CMS Response to Public Comments Received for CMS-209
The Centers for Medicare and Medicaid Services (CMS) received a comment from a state agency related to the CMS-209. This is the reconciliation of the comment.
Comment:
CMS received a comment from a state agency suggesting that information in the CMS-209 contains the same information that is in the College of American Pathologists (CAP) template used when CAP surveys a facility. The agency requested to submit the CAP survey instead of submitting both surveys.
Response:
CMS appreciates the suggestion expressed by this commenter but that the CMS-209 contains the same information as the template used by CAP. The CMS-209 form is used by the laboratory to report the names and positions of personnel serving in the laboratory. The CLIA surveyor uses the information in the CMS-209 to choose a sample of personnel to verify compliance with the CLIA personnel requirements. The CAP template form is broader in scope than the CMS-209 and collects additional information such as date of hire and Florida licensure information that is not needed for federal purposes. In addition, CAP is a CMS-approved accreditation organization with deeming authority under CLIA and must have requirements that are equal to or more stringent than CLIA. Hence, CAP may collect additional information beyond what is required by CLIA.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Kathleen Todd |
| File Modified | 0000-00-00 |
| File Created | 2021-01-25 |