DOK’s corner is constantly looking for ways to help hospitals meet their Joint Commission standards for tissue management. In this edition, I would like to discuss an issue that is commonly asked of us during our consulting work: what is the difference between tracking and tracing of tissue?
The Joint Commission in QC.5.310 (PC 17.20) states: The organization’s record keeping permits the traceability of all tissues from the donor or source facility to all recipients or other final disposition.
The elements of performance include:
A.1- The organization’s records permit tracing of any tissue from the donor or source facility to all recipients or other final dispositions including discarding of tissue
A.4- The organization’s records include documentation in the recipient’s clinical record of tissue use, including documentation of the unique identifier of the tissue
We have been asked whether this means a hospital needs only to find any piece of tissue it has received and subsequently transplanted, discarded or returned. This is not a minor task by itself. During each of the major recalls of tissue there has been a major quantity of tissue products that hospitals have not been able to find, even years later, which has become a liability nightmare. But the Joint Commission has further requirements for tracing as seen in the following elements of performance:
C.2- The organization’s records track and identify material used to prepare or process tissues and instructions used for preparation
A.3- The organization’s records identify the following:
- Identity of staff involved in preparing or issuing tissue
- Identity of staff who accepts the tissue
- Dates and times of the preceding activities
C.2 uses the term tracking. There has been much confusion about the difference between tracking and tracing of tissue. Obviously, tracing requires much more than simply finding or tracking the tissue.
The AORN’s Recommended practices for surgical tissue banking offers many suggestions that will help hospitals in their quest to move into compliance, especially for those hospitals that collect their own allografts or autografts. We will examine more of AORN’s recommendations in future issues of DOK’s corner, but for this article I wanted to examine how they differentiate between the terms tracking and tracing. These two terms are used almost interchangeably in their document and unfortunately neither is defined. So where can we go to separate these two concepts?
In the dictionary the two terms are almost synonymous, but one definition of traceability is: to discover by going backward over the evidence step by step. Tracking is defined as: to search for by following evidence until found. This is a critical distinction. Tracking of tissue is merely finding what its final disposition was, while tracing requires more information about the entire history of the tissue.
The American Association of Tissue Banks (AATB) clarifies this in their standards. In C1.400 they state that in addition to being able to track tissue, records shall also indicate the dates and the identities of the staff involved in each significant step of the operation from the time of retrieval through final disposition of the cells and/or tissue.
The American Association of Blood Banks (AABB) also has a standard for tissue within hospitals:
5.1.6.2 - Traceability:
The blood bank or transfusion service shall ensure that all blood, components, tissue, derivatives, and critical materials used in their processing, as well as laboratory samples and donor and patient records, are identified and traceable.
So tracing is more of a chronological record of the tissues. It tries to identify each time a product is moved, who has handled it, was it monitored properly and how was it altered. Currently very few hospitals can document the history of the tissue within their institution. In cases where a recipient of tissue has an adverse reaction, the first question asked will be whether the tissue was handled properly by the hospital. For example, if an allograft breaks, it may be impossible to discern if there was a defect in the tissue or whether the hospital failed to use the proper solutions to reconstitute the tissue or whether the tissue was soaked long enough in the OR. If the patient develops a bacterial infection, did the hospital fail to manage the tissue appropriately or did they contaminate the tissue while it was in the hospital?
Hospitals are looking for automated help to monitor tissue, but computer software is rarely capable of tracing tissue through all its moves within a hospital. The software with such capabilities is TRACS 4 Life™. If you want further information about this product, click on the icon on the home page. |
