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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. [1]
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. [1] Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on ...
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. [1] [2]
The GLP regulations aim to standardize procedures and practices in nonclinical studies to ensure accurate, reliable, and traceable data. This background helps highlight the significance of adhering to GLP standards in research and regulatory contexts. GLP was first introduced in New Zealand and Denmark in 1972. [6]
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The COM checklist also describes the requirements for analytical validation/verification of the method performance specifications (i.e. accuracy, precision, reportable range) that laboratories must perform for each test, method, or instrument system before use in patient testing. [10]
Clinical and Laboratory Standards Institute. The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.