Scheduling Priorities

6102.1 – Scheduling Priorities (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) When scheduling surveys use the following priorities: • Complaint surveys indicating possible immediate jeopardy; • Laboratories with other complaint investigations pending; • Initial surveys; • Recertification surveys; • Follow-up/Revisit surveys; • Validation (non-complaint) surveys; • Special Surveys for Certificate of Waiver and Provider-performed Microscopy Laboratories. Scheduling surveys - There are two activities associated with scheduling surveys: • Contacting the laboratory to schedule the date and time of the survey using scheduling guidelines, geographic areas, and appropriate survey timeframes. • Providing the appropriate forms to the laboratory (Forms CMS-116, CMS-209, etc.) For efficiency when scheduling, attempt to cluster surveys geographically, to include initials, recertifications, complaints, and validations. Extenuating circumstances require CMS review. In instances where the State requires a laboratory survey at a different time frame than CLIA, the State should meet both survey scheduling requirements as efficiently as possible. For example: The State requires a survey before the laboratory can operate in that State. The SA can survey the laboratory for compliance with the State requirements and return in the appropriate time frame to survey for compliance with the CLIA requirements. 1. Initial Surveys: In order to permit observation of actual testing during the initial survey, schedule the initial survey to occur at least 90 days after the data entry date of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, Form CMS-116, but no later than 12 months after the data entry of the Form CMS-116. For example: Form CMS-116 data entry date is May 12, 2015. Initial survey should be conducted between August 10, 2015 (90th day after May 12, 2015) and May 11, 2016 (365th day after May 12, 2015). If after the 90 days a representative from the laboratory states that laboratory testing is not being performed because equipment is not ready, etc., please notify CMS. If there is suspicion that the laboratory is being operated in a manner that constitutes a risk to human health, schedule an unannounced survey. An unannounced survey could be an option for either case. 2. Recertification Survey: Schedule the recertification survey to occur at least 6 months (180 days) prior to the expiration date of the laboratory’s current certificate, but no earlier than 12 months prior to the expiration date of the current certificate. For example: Current certificate expiration date is December 31, 2014. Recertification survey should be conducted between December 31, 2013, and July 4, 2014. Establish a date and time for the survey once the schedule has been completed. If a laboratory operates more than one shift or location, schedule survey hours to include a representative cross-section of shifts or locations, as necessary. All surveys of accredited laboratories must have prior approval from CMS. To enhance survey effectiveness and efficiency, except in the case of complaints or other instances in which you would conduct an unannounced survey, consider providing the following forms to the laboratories before the scheduled survey date. Request that the laboratory complete the forms and either return them prior to the onsite survey or hold them for review during the onsite survey. • Laboratory Personnel Report (CLIA), Form CMS-209 (required) with directions for completing or updating information, including all testing personnel since the last survey and any new personnel or changes in positions or status; and • The laboratory should accurately complete the Form CMS-116. Request the following information be accessible and retrievable at the time of survey: • Standard operating procedure manual with all test procedures (e.g., package inserts and supplemental information, as necessary); • Reference laboratories’ client services manual, if applicable; • Records of tests referred to other laboratories; • Personnel records, including: a. Diplomas, certificates, degrees, transcripts; b. Training and experience; c. Continuing education; d. Competency assessment; e. Duties/responsibilities; f. Personnel changes; and g. Primary Source verification (PSV) reports if applicable. • Quality control records, including: a. Corrective and or remedial action information; b. Calibration and calibration verification records; c. Statistical limits; and d. Instrument maintenance and function checks records. • All proficiency testing (PT) records, including: a. Test runs with PT results; b. Direct printouts; c. Corrective and or remedial actions for unsatisfactory results; d. Copies of the signed PT attestation forms provided by the PT program; and e. For nonwaived tests and procedures that are not listed in Subpart I, verification of test or procedure accuracy twice yearly. • Quality system assessment plan and documentation: For each of the systems: a. Policies and procedures to monitor, assess, and correct identified problems; b. Documentation of ongoing assessment activities, including: 1. Review of the effectiveness of corrective actions taken; 2. Revision of policies and procedures to prevent recurrence of problems and address complaints; and 3. Discussion of assessment reviews with staff. • Safety information; and • Patient testing records: a. Requisition (patient charts may be used); b. Work records (direct printouts); and c. Patient test reports (patient charts may be used)