Different Lab, Same Pressures

How safe is today’s blood supply? “It’s so safe, it’s difficult to measure how safe it is. When improvements in test systems are developed, elaborate mathematical models have to be applied to the data in order to be able to demonstrate the magnitude of any improvement,” says James P. AuBuchon, MD, FCAP, FRCP(Edin), president and CEO of Puget Sound Blood Center in Seattle.

Much of the risk in the blood supply related to infectious disease is eliminated simply through donor-screening questionnaires. “We weed out approximately 99 percent of all individuals who might be at risk of transmitting an infectious disease just by the health history qualifications,” AuBuchon says.

The remaining 1% of this risk is tackled with laboratory testing. Greg Sunset, divisional vice president of US strategic accounts at Abbott Diagnostics, a division of Abbott Laboratories, Abbott Park, Ill, recalls when he first entered the field 27 years ago there was only one manually performed immunoassay test, which screened blood for hepatitis B surface antigen. “Within about a 10- to 12-year period, we had a full battery of tests to ensure the blood was safe,” Sunset says.

Early testing technologies relied on some type of immunologic response in the donor, but the next-generational step in development after detection was greater sensitivity. This led to the introduction of nucleic acid testing in the 1990s, which, by looking for the genome of infectious agents in the donor’s blood, shortened the window period (the time between the acquisition of the infection and a detectable immunologic response) and increased safety. “As a result, the window period for HIV is now on the order of 9 to 11 days. So it’s only a very short time period during which someone could donate blood and not be detected by the advanced tests,” AuBuchon says.

The next developmental step in the evolution of blood bank testing has been automation. Blood banks face challenges similar to their clinical counterparts. “They’re under the same pressures as far as reimbursement, limitations, and, of course, increasing volume,” says Gilbert Hakim, CEO of SCC Soft Computer in Clearwater, Fla. As in clinical laboratories, automation helps to address some of problems presented by these issues.

As the efforts to screen the blood supply have grown increasingly successful, manufacturers have turned their R&D efforts to improving safety and performance outside of infectious disease screening. “Applying more and more and more tests has become a very expensive prospect without a whole lot of return. Instead, over the last few years, blood bankers have been turning their developmental attention to improve the whole process [impacting] noninfectious risk,” AuBuchon says.

Improving Quality with Automation

The largest area of risk affecting the blood supply outside of infectious disease is human error, and it can be introduced at any time in the process. Manual processes were traditionally responsible for testing, processing, labeling, and administering of blood. “Technology has helped mitigate some of these risks, but there certainly remains real room for improvement,” Sunset says.

Automated processes can provide significant improvement by reducing hands-on time and, therefore, the opportunity for error. In developing its automated immunoanalyzer system, Abbott documented 44 opportunities for human error in the testing process, which it then proceeded to automate.

Smart automated systems can help to ease staffing requirements, enabling more highly skilled technologists to focus on areas where their skills are better used. “We are highly automated, but also we have a very well-developed and instructional program whereby we can take someone with some college training or with a bachelor’s degree and over several months train them and bring their skills up to a level of where they can function in a manner similar to a medical technologist,” AuBuchon says.

“If the systems are hard to use, then this is more complicated,” says John Van Blaricum, vice president, marketing and communications for Mediware Information Systems, Lenexa, Kan. Smarter systems, particularly those with intuitive and user-friendly interfaces, provide training advantages.

Manufacturers, therefore, continue to produce enhancements to their systems to achieve these goals. Test menus expand, more tasks are automated, and turnaround times are reduced. “Blood is a perishable product. A unit of red blood cells has a shelf life of about 35 days, and a unit of platelets is only good for about 5 days. High-throughput helps our customers get those blood products to the shelf quicker,” says Stacey Delgrosso, product manager, strategic marketing, immunohematology, with Beckman Coulter Inc, Brea, Calif.

Reducing Error with Process Change

As a result, a number of tasks have been automated, facilitating advanced tasks, such as auto-interpretation and electronic cross-match. “These are techniques we use to get the result out of the lab as quickly as possible,” Hakim says. Newer automated features, such as auto-identification and remote dispensation, further improve safety and efficiency. “These are the areas which are more popular now because they reduce the transfusion errors to almost nil,” Hakim says.

The Puget Sound Blood Center is looking into implementing a new approach to blood delivery, where the supply is closer to the patient. The remote allocation system uses cart refrigerators in which blood is placed until it is electronically released, labeled, and delivered. “By bringing [the blood supply] closer to the patient, it reduces the possibility that [the blood] could go to the wrong patient,” AuBuchon says.

A point-of-care process also reduces turnaround time. For Puget Sound, the new methodology would replace the existing centralized system where the blood is shipped back and forth for testing. Tools on the market that can help to accomplish this range from remote storage refrigerators to intelligent remote release systems. Van Blaricum describes these more advanced systems as “vending machines for blood.”

“The machine sees a valid order and that there’s blood available for the patient. It identifies that you have the right patient and the right type of blood and sends a request to the blood bank system, wherever the blood bank is. It then performs the remote electronic cross-match and releases the blood,” Van Blaricum says, noting this happens within 60 seconds.

As the physicians’ confidence in the system and the availability of blood grows, the supply and demand patterns change to encourage greater efficiency and less waste. The need for large orders is reduced, freeing up blood bank time and eliminating inventory swings, while the blood remains stored in a safe, controlled environment and made available as needed. During times of trauma, when large amounts of blood are needed immediately and processes are shortened, some systems can provide the blood on demand and catch up documentation behind the scenes.

Improving Efficiency Through Integration

Documentation is a particular issue for blood banks as they tend to be under greater regulation than clinical and research counterparts. “Blood bank testing is regulated with a much heavier inspection and compliance focus from the US government,” Sunset says. Manufacturers must meet stricter requirements in this area (described as rigorous, lengthy, and expensive), and small changes can have a big impact (affecting scope, time, and cost).

This has, therefore, limited the number of vendors in the field. “Generally, there are two purveyors of a test in this country, and in some cases, there is only a single supplier of reagent,” AuBuchon says. This leads to difficult budgeting since prices may be impacted by anywhere from 10% to 100% and single supplier discounting is a rare option. However, cost is a major issue in health care, and today’s economy in general, so price changes are always controversial.

“Both blood and plasma establishments have historically been very science driven, but they’re spending a lot more time on improving their business processes and focusing on the supply chain. And they’re trying to drive all the efficiencies that can be realized,” Sunset says.

Van Blaricum suggests that blood banks will modify their business model from one of producing inventory for sale to producing product to meet predicted need. “We expect it to get to more of a supply chain-management type of model. Processes and systems can become more integrated to the point where they talk to each other [to predict and fulfill need],” Van Blaricum says.

Known needs can therefore always be met, an advantage since many surgeries are scheduled months in advance. STAT changes can be avoided, and rare blood types can be managed more easily. “It makes everybody, from the blood centers all the way through the hospitals to transfusion and clinicians on the floor, more productive because they don’t necessarily need to manage their orders in the same way,” Van Blaricum says.

Of course, this happens only if electronic communication is two-way, and in many instances, this connectivity is not standard. “Not many vendors have integrated LIS with the blood bank systems, so stand-alone vendors have this challenge in terms of synchronizing the database with the laboratory information systems,” Hakim says. However, having the information in one database brings advantages that include easier tracking, reporting, and data mining.

Continued Improvement with Continued Development

Of course, all development is not focused solely on systems and features. “We do believe that the search for blood-borne viruses is not over by any stretch. Active research is ongoing to identify the risk profile of many pathogens found in humans, identify any clinical impact they have on an individual, figure out how they’re transmitted, and develop new tests that may be used to detect the virus/agent and further protect the blood supply,” Sunset says.

Some tests are likely to be run based on geography. “A key trend we see right now is the regionalization of testing for agents, such as babesiosis,” Sunset says. Babesiosis is a blood-borne parasitic disease that originates with a tick bite. It is typically limited geographically, in areas similar to those at risk for Lyme disease.

“The thought is they’re going to regionalize the requirement for testing just to those states. They’re not going to require blood centers in Arizona, for example, to do testing for tick-borne viruses on 100 percent of donated blood, if at all, because the incidence is very low. So the regionalization of this testing should represent better spending of health care dollars,” Sunset says.

In addition, many industry watchers also expect that blood banks will continue to absorb more of the testing related to other materials, such as bone, tissue, tendons, and stem cells. And they expect that this testing will become more regulated. “Hospitals don’t want any risk of contaminated tissues being put into patients, and so a lot of them are turning to their blood bank because it’s used to dealing with a regulated environment,” Van Blaricum says. Mediware has built a biologics management companion system for blood banking that is aligned with requirements of both the College of American Pathologists and The Joint Commission.

As newer generations of blood and biologic materials instruments are introduced, they expand their reach. “Newer instruments are coming to the market and are affordable, so they’re penetrating smaller and smaller laboratories,” Hakim says.

Ultimately, AuBuchon expects vendors, driven by the existing safety of the blood supply, to turn their attention to pathogen inactivation. He defines pathogen inactivation as a broad term applied to any one of the several techniques that lead to the killing or inactivation of pathogens that remain in a unit of blood “because we couldn’t detect them—because they were at too low a level below the activity threshold of a test, we didn’t have a test, or we didn’t apply a test to detect them,” AuBuchon says. With such an extra step, the blood supply will be even safer. How safe will it be? Probably so safe, it will be difficult to measure.

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Renee Diiulio is a contributing writer for CLP.