CLIA compliance support for Mohs labs
A Mohs lab is a CLIA lab, with the paperwork that comes with it. Mohs Pros helps practices keep the documents and records in order, whether you're applying for a certificate or getting ready for an inspection.
What CLIA requires for a Mohs lab
A Mohs lab performs high-complexity testing under CLIA, so it needs a CLIA certificate for non-waived testing: a Certificate of Compliance (inspected by the state for CMS) or a Certificate of Accreditation (from a CMS-approved accrediting organization). It also needs a qualified laboratory director, written procedures, quality control and equipment maintenance records, and personnel training and competency records, and it is inspected every two years. California also requires a state clinical laboratory license.
Where we can help
- Preparing for CLIA certification when you open a new Mohs lab
- A procedure manual written for how your Mohs lab works
- Quality control, temperature and maintenance logs
- Personnel records and competency documentation for lab staff
- Getting ready for an inspection, and following up on findings
Mohs Pros supports your compliance work; it doesn't replace your laboratory director or give legal advice.
Pairs well with
Mohs lab setup, for new labs, and Mohs Pros techs, who keep the day-to-day logs as part of their work.
Questions
- Does a Mohs lab need CLIA certification?
- Yes. A Mohs lab examines patient tissue to guide treatment, which makes it a laboratory under CLIA. Your state may have its own lab rules as well.
- Who is responsible for compliance?
- Your laboratory director stays responsible under CLIA. Mohs Pros supports the work: documents, records and preparation.