As we approach AABB 2010, I thought it would be a good time to revisit and refresh ourselves on a topic that will likely be up for conversation amongst our Blood Bank and Tissue Bank stakeholders. ‘Hospital Tissue Services: Compliance with Standards and Regulations,” was presented by Ellen F. Lazarus, Scott A. Brubaker, and Mary Ghiglione at the 2009 AABB. A PDF of this presentation is included for your reference, and serves as background for this VUEPoint position. View PDF
Coming from the William Labs’ blood management perspective and expertise, we have taken particular interest in conversations that blood management and tissue management have a lot in common. There is a perception that there is similarity in their record-keeping requirements, which has generated the idea of hospitals possibly combining Tissue Banks and Blood Banks.
This perception reminds me of a boss I once had who, for almost any project, had a standard comment… ‘All you gotta do is…’ As developers and suppliers of products designed to help ensure compliance to blood management regulations, our perspective is that the “real world compliance requirements” for blood products and tissue have some significant differences. There are at least 15 different tissue types defined as ‘tissue.’ For each of these types there are written procedures for acquisition, receipt, storage, and issuance.
Software used to manage the data is also an area of concern. Blood banks have some software choices that have been tested and implemented by a fairly large number of blood banks, providing good input on which software will work best for any given blood bank environment. On the other hand, the software available to meet compliance requirements for tissue offers few choices and limited implementation. The most successful software implementations appear to be from in-house development between the blood bank and tissue departments.
There are also somewhat different definitions for tissue storage conditions to be learned. For instance, in tissue regulations “ambient temperature, or colder” is identified as ‘just above freezing’, with an upper endpoint for “ambient” that can vary, depending on various processing/preservation methods and graft packaging configurations used by the tissue bank. And tissue handling responsibility includes everything from ordering and supplier qualification to adverse event reporting.
The American Association of Tissue Banks (AATB) offers a Guidance Document for Identifying, Reporting and Investigating Tissue Recipient Adverse Reactions. The presentation cited in this VUEPoint also offers a host of useful information for blood banks and tissue services who may be considering combining. Mary Ghiglione, Director of Blood & Tissue at Swedish Medical Center in Seattle, Washington, has been part of an implementation team, and her presentation is also included in the PDF presentation. Like the AABB, the AATB offers a ‘Standards’ publication that is available at the AABB bookstore.
See you in Baltimore!
Ed Sharpless, VP Product Development
William Laboratories, Inc.
Authors of Presentation:
Scott A. Brubaker, CTBS, 1320 Old Chain Bridge Road, Suite 450, McLean, Va, 22101, USA, 7038279582, email@example.com
Mary Ghiglione, RN, BSN, 747 Broadway, Seattle, Washington, 98122, USA, (206) 386-3544, firstname.lastname@example.org
Ellen F. Lazarus, MD, CAPT, USPHS FDA CBER, 1401 Rockville Pike HFM 775, Rockville, MD, 20852, US, (301) 827-6031, Ellen.Lazarus@fda.hhs.gov