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ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
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 fact that universal standards are being promoted (if not adopted by national organizations and agencies) is an indication that the dialogue will continue regarding the development, structure, financing, monitoring, enforcement, and integration of standards within the broader health care system. International interest in LOINC continues to grow.
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]
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.
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]