in medical-biochemical laboratories in order to ensure the safety of workers. Methods: A cross-sectional questionnaire-based study was conducted among 100 laboratory proffesionals from Bosnia and Herzegovina (BiH) and Croatia. The research was conducted over a period of three months. Results: A higher percentage of exposure to infectious agents and needles and sharp objects was found among respondents from BiH compared to CRO (p=0.018 and p=0.001, respectively). We found that respondents employed in accredited laboratories are aware of exposure to hazards in a high percentage related to infectious agents, toxins (p=0.0012 and p=0.0046, respectively). A significant statistical difference was found between respondents with BiH and respondents with CRO in terms of knowledge of accreditation standards of medical-biochemical laboratories (p=0.0155). Respondents who have standard operating procedures available are aware of the hazards of infectious agents (p=0.0001), toxins (p=0.0466), needles and sharp objects (p=0.0052), noise (p=0.0030), vibration (p=0.0007) and extreme temperatures (p=0.0014). Conclusion: Efficient implementation and continuous compliance with the ISO 15189: 2018 standard requires constant commitment and active participation of laboratory staff. Laboratories must have standard operating procedures in place and actively monitor their use.
“… 39 When the results from many methods are comparable to those from patient samples containing the same number of analytes, the EQA sample is considered commutable. 37 , 44 , 45 Nevertheless, cost-effectively attaining commutability poses a challenge for EQA providers when developing fit-for-purpose EQA materials. 12 The need for large sample volumes, a wide range of concentrations of the measurand, and sample stability has led providers to use materials treated with stabilizers and supplemented with materials of human or nonhuman origins, leading to EQA samples that are not commutable with authentic clinical samples.…”
Section: Eqa Sample Managementmentioning
confidence: 99%
“…Using the same procedure and assuming matrix-related bias, peer groups or participant groups are used to evaluate and classify laboratories because it is not feasible to compare them to the same given value. 44 , 47 , 48…”
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.
“…A variety of quality standards can be implemented by laboratories, being requirements from ISO 9001 for the quality management system (QMS) the most widely used [26]. Briefly, ISO 9001 is characterized by a process-based approach following the plan-do-check-act cycle, not only focused on the quality of a product or service or the satisfaction of its users but on the way to obtain them.…”
In the frame of multicenter research studies, biobanks ensure the harmonization and traceability of the prospective collection of quality samples. This is significant because pre-analytical variables must be carefully considered to guarantee the integrity of biomarkers to be tested and to avoid bias affecting the validity of the analytical results. According to a quality management system, biobanks contribute with documents and records; consumable preparation for collection, processing, and conservation; sample quality controls; and centralized management of sample handling, storage, and distribution. Traceability of samples is based on unique standard codes and the use of pre-assigned, pre-coded, and pre-labeled materials for sample collection, processing, and conservation. By using these supporting tools, quality derivatives are obtained based on common and evidence-based standard operating procedures (SOPs), with associated traceability information in relation with their collection, processing, conservation, and distribution. The biobank-supported workflow, specifically designed and implemented for each project, allows obtaining harmonized quality samples contributing to the quality of large and complex research projects and the corresponding validity of the analyses.
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