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LICENSURE & COMPLIANCE

Quality Control Program CGI is committed to providing reliable and accurate diagnostic services to our clients. Patient safety, in the form of accurate specimen identification, timely communication of life-altering diagnoses is paramount in everything we do. We monitor and improve our performance through a variety of methods, including performance improvement indicators, proficiency testing, external audits, and satisfaction surveys. All quality concerns and incidents are subject to root cause analysis, and our procedures are all put through periodic evaluation via the Plan-Do-Check-Act model of continuous improvement, to ensure that we are providing the best services possible to our patients and clients. Protection of patient results from misuse or poor access is imperative and thus electronic and paper results are strictly guarded via password-protection and ID cards according to HIPAA guidelines. CGI’s laboratory is GCP and HIPAA compliant, CLIAcertified, CAP-accredited, and holds licensure in several US States including New York State. Our commitment to quality extends to our employees as we have a comprehensive safety program to ensure the health and well-being of everyone at CGI.

Licenses and Credentials CGI and CGI Laboratories are fully approved, accredited and licensed by CLIA, CAP, Medicare/Medicaid and states of California, Florida, Maryland, New Jersey, New York, and Pennsylvania. Our operations extend throughout the East Coast and include multiple states in New England, Mid-Atlantic and the South. The laboratory operations adhere to HIPAA guidelines and policies.

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RUTHERFORD, NJ CAP Accreditation

Lab Number: 7191582, AU-ID: 1434060

CLIA Certificate

Certificate Number: 31D1038733

California License

COS 00800558

Florida License

800018142

Maryland License

1395

New Jersey License

CLIS ID: 0002299

Pennsylvania License

031978

New York License

PFI: 8192

LOS ANGELES, CA CAP Accreditation

Lab Number, LAP#: 7209131

CLIA Certificate

Certificate Number: 05D1066073

California License

CLF00335062

Florida License

800024084

Maryland License

1471

New York License

PFI8384

Pennsylvania License

030842

Rhode Island License

LC00525

RALEIGH, NC CAP Accreditation Biorepository

Lab Number: 8033768, AU-ID: 1636028

CLIA Certificate

Certificate Number: 34D1009209

21 CFR 58 compliant GLP 21 CFR 11 compliant (Electronic Signatures) ISBER Best Practices

SHANGHAI, CHINA Meets or exceeds all local regulatory compliance expectations and is both CLIA and CAP compliant.

Licenses can be printed directly from the Clinical Testing tab on our website at: www.cancergenetics.com/clinicaltrials/regulatory-licensing


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