Announced and/or Unannounced Surveys

6106 - Announced and/or Unannounced Surveys (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Section 353(g)(1) of the PHSA provides for either announced or unannounced surveys, but it is generally CMS’ policy to use announced surveys. Complaint and onsite follow-up/revisit surveys must be conducted on an unannounced basis. For either an initial CLIA survey or recertification CLIA survey, an unannounced survey may be performed after one appointment is cancelled by the laboratory. For announced surveys, allow up to two weeks’ notice. The laboratory should be notified in writing (e.g. email, mail, etc.) and followed up by telephone as necessary. Notification may include the actual date and time of the survey. Use this communication to notify the laboratory about the potential consequences of cancelling an appointment. Request that the laboratory notify the SA, as appropriate, if its laboratory operations are not conducted during usual hours of operation or only on specific days and times. Surveys are to be conducted during the laboratory’s routine hours of operation. Confirm the laboratory’s certificate type and advise the laboratory to notify the SA of any changes that would necessitate a different certificate. Validation surveys of accredited or CLIA-exempt laboratories are typically announced, except for simultaneous validation surveys of laboratories accredited by certain accreditation organizations (See sections 6227.3.1 - 6227.3.2). In cases where there is significant evidence of noncompliance in the survey findings of the accreditation organization or CLIA-exempt SA, CMS has the latitude to treat such a survey as a complaint survey, which is unannounced. (See SOM Chapter 5 “Complaint Procedures” for guidance regarding complaint investigations.)