Processes | Hematogenix — Bringing Precision Medicine to Everyone

Hematogenix® is committed to providing the highest level of quality services compliant with all laws, rules, and applicable regulations.

We adhere to critical policies consistent with all relevant laws and industry standards, and strive toward continual process improvement in all we do. Our Quality and Regulatory department ensures our procedures and training programs are current, and always emphasize integrity and respectful practices. We have had favorable outcomes with no actions indicated for all routine FDA inspections.

Information Protection

Hematogenix® will not use or disclose protected health information (PHI) or confidential client information without prior consent, and is fully compliant with the (amended) Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Upon hire, each employee is trained on HIPAA regulations.

Hematogenix® offers a secure method for data transfer, sample tracking, and trial management called HematoPass. Both internal and external internet and interface connectivity to the system is encrypted, password protected, and access is granted only with authorization. Hematogenix® utilizes layered physical security measures through electronic badge access, security cameras, and alarm monitoring systems, and planned redundancy measures. De-identified test result data may be made available to pharmaceutical companies and other third parties involved in cancer research, but this data will never include protected patient or confidential client information. Our customized reporting and customizable laboratory information system offers a thorough chain of custody for specimens, and is compliant with 21 CFR Part 11 requirements. We are compliant with the current EU General Data Protection Regulation (GDPR), and abide strictly to our Hematogenix® Privacy Policy.

CLIA

The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Hematogenix® is CLIA- certified to accept Medicare and Medicaid payments as a US laboratory providing quality testing services. Clinical diagnostic tests without US Food and Drug Administration (FDA) approval (class I and II in Vitro Diagnostic medical device-based methods) must meet CLIA performance specifications. Hematogenix® maintains full compliance with regulations for labeling non-FDA approved tests.

CAP

Hematogenix® is accredited through the College of American Pathologists (CAP) Laboratory Accreditation Program for comprehensive integrated Pathology services, and employs in-house Staff Pathologists from Chicago, Illinois USA headquarters, as well as many partnering pathologists and specialists. Hematogenix® staff pathologists and PhD-credentialed scientists train to master cutting-edge diagnostic techniques and new technologies, while specializing in pertinent clinical and research areas such as hematopathology, prostate and solid tumor pathology, immune-oncology, genetics, molecular diagnostics, and precision medicine.

GCP

The International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use has outlined standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. These standards provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Hematogenix® is compliant with these standards, and supportive to all pharmaceutical clients sponsoring GCP-compliant clinical trials.

Audits

Audits provide independent evidence of compliance status with relevant regulatory requirements and sponsor contracts. Hematogenix® conducts internal audits through its Quality Assurance program, and welcomes audits from external partners. We request advance notice to ensure availability of relevant personnel.

If a regulatory body or certification agency requests test performance or quality assurance data for Hematogenix® testing, please contact the Hematogenix® Quality & Regulatory department.

Quality Assurance

Our Quality and Regulatory department leads Hematogenix® Compliance and Quality Assurance programs globally, and is based within company headquarters in Chicago, Illinois, USA.

Hematogenix® utilizes standardize validation practices for the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of laboratory instrumentation during initial installation, after substantial repair, after relocation, or any other instance that may affect the function of instruments. For each platform, department, and client project, experiment protocols are maintained, and reagent, sample and operator information is recorded in SOP-specific worksheets, data files, and notebooks. Hematogenix® has a numbering system to systematically identify and label SOPs, and maintains top line informational management hardware, software, personnel, and technical capabilities to ensure systems uptime, data integrity and availability, and business continuity.

Continual Process Improvement at Hematogenix® ensures we strive for excellence and take every opportunity to make changes that decrease errors and successfully deliver to clients. We engage in ongoing regular communication with clients and partners in an honest dialogue. We encourage the identification of these opportunities to improve as well as any collaborative suggestions that will ultimately impact patient care.