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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).” “Regulation 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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