Disposal of Unused Cellular Therapy Products

[Eleyda]

We are currently in pre process to review our SOP on Disposition of Unused Cellular Therapy Products and we do have a question.

Currently we are requesting for any of the following documents if the patient has deceased:

1.) Copy of Death Certificate (From County, Hospital, or next of kin)

2.) Death Pronouncement from hospital (in the form of autopsy report or clinical attending note in patient chart).

Is this information OK or what is the trend to document the disposition? Is a letter from the recipient Doctor and either the recipient or donor (in this case relative) enough?

[Franklyn]

You have to be very careful about what you put in your policy because whatever you say, you are STUCK with! Prior to harvest, at our facility, the donor must sign a storage consent that clearly spells out the terms and length of storage. If the patient is deceased (per the SS death index, hospital records, death certificate, etc.) we do not, necessarily, ask for the death certificate as we can determine if a patient is deceased by other means and merely document that we have, indeed, confirmed that the patient is deceased. If we have reached our five year limit we then contact the physician and patient (if surviving) and request permission to destroy or transfer ownership of the cells. Storing those cells has a significant cost and if the patient is unwilling to allow us to destroy or transfer the cells (e.g. research or to an outside storage facility of their choice) we need to bill them for the storage on an annual basis. Again, this is all spelled out in the storage consent that must be signed prior to harvest.

The only hiccups we have run into are physicians who want to use the cells for research (with or without patient consent) and family members that want to retain the cells in case a sibling needs future transplantation. We are talking BIG BUCKs for storage, so that needs to be worked out within your institution and do not forget to run it past the lawyers.

[quint]

agree with Franklyn. careful what you start, then you must always do.