BIO Storage
Monitor temperature for patient safety and regulatory compliance
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| The demand for tissue implants of all kinds—skin, ligament, tendons and bone, for example—is increasing with each passing year. Because tissue supplies are limited, it’s important that hospitals, specifically materials managers, properly track and store them to maintain their integrity. Ensuring tissue supplies are shipped and stored at the right temperature is critical not only for patient safety, but also because regulatory bodies such as the FDA are closely monitoring tissue storage in hospitals and assessing heavy fines for those not in compliance. |
When it came to working with human tissue, the record-keeping system at Penn State Hershey (Pa.) hospital was effective, if not exactly efficient. Each interaction with tissue was carefully recorded in a series of three-ring binders. A nurse or materials manager entered data in columns for the type of shipment and the date and time it was received. At first glance, it might seem like an elementary system, particularly for a hospital that performs a significant number of transplant surgeries and keeps about half-a-million dollars worth of tissue in storage.
But Penn State is hardly unique. Many hospitals record tissue implants in logbooks or Excel spread sheets. The binder system isn’t high-tech, but it worked. Or at least it used to until last year when the FDA came calling. A clerical error had accidentally listed the hospital as an improper tissue harvester; and the FDA had questions. It wanted a thorough record of every piece of tissue—from heart valves to tendons to flaps of skin and bone. How were they stored? Who handled them? And, most importantly, what patients received them?
“I think I lost several pounds of sweat [the day the FDA came],” says Matt Brennan, the hospital’s director of surgical services. The clerical error was quickly straightened out, but the FDA still combed over his binders in excruciating detail. Brennan was aware of the agency’s penchant for levying stiff fines and penalties. He knew about another hospital that was fined $250,000 for bad tissue paperwork. “They weren’t doing anything malicious,” he recalls. “They just couldn’t produce the right documentation when asked.” For hours, a team of five agents grilled Brennan. Luckily, he says, he recovered every document they requested—even if it took a few frantic searches through his binders. Still Brennan walked away from that encounter convinced of two important facts.
First, health agencies, from the FDA to state Departments of Health to the Joint Commission are serious about recording and tracking the use of human tissue. And, second, materials managers are not ready for this level of scrutiny.
“The old days of handing off a logbook or rooting around a freezer are over,” he says. “Now, you really have to be on the ball.”
Experts say there are few clinical areas that require materials managers’ attention more than human tissue and even fewer areas with which materials managers are as ill-prepared to deal. Materials managers are often responsible for most nonclinical phases of tissue work, from receiving to transporting to storing. To keep their hospitals on the right track, they must immerse themselves in FDA regulations and Joint Commission standards. And they frequently act as middlemen between tissue banks and clinical staffs.
“There’s a lot that goes into [working with tissue],” says Scott Brubaker, the chief policy officer for the American Association of Tissue Banks (AATB), McLean, Va., a trade organization that registers 108 members in the United States and Canada. “Hospitals don’t always have the right level of expertise for everything tissue encompasses.”
And materials managers jobs are about to get harder. Recent tissue controversies have included a small number of highly publicized infections and recalls. Stories of research facilities and banks buying tissue from unscrupulous mortuaries rocked the medical world in 2004—including the case of Masterpiece Theatre host Alistair Cooke, whose stolen bones were believed to be sold to tissue banks. In 2003, CryoLife, then a major supplier of donated tissue, was shut down after a mass recall of poorly refrigerated tissue.
The controversies spurred an increase in regulations and investigations. In 2005 and again in 2007, the Joint Commission strengthened guidelines on tracking and recording tissue use. The agency is preparing to revisit the topic again in 2009. At the same time, the FDA has begun unannounced inspections of hospital tissue policies. Agents assured Brennan the he wasn’t being singled out, that human tissue was very much on their radar screen. “I was left with the impression that we may have been ahead of the curve, but everyone was eventually going to get a similar visit,” he says.
Unlimited demand
The demand for human tissue is growing, particularly for orthopedic procedures and neurosurgeries, experts say. With the explosion of sports medicine technology, tendons have become hot properties for ACL repairs and shoulder surgeries. More than 19,000 square feet of skin were distributed by tissue banks in 2003, AATB notes, up from 7,700 square feet in 1999.
But the supply of tissue is limited. Americans don’t donate tissue at the same rate as European nations, notes Alan Brander, R.N., director of training and implementation for LPIT Solutions, a Michigan-based manufacturer of tissue tracking software. That’s led to back orders on ligaments and tendons.
Tissue is also finite. Depending on how it’s preserved, tissue can typically expire in a few months or two-to-five years. Experts say that poor tracking costs hundreds of thousands in wasted tissue each year. “I guarantee there is no hospital out there that isn’t wasting tissue,” Brander says. “And, speaking just from the monetary standpoint, it’s a tremendous loss.” A 3-inch piece of tissue, Brander notes, may cost as much as $15,000.
The type and amount of tissue in hospital stock depends on factors such as the number of procedures performed and the strength of storage capacities. But it’s not unusual for a typical hospital to carry 100 to 200 pieces of tissue, Brander says. Major surgery centers may store as much as 3,000 pieces.
Even hospitals without cryo-preserve freezers can deal with significant tissue storage. Ideally, materials managers say tissue should be stocked in a first-in/first-out system to prevent expiration. But poor inventory control can lead to mishaps, Brennan notes.
The Penn State official recalls having two pieces of bone in storage, one that expired in six months, the other in two years. “We put a note on the first one that said, ‘Please use me first. I expire in six months,’” he says. “We had some clinicians ignore the note and reach in the back to get the newer piece.”
Their reasoning? “They thought it would be better for the patient if they received fresh tissue,” Brennan says. “There’s a lot of ignorance with regard to this issue, and there are a lot of opportunities to make mistakes.”
Controlling tissue inventory also depends heavily on the interaction between materials managers and clinicians—particularly in the OR. While materials oversees acquisitions and transportation, tissue decisions are ultimately governed by OR staff, who may be unfamiliar with supply limit realities. “Communication is key,” Brennan says. “I publish a tissue catalog for my surgeons. I tell them what I have in stock and I ask them to tell me immediately if it’s not acceptable. If it’s not right or if they use more of something than expected, we may not get a similar supply for another month.”
Brander, a former CNO at a Michigan-area hospital system, helped design LPIT’s tracking software after his facility was cited for poor record-keeping by the Joint Commission. “I looked for something that would help me meet the Commission’s tracking standards, but there really was nothing out there,” he notes. In 2005, the Joint Commission accented the importance of tracking tissue by separating transplant/implant guidelines into its own standards chapter. Previously, tissue had been one of about 2,000 patient care standards. The new chapter had greater emphasis on record-keeping and accounting for each piece of tissue throughout its time in a health care facility. The move, plus small language changes in 2007, signaled the importance of keeping a close watch on tissue chain of custody.
Tracking tissue
LPIT’s bar-coded Web-based system allows materials managers to track human tissue at each point of contact. “Once a bank sends [tissue] to you, it becomes your responsibility,” Brander says. The $9,000 software allows materials managers to chart the movement, condition and status of implants. The software has full inventory tracking capabilities, alerting staff to supply levels, upcoming expiration dates and reorder needs. “That’s a lot easier than going to the shelf and counting to see if your stock is low,” Brander says. The software also transmits recall messages and indicates any problems with freezer maintenance.
In 2007, the FDA also has signaled its interest in human tissue by issuing a report from its Human Tissue Task Force. Although mostly concerned with tissue banks and distributors, the agency stressed that hospitals must carefully audit all of their tissue-related contractors. The FDA requires hospitals to ensure that their tissue partners are accredited by organizations such as AATB. Distributors must follow federal regulations, including strict donor screening and testing requirements.
Likewise, the FDA instructs hospitals to check if their tissue couriers are certified and in good-standing with the Department of Transportation. “You don’t want to find out that one of your couriers let a box sit in their trunk all weekend,” Brennan says. The federal agency’s guidelines also require hospitals to monitor their storage manufacturers. Penn State Hershey contracts with an outside maintenance facility to maintain its freezers and make sure their storage meets FDA standards. “You can’t assume that just sticking a thermometer in there will get the job done,” Brennan says.
Companies such as Terso Solutions, Madison, Wis., provide storage products that not only meet FDA temperature regulations, but also collect tracking information. Terso’s automated cabinets, freezers and refrigerators “provide hospitals, tissue banks and distributors with the data they need to meet federal guidelines,” says Terso Director of business development Joe Pleshek.
According to the FDA, hospitals that supply tissue to more than three other facilities—even within their own networks—are considered tissue distributors. By federal law, that invites new levels of scrutiny and penalties. As a distributor, hospitals would be subject to as many as three FDA inspections a year and would be even more responsible for tissue tracking, including collecting donor information. But while some hospitals have been slow to realize the importance of intense tissue tracking, regulatory oversight is spurring a more serious health care culture, Brander says.
“In the past, materials managers really cared about whether the right order showed up at the right time on the loading dock,” he maintains. “Now the Joint Commission wants you to track every interaction that every person has with that tissue.” At Penn State, Brennan checks off a long list of tissue to-dos. “You need to make sure your freezers are in good working condition; to know that when a box arrived, the dry ice was still intact and hadn’t evaporated; how to inspect the contents of an order based on temperature, vibration and physical appearance; and if someone dropped the box and dented a corner. And all of it has to be documented.”
To others, the easiest way to deal with tissue demands is to cut supply—and liability. Many hospitals, Brennan says, are storing less tissue on-site and relying on just-in-time deliveries for much of their inventory. By keeping less tissue on hand, hospitals are saving expensive storage space and limiting points of contact that can lead to higher scrutiny. “If you are working with a courier, the chain-of-custody issue becomes simpler,” he says. “It’s a line directly from the supplier to the patient. The downside is that you leave yourself with no room for error if that supply doesn’t come through.”
Brennan says materials managers must be aware that a new age of tissue care has dawned—one that requires increased tracking, record keeping and accountability. Sooner or later, some agency will knock on every hospital door, experts say. “If you can show that you have your ducks in a row, you won’t have a problem,” Brennan says. “If not, the consequences can be serious.
| Storage Methods to Maintain Tissue Integrity |
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• Ambient: Or normal air temperature, typically for items like bone chips. Source: American Association of Tissue Banks, McLean, Va. |
Tissue storage can be as simple as placing items on a shelf in the OR. Or it can be as complicated as tending to a liquid nitrogen freezer. Tissue is stored in four conditions:This article first appeared in the October 2008 issue of Materials Management in Health Care.
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