Reliability Of Laboratory Results Research Articles

Identifying risk management challenges in laboratories

Over the years, risk management gains significant importance in laboratories of every kind. The safety of workers, the accuracy and reliability of laboratory results, issues of financial sustainability as well as the protection of the environment play an important role in decision-making in both industry and services. In order a laboratory to be considered as reliable, safe, and therefore competitive, it is recommended to comply with the requirements of international standards and other regulatory documents as well as to use tools and risk management procedures. In this paper, information is summarized concerning the terms “risk” and “risk management” which are then approached through the latest ISO 9001, ISO/IEC 17025, and ISO 14001 standards. The process of risk management based on the ISO 31000 standard is described, the options for treatment and the techniques that can be applied in the risk management process based on the latest ISO 31010 standard are grouped and indicated. Additionally, information from the literature is referred to the reasons that led the laboratories to integrate in their quality system risk management techniques, the most common mistakes that occur in the various phases of laboratory tests, their causes, their consequences as well as the proposed treatments. The aim of this work is to highlight significant challenges concerning the need to implement management procedures in the daily routine, to warn, raise awareness and inform about existing ways of risk management that can be implemented, methodologically and technically, to laboratories, under internationally recognized and updated standards.

RISK-BASED QUALITY CONTROL IN THE SURGICAL PATHOLOGY LABORATORY; BRIEF REVIEW AND DEVELOPMENT OF AN INDIVIDUALIZED QUALITY CONTROL PLAN

One of the most important tools for reducing or preventing diagnostic errors in the surgical pathology laboratory is the establishment of a quality management system. Risk analysis and quality assurance are important components to ensure the sustainability of the quality management system. Quality assurance ensures the integrity of program design and includes interrelated activities quality control and quality monitoring-evaluation programs. Risk-based thinking is expressed as the planning of risks and how they should be managed by determining the possible dangers and risks in achieving the determined goals and objectives, using the available information systematically. Laboratories must identify and carry out a large number of interrelated activities to maintain their functions effectively. To achieve its goals, it must demonstrate the ability to measure and evaluate process performance, as well as to demonstrate the effectiveness of past decisions, along with improving operational effectiveness and efficiency. With a successful quality management process, the reliability of laboratory results can be increased. In this study, our objective was to develop a roadmap for the detection, monitoring and minimization of diagnostic errors in the surgical pathology laboratory, in line with the views of international regulatory organizations, to develop a quality plan based on risk management that covers the entire analytical cycle. It is not possible to discuss the quality control of laboratories without accepting the possibility of error in surgical pathology. Investing in continuing medical education and patient safety, as well as the training of new pathologists with a critical view to reducing errors is an imperative way to improve the practice of pathology.

Clinical Research in Ghana: Accuracy and Reliability of Laboratory Results

The rising cost of clinical research is driving the current trend of outsourcing to developing countries1. Many developing countries, such as Ghana, conduct research but face many challenges in ensuring that the trial conduct and results conform to internationalstandards2. Such challenges include staff recruitment and retention3 and the reliability of laboratory results. Ethical aspects of research are governed by international regulations but policing and enforcing such regulations are less well documented. There arechallenges to overcome, including reliability of laboratory results and inadequate resources, with overreliance on those that are adequate. Thus there is a need to develop a research infrastructure that can cope with these challenges.

Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium®

ABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories.

English

Several studies report that between 60 to 85% of laboratory errors are produced during the preanalytical phase. The objective of this study was to identify the factors at the origin of nonconformities during this phase at the Civil Hospital of Tetouan. A mixed preanalytical descriptive study realized between April and May 2014 was based on a questionnaire, an observation grid, focus groups and semi-structured interviews. The quality of preanalytical phase determines the quality and reliability of laboratory results. Indeed, 30% of the prescriptions of biologic tests are drafted by nurses and not doctors this is in the absence of an updated list of exams. The samples are taken at 84.6% by unqualified personnel and 98% without any guide or manual. For the traceability aspect, the name of the sampler is never placed on the sheet of examination, age, sex of the patient; time and nature of the sample are often not mentioned in the label vials of samples. The factors causing nonconformities laboratory tests at the civil hospital may have an impact on the quality of care. They result from a major defect of coordination between the laboratory and the services and the weak competence of the staff involved in this process. Key words: Nonconformities, quality, biological sample, preanalytical phase, hospital laboratory.

Inter-Laboratory Robustness of Next-Generation Bile Acid Study in Mice and Humans: International Ring Trial Involving 12 Laboratories.

The increasing relevance of individual bile acids quantification in biological samples requires analytical standardization to guarantee robustness and reliability of laboratory results. We have organized the first international ring trial, carried out in 12 laboratories, to evaluate the newly developed LC-MS/MS-based test kit for bile acid analysis. Each laboratory received a Biocrates® Bile Acids Kit including system suitability test (SST) protocol. The kit is designed to analyze 16 individual human and 19 mouse bile acids. A set of 9 human and mouse plasma samples was measured in replicates. Laboratories were first required to pass the acceptance criteria for the SST. Within the subset of laboratories passing SST criteria, we evaluated how many laboratories met the target criteria of 80% of reported values with a relative accuracy within the 70%-130% range and analytical precisions (%CV) below 30%. A total of 12 of 16 participating laboratories passed the SST as the prerequisite to enter the ring trial. All 12 laboratories were then able to successfully run the kit and ring trial samples. Of the overall reported values, 94% were within 70%-130% relative accuracy range. Mean precision was 8.3% CV. The condition of CV <30% was fulfilled by 99% of the reported values. The first publically available interlaboratory ring trial for standardized bile acids quantification in human and mouse plasma samples showed very good analytical performance, within acceptance criteria typically applied in the preclinical environment. The kit is therefore suitable for standardized quantitative bile acid analysis and the establishment of reference values.

АВТОМАТИЗАЦІЯ РОБОЧОГО МІСЦЯ ЛІКАРЯ-БІОХІМІКА ГЕНЕТИКА

In the laboratory of medical genetics NCSH «OKHMATDYT» to identify the reliability of laboratory results and control the number and frequency of errors, carry out internal quality control. In order to evaluate the results of measurements of samples and eliminate harmful analytical errors developed and introduced software that allows you to build a calibration curve and process the results of biochemical research activity of lysosomal enzymes.

Study of the Stability of various Biochemical Analytes in Pooled Sera preserved at 4-8 o C

Biochemical laboratory plays an important role in today’s clinical practice. The reliability of laboratory results is therefore most important. Through the quality control (QC), errors can be minimized and the laboratory can ensure about the reliability of its results. The quality control sera are useful for this purpose. But commercially available quality control sera are costly and not available at all places. Also at peripheral levels the storage of the sera at very low temperature is not possible. So we have studied the stability of various biochemical analytes in the pooled sera stored in readily available refrigerator. We have collected 42.5 ml of pooled sera in a plastic jar and we have added 7.5 ml of ethanediol to it (15%). This pooled serum is tested for HIV and HBS Ag. Then serum is kept in the refrigerator at 4 – 8 oC . Daily 1-2 ml of the serum is taken in a plastic test tube with new micro pipette tip from the jar after thorough mixing. When serum attains the room temperature various tests were performed. The results of the tests were noted. We have compared these results with ERBA multi-calibrated sera We have studied 10 such pooled sera. We have found that total proteins and bilirubin get deteriorated (values varies more than 10%) early i.e. between 18-20 days in all 10 samples. Then alkaline phosphatase and amylase get deteriorated between 22-26 days. Glucose and albumin remain stable for 27-30 days. Cholesterol, triglycerides and uric acid starts deteriorating after 32 days. SGOT, SGPT, LDH deteriorates after 35 days. Urea, creatinine, calcium and phosphorus remain stable for long period i.e. more than 45 days.

Report on the status of the external quality-control programs for occupational-medical and environmental-medical toxicological analyses in biological materials in Germany.

Basis of the intercomparison programs for toxicological analyses in occupational and environmental medicine Intercomparison programs are intended to improve the reliability of laboratory results by objectively testing their accuracy under medical requirements. Such intercomparison programs are regulated in Germany by guidelines of the German Federal Medical Council. According to these guidelines, the supervisors of the intercomparison programs are responsible for the announcement, organization, and implementation of each intercomparison program and for the evaluation of the results. The supervisors are therefore scientifically responsible for the intercomparison programs that they organize and for the selection and testing of the suitability of the samples. Their suitability is tested, e.g., by the determination of reference values. The reference values and their tolerance ranges represent the target values for the participants in the intercomparison program. The supervisor awards the participants a certificate for successful participation in the intercomparison programs for each parameter within the tolerance range. The certificate is valid for 12 months. The guidelines for setting of the tolerance range are based both on the analytical conditions and the medical requirements. The medical requirements in the occupational-medical and environmental-medical range must be oriented to the valid reference intervals, and limits of decisions for medical evaluation and in the area of preventive medicine must be applied more strictly than in curative medicine. At least two intercomparison programs must be carried out per year, and for each analyte, two samples must be analyzed with diAerent concentration settings. The reference values are determined by reference laboratories [5, 6]. These laboratories are commissioned for toxicological analyses by the supervisor on the basis of their qualifications. These qualifications are apparent, e.g., from the observation that the laboratory or its head has evaluated methods for biological monitoring and published them in the international scientific literature. In addition, the laboratory should have successfully taken part in intercomparison programs organized by other institutions. Our laboratories take part in intercomparison programs in Canada, Finland, and Denmark and in the certification programs of the EU and the assignment programs for manufacturers of control materials (USA, Germany, and Norway). Also, the reference laboratories should routinely carry out toxicological analyses. A description of the requirements for reference laboratories has been published by Lehnert et al. [9] and by Angerer and Lehnert [2]. At present, 10 national and 14 international laboratories are commissioned to determine the reference values in the assurance program supervised by one of us (G.L.).

QUALITY CONTROL OF LABORATORY RESULTS IN REAL TIME

An integrated informatic system may have an important role in identifying and reducing those errors which affect the reliability of laboratory results. The present work reports on the development of a system that, by means of a computer connected with laboratory instrumentation, allows monitoring of global error (bias, random, gross) using classical statistical quality control systems, integrated by auxiliary methods built on a database stored in the computer. These methods succeeded in greatly reducing bias and random error in the most frequent laboratory tests. Further methods to find, quantify, and reduce the gross and extra-analytical errors are under development.

A PROCEDURE FOR EVALUATION OF COMMERCIAL FCC CATALYSTS

Abstract Based on the correlations between laboratory units and commercial plants, a procedure has been developed to guide commercial FCC (Fluid Catalytic Cracking) catalysts selection. Examining the operability of catalyst mixtures during catalyst transition period is emphasized. The testing procedure is simple and reliable. A commercially available catalyst and the catalyst currently in use have been compared to demonstrate the applicability of this procedure. The commercial testing has confirmed the reliability of laboratory results. The use of the catalyst evaluated led to a 30% saving in catalyst cost.

The reliability of laboratory results

The reliability of laboratory results