Quality

Experts accredited in
genetic diagnostic testing
of inherited diseases

CLIA (Clinical Laboratory Improvement Amendments)

CLIA (Clinical Laboratory Improvement Amendments): awarded by the US federal government’s Centers for Medicare & Medicaid Services (CMS).

ACCREDITATIONS

Quality assurance and technical competence [downloadable technical appendix]:

Health in Code is a member of the European Molecular Genetics Quality Network (EMQN) and participates periodically in strict proficiency testing schemes (EQA Schemes).

Health in Code is listed in the GTR® (Genetic Testing Registry) and registered with the Consellería de Sanidade, Xunta de Galicia (C-15-002226) and with the Ministry of Economy and Competitiveness, Spain (MINECO).

CERTIFICATIONS

Quality management system:

AWARDS

• Innovative SME Award 2016.
• Seal of Excellence: Certificate delivered by the European Commission as managing institution for Horizon 2020, the EU Framework Programme for Research and Innovation 2014-2020. Project proposal no. 729192, HIC-SW_HIC-Software: A new Laboratory Management System (LIMS) for genetics.

Quality Control and Analytic Validation

Quality control at Health in Code is understood as management of the performance of the pre-analytical, analytical and post-analytical stages of the clinical laboratory process; which includes monitoring the test methodologies and specifications, reagents, equipment, sample handling, test reporting, internal and external audits to ensure the continuous high quality of testing.

Health in Code performs analytic validation studies following the guidelines from the EuroGentest Group and the ACMG (American College of Medical Genetics), in accordance with the requirements of UNE-EN ISO 15189 quality standard for clinical laboratories. Analityc validity of Health in Code’s NGS panels has been demostrated for SNPs and INDELs (≤20 pb) utilizing a standard reference sample NA 12878 (Coriell Cell Repositories, NJ) with results yielding on average: 1.000 sensitivity, 1.000 specificity and 0.999 accuracy for both SNPs and INDELs; as well as high repeteability and reproducibility scores (≈96%) for variant detection. In addition, Sanger sequencing is used to confirm those clinically relevant variants obtained with suboptimal quality parameters, as well as variants located in low coverage regions.