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Video instructions and help with filling out and completing clia waiver application texas
This lecture covers chapter 15 and explores the regulations by which laboratory testing including point-of-care testing is performed central to this discussion are the clinical laboratory Improvement Amendments of 1988 referred to as CLIA 88 or JA CLIA CLIA is a federal mandate that identifies laboratory testing standards and supersedes the requirements outlined in the clinical laboratory Improvement Act of 1967 the regulations related the safety that is the Occupational Safety and Health Administration requirements are also discussed along with the protection of patient medical information by the Health Insurance Portability and Accountability Act following successful completion of this chapter the learner will be able to in the framework of CLIA discuss the concepts of site neutrality certification test complexity categories proficiency testing quality systems for non webs testing and professional personal hierarchy in a laboratory setting second objective compare and contrast CLIA Co la TJ c and c AP testing requirements for waived and non waived testing third formulate strategies for meeting the regulations that are applicable to his or her healthcare organization fourth described the Oh sh a requirements in terms of laboratory testing and finally discussed the laboratory requirements for meeting the HIPAA legislation the clinical laboratory Improvement Amendments of 1988 it regulates all laboratory testing used for diagnosis monitoring or treatment it stablish --is quality standards for all laboratory testing to ensure accuracy reliability and timeliness of patient test results it is also a test site neutral which means same regulations apply regardless of the location of testing see with the Centers for Disease Control and Prevention or CDC were charged originally with developing and promulgating the CLIA regulations each certificate has a fee schedule which is dependent on the number of test specialties test complexity level and test volume the testing requirements are based on the complexity or difficulty to perform a test method the three categories of test methods are waived moderate complexity which includes the subcategory of provider performed microscopy procedures or ppm P for clinicians and mid-level practitioners only and high complexity if a site develops its own test procedure or chooses to modify an existing fda-approved procedure which includes not following the manufacturer's directions the test automatically falls into the high complexity category in is subject to CLIA s-- most stringent requirements the most up-to-date version of the CLIA requirements that include all of the changes can be downloaded from the Centers for Medicare and Medicaid Services website once the laboratory is judged to be in compliance with the requirements through inspection a permanent certificate of compliance is issued to those laboratories inspected by an agent of CMS or a certificate of accreditation is issued the laboratory seeking accreditation when a CMS deemed professional organization as of June 2021 approximately 220,000 CLIA certificates have been chewed information and applying for a CLIA certificate along with associated certificate fees is available on CMS s website CLIA eighty-eight law specifies that laboratory requirements are to be based on complexity of the test.