Quality In Laboratory Medicine Research Articles

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 indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies.

In the last few decades, quality in laboratory medicine has evolved in concert with the transformation and the changes (technological, scientific and organizational) in this sector. Laboratory professionals have faced great challenges, at times being overwhelmed, yetalso involved in this progress. Worldwide, laboratory professionals and scientific societies involved in laboratory medicine have raised awareness concerning the need to identify new quality assurance tools that are effective in reducing the error rate and enhancing patient safety, in addition to Internal Quality Control (IQC) procedures and the participation in the External Quality Assessment Schemes (EQAS). The use of Quality Indicators (QIs), specifically designed for laboratory medicine are effective inassessing and monitoring all critical events occurring inthe different phases of Total Testing Process (TTP), in particular, in the extra-analytical phases. The Model ofQuality Indicators (MQI), proposed by the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry andLaboratory Medicine (IFCC) and validated by experts in consensus conferences, is an important window of opportunity for the medical laboratory to demonstrate the use of an effective quality assurance tool fit for this purpose. Aim of this paper is to provide an update of the state-of-the-art concerning the most used QIs data collected in 2021 and the Quality Specifications (QSs) proposed for their evaluation. Moreover, a strategy for the future is proposed in order to improve the MQI and encourage its use in medical laboratories throughout the world.

An Innovative Teaching Approach for Diabetes Mellitus in Laboratory Medicine Uses the Clinical Laboratory Diagnostic Pathway.

The routine teaching mode of diabetes mellitus (DM) is divided into various sub-majors of medical laboratory, which is not conducive to clinical laboratory physicians quickly mastering relevant knowledge. A novel DM laboratory testing pathway is established to improve teaching efficiency and enhance the effects of talent cultivation in laboratory medicine. The guidelines and expert consensuses of DM were gathered from professional websites and databases. The clinical laboratory diagnostic pathway was formulated, and the questionnaire and mutual evaluation were used to evaluate the teaching effectiveness of 8-year undergraduate students enrolled in 2018 and enrolled in 2019, respectively. Clinical laboratory physicians developed and approved the DM clinical laboratory diagnostic pathway, which included the entire process of DM diagnosis and differential diagnosis, drug selection, treatment impact monitoring, prognosis evaluation, etc. The results of the questionnaires showed that, in comparison to the teaching mode used with the students enrolled in 2018 and enrolled in 2019, the percentages of more improvement and significant improvement were significantly increased (P < 0.01) and the percentages of no improvement and slight improvement were significantly decreased (P < 0.01). Following the instruction of the DM clinical laboratory diagnostic route, the results were greatly improved, including points emphasized and the accuracy of responding to questions, among other things, according to the teachers' and students' mutual evaluation (P < 0.05). To enhance the teaching quality in laboratory medicine, it is required to build the disease clinical laboratory diagnostic pathway for a novel teaching method. This may boost teachers' and students' confidence and broaden their knowledge.

Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications.

IntroductionThe aim of the study was to determine the current state of laboratory’s extra-analytical phase performance by calculating preanalytical and postanalytical phase quality indicators (QIs) and sigma values and to compare obtained data according to desired quality specifications and sigma values reported by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group – Laboratory errors and Patient Safety.Materials and methodsPreanalytical and postanalytical phase data were obtained through laboratory information system. Rejected samples in preanalytical phase were grouped according to reasons for rejection and frequencies were calculated both monthly and for 2019. Sigma values were calculated according to “short term sigma” table.ResultsThe number of rejected samples in laboratory was 643 out of 191,831 in 2019. Total preanalytical phase rejection frequency was 0.22%. According to the reasons for rejection, QIs and sigma values were: “Samples with excessive transportation time”: 0.0036 and 5.47; “Samples collected in wrong container” 0.02 and 5.11. In December, QIs and sigma values were: “Samples with excessive transportation time”: 0.01 and 5.34; “Samples collected in wrong container”: 0.03 and 4.98. The postanalytical QIs and sigma values were: “Reports delivered outside the specified time”: 0.34 and 4.21; “Turn around time of potassium”: 56 minute and 3.84, respectively. There were no errors in “Critical values of inpatients and outpatients notified after a consensually agreed time”.ConclusionsExtra-analytical phase was evaluated by comparing it with the latest quality specifications and sigma values which will contribute to improving the quality of laboratory medicine.

Quality in laboratory medicine and the Journal: walking together.

Quality in laboratory medicine is defined as "an unfinished journey", as the more essential the laboratory information provided, the more assured its quality should be. In the past decades, the Journal Clinical Chemistry andLaboratory Medicine has provided a valuable forum forgarnering new insights into the analytical and extra-analytical phases of the testing cycle, and for debating crucial aspects of quality in clinical laboratories. The impressive number of papers published in the Journal is testimony to the efforts made by laboratory professionals, national and international scientific societies and federations in the quest to continuously improve upon the pre-, intra- and post-analytical steps of the testing cycle, thus enhancing the quality of laboratory information. The paper appearing in this special issue summarizes the most important and interesting contributions published in the Journal, thus updating our knowledge on quality in laboratory medicine and offering further stimuli to identify the most valuable measures of quality in clinical laboratories.

Quantification of Pre-Analytical Quality Indicator in a Clinical Laboratory

Introduction: Quality in laboratory medicine have a significant role in ensuring the adequate and complete total testing process. Clinical laboratory and testing process is an integral part of modern medicine as it has a direct effect on the patient. As per the requirement of certification or accreditation bodies, different laboratories use different ways of developing quality indicators (QI), which helps to monitor, progress and maintain the quality of the laboratory services.&#x0D; Materials and Methods: A cross sectional retrospective study carried out in the Hematology Laboratory of a tertiary care hospital. Data of pre-analytical quality indicators was collected for months from August 2015 to January 2016. Pre-analytical quality indicators analysed for sample collections were clotted sample, hemolyzed sample, incompletely filled form, wrong labelled sample, insufficient sample volume and patient waiting for sample collection after registration in the laboratory- turnaround time (TAT). Turn around time for patient waiting for sample collection is 15 minutes from the registration of the request form.&#x0D; Results: The overall sample received during the six months was 2,03,337 among these pre-analytical errors found in 1067. The highest rate indicators were clotted sample 589 (0.28%), followed by insufficient sample volume 376(0.18), incompletely filled form and wrongly labelled sample 67(0.03%), Hemolyzed sample 35(0.017%). 94.49 % of the patient waiting time for the sample collection from registration was within the Turnaround time (TAT).&#x0D; Conclusion: The development of a quality indicator for clinical laboratory medicine helps to improve quality in processing and testing of samples. Quality indicator plays a vital role in continuous improvement activities of clinical practice, which are aiming to deliver quality result and reducing the errors.&#x0D; Bangladesh Journal of Medical Science Vol.20(3) 2021 p.525-529

The hospital as a sorting machine

Large hospitals sort patients into wards or clinics based on a number of factors. The information of a patient’s location is potentially useful in a number of medical contexts. By demonstrating and studying the sorting that occurs in a hospital, we show that each ward has characteristic signatures emergent from the blood test results associated with patients in those wards. We further demonstrate the utility of this information to fundamental research by evaluating the distribution of serum alanine aminotransferase, a liver enzyme hypothesised to be linked to heart disease. We demonstrate the creation of classifiers to determine to which ward a patient is assigned with greater than 60 % accuracy within the first three prioritised predictions across 28 wards. This study is extended to predict patients’ movements from intake wards through to destination wards as a proof-of-concept into patient routing. We propose that this study provides a basis for leveraging metadata in a number of fields, including: fundamental research, laboratory medicine quality assurance, hospital and admissions management, and patient triage.

The pre-analytical phase in laboratory medicine quality management: a brief overview

The pre-analytical phase in laboratory medicine quality management: a brief overview

Laboratory verification of an RT-PCR assay for SARS-CoV-2.

BackgroundReverse transcription‐polymerase chain reaction (RT‐PCR) is an extremely common clinical method for detecting pathogens, particularly for emerging infectious diseases such as the new coronavirus disease (COVID‐19). Currently, detection of the RNA from the novel coronavirus SARS‐CoV‐2 is the gold standard for establishing a COVID‐19 diagnosis. This study evaluates the characteristic performance of the analytical system in a clinical laboratory.MethodsA commercial SARS‐CoV‐2 RNA RT‐PCR Kit used in a clinical laboratory is assessed based on ISO 15189 verification requirements. A multiple real‐time RT‐PCR assay for the RdRP, N, and E genes in SARS‐CoV‐2 is verified.ResultsThe analytical system exhibits good analytical sensitivity (1000 copies/mL) and specificity (100%); however, the values of 86.7% and 100% for analytical accuracy deserved attention, compared with two other types of methods. Overall, the kit is potentially useful for SARS‐CoV‐2 diagnostic testing and meets the verification requirements.ConclusionCompliance with international standards, such as ISO 15189, is valuable for clinical laboratories and for improving laboratory medicine quality and safety. Normalization is essential for obtaining reliable results from the SARS‐CoV‐2 RNA RT‐PCR assay. This study aims to develop an improved SARS‐CoV‐2 verification framework compared with traditional molecular diagnostic methods, given the urgency of implementing new assays in clinical laboratories.

Simple errors but great loss – Can these be avoided

Introduction: Quality in laboratory medicine refers to satisfaction of the needs and expectations of users or customers which can be achieved by providing a guarantee in each and every step like the whole testing process which in turn includes the physician ordering the test, pre – analytical, analytical, post – analytical phases and finally the results for interpretation. The aim of this study is to highlight human dependent errors that affects biochemical tests, through cases which we encountered in our lab. Conclusion: To prevent these errors, a symbiotic and synergistic participation should be there amongst the lab personnel and the health care team. This goal can be achieved with proper education and training of individuals involved in this process. Thus, prevention of these errors will help in better and effective patient management. Keywords: Errors, Hyperkalemia, Hypernatremia, Lipemic, Preanalytical.

QUALITY MANAGEMENT PRINCIPLES OF CLINICAL AND LABORATORY ACTIVITIES

Providing a specific level of healthcare quality is an important and a complex issue, determined by the extent of influence of number of interrelated and predetermined factors that act at different stages throughout the continuum of healthcare activities. A final healthcare product is a complex conglomerate of goods and services being heterogeneous with a time-varying result and a pronounced individuality. Thus, healthcare managers are required to put its supporting and continuous upgrading at the core of their efforts, which in turn will result in cost reduction, good collaboration between individual professionals, improved financial performance and, ultimately, patients will be optimally serviced and their needs and expectations will be satisfied.Indicators to measure quality of medical services give an idea of their characteristics, conditions and requirements for implementation. In this respect, quality assurance in clinical laboratories is an important process involving a complex system of planned actions at all stages of laboratory analysis in order to achieve the most accurate results with the aim of achieving the most accurate result, of monitoring the effect of the treatment and prognosis of the disease in question. The high quality of laboratory medical services helps modern clinicians in their practical activities and is a guarantor of achieving an adequate healthcare outcome. The ‘Quality in Laboratory Medicine’ concept evolves over time, focusing not only on analytical accuracy but also on a broader and more comprehensive basis that takes into account all the steps of clinical and laboratory analysis, providing valuable information in the process of making clinical decisions that are subordinated entirely to the cares of the patient.All healthcare professionals under the administrative authority of the medical institution, that should guarantee the necessary resources for this process, should participate in providing and improving the quality of services. It is necessary to cover the entire organizational structure, by paying attention to the optimization of the relations between staff and patients. Healthcare managers should provide permanent monitoring and a process evaluation system at each stage, allowing options for choosing alternatives for a solution and precise selectivity, aimed at improving the quality of healthcare, in particular, clinical and laboratory activities and services.

Identifying Preanalytic and Postanalytic Laboratory Quality Gaps Using a Data Warehouse and Structured Multidisciplinary Process.

The laboratory total testing process includes preanalytic, analytic, and postanalytic phases, but most laboratory quality improvement efforts address the analytic phase. Expanding quality improvement to preanalytic and postanalytic phases via use of medical data warehouses, repositories that include clinical, utilization, and administrative data, can improve patient care by ensuring appropriate test utilization. Cross-department, multidisciplinary collaboration to address gaps and improve patient and system outcomes is beneficial. To demonstrate medical data warehouse utility for characterizing laboratory-associated quality gaps amenable to preanalytic or postanalytic interventions. A multidisciplinary team identified quality gaps. Medical data warehouse data were queried to characterize gaps. Organizational leaders were interviewed about quality improvement priorities. A decision aid with elements including national guidelines, local and national importance, and measurable outcomes was completed for each gap. Gaps identified included (1) test ordering; (2) diagnosis, detection, and documentation, and (3) high-risk medication monitoring. After examination of medical data warehouse data including enrollment, diagnoses, laboratory, pharmacy, and procedures for baseline performance, high-risk medication monitoring was selected, specifically alanine aminotransferase, aspartate aminotransferase, complete blood count, and creatinine testing among patients receiving disease-modifying antirheumatic drugs. The test utilization gap was in monitoring timeliness (eg, >60% of patients had a monitoring gap exceeding the guideline recommended frequency). Other contributors to selecting this gap were organizational enthusiasm, regulatory labeling, and feasibility of a significant laboratory role in addressing the gap. A multidisciplinary process facilitated identification and selection of a laboratory medicine quality gap. Medical data warehouse data were instrumental in characterizing gaps.

International Conference on Laboratory Medicine: celebrating 25 years

The celebration of the 25th edition of the International Conference on Laboratory Medicine offers us the opportunity to review the story of the meeting that was dedicated to the memory of Angelo Burlina, the scientist who recognized the need to identify the discipline with the name of “laboratory medicine”. The several editions of the conference have been dedicated to emerging topics in the field of laboratory testing, thus highlighting the monumental advances and changes in clinical laboratory practice. The “core principle” of all conferences was the search for better quality in laboratory medicine. that should be achieved by promoting development of programs and processes inside and outside the laboratory itself. In particular, the discovery that pre- and post-analytical phases are more vulnerable to errors than intra-analytical processes led us to promote the vision of laboratory testing as described by Lundberg, in the seminal concept of the “brain-to-brain loop”, and focusing on the ultimate goal that is an action on the patient to improve the diagnostic and therapeutic process, along with major emphasis on the emerging role of laboratory medicine in identifying risk factors, disease prevention and personalized medicine. The vision of the testing process as a continuum, led us to promote a project on quality indicators covering all steps of the testing process, thus including pre-pre and post-post-analytical steps, and for identifying performance specification which should create a culture of, monitor, and continuously improve, quality. In particular, we have highlighted the need to assure and improve patient safety as laboratory tests increasingly impact both clinical decision-making and patient outcomes.

Quality and future of clinical laboratories: the Vico's whole cyclical theory of the recurring cycles.

In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.

Quality in laboratory medicine: an unfinished journey

Quality in medicine is an evolving concept, but currently the focus is on a patient-centered delivery of services and on the ultimate outcomes. In laboratory medicine, quality is moving from a simple focus on analytical quality toward global assessment of laboratory information, its real value in the clinical decision-making, so assuring valuable outcomes for patients and communities. The evidence collected in the last decades on the vulnerability of extra-analytical phases of the testing cycle requires developing and adopting quality indicators (QIs) covering the entire testing cycle, starting from the initial steps (test request, sample collection and transportation), to the analytical phase and, finally, to the correct interpretation and utilization of laboratory information (post-post-analytical phase), so finally improving diagnostic and therapeutic decisions.

External Quality Assessment in Croatia: problems, challenges, and specific circumstances.

In Croatian medical laboratories (ML), external quality assessment (EQA) has a long tradition of almost half of a century. At national level, EQA is provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) which is a part of Croatian Society of Medical Biochemistry and Laboratory Medicine. This case study aimed to summarize the main challenges, which are set to CROQALM and their possible solutions. CROQALM has 10 schemes, covering majority of analysis for which medical biochemistry laboratories in Croatia are authorized for, including pre-analytical and post-analytical phase of laboratory work. Assessment scheme has three exercises per year. One sample per scheme and exercise is distributed to participants depending on their application. All data transfer and evaluation of the results are done using web interface and statistical software for evaluation of quality in laboratory medicine. Since CROQALM has relatively small number of participating laboratories (N = 197) with lot of different manufacturers of instruments used for analysis in all schemes, constant challenges are present in the evaluation of the results (commutability problems, statistical analysis etc.). Further, number of participating medical laboratories is even lower for highly specific parameters, which are in the scope of clinical laboratories only. Despite the obstacles we are faced to, EQA at national level is useful tool regarding standardization and harmonization aspects in total testing process within the country. Furthermore, it gives participating laboratories recognition and proof for meeting expected quality criteria in the community they serve.

Quality in laboratory medicine: 50 years on

The last 50years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the quality of laboratory services is changing. The need to control and improve quality in clinical laboratories has grown hand in hand with the growth in technological developments leading to an impressive reduction of analytical errors over time. An essential cause of this impressive improvement has been the introduction and monitoring of quality indicators (QIs) such as the analytical performance specifications (in particular bias and imprecision) based on well-established goals. The evolving landscape of quality and errors in clinical laboratories moved first from analytical errors to all errors performed within the laboratory walls, subsequently to errors in laboratory medicine (including errors in test requesting and result interpretation), and finally, to a focus on errors more frequently associated with adverse events (laboratory-associated errors). After decades in which clinical laboratories have focused on monitoring and improving internal indicators of analytical quality, efficiency and productivity, it is time to shift toward indicators of total quality, clinical effectiveness and patient outcomes.

Towards a new paradigm in laboratory medicine: the five rights.

A body of evidence collected in the last few decades demonstrates that the pre- and post-analytical phases of the testing cycle are more error-prone than the analytical phase. However, the paradigm of errors and quality in laboratory medicine has been questioned, analytical mistakes continuing to be a major cause of adverse clinical outcomes and patient harm. Although the brain-to-brain concept is widely recognized in the community of laboratory professionals, there is lack of clarity concerning the inter-relationship between the different phases of the cycle, interdependence between the pre-analytical phase and analytical quality, and the effect of the post-analytical steps on the quality of ultimate laboratory information. Analytical quality remains the "core business" of clinical laboratories, but laboratory professionals and clinicians alike should never lose sight of the fact that pre-analytical variables are often responsible for erroneous test results and that quality biospecimens are pre-requisites for a reliable analytical phase. In addition, the pressure for expert advice on test selection and interpretation of results has increased hand in hand with the ever-increasing complexity of tests and diagnostic fields. Finally, the data on diagnostic errors and inappropriate clinical decisions made due to delay or misinterpretation of laboratory data underscore the current need for greater collaboration at the clinical-laboratory interface.

Challenges in the Standardization of Autoantibody Testing: a Comprehensive Review.

Standardization and harmonization are complementary tools to achieve higher testing quality in laboratory medicine. Both are of great relevance and are strongly needed in autoimmune diagnostics, due to the impressive advance in basic research and technological development observed in this diagnostic field in recent years that has led to the introduction of many new tests and new analytical methods. It is, therefore, essential that this strong innovative thrust is translated into clinical practice in a coordinated way to avoid confusion and the risk of potentially harmful errors for the patient. However, while standardization of antibody assays is a very complex task, harmonization of procedures and behaviors is a more feasible target and should necessarily include all the phases of the total testing process-in the pre-analytical phase, appropriateness of test requests, harmonization of autoantibody terminology, and adoption of uniform nomenclature for laboratory tests; in the analytical phase, harmonization of measurements, and sharing of test profiles and diagnostic algorithms; and in the post-analytical phase, harmonization of data reporting, and criteria for interpreting immunoserological results, especially harmonization of units, reference intervals, decision limits, and definition and notification of critical values. We here provide and discuss some examples of harmonization initiatives related to anti-nuclear antibodies, TSH receptor, and anti-thyroid peroxidase antibodies and to antibodies associated with autoimmune hepatitis and with celiac disease. These initiatives could be the starting steps to achieve a wider consensus and a closer interaction among stakeholders in the path of autoimmune diagnostics harmonization to enhance clinical effectiveness and provide greater patient safety.

Cost evaluation of clinical laboratory in Taiwan's National Health System by using activity-based costing.

To cope with the government's policies to reduce medical costs, Taiwan's healthcare service providers are striving to survive by pursuing profit maximization through cost control. This article aimed to present the results of cost evaluation using activity-based costing performed in the laboratory in order to throw light on the differences between costs and the payment system of National Health Insurance (NHI). This study analyzed the data of costs and income of the clinical laboratory. Direct costs belong to their respective sections of the department. The department's shared costs, including public expenses and administrative assigned costs, were allocated to the department's respective sections. A simple regression equation was created to predict profit and loss, and evaluate the department's break-even point, fixed cost, and contribution margin ratio. In clinical chemistry and seroimmunology sections, the cost per test was lower than the NHI payment and their major laboratory tests had revenues with the profitability ratio of 8.7%, while the other sections had a higher cost per test than the NHI payment and their major tests were in deficit. The study found a simple linear regression model as follows: "Balance=-84,995+0.543×income (R2=0.544)". In order to avoid deficit, laboratories are suggested to increase test volumes, enhance laboratory test specialization, and become marginal scale. A hospital could integrate with regional medical institutions through alliances or OEM methods to increase volumes to reach marginal scale and reduce laboratory costs, enhancing the level and quality of laboratory medicine.