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US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
What is US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)?
The CLIA laboratory requirements in 42 CFR Part 493: certificates and notifications, proficiency testing, facility administration and record retention, the quality system for nonwaived testing across all phases, personnel qualifications and responsibilities, and inspection, as a CLIA-certified laboratory must meet them for certification and Medicare approval. It comprises 47 controls organised across 8 domains, and applies in the United States.
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US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs ISO 27001:2022View comparison →US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs SOC 2View comparison →US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs NIST CSF 2.0View comparison →US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs GDPRView comparison →US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs HIPAAView comparison →US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) vs PCI DSS 4.0View comparison →
What US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) means in your sector
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What US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) means for your job
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for CISOs→US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for Compliance Officers→US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for Risk Managers→US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for IT Directors→US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for DPOs→US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) for Auditors→
Questions people ask about US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
What is US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)?
The CLIA laboratory requirements in 42 CFR Part 493: certificates and notifications, proficiency testing, facility administration and record retention, the quality system for nonwaived testing across all phases, personnel qualifications and responsibilities, and inspection, as a CLIA-certified laboratory must meet them for certification and Medicare approval.
How many controls does US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) have?
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) contains 47 controls organized across 8 domains.
Where does US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) apply?
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) applies in United States. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) is covered here?
This page covers 42 CFR Part 493 as codified in the eCFR at the 2026-10-15 issue date (incorporating the CLIA fees, histocompatibility, personnel and alternative sanctions final rule of 28 December 2023, effective 27 December 2024).
Query US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) programmatically
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493), its 47 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) API reference and MCP config →How ready are you for US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)?
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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .