Each laboratory should always be in a state of inspection readiness and be prepared for an unannounced inspection at any time. State and local departments of health may have specific laboratory regulations. The specific department of health has the right to conduct an independent inspection.
All laboratories are required by CMS to participate in CLIA inspections/surveys to verify compliance with CLIA regulations. These surveys are not voluntary and may be conducted in conjunction with the state or local department of health or accreditation agency. The regulations can be viewed in the
Code of Federal Regulations (CFR).
CLIA inspections are performed by inspectors provided by state or local agencies who perform both routine and unannounced surveys. Routine surveys are most often scheduled with two weeks or less notice. CMS may also choose to perform unannounced surveys. These surveys most often result from a complaint or as a follow-up to a previous inspection. Post-inspection follow-up surveys are most often performed after the submission of a plan of correction. The purpose of the post-submission survey is to verify that the corrections have been made and that the scheduling of the corrections has met the deadlines submitted in the plan of correction (POC). Contacts for CLIA offices may be found
on their website.
The Food and Drug Administration (FDA) is charged with overseeing the collection and distribution of human blood products. Transfusion services and blood banks are inspected by FDA inspectors utilizing unannounced inspections. These inspections are required.
There are multiple accreditation agencies in which a laboratory may elect to enroll. Enrollment is voluntary.
| CMS grants deemed authority to accreditation organizations to conduct inspections for compliance with the CLIA regulations in conjunction with the inspection process to verify accreditation requirements. |
Despite the fact that the accrediting organization has been given the authority to inspect for CMS and establish compliance with CLIA regulations, CMS retains the authority to conduct a validation inspection if they desire. The purpose of such an inspection is to verify that compliance with CLIA regulations is being confirmed by the accreditation inspectors and that the outcome is aligned with CMS expectations.
