Quality Control In Medical Laboratory Pdf
Internal audits can be conducted by the staff of the laboratory to identify weaknesses and undertake corrective actions. Totally independent laboratories are required to generate genuinely independent, multi-method, and multi-analyser data.
Continuous education opportunities should be offered to the staff and recorded, especially if new tests or methods are introduced. The laboratory should prepare an organizational chart that reflects the hierarchy and lines of authority with functions and responsibilities of each post. Rules, such as the Westgard rules can be applied to see whether the results from the samples when the control was done can be released, or if they need to be rerun. The mean and one, two, and three standard deviation limits are also marked on the Y-axis. It should be stable for long periods of time, and available in large enough quantities for a single batch to last at least one year.
Equipment manuals should be available in the laboratory area for easy reference. Many of them are detailed again in the respective chapters of this manual. The rules applied to high volume chemistry and hematology instruments should produce low false rejection rates. Process control Process control refers to control of all activities involved in the operation of a laboratory, from pre-examination to post-examination steps. The inventory should be kept up to date including information on reception, storage, and issuance.
Confirmation by sending a subset of isolates to a reference laboratory for re-identification and characterization. These results would indicate a low bias result in the instrument. The current duties and responsibilities of staff should be specified in written job descriptions including training required and necessary experience. The Levey-Jennings chart uses the long-term i.
In fact target ranges are often so wide that the laboratory is unlikely to fall outside them regardless of their performance. Westgard rules are programmed in to automated analyzers to determine when an analytical run should be rejected.
Assessment Assessment is a tool for examining laboratory performance and comparing it to known standards or to performance of other laboratories. The focus on trends and biases is a good identification of potential changes in results that can affect accuracy of overall results.
Jennings who in suggested the use of Shewhart's individuals control chart in the clinical laboratory. Westgard rules are commonly used to analyse data in Shewhart control charts. Process control refers to control of all activities involved in the operation of a laboratory, from pre-examination to post-examination steps. Proper management of purchasing and inventory of reagents, media, rene david los grandes sistemas juridicos contemporaneos pdf and supplies can produce cost savings in addition to assuring accurate and timely reporting of laboratory results.
Some of these elements constitute management requirements i. Percentage of results reported on time, which provides information on examination and reporting performance.
The Levey-Jennings chart differs from the Shewhart individuals control chart in the way that sigma, the standard deviation, is estimated. The dates of analyses are plotted along the X-axis and control values are plotted on the Y-axis. Immediate remedial corrective action should be undertaken before the result is reported to the clinician or public health authorities. Investigation among the laboratories showed that controls were well within established parameters and calibrations were valid. Unreliable performance can result in misdiagnosis, delayed treatment and increased costs due to retesting etc.
This makes it easy to see how far off the result was. The company investigated the claim and substantiated it. Site visits conducted by inspection, certification, or accreditation bodies. The formulation of Westgard rules were based on statistical methods.
Assessment is a tool for examining laboratory performance and comparing it to known standards or to performance of other laboratories. The laboratories contacted patient providers and thousands of patients so that patients could be assessed and retested. Regular competency assessment and proficiency testing should be conducted and documented.
An inventory of equipment including records of maintenance and repair should be maintained. As laboratorians, our function as managers is as valuable to the patients as our ability to analyze their samples. According to Ibrahim et al. These consequences result in increased cost in time, personnel effort, other resources, and poor patient outcomes in terms of morbidity and mortality.
The distance from the mean is measured in standard deviations. The procedures should be written and implemented to assure that all reagents and supplies are correctly selected, purchased, used, and stored in a manner that preserves integrity and reliability. The most important laboratory resource is a competent, trained, and motivated staff. Personnel The most important laboratory resource is a competent, trained, and motivated staff. Also, management of matrix effects and calibration misalignment are important aspects to observing shifting L-J charts and adjustments of accuracy over time.
Laboratory testing of patient samples can be a complex procedure, depending on clinical analysis, microbiological study, or blood banking testing among other facets of the clinical laboratory. This broad concept applies to any kind of laboratory testing, including diagnostic testing for bacterial meningitis.
These methods are based on continuous monitoring of process variation. Fewer controls to purchase and stock means fewer controls to manage and fewer vendors to deal with. Facebook Twitter Email Syndicate.
On the x-axis the date and time, or more usually the number of the control run, are plotted. According to Miller et al. Lines run across the graph at the mean, as well as one, two and three standard deviations to either side of the mean. The Westgard Rules observe the normal distribution expected and identify standard deviations produced. This indicator provides information on the pre-examination performance.
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