493.1816—Action when deficiencies are not at the condition level.

If a laboratory has deficiencies, that are not at the condition level, the following rules apply:

(a) Initial action. The laboratory must submit a plan of correction that is acceptable to CMS in content and time frames.

(b) Failure to correct deficiencies. If, on revisit, it is found that the laboratory has not corrected the deficiencies within 12 months after the last day of inspection, the following rules apply:

(1) CMS cancels the laboratory's approval to receive Medicare payment for its services.

(2) CMS notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's CLIA certificate and of the laboratory's right to a hearing.

CFR

493.1816—Action when deficiencies are not at the condition level.