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Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the measurement system reproduces the ...
The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative.
The Individualized Quality Control Plan (IQCP) is a quality management system under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. It is designed to enable regulated medical laboratories to manage the frequency of their quality control .
Quality control begins with sample collection and ends with the reporting of data. [4] AQC is achieved through laboratory control of analytical performance. Initial control of the complete system can be achieved through specification of laboratory services, instrumentation, glassware, reagents, solvents, and gases.
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
This is because relying solely on the lab-internal quality management can create a false sense of safety. Laboratories are instructed to treat proficiency testing samples in the same way as normal patient samples. [1] For a laboratory, gaining and keeping the ISO 17025 accreditation status is of high commercial importance.
They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control. [1] They are plotted on Levey–Jennings charts , wherein the X-axis shows each individual sample, and the Y-axis shows how much each one differs from the mean in terms of standard deviation (SD).
That functionality can roughly be divided into five laboratory processing phases, with numerous software functions falling under each: [2] (1) the reception and log in of a sample and its associated customer data, (2) the assignment, scheduling, and tracking of the sample and the associated analytical workload, (3) the processing and quality ...
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