Data analytics for error detection in clinical laboratories

Clinical laboratories worldwide need to report IgE antibody results on clinical specimens as analytical results and not use differential positive thresholds

Clinical laboratories must adhere to Good Laboratory Practices (GLP) to ensure the quality, integrity, and reliability of patient results. GLP principles include organization and personnel, a quality assurance program, facilities, equipments, reagents and materials, test systems, standard operating procedures, result reporting, and archiving of records and reports (Wikipedia,2010). This chapter presents a review of the latest requirements in quality control and quality management in certified clinical laboratories. We will describe different stages in clinical testing procedures and highlight the critical steps that need to be monitored using quality assurance indicator tools. In addition, we will present our latest contribution to the field of quality control computer software which encompasses an innovative approach in monitoring quality control and quality assurance in laboratories. Accumulating and analyzing quality control data as well as quality indicators help in developing the performance improvement plan in the laboratory. Performance improvement is a process which uses information from multiple sources to increase the probability of accomplishing desired outcomes to better serve the needs and expectations of patients. The most frequently used performance improvement tools are: 1. FOCUS-PDCA – framework for improvement, 2. Failure Modes and Effects Analysis (FMEA), 3. Root Cause Analysis (RCA) and 4. Control Charts. However, in this chapter we will focus on one model of quality improvement approaches which is FOCUS-PDCA and control charts and give examples on its implementation in a clinical laboratory setting.

When quality is referred to in clinical chemistry and laboratory medicine, the focus is mainly on the analytical process. But good professional quality starts with a sound education. In an attempt to describe the practice of clinical chemistry and laboratory medicine in the 15 member states of the "old" European Union, it was noticed that (sometimes) large differences existed in the way professionals are being trained (see: Sanders et al, Clin Chem Lab Med 2002; 40: 196-204). With that outcome, a survey of the Websites of the different Member Societies and Corporate Members of IFCC was conducted. It showed that less than one third of either two groups paid attention to, or offered, education. This led to a series of questions to a non-representative group of colleagues outside the former EU who were willing to give more insight in the educational system of their country. All colleagues were known to be involved actively in clinical chemistry and laboratory medicine. The outcome did not give a uniform pattern, since every country regulates health care in its own way, according to its own historical development, needs, social vision, etc. From that a number of conclusions have been drawn: a. Proper University Training is required to enter vocational training b. Regulated Vocational Training seems to be necessary (4 years) c. A clear Syllabus as an indicative guide to the vocational training is important d. Management training should be included since a clinical chemist will have organizational responsibilities as well e. Examinations may help in improving the quality of the education f. Official Register, recognized by Law, is essential, but not always existing h. Re-Registration can be seen as part of the Quality Cycle. Finally, some attention is being paid to the activities of the EMD. This Division of the IFCC provides the membership of IFCC and the health-care community with education which it considers relevant to Clinical Chemistry and Laboratory Medicine. It is the intention of EMD to improve the quality of the profession by educational activities in molecular biology, evidence based laboratory medicine, quality assurance, distance education, and laboratory management. Specific projects are a Master Course in Laboratory Science, a course in Flowcytometry, and the Visiting Lecturer Program which supports national societies in inviting lecturers on specific topics. More information can be found on the IFCC Web-site (www.ifcc.org). In the future, it is to be expected that emphasis on education in our profession will be on the clinical use of tests, modern media and e-learning, and specific courses in new technologies. EMD works continuously to improve the quality of clinical chemistry and laboratory medicine. The input from all National Societies is appreciated to discern topics most relevant to the membership of IFCC. .

Molecular pathology, a rapidly expanding discipline connecting pathology and molecular biology, is providing a deeper insight and understanding of the molecular basis of the aetiology and pathogenesis of human disease. This well-laid-out book covers the basic principles of molecular pathology, explains the most important molecular diagnostic techniques in user-friendly language, and describes their applications across a broad range of human diseases and problems, including cancer, hereditary disorders, identity testing, and infectious diseases. The book is divided into 11 comprehensive yet concise chapters, each providing extensive bibliographic references to the primary literature for those wanting to delve deeper into the subject. In the first four chapters the reader is introduced to basic concepts of gene structure and function, epigenetics, Mendellian and non-Mendellian patterns of inheritance, population genetics, types of mutations and chromosomal abnormalities, and modern molecular diagnostic techniques. In chapter five, common inherited diseases such as cystic fibrosis and Huntington's disease are discussed as examples of molecular screening for specific mutated genes or linked DNA polymorphisms now commonplace in clinical laboratories. The material covered in this chapter also includes testing for common mitochondrial and metabolic disorders, and the implementation of newborn and carrier screening programmes. In chapters six, seven and eight, basic concepts of tumour biology are covered, including oncogenes and tumour suppressor genes, programmed cell death (apoptosis) and telomere maintenance, and are reviewed in the context of molecular detection of gene rearrangements, tissue-specific gene transcription and oncogene activation in selected sporadic cancers, haematological malignancies, and familial cancer syndromes. Chapter nine provides a useful introduction to the field of pharmacogenetics and includes examples of genes demonstrating pharmacokinetic and pharmacodynamic variation together with their phenotyping. Chapter ten describes the differentiation of individuals from one another by ‘DNA fingerprinting' for purposes of paternity testing, forensic sample identification, and bone marrow engraftment monitoring. The final chapter discusses the diagnosis and monitoring of human immunodeficiency virus and hepatitis C virus infections as examples of how DNA probes for viruses, bacteria, and parasites promise to revolutionise the practice of medical microbiology. Overall the book provides an excellent overview of the ongoing molecular revolution that is now transforming pathology and the practice of laboratory medicine. As well as providing a basic reference text for staff in clinical molecular diagnostic laboratories, it also forms a good basis for tutorials and exam preparations. I would highly recommend this book to scientists and health-care professionals working in the field of pathology, including pathology residents, clinicians, and medical students.

Introduction/Objective Quality control (QC) monitoring is a cornerstone of quality assurance in clinical laboratories. A mainstay of QC monitoring is the use of Levey-Jennings charts—introduced in 1950 as an adaptation of Shewhart’s statistical control charts used in industrial manufacturing. In these charts, consecutive assay results of QC materials are plotted over time, allowing for the detection of shifts, drifts, or outliers in repeated measures using well-established Westgard Rules or Six Sigma principles. A practical challenge in traditional QC monitoring is determining appropriate values for setting the mean and standard deviation control parameters, particularly in laboratories with extensive test menus and multiple analyzers performing the same test. Methods/Case Report We employ a variety of analytical and machine learning approaches—such as Gaussian curve fitting, moving averages, and unsupervised machine learning algorithms—to examine whether QC parameters can be generated analytically and automatically from live QC data. Results We remove outliers, adjust for instrument performance-related drifts, and account for reagent or QC material lot changes that would otherwise confound control limits calculated from noisy, uncurated data. Conclusion This work confirms that QC limit establishment and evaluation can be performed using more automated methods to help improve laboratory operations.

Inaccuracy quality control in the monitoring of trace metal concentrations in biological fluids

Clinical laboratory instrument verification testing is often an accreditation requirement. However, it is not known what verification procedures are in routine use or how often the process identifies problems which need addressing prior to testing clinical samples. To investigate which standards are currently being used for laboratory verification in UK and New Zealand (NZ) clinical laboratories and to help establish if the activity justifies the effort required. A survey of verification of clinical laboratory instrumentation was distributed to members of the Association for Clinical Biochemistry and Laboratory Medicine and New Zealand Institute of Medical Laboratory Scientists. The survey consisted of questions on the verification elements used and whether acceptance criteria were met. Nineteen of 72 (26%) of responders only used organization-developed protocols for verification, 20/72 (28%) solely used national/international guidelines, while 16/72 (22%) used a combination. Manufacturers' claims were partly or entirely used as acceptance criteria for imprecision (89%), accuracy (64%) and analytical measuring range (94%), with these being met on 61%, 67% and 93% of occasions, respectively. For patient comparison and linearity, acceptance criteria were met by 71% and 91%. Only 27-36% undertook any troubleshooting before accepting a failed component of verification. Laboratories in the UK and NZ are currently using a variety of verification standards and acceptance criteria for instrument verification. It is common for instruments to fail, especially following the assessment of imprecision and accuracy. While this suggests the process is warranted, only a minority address failed elements before accepting verification.

New quality assurance standards for rare disease testing

This chapter describes laboratory practices that provide value-added services. It discusses the information society as it relates to clinical laboratory services and patient safety needs. The chapter defines the “knowledge worker” and advocates the benefits of clinical scientists who perform this role, compares and contrasts the old laboratory and new laboratory paradigms and determines the value of the new laboratory as it improves patient safety. It describes conditions of good work, which can have a positive impact on current clinical laboratory vacancy rates. The chapter explains the consultation process and determine the benefits in clinical laboratory practice as it relates to patient safety. There are four interactive skills that contribute to the effectiveness of consulting practice. The chapter describes the various competencies of successful consultants, and assesses the benefits to the healthcare delivery system when clinical scientists act as consultants. The focus of the chapter is the discussion of this value-added service, that is, service which addresses effectiveness as well as cost and efficiency. Throughout the chapter, the imperative for an information revolution in laboratory medicine practice is described with corresponding implications for a future workforce comprised of clinical scientists as knowledge workers.

Artificial Intelligence for Kidney Stone Spectra Analysis: Using Artificial Intelligence Algorithms for Quality Assurance in the Clinical Laboratory

Artificial Intelligence for Computer Vision in Surgery: A Call for Developing Reporting Guidelines.

This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively. In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively. In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data

Over the past 50 years, the clinical laboratory has evolved into a complex, technology-driven enterprise with the principal tasks of diagnosing and screening for disease, monitoring health and therapeutic response, and gauging deviations from normal physiology in humans and animals. Advances in diagnostic medicine, on the other hand, have come through the application of science and technology as a result of a coordinated effort among academia, industry, government, and private institutions. We are now entering the era of Molecular Diagnostics and Pathology, which is bringing forth the newest and most powerful science and technology available for the modern-day practice of diagnostic laboratory medicine. Among the numerous important areas to consider with molecular diagnostics are the emerging issues concerning the development of genetic assays and their use for testing individual patient responses or suitability for pharmaceutical drugs. The definitions of pharmacogenomics (PGo) and pharmacogenetics (PGe) to be used in this context are as follows: The distinction between the two terms has become somewhat arbitrary in the literature, and they have been used interchangeably(1); however, we wish to apply them in their proper context in the following discussion. Recently, the US Food and Drug Administration (FDA) made recommendations to pharmaceutical companies to evaluate the PGo of their drugs. These recommendations eventually evolved into a draft guidance document(2)(3), and as a result, many pharmaceutical and biotechnology companies developed internal PGo committees to handle this aspect of drug behavior. The role of some of these committees was to review the data from internal research, clinical …

Future Role of the Clinical Lab in Population Health.

> “Not everything that can be counted counts, and not everything that counts can be counted.” > > —William Bruce Cameron In the United States, the practice of pathology and laboratory medicine is one of the most heavily regulated parts of health care. American hospital laboratories must be accredited to meet the regulatory requirements of the Clinical Laboratory Improvement Amendments, usually through the laboratory accreditation programs of the College of American Pathologists and Joint Commission. In addition, because the Joint Commission accredits almost all American hospitals, even in hospitals where laboratory accreditation is through another source many Joint Commission standards extend to laboratory operations (particularly preanalytic components of laboratory testing and transfusion practices). Within clinical laboratories, blood banks/transfusion services fall under the jurisdiction of the Food and Drug Administration, both for transfusion practices as well as oversight of tissue used in transplantation. Clinical laboratories in most states fall under state regulations regarding reporting of communicable diseases, death certification, and newborn screening. Most states also have specific requirements regarding disposal of hazardous wastes generated within clinical laboratories. Almost all clinical laboratories fall under the jurisdiction of the Occupational Safety and Health Administration for employee safety. And all laboratories, with a few exceptions, must address myriad requirements and regulations regarding billing and reimbursement … Corresponding author: Michael Wilson, MD, Denver Health Medical Center, 777 Bannock St, Denver, CO 80204. michael.wilson{at}dhha.org