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CLIA and Other Regulatory Information
CLIA Regulations
-- Current CLIA regulations from the Centers for Disease Control and Prevention (CDC).
Good Laboratory Practices for Waived Testing Sites
-- "Survey Findings from Testing Sites Holding a Certificate of Waiver Under CLIA and Recommendations for Promoting Quality Testing" from the Centers for Disease and Control Prevention (CDC).
CLIA Waived Tests
-- A list of currently waived analytes from the U.S. Food and Drug Administration (FDA).
CLIA Waived and PPM Tests Defined
-- Information on defining CLIA waived and Provider Performed Microscopy (PPM) tests.
Regulated Analyte List
-- Including hematology, diagnostic immunology, chemistry, immunohematology and microbiology.
CLIA Test Database
-- Search the CLIA database via the U.S. Food and Drug Administration (FDA).
CLIA Laboratory Classifications
-- How to classify your lab, including small, medium and large volume laboratories, and specialties.
Changing the Status of a Laboratory
-- How to change the status of your lab.
Physician Office Laboratory Director Duties
-- List of duties for a Physician Office Laboratory Direction.
CLIA Personnel Requirements
-- Qualifications and responsibilities for Provider Performed Microscopy (PPM) and Moderate and High Complexity laboratories.
Recordkeeping Requirements
-- Including requirements for PT record retention, test record retention and QC record retention.
Private Accrediting Agencies
-- Contact information for private accrediting agencies.
CMS Contact Information
-- State Agency, Regional offices and a link to obtain a copy of form CMS-116.
Bloodborne Pathogens Regulations
-- Information on bloodborne pathogens regulations from the Occupation Safety and Health Administration (OSHA).
Office Lab Proficiency Testing
2013 Brochure (*PDF file)
CLIA and Other Regulatory Information
Physician Office Laboratory Topics
2013 PT Handbook (*PDF file)
(*PDF file. About PDFs)
