Quality control in tissue banking—ensuring the safety of allograft tissues

AORN Journal, Sept, 2006 by Linda K. Humphries, Vicki L. Mansavage

The article "Quality control in tissue banking--Ensuring the safety of allograft tissues" is the basis for this AORN Journal independent study. The behavioral objectives and examination for this program were prepared by Rebecca Holm, RN, MSN, CNOR, clinical editor, with consultation from Susan Bakewell, RN, MS, BC, education program professional, Center for Perioperative Education.

Participants receive feedback on incorrect answers. Each applicant who successfully completes this study will receive a certificate of completion. The deadline for submitting this study is Sept 30, 2009.

Complete the examination answer sheet and learner evaluation found on pages 401402 and marl with appropriate fee to

AORN Customer Service

c/o Home Study Program

2170 S Parker Rd, Suite 300

Denver, CO 80231-5711

or fax the information with a credit card number to (303) 750-3212.

You also may access this Home Study online at http://www.aornjournal.org

BEHAVIORAL OBJECTIVES

After reading and studying the article on ensuring the safety of allograft tissues, nurses will be able to

1. explain the roles of the different entities within the tissue-banking industry,

2. discuss the October 2005 US Food and Drug Administration allograft tissue recall,

3. describe the components of quality control that affect American Association of Tissue Banks accreditation, and

4. identify tissue recovery and processing variables.

This program meets criteria for CNOR and CRNFA recertification, as well as other continuing education requirements,

A minimum score of 70% on the multiple-choice examination is necessary to earn 2.6 contact hours for this independent study. One contact hour is equal to 50 minutes.

Purpose/Goal: To educate perioperative nurses about how allograft tissues are selected, recovered, and tested and how to ensure the safety of allograft tissues.

In the past, inadequate precautions in allograft donor selection and donor testing have led to disease transmission via tissue transplantation. (1) To protect the health of the American public, federal regulations directed at the tissue-banking industry were developed. (1,2) Federal regulations established donor medical and behavioral suitability requirements, mandated minimum donor testing, and outlined extensive procedural and record-keeping requirements for the tissue-banking industry. (1,3-5)

Tissue banks include any entity involved in any portion of the recovery, processing, or distribution of tissues. This includes health care facilities that routinely transfer tissues to another hospital even if the hospital is an associated (ie, sister) facility. Tissue procurement, tissue retrieval, and tissue recovery agencies are synonymous terms. These agencies perform the actual bodily tissue removal from cadaveric donors. Tissue processor agencies take recovered tissue and prepare it for use before it is sent to health care facilities for clinical use. Tissue distributor agencies send the processed tissues to health care facilities; they may not have been involved, however, in the recovery or processing phases.

Tissue banks (eg, recovery, processing, and distribution entities); organizations that perform donor screening and testing functions; and human cell, tissue, and cellular- and tissue-based product storage facilities must register with the US Food and Drug Administration (FDA). This includes health care facilities that routinely transfer tissues to another hospital. The registration process includes describing the allografts they obtain or distribute and places the tissue banks in a federal inspection rotation.

Regulatory steps taken by the federal government have done much to increase the safety of allograft tissues being transplanted in this country. Recent events, however, have illustrated that the actions of a few individuals still have the potential to endanger thousands of patients.

THE RECALL EVENT

A series of articles published in 2005 by the New York Daily News alerted the public to shocking practices alleged to have taken place in a tissue procurement agency between May 2002 and September 2005. (6-8) The articles outlined allegations that included forging family consent-for-donation documents and altering donor medical and social history records to mask conditions considered unacceptable according to eligibility standards for donation.

An FDA investigation began when Michael Bauer, MD, medical director of Bonfils Blood Center, Denver, reportedly discovered donor-record discrepancies when he was reviewing infectious disease testing records. (9,10) These discrepancies revealed that one tissue recovery agency's donors "may not have met FDA donor eligibility requirements ... [and] may not have been properly screened for certain infectious diseases." (11) Dr Bauer was performing routine follow-up on donor records. When he called to obtain additional medical information on a donor, he discovered that the reference telephone number listed in the medical record was incorrect. Many subsequent calls to other reference telephone numbers proved those numbers to be incorrect as well. (9,10) The resulting investigation "uncovered a pattern of false documentation" of donor records.