State Operations Manual (Pub. 100-07), Ch. 6 § 6016.1.2
Change in Specialty or Subspecialty (Certificate of
6016.1.2 - Change in Specialty or Subspecialty (Certificate of
Compliance)
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
Based on the timing of the notification of a change in specialty or subspecialty, the SA
should determine if a revisit needs to be performed. The timing may allow for the new
specialty or subspecialty to be reviewed during the recertification survey. If a revisit
needs to be performed, the SA determines whether the revisit should be onsite or offsite
depending on the added specialty or subspecialty and equipment in place at the
laboratory. The SA should contact CMS for further guidance if needed.