Pre-Survey Preparation

6112 - Pre-Survey Preparation (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Prior to each survey, review the laboratory’s file, including CLIA-database information. To determine the size of the survey team and the expected time required for the survey, consider the number of sites under the certificate, the scope and volume of testing, and the test complexity. 1. Personnel - Include the completed or updated Form CMS-209 in each survey package. Use this information during the onsite survey to evaluate positions currently held by employees in accordance with the requirements. Focus on new personnel since the last survey. 2. Services Offered - Review the CLIA application, the list of tests and specialties/subspecialties, laboratory services manual, and any correspondence from the laboratory to determine the complexity of tests performed. Ascertain whether the laboratory has changed analytes, specialties or subspecialties, or added/deleted tests or procedures since the last survey. 3. PT - Review PT records to ensure that the laboratory is enrolled and participating in an approved program for each PT listed in Subpart I, specialty, subspecialty, analyte, or test for which testing is performed. Note any unacceptable, unsatisfactory, or unsuccessful scores and any specialty, subspecialty, analyte or test that is not evaluated by the proficiency testing program provider. Use this information to target particular tests for review during the survey. 4. File Review-Evaluate the laboratory’s ability to maintain compliance between surveys by reviewing its file for: • Previous survey results, allegations of compliance, and plans of correction by noting patterns, number, nature of deficiencies, and dates of correction; • Enforcement action(s) taken or in progress, e.g., limitations of the certificate or voluntary withdrawal of a specialty, subspecialty, analyte or test due to unsuccessful proficiency testing or loss of qualified personnel; and • Complaint allegations noting frequency, significance, severity and, if substantiated, the resolution. 5. Initial Survey - Preparation for an initial survey may focus on the personnel qualifications, verification of data in the Form CMS-116, specialty/subspecialties, test volumes, and any correspondence with the laboratory prior to the survey.