By Stacy Freeburg, FACT Accreditation Coordinator
Programs monitor adverse events for patient safety and report events to third party organizations (FDA, Trial Sponsors), who consider the implications of single adverse events and compile the data to identify potential trends. Management of adverse events within an organization related to the administration of cellular therapy products is required by the FACT Standards.
FACT defines an adverse event as any unintended or unfavorable sign, symptom, abnormality, or condition temporally associated with an intervention that may or may not have a causal relationship with the intervention, medical treatment, or procedure. An adverse reaction is classified as a type of adverse event. In the standards, references are made to adverse events that encompass required detection, investigation, documentation, reporting, corrective and preventive action, and the responsibility to report incidents to different entities.
If an unexpected or serious adverse reaction occurs due to cellular therapy product collection or administration for which there is a reasonable possibility that the response may have been caused by the product, the report of the adverse reaction and its outcome and investigation should be communicated to all facilities associated with collection, processing, and/or administration of the product.
Organizations must comply with FACT Standards and policies throughout their accreditation cycle, including submission of the Annual and Renewal Report within 30 days of receipt (refer to the FACT Maintaining Accreditation Policy). The Annual Report is sent on the 12-month anniversary of current accreditation, whereas the Renewal Report is sent 14 months prior to expiration.
These reports allow organizations to update FACT regarding their demographics, changes in key personnel, facilities, or services, and submit required documentation of corrective action, as applicable. The report also requires programs to provide an explanation of any serious or unexpected adverse event that occurs during the reporting period. As defined by the FDA, serious adverse events have a severe impact on an individuals’ health, potentially leading to life-threatening consequences, permanent damage, or extended hospital stays (refer to the FDA, “What is a Serious Adverse Event?”).
When reporting an adverse event, organizations must include an explanation and supporting documentation that demonstrates compliance with the FACT Standards and includes the following:
- A description of relevant patient details. Do not include Protected Health Information (PHI).
- A description of relevant product details, if applicable.
- A summary of how the event was identified and investigated, corrective action(s) implemented, and that appropriate follow-up of implemented corrective action(s) was performed to ensure the corrective action(s) were effective.
- 3.4.8 Management of complications related to the administration of cellular therapy products.
- B/C/D126.96.36.199 Occurrences shall be reported to other facilities performing cellular therapy product functions on the affected cellular therapy product and to the appropriate regulatory and accrediting agencies, registries, grant agencies, sponsors, IRBs, or Ethics Committees,