Transfusion-Related Fatalities

6040 - Transfusion-Related Fatalities (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Facilities, including laboratories, involved in the collection or transfusion of blood or blood products must report transfusion-related fatalities to the FDA’s Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality. The FDA notification process, including contact information, can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying- fda-fatalities-related-blood-collection-or-transfusion. The FDA notifies CMS of all transfusion related fatalities. (NOTE: The reports from the FDA are considered confidential and may only be shared within CMS or the SA. They may not be shared with any other party, including accreditation organizations.) 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 from CMS or SA when the investigation is complete. CMS evaluates the information received from the FDA. As applicable, CMS may request that a survey of the facility be performed. Depending on the circumstances of the fatality, a CLIA survey, a survey by another CMS program (e.g., hospital), or both, may be necessary. The surveys may be performed simultaneously or separately. Either CMS or SA (including CLIA-exempt States) may perform the survey, but the survey may not be delegated to an accreditation organization. For investigations involving staff from more than one program unit (e.g., CLIA and hospital), it is important to work as a team to coordinate activities. The investigation should also include a review of other transfusion reaction reports to ensure that proper procedures were followed and corrective actions implemented. CMS should assure that all measures are taken to correct the situation which led to the death as well as any other serious deficiencies uncovered in the course of the survey. For CLIA purposes, transfusion-related fatalities that warrant surveys are considered to be complaints. The policies and procedures that apply to complaint investigations apply to transfusion-related fatality investigations. The investigations are entered and tracked in the ASPEN Complaints/Incidents Tracking System (ACTS). When performing investigations in accredited laboratories or laboratories in exempt states, follow standard policies and procedures for CMS authorization, review of deficiencies, and communication with the laboratory, the accreditation organization, and the exempt state. CMS or SA will conduct the survey within 45 days of the notice. The information entered in ACTS is sufficient for reporting to CMS. Investigations of transfusion- related fatalities may be 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. CMS or SA will assess the facility’s compliance with applicable CLIA conditions and standards during the onsite review. If condition-level deficiencies are found, a full CLIA inspection is conducted. The survey may uncover problems that warrant investigation of departments outside the laboratory, e.g., Operating Room, Emergency Room, nursing services, or medical records, to follow up on problems that may have led to the fatality. Since CLIA is specific only to laboratory testing, CMS forwards relevant information to other programs, e.g., hospital, for follow up as necessary. (NOTE: When citing deficiencies related to a CLIA survey, only D-tags should be used on the 2567. A-tags and State tags should not be used on the 2567 given to the laboratory for the CLIA survey.) In addition, more than one location may be involved, for example, when the blood is tested in one facility and transfused in a different facility. CMS or the SA will issue deficiencies and document the survey in ACTS using standard policies and procedures. Ensure that all documentation is included in ACTS. Proficiency Testing