CLIA · CAP · ISO 15189 · State licensure
We help laboratories earn and keep CLIA certification, CAP and ISO 15189 accreditation and state licenses, guided by a team that runs its own accredited laboratory.
What we do
Turnkey support for new laboratories, or targeted help alongside your team.
CLIA applications, test complexity review and choosing between a Certificate of Compliance and a Certificate of Accreditation.
Checklist mapping, quality system build-out and responses to CAP and ISO 15189 audit findings.
California, New York, Pennsylvania and other state licenses, including requirements for out-of-state specimens.
Document control, SOPs, logs and proficiency testing enrollment built to accreditor requirements.
Gap assessments, mock inspections, inspection-day support and deficiency responses.
Director and personnel qualification review, plus contracted or interim laboratory directors.
How it works
Gap assessment of your tests, personnel, facility and documents against CLIA, accreditor and state requirements.
Close the gaps: quality system, SOPs, validations, proficiency testing and personnel files.
Prepare and submit CLIA, accreditor and state applications, and track them to approval.
Mock inspection, inspection-day support, deficiency responses and ongoing compliance.
Who we help
We support new diagnostic laboratories, biopharma and biotech teams launching LDTs or companion diagnostics, international laboratories entering the US market, and academic groups moving research assays into clinical testing.
PacificDx, our own laboratory, is CLIA certified, CAP accredited and licensed in four states, so our advice comes from going through inspections ourselves.
Tell us where your laboratory is today and the accreditation you need, and we will scope the work.