Laboratory Quality Management System 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.

Continual Improvement in Laboratory Quality Management System of a Regulatory Laboratory in West Africa

Continual Improvement in Laboratory Quality Management System of a Regulatory Laboratory in West Africa

NPS–EQA PART I: Four years’ experience in external quality assessment program in Italy for classical and new psychoactive substances analysis in oral fluid

In 2019, Italian National Institute of Health established an external quality assessment program (EQA) to evaluate the performance of oral fluid testing for classical and new psychoactive substances by laboratories participating in the National Early Warning System collaborative centres. This report presents the results of four rounds between 2019 and 2023. Eleven oral fluid specimens, including 3 blank samples, were prepared by adding different classes of and new psychoactive drugs at known concentrations to pre-screened drug-free oral fluid. False-negative and false-positive results were calculated for the qualitative data evaluation. The quantitative evaluation measured the imprecision and accuracy of the results, in terms of coefficient of variation (CV%) and percent error (ERR%), respectively, with respect to a mean value obtained by reference laboratories. Z-score values were then calculated. Over the years, there has been a significant improvement in false-negative results (from 42.7% in the first year to 19.4% in the last year), but not in false-positive results (from 33.3% in the first year to 22.2% in the last one). In addition to the classic drugs of abuse (e.g. cocaine, amphetamine, methadone), the substances found in false positive samples belonged to the class of synthetic cannabinoids (e.g 5-fluoro CUMYL-PINACA and 5-fluoro-EDMB-PICA), synthetic opioids (e.g butyrylfentanyl) and tryptamines (e.g. 5-methoxy-N-methyl-N-isopropyltryptamine). The four rounds yielded a mean ERR% of approximately 22.1% and a mean CV% of around 41.5%. The participating laboratories demonstrated variable performances in relation to the class of analysed psychoactive substances, as evidenced by the calculated Z-scores. Between 25% and 60% of the reported results in all rounds should be considered satisfactory. EQA is a crucial element of laboratory quality management systems. It promotes continuous improvement and maintains high standards in the field of forensic and clinical drug testing.

Re-testing as a method of implementing external quality assessment program for COVID-19 real time PCR testing in Uganda.

Significant milestones have been made in the development of COVID19 diagnostics Technologies. Government of the republic of Uganda and the line Ministry of Health mandated Uganda Virus Research Institute to ensure quality of COVID19 diagnostics. Re-testing was one of the methods initiated by the UVRI to implement External Quality assessment of COVID19 molecular diagnostics. participating laboratories were required by UVRI to submit their already tested and archived nasopharyngeal samples and corresponding meta data. These were then re-tested at UVRI using the WHO Berlin protocol, the UVRI results were compared to those of the primary testing laboratories in order to ascertain performance agreement for the qualitative & quantitative results obtained. Ms Excel window 12 and GraphPad prism ver 15 was used in the analysis. Bar graphs, pie charts and line graphs were used to compare performance agreement between the reference Laboratory and primary testing Laboratories. Eleven (11) Ministry of Health/Uganda Virus Research Institute COVID19 accredited laboratories participated in the re-testing of quality control samples. 5/11 (45%) of the primary testing laboratories had 100% performance agreement with that of the National Reference Laboratory for the final test result. Even where there was concordance in the final test outcome (negative or positive) between UVRI and primary testing laboratories, there were still differences in CT values. The differences in the Cycle Threshold (CT) values were insignificant except for Tenna & Pharma Laboratory and the UVRI(p = 0.0296). The difference in the CT values were not skewed to either the National reference Laboratory(UVRI) or the primary testing laboratory but varied from one laboratory to another. In the remaining 6/11 (55%) laboratories where there were discrepancies in the aggregate test results, only samples initially tested and reported as positive by the primary laboratories were tested and found to be false positives by the UVRI COVID19 National Reference Laboratory. False positives were detected from public, private not for profit and private testing laboratories in almost equal proportion. There is need for standardization of molecular testing platforms in Uganda. There is also urgent need to improve on the Laboratory quality management systems of the molecular testing laboratories in order to minimize such discrepancies.

Certification of extension tubes for medical use according to TIS 2385-2551

The extension tube is a medical device for delivering substances into or out of the body through blood vessels of the patient. To ensure the safety of users and promote the domestic production, the industrial product standard of extension tubes was established as Thai Industrial Standard (TIS) No. 2385-2551: Extension tubes for medical use. Bever Medical Industry (BMI) is a medical device company that manufactures and markets medical supplies for single use. At present, the overall physical requirements standard of extension tubes has not been accredited according to ISO/IEC 17025. This study aims to certify the physical test of extension tubes for medical use and to implement the laboratory quality management system according to ISO/IEC 17025. We set up a laboratory to perform the physical test of extension tubes according to TIS 2385-2551. The measuring equipment was applied appropriately and calibrated by accredited laboratories to ISO/IEC17025 related to metrological traceability. The established laboratory performed the evaluation of measurement uncertainty for some testing and reported the results to the customer as a test certification report. In this study, a total of 1.75 million pieces of extension tubes have been certified the quality improvements. Therefore, it is valuable for entrepreneurs, importers, and exporters in both domestic and international markets.

Evaluating the effectiveness of Uganda’s Supranational TB Reference Laboratory quality management system training program

BackgroundAchieving the targeted organizational goals through effective training can increase employee satisfaction. Since 2015, the Supranational Reference Laboratory Uganda (SRL Uganda) has trained National Tuberculosis Reference Laboratories (NTRLs) from 21 countries in a variety of areas that cover both technical and programmatic aspects pertinent to TB laboratories. The Laboratory Quality Management System (LQMS) under SRL coordinates actions intended to ensure sustained quality of the laboratory services offered by the National TB Reference Laboratories. In order for laboratory results to be helpful in a clinical or public health setting, they must be accurate, reliable, and timely. The LQMS course aims to provide learners with knowledge on how to attain and maintain this quality. Prior to this study, there was hardly any data available on the effectiveness of LQMS trainings provided by SRL Uganda; using Kirkpatrick model, which is popular among researchers for evaluating the efficacy of the training program, this paper seeks to establish the effectiveness of the LQMS training offered by the SRL Uganda.MethodWe evaluated the effectiveness of LQMS training within the Uganda’s SRL network for courses offered during the period 2017 and 2021 for participants from the Southern and East African sub-Saharan region.ResultsIn 2017 and 2021, respectively, test results from 10/17 and 9/17 showed overall post-test scores above 80%. Of the 18 labs evaluated, 14 showed improvement; of these, 7 labs were from the Eastern region and the other 7 were from Southern Africa; one facility in this region also maintained its accreditation. In the post-evaluation assessment, attendees of the LQMS course gave feedback of strongly agree and agree variety.ConclusionMore SRL Uganda network laboratories in the regions achieved a 5-star SLIPTA level rating and among these, 5 NTRLs got ISO 15189:2012 accredited by the end of 2021, while one maintained its accreditation status. This proves that the Laboratory Quality Management System training program was an effective tool in improving the quality of laboratory services, work practices, and processes.

Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology.

Analytical verification and validation of immunohistochemical (IHC) tests and their equipment are common practices for today's anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant interlaboratory variation in validation procedures of IHC tests among Belgian laboratories. These results suggest the unavailability of practical information on the approach to the verification and validation of these tests. The existing Belgian Practice Guideline for the implementation of a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and, in addition, to prepare the laboratories for the EU-IVD revised regulations (IVDR). This paper describes Belgian recommendations for the verification and validation of IHC tests before implementation, for ongoing validation, and for revalidation. For each type of test (according to the IVDR classification and the origin) and its intended use (purpose), it addresses how to perform analytical verification/validation by recommending: (1) the number of cases in the validation set, (2) the performance characteristics to be evaluated, (3) the objective acceptance criteria, (4) the evaluation method for the obtained results, and (5) how and when to revalidate. A literature study and a risk analysis taking into account the majority of variables regarding verification/validation of methods have been performed, resulting in an expert consensus recommendation that is a compromise among achievability, affordability, and patient safety. This new consensus recommendation has been incorporated in the aforementioned ISO 15189:2012-based Practice Guideline.

Quality Management System in Clinical Digital Pathology Operations at a Tertiary Cancer Center

Digital pathology workflows can improve pathology operations by allowing reliable and fast retrieval of digital images, digitally reviewing pathology slides, enabling remote work and telepathology, use of computer-aided tools, and sharing of digital images for research and educational purposes. The need for quality systems is a prerequisite for successful clinical-grade digital pathology adoption and patient safety. In this article, we describe the development of a structured digital pathology laboratory quality management system (QMS) for clinical digital pathology operations at Memorial Sloan Kettering Cancer Center (MSK). This digital pathology–specific QMS development stemmed from the gaps that were identified when MSK integrated digital pathology into its clinical practice. The digital scan team in conjunction with the Department of Pathology and Laboratory Medicine quality team developed a QMS tailored to the scanning operation to support departmental and institutional needs. As a first step, systemic mapping of the digital pathology operations identified the prescan, scan, and postscan processes; instrumentation; and staffing involved in the digital pathology operation. Next, gaps identified in quality control and quality assurance measures led to the development of standard operating procedures and training material for the different roles and workflows in the process. All digital pathology–related documents were subject to regulatory review and approval by departmental leadership. The quality essentials were developed into an extensive Digital Pathology Quality Essentials framework to specifically address the needs of the growing clinical use of digital pathology technologies. Using the unique digital experience gained at MSK, we present our recommendations for QMS for large-scale digital pathology operations in clinical settings.

Quality Management of the Pre-Analytical Phase Errors: Monitoring and Way Forward

Inadequate quality management during laboratory analysis can increase errors, specimen rejection, and economic resources wastages. A laboratory quality management system (QMS) helps to streamline and coordinate all the processes and operations within the lab, ensuring that each step is well planned, controlled, and correctly performed. Quality management ensures that results are accurate, reliable, and obtained under a traceable process that can easily detect errors. The study aimed to investigate quality practice among laboratory workers during pre-analytical phase activities. Unexpected deviation from quality procedures consequently compromise laboratory test results, leading to patient mismanagement and patient safety risks. Analysis of results showed that 97.1% (340 respondents) were knowledgeable on quality management of pre-analytical phase, and 2.9% (10 respondents) were not. 99.1% (347respondents) agreed to availability of quality management materials and 0.9% (3 respondents) had no resources. 4.6% (16 respondents) do not practice quality management system at pre-analytical phase and 94.5% (334 respondents) practiced quality improvements. 3.4% (12 respondents) agreed that quality improvement is the responsibility of phlebotomist and field staff. 96.6% (338 respondents) agreed that quality management is the responsibility of everyone at the facility. There was maximum knowledge of quality management at the facility. Availability of quality management resources at the facility was standard. The practice of quality management was below standard. Facility requires training in quality management. It is recommended that quality management system be integrated into the curriculum of school of health technology to guide graduates at work. Keywords: Quality, Improvement, Patient, Management, System.

Penyusunan Dokumen Mutu Laboratorium Guna Peningkatan Kualitas Pengelolaan Laboratorium di Sekolah Menengah Kejuruan Negeri (SMKN)

Vocational High Schools (SMK) in the learning process are supported by laboratories or workshops that provide competence to students. The existence of the Teaching Factory program as a result of cooperation between SMKN and industry is one factor that requires the school to prepare quality documents, competent laboratory managers, and skilled students. Therefore, well-organized Laboratory Management will benefit schools, students, laboratory users, and stakeholders. This activity aims to provide understanding and assistance in compiling laboratory quality documents that adopt the SNI ISO 17025:2017 quality management system. This system regulates testing laboratories and calibration laboratories, but it is very appropriate if adopted in several cases to be applied to educational laboratories, especially the preparation of laboratory quality documents. Community Service activities were conducted at SMKN 4 in Bondowoso Regency and SMKN 8 in Jember Regency. Based on the discussion and questionnaire results, the activity showed that at both SMKNs, the understanding of the laboratory quality management system increased (72.7%) for both students and managers (teachers and technicians/labor). Quality documents for levels 2, 3, and 4 at both SMKNs have been compiled. The number of Standard Operational Procedure (SOP) documents at SMKN 4 is 8 SOPs; at SMKN 8, as many as 31 SOPs are based on SNI ISO 17025:2017 laboratory QMS.

IMPACT OF THE TECHNICAL REQUIREMENTS OF THE AZS ISO/IEC 17025-2020 STANDARD ON THE RESULTS OF MEASUREMENTS CARRIED OUT IN TESTING AND CALIBRATION LABORATORIES

For the adequacy of calibration/testing laboratories general conditions are defined in the AZS ISO/IEC 17025-2020 [1] standard, and the Azerbaijan Accreditation Center accreditation by (AZAK) audits in accordance with the conditions specified in this standard being carried out. The conditions to be complied with in the AZS ISO/IEC 17025-2020 standard are specified in the sections under the headings of "Management Conditions" and "Technical Conditions". In accreditation audits, the quality management system of laboratories, “Management Conditions”; calibration/testing activities are evaluated according to the requirements specified under “Technical Conditions”. To be accredited for calibration/testing services a laboratory that wants to meet the conditions specified in the standard creates/maintains the quality management system (QMS) in line with in this context, it creates the quality management system documentation in which the QMS applications are defined. The laboratory's quality management system policies and quality policy The Quality Handbook, which contains the declaration, is the most important document of this documentation. During the accreditation process, these documents and those defined in these documents. The services/activities provided according to the practices are subject to audits. In this statement, by giving information about the technical conditions considered, mostly in the technical activities of laboratories an assessment of the observed nonconformities is done.

Perceived Determinants of Adherence to Standard Operating Procedures among Laboratory Personnel as per the Staff in Bomet County, Kenya

Laboratory errors are a major burden in health care systems. To reduce laboratory errors and increase laboratory quality, international health organizations such as the World Health Organization developed laboratory quality management systems (QMS). One of the QMS essentials (Documents and Records) contains Standard Operating Procedures (SOPs). SOPs are step-by-step instructions that laboratory personnel use as a guide in performing laboratory procedures. Thus, adhering to SOPs ensures consistency, accuracy, and quality of laboratory procedures, thereby increasing laboratory data quality and reducing errors. However, studies in Kenya have shown low percentage results in evaluating documents and records, which means low adherence to SOPs. This study aimed to identify the determinants of adherence to SOPs. A qualitative phenomenological study was conducted in two conveniently selected hospitals (Tenwek Mission Hospital and Longisa County Referral Hospital) in Bomet County, Kenya. Four focused group discussions and eight key informant interviews were done. Based on the objectives, collected data were analyzed using manual coding and thematic analysis. The study identified themes that determine adherence to SOPs which mainly are the working environment, and factors that promote adherence to SOPs are professional education, leadership factors, and work environment. Key areas that needed intervention on SOPs adherence are personal reasons, professional education, and quality equipment. Professional education and leadership have been suggested for the sustenance of intervention. Recommendations to hospitals to increase opportunities for professional education and to increase the number of staff to help lower workload are made.

Impact of mentoring on the implementation of the quality management system in clinical laboratories in Burkina Faso, West Africa

ABSTRACT In Burkina Faso, the implementation of the quality management system remains weak in diagnostic laboratories. Integrating mentoring into the life of clinical diagnostic laboratories, a qualified mentor is essential for quality system control. The objective of this study was to evaluate the impact of the mentoring process on quality improvement. Mentoring process was implemented at nine laboratories. The process consisted of a one-week mentor stay in the laboratory as one visit, with four in total. The SLIPTA checklist was used as a measurement tool. Two audits were performed (before and after the implementation of the mentoring process. The audit data were analyzed to estimate the effect of mentoring on quality improvement. A score difference of 24.55% was found significant between the two audits (paired Student’s t-test p-value = 0.0002). The variables non-conformities, corrective/preventive actions, and facilities/safety have factored more than eight points between the two audits. However, the management/customer service and information one have only slightly increased (2.27 and 0.63, respectively). Mentoring has improved the quality management system in laboratories. However, some points of the process need to be improved to bring these laboratories toward international accreditation.

Practical considerations for laboratories: Implementing a holistic quality management system.

A laboratory quality management system (LQMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and process changes to meet the continued demand. It is critical for laboratories to maintain a robust LQMS that accommodates laboratory activities (e.g., basic and applied research; regulatory, clinical, or proficiency testing), records management, and a path for continuous improvement to ensure that results and data are reliable, accurate, timely, and reproducible. A robust, suitable LQMS provides a framework to address gaps and risks throughout the laboratory path of workflow that could potentially lead to a critical error, thus compromising the integrity and credibility of the institution. While there are many LQMS frameworks (e.g., a model such as a consensus standard, guideline, or regulation) that may apply, ensuring that the appropriate framework is adopted based on the type of work performed and that key implementation steps are taken is important for the long-term success of the LQMS and for the advancement of science. Ultimately, it ensures accurate results, efficient operations, and increased credibility, enabling protection of public health and safety. Herein, we explore LQMS framework options for each identified laboratory category and discuss prerequisite considerations for implementation. An analysis of frameworks' principles and conformity requirements demonstrates the extent to which they address basic components of effective laboratory operations and guides optimal implementation to yield a holistic, sustainable framework that addresses the laboratory's needs and the type of work being performed.

Redesign of Laboratory Facilities Layout Quality Control at PT. Industri Kimia

PT. The chemical industry is a company that has been producing hydrogen peroxide since 1992. One of the essential roles of this chemical factory is the Quality Control Laboratory, which functions to analyze raw materials and hydrogen peroxide products before distributing them to consumers to ensure product quality. Based on the standard of laboratory quality management system, SNI ISO/IEC 17025:2008 states that in order to facilitate the correctness of test performance, the laboratory must monitor, control and record the temperature and humidity in the testing room because it will have an impact on the validity of the quality of the data produced—however, Procurement of test equipment facilities in the QC laboratory of PT. The chemical industry is not supported by good facility layout planning, so it is necessary to rearrange the layout, including the function of equipment and materials and the conditioning of utility and electricity systems. The laboratory layout redesign parameters used are floor area measurement, ARC (Activity Relationship Chart) analysis, and ARD (Activity Relationship Diagram) analysis. The study results are in the form of calculating the total closeness rating value on the activity proximity relationship diagram, the largest value is the sample space of 6200, and the lowest value is the computer room of 200. From these calculations, a layout template for testing laboratory facilities is created based on the order of the highest total closeness rating value to the smallest value so that a laboratory layout will be obtained according to the SNI ISO/IEC 17025:2008 standard and can create an effective and efficient work environment.

EFFECT OF ISO 17025 STANDARD ON QUALITY MANAGEMENT SYSTEM IN ACCREDITED CIVIL ENGINEERING LABORATORIES

Due to the earthquakes that have occurred in recent years, many lives and property have been lost in the world. After these earthquakes, national and international regulations used in the world have updated with various changes. Especially the regions where the population and industry in Turkey are dense are under the risk of heavy earthquakes. When the damages in the buildings after the earthquakes were examined, it has seen that they are in poor quality and uncontrolled structures. The inspection of the buildings has built in Turkey is carried out by the relevant municipalities and ministries. The most important part of these inspections is carried out by laboratories that inspect the suitability of the materials used. The importance of public and private control laboratories in the field of construction organized under the ISO/IEC 17025 standard in Turkey is important for the safety of buildings. In this context, the effectiveness of the construction materials laboratories in Turkey according to the ISO 17025 standard has investigated. In this context, the establishment processes of the civil engineering laboratory, which is in the process of establishment and for which an accreditation application will be made, have examined in accordance with the ISO 17025 standard. In addition, the compliance of the laboratory's quality management system documents with the ISO 17025 standard has investigated. Thanks to this study, it is aimed to assist the accreditation processes of organizations that want to be accredited. Keywords: ISO 17025, Quality management, Accreditation

M223 Implementation of a quality management system in toxicological laboratories of health-care institutions of the Republic of Belarus

M223 Implementation of a quality management system in toxicological laboratories of health-care institutions of the Republic of Belarus

Development of Scenario-based Online Training Flatform For Laboratory Quality Management System

Development of Scenario-based Online Training Flatform For Laboratory Quality Management System

Effect of Pre-Analytical Errors on Turnaround Time of Central Clinical Laboratory: A Study Protocol

Clinical laboratories are crucial for medical care and recovery because they have evidence from body fluid analysis. Laboratory observations are used to make the majority of medical decisions. As a result, clinical lab results must be precise and timely. Laboratory quality management systems must include the influence of pre-analytical procedures in regions, including non conformance detection and control, continuous upgrade, internal audit, and quality indicators in order to be accredited as per ISO 15189:2012. Quality assurance (QA) has risen to the top of the priority list as a major source of worry. In terms of QA, "errors" in lab services are the most significant category that laboratories constantly monitor and assess. It is the responsibility of the clinical laboratory to provide precise and punctual results. The pre-analytical phase, on the other hand, is directly connected to the specimen collecting method and is mostly out of the laboratory's direct control; additionally, the majority of pre analytical mistakes are caused by human errors. As a result, the most essential and required methods to prevent these mistakes are phlebotomy team education and training programs. In this article, we have observed the effect of pre-analytical errors on turnaround time of central clinical laboratory of the hospital and also discovered the way to decrease the pre-analytical errors of inpatient samples.

Maintaining laboratory quality assurance and safety in a pandemic: Experiences from the KEMRI-Wellcome Trust Research Programme laboratory’s COVID-19 response

Laboratory diagnosis plays a critical role in the containment of a pandemic. Strong laboratory quality management systems (QMS) are essential for laboratory diagnostic services. However, low laboratory capacities in resource-limited countries has made the maintenance of laboratory quality assurance, especially during a pandemic, a daunting task. In this paper, we describe our experience of how we went about providing diagnostic testing services for SARS-CoV-2 through laboratory reorganization, redefining of the laboratory workflow, and training and development of COVID-19 documented procedures, all while maintaining the quality assurance processes during the COVID-19 pandemic at the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (KWTRP) laboratory. The KWTRP laboratory managed to respond to the COVID-19 outbreak in Kenya by providing diagnostic testing for the coastal region of the country, while maintaining its research standard quality assurance processes. A COVID-19 team comprising of seven sub-teams with assigned specific responsibilities and an organizational chart with established reporting lines were developed. Additionally, a total of four training sessions were conducted for county Rapid Response Teams (RRTs) and laboratory personnel. A total of 11 documented procedures were developed to support the COVID-19 testing processes, with three for the pre-analytical phases, seven for the analytical phase, and one for the post-analytical phase. With the workflow re-organization, the development of appropriate standard operating procedures, and training, research laboratories can effectively respond to pandemic outbreaks while maintaining research standard QMS procedures.