A high-complexity Mohs lab operating under CLIA (42 CFR Part 493) documents daily quality control, investigates and corrects out-of-range results, tracks personnel competency, and keeps records retrievable for inspection. This guide summarizes what to document, what triggers a corrective action, how long to keep records, and what a surveyor checks first.
What daily QC does a Mohs lab document?
A Mohs histology lab documents daily hematoxylin and eosin (H&E) stain quality, cryostat temperature, and control slide checks, each signed by the technician performing the work (42 CFR §493.1256). Reagent lot numbers and expiration dates are tracked alongside daily use so an expired reagent cannot be used unnoticed.
What triggers a corrective action report?
Any QC result outside its defined acceptable range triggers a corrective action, most commonly a cryostat temperature reading outside the validated range or a control slide that fails to stain correctly. The report documents the incident, the root cause, and the preventative action taken, and the day's QC record is not considered complete until the corrective action is filed.
How long must records be retained?
CLIA generally requires test records, QC records, and proficiency testing records to be retained for at least two years (42 CFR §493.1105). Some record types, such as personnel qualifications and competency assessments, are commonly kept for the duration of employment plus additional time under state licensing requirements. Confirm specifics with your CLIA state agency, since requirements vary by record type and jurisdiction.
What do inspectors check first?
A CLIA surveyor typically starts with the facility's CLIA certificate and personnel credentials, then moves to daily QC logs, looking for gaps, illegible entries, and how corrections are handled. From there, inspectors trace out-of-range results to their corrective action reports, review competency and peer review documentation against the CLIA schedule, and check that procedure manuals are under document control (42 CFR §493.1251).
Definitions
- CLIA
- Clinical Laboratory Improvement Amendments, the federal program that regulates laboratory testing under 42 CFR Part 493.
- QC (Quality Control)
- Routine checks, such as stain quality and cryostat temperature, that confirm testing is performing correctly on a given day.
- QA (Quality Assurance)
- The broader program that ensures overall lab quality, including personnel competency, peer review, and corrective actions.
- CAR (Corrective Action Report)
- Documentation of the root cause and remediation for an out-of-range or nonconforming QC result.
- 21 CFR Part 11
- The FDA regulation governing electronic records and electronic signatures, relevant when QC documentation moves from paper to software.
Frequently asked
Does CLIA require paper QC records?
No. CLIA requires records to be complete, retrievable, and attributable. It does not require paper. Electronic QC records with e-signatures and an audit trail can meet these requirements.
What is a Corrective Action Report?
A Corrective Action Report documents the root cause and remediation steps when a QC result falls outside the acceptable range, such as a cryostat temperature reading outside the validated range.
How long should a Mohs lab keep QC records?
CLIA generally requires test and QC records to be retained for at least two years (42 CFR 493.1105). Some record types carry different retention periods, so confirm specifics with your CLIA state agency.
This guide is general information about CLIA documentation practices, not legal or regulatory advice. Confirm current requirements with your CLIA state agency and legal counsel before changing how your lab documents QC.
MohsBinder covers each of these record types as a signed, chained digital record: enforced daily QC with role-gated signatures, automatic Corrective Action Reports for out-of-range results, and a tamper-evident SHA-256 audit trail. Request early access or read more about our security and compliance approach.