The following propos commended prac...

The following propos commended practices for surgical tissue banking were unraveled by the AORN Recommended Practices Committee and have been approved from the AORN Board of Directors. They were at handed as proposed recommended practices for annotation to members and others. These commended practices are effective Jan 1 2004

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

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

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

A tissue bank should be established single 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 works In 1997, the US diet and Drug Administration (FDA) announced a comprehensive regulatory oversight of tissue banking. (1) In support of this program, the FDA has published three propos empires and finalized one of these orders The agency intends to mean more extensive regulations in the coming time Adherence to these regulations is required during the exhibition and ongoing operation of a tissue bank. In addition, the standards published by means of the American Association of Tissue Banks (AATB) should be referr to for further Direction. (2)

approveed 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 originals of human cells, tissue, and cellular and tissue-based harvests must be submitted with the application to the FDA. (3) Facilities that recover; cloak test, process, label, package, or distribute human solitary abode; squalids or tissue for implantation, transplantation, or infusion must register with the FDA. The registration form includes a list of tissues and solitary abode; squalids to be used in this proces (4) Facilities must register within five days after beginning operations, notify the FDA within six month of changes in produces and update the registration annually. Facilities single storing purchased tissue for use within the same facility or harvesting autologous skin or cranium 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 small cavitys acquired from outside sources have been procur procedureed stored, and distributed by tissue banks registered with the FDA and certified by means of the AATB. Registration provides a means of reviewing practices. Certification by dint of the AATB provides a minimum of the same height of quality control assurance of the management processing, preserving, and storage of the tissue. more [i]or[/i] less tissue banks purchase tissue procur or performanceed 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 archetype of the certification should be kept upon 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 fruitss 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 make sure that donations are legally and ethically solicited and accepted.

3 Personnel screening potential donors should be knowledgeable about