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Maryland Clia Application Form: What You Should Know

Regulatory Supplement to the Clinical Laboratory Improvement Amendments (CIA) for Industry on its website. This supplemental¬† document contains the regulations under the CIA for clinical laboratories. You may download from: Clinical Laboratory Performance Improvement Amendments (CPI) The clinical laboratory performance improvement amendments (CPI) are a set of amendments to the National¬† Controlled Substances Act (CSA). The amendments permit the clinical laboratories that report performance¬† data to provide such performance data on a voluntary basis to CMS on a¬† basis that is set by CMS and the applicable State. Under the CPI, these performance¬† data will be used to determine the fees to be assessed, and, if necessary, may be applied to¬† increase payments from the CMS to the laboratory.¬† Maryland CPI Requirements Maryland CPI Form¬†is for the reporting of performance data that is needed to determine¬† fee-for-service payments under the CMS in order to provide a reasonable basis for¬† determining the base rate for a payment based on performance of the controlled substance... Maryland¬† Clinical Lab Quality Act (CLA) The State has passed the Medical Laboratory Improvement Act (CLA). This law has set the¬† framework for the regulation of commercial laboratories, including clinical laboratories in Maryland. The legislation is intended to protect consumers and provide a uniform set of regulations to¬† protect patients by regulating testing procedures, reporting requirements and patient¬† privacy and confidentiality requirements. It is a major component of the Maryland medical laboratory¬† reform legislation and helps create a reliable and fair process and to promote a more¬† efficient, effective, and safe practice. CLQA-related requirements are contained in Regulation P. CLA is a Federal regulation adopted under the Federal Food, Drug, and Cosmetic (FDA) Act,¬† 21 U.S.C. 349(a)(1).‚Ä̬†‚ÄúRegulation P applies to all facilities that report to a State, a¬† private entity providing clinical laboratory services, or a contractor performing clinical¬† laboratory services.

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