CTBT Prep Course Module Two: Donor Screening
Informed Consent - ANS--Living Donors
-presented with a description of the scope, use, and risks/benefits for the donor.
-the donor has been given the opportunity to ask questions and receive accurate answers
-must be documented in the donor's record
Document of Gift - ANS--Legal record of the donor's wishes
-defines and allows postmortem recovery
-discusses transplant, therapy, research, and/or education
-signed by the donor (or the legal authority) DURING the donors lifetime
Document of Authorization - ANS--Legal record that is signed by the authorizing person (not the
donor) AFTER death
-defines and allows postmortem recovery
-discusses transplant, therapy, research, and/or education
Authorization - ANS-Permission is given after Adequate Information concerning the donation,
recovery, and use of the tissue is conveyed.
Adequate Information - ANS-Information sufficient for the donor, the authorizing person, or the
living donor to make a voluntary decision regarding the gift of tissues for transplantation,
therapy, research, and/or education.
Notification of Gift - ANS--Provision and documentation of notice concerning an anatomical gift
that was made by the donor DURING the donor's lifetime.
-notified the person who would be the authorizing person (LNOK)
-must contain core elements
-good faith efforts to reach the LNOK must be made within a reasonable time frame that's
compatible with recovery.
-all attempts to make a notification must be documented
Donor Registry - ANS-A database established in accordance with law, consisting of legally valid
documents of gift.
Responsible Person - ANS-A person who is authorized to perform designated functions for
which they are trained and qualified.
Donation Coordinator - ANS--a responsible person who seeks authorization or informed consent
-can give notification of donation, recovery, and use of the gift.
Requirements of Authorization - ANS--completed by the authorizing person
, -is in accordance with anatomic gift acts at the local, state, and federal levels.
-shall be maintained in the donor's record
Revoking the Donation - ANS--the Donation Coordinator shouldn't indicate that the person can
revoke the donation
HOWEVER
-should ask if the donor ever revoked their decision
Elements of Authorization - ANS--Authorizing persons; name, mailing address, phone number,
relationship to donor, signature (if in person)
-donations coordinatiors; signature, date, organization info
-signature of witnesses is required (recordings can be witnesses)
-documentation of the use of the core elements
-a statement authorizing the tissue recovery
Elements of the Consent - ANS--Living donor's: name, signature, -mailing address, phone
number
-Donation Coordinators: signature, date, organization details.
-Signature of each witness
-documentation of the use of the core elements
-A statement of understanding
-a statement of record keeping
Sampling plans - ANS-Sampling of phone calls and electronic authorizations must be preformed
-plans must be established and based on a valid statistical rational (ex: the FDA Guide to
inspection of quality systems)
Core Elements for Authorization - ANS--Donors Name
-Authorizing persons: Name, mailing address, phone number
-explanation that the tissue is a gift
-a description of the general types of tissue recovered
-a discription of the permitted uses of the tissue
-explanation that the following actions will be taken
-access and disclotion of medical records
-testing and repording for rcdads
-removal of samples for testing perposes
-release of ME records
-notice that transport, archiving of samples, and pictures may occur
-contact info for the organization
-any additional info required by law
Other Info Included with Core Elements for Authorization - ANS--General description of recovery
-explanation that cost will be covered
-explanation of the impact of final arrangements
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