QC2 offers the following central laboratory / clinical pathology laboratory audits:

Safety Panels

QC2 conducts audits of clinical pathology/central laboratories to assess systems and facilities for compliance with industry best practice, Standard Operating Procedures, 21 CFR Part 11, CLIA, CAP, applicable state regulations, and FDA guidances.  Assays typically include automated chemistry, hematology, urinalysis, special chemistry, and other contracted assays.  Additionally, the audits include assessments of instrument and assay validation.

Flow Cytometry

QC2 conducts audits of flow cytometry laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays include immunophenotyping and client-specific assays.  Additionally, the audits include assessment of instrument and assay validation.

Molecular Diagnostics

QC2 conducts audits of molecular diagnostics laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays include detection of viruses as well as gene rearrangements or client-specific assays.  Additionally, the audits include assessments of instrument and assay validation.

Cell-Based Assays

QC2 conducts audits of cell-based assays laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays are typically client-specific.  Additionally, audits include assessments of instrument and assay validation.

Specialty Diagnostics

QC2 conducts audits of specialty diagnostic laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays are typically commercially available and kit-based, but may also be client-specific.  Additionally, audits include assessments of instrument and assay validation.