Exit Conference

6126 - Exit Conference (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The purpose of the exit conference is to provide an overview of your findings with the laboratory. It is not meant to be an exhaustive discussion of your findings. It is the continuation of the survey process and is the first opportunity for the laboratory to present additional information in response to the findings. Acknowledge staff cooperation and operational support, as appropriate, before addressing the non- compliance issues. The exit conference is also the beginning of the period during which corrective action can be taken if the laboratory is to be subject to a corrective or an enforcement action. If immediate jeopardy or condition-level deficiencies are identified, inform the laboratory of the seriousness of the problem(s)/finding(s) and indicate that they are not final until receipt of the written statement of deficiencies Form (CMS-2567). In this or any other instance where adverse action is anticipated, the surveyor explains the implications, making it clear that only compliance will stop the action. If the surveyor(s) calls IJ at the time of the onsite survey, the IJ Template in Appendix Q must be used. If the surveyor(s) determines that IJ exists after leaving the onsite survey, upon review of the information and evidence collected at the onsite survey, the completed template must be given to the laboratory at the time IJ is determined. This may be done electronically. CLIA surveyors are not required to return to the laboratory to deliver the completed template (see CLIA subpart of Appendix Q for sections that do not apply to CLIA). The laboratory will still be notified of the IJ, via written notice, when the Form CMS-2567 is sent to the laboratory requesting an Allegation of Compliance (AoC). Refer to Revisions to Appendix Q, Guidance on Immediate Jeopardy, for further information. The surveyor advises the laboratory that a revisit to verify correction of deficiencies occurs only when the laboratory submits a credible AoC. If the laboratory does not provide CMS/SA with a credible AoC, no revisit will be made and the adverse action process will continue. Consider the following when conducting an exit conference: • Conduct the exit conference with the facility’s administrator, director, consultant, or supervisor, and/or other invited staff; • Describe the laboratory practices that fail to be in compliance with the regulatory requirements and the findings that substantiate these potential deficiencies. In presenting findings, the surveyors cite problems that clearly violate regulatory requirements and provide an explanation to the laboratory concerning the deficiency in specific terms (without using data tags or regulation citations) to allow the laboratory to understand why the requirement is not met. Frequently, the explanation will imply the action needed to correct the problem. Because there may be several possible causes for any deficiency, it is not the surveyor’s responsibility to sift through various alternatives to suggest an acceptable remedy. For example, if a laboratory was cited for maintaining incomplete patient specimen records, the surveyor specifies what is missing, not why it is missing or what process is best for ensuring that the records are complete in the future. If asked for the regulatory basis, the surveyor provides the regulatory basis for noncompliance; • Provide the laboratory an opportunity to discuss and provide additional information regarding potential deficiencies. It is the laboratory’s responsibility to determine the corrective action(s) necessary to remedy the problem(s); • Inform the laboratory that they will receive a written statement of deficiencies (Form CMS-2567) with the final deficiencies cited; • A team member should indicate that the official findings are presented in writing on the Form CMS-2567 and will be forwarded to the laboratory within 10 working days. The laboratory must also be informed they are to return the PoC or credible AoC in 10 calendar days of receiving the Form CMS-2567 Statement of Deficiencies; • Given the complexity of the regulations and nature of the survey, the surveyors must indicate to the laboratory that the specific regulatory reference will be found in the Form CMS-2567 report that will be issued to them. The laboratory is informed that the information discussed in the exit interview is preliminary and the lab management will have an opportunity at the exit interview to talk in general about the issues that were found; • Inform the facility of your intended recommendation to CMS to certify, recertify, or deny certification of the laboratory. In an initial survey, the surveyor tells the laboratory to expect notification from CMS of their initial approval (issuance of a certificate). For subsequent biennial surveys, the surveyor explains that CMS issues an updated certificate reflecting any changes in approved services; and • At the exit interview, inform the laboratory (director/administrator/supervisor) of changes in test volumes which may result in fee changes. Although it is CMS’ general policy to conduct an exit conference, the surveyor should be aware of situations that would justify a refusal to conduct or continue an exit conference. Please document the reason if no exit conference is conducted. For example: • If counsel represents the laboratory (all participants in the exit conference should identify themselves), the surveyor should refuse to continue the conference if the lawyer tries to turn the exit conference into an evidentiary hearing. • Any time the laboratory creates an environment that is hostile, intimidating, or inconsistent with the informal and preliminary nature of an exit conference, the surveyors should refuse to continue the exit conference. • If the laboratory wishes to audio tape the conference, the surveyor should refuse to continue the conference unless the laboratory agrees to tape the entire meeting and provide surveyor(s) with a copy of the tape at the conclusion of the conference. Videotaping is also permitted if it does not intimidate the surveyors or disrupt the conference, and a copy is provided at the conclusion of the conference. Use discretion in deciding whether to permit videotaping. The survey team should establish and maintain control throughout the exit conference. The survey team presents the findings but should refrain from arguing. The surveyors should be mindful that laboratory staff may disagree with the survey findings. The laboratory representatives have a right to disagree with survey findings and to present information to refute them and the team should be receptive to such disagreements. If the laboratory representatives present information to negate any of the survey findings, the surveyor(s) should indicate willingness to reevaluate the findings before leaving the laboratory. If deficiencies are corrected before the completion of the survey, the surveyor should acknowledge the corrections and explain how this situation will be documented.