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Quality Assurance and Quality control in chemical and physical Analysis. 2009, 383 - 388
Analytical measurements are important part for many human activities and in such cases they used in order to take important decision in the problem of economy, technology of production, environment, legislation etc. Evaluation of quality in different productivities and materials, process control of produce, consumer assurance, environment protection and healthy safeguard of people are some of the important activity that based in chemical and physical analysis. Basic problem for all quality system is establishment of reliability in the results that give laboratory. But, reliability toward the laboratory must exist only if it based in reliability of measurement which prove these quality. Today the important problems of analytical measurement are establishment of quality system, quality assurance and quality control of measurements in analytical laboratory. In the end of this purpose is that laboratory must provide to consumers some analytical data with known quality (acceptable).
Quality assurance systems in research and routine analytical laboratories
Accreditation and Quality Assurance, 2000
In our article we explain the connections between the implementation of quality assurance (QA) in research and routine analytical laboratories. J. K. Taylor claims that QA in an analytical laboratory consists of two independent but closely related terms, quality control and quality assessment. If we construct the QA system according to his ideas, problems concerning quality can be solved with only one concept regardless of the type of analytical laboratory. Therefore there is no need to introduce new QA standards for research laboratories as suggested in some papers. In the routine laboratory quality control is more important, while in the research laboratory quality assessment is dominant.
TrAC Trends in Analytical Chemistry, 2004
It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving attention to the different characteristics of method performance. We deal with the concepts of single-laboratory or in-house validation, inter-laboratory or collaborative study, standardization, internal quality control (IQC), proficiency testing (PT), accreditation and, finally, analytical QA (AQA).
Quality Assurance of Laboratory Results
In health care clinical laboratories plays very important role in diagnosis and prognosis of the disease. So clinical laboratories are rapidly transforming into an efficient and extremely automated fashion and its metamorphosis has been expensive. Due to cost factor, unbiased report, emergency services and shortage of skilled manpower, running such establishment is tedious task. Atomization of clinical laboratories minimizes certain workstations but quality delivery was lacunas before few decades. Quality control in clinical laboratories may be practiced prospectively and provide information about the acceptability of the most recent analytical run(s) or may be practiced retrospectively and provide information about past performance. The results of quality control evolved with the growing use of the multitest analyzer within the early 1970s. Laboratory managers gradually accomplished that the applying of ±2s qualitycontrol limits to multitest analyzer. As early as 1974, Haven expanded the allowable deviations of quality-control results by defining a run as out of control if either a single control observation exceeded the ±3s limits or 2 observations exceeded the ±2s limits. This approach was rationalized by Westgards investigations into the efficiency and appropriateness of various laboratory quality-control rules which describes of two control rules, one sensitive to systematic error and the other sensitive to random error. Point-ofcare (POC) analyzers are more precise and accurate but daily electronic quality control recommend. Laboratory professionals are reluctant to change systems if they are perceived to be working satisfactorily. The great emphasis on proficiency testing in CLIA 88 laboratory quality reports enhanced.
Quality Indicators of the Pre-Analytical Phase
Journal of Medical Biochemistry, 2012
Quality indicators are tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (postanalytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force called Laboratory Errors and Patient Safety (WG-LEPS) with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra-and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and postana lytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.
Performance criteria and quality indicators for the pre-analytical phase
Clinical chemistry and laboratory medicine : CCLM / FESCC, 2015
The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data co...
On-site laboratory evaluations, a key element of the laboratory approval process, encourage the proper implementation of analytical methods and provide supporting documentation to demonstrate method performance. These evaluations, regardless of their complexity, usually do not focus on identifying the key, explicit QA program activities that may in fact adversely affect the production of acceptable level data quality. They emphasize secondary elements of a QA system or program, such as, the organization, facilities, equipment, good laboratory practices, record keeping habits, and performance in the external intercomparison studies.