Lab Regulatory Compliance
Meeting Laboratory Quality Standards
Trusted by leading diagnostic labs and life sciences companies
- Regulatory Compliance
- Regulatory compliance for laboratories means meeting the requirements of federal, state, and accreditation body standards. In the U.S., this includes CLIA, CAP, state licensing, and specialty regulations like HIPAA for patient privacy and potentially FDA for certain tests.
Laboratory compliance is essential for maintaining certification, avoiding penalties, and ensuring patient safety. It encompasses personnel qualifications, quality control, proficiency testing, documentation, and audit trails. Modern LIMS systems are designed to support these compliance requirements.
Key Regulatory Frameworks
CLIA
Federal quality standards for lab testing (CMS)
CAP
Voluntary accreditation program (deemed CLIA status)
State Regulations
State-specific licensing and requirements
HIPAA
Patient privacy and data security standards
FDA
Regulation of certain tests and LDTs
COLA
Alternative accreditation for smaller labs
Compliance Areas
Personnel qualifications and competency
Quality control and quality assurance
Proficiency testing participation
Equipment maintenance and calibration
Procedure documentation (SOP)
Result verification and review
Audit trails and record retention
Patient privacy and data security