CMS updates immediate jeopardy guidance for clinical laboratories

On Nov. 21, 2024, the Centers for Medicare & Medicaid (CMS) issued QSO-25-09-ALL, announcing that all guidance for clinical laboratories that was previously included in Appendix Q, Guidance on Immediate Jeopardy, was moved to the new Subpart XI, Clinical Laboratory Improvement Amendments (CLIA) of 1988, with specific immediate jeopardy policies for clinical labs.

In the letter, CMS announced that Subpart XI has been revised to reflect that laboratories that have been cited for immediate jeopardy can choose to cease testing operations to remove the immediacy of the immediate jeopardy citation. Laboratories that choose this route will be given 90 days rather than 23 days to correct the root cause of the deficiency, issue corrected reports as applicable and establish a mechanism to monitor the effectiveness of the actions before determination of compliance can be made by the surveyor.

For additional information, see QSO-25-09-ALL.