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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.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
The CDC Good laboratory practice guidelines for newborn screening recommends that "laboratory specimen retention procedures should be consistent with patient decisions." [ 49 ] Researchers have described the NBS samples as a gold mine representing a patient population that would otherwise be impossible to get. [ 46 ]
Through its Committee on Laboratory Standards and Practices, the APHA developed clinical laboratory books, such as Diagnostic Procedures for Bacterial, Mycotic, and Rickettsial Diseases. In 1971, CLASP determined that a comprehensive book on quality assurance would be useful for laboratory personnel faced with new CLIA guidelines.
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
It has Mutual Recognition Arrangement (MRA) with Asia Pacific Accreditation Cooperation (APAC), International Laboratory Accreditation Cooperation (ILAC). NABL is a constituent board of Quality Council of India which is an autonomous body setup under Department for Promotion of Industry and Internal Trade (DPIIT) , Ministry of Commerce and ...
Laboratories first began receiving CAP accreditation in 1964, [8] and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments of 1988. [9] The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests.
In 2019 the question was asked "How Does ISO 15189 Laboratory Accreditation Support the Delivery of Healthcare in Ethiopia?" and answered by a systematic review. [6] In 2021 it became apparent that the International Health Regulations was a driver for ISO 15189 accreditation when the UKHSA provided training to EPHI staff. [7]