Quality

AcelaBio delivers robust quality assurance and quality control at every stage of sample analysis, thereby adhering to State, U.S., Federal, and international industry standards and regulations.

 

Our quality management system (QMS) provides rigorous oversight of the development, maintenance, and implementation of policies and procedures to ensure our deliverables are accurate and consistent.

CAP (College of American Pathologists)

AcelaBio is CAP-accredited, which indicates that the laboratory meets stringent requirements of quality, accuracy, and consistency of test results to ensure optimal assessment of patient diagnoses and outcomes. It also ensures that the laboratory complies with the standards of the Clinical Laboratory Improvement Amendments (CLIA), U.S. Food and Drug Administration (FDA), and Occupational Safety and Health Administration (OSHA), since CAP requirements commonly exceed those standards.

CLIA (Clinical Laboratory Improvement Amendments)

AcelaBio is a registered Clinical Laboratory Improvement Amendments (CLIA) lab that indicates compliance with regulations focused on laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention, or treatment of disease or the assessment of health.

CDPH (California Department of Public Health) 

AcelaBio is a licensed laboratory by the California Department of Public Health (CDPH).

21 CFR Part 11

A documented audit trail is generated in a laboratory information system (LIS) for every specimen from receipt at the AcelaBio laboratory onwards and throughout the entire workflow.

GCP (Good Clinical Practice) / GCLP (Good Clinical Laboratory Practice)

Our lab has been set up in adherence to international standards: Good Clinical Practice (GCP) guidelines provide an international quality standard for the regulation of clinical trials. Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles in the analysis of samples from a clinical trial.

HIPAA (Health Insurance Portability & Accountability)

AcelaBio procedures comply with Health Insurance Portability & Accountability (HIPAA), which are the U.S. Federal standards protecting individuals’ medical records and other personal health information.

GDPR (EU General Data Protection Regulation)

AcelaBio procedures comply with the EU General Data Protection Regulation (GDPR), which protects the data and privacy of all individual citizens of the European Union (EU) and addresses the transfer of personal data outside the EU.