Recommended practices for surgical tissue banking - Recommended Practices

AORN Journal, Feb, 2004

The following proposed recommended practices for surgical tissue banking 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 comment to members and others. These recommended practices are effective Jan 1, 2004.

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 centers, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where surgical and other invasive procedures may be performed.

PURPOSE: Surgical tissue banking encompasses procuring, processing, preserving, and storing selected human cells and tissue. Human tissue includes, but is not limited to, bone, cartilage, ligaments, tendons, fascia, dura mater, corneas, heart valves, bone marrow, vessels, and skin. It is beyond the scope of these recommended practices to address all areas of tissue banking or nonhuman tissue. These recommended practices provide guidance for developing institutional policies and procedures that are specific to the needs of surgical patients and address the perioperative practice setting and expertise required of personnel.

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 products. In 1997, the US Food and Drug Administration (FDA) announced a comprehensive regulatory oversight of tissue banking. (1) In support of this program, the FDA has published three proposed rules and finalized one of these rules. The agency intends to propose more extensive regulations in the future. Adherence to these regulations is required during the development and ongoing operation of a tissue bank. In addition, the standards published by the American Association of Tissue Banks (AATB) should be referred to for further Direction. (2)

RECOMMENDED PRACTICE I

Facilities procuring, processing, or preserving tissue and facilities storing tissue for use in a different facility must register as tissue banks with the FDA. (3)

1. A list of types of human cells, tissue, and cellular and tissue-based products must be submitted with the application to the FDA. (3) Facilities that recover; screen, test, process, label, package, or distribute human cells or tissue for implantation, transplantation, or infusion must register with the FDA. The registration form includes a list of tissues and cells to be used in this process. (4) Facilities must register within five days after beginning operations, notify the FDA within six months of changes in products, and update the registration annually. Facilities only storing purchased tissue for use within the same facility or harvesting autologous skin or skull bone flaps for later reimplantation are not required to register as tissue banks. Additional clarification is available from the FDA.

(2.)Facilities should verify that tissue and cells acquired from outside sources have been procured, processed, stored, and distributed by tissue banks registered with the FDA and certified by the AATB. Registration provides a means of reviewing practices. Certification by the AATB provides a minimum level of quality control assurance of the procurement, processing, preserving, and storage of the tissue. Some tissue banks purchase tissue procured or processed by other tissue banks and have limited registration or certification. All tissue banks involved in handling the tissue must be registered and should be accredited. A copy of the certification should be kept on file.

RECOMMENDED PRACTICE II

Surgical tissue bank personnel should be knowledgeable about the aspects of tissue banking in which they participate. (5)

1. Personnel should be knowledgeable about the importance of tissue bank products and services. An understanding of the importance of tissue bank activities instills an attitude of attention to detail and may minimize errors.

2. Personnel soliciting tissue donations should be knowledgeable about

* federal and state regulations,

* screening and testing criteria,

* the grieving process,

* aspects of informed consent,

* donor and recipient rights, and

* ethical considerations.

Soliciting donation of tissue requires unique interpersonal skills to ensure that donations are legally and ethically solicited and accepted.

3. Personnel screening potential donors should be knowledgeable about