Informed consent for use of allograft tissues; documentation of purchased tissue; organ compatibility

AORN Journal, May, 2007 by Victoria Steelman

QUESTION: I work with an orthopedic surgeon who routinely uses allograft bone but does not indicate this on the consent. Should patients provide informed consent before receiving allograft bone? Some of the nurses believe that signing a consent for surgery indicates consent to receive allograft tissue, even if it is not written on the consent form. Is there a legal responsibility for the surgeon to disclose the use of allograft bone on the consent form?

ANSWER: Patients have a right to know the risks, benefits, and alternatives to treatments. This information is essential for providing informed consent; therefore, when the use of allograft tissue is intended or possible, the surgeon should discuss this with the patient or patient's representative when obtaining consent for surgery. Although there is no federal requirement that this consent be put in writing, it would be prudent to include it in the written consent for the surgical procedure. For more direction or clarification, perioperative nurses should consult their facility's policies and discuss the issue with the operating surgeon.

QUESTION: We are revising our policy on the care and handling of tissue. What information do we need to record after receiving purchased tissue in our facility? Is additional documentation needed when a sates representative brings tissue for a specific surgery? What AORN resources address donor tissue handling?

ANSWER: When tissue is shipped from a commercial tissue bank, receipt of the tissue by a hospital or ambulatory surgery center indicates acceptance of the tissue into the facility's tissue bank. This means that the tissue is deemed acceptable for later implantation. To ensure that the tissue has not been compromised, the integrity of the tissue and conditions of transport should be verified and documented upon its receipt. (1,2) The US Food and Drug Administration (FDA) requires additional documentation to be completed upon receipt of the tissue to facilitate tracking of the tissue from donor to recipient. (3,4) These records must be available for potential use in investigations regarding the tissue or when tissue is recalled.

When the tissue arrives and is examined by the designated individual, the following key information should be recorded:

* unique identifier of the tissue (eg, serial number);

* source facility's name;

* verification that the transport temperature was controlled and acceptable;

* verification that the package integrity is intact;

* date and time; and

* name of the person accepting the tissue.

After this documentation is complete, the tissue should be placed immediately into secure, controlled storage at a temperature consistent with the source tissue bank's written instructions.

The same documentation is required if a sales representative hand delivers the tissue. Most commercial tissue banks ship directly from the tissue bank and do not have representatives deliver tissue. If a representative delivers the tissue, safeguards should be in place to provide assurance that the tissue has not been out of secure, controlled storage conditions while in the possession of the representative and that the necessary documentation of receipt has been completed upon acceptance of the tissue.

Completing this documentation is important for patient safety and compliance with FDA regulations, so the person who receives tissue in a hospital or ambulatory surgery center should be specifically trained in the responsibilities involved, and records should be audited to verify compliance. For a concise reference, perioperative nurses should review AORN's "Recommended practices for surgical tissue banking." (2)

QUESTION: I work at a hospital that performs organ transplantations. Recently we began an additional verification process to ensure donor compatibility with the recipient. Are there new requirements for checking compatibility of organs before transplantation procedures? What measures should be taken intraoperatively to prevent an implantation error from occurring?

ANSWER: Yes, there are new requirements for verifying transplant organ compatibility. In 2004, the United Network for Organ Sharing (UNOS) investigated a devastating error that resulted in a patient receiving a kidney that did not match the blood type of the recipient. In response, UNOS implemented a change requiring that the ABO compatibility of recipients and organs be verified at the transplanting facility before transplantation. Although this change verifies ABO-compatibility, it does not verify a full cross-match compatibility.

More recently, an incident occurred in which two ABO-identical patients at a single transplant center received ABO-identical kidneys on the same day. Mistakenly, patient A received the kidney for patient B, and patient B received the kidney for patient A. The error was not detected until the next business day. Both patients suffered reversible complications from the incident because the organs were not cross-matched to the patients.

In response, UNOS conducted a root-cause analysis and in November 2006, proposed revisions to its own policies to minimize the risk of this type of error recurring. (5) If approved by the UNOS board of directors, these policies should go into effect after their June 2007 board meeting.