Conducting Investigations in a Laboratory with Certificate of

5510.4 – Conducting Investigations in a Laboratory with Certificate of Registration (Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25) Certificates of Registration (CoR), regardless of whether it is a pending CoC or Certificate of Accreditation (CoA), will be investigated by the SA or CMS. The SA enters all complaints received into the CLIA Data System and notifies CMS for approval or denial to perform the survey. Note for Transfusion-Related Fatality Investigations: CMS or the SA will conduct the survey within 45 days of the notice from CMS, with notification to CMS when the survey is complete. A copy of the investigation report should be submitted to CMS within 60 days, including the Form CMS-2567, if issued. Investigations of transfusion-related fatalities are generally announced, since the facility is aware of the possibility of a follow up after the report is made to the FDA. These investigations are an exception to the general policy that complaint surveys are not announced. However, if the report of the fatality originates with any other source, e.g., media or anonymous complaint, the SA or CMS conducts an unannounced survey. Transfusion-related fatality investigations must not be referred to an AO for action. However, the AO or multiple AOs, as appropriate, will receive a copy of the Form CMS-2567 and the accompanying notification letter from CMS when the investigation is complete. Summary and information from the FDA are considered confidential and may only be shared within CMS or the SA. It may not be shared with any other party, including AOs. See SOM Chapter 6 section 6040.