CMS SOM App. C, Tag D6005

(c) The laboratory director must:

(c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum

two on-site visits. Laboratory directors may elect to be on-site more frequently and must

continue to be accessible to the laboratory to provide telephone or electronic consultation as

needed; and

(c)(2) Provide documentation of these visits, including evidence of performing activities that

are part of the laboratory director responsibilities.

Interpretive Guidelines §493.1407(c)(2)

The on-site visits are meant to supplement regular interactions between off-site directors

and the lab (for example, by telephone or other telepresence). Documentation of

laboratory director’s on-site visits should demonstrate the laboratory is in continuous

compliance with current laws and regulations, including but not limited to the assessment

of the physical environment for safe laboratory testing. The laboratory director’s on-site

visits cannot be delegated.

The laboratory director determines the type or process of documentation needed as

evidence of performing on-site visits. Documentation may include, but is not limited to,

sign in/sign out logs, meeting minutes/summary, notes of observations, and travel

vouchers.