CMS Validation Inspections: A Real Possibility
Sam Prien, Ph.D., HCLD(ABB)

During the summer of 2025 my lab had its normal bi-annual CAP inspection for the endocrine section. It went so well. So well, in fact, that we completed all post inspection issues and received our updated certificates within 21 days of our inspection date. As you can imagine there was a collective lab sigh of relief as we prepared to return to the day-to-day routine of laboratory work. Then the phone rang. It was from the state health department; in our state they are responsible for CMS inspections. “Hello, I am _____ with the State Health Department. This is to inform you your laboratory has been randomly selected to undergo a CMS Validation inspection,”

I will not lie, my heart skipped more than one beat. A Validation inspection? A term heard long ago but forgotten. The inspector continued, “I will arrive on ___(in two weeks) please have all materials you had available to you CAP inspector available for my review.” As she could obviously sense my confusion, she added, “I want to make clear this inspection is to validate the integrity of the inspection process and that CAP conducted your inspection in accordance with CMS guidelines. This is not a reflection of an issue or complaint with your laboratory but a Congressional mandate to do a reinspection of CAP and JCHO inspections. We are required to report any deviations between their inspections and our review in an annual report to Congress.”

While I remembered reading about these in the mid- 2010’s¹, I had never actually heard of one being done. The inspector was thorough, and the day was intense. We learned several places where CAP and CMS have differences. But at the end of the day we were found in compliance and the CAP inspection team had done its job.

Bottom line, CMS Validation Inspections are rare but real. By law they must occur within 90 days of the original inspection date. They will be as or even more thorough than a CAP or JCHO inspection. And the possibility should not be forgotten.

Oh, and one other thing we learned, beginning in 2026, CMS renewals will be emailed, but only if your lab signs up.

“Important Action! Laboratories have until March 1, 2026, to switch to CMS email notifications and begin receiving electronic CLIA fee coupons and certificates. After this date, paper fee coupons and CLIA certificates will no longer be available. Don’t wait! Reach out to your State Agency for assistance. For more details, visit Clinical Laboratory Improvement (CLIA) Amendments.”

¹ QC for accreditation: CMS validation inspections - CAP TODAY