The Survey Process - Emphasis, Components, and Applicability

6100 - The Survey Process - Emphasis, Components, and Applicability (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Survey protocols and Interpretive Guidelines provide guidance to personnel conducting surveys of laboratories. Surveys are conducted using an outcome-oriented survey process, which places emphasis upon performance or outcome measurements to ensure accurate and reliable test results and other related activities. The purpose of the protocols and guidelines is to provide suggestions, interpretations, and other tools to use in preparing for and conducting the survey and for analyzing and evaluating survey findings. Both the SA and CMS use the same survey protocol. The SA and CMS are responsible for conducting the onsite survey and entering the information concerning the results of the survey into the CLIA Data System. The following protocols represent an outcome-oriented method to be used to conduct the survey. The focus of the survey is to assess how the laboratory monitors its operations and ensures the quality of its testing. The intended use of these protocols is to promote consistency in the survey process, and to ensure that a laboratory’s operations are reviewed in a practical, efficient, and effective manner so that at the completion of the survey there is sufficient information to make compliance determinations. While the purpose of the protocols and guidelines is to provide direction in preparing for the survey, conducting the onsite survey, and analyzing, evaluating, and documenting survey findings, the surveyor’s professional judgment is the most critical element in the survey process. CMS’ objective is not only to determine the laboratory’s regulatory compliance but also to assist regulated laboratories in improving patient care by emphasizing those aspects of the regulatory provisions that have a direct impact on the laboratory’s overall test performance. CMS promotes the use of an educational survey process, especially on the initial laboratory surveys to help laboratories understand and achieve the quality system concepts. It is the surveyor’s objective, using professional judgment, to determine, based on observation of the laboratory’s (past and current) practices, interviews with the laboratory’s personnel, and review of the laboratory’s relevant documented records, if the laboratory is performing quality clinical laboratory testing. Surveyors should make every effort to minimize the impact of the survey on laboratory operations, patient care activities, and to accommodate staffing schedules and departmental workloads as much as possible. In facilities providing direct patient care (e.g., physician offices, clinics, residential care facilities, and hospitals), surveyors should avoid interrupting or interfering with patient care. Surveyors should respect patient privacy and confidentiality at all times in all survey settings.