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Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
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.
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]
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]
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).
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 ...
Practiced clinical services for at least 1 year under a CPA, which must be included as documentation; Once licensed by the Board of Pharmacy, APh's can perform patient assessments, refer patients to providers, and work with other healthcare providers to help manage patients' disease states by optimizing drug therapies.
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] These regulations set the ...