State Operations Manual (Pub. 100-07), Ch. 6 § 6116.6

During the Survey

Last amended: 2020Year: 2020Length: 149 wordsOfficial source
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.
State Operations Manual (Pub. 100-07), Ch. 6 § 6116.6: During the Survey | Justis AI