HCT Accreditation Manual Provides Additional Examples of Proof of Death
Standard D12.1.3.1 of the FACT-JACIE Hematopoietic Cell Therapy Standards1 requires proof of death of the intended recipient of any hematopoietic progenitor cell (HPC) product before it is discarded. Many cellular therapy programs noticed an additional sentence added to the examples in the accompanying Accreditation Manual2:
Eighth Edition Standards:
D12.1.3 Documentation of no further need for the cellular therapy product before any product is discarded.
D12.1.3.1 For HPC products, this shall include documentation of the designated recipient’s death, if applicable.
Examples in the Eighth Edition Accreditation Manual:
FACT Seventh Edition: Proof of death includes an autopsy report, a dictated clinical note, or the Social Security index in the U.S. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.
FACT Eighth Edition: Proof of death includes an autopsy report, a signed statement by the treating physician, or the Social Security index in the U.S. The institution registry or the governmental regional registries are also adequate sources. Secondary sources of information, such as newspaper articles, do not satisfy this requirement.
The Standards Committee’s intent is to no longer require the Processing Facility to obtain primary documentation of death for every discarded cellular therapy product. As stated in the Explanation, the facility may use an institutional process for documentation of death, such as having the patient listed as deceased in the electronic medical record. However, the institutional process must be based on primary documentation. Examples of acceptable primary sources are a death certificate, death at the institution, or the Social Security Index. The facility may consider doing a process validation of the institutional process to document death and confirm that it is based on a primary record. This confirmation would only need to be performed as part of the validation and not for every death record that the facility obtains.
The institutional cancer registry worksheet would suffice for the Processing Facility’s records, as long as the facility has confirmed that the registry’s process for noting death does include a primary source.
The term “governmental regional registries” was included at the request of international groups, and would include death registries maintained by states.
Most informed consent processes now state a time limit for how long a cellular therapy product will be stored, or when a product will be moved to long-term storage. For informed consent that states that products will be stored until death, FACT recommends that the Processing Facility consults with its legal department if it desires to dispose of the product.
[1] FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Eighth Edition, Version 8.1
[2] FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual, Eighth Edition, Version 8.2
