Survey Due to Unanticipated Events

6102.2 – Survey Due to Unanticipated Events (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The SA or CMS conducts a survey at an earlier date than planned if there is reason to believe the laboratory is being operated in a manner that constitutes a risk to human health. Possible reasons for this would be a complaint about deteriorating standards of operations, results of an accreditation survey of an accredited laboratory, loss of laboratory accreditation, substantial changes in managerial personnel, continued unsatisfactory PT performance, or a significant change (e.g., from moderate to high complexity) in the type of testing performed. The decision to conduct a survey at an earlier date than originally planned depends upon whether there is likelihood that certification status could be changed. Such surveys must be unannounced.