State Operations Manual (Pub. 100-07), Ch. 6 § 6114
Entrance Interview
6114 - Entrance Interview
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
The entrance interview sets the tone for the entire survey. Be prepared, positive,
courteous, and make requests, not demands. Upon arrival, present the appropriate
identification, introduce other team members, inform the facility’s administrator,
director, or supervisor of the purpose of the survey, the time schedule, and explain the
survey process. Identify a contact person and establish a communication level based on
the degree of technical knowledge of the contact person.
If the laboratory consists of multiple testing sites, verify all information concerning
testing performed at each site. If one or more sites do not meet the multiple site
exceptions in the regulations (42 CFR 493.35(b), 493.43(b) and 493.55(b)), explain the
reason and have the owner/operator/director complete Form CMS-116 for each
applicable site. (Refer to section 6010 for information concerning conducting surveys of
multiple testing sites under one certificate.)
Inform the laboratory that the survey will include a tour of the laboratory, record
review, observation, and interviews with personnel involved in the preanalytic, analytic,
and postanalytic phases of the testing process. Establish personnel availability and
discuss approximate time frames for survey completion. Determine whether the
deficiencies, when identified, are to be discussed with testing personnel, and explain
that an exit conference may be held to discuss survey findings. Refer to section 6124
and section 6126, for additional information regarding the exit conference.
Request that the laboratory collect any documents, records, or information that may be
needed to complete the survey and solicit and answer any questions the laboratory may
have concerning the survey process.