Recommended practices for surgical tissue banking - Recommended Practices

AORN Journal,  Feb, 2004  

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RECOMMENDED PRACTICE IV

Tissue for transplantation should be procured from suitable donors.

(1.) Personnel should obtain informed consent from the donor or donor's responsible party before tissue procurement. Permission to retrieve tissue from nonliving donors should be sought from next of kin in order of legal precedence. If the next of kin is unavailable, local, state, and federal regulations should be followed. The Uniform Anatomical Gift Act (UAGA) of 1968, which passed in all 50 states, provides guidelines within which consent may be obtained upon death of the donor, including an order of priority for the potential donor's next of kin. Further guidelines concerning donations appear in the 1987 amendments to the UAGA, and were clarified in 2001 by the US Department of Health and Human Services. (6) Individual state laws may vary. Key elements of an informed consent include

* identification of tissues to be recovered;

* explanation of the potential uses of the tissue (eg transplantation, research, education);

* a general description of the recovery process; and

* explanations that the family may limit or restrict the use of the tissue. (6)

(2.) Personnel should provide family members with written materials disclosing the intended uses of the tissue and the nature of the donation, including

* a copy of the signed consent form.

* a description of how to follow up with the tissue bank should concerns arise,

* a description of the uses for donated tissue, and

* a list and description of other companies and entities with which the tissue bank has relationships for processing and distributing tissue.

The tissue bank is responsible for ensuring accurate, sensitive, and appropriate information is shared with the person giving consent. Using written materials ensures consistency and allows the person providing consent an opportunity to review the material again. (6)

(3.) Allograft donations from living donors should be accepted only if the medical, legal, and ethical conditions surrounding the donations meet approved criteria. Questionable conditions include undue medical risk to the donor, coercion, promises of monetary gain, and the diminished capacity of the donor to evaluate the medical or surgical risks. (2)

(4.) A responsible individual should determine allograft donor suitability, based on results of required screening and testing for relevant communicable disease agents and diseases. (7) Individuals making the determination of donor suitability should be knowledgeable about the legal requirements and medical risks involved and have the formal authority to make this determination. This responsibility may rest with a medical director or a medical advisory committee.

(5.) A responsible individual should screen allograft donors for risk factors and clinical evidence of relevant infectious agents and diseases before procurement of tissues. Screening includes review of pertinent medical records, a physical examination, and interviews. Donor screening minimizes the risk of transmission of infectious agents and diseases to the recipient and minimizes the risk of retrieving tissue that is not suitable for transplantation.