Stream: Orders and Observation WG
Topic: GF#16100
Eric Haas (Oct 31 2018 at 16:12):
@ Bob Milius GF#16100 needs example use case where the patient or related person is a collector. can you provide one?
Eric Haas (Oct 31 2018 at 16:39):
Ditto for for GF#16097 need use case examples
Eric Haas (Oct 31 2018 at 16:49):
and GF#16101
Bob Milius (Oct 31 2018 at 17:14):
@Kirt Schaper @Robinette Renner @Jane Pollack
Bob Milius (Nov 02 2018 at 14:34):
@Jane Pollack commented on the trackers with use cases. Let us know if you have any questions about them.
Jane Pollack (Nov 02 2018 at 16:07):
For the issue related to "BiologicallyDerivedProduct.Collector is not a related person."
While it is possible for a person to collect their own specimen, in the case of someone using a buccal swab to collect their own cheek cells, or spit into a tube for a saliva sample, this is a SPECIMEN, not a collector of a BiologicallyDerivedProduct. Therefore, the collector of a BiologicallyDerivedProduct is never the patient but a practitioner.
Resolution: please remove patient and related person as the collection collector.
Jane Pollack (Nov 02 2018 at 16:08):
[#16097] Summary: Unclear distinction between Processing and Manipulation.
Yes, we are aware that this can seem like splitting hairs, but we do make the distinction between Processing and Manipulation:
During the collection of a Stem-Cell Product such as PBSC (Peripheral Blood Stem Cells), we process a product by adding anti-coagulants during the collection in order to ensure that the collection can finish seamlessly to protect the product and make it easier on the donor. Once the collection is completed, we manipulate the product by doing buffy-coat enrichment or CD8 reduction to alter the product to make it more suitable for infusion to the recipient. We make the distinction because the first (Processing) is not to change the fundamental nature of the product, but the second (Manipulation) is intended to alter the product.
Jane Pollack (Nov 02 2018 at 16:10):
[#16101] For Summary: BiologicallyDerivedProduct needs example of how many BDPs can have one BDP as a parent. (Transplantation)
In the Stem Cell Therapy domain, one person can spend up to two days donating PBSC (Peripheral Blood Stem Cells). The totality of the donation is one BiologicallyDerivedProduct (the Parent), spanning 'n' days, while the children of this BiologicallyDerivedProduct are the number of bags of BiologicallyDerivedProduct cells collected on each day. Each bag has an identifier that must be tracked, and the parent has a distinct identifier that must be tracked, thus requiring the one-to-many relationship.
Bob Milius (Nov 02 2018 at 16:32):
@Jane Pollack @Kirt Schaper @Robinette Renner
in the case of someone using a buccal swab to collect their own cheek cells, or spit into a tube for a saliva sample, this is a SPECIMEN, not a collector of a BiologicallyDerivedProduct
Maybe there's confusion here. The donor of the BiologicallyDerivedProduct is not the collector. Often the donor is the patient (autologous transplant) or related person, or unrelated person. There may be a case (not in Stem Cell Transplant) where the collector might be a related person or the patient, ie the person performing the collection. I can't think of a use case where that happens though.
I don't think there's any question that the stuff being collected for analysis is a Specimen, and the material being collected for transplantation is a BiologicallyDerivedProduct. But the collector in both is the person/org doing the collecting, and is different for each.
Kirt Schaper (Nov 02 2018 at 18:13):
The donor of the BiologicallyDerivedProduct is the collection.source, reference to either Patient or Organization (in the case of a UCAR)
Kirt Schaper (Nov 02 2018 at 18:16):
The collection.collector (reference to a Practitioner) is the individual actually performing the collection. For this purpose, a bucal swab is NOT a BDP, and we assume that a BDP comes from a medical procedure requiring a trained medical staff person (the Practititioner).
Kirt Schaper (Nov 02 2018 at 18:16):
Even if the donor is a related person, the reference would be to a Patient, as the act of donation would entail a medical procedure.
Eric Haas (Nov 07 2018 at 00:54):
for GF#1600 to change the proposal it needs to be formally reopened and a new disposition applied by committee vote. I will will preapply the your proposed changes to ( remove patient and related person as the collection collector.) however it will not be closed until it revoted upon.
Last updated: Apr 12 2022 at 19:14 UTC
