State Operations Manual (Pub. 100-07), Ch. 6 § 6116.6
During the Survey
6116.6 - During the Survey
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20)
The surveyors should allow laboratory personnel to accompany them during the tour of
the facility. The tour of the facility should include observation, record review and
interviews with personnel involved in preanalytic, analytic and postanalytic phases of
testing. Managerial staff generally should not be present during staff interviews. The
SA should exercise discretion in each case. Laboratory personnel may be helpful,
answer questions, or point out certain things of concern to the surveyors. The surveyor
should use such assistance if it is helpful to the survey and makes the process easier.
Laboratory personnel should give the surveyors privacy as needed when the surveyors
discuss their survey findings. Conversely, if the laboratory personnel harass
surveyor(s), argue about observed problems, and make the survey more difficult, the
surveyor should remove themselves from the difficult and or hostile environment.