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Individualized Quality Control Plan
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 (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach plac .... Reference category:Health standards Quality management Healthcare in the United States Clinical Laboratory Improvement Amendments {{medical-stub ...
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Quality Management System
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. ...
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Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. CLIA Program In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: * diagnosis, prevention, or treatment of disease or impairment * health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs. Test Complexity Per CLIA, each specific laboratory system, assay, examination is graded for ...
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Medical Laboratories
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions. Medical laboratories vary in size and complexity and so offer a variety of testing services. More comprehensive services can be found in acute-care hospitals and medical centers, where 70% of clinical decisions are based on laboratory testing. Doctors offices and clinics, as well as skilled nursing and long-term care facilities, may have laboratories that provide more basic testing services. Commercial medical laboratories operate as independent businesses and provide testing that is otherwise not provided in other settings due to low test volume or complexity. Departments In hospital ...
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Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introductio ...
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Dark Daily
Darkness is the condition resulting from a lack of illumination, or an absence of visible light. Human vision is unable to distinguish colors in conditions of very low luminance because the hue-sensitive photoreceptor cells on the retina are inactive when light levels are insufficient, in the range of visual perception referred to as scotopic vision. The emotional response to darkness has generated metaphorical usages of the term in many cultures, often used to describe an unhappy or foreboding feeling. "Darkness" may also refer to night, which occurs when the Sun is more than 18° below the horizon. Scientific Perception The perception of darkness differs from the mere absence of light that sometimes lead to afterimages. In perceiving, the eye is active, and the part of the retina that is unstimulated produces a complementary afterimage. Physics In terms of physics, an object is said to be dark when it absorbs photons, causing it to appear dim compared to other objects. ...
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Health Standards
Health has a variety of definitions, which have been used for different purposes over time. In general, it refers to physical and emotional well-being, especially that associated with normal functioning of the human body, absent of disease, pain (including mental pain), or injury. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive stress. Some factors affecting health are due to individual choices, such as whether to engage in a high-risk behavior, while others are due to structural causes, such as whether the society is arranged in a way that makes it easier or harder for people to get necessary healthcare services. Still, other factors are beyond both individual and group choices, such as genetic disorders. History The meaning of health has evolved over time. In keeping with the biomedical perspective, early definit ...
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Quality Management
Total quality management, Total Quality management (TQM), ensures that an organization, product, or service consistently performs as intended, as opposed to Quality Management, which focuses on work process and procedure standards. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Customers recognize that quality is an important attribute when choosing and purchasing products and services. Suppliers can recognize that quality is an important differentiator of their offerings, and endeavor to compete on the quality of their products and the service they offer. Thus, quality management is focused both on product and service quality. Advancement In earlier periods, arts and crafts were led by Master craftsman, master craftspeople or artists who supervised studios, trained apprentices, and oversaw the product development process. With the advent of the Industrial Revolution, steam engines, and mass production, the role of crafts ...
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Healthcare In The United States
Healthcare in the United States is largely provided by private sector healthcare facilities, and paid for by a combination of public programs, private insurance, and out-of-pocket payments. The U.S. is the only developed country without a system of universal healthcare, and a significant proportion of its population Health insurance coverage in the United States, lacks health insurance. The United States List of countries by total health expenditure per capita, spends more on healthcare than any other country, both in absolute terms and as a percentage of GDP; however, this expenditure does not necessarily translate into better overall health outcomes compared to other developed nations. In 2022, the United States spent approximately 17.8% of its Gross Domestic Product (GDP) on healthcare, significantly higher than the average of 11.5% among other high-income countries. Coverage varies widely across the population, with certain groups, such as the elderly, disabled and low-income ...
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