More than 1 million people in the US receive tissue transplants every year, according to the Food and Drug Administration (FDA). Appropriate management of that tissue in the hospital is essential to ensure patients receive safe tissue and that tissue can be tracked if a recall or infection occurs.

“Managing tissue is very complex,” says Ruth Damron, MBA, BSN, RN, CRMP, strategic solutions, Cardinal Health. That complexity includes adhering to regulatory guidelines, maintaining a “chain of custody,” storing tissue according to specific requirements, monitoring proper handling (including proper reconstitution, if necessary) and documenting use correctly.

Proper oversight of these functions, including the use of automated tracking management systems, will help OR managers avoid regulatory penalties and possible litigation related to tissue management. Although manual tracking systems suffice for some facilities, others are finding they are better served by an automated tracking system.

Anne Chenoweth, MBA, MT (ASCP), senior director for accreditation and quality at AATB, succinctly explains the difference between AATB and other accrediting bodies: “AATB is responsible for the tissue until it goes through the front door [of the hospital]. After that, AABB—or another accrediting body such as the Joint Commission—is responsible.”

A resource for information about FDA regulations is the agency’s Tissue Reference Group, which is intended to be “a single reference point” for questions related to the jurisdiction and applicable regulation of tissue.

AABB has standards and accreditation programs that focus on specific areas of managing tissues, and the Joint Commission has standards that focus on hospitals and other organizations it accredits.

Chain of custody

Consistent among regulatory and standard-setting agencies and organizations is an emphasis on the chain of custody. Just as with crime scene evidence, each tissue must be assigned a unique identifier number and tracked as it moves through the system.

For example, the Joint Commission requires organizations to have the capability for bidirectional tracking of tissue in the event of a recall or a postoperative infection. In essence, the hospital’s records must enable tissue to be traced from the donor or tissue supplier to the recipient(s) or other final disposition, including discard, and from the recipient(s) or other final disposition back to the donor or tissue supplier.

“If you get a notification from the supplier that a tissue is suspect [or being recalled], you need to be able to determine which patient received the implant or where it is in the inventory,” Rosing says. In the case of an infection, records should contain sufficient information to determine if it is related to storage or handling of the tissue, including storage temperatures.

A team approach yields success

Kimberly Cheuvront, PhD, MT, a quality coordinator in perioperative services at West Virginia University Medicine, was part of a quality improvement team formed to improve tissue management. Actions included implementing software that tracks receipt of tissue, storage, disposition, documentation, and reporting. Staff education was provided, and tissue is now delivered to the OR instead of having RNs leave patients to obtain it.

Eight inventory-control analysts, who are based in the materials management department, provide 24-hour coverage of a tissue storage room. The analysts are high school graduates who have received on-the-job training.

“They receive the tissue, tag it with the unique label, and place it in the storage area,” Cheuvront says. She monitors tissue implantation, checking for discrepancies between the automated system and the electronic medical record.

The team’s efforts reduced the documentation error rate from 3% to less than 1% and decreased the tissue expiration rate by 1.1%. West Virginia University Medicine uses about 500 implants a month in its 35 ORs and procedure rooms, so the financial benefits were significant.

Kimberly Mitchell, MS, RN, ACNS-BC, CNS-CP, CNOR, a perioperative clinical nurse specialist at Aurora St Luke’s Medical Center, says the team involved with tissue management works closely with quality improvement staff. “They ensure we are meeting the standards, review our policies, and check that we are compliant so our patients are safe,” she says. Mitchell works in a 15-hospital system that has a tissue coordinator role at each facility; the coordinator may be a nurse, a technician, or a materials management staff member. She works with her perioperative clinical nurse specialist colleagues and other OR leaders to help ensure proper tissue management across the system.

“Use of automation depends on how much tissue is used and the complexity of your system,” Mitchell says, adding that some hospitals may find a paper tracking system sufficient to meet their needs.

An automated system, however, has several advantages, including use of prompts for required fields and elimination of redundant information. Computer automation eliminates handwritten or keystroked entries in more than one place, which can lead to errors such as transposing lot numbers. Another advantage is being able to pinpoint the location and current state of a tissue as part of the chain of custody requirements.

“It gives time back to clinicians so they can take care of patients instead of spending significant amounts of time documenting duplicative and redundant information,” Damron says. Systems should have the ability to look at real-time activity. For example, real-time tracking of inventory and expiration dates eliminates the need for staff to open the freezer to check dates.

Inventory reports are also helpful for tracking utilization by surgeon and case type. “You can look at utilization of an expensive product to see if it’s being used appropriately for the right patients,” Damron says.

Automated systems typically contain a variety of alerts such as receipt of tissue from a tissue bank that is not licensed or accredited, low inventory, and upcoming and already expired items. Cheuvront says “hard stops” in automated systems at key points ensure steps such as checking integrity of the tissue on receipt are followed.

“You can easily run reports to track usage and reconcile inventory, the data is much more accessible, and you eliminate the legibility issue,” Mitchell says. “It’s a tremendous time savings from a recall aspect.”

Cheuvront concurs, adding, “It’s easy to track all the inventory to see if it was implanted or is still on the shelf. When it was manual, you had to go through many books.” In addition, software that interfaces with the electronic health record ensures complete documentation.

Damron suggests including the following on the team that will select the system: OR manager, tissue coordinator in the OR, supply chain representative, RN circulator (who can bring the frontline perspective), and a representative from information technology. The team should ask questions to assess possible options.

Of course, as Chenoweth points out, automated systems aren’t a panacea. “It’s a tool like any other tool, and you still need the same oversight.”

Staff education

Staff must understand how to properly care for tissue to be implanted, including adherence to practice guidelines. For instance, AORN guidelines state autologous bones shouldn’t undergo steam sterilization “unless there is a clinical indication to do so.”

If tissue is contaminated or dropped on the floor before it’s implanted, the multidisciplinary team should conduct a risk assessment of the risks and benefits for continuing with implantation. The event should be discussed and documented in a variance report, with followup as to whether steps can be taken to avoid the situation in the future.

Staff education should include the chain of custody concept. “They often don’t think about the importance of traceability every step of the way,” Chenoweth says. That includes details such as when a tissue was thawed and who thawed it. “It’s a mindset,” she says.

There also are the ever-present requirements for correct and complete documentation related to tissue. For example, Cheuvront notes that staff should record the preparation time for the implant, which includes start and completion times, and the time the tissue was implanted.

In addition, Damron notes, “Frontline clinicians might not be aware of regulatory requirements,” so this should be included in staff education as well.