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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.
This file is a work of the Centers for Disease Control and Prevention, part of the United States Department of Health and Human Services, taken or made as part of an employee's official duties. As a work of the U.S. federal government , the file is in the public domain .
The laboratory industry is a part of the broader healthcare and health technology industry. Companies exist at various levels, including clinical laboratory services , suppliers of instrumentation equipment and consumable materials, and suppliers and developers of diagnostic tests themselves (often by biotechnology companies).
Stark II" extended the "Stark I" provisions to Medicaid patients and to DHS other than clinical laboratory services. [3] The Centers for Medicare and Medicaid Services has issued rules in the Federal Register to implement Stark Law, including a 2001 "Phase I" final rule, a 2004 "Phase II" interim final rule, and a 2007 "Phase III" final rule. [4]
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.
Most of the regulations specific to CBER are found from 21CFR600-680. 21CFR1271 contains the rules for HCT/Ps. For products which are also drugs, such as blood for transfusion, rules in 21CFR200 and following apply. Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply. [citation ...
However, without licensure, it can be difficult to hold bad actors accountable. Nonphysician healthcare personnel, including phlebotomists, may be sued due to poor practice standards. [8] Increasingly, a number of healthcare facilities are rolling phlebotomy duties into their patient care technician roles or other allied health roles. [9] [5]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]