Inspection, Certification, and Enforcement
What this domain tests
This domain covers how laboratories become certified, how they are surveyed, and what happens when requirements are not met.
Core rules
- A laboratory applies for a CLIA certificate and is surveyed according to certificate type. Certificate of compliance laboratories receive routine surveys, generally every two years; certificate of accreditation laboratories are surveyed by an approved accrediting organization with CMS oversight.
- Complaint surveys and validation surveys may be unannounced.
- Immediate jeopardy allows immediate action to protect patients.
- Enforcement can include alternative sanctions (directed plan of correction, on-site monitoring, civil money penalties) and principal sanctions (suspension, limitation, or revocation of the certificate).
- Waived laboratories are not routinely surveyed but must permit inspection and can be investigated after complaints.
Worked example
A patient complaint alleges that a laboratory reports results without performing daily QC. The laboratory holds a certificate of compliance. Reasoning: CMS or the state agency may conduct an unannounced complaint survey. If immediate jeopardy is found, the laboratory can be subject to immediate suspension or limitation while corrective action is required. A plan of correction alone is not the only possible outcome.
Traps
Believing accreditation removes CMS authority. Assuming all surveys are announced. Forgetting that waiver labs can be inspected. Confusing alternative and principal sanctions.