Newly regulated labs will be 'treated differently' and will not be sanctioned for deficiencies found during the first inspection, unless they pose
immediate jeopardy to patient care. The first inspection is educational. If deficiencies are cited, the facility will have to submit a "corrective action" plan within 14 days of notification.
If the lab requires additional inspections due to sanctions or deficiencies there would be additional fees for these subsequent investigations.
Sanctions that CMS might impose on labs found to be "out of compliance" with federal requirement might include: directed plans of correction; civil money penalties; payment for on-site monitoring by the agency conducting inspections; suspension of all or part of the payment for services furnished, suspending the lab testing, limiting performance on a specific lab test, or revoking the lab's CLIA certificate. CLIA does not exempt a facility from state regulation unless the state has been deemed by CMS. Examples: in New Jersey, offices with 5 or more physicians must apply for a state licence, in Florida and Pennsylvania all POL's must have a state licence. Offices should check with their state about similar regulations.
The laboratory must perform test only at the written or electronic request of an authorized person. Records of test requisition or test authorization must be retained for a minimum of two years. The patient's chart may be used. If the patients chart is used as the test requisition, it must be retained for a minimum of two years. This information must be available to the HHS upon request.