Recommended Practices for Surgical Tissue Banking

AORN Journal, March, 1999

The following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1, 1999.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented.

AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed.

Purpose: Surgical tissue banking encompasses the retrieval, processing, preserving, and storing of selected human tissue. Human tissue includes, but is not limited to, bone, cartilage ossicles, corneas, heart valves, and skin. It is beyond the scope of these recommended practices to address all areas of tissue banking. These recommended practices provide guidance for developing institutional policies and procedures that are specific and compatible with patient needs, the practice setting's facility, and personnel capabilities and expertise.

A tissue bank should be established only where a need exists. Before the decision is made to establish a tissue bank, consideration should be given to personnel, equipment, and practical operational requirements for providing safe, reliable, and biologically useful grafts. In December 1993, the US Food and Drug Administration (FDA) issued an interim rule pertaining to human tissue intended for transplantation. The FDA intends to propose more extensive regulations in the future. These regulations must be adhered to during the development of a tissue bank and for all surgical tissue banking. In addition, the standards published by the American Association of Tissue Banks (AATB) should be consulted and used.

RECOMMENDED PRACTICE I

Tissue for transplantation should be procured from suitable donors.

Interpretative statement 1:

The donor or donor's responsible party should sign an informed consent. Permission to retrieve tissue from nonliving donors should be sought from next of kin in order of legal precedence. If next of kin is unavailable, local, state, and federal regulations should be followed.

Rationale:

The Uniform Anatomical Girl Act (UAGA) of 1968, passed in all 50 states, provides guidelines within which consent may be obtained, 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 in various required and routine inquiry laws.(1)

Interpretive statement 2:

Donations from living donors should be accepted if the conditions surrounding the donations are not questionable.

Rationale:

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)

Interpretive statement 3:

A history and assessment of all donors (living or dead) should be obtained to identify contraindications before implantation of tissue. The donor should be free of

* viral, bacterial, or fungal infection or disease;

* sexually transmitted disease;

* neurologic disease;

* autoimmune disease;

* metabolic bone disease;

* malignancy or suspected malignant neoplasm;

* disease of unknown etiology;

* systemic medication use;

* parenteral drug use;

* exposure to toxic substances; and

* history of receiving pituitary-derived human growth hormone.

The donor should be normothermic 98.6 [degrees] F (37 [degrees] C) for at least seven consecutive days immediately before brain death. In addition, the donor should not have been ventilator-dependent, immobile, or bedfast for more than seven consecutive days immediately before brain death.

Rationale:

The potential donor is screened to avoid transmission of infection or disease.(3)

Interpretative statement 4:

Potential donors meeting any of the high-risk criteria for HIV as set forth by the FDA, Centers for Disease Control and Prevention, and the US Public Health Service should be excluded. These criteria include

* people with clinical or laboratory evidence of HIV infection;

* men who have had sex with another man in the preceding five years;

* people who report nonmedical IV, intramuscular, or subcutaneous injection of drugs in the preceding five years;

* people with hemophilia or related clotting disorders who have received clotting-factor concentrates;

* people who have engaged in sex in exchange for money or drugs in the preceding five years;

* people who have had sex in the preceding 12 months with any person meeting the above description or with a person known or suspected to have HIV infection;